2018 Events

2018 Events

There was a government shutdown, a super blue blood moon, historic midterm elections and a very American addition to the British royal family. Take a look back at the eventful year of 2018 with a review of the most important events in politics, culture, science and the environment.










Politics

Immigration crisis: In President Donald Trump’s second year in office, the issue of immigration became an even bigger flashpoint for controversy. In January, the federal government briefly shut down over the fate of an Obama-era program deferring deportation for immigrants brought illegally to the United States as children.

Under the Trump administration’s “zero-tolerance” policy against illegal border crossers, U.S. authorities separated some 2,300 children from their parents, provoking widespread international outrage until Trump ended the family separation policy by executive order in June. And in November, his administration deployed nearly 6,000 active-duty military troops to the Mexico border to meet the arrival of a large caravan of migrants from Central America.

Trump’s legal troubles: The investigation led by Special Counsel Robert Mueller into possible collusion between Russia and the Trump campaign during the 2016 presidential election handed down dozens of indictments, including charges against 12 Russian intelligence officers for cyber-attacks against Democratic officials.

Paul Manafort, former Trump campaign chairman, and Michael Cohen, the longtime aide who acted as Trump’s legal “fixer” in the case involving an alleged affair with porn star Stormy Daniels, made plea deals to cooperate with the investigation. For his part, Trump continued to denounce Mueller’s investigation as a “witch hunt,” and his firing of Attorney General Jeff Sessions increased speculation that he might be trying to shut the whole thing down.

Supreme Court battle: Judge Brett Kavanaugh, Trump’s pick to replace longtime swing vote Justice Anthony Kennedy and create a solid conservative majority on the nation’s highest court, faced a fierce confirmation battle after Dr. Christine Blasey Ford alleged that Kavanaugh sexually assaulted her when they were both teenagers.

Amid the #MeToo movement and a renewed focus on sexual misconduct, the nomination fight galvanized supporters on both sides, and brought up memories of Anita Hill’s accusations against Justice Clarence Thomas during his confirmation hearings in 1991. After both Ford and Kavanaugh testified, and after an five-day FBI investigation into the allegations, the Senate Judiciary Committee voted 50-48 to confirm Kavanaugh. It was the narrowest margin in history for a Supreme Court justice.

Midterm elections reshuffle Congress: In November, U.S. voters turned out in record numbers for a midterm election. Democrats took back control of the House of Representatives after eight years, flipping 43 seats from red to blue (three seats went the other way). Republicans retained a majority in the Senate, with a net gain of two seats.

A united Korea?: All eyes turned toward the Korean peninsula in 2018, and not just during the Winter Olympics, which were held there in February. After decades of estrangement, the leaders of North Korea and South Korea met in an historic summit in April, agreeing to an official end to the Korean War and pledging to rid the peninsula of nuclear weapons. And after trading barbs about nuclear war on Twitter, President Trump and Kim Jong Un appeared to make up. Their summit in Singapore in June marked the first-ever meeting between a U.S. president and a North Korean leader.

Ongoing conflict in Syria: The long-running civil war in Syria continued, involving forces of President Bashar al-Assad’s government, opposition rebels and ISIS, among others. In April, in response to a suspected chemical attack on the rebel stronghold of Douma that killed dozens of civilians, U.S. and other Western forces launched air strikes against government targets. As of mid-2018, more than 5.6 million Syrians had fled the country’s violence, according to the U.N. High Commissioner of Refugees.

Europe and beyond: Angela Merkel was sworn in for her fourth term as German chancellor, but announced she would be stepping aside when it ends. In less democratic news, Vladimir Putin won election to a new six-year term as Russia’s president, and China changed its constitution to remove presidential term limits, effectively allowing leader Xi Jinping to remain “president for life.”

Saying goodbye: It was a sad year for Republican nobility: John McCain died in 2018, as did both Barbara Bush and George H.W. Bush.

Culture

Meghan Markle joined the British royal family: On May 19, the biracial, divorced American actress Meghan Markle married Prince Harry, becoming a real-life princess (officially, the Duchess of Sussex). In October, the royal couple announced they were expecting their first child.

#MeToo saw some justice served: Former Hollywood powerhouse Harvey Weinstein turned himself in at a New York City police station in May to face rape and sexual assault charges. Dozens of women have come forward to accuse Weinstein of sexual misconduct over a period of decades. A Pennsylvania judge sentenced Bill Cosby to three to 10 years in prison after his conviction for aggravated indecent assault of Andrea Costand, the only one of more than 60 women who accused Cosby of sexual misconduct to see her case lead to criminal charges.

Advances for women: The Miss America pageant announced an end to its swimsuit competition, and women were allowed to drive in Saudi Arabia for the first time in history.

Two retail icons went bankrupt: Founded as a mail-order watch business in 1886, Sears filed for bankruptcy this year, marking the end of an era for many Americans who remember paging through its massive catalog. And after declaring bankruptcy late last year, the former toy giant Toys “R” Us shuttered all of its stores after more than 65 years in business.

Facebook woes: A data mining scandal involving Cambridge Analytica and the sale of data from some 50 million users, a Congressional grilling for founder Mark Zuckerberg and losing $119 billion in value in a single day all spelled a terrible year for the world’s leading social network. In other tech giant news, Apple became the first American publicly traded company to reach $1 trillion in value, and Jeff Bezos of Amazon became the world’s richest man.

National nightmare: Mass shootings at high schools in Florida and Texas, a bar in Southern California, and a synagogue in Pittsburgh, among many other places, fueled the ongoing debate about gun control and Second Amendment rights—and reinforced the presence of gun violence as a horrifying reality of American life. On March 24, hundreds of thousands of people gathered in Washington, D.C. and at sites across the country to call for tighter gun laws.

Troubled history confronted: 2018 saw the opening of the National Memorial for Peace and Justice. The memorial and museum in Montgomery, Alabama commemorates the United States' own history of slavery, lynching and Jim Crow laws.

Science and the Environment

Super Blue Blood Moon: Three lunar events coincided early in 2018 producing a rare “super blue blood moon” for the first time since 1866. The night of January 30-31 saw a total lunar eclipse (also called a “blood moon,” due to the reddish color of the moon while in Earth’s shadow) as well as a “blue moon,” or the second full moon of the month. Not only that—the moon was also at the closest point to Earth in its orbit, making it a “supermoon.”

Hurricane damage control: The 2018 Atlantic hurricane season opened in early September with the arrival of Florence, a Category 4 hurricane that battered the Carolinas and Virginia for days, resulting in some 51 fatalities. October brought Hurricane Michael, which killed 46 people across Florida, Georgia, North Carolina and Virginia. Meanwhile, Puerto Rico continued to struggle from the devastating effects of last year’s Hurricane Maria. In August, the Puerto Rican government revised the official death toll from 64 to 2,975, although some experts estimated it could be as high as 4,600.

Mission to the sun: In August, NASA launched the $1.5 billion Parker Solar Probe, its long-awaited first mission to the sun and its outermost atmosphere, the corona. After zooming by the planet Venus, the spacecraft got its first up-close-and-personal (or at least from 3.83 million miles away, by far the closest of any mission in history) look at the sun in early November. Parker will make 24 similar approaches over the next seven years.

Wildfires ravaged California: 2018 marked the most destructive fire season ever for California, with massive wildfires ravaging hundreds of thousands of acres in both the northern and southern parts of the state. In November, at least 90 people died as the Camp Fire destroyed the northern California town of Paradise, becoming the deadliest fire in the state’s history.

Dismal news on climate: In not-unrelated news, a major report from the United Nations Intergovernmental Panel on Climate Change found that Earth will warm by 2.7 degrees Fahrenheit by 2040, with dire consequences—including extreme heat, increased flooding, wildfires. drought, food shortages and poverty. Adding to the grim prognosis, a report by numerous U.S. federal government agencies released in November argued climate change will reduce the U.S. economy by 10 percent by 2100, including a $141 billion cost from heat-related deaths.

Sources

“Timeline: Immigrant children separated from families at the border,” USA Today, updated July 25, 2018

“Trump Is Expected To Extend U.S. Troops' Deployment To Mexico Border Into January,” NPR, November 28, 2018

“‘Mueller knows a lot': Manafort and Cohen moves put Trump in line of fire,” Guardian, December 1, 2018

“Kavanaugh Is Sworn In After Close Confirmation Vote in Senate,” New York Times, October 6, 2018

“The 2018 Elections Saw Record Midterm Turnout,” Time, November 13, 2018

“What’s Happening in Syria”, BBC, April 16, 2018

Syrian War Fast Facts, CNN, May 3, 2018

“In pictures: President Trump meets Kim Jong Un,” CNN, June 2018

“China's Xi allowed to remain 'president for life' as term limits removed,” BBC, March 11, 2018

“Harvey Weinstein surrenders to NYC police, is charged with rape,” NBC News, May 25, 2018

“Facebook just had the worst day in stock market history,” CNN Money, July 26, 2018

“Apple hangs onto its historic $1 trillion market cap,” CNBC, August 2, 2018“

Jeff Bezos Becomes the Richest Man in Modern History, Topping $150 Billion,” Bloomberg, July 16, 2018

“The Super Blue Blood Moon Wednesday Is Something the US Hasn't Seen Since 1866,” Space.com, January 30, 2018

“Puerto Rico increases Hurricane Maria death toll to 2,975,” BBC, August 29, 2018

“NASA Solar Probe Flies By Venus on Its Way to 'Touch' the Sun,” Space.com, October 3, 2018

“Stanford experts reflect on the most destructive fire season in California history,” Stanford News Service, November 29, 2018

“Major Climate Report Describes a Strong Risk of Crisis as Early as 2040,” New York Times, October 7, 2018

“Major Trump administration climate report says damage is ‘intensifying across the country,’” The Washington Post, November 23, 2018


What Will History Books Say About 2018?

At the end of last year, POLITICO Magazine asked historians if 2017 had been the craziest year in American politics. That was before 2018, when several of President Donald Trump’s onetime cronies were indicted for financial crimes, when rapper Kanye West delivered a soliloquy in the Oval Office and when an accidental alert had Hawaii residents convinced nuclear missiles were inbound for a full 38 minutes. That was before one midterm election and three government shutdowns, before the Trump administration ordered migrant children be separated from their parents at the U.S.-Mexico border and before the president’s historic meeting with North Korean leader Kim Jong Un. It was before the Brett Kavanaugh hearings, and before 13 federal agencies issued a dire report on climate change that the White House attempted to bury.

How will history remember this wild year? Which events were significant and which were distractions? POLITICO Magazine asked the smartest historians we know to put all that happened over the past 12 months in its proper historical context—by literally writing the paragraph that history books of the future will include about 2018. Here’s what they had to say:

The year of distraction
Joseph J. Ellis is the author of American Dialogue: The Founders and Us.

It is difficult to believe, but exactly a century ago, in 2018, the American media was obsessed with the fractured and frivolous presidency of Donald Trump.

Unmentioned, what they might have called “unbreaking news,” were the following movements in the historical templates fated to shape our own world: the ascendance of the Asian Empire, then called China the crisis of confidence in all three branches of the federal government, which led to the calling of the Second Constitutional Convention and our current American Confederation the accelerating erosion of the Greenland glacier, which eventually forced the evacuation of our coastal cities.

For all these reasons, 2018 has come to be called “The Year of Distraction.”

The end of American exceptionalism
Jacqueline Jones is a professor of American history at the University of Texas at Austin, and author, most recently, of Goddess of Anarchy: The Life and Times of Lucy Parsons, American Radical (2017).

The year 2018 was reckoning time for those stubborn optimists who believed that the end of the Cold War would inevitably bring a more prosperous, interconnected world. At the dawn of the 21st century, free trade, advanced technology and social media seemed to hold great promise as engines of worldwide peace and security. By 2018, however, the global economy was enriching a few and consigning the many to ill-paid jobs. Social media users sought to undermine free elections at home and abroad, and fanned the flames of hate and division via Facebook, Twitter and Instagram. The late 20th-century ideal of a world moving inexorably toward universal human rights and the eradication of poverty crumbled under the weight of terrorist attacks, civil wars, massive displaced populations, and environmental disasters such as droughts, wildfires, hurricanes and floods. Meanwhile, enemies of democracy joined with reactionaries to embrace authoritarian “strong men” who vowed to bring order out of chaos and restore nations to their mythical former glory.

In 2018, striking, irrefutable evidence of this encroaching revanchism appeared in the piece-by-piece dismantling of the American “city upon a hill” story—the notion that the United States represented a beacon of enlightenment and progress in a craven world. Many Americans seemed willing to accommodate themselves to the casual destruction of values and institutions that the country had long claimed were proof of its own “exceptionalism.” President Donald Trump, buoyed by the cult-like devotion of his Republican base, mocked the principle of a free press, calling journalists “the enemies of the people.” He tried to treat the Department of Justice as his personal law firm, and dismissed the idea that truth and facts should be honored as standard currency in political discourse. Trump openly ridiculed people of color as “low-IQ individuals,” and called for the jailing of his political opponents. He took credit for the stock market when it was up, and blamed the head of the Federal Reserve when it was down. He cozied up to dictators and prioritized money and arms deals over human life. He scorned science and declared climate change a “hoax,” opening the way for the despoiling of land, air and sea. Though erratic, petulant and willfully ignorant, he held in his thrall even the most powerful Republican lawmakers, who were terrified that someday he might “primary” them. The traditional narrative of the United States as a noble world leader and defender of human rights was slipping away, and by the end of Trump’s second year in office, the country was in danger of sliding into a garden-variety authoritarianism. To paraphrase the historian Henry Adams, the progress of evolution from President Lincoln to President Trump was alone evidence enough to upset Darwin.

Insignificant, or an earthquake—depending on 2020
H. W. Brands teaches at the University of Texas at Austin. He is the author of Andrew Jackson and other works of American history.

Scenario A (Donald Trump was not elected to a second term):

The year 2018 was full of sound and fury signifying, in the end, very little. Trump’s boorish model of leadership was repudiated by voters at the first opportunity, and his polices on trade, international security, immigration and the environment were sooner or later undone.

Scenario B (Trump was reelected to a second term):

The year 2018 marked the moment when America’s abdication of its role of leadership in the world, begun in 2017, grew more pronounced and irreversible. Trump called into question or flatly rejected America’s commitments to its allies, to free trade, to the rule of law, to democratic norms and to a global effort to avert the most dire consequences of climate change. He made America, in the eyes of much of the rest of the world, a rogue state. The president of the United States had long been the most consequential person in the world that distinction shifted to the president of China in 2018. The world has never been the same.

When we saw the fault lines after the earthquake
Nicole Hemmer, assistant professor of presidential studies at the Miller Center at the University of Virginia and author of Messengers of the Right: Conservative Media and the Transformation of American Politics.

In 2016, a political earthquake hit the United States. In 2018, we got our first real look at the fault lines it exposed and the extent of the damage that it did.

In the midterm elections, women’s rage transformed into women’s power as historic numbers of women, almost all of them representing the Democratic Party, won congressional seats. That blue wave came on the heels of Brett Kavanaugh’s sexual assault accusations and Supreme Court confirmation, an event that drove even more women into the Democratic camp—while driving even more men into Trump’s.

Democratic Rep.-elects Alexandria Ocasio-Cortez (N.Y.), Debbie Mucarsel-Powell (Fla.), Abby Finkenauer (Iowa) and Sharice Davids (Kansas) pose for the 116th Congress members-elect group photo. They are a part of the record number of women elected to Congress. | Mandel Ngan/AFP/Getty Images

The election also took place against the backdrop of escalating hate crimes against people of color, Jews, and women, including the deadliest anti-Semitic attack in American history. While progressives organized to transform the face of American politics—electing the most diverse set of officials in the nation’s history—the administration set out to fulfill its restrictionist vision, separating migrant families, erecting detention camps at the border and using teargas on refugees. At the end of 2018, both parties had organized a clear response to 2016’s earthquake—responses that could not have been more different.

The moment the parties switched their bases
Geoffrey Kabaservice is director of political studies at the Niskanen Center and the author of Rule and Ruin: The Downfall of Moderation and the Destruction of the Republican Party.

Half a century later, 2018 stands out as the point at which it became evident that the Republican and Democratic parties had switched their political bases. The 2016 elections already had confirmed that the white working class—the foundation on which New Deal liberalism was built—had become overwhelmingly Republican. But the 2018 midterms gave the first real indication that Donald Trump’s self-destructive presidency, combined with conservative ideological zealotry in Congress, had broken the long-standing GOP loyalty of college-educated, suburban voters, and that this group would reliably support Democrats going forward. It would take several more electoral cycles for the implications of this switch to become obvious. But by 2036, the Democratic Party—whose middle- and upper-class constituents were deeply disturbed by the impending threat of national bankruptcy—had become the fiscally conservative party. The Republicans, meanwhile, had become the party more supportive of government spending—so long as that spending was on universal social benefits like Social Security and Medicare, as well as the spending programs that were the sole economic lifeline for the 30 percent of the population that still lived in the semi-inhabited small towns and environmentally ravaged rural areas of the American heartland. The peculiar arithmetic of the Electoral College meant that Republicans still commanded supermajorities in the Senate, even though Trump had been the last Republican to occupy the White House. But the Grand Bargain of the 2030s rallied the whole country around the slogan, “Build the Walls!”—the massive seawalls, constructed mostly by the white working class of the heartland, that saved the coastal cities from inundation by rising oceans.

The decline of America’s dominance
Michael Kazin is a professor of history at Georgetown University and co-editor of Dissent. He is currently a member of the School of Social Science at the Institute for Advanced Study at Princeton where he is writing a history of the Democratic Party.

The slow decline and eventual fall of America’s dominance in the world began with its debacle in Indochina 50 years earlier. But that decline accelerated in 2018. A delusional president who thought his daily threats and boasts could replace shrewd diplomacy was unable and unwilling to prevent China from expanding its markets and influence in East Asia and Africa. Meanwhile, authoritarian leaders in such nations as Hungary, Russia and Iran aggressively carved out their own spheres of influence, undeterred by protests emanating from the State Department and Congress. Dismissive of climate change, Trump’s actions also made that problem a good deal worse, although the massive flooding in Miami Beach, Cape Cod and Norfolk that caused millions to flee those areas in 2021 did not begin until after the president left office. In his one unhappy term in the White House, the man who vowed to “Make America Great Again” made it less powerful and persuasive around the globe and more vulnerable to environmental damage at home.

When we realized the past isn’t so past after all
Lizabeth Cohen is the Harvard University Distinguished Service Professor and Howard Mumford Jones professor of American Studies, Department of History.

The year 2018 was notable for giving many Americans a living lesson in history. Let me explain what I mean with two examples. For many of us, our understanding of the deep divisions that led our nation to Civil War in the 1860s is based on textbook explanations of the irreconcilable differences of the past: disputes over the fate of African-American enslavement or the extension of slavery into the territories or what kind of economic future the United States would have—a manufacturing-based one dictated by the North or a market-oriented agricultural alternative desired by the South. Suddenly, the election of Trump in 2016 and the two years of his presidency that have followed, particularly the last year, have thrust many of us into the reality of living in a nation severely divided. Certainly, we already knew that there were red and blue Americas, and divergent rural and urban experiences and opportunities. But few of us had any idea how deep were those cultural chasms, how intense were those economic resentments, how sharp were those political disagreements. And both the new social and the traditional media—ranging from Fox to MSNBC—have caricatured and then amplified these distinctive worldviews, creating echo chambers in which our disagreements reverberate and louden. The United States is not on the brink of another civil war—there are still values and commitments that continue to unite us as Americans and institutions like the courts that put checks on the screaming matches. But some days it feels like we are close, particularly when it’s a day when Trump chooses to fuel the divides between his “base” and his enemies, immigrants and “real” Americans, blacks and whites.

A two-year-old Honduran asylum seeker cries as her mother is searched and detained near the U.S.-Mexico border in June 12 in McAllen, Texas. The photo went viral as a representation of the Trump administration's family separation policy. | John Moore/Getty Images

The other example I would point to is how recent events have shocked many of us into realizing that we can no longer assume that “it can’t happen here,” that the United States is somehow immune to the kind of fascism that arose in Nazi Germany and traumatized the world in the mid-20th century. Here, too, it had been easy to distance ourselves from the past, from the kind of xenophobic, nationalistic and anti-Semitic fervor that had plagued Europe, in particular Germany. But as we have lived through events like the frightening white nationalist march in Charlottesville, the cruel family separations at the Mexican border, the brutal synagogue shooting, the racially motivated killings (including by law enforcement), the deliberate voter suppression, the attacks on a free press, and more, it suddenly seems possible that American democracy too could be seriously jeopardized. And were that to happen, we the American people would have no one to blame but ourselves. As we move into 2019, let us hope that we can learn, in Abraham Lincoln’s words, to be touched “by the better angels of our nature” and reconnect with American aspirations for tolerance, compassion, morality and equality under the law. It is commonplace to say that knowing history helps us understand the present. Today, the present may also be helping us to better understand the past—and to heed its warnings.

A Manichean year of rage and violence
Bradley Birzer is a history professor at Hillsdale College.

The United States of America—the most noble attempt at an ordered and free republic since the beheading of the Roman Cicero in 43BC—had not been so polarized since 1968, a full half century earlier. Led by a mercurial president, known more for his passions than his restraint, the people of America found themselves awash in a whirligig of dualistic propaganda, country against city, race against race, gender against genders, and party against party. It was though the ancient Christian heresy of Manicheanism—that which had posited evil the co-equal of good—had once more reared its divisive head. Not surprisingly, the streets of major cities were as violent in action as were the screams in the halls of government. The extremes of left and right predominated, each filled with hatred and rage. Rarely had a people been so strongly at odds with themselves. Though America had found itself the sole world power in 1991, the years following were years of the “forever war,” mostly waged against the peoples (innocent and not) of the Middle and Near-east. There seemed no end of history. As the country militarized abroad, it militarized at home, war becoming the habit of its people. Niggling away at a myriad of conflicts and restless at home, America felt the challenge of other powers in 2018—such as Russia, China, North Korea, and Iran. America’s time had seemingly come and gone. The next few years would prove decisive as America decided whether or not to lead by example or force.

A pivotal year for the American worker
William P. Jones is a professor of history at the University of Minnesota.

2018 was a pivotal year in the history of American workers, both in deepening a half-century-long erosion of income, labor rights and political power and in the rise of new forms of organization and mobilization aimed at addressing those same trends. The year opened with speculation about the potential impact of Janus v. AFSCME, a Supreme Court case that, as expected, delivered a blow to the ability of unions to represent public employees. Coupled with administrative decisions weakening protections for independent contractors, workers employed by franchises and federal employees, and open attacks on immigrant workers, the year saw a continuation of trends going back to the 1970s. Paradoxically, however, 2018 also saw a resurgence of working-class activism that promised to reverse those patterns. Most dramatic was the strike by thousands of teachers in West Virginia, followed by similar protests in Oklahoma, Arizona, Kentucky, North Carolina, Georgia and Colorado. Emerging in conservative states known for low wages and weak labor laws, those actions demonstrated that legal setbacks would not necessarily spell the end of organized labor. Workers also displayed renewed militancy in places where unions were strong: striking against Marriott hotels in Massachusetts, Michigan, California and Hawaii winning recognition for unions of teaching assistants and contingent faculty at Harvard, Columbia and other colleges and forcing Amazon to negotiate with Somali immigrant warehouse workers in Minnesota. Finally, unions mobilized politically defeating Scott Walker, the anti-union governor of Wisconsin, and helping elect a pro-union senator, Jacky Rosen, in Nevada. And increased militancy did not seem to damage the public image of organized labor. Late in 2018, a Gallup poll found that 62 percent of Americans approved of labor unions, up from 56 percent in 2016 and just 48 percent in 2009. After a 50-year decline, the union representation rate held steady and the total number of union members increased.

Trump fiddled while the climate burned
Elizabeth Cobbs is professor of American history at Texas A&M University and the author of The Hello Girls: America’s First Women Soldiers.

American politics in 2018 were characterized by a colorful blur of human activity: the #MeToo Movement, the Mueller Investigations, the confirmation of a Supreme Court justice accused of sexual misconduct and Trump’s declaration that he is “A Tariff Man.” At the global level, nature took center stage. Weighed against five millennia of recorded events, the big story was humanity’s failure to slow climate changes that flooded coastal habitats, sparked fires in dry inland areas, sped the extinction of flora and fauna and devastated food crops. The United States attracted special condemnation as the largest producer of greenhouse gases behind China and greatest consumer of beef behind Australia. American historians focus on domestic squabbles of the era, but world historians highlight the melting of Alaska while Trump opened new public lands to oil exploration, reduced the size of national parks and waived protections for endangered species. They also point to record-breaking wildfires sparked by drought, and note the parallel to ancient history: Trump fiddled while California burned.

The fight between authoritarianism and democracy
David Greenberg is a professor of history and media studies at Rutgers, and author of Republic of Spin: An Inside History of the American Presidency.

In 2018, the fight to beat back populistic authoritarianism and uphold liberal democracy ground on, with no resolution. Countries worldwide elected populists of the left (Mexico) and the right (Italy, Brazil) in Russia and Turkey, Putin and Erdogan shored up power once-free Eastern European nations like Hungary and Poland slouched toward fascism reformist hopes in North Korea and Saudi Arabia were dashed. In the U.S., Donald Trump oversaw unending chaos and mendacity, provoking an onslaught of outrage that dispelled worries that his norm-breaking would be normalized. Still, Trump confirmed fears that his reckless hypernationalism amounted to a break from the older Reagan-Bush conservatism—even as most Republicans followed him down his treacherous path. He provoked controversies with his reactionary, heartless immigration policies, clumsy trade wars and shortsighted abandonment of international protocols. Throughout America, a rising intolerance of political difference led to firings, suppression of speech and ugly public confrontations. And mad violence, from Parkland to Pittsburgh, showed how easily rage was now proving lethal, even commingling with ancient hatreds like anti-Semitism. As the year closed some big indicators—abrupt volatility in an otherwise strong economy, Robert Mueller’s prosecutorial doggedness, Democratic election triumphs—signaled that Trump’s strength might be ebbing. But in Europe, the three hitherto-solid Ms of stability—Merkel, May and Macron—faced major crises of legitimacy, offering paltry grounds for confidence that, come 2019, the center would hold.

A revolt against Republican control
Heather Cox Richardson is a professor of American history at Boston College.

2018 marked a pivotal year in the demise of the political era that began in 1981 with the election of Ronald Reagan. For a generation, Republican leaders had tried to kill New Deal-era government policies that regulated business, protected social welfare and promoted infrastructure. In 2018, in control of Congress and the White House, they enacted their agenda. Congress slashed taxes for the very wealthy, while the Trump administration gutted government regulation and tried to destroy the Affordable Care Act. Since 1981, Republicans had argued that the taxes necessary to pay for an active government simply redistributed money from white men to undeserving minorities, and in 2018, Americans watched attacks on minorities escalate as the Trump administration called immigrants terrorists and incarcerated refugee children in camps, killing at least one. Finally, in October, the administration forced through the Senate confirmation of the highly controversial Supreme Court nominee Brett Kavanaugh, who had been credibly accused of sexual assault and whose previous political record was largely concealed during the nomination process. This inspired widespread anger at what appeared to be an attempt to pack the judicial branch for Republicans in violation of norms and precedents. The extremes of the Republican Party inspired grassroots opposition, especially among women and people of color, and the 2018 midterms were a wave election that flipped 39 seats and put women in two-thirds of them. Overall, 2018 resembled the pivotal year of 1856, when a revolt against the Democratic Party’s control of the federal government in the interests of wealthy Southern slaveholders prompted Americans to reject the Democrats and begin the process of taking their democracy back.

The year Trump broke the mold
Meg Jacobs teaches history and public affairs at Princeton University.

The year 2018 was when American politics pivoted. At the time, it appeared that Trump took a beating in the midterms, surely in the House, and his approval ratings remained stuck at a low level. Each day the chief executive found himself in greater and greater legal jeopardy. By the end of the year, with some of his chief advisers accepting plea deals for their illegal campaign activities and with Democrats ready to assume their majority standing in the House, it appeared that Trump’s days in office were numbered.

Yet, in hindsight, 2018 turned out to be the moment when Trump finally broke the mold of American politics, a fissure that was in the works for decades. Despite all the indications of declining popularity and rising political vulnerability, Trump remained standing. His durability suggested that, in an age of polarization exacerbated by the fracturing of the media, the traditional markers of political success no longer applied. As a candidate and then as a president, even one under siege, Trump appreciated that no longer did he need to be loved by all or even by a majority of the public, no longer were there consequences to having your own version of the truth, and no apologies were necessary for what half the country, if not more, thought of as unpresidential, if not illegal, behavior.

A large part of why Trump won his election and, by his own measures continued to succeed in his first two years in office, was because he knew how to appeal to his segmented base. | Drew Angerer/Getty Images

What mattered most in 2018 was playing to the loyal Trumpian base that voted for the GOP in 2016 and turned elections in Trump’s favor. While the GOP lost the House midterms and Trump’s fearmongering, Twitter-based outreach backfired in many districts that flipped in favor of the Democrats, the president chose to double-down on a race-based strategy of stirring up anxieties and animosities as part of his populist appeal to white working class Americans. To the extent that the rest of the GOP appreciated the president’s support of tax cuts, deregulation and other standard Republican policies and felt that this approach would deliver the White House again in 2020, they stuck with him.

It is not that Trump was the true Teflon president—rather, he governed in a polarized media-driven atmosphere in which many of the norms were changing. He himself helped to rewrite the rules of the game and no one excelled better than he in controlling the news cycle and even generating the cycle. A large part of why Trump won his election and, by his own measures continued to succeed in his first two years in office, was because he knew how to appeal to his segmented base.

When The Apprentice was a hit TV show, it was not for everyone. But millions of fans loved it. Until they didn’t. The downside of a media-based presidency, premised on securing ratings just high enough to hold your audience, was that like the TV show that made him famous, he, too, could jump the shark. While Republicans remained loyal to Trump throughout the year, they had to consider how long to stick with the president before tuning in to a different show, where the cameras turned on the star and they said “you’re fired.” Either way, 2018 proved that Trump could stir hatreds, engage in intentionally shocking and possibly treasonous behavior, whip his supporters into an appreciative frenzy, and yet command support among Republicans. While historians might cringe, the base got exactly what it wanted, and Trump started 2019 thinking ahead to his 2020 reelection campaign.

The year of cruelty
Mary L. Dudziak is the Asa Griggs Candler professor of law at Emory University School of Law.

2018 will be remembered as the year of cruelty. The United States separated thousands of migrant children from their families and created prison camps for them. The country aided Saudi Arabia’s war in Yemen resulting in a humanitarian catastrophe seen in images of starving children. Trump refused to sanction or even criticize Saudi Crown Prince Mohammed bin Salman for the brutal murder of journalist Jamal Khashoggi. Trump told Californians devastated from the loss of homes and loved ones to fire that the tragedy was, in essence, their own fault. He said the same to victims of mass shootings. The list goes on and on—there is too much cruelty for one paragraph. Congress, and the American people, aided the president’s cruelty by failing to do whatever it would take to stop him.

Liberal democracy vs. Trumpism
Richard Steigmann-Gall is a history professor at Kent State University.

Many historians of fascism wondered whether 2018 would see a Reichstag Fire moment, when Trump would confect a national emergency or take advantage of a real one, to consolidate dictatorial power. That did not transpire. In fact, the liberal constitutional state continued to function, with a remarkable election result in the midterms, which can reliably be understood as a reassertion of parliamentary power in the face of a strongman presidency. However, it was a mistake to construe Trump’s failures to consolidate fascist power for a lack of ambition to be a fascist. However well the liberal constitutional state still functions, it was very much in spite of Trump, not because of him. His closest White House advisers—especially Stephen Miller—as well as his fellow travelers in the media, pushed Trump to scornfully defy the rule of law whenever he could. Trump showed no interest in the consensus that is the basis of a true parliamentary democracy, choosing instead time and again to impose his will by fiat until stopped by the legislative or judiciary branches. We could not describe the U.S. government in 2018 as “fascist”—but those who failed to recognize Trump’s fascist aspirations continued to underestimate the danger of Trumpism.

2018 and the Turning of the Tide?
Timothy Naftali is a history professor at New York University and co-author of Impeachment: An American History. From 2007 to 2011, he directed the Richard Nixon Presidential Library and Museum.

In the year 2018, the Earth continued to warm, with greenhouse gases reaching their highest level ever. In the greater scheme of things those data points may ultimately matter most. But when thinking of years instead of decades or centuries, 2018 saw the intensification of the struggle in the developed world between the ideas and movements associated with modernity—of which worrying about climate change is a part—and the forces of reaction, largely defined by nativism, protectionism and an aversion to science. In the United States, the struggle largely centered on the id and reputation of one man, Donald J. Trump, a provincial New York City developer and reality TV star, who won a hard-fought campaign in 2016 by a total of less than 100,000 votes in three key states.

Over the course of 2018, the U.S. government experienced more turmoil at its highest level that at any time since the Watergate-sodden year of 1973. Trump forced out his secretary of State, secretary of Defense, attorney general, national security adviser, chief of staff and secretary of Interior. Meanwhile, his personal lawyer in the White House, the White House counsel, the director of the National Economic Council, the director of White House Communications, the director of the Environmental Protection Agency and the permanent U.S. representative to the United Nations also chose to leave.

North Korean leader Kim Jong Un and President Donald Trump shake hands during their June summit in Singapore, the first time a sitting U.S. president met with a leader from the country. | Anthony Wallace/AFP/Getty Images

In foreign policy, the collapse of Trump’s first national security team heightened the significance of the whims of the occupant of the Oval Office. As a result, for the first time since 1945, the United States was like an aircraft carrier with three of its four propellers broken. Many of those fired or forced out had tried to preserve some of the traditional U.S. commitment to a liberal security environment by softening or redirecting the president’s preference for an amoral, transactional, protectionist and unilateral approach to the world. In each case, Trump prevailed. The vanity and stubbornness that prevented him from taking domestic advice, however, made Trump a soft target for foreign flattery. After berating and baiting North Korean dictator Kim Jong Un early in the year, Trump abruptly changed course and ushered in a love fest at a summit in Singapore. Neither approach moved Kim toward unilateral nuclear disarmament as predicted by Trump. At a joint news conference a month later, Trump embraced Russian President Vladimir Putin’s worldview in—at best—a childish attempt to show his domestic fans that the U.S. intelligence community, which consistently warned (and leaked) about the Kremlin’s malevolent intentions, was not getting the better of him. At the end of the year, Trump did favors for both the strongmen of Saudi Arabia and Turkey. Excusing one for killing dissident journalist Jamal Khashoggi on Turkish soil and then paying off the aggrieved Turkish leader by withdrawing U.S. troops from Syria to allow him to finish off his enemies—the Kurds—there. In both cases, Trump’s willfulness signaled the strategic and moral bankruptcy of U.S. leadership. Meanwhile, China fought back against Trump’s reflexive steel tariffs by targeting industries critical to Trump’s electoral base, later contributing to historic Democratic gains in the farm belt. Even allies figured out how to play the Child-Emperor. Both Mexico and Canada convinced Trump that by renaming the North American Free Trade Agreement and making microscopic changes he could declare victory on that front, despite having repeatedly called NAFTA “perhaps the worst trade deal ever made” and promising to tear it up. As Trump raged at the world and came up empty, the deaths this year of Senator John McCain and former President George H.W. Bush, both lions of U.S. global responsibility, put a fine and solemn point on this historical moment being, at least temporarily, the close of a 75-year era of U.S. foreign engagement.

In the first year of the Trump crisis, observers—including this historian—had hoped that senior presidential advisers, nonpartisan civil servants and traditionally Republican congressional leaders would be willing and able to contain the worst instincts of the novice president. The second year showed that the most effective containment would have to come from newly empowered Democrats, the judiciary and the results of the ongoing Mueller investigation. In the November midterm elections, some of the political laws of gravity had held and public revulsion toward Trump translated into a blue wall of support, allowing Democrats to win about 40 House seats and take the majority. Although the year saw Trump put a second justice on the Supreme Court—whose confirmation hearing highlighted the sectarian fervor of Trump supporters who passionately embraced a deeply flawed human being for a lifetime appointment—he had no more success with the third branch of government in 2018 than in 2017. Indeed, in 2018 the judiciary buttressed the work of the Mueller inquiry, arguably the institution that most symbolized that the U.S. constitutional system was not buckling under Trump. Despite a torrent of invective from the president, the former FBI Director Robert Mueller and his team of nonpartisan lawyers continued their investigation of Russian influence in the 2016 election. The indictment and sentencing of the Trump family lawyer, Michael Cohen, would not have been possible in the authoritarian regimes that the president so admired. In Turkey, Russia or Saudi Arabia, it would be the prosecutor who disappeared to a cell or worse. But in the United States, despite Trump, it was not only Cohen who faced justice but prosecutors left breadcrumbs leading to the Oval Office itself.

As the year ended, the victory of the Democratic Party in the midterm elections (with its promise of subpoena-led investigations and accountability), the hollowing out of the Trump regime, the president’s consistently low approval ratings, and the possibility that the Mueller inquiry would produce evidence of Trump as an unindicted co-conspirator either in financial crimes or collusion with Russia signaled for some observers that the tide in the United States, at least, had turned against the nativist wave of 2016. On the other hand, there was no reason to believe that the dark populism of Trumpism was fading outside American cities and suburbs or that Trump and his acolytes were doing anything but digging in for a long struggle, whatever the political, human or economic costs to the nation or the world.

Tech disrupted
Maragaret O’Mara is a history professor at the University of Washington.

By the end of the 21st century’s second decade, America’s largest technology companies had amassed wealth and influence impossible to imagine at the dawn of the digital age 70 years before. With user bases in the billions, market capitalization in the trillions, and products and platforms that had become ubiquitous and essential tools for modern life, Big Tech had disrupted nearly every other business sector and become celebrated as a shining example of American innovation and entrepreneurship.

The mood changed abruptly in 2018, amid a cascade of new revelations about the role of social media and other internet platforms in fueling the era’s political discord. Both in a fractious United States and in fragile and volatile democracies overseas, the open and connected platforms of techno-optimistic Silicon Valley had become weaponized in ways that their creators had never intended. It was hardly the first time that a new communications medium had been accused of upending politics—newsprint, radio and television had been vulnerable to nefarious influences when they too were new on the scene—but the scope, speed and scale of online media dwarfed all that came before.

With cooling sentiment about some tech products came also a new skepticism toward big tech companies that made them. After decades of wanting to become the next Silicon Valley, cities started to look at tech’s presence with new wariness. When online giant Amazon concluded its headline-making search for a second headquarters city by announcing that it would locate tens of thousands of workers in New York City and suburban Washington D.C. (receiving billions in local tax incentives in exchange), the news was greeted with as much trepidation as celebration.

The extraordinary reach of these remarkably young and market-defining firms—Facebook was 14 years old in 2018, Google was merely 20—recalled the rapid-fire growth of the great oil, steel and railroad trusts in the late 19th century’s Gilded Age. And 2018’s freshly combative stance toward tech in the nation’s newsrooms and its corridors of political power recalled the growing calls for reform in the early 20th century’s Progressive Era. Would Washington once again increase its regulatory power and flex its antitrust muscle to curb the power of big business as it did in the age of Teddy Roosevelt and Woodrow Wilson? Our textbook’s next chapter will hold the answer.


Ten Most Significant World Events in 2018

You aren’t alone if you’re feeling worn down as 2018 comes to a close. It’s been a trying year when it comes to the world scene. A seemingly unending parade of summits, crises, protests, and conflicts dominated the news. Below is my list of the top ten world events of the year, listed in descending order. You may want to read what follows closely. Several of these stories will continue into 2019.

10. Democrats Win Back the House. Republicans and Democrats both came away from the November midterms elections with something to brag about. Democrats, though, secured the bigger victory. Republicans picked up two seats in the Senate, meaning they will continue to have the final say on President Donald Trump’s judicial and cabinet appointments. Democrats, by contrast, picked up forty seats on their way to regaining control of the House. It was the Democrats’ biggest seat gain since the iconic Watergate class of 1974, and it came because Democratic House candidates outpolled their Republican counterparts by a record eight percentage points. When the 116 th Congress opens for business on January 3, Democrats will chair House committees and decide the agenda. Democrats likely won’t succeed very often in directly overturning Trump’s decisions, whether at home or abroad. That in most instances requires them to reach agreement with the Republican-controlled Senate and override a Trump veto. But they will be able to block him on issues requiring their consent, like funding for a wall on the U.S.-Mexico border. They will also use their oversight powers to highlight their disagreements with the White House, potentially putting public pressure on Trump to reverse course. So the biggest consequences of the 2018 elections have yet to be felt.

9. Humanitarian Crises Deepen. Venezuela and Yemen were sad stories in 2017. Things only got worse in both countries in 2018. Over the past four years an estimated 2.3 million Venezuelans have fled the country millions more have stayed behind and face grinding economic hardship. The cause of Venezuela’s collapse has been the mismanagement of the economy, first by Hugo Chávez, and then by Nicolás Maduro. Both men also attacked and dismantled Venezuela’s democratic institutions. Maduro won reelection in May in a rigged vote and shows no signs of retreating from policies that have brought Venezuela sky-rocketing inflation, water and electrical shortages, and growing rates of malnutrition. The Yemeni civil war entered its fourth year in 2018. Yemen now holds the dubious distinction of being the world’s worst humanitarian crisis. As many as fourteen thousand Yemenis have died in the fighting, and fifty thousand or more are thought to have died because of a war-induced famine. The horrifying photographs of emaciated Yemeni children have not persuaded either side to lay down their weapons. Meanwhile, humanitarian crises in the Central African Republic, Congo, Syria, and South Sudan, among other places, continue to grind on. It seems like ages since world leaders embraced the principle of a responsibility to protect.

James M. Lindsay analyzes the politics shaping U.S. foreign policy and the sustainability of American power. 2-4 times weekly.

8. Ethiopia Signs a Peace Deal with Eritrea. Not all news in 2018 was bad. In June, new Ethiopian Prime Minister Abiy Ahmed surprised the world by announcing he would accept a peace deal with Eritrea that had been gathering dust for eighteen years. The two countries fought a twelve-year long war that ended in 2000 with nearly eighty thousand dead. In July, Ahmad traveled to Asmara to meet Eritrean President Isaias Afwerki and sign the peace deal. Both countries have now reopened embassies in each other’s capitals, resumed commercial air traffic, and begun demilitarizing their joint border. Besides agreeing to peace, Ahmed instituted significant reforms at home, freeing political prisoners and ending Ethiopia’s state of emergency. Some experts hope that the peace deal might undermine Afwerki’s authoritarianism in Eritrea, which is sometimes dubbed “Africa’s North Korea.” Perhaps. What is clear is that Eritrea has moderated its foreign policy, signing peace accords with Somalia and Djibouti that ended long-running border disputes with the two countries. In response, the United Nations Security Council lifted an arms embargo on Eritrea. With some luck and smart political leadership, peace on the Horn of Africa could boost the region’s economic development as well.

7. Trump’s Summitry Alarms Friends and Delights Foes. Donald Trump campaigned pledging to do different things in foreign policy and to do them differently. His summit meetings in 2018 showed him to be a man of his word. He spent the G-7 summit in Quebec in June berating other leaders for their country’s trade policies, left the meeting before it ended, and tweeted from Air Force One that he wouldn’t sign the communique he had agreed to before he left. He then went to Singapore where after five hours of meetings with North Korean leader Kim Jong-un he signed a vague, four hundred word communique and declared that “there is no longer a nuclear threat from North Korea,” despite abundant evidence to the contrary. At the NATO summit in July, Trump accused German Chancellor Angela Merkel of being “totally controlled” and “captive to Russia,” demanded an emergency session so he could push NATO members to spend more on defense, and suggested he might take the United States out of the alliance if he didn’t get his way. Days later at a joint press conference in Helsinki with Russian President Vladimir Putin, Trump seemingly rejected the unanimous assessment of the U.S. intelligence community that Russia had interfered in the 2016 election, triggering stinging bipartisan criticism back home. In November, Trump criticized French President Emmanuel Macron in a tweet as he was arriving in Paris for ceremonies to mark the centennial of the end of World War I, canceled a visit to an American military cemetery because of rain, and declined to attend a peace forum the French government hosted. Trump’s final summit meeting of the year, though, the G-20 summit in Buenos Aires, was uneventful. That prompted news stories speculating about why he hadn’t been disruptive.

6. #MeToo Movement Goes Global. The #MeToo movement took off in the United States last year in the wake of the sexual abuse allegations against Hollywood producer Harvey Weinstein. In 2018, the movement went global as millions came forward to share their stories. In Italy the movement became #QuellaVoltaChe (“that time when”), in Spain it is #YoTambien, in France it is #BalanceTonPorc (“squeal on your pig”), and in Arab-speaking countries it is #AnaKaman. According to analytics from Google, searches related to #MeToo and its variants remain high around the world, and the 2018 Nobel Peace Prize was awarded jointly to Congolese physician Denis Mukwege and Yazidi assault survivor Nadia Murad “for their efforts to end the use of sexual violence as a weapon of war and armed conflict.” The precise form the #MeToo movement has taken and the success it has achieved have varied across countries and regions as legal, political, economic, and cultural conditions have differed. China, Russia, and sub-Saharan Africa are among the places where the effort to highlight and end sexual abuse and harassment hasn’t taken off. But elsewhere #MeToo has highlighted specific instances of abuse and harassment by powerful figures and ordinary people alike. The question now is whether the #MeToo movement will make a lasting difference. For that to happen, governments, businesses, organizations, and most important, people will all need to change.

5. The Murder of Jamal Khashoggi. On October 2 Saudi dissident and Washington Post columnist Jamal Khashoggi entered the Saudi consulate in Istanbul. He didn’t come out alive. In the weeks that followed, Saudi officials told various stories about what happened. What they hadn’t counted on was that Turkish intelligence had bugged the consulate and that Turkish President Recep Tayyip Erdogan was willing to release what he knew to embarrass them. President Trump initially suggested the murder wasn’t America’s concern because “to the best of our knowledge, Khashoggi is not a United States citizen.” Congress took a different view, especially after the CIA concluded that Saudi Crown Prince Mohammed bin Salman (MBS) had ordered Khashoggi’s murder. Trump repudiated that conclusion, releasing a statement saying “it could very well be that the Crown Prince had knowledge of this tragic event—maybe he did and maybe he didn’t!” The president said Riyadh’s commitment to spend more than a $100 billion on U.S. weapons systems and its importance as an ally justified his business-as-usual approach. But Saudi arm purchases actually are much smaller, and it’s questionable whether relying on MBS serves U.S. interests. He has shown a penchant for recklessness: he had many of his royal cousins arrested championed Saudi Arabia’s ill-advised intervention in Yemen detained Lebanon’s prime minister and temporarily forced him to resign led the effort to impose an embargo on Qatar and broke off diplomatic relations with Canada over a tweet. Saying that the Saudi relationship is too important to jeopardize only encourages further risk-taking.

4. The United States Leaves the Iran Nuclear Deal. Donald Trump vowed on the campaign trail to withdraw the United States from the Iran nuclear deal, formally known as the Joint Comprehensive Plan of Action (JCPOA). In May, Trump made good on his pledge, claiming it was a “one-sided deal that should have never, ever been made.” Trump took steps against the counsel of many of his advisers and of America’s closest allies. Secretary of Defense James Mattis was among the cabinet officers who argued that for all deal’s weaknesses it was better to stay in it. British, French, and German leaders flew to Washington to lobby for the United States to stay in the deal, pledging to act to address the deal’s shortcomings. No other country followed the United States out of the deal, even after the White House announced that it would sanction any firm that does business with Iran. Iran remains in compliance with the deal, and the other signatories are looking for ways to help Tehran ease the pain of U.S. economic pressure. Whether they will succeed and whether Iran will leave the deal if they don’t are two open questions. The Trump administration has suggested that its goal in Iran goes beyond shutting down its nuclear program. Secretary of State Mike Pompeo says the administration “wants to restore democracy” in Iran. And even if the White House’s goals are more modest, its sanctions effort could trigger a transatlantic brawl if European firms become the target of U.S. penalties.

3. Dire Warnings About Climate Change Mount. The world’s climate is changing and human activity is the cause. Scientists have been telling us this for more than three decades and evidence backs them up. But these warnings haven’t led us to change our ways. The emission of the heat-trapping gases that produce climate change continues to rise globally. Now a sobering report released by the United Nations Intergovernmental Panel on Climate Change (IPCC) in October 2018 says we may have as few as twelve years to act or pass the point of no return. To judge by the powerful hurricanes, devastating wildfires, floods, and record-breaking heat in 2018 that climate change fueled, we won’t like the world we are heading toward. But neither the UN report, nor the freak weather events of 2018, nor the release of a U.S. government report outlining how much climate change will harm the U.S. economy has turned President Trump into a climate-change believer. His rebuttal to the National Climate Assessment Report was simple: “I don’t believe it.” The odds are good—very, very good—that scientists have a better handle on the future we face. But sadly, they don’t have the ability that an American president has to keep us from going there.

2. The Weakening of the West Worsens. For experts calling on America’s friends to step up as America steps down in world affairs, 2018 wasn’t a good year. Friend after friend faced domestic problems that made it hard for them to look, let alone act, beyond their borders. Hopes that the United Kingdom could orchestrate an orderly divorce from the European Union (EU) faded. While the two sides reached a deal, British Prime Minister Theresa May couldn’t persuade the House of Commons to endorse it. Whether Britain is headed toward a hard Brexit, a soft Brexit, or no Brexit at all is anyone’s guess. Across the English Channel, French President Emmanuel Macron saw his public approval ratings tumble into the mid-twenties in the face of the gilets-jaunes, or yellow-vest, protests. The sometimes violent demonstrations diminished Macron’s ability to push ahead with his ambitious plans to reform the French economy. Further south, Italian voters elected a populist coalition combining the anti-establishment Five Star Movement and the right-wing League. The new government is now fighting with Brussels over a draft budget that violates EU rules. Prime Minister Victor Orbán continued to dismantle Hungary’s democracy, and several other central European countries drifted in the same direction. Even Germany saw domestic turmoil. Chancellor Angela Merkel stepped down as head of the Christian Democratic Union after the party lost several critical state elections. Merkel’s protégé Annegret Kramp-Karrenbauer, succeeded her. However, the chancellor no longer commands the authority at home or abroad she once did, raising fears that Europe has become leaderless.

1. Trump Triggers a Trade War and More. “I want tariffs,” Donald Trump told his advisers in July 2017. In 2018, he got his wish. In January the administration imposed tariffs on imported washing machines and solar panels. A bigger move came in March, though, when tariffs were slapped on imported steel and aluminum from friends and foes alike because they posed a national security threat. Trump subsequently imposed tariffs on $50 billion worth of Chinese imports, which by July he had raised to $250 billion. Despite tweeting that “Trade wars are good, and easy to win,” Trump’s tariffs had by year’s end hurt Americans more than helped them. The stock market sold off, the overall U.S. trade deficit widened, and America’s trading partners slapped retaliatory tariffs on U.S. exports, causing American farmers to lose overseas markets and leading some U.S. manufacturers cut jobs as higher input costs punished their bottom lines. Amidst this bad news, the administration had second thoughts about fighting trade wars across multiple fronts. In July, Trump struck a deal with the EU to hold off on imposing further tariffs while the two sides conducted new trade talks. In November, he struck a ninety-day trade truce with China. Trump’s tariffs, coupled with his repeated references to the EU as a “foe” and threats to impose tariffs on imported autos, left many Europeans wondering whether traditional transatlantic relations had changed for good. Meanwhile in Beijing, Chinese leaders hearing the talk in Washington about “strategic competitors” and reading Vice President Mike Pence’s tough speech on Chinese behavior were debating whether Trump was looking to do more than just reset the bilateral trade balance and instead seeking to contain China’s rise as a great power.

Other stories of note in 2018. In January, the Pentagon released a National Defense Strategy that said “great power competition—not terrorism—is now the primary focus of U.S. national security.” In February, South Korea hosted the Winter Olympics at PyeongChang. Russian President Vladimir Putin touted a new arsenal of weapons, including an intercontinental nuclear cruise missile, in March. John Bolton became President Trump’s third national security advisor in April. In May, the U.S. Embassy in Jerusalem opened. Nikki Haley announced in June that the United States is pulling out of the UN Human Rights Council, calling it a “protector of human rights abusers, and a cesspool of political bias.” In July, the Japan-EU Economic Partnership Agreement was signed, creating the largest world’s largest free-bloc, covering 30 percent of global trade. In August, Apple became the first public company to achieve a market capitalization of $1 trillion. At the very last minute in September, Canada agreed to join with Mexico and the United States in revamping the North America Free Trade Agreement, now renamed the United States-Mexico-Canada Agreement. In October, the United States informed Russia that it intended to withdraw from the Intermediate Nuclear Forces Treaty because Russia was violating the terms of the treaty. In November, Russia fired upon and then seized three Ukrainian naval vessels in the Sea of Azov, escalating tensions between Moscow and Kiev. In December, the Comprehensive and Progressive Agreement for Trans-Pacific Partnership, essentially the Trans-Pacific Partnership minus the United States, went into effect.

So that’s my top ten world events of 2018 plus some other events of note. You may have a different list or you might put these events in a different order. If so, let me know on Facebook or Twitter.

Corey Cooper, Angela Peterson, Patrice Narasimhan, and Sofia Ruiz assisted in the preparation of this post.


Significant Weather Event Archive

The following summaries cover "significant" or widespread weather events that occurred in the region in 2020. Summaries are color coded in the following manner according to their type.

The following summaries cover "significant" or widespread weather events that occurred in the region in 2020. Summaries are color coded in the following manner according to their type.

The following summaries cover "significant" or widespread weather events that occurred in the region in 2019. Summaries are color coded in the following manner according to their type.

The following summaries cover "significant" or widespread weather events that occurred in the region in 2018. Summaries are color coded in the following manner according to their type.

The following summaries cover "significant" or widespread weather events that occurred in the region in 2017. Summaries are color coded in the following manner according to their type.

The following summaries cover "significant" or widespread weather events that occurred in the region in 2016. Summaries are color coded in the following manner according to their type.

The following summaries cover "significant" or widespread weather events that occurred in the region in 2015. Summaries are color coded in the following manner according to their type.

The following summaries cover "significant" or widespread weather events that occurred in the region in 2014. Summaries are color coded in the following manner according to their type.

The following summaries cover "significant" or widespread weather events that occurred in the region in 2013. Summaries are color coded in the following manner according to their type.

The following summaries cover "significant" or widespread weather events that occurred in the region in 2012. Summaries are color coded in the following manner according to their type.

The following summaries cover "significant" or widespread weather events that occurred in the region in 2011. Summaries are color coded in the following manner according to their type.

The following summaries cover "significant" or widespread weather events that occurred in the region in 2010. Summaries are color coded in the following manner according to their type.

The following summaries cover "significant" or widespread weather events that occurred in the region in 2009. Summaries are color coded in the following manner according to their type.

The following summaries cover "significant" or widespread weather events that occurred in the region in 2008. Summaries are color coded in the following manner according to their type.

The following summaries cover "significant" or widespread weather events that occurred in the region in 2007. Summaries are color coded in the following manner according to their type.

The following summaries cover "significant" or widespread weather events that occurred in the region in 2006. Summaries are color coded in the following manner according to their type.

The following summaries cover "significant" or widespread weather events that occurred in the region in 2005. Summaries are color coded in the following manner according to their type.

The following summaries cover "significant" or widespread weather events that occurred in the region in 2004. Summaries are color coded in the following manner according to their type.

The following summaries cover "significant" or widespread weather events that occurred in the region in 2003. Summaries are color coded in the following manner according to their type.

The following summaries cover "significant" or widespread weather events that occurred in the region in 2002. Summaries are color coded in the following manner according to their type.

The following summaries cover "significant" or widespread weather events that occurred in the region in 2001. Summaries are color coded in the following manner according to their type.

The following summaries cover "significant" or widespread weather events that occurred in the region in 2000. Summaries are color coded in the following manner according to their type.

The following summaries cover "significant" or widespread weather events that occurred in the region in 1999. Summaries are color coded in the following manner according to their type.

The following summaries cover "significant" or widespread weather events that occurred in the region prior to 1999. Summaries are color coded in the following manner according to their type.


Event Summaries

This page serves as a location to find past weather event information for northern Illinois and northwest Indiana.

T o the right is a link to Storm Data, a monthly publication by the NWS's National Centers for Environmental Information (NCEI). Storm Data will list all of the finalized, quality controlled hazardous weather reports and damage survey assessments within the NWS Chicago County Warning Area broken down by month. These publications are available three months after the end of the month. To the lower right there is a thumbnail link to a searchable database of these quality controlled reports.

Further below on this page are individual event reviews for the local area sorted by event type. Many of these are archived stories from web top news headlines on our home page in the hours to days after the events occurred. Click on the date to jump to the full archived event review. Each story contains data and records from the event, and often meteorological insight and photos . To quickly search for an event that you may not recall the date of, click the "All" tab, hit Ctrl + F to search your browser, and enter the event and/or city or county impacted.

If you cannot find what you are looking for here, try our Local Climate Page, or for visualizing various datasets also try the NOAA Weather and Climate Toolkit.


10 Interesting but Lesser-Known Events from History

Millions of historical events have contributed to creating the world we know today. Our school textbooks just provide us information on some of the grandest historical events but leave out the lesser-known stories. So, we decided to bring to you some lesser-known historical events. From the purchase of Alaska by the United States to the project of creating spy cats, we bring to you some of the most interesting but lesser-known events from history around the world.

1. In 1867, Russia sold the territory of Alaska to the U.S. for $7.2 million. A mere 50 years later, the Americans had earned that amount back 100 times over.

With this check, the United States completed the purchase of almost 600,000 square miles of land from the Russian Government with $7.2 million. Image Credit: Edouard de Stoeckl and William H. Seward via Wikipedia

The United States acquired Alaska from the Russian Empire on March 30, 1867. The Russian Empire was eager to sell off Alaska as the place lacked natural resources and was uninhabitable. Moreover, they feared that the UK might seize Alaska in case war broke out between the two. As a result of the purchase, the United States added 586,412 square miles of new territory.

There were mixed reactions from both the nations on the purchase. It was not quite clear why the United States wanted to purchase Alaska and whether the deal would be profitable. One of the American newspapers asked, “Why does America need this ‘ice box’ and 50,000 wild Eskimos who drink fish oil for breakfast?” Even the Congress disapproved of the purchase. But the deal was finalized at $7.2 million, or about 2 cents per acre ($4.74/km 2 ).

It was in 1896 that the Klondike Gold Rush took place and Alaska came to be seen as a valuable addition to the United States. The gold rush brought in hundreds of millions of dollars. The seal fishery was another attraction that brought considerable revenue to the US. There have been reports suggesting that the revenue that came from the seal fisheries was in excess of the price paid for acquiring Alaska. So, in no more than 50 years, the United States was able to profit from its purchase. (source)

2. Inspired by Jules Verne’s Around The World in 80 Days, Nellie Bly was the first to attempt traveling around the world in 1889. She completed her journey in only 72 days and even met Jules Verne himself.

Cover of the French first edition of Jules Verne’s Around the World in Eighty Days. Published on January 30, 1873/ Nellie Bly who traveled around the world in 72 days. Image Credit: Jules Verne via Wikipedia, H. J. Myers via Wikipedia

Jules Verne’s Around the World in 80 Days is a classic that took us around the world with Phileas Fogg. An American journalist, Elizabeth Cochrane Seaman, or better known by her pen name Nellie Bly, was the first to attempt to travel the world in 80 days. In 1888, Bly suggested to her editor that she take a trip across the world to prove Jules Verne’s calculations. A year later, on November 14, 1889, she embarked upon the 40,070-kilometer journey and boarded the Augusta Victoria, a steamer of the Hamburg America Line.

At the same time, the New York newspaper Cosmopolitan sponsored its own reporter, Elizabeth Bisland, to beat both Bly’s and the fictional Phileas Fogg’s time. During the course of her journey, Bly traveled through England, France (where she met Jules Verne in person), Brindisi, the Suez Canal, Colombo (Ceylon), the Straits Settlements of Penang and Singapore, Hong Kong, and Japan. As she was traveling via steamships and rails, she had to suffer occasional setbacks due to bad weather and arrived at San Fransisco two days behind her schedule. But she was able to make up for the delay as her employer, Joseph Pulitzer, the owner of the New York World, chartered a private train for her. She reached New Jersey on January 25, 1890. It only took her around 72 days to get back to New York, thus completing her travel around the world in just 72 days. She beat Phileas Fogg’s record and became the first person to travel around the world. The other reporter arrived four days later. (source)

3. Switzerland attacked its neighboring country, Liechtenstein, three times and by mistake every time.

Swiss–Liechtensteiner border. Image Credit: Wikipedia, Wikipedia

Switzerland holds a strange record in attacking its neighbor, Liechtenstein. Apparently, Switzerland has attacked Liechtenstein three times in 30 years, surprisingly by mistake each time!

Liechtenstein is a small country only 62 square miles in area. The country has a population of 37,000 people. But in spite of its small size, Liechtenstein is one of the richest countries in the world with one of the lowest unemployment rates. Another thing about Liechtenstein is that it does not have an army of its own. It disbanded its army in 1868 and is one of the 22 countries today without an armed force.

The first time Switzerland attacked Liechtenstein was on December 5, 1985. The Swiss Army was organizing a training exercise that involved launching missiles. Unknowingly, the Swiss Army launched the missiles into the heavily forested Liechtenstein causing a massive forest fire. The Liechtenstein government was very angry and Switzerland had to pay a heavy sum for the environmental damage.

The second attack took place on October 13, 1992. The Swiss Army received orders to set up an observation post in Treisenberg. They followed the orders and marched to Treisenberg. What they didn’t realize was that Treisenberg lies within the territory of Liechtenstein. They marched into Treisenberg with rifles and only later realized that they were in Liechtenstein.

The last attack was on March 1, 2007. A group of Swiss Army infantry soldiers was in training when the weather took a bad turn. There was heavy rainfall and the soldiers were not carrying any GPS or compass. Eventually, they ended up in Liechtenstein! Switzerland apologized to the Liechtenstein government for the intrusion, yet again. (source)

4. In the first Olympics of 1904, the men’s marathon first place finisher completed the race in a car and was disqualified. The second-place finisher was carried to the finish line by his trainers, and the fourth finisher took a detour to eat during the race.

Frederick Lorz, who finished first with the help of a car and Andarín Carvajal who ran the marathon wearing street clothes and even took a nap in between. Image Credit: Wikipedia, Wikipedia

The men’s marathon in the 1904 Olympic Games might have been one of the strangest races in history. It was more of a comedy show than a serious event. Only a few of the runners in the marathon had previous experience. The other participants were “oddities.” There were 10 Greeks who had never run a marathon, two belonged to the Tsuana tribe of South Africa and arrived barefoot to the race, and one was a Cuban mailman who wore street clothing to the race.

That was not all. The first to complete the race was American runner Fred Lorz. Apparently, Lorz had dropped out of the race after nine miles and then hitch-hiked in a car. When the car broke down at the 19th mile, he jogged to the finish line. He was banned from the competition for life.

Tom Hicks, Marathon Olympic Champion and his supporters at the marathon. St. Louis Olympic Games, 1904. Image Credit: Wikipedia

The second to arrive, and the champion, was Thomas Hicks. Ten miles from the finish line, he almost gave up but his trainers urged him to continue. He was given several doses of strychnine, a common rat poison, to help get him to the end of the race. When he reached the stadium, his trainers and supporters who carried him to the finish line! Even though he got the gold medal that time, he never ran professionally again.

Andarín Carvajal, a Cuban postman, ran the race in street clothes. He had not eaten in 40 hours and took a detour into an apple orchard during the race. He ate some rotten apples that gave him stomach cramps. Despite falling ill, he managed to finish in the fourth place! (source)

5. The world’s first completely covered underwater diving suit was invented as far back as 1715 and consisted of an airtight oak barrel. The suit was used mainly for salvage operations of shipwrecks.

Replica of the John Lethbridge barrel (1715), intermediate between diving bell and standard diving dress. Cité de la Mer, a maritime museum in Cherbourg, France. Image Credit: Ji-It via Wikipedia

John Lethbridge was the inventor of the first underwater diving suit. Lethbridge came up with this idea while working as a salvager for the East India Company. His design consisted of an airtight, oak barrel. The barrel was six feet in length and the diver had to lay flat on his stomach once the barrel was put into the waters with the help of a rope. It had two airtight holes on the sides for the hands and a hole with glass in the front for the diver’s window. During trials, Lethbridge demonstrated that the suit enabled divers to stay 12 fathoms underwater for at least 30 minutes at one go.

Once the diver comes out of the water after 30 minutes, fresh air was pumped into the suit through a vent using bellows. The used air was let out through another vent at the same time.

The suit was used mostly to retrieve material from wrecks. During Lethbridge’s first salvage operation using his invention, he recovered 25 chests of silver and 65 cannons! (source)


A Brief History of the Corporate Form and Why it Matters

Take a brief moment to look around at your surroundings. Ask yourself, “how much of the ‘stuff’ in the room is directly or indirectly related to a corporation?” 150 years ago, the answer would have been very little. But today, there can be no doubt that corporations are intimately involved in all aspects of our lives. In light of that fact, it is appropriate to consider: (1) why we have corporations (2) where they come from and (3) how they will impact our future.

Part One: What Exactly is a Corporation?

A corporation is a legally distinct entity that has many of the rights attributed to individuals.[1] These rights include the ability to enter into contracts, take out loans, sue others, be sued, own assets, pay taxes, and so on.[2] A corporation is formed when individuals exchange consideration (usually in the form of cash) for shares of the corporation, which in turn creates a right to a portion of profits.[3] Generally, the losses incurred by a shareholder of a corporation are limited to the amount invested this concept is known as limited liability.[4] Limited liability allows individuals to avoid personal liability for a business entity’s losses, thereby allowing risk-averse individuals to assume risks they otherwise would not have undertaken.[5] Corporations also allow individuals to pool resources to achieve goals that would be unattainable by a person acting in an individual capacity, and can last longer than an individual’s lifetime.[6] The benefits of the corporate form also create opportunities for abuse, which will be discussed below.

Part Two: The Development of the Corporate Form

The roots of the corporate form can be traced into antiquity.[7] Below, I will discuss important developments which have shaped the corporations we know today. I will begin with the emergence of limited liability.

Early Notions of Limited Liability: The corporate form emerged from economic arrangements that mirrored the concept of limited liability offered by modern corporations. One such arrangement was the commenda, a system developed in Eleventh Century Italy, wherein a ‘passive partner’ provided funding for a merchant vessel to be sailed by a ‘managing partner’ who invested no capital.[8] Upon completion of the voyage, the partners divided up the profits under a predetermined formula.[9] This arrangement allowed the passive partner to limit his or her liability of their investment, while the managing partner assumed the risks associated with the cargo and the voyage.[10] Soon, investors began pooling their funds to diminish the risk of losing their entire fortune on a single voyage.[11] In doing so, the investors realized the benefits of pairing limited liability with diversification.[12]

Development of ‘Joint-Stock’ Companies: In the 1600s, the British Crown began granting monopolies to groups of investors willing to undertake certain ventures.[13] These monopolies took the form of “joint-stock” companies that allowed labor and capital to be aggregated for the purpose of undertaking tasks that would be too large for any one person.[14] A famous example was that of the East India Company, in which investors pooled capital into a single “joint-stock” company from which profits would be distributed according to capital invested.[15] Only members of the East India Company had the privilege of conducting trade with India.[16] The East India Company eventually came to form a government over large portions of India and maintain a standing army. [17] Other notable “joint-stock” companies, such as the Virginia Company, helped expand British control of North America.[18] In fact, the Virginia Company established the General Assembly, which was the first legislature in North America.[19] These examples show that by allowing the aggregation of resources, corporations can be organized to carry out tasks too big for one person, or even one government.

Government-Chartered Corporations in the U.S.: Considering that America was literally settled by corporations,[20] their early popularity in the U.S. should not be surprising. In Alexander Hamilton’s second Report on Public Credit, he argued for a federally chartered national bank to help provide centralized direction for the financial sector.[21] The bank was established soon thereafter.[22] In his Report on Manufacturers, Hamilton argued for a comprehensive federally backed plan to expand public works, which was not immediately accepted.[23] In later years, however, the government would embrace its ability to direct industry through the creation of industrial corporations.[24] A famous example of this was the chartering of the Union Pacific Railroad, and other railroad companies, for the purpose of constructing the transcontinental railroad.[25]

Emergence of Truly Private Corporations: Throughout the 1800s, and particularly in the late 1800s, corporations began to shift away from the strict limitations of their legislature-approved charters.[26] This shift was illustrated in 1896 when New Jersey passed a statute allowing corporations to define the scope of their charters themselves, independent of the government.[27] Many of the benefits of the corporate form discussed above quickly came to be abused in the late 1800s.[28] For example, John D. Rockefeller’s Standard Oil Company came to control 90-95% of oil refineries in the U.S..[29] Journalists, such as Ida Tarbell, exposed the nefarious methods used by John D. Rockefeller to push out honest competitors.[30]

Federal Regulation of Privately-Owned Corporations: The government responded to harmful corporate behavior through the passage of the Sherman Antitrust Act, which sought to limit large corporations’ ability to fix prices and exclude competition.[31] Under the administration of Theodore Roosevelt, the Sherman Act was vigorously enforced through over 40 antitrust suits.[32] The most famous of these cases, Northern Securities Company v. United States, resulted in a 5-4 decision where the Supreme Court ordered the dissolution[33] of J.P. Morgan’s Northern Securities Trust.[34] Justice Harlan, writing for the Court, stated that “the court may make any order necessary to bring about the dissolution or suppression of an illegal combination that restrains interstate commerce.”[35]

For the Benefit of Shareholders: Traditionally, directors of corporations, governed by American law, must manage corporations primarily for the benefit of shareholders.[36] The effect of this principle is made clear in a famous case, Dodge v. Ford Motor, wherein Henry Ford decided to stop paying dividends “to employ still more men, to spread the benefits of this industrial system to the greatest possible number, [and]to help them build up their lives and their homes.”[37] The court held that the profits of a corporation cannot be withheld from stockholders for the benefit of the general public and that a dividend must be reinstated.[38]

Further Federal Regulation Following the Great Depression: The abuses of the corporate form, which caused the 1929 stock market crash, led to the passage of the Securities Exchange Act in 1934 under President Franklin Roosevelt.[39] The focus of this legislation was to promote transparency in the market for public securities by requiring disclosure of audited financial records and empowering the Securities and Exchange Commission to enforce compliance with the law’s objectives.[40]

State Regulation of Corporations: While federal regulation has had a significant impact on corporate law, the bulk of regulation occurs at the state level. State law largely defines the duties of corporate directors,[41] the shareholder voting process,[42] the procedures for amending bylaws and certificates,[43] and other areas central to proper corporate governance.[44]

Status as Individuals for Purposes of Free Speech: Under the law, the status of corporations as “individuals” has taken on new meaning in recent years. In Citizens United v. FEC, the Supreme Court held in a 5-4 decision that corporations have a political right to free speech under the First Amendment.[45] Under Citizens United, corporations’ right to free speech includes the right to “use money amassed from the economic marketplace to fund their speech.”[46] In effect, this gives corporations the ability to capitalize on their vast resources to engage in political speech protected under the First Amendment. This decision adds another dimension through which corporations have a great impact on our day-to-day lives.

Collectively, the events described above deliver three main takeaways: (1) historically, corporations have had a vast impact on our economic, political, and social relationships – a phenomenon that will likely continue into the future (2) corporations have the beneficial capacity to facilitate large-scale, risk-intensive endeavors that would be impossible for individuals or governments to achieve alone, and (3) the opportunity for abuse of the corporate form may, in appropriate cases, call for government regulation to ensure that corporations serve legislatively-defined societal interests.

Part Three: Corporations and Public Benefit

The shape and evolution of the corporate form through the Colonial Era, the Industrial Revolution, the Great Depression, and Citizens United demonstrate how the government has expanded and limited corporate power to ensure that corporations are working for the benefit of society. This begs the question: where will be we 100 years from now? This is a very important question, especially considering the vast impact that corporations have on our lives.

Some states, including New York, allow companies to incorporate as “benefit corporations” (“B-corps”).[47] In New York, B-corps may be run for a specific public benefit, which may include but is not limited to, “‘(1) providing low-income or underserved individuals or communities with beneficial products or services (2) promoting economic opportunity for individuals or communities beyond the creation of jobs in the normal course of business (3) preserving the environment (4) improving human health (5) promoting the arts, sciences or advancement of knowledge (6) increasing the flow of capital to entities with a public benefit purpose and (7) the accomplishment of any other particular benefit for society or the environment’ (BCL §1702(e)).”[48]

To become a B-corp in New York, a new corporation must define the specific benefit it aims to pursue within its certificate of incorporation.[49] Existing corporations can become B-corps through amendments to their certificates.[50]

The effects of laws like these are significant. B-corps do not have the same duties as other corporations to run the business exclusively for the profit of shareholders,[51] like Henry Ford was compelled to do. Instead, directors of B-corps can actively consider the interests of other stakeholders.[52] If Ford Motor Co. was defined as a B-corp in 1919, perhaps Henry Ford would have been allowed to provide for his workers and make cars more affordable for the general public, to the possible detriment of other shareholders. There will likely be court cases that decide that question in coming years. Today, well-known companies such as Patagonia, Eileen Fisher, Warby Parker, Method, Seventh Generation, Ben & Jerry’s, and Etsy are already designated as B-corps.[53]

The development of B-corps has coincided with a larger corporate trend of corporate social responsibility (“CSR”), which calls for companies to be held accountable to stakeholders in addition to their traditional duty to shareholders.[54] An apt example of a traditional corporation practicing CSR is Starbucks, which has made efforts to ethically source its coffee, sponsor community service endeavors, and reduce the environmental impact of its products, amongst other stakeholder-oriented initiatives.[55]

B-corps and traditional corporations practicing CSR present many questions that remain unanswered, including: (1) how will these operate in the era of Citizens United, (2) will consumers favor these companies over traditional shareholder-oriented companies, (3) what limitations do B-corps pose on businesses, (4) what are the legal obligations of B-corps to provide profit for shareholders versus benefits for stakeholders, and (5) will existing corporations voluntarily convert to B-corps? The answers to these questions will determine whether B-corps and trends involving CSR will have a significant societal impact in the future. Legislative bodies, at the federal, state, and local levels, will be called upon to resolve these intricate policy issues, with input from all stakeholders.

[1] Corporation, Investopedia, https://www.investopedia.com/terms/c/corporation.asp, (last visited Nov. 11, 2018).

[5] Cf. Limited Liability, Investopedia, https://www.investopedia.com/terms/l/limitedliability.asp, (last visited Nov. 11, 2018) (discussing how limited liability “protects the partner’s personal assets from the risk of being seized to satisfy creditor claims in the event of the company’s or partnership’s insolvency…”).

[6] Cf. Williston, infra note 13, at 109 (discussing how joint-stock companies enabled individuals to pool their capital and labor to achieve results that would be difficult for one person to achieve).

[7] Robert W. Hillman, Limited Liability in Historical Perspective, 54 Wash. & Lee L. Rev. 613, 617 (1997) (discussing an arrangement in Ancient Rome called the peculium).

[13] Samuel Williston, History of the Law of Business Corporations before 1800, 2 Harv. L. Rev. 105, 109 (1888).

[14] See id. (discussing how the structure of the East India Company was the result of a determination by Queen Elizabeth that it was easier to conduct trade with India when the efforts of “noblemen, gentlemen, shopkeepers, widows, orphans” are combined by “employ[ing]their capital in a joint stock,” rather than on an individual basis).

[17] Peter Marshall, The British Presence in India in the 18th Century, BBC (Feb. 17, 2011), http://www.bbc.co.uk/history/british/empire_seapower/east_india_01.shtml.

[18] Virginia Company, Encyclopaedia Britannica, https://www.britannica.com/topic/Virginia-Company, (last visited Nov. 11, 2018) see also Zephyr Teachout, How Corporations Became People, N.y. Times (Mar. 5, 2018), https://www.nytimes.com/2018/03/05/books/review/adam-winkler-we-the-corporations.html.

[21] Hamilton’s Economic Plan, Encyclopedia.com, https://www.encyclopedia.com/history/encyclopedias-almanacs-transcripts-and-maps/hamiltons-economic-plan, (last visited Nov. 11, 2018).

[25] Union Pacific Railroad, Encyclopedia.com, https://www.encyclopedia.com/social-sciences-and-law/economics-business-and-labor/businesses-and-occupations/union-pacific, (last visited Nov. 11, 2018).

[26] See Harwell Wells, The Modernization of Corporation Law, 1920-1940, 11.3 U. Penn. L. Rev. 573, 581 (1888).

[28] See Eduardo Porter, The Politics of Income Inequality, N.y. Times, (May 13, 2014), https://www.nytimes.com/2014/05/14/business/economy/the-politics-of-income-inequality.html.

[29] Standard Oil Company and Trust, Encyclopaedia Britannica, https://www.britannica.com/topic/Standard-Oil-Company-and-Trust, (last visited Nov. 11, 2018).

[30] Gilbert King, The Woman Who Took on the Tycoon, Smithsonian.com (Jul. 5, 2018), https://www.smithsonianmag.com/history/the-woman-who-took-on-the-tycoon-651396/.

[31] Sherman Antitrust Act, Encyclopaedia Britannica, https://www.britannica.com/event/Sherman-Antitrust-Act, (last visited Nov. 11, 2018).

[32] Trust-Busting, Encyclopedia.com, https://www.encyclopedia.com/history/encyclopedias-almanacs-transcripts-and-maps/trust-busting, (last visited Nov. 11, 2018).

[33] Northern Securities Co. v. United States, 193 U.S. 197, 317 (1904).

[36] See Dodge v. Ford Motor Co., 204 Mich. 459, 507 (1919) (“A business corporation is organized and carried on primarily for the profit of the stockholders. The powers of the directors are to be employed for that end.”).

[39] Securities Exchange Act of 1934, Investopedia, https://www.investopedia.com/terms/s/seact1934.asp, (last visited Nov. 11, 2018).

[41] Richard W. Jennings, The Role of the States in Corporate Regulation and Investor Protection, 23 L. and Contemp. Prob. 193, 200 (1958).

[44] See id. at 202-205 (discussing various provisions of corporate governance which are governed by state law).


Abraham Lincoln Reminds America of Its Founding Principles (Nov. 19, 1863)

When Abraham Lincoln dedicated a national cemetery for the soldiers who had died at Gettysburg, four months after that central battle of the American Civil War, he was not the principal speaker. But no other speech that day has been remembered the way Lincoln&rsquos words are. He spoke of the past, of the &ldquoproposition that all men are created equal&rdquo on which the Republic was founded he spoke of the present, of the sacrifices ordinary men in blue had made to vindicate that proposition and he spoke of a future in which living Americans must continue to dedicate themselves to the &ldquogreat task&rdquo of preserving that ideal forever. Nothing else anchors the challenges of our present to the intentions of our past more clearly than the Gettysburg Address. Whatever else changes in American life, that proposition does not change and holding it close is the best guarantee that democracy will endure.

Allen C. Guelzo is Henry R. Luce Professor of the Civil War Era and Director of Civil War Era Studies at Gettysburg College, James Madison Program Garwood Visiting Professor at the James Madison Program in American Ideals and Institutions at Princeton University, and a 2018 Bradley Prize winner. He is the author of Reconstruction: A Concise History.


California Wildfires

A massive wildfire that killed dozens of people and destroyed thousands of homes wreaked havoc in Northern California this year. The fire was fully contained after burning for more than two weeks on 25 November.

The nation’s deadliest wildfire in a century killed at least 85 people, and 249 are on a list of those unaccounted for.

The fire began on 8 November, in the parched Sierra Nevada foothills and quickly spread across 240 square miles (620 square kilometers), destroying most of Paradise in a day.


Timeline of Selected FDA Activities and Significant Events Addressing Opioid Misuse and Abuse

This timeline provides chronological information about FDA activities and significant events related to opioids, including abuse and misuse.

1911-1999

1911 to 1990s

Opioid pain medications were used primarily for acute pain and cancer pain. Studies showing inadequate treatment of chronic non-cancer pain by physicians lead to an increased use of opioids.

May: MS Contin, (morphine sulfate) approved first formulation of an opioid pain medicine that allowed dosing every 12 hours instead of every 4 to 6 hours.

August: Duragesic (fentanyl transdermal system) approved first formulation of an opioid pain medicine in a patch (sometimes referred to as a “skin patch”) that is changed every 3 days.

December: OxyContin (oxycodone controlled-release) approved first formulation of oxycodone that allowed dosing every 12 hours instead of every 4 to 6 hours. OxyContin would soon become a focal point of opioid abuse issues that would continue to escalate into the late 2000s and beyond.

  • At the time of approval, FDA believed the controlled-release formulation of OxyContin would result in less abuse potential, since the drug would be absorbed slowly and there would not be an immediate “rush” or high that would promote abuse. In part, FDA based its judgment on the prior marketing history of a similar product, MS Contin, a controlled-release formulation of morphine approved by FDA and used in the medical community since 1987 without significant reports of abuse and misuse.
  • Also at the time of OxyContin’s approval, FDA product labeling warned of the danger of abuse of the drug and that crushing a controlled-release tablet followed by intravenous injection could result in a lethal overdose. There was no evidence to suggest at the time that crushing the controlled-release capsule followed by oral ingestion or snorting would become widespread and lead to a high level of abuse.

November: Actiq (fentanyl) approved first pain medicine approved to treat cancer breakthrough pain but with additional safety concerns. Actiq was approved with a restricted distribution program to try to prevent 1) accidental exposure in children because the product looked like a lollipop, and 2) potential abuse. This drug would later become part of a category of opioids now known as transmucosal immediate-release fentanyl (TIRF) products. Transmucosal means that the dose of the drug is delivered across mucous membranes, such as inside the cheek, under the tongue, or in the nose.

2000-2004

Early 2000s

Reports of overdose and death from prescription drug products, especially opioids, began to rise sharply, with OxyContin at the center of the problem. For instance, the number of people who admitted to using OxyContin for non-medical purposes increased dramatically from approximately 400,000 in 1999 to 1.9 million in 2002 and to 2.8 million in 2003.

By 2009, about 1.2 million emergency department (ED) visits were related to misuse or abuse of pharmaceuticals, an increase of more than 98% since 2004 and more than the number of ED visits related to use of illicit drugs such as heroin and cocaine. Most prominent among these prescription drug-related deaths and ED visits were opioid pain relievers (OPR), especially OxyContin.

FDA had worked with sponsors for more than a decade to implement risk management programs for a number of opioid products. However, data demonstrated that these programs did not adequately manage the risks of misuse, abuse, addiction, and overdose. More was needed.

January: Beginning in 2001 and ongoing, inter-agency collaboration occurred to develop public education regarding prescription drug abuse. The involved agencies included FDA, SAMHSA, the Center for Substance Abuse Treatment (CSAT), and the National Institute on Drug Abuse (NIDA).

March: CSAT hosted a meeting with FDA and other federal agencies, including DEA, NIDA, and the Centers for Disease Control and Prevention (CDC).

July: Additional stronger warnings about the potential for misuse and abuse were added to the OxyContin label.

  • To help prescribers choose patients who would benefit from using OxyContin, the indication for using the drug was changed from “moderate to severe pain where use of an opioid analgesic is needed for more than a few days” to “management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.”
  • The label was also changed to say that OxyContin is not appropriate for “as needed” pain or in the immediate-post operative period if the pain is mild or not expected to persist for an extended period of time.
  • A Boxed Warning was added to reinforce the most important warnings, and information in the DRUG ABUSE AND DEPENDENCE section was updated. OxyContin’s manufacturer, Purdue Pharma, agreed to implement a Risk Management Program (RMP) to try to reduce misuse and abuse of OxyContin and issued a Dear Healthcare Professional Letter about changes to the label.

January: Patient Package Insert (PPI) approved for OxyContin. This is a document written for patients that provides information about how to safely use the drug.

March: Inter-Agency Working Group Meeting held to discuss OxyContin and other extended-release opioids and their abuse and diversion. FDA, DEA, NIDA, and SAMHSA involved.

January: FDA issued a Warning Letter (PDF - 149KB) to OxyContin’s manufacturer, Purdue Pharma, for misleading advertisements. Among many other details, the warning specified that the ads left out and minimized the serious safety risks associated with OxyContin and promoted it for uses beyond those which had been proven safe and effective. Specifically, the letter pointed out that the advertisements failed to clearly present information from the product label’s Boxed Warning regarding the potentially fatal risks and the danger of abuse.

2005-2008

September: PPI for Actiq converted to a Medication Guide (MG) due to heightened safety considerations. The conversion was to better ensure that each patient prescribed the drug was fully informed of its serious risks. In contrast to PPIs, MGs are required to be given to each patient when they fill a prescription.

September: Fentora (fentanyl buccal tablets), the second TIRF product, approved with an MG and RMP but not restricted distribution.

September: FDA issued a Public Health Advisory for Fentora due to reports of medication errors resulting in adverse events and deaths.

September: The Food and Drug Administration Amendments Act (FDAAA) became law, providing the Agency with a wide array of new authority designed to enhance drug safety. One of these is the authority to require Risk Evaluation and Mitigation Strategies (REMS) in order to ensure the benefits of the drugs continue to outweigh their risks. REMS are intended to require manufacturers to implement various safety measures for certain drugs. This new law helped provide the basis for a future comprehensive REMS program for all FDA-approved Extended-Release (ER)/Long Acting (LA) opioid products (see 2009 through 2012 below).

September: FDA announced it would require companies to stop marketing any unapproved drug containing the opioid pain medication hydrocodone bitartrate (the active ingredient in the opioid sold under the familiar trade name Vicodin).

Fentora’s manufacturer, Cephalon, requested an expansion of the drug’s indication to include patients with non-cancer breakthrough pain. An FDA Advisory Committee concluded that the existing RMP for the drug was not effective, and Cephalon was told that a REMS program would be required before the drug could be considered for a broader indication.

February: Fentora’s label and MG were revised to strengthen warnings.

February: FDA informed Cephalon that the RMP was not sufficient to ensure the safe use of Fentora for the already approved indication for treatment of breakthrough cancer pain and needed to be replaced by a REMS.

March: FDA met with manufacturers of ER/LA opioid pain medications to discuss the requirement for a class-wide, shared-system REMS, which is a single uniform program for all products in a drug class.

April: FDA partnered with SAMHSA to launch an initiative to help ensure the safe use of the opioid methadone, as this drug appeared to be responsible for a highly disproportionate number of overdoses and deaths in pain patients compared with all other opioids. (Methadone is best known as a treatment for addiction to and dependence on heroin and other narcotic pain medicines, but it is also prescribed to treat moderate-to-severe chronic pain.)

May: Among a variety of public and stakeholder meetings that occurred in 2009, FDA held a large public meeting on May 27-28 where more than 100 people provided comments on their experiences with opioid drugs along with suggestions for a REMS targeting ER/LA opioid products. Groups that participated included patient advocacy organizations, prescriber organizations, pharmacy organizations, insurance providers, and other government agencies. In addition, FDA solicited written comments through a public docket. (See summary of comments (PDF - 6MB).)

July: FDA approved Onsolis (fentanyl), the third TIRF for breakthrough cancer pain. It was approved with a REMS in place. At this point, FDA decided that a separate REMS for each TIRF product would create a great burden to patients, pharmacies, and prescribers and so began discussion of a single-shared REMs for all TIRF products.

FDA informed Cephalon in 2009 of the requirement to convert the RMP for Fentora and Actiq to a REMS.

August: Embeda (morphine sulfate and naltrexone extended-release tablets) approved. Naltrexone helps block the effects of opioids. Embeda was the first product approved combining an opioid pain medicine and opioid blocker since Talwin NX (pentazocine and naloxone) was approved in 1982. [Suboxone (buprenorphine and naloxone) sublingual tablets, approved in 2002, has an opioid blocker but is specifically for the treatment of opioid dependence, not for pain.]

October: Similar to actions in 2007 against makers of unapproved hydrocodone products, FDA warned companies they must stop marketing unapproved codeine sulfate tablets, a widely used opioid to treat pain.

November: FDA launched the Safe Use Initiative to create and facilitate public and private collaborations within the health care community, with a goal to reduce preventable harm from medication. Safe use of opioids is a primary focus of this ongoing effort.

November: The November 26, 2009, issue of The New England Journal of Medicine featured an article titled A Difficult Balance – Pain Management, Drug Safety, and the FDA by Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research (CDER). In the article, Dr. Woodcock discussed FDA’s efforts to strike a balance between legitimate patient access to pain medications and managing the risks posed by various analgesics. She cited recent FDA actions on the over-the-counter pain reliever acetaminophen, the low-potency opioid propoxyphene, and high-potency opioids such as OxyContin.

December: FDA held a stakeholder meeting on December 4 with the Industry Working Group (IWG), consisting of representatives from 22 pharmaceutical companies asked to help develop an effective opioid REMS program for a proposed class-wide opioid REMS. [IWG would be re-named REMS Program Companies (RPC) in August, 2011].

A significant percentage of deaths and overdose from opioids, especially from ER/LA opioids, results from theft of pain medicine from medicine cabinets and accidental exposure to the drugs. Since 2009, FDA has worked with DEA and other organizations to help educate the public on safe disposal of opioids when they are no longer needed for pain.

July: FDA held a joint meeting of its Anesthetic and Life Support Drugs Advisory Committee (ALSDAC) and the Drug Safety and Risk Management (DSaRM) Advisory Committee to discuss the Agency’s proposal for a class-wide REMS for ER/LA opioid analgesics (for complete background information discussed at this meeting, see the July 22-23, 2010, AC meeting entry).

September: To improve clinical studies of pain medicines with the goal of advancing the development of novel, less abusable, safer, and more effective pain medicines, FDA announced a plan to establish a public-private partnership to conduct multiple scientific projects under the umbrella of the Analgesic Clinical Trial Translation, Innovations, Opportunities, and Networks (ACTTION) Initiative. The University of Rochester (UR) was chosen for the contract to establish the infrastructure of the ACTTION PPP initiative and to establish relationships with the key experts and organizations in the field.

October: FDA held a joint Advisory Committee Meeting (PDF - 149KB) (ALSDAC and DSaRM) on studies for demonstrating effectiveness of abuse-deterrent formulations on addiction, overdose, and death, with OxyContin and Embeda featured.

October: FDA held a meeting with TIRF sponsors and informed them that in order to decrease the burden on the healthcare system, they must form a single-shared REMS for these products. The Agency committed to working with the firms to assist in the regulatory aspects of developing this program. Regular meetings followed, after which the firms formed a working group, the Transmucosal Immediate-release Fentanyl REMS Industry Group (TRIG).

November: Separate from the developing REMS program but connected to FDA’s overall effort toward safe use of opioids, FDA recommended voluntary market withdrawal of propoxyphene, sold under the familiar trade name Darvon. New data showed the drug could cause serious toxicity to the heart, even in therapeutic doses.

January: Abstral (fentanyl) approved the fourth TIRF product. This product was approved with a MG and REMS in place.

April: FDA supported the White House Office of National Drug Control Policy (ONDCP) report Epidemic: Responding to America’s Prescription Drug Abuse Crisis(PDF - 306KB), a comprehensive action plan to address the national prescription drug abuse epidemic.

June: Oxecta (oxycodone hydrochloride) approved.

June: Lazanda (fentanyl) approved the fifth TIRF product. This product was approved with a MG and REMS in place.

September: FDA provided funds through a one-year cooperative agreement grant to the University of South Carolina to develop a statewide collaboration to decrease rates of misuse, overuse, and abuse of opioids. This was to be accomplished through the detailing of information regarding prescription opioids and the use of state prescription drug monitoring programs (PDMPs) geared to individual physicians who are high volume prescribers of opioids.

October: As part of a three-year inter-agency agreement with the Department of Justice’s Bureau of Justice Administration and in collaboration with the CDC, FDA provided funding to support efforts by the Prescription Drug Monitoring Program Center of Excellence at Brandeis University. The effort was to develop a national database of state PDMP data to be used for surveillance of emerging problems or concerns with scheduled drugs and to examine the impact of national, state and community initiatives implemented to curb misuse, overuse, and abuse of opioids.

December: FDA announced the approval of a new formulation of the ER/LA opioid OPANA ER (oxymorphone hydrochloride).

December: FDA approved a single-shared REMS system for all TIRF products (the “go-live” date would be March 2012). The industry working group (TRIG, see above) was encouraged to continue working to complete its single-shared TIRF REMS system. The Agency continued to provide regulatory input and review of TRIG’s proposals throughout the year.

December: FDA began working to streamline the process for managing the TIRF single-shared REMS.

January: Subsys (fentanyl sublingual spray) approved the sixth TIRF product. It was approved directly into the single-shared TIRF REMS in anticipation of its upcoming “go live” date.

January: FDA awarded a Center of Excellence in Research Science and Innovation grant to the University of Maryland to examine the use and utility of Patient Prescriber Agreements in reducing prescription opioid abuse.

March: The single-shared TIRF REMS went “live,” and FDA began work with TRIG to address patient access issues.

April: FDA hosted a scientific workshop to initiate a public discussion about the potential value of making naloxone available in the community to reduce the number of opioid overdose fatalities. In simple terms, naloxone, marketed under the trade name Narcan and others, reverses the effects of opioids.

May: FDA and the National Institutes of Health (NIH) Pain Consortium held a meeting on May 30-31, called Assessment of Analgesic Treatment of Chronic Pain: A Scientific Workshop, to review available data on the effectiveness of pain medications in the treatment of chronic non-cancer pain.

September: FDA awarded funding for up to three years for three cooperative agreement grants to examine strategies and interventions and their potential to impact opioid analgesic misuse and abuse. The following research topics were funded:

Examine the prescribing habits of physicians who prescribe doses of opioids above 100 mg morphine equivalents per day and/or prescribe opioids in combination with benzodiazepines. Those prescribers will be targeted for educational and informational mailings, and the PDMP data will be examined for changes in prescribing habits post-education and over time.

Examine the clinical use of different tools that can guide a clinician in prescribing opioids and reduce patient misuse, overuse, and abuse of opioids. All of the risk reduction strategies described are currently in use. They include 1) screening, brief intervention, and referral to treatment (SBIRT), 2) PDMPs, 3) REMS, 4) health insurer initiatives, and 5) treatment contracts. The study will survey approximately 1,300 prescribers (1,000 internists, 200 pain specialists and 100 addiction specialists) to gain an understanding of the knowledge, use, and perceptions of utility of these strategies.

Estimate the incidence of urine drug testing (UDT) during the year following initiation of chronic opioid therapy (COT) and identify demographic, clinical, provider, and facility variables associated with the use of UDT within the national Veterans Affairs (VA) healthcare system. Use qualitative interviews with primary care providers to explore perceptions of barriers to UDT, appropriate care for patients who misuse opioids, and opportunities to coordinate treatment with substance abuse specialty care. Describe current clinical practice following an aberrant UDT result, including rates of follow-up assessments and treatment changes among patients who initiate COT for chronic pain.

June: The Randomized Enrollment Study of Opioid Long-term use to eValuate Efficacy (RESOLVE) working group, under the auspices of ACTTION (see September 2010 above), was established. Formation of this group was initiated based on the FDA-sponsored meeting held at NIH in May (see directly above) and on plans to develop protocols for clinical trials to assess the effectiveness of long-term use of opioid pain medicines.

July: FDA approved the ER/LA opioids class REMS program. This program included new product labeling for ER/LA opioids and a requirement for manufacturers to develop and offer opioid training programs that prescribers can take on a voluntary basis.

August: ACTTION established the Consortium for Addiction Research on Efficacy and Safety (CARES) to address challenges in addiction drug trials. The Abuse Liability Evaluation for Research, Treatment, and Training (ALERTT) project was also initiated under ACTTION. This project was initiated with the intent to create a classification scheme and a risk assessment tool for use in clinical trials and for post-marketing adverse event reports to help identify incidents of drug abuse or emergence of drug addiction.

October: FDA and ACTTION hosted a scientific workshop October 24-26 to discuss preclinical models and clinical study issues to find ways to improve analgesic drug discovery and development.

October: FDA scheduled a meeting of the Drug Safety and Risk Management Advisory Committee for October 29-30 to discuss the public health benefits and risks, including the potential for abuse, of drugs containing hydrocodone, either combined with other analgesics or as a cough suppressant. This meeting was postponed due to Hurricane Sandy.

November: FDA scheduled a meeting November 28-29 for ACTTION’s ALERTT project working group for stakeholders to discuss consensus recommendations and research studies on definitions, measures, and prediction tools for abuse liability.

December: FDA held a December 7 meeting of the Anesthetic and Analgesic Drug Products Advisory Committee to discuss the risks and benefits of new drug application, for hydrocodone bitartrate extended-release capsules, which would be the first single-entity hydrocodone-containing drug product. The committee voted against approval.

January: FDA issued a draft guidance document, January 9, to assist industry in developing new formulations of opioid drugs with abuse-deterrent properties. The document, entitled Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling (PDF - 463KB), explains FDA’s current thinking about the studies that should be conducted to demonstrate that a given formulation has abuse-deterrent properties, how those studies will be evaluated by the agency, and what labeling claims may be approved based on the results of those studies.

January: FDA held a January 24-25 meeting of its Drug Safety and Risk Management Advisory Committee (PDF - 69KB) to discuss the public health benefits and risks, including the potential for abuse, of drugs containing hydrocodone either combined with other analgesics or as an antitussive. The Department of Health and Human Services (HHS) received a request from the Drug Enforcement Administration (DEA) for a scientific and medical evaluation and scheduling recommendation for drugs containing hydrocodone either combined with other analgesics or as an antitussive, in response to a citizen petition citing increasing reports of abuse related to these products. Currently, these products are Schedule III drugs under the Controlled Substances Act (CSA), and DEA is considering whether to reschedule the products to Schedule II, which would subject the products to more stringent requirements regarding storage, record keeping, and prescribing, such as limitations on oral prescriptions and refills. The committee voted in favor of rescheduling hydrocodone products from Schedule III controlled substances to Schedule II controlled substances.

February: FDA held public hearing on February 7 & 8 to obtain information -- particularly scientific evidence, such as study data or peer-reviewed analyses -- on issues pertaining to the use of opioid drugs in the treatment of chronic pain. Impact of Approved Drug Labeling on Chronic Opioid Therapy: Part 15 Hearing.

March: March 1, in an open letter to prescribers, FDA and health professional organizations asked all prescribers of opioids to ensure they have thorough knowledge of the FDA-approved product labeling for the opioids they prescribe, and to ensure they have adequate training in opioid therapy. FDA also encouraged all prescribers to help curb our nation's opioid epidemic.

April: April 16, FDA took multiple actions related to OxyContin.

May: May 10, FDA responded to a petition and decided that the original formulation of Opana ER (oxymorphone hydrochloride) Extended-Release Tablets was not withdrawn from the market for reasons of safety or effectiveness. As a result, generic versions of the original formulation can continue to be approved and marketed.

July: On July 29, FDA held the Clinical Development Programs for Opioid Conversion Public Workshop Request for Comments. The scientific workshop was held to address public health concerns associated with the inclusion of equianalgesic opioid conversion tables in opioid product labeling.

September: On September 10, FDA announced a set of significant measures to enhance the safe and appropriate use of extended-release and long-acting (ER/LA) opioids. These actions include class-wide safety labeling changes and new post-marketing requirements for all ER/LA opioid analgesics. FDA also responded to two citizen petitions regarding labeling of opioids.

April: On April 3, FDA approved Evzio (naloxone hydrochloride injection) for the emergency treatment of known or suspected opioid overdose. Naloxone is a medication that rapidly reverses the effects of opioid overdose. Evzio is the first auto-injector designed to deliver a dose of naloxone outside of a healthcare setting.

April: On April 14, FDA finalized the proposed class-wide safety labeling changes for all extended-release and long-acting (ER/LA) opioid analgesics, and responded to two citizen petitions regarding labeling for neonatal opioid withdrawal syndrome (NOWS).

July: On July 23, FDA approved Targiniq ER, an extended-release pain reliever that contains a combination of oxycodone and naloxone. Targiniq ER is the second extended-release/long-acting (ER/LA) opioid analgesic with FDA-approved labeling describing the product’s abuse-deterrent properties.

August: On August 19, FDA approved revisions to the ER/LA Opioid Analgesics REMS to incorporate information from the ER/LA opioid analgesic safety labeling changes (SLCs) announced on September 10, 2013, and approved on April 16, 2014. The most significant changes were to clarify the approved indications for use and limitations of use, and to revise warnings, including boxed warnings.

October: On October 17, FDA approved new labeling for Embeda (morphine sulfate and naltrexone hydrochloride), an extended-release (ER) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Embeda is the third ER opioid analgesic to be approved with labeling describing the product’s abuse-deterrent properties consistent with the FDA’s 2013 draft guidance, Abuse- Deterrent Opioids – Evaluation and Labeling. The new labeling includes a claim indicating that Embeda has properties that are expected to reduce oral and intranasal abuse when the product is crushed.

November: On November 20, FDA approved Hysingla ER (hydrocodone bitartrate), an extended-release (ER) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Hysingla ER is the fourth ER opioid analgesic to be approved with labeling describing the product’s abuse-deterrent properties consistent with the FDA’s 2013 draft guidance for industry, Abuse-Deterrent Opioids – Evaluation and Labeling. Hysingla ER has properties that are expected to reduce, but not totally prevent, abuse of the drug when chewed and then taken orally, or crushed and snorted or injected.

January: On January 30, FDA approved a modified formulation of Zohydro ER (hydrocodone bitartrate extended-release capsules). The FDA has not approved an abuse-deterrent labeling claim for Zohydro ER.

April: On April 1, FDA issued a final guidance to assist industry in developing opioid drug products with potentially abuse-deterrent properties.

June: On June 8-9, the FDA’s Risk Communication Advisory Committee discussed approaches to communicating information about fetal effects in product labeling for methadone or buprenorphine maintenance therapy for opioid addiction, and about the maternal benefits and risks of treatment, to best enable patients and healthcare providers to make informed decisions about the use of these drugs during pregnancy.

July: On July 1-2, FDA, in collaboration with the National Institutes of Drug Abuse, the Centers for Disease Control and Prevention, the Substance Abuse and Mental Health Services Administration, and the Health Resources and Services Administration, held a scientific workshop to initiate a public discussion about issues surrounding the uptake of naloxone in certain medical settings – such as on ambulances and in association with prescriptions for opioids – as well as outside of conventional medical settings to reduce the incidence of opioid overdose fatalities. Discussions focused on which populations are at risk for opioid overdose how public health groups can work together to use naloxone to reduce the risk of overdose and legal, regulatory, logistical and clinical aspects related to making naloxone more widely available.

August: On August 13, FDA approved OxyContin for certain pediatric patients for pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. This approval is limited to opioid-tolerant pediatric patients 11 and up who are already taking and tolerating a minimum daily dose of at least 20 mg oxycodone orally or its equivalent. These patients can be expected to remain on treatment with an opioid for several weeks or more.

October: On October 2, FDA approved MorphaBond (morphine sulfate), an extended-release (ER) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate. MorphaBond is the fifth ER opioid analgesic to be approved with labeling describing the product’s abuse-deterrent properties consistent with the FDA’s 2015 guidance for industry, Abuse-Deterrent Opioids – Evaluation and Labeling. MorphaBond has properties that are expected to reduce, but not eliminate, abuse of the drug when crushed and snorted or injected.

November: On November 18, FDA approved Narcan nasal spray, the first FDA-approved nasal spray version of naloxone hydrochloride, a life-saving medication that can temporarily stop or reverse the effects of an opioid overdose, including an overdose from heroin.

February: On February 4, FDA leaders, in response to the opioid abuse epidemic, called for a far-reaching action plan to reassess the agency’s approach to opioid medications. The plan will focus on policies aimed at reversing the epidemic, while still providing patients in pain access to effective relief.

On February 4, FDA released five postmarketing (PMR) requirements announced on September 13, 2013, and replaced them with 11 PMRs (10 postmarketing studies and one clinical trial) because the 10 postmarketing observational studies and one clinical trial include refined measures for assessing the known serious risks of misuse, abuse, addiction, overdose, and death.

On February 19 the FDA announced that during the April 12th meeting of the Pediatric Advisory Committee (PAC) they will present a framework of current plans for a 2-day joint meeting of the PAC, the Anesthetic and Analgesic Drug Products Advisory Committee, and the Drug Safety and Risk Management Advisory Committees. This joint meeting is scheduled for September 15 and 16, 2016 and during this meeting the FDA will be calling on a broad range of independent experts with real-world experience to provide recommendations on how to address the unique needs of children in pain.

March: On March 1, the FDA convened the Science Board to hear about and discuss a range of pressing issues related to the current opioid epidemic, including: (1) the role of opioids in pain management (2) scientific challenges facing FDA in supporting the development of pain medications (3) scientific challenges facing FDA in seeking to understand the real-world use of opioids to treat pain (4) the role that FDA plays as a part of a larger Federal, State and local response to the challenges of providing appropriate pain treatment while reducing opioid abuse and (5) postmarket surveillance activities related to opioids.

On March 22, FDA announced required class-wide safety labeling changes for immediate-release (IR) opioid pain medications. Among the changes, the FDA is requiring a new boxed warning about the serious risks of misuse and abuse, which can lead to addiction, overdose and death. The FDA is also requiring several additional safety labeling changes across all prescription opioid products to include additional information on the risk of these medications.

On March 24, FDA issued a draft guidance titled “General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products.” This guidance recommends studies a generic applicant should conduct so FDA can evaluate the abuse deterrence of certain generic opioid drug products and help ensure that generic versions of approved opioids with abuse-deterrent formulations (ADFs) are no less abuse-deterrent than the brand named drug.

April: On April 26, FDA approved Xtampza ER (oxycodone), an extended-release (ER) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate. Xtampza ER is the sixth ER opioid analgesic to be approved with labeling describing the product’s abuse-deterrent properties consistent with the FDA’s 2015 guidance for industry, Abuse-Deterrent Opioids – Evaluation and Labeling. Xtampza ER has properties that are expected to reduce, but not eliminate, abuse of the drug when crushed and snorted or injected.

May: On May 3-4, FDA convened a joint meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee to discuss results from assessments of the extended-release and long-acting (ER/LA) Opioid Analgesics Risk Evaluation and Mitigation Strategies (REMS). The committees provided comments as to whether this REMS with Elements to Assure Safe Use (ETASU) assures safe use, is not unduly burdensome to patient access to the drugs, and to the extent practicable, minimizes the burden to the healthcare delivery system.

On May 26, FDA announced required safety labeling changes for methadone and buprenorphine products when used by pregnant women for medication-assisted treatment (MAT) of opioid use disorder to ensure providers have complete information about the benefits and risks of these products.

On May 26, FDA approved Probuphine, the first buprenorphine implant for the maintenance treatment of opioid dependence. Probuphine, an implant designed to provide a constant, low level of buprenorphine for six months, should be used in patients who are already stable on low-to-moderate doses of other forms of buprenorphine and as part of a complete treatment program that includes counseling and psychosocial support.

August: On August 19, FDA approved Troxyca ER (oxycodone hydrochloride and naltrexone hydrochloride extended-release capsules), an extended-release (ER) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate. Troxyca ER is the seventh ER opioid analgesic to be approved with labeling describing the product’s abuse-deterrent properties consistent with the FDA’s 2015 guidance for industry, Abuse-Deterrent Opioids – Evaluation and Labeling. Troxyca ER has properties that are expected to reduce, but not eliminate, abuse of the drug when crushed and then taken orally, snorted, or injected.

On August 31, FDA announced required class-wide changes to drug labeling to help inform health care providers and patients of the serious risks associated with the combined use of certain opioid medications and a class of central nervous system depressant drugs called benzodiazepines. Among the changes, the FDA is requiring boxed warnings and Medication Guides for prescription opioid analgesics, opioid-containing cough products, and benzodiazepines with information about the serious risks, including extreme sleepiness, respiratory depression, coma and death, associated with using these medications at the same time.

September: On September 15-16, the FDA convened a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee, the Drug Safety and Risk Management Advisory Committee, and the Pediatric Advisory Committee to discuss the appropriate development plans for establishing the safety and efficacy of prescription opioid analgesics for pediatric patients, including obtaining pharmacokinetic data and the use of extrapolation.

October: On October 5, the FDA convened a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management to discuss naloxone products intended for use in the community, specifically the most appropriate dose or doses of naloxone to reverse the effects of life-threatening opioid overdose in all ages, and the role of having multiple doses available in this setting. The committees also discussed the criteria prescribers will use to select the most appropriate dose in advance of an opioid overdose event and the labeling to inform this decision, if multiple doses are available.

On October 31 – November 1, the FDA held a public meeting, Pre-Market Evaluation of Abuse-Deterrent Properties of Opioid Drug Products, to discuss scientific and technical issues relating to formulation development and pre-market evaluation of opioid drug products with abuse-deterrent properties. The meeting was intended to give FDA the opportunity to discuss, and seek public input from stakeholders on, the approach to testing FDA recommended in its draft guidance General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products. The meeting also provided an opportunity to discuss FDA’s efforts to develop standardized in vitro testing methodologies for evaluating the abuse deterrence of opioid drug products.

December: On December 16, the FDA approved several safety labeling changes (SLCs) about the serious risks of prescription opioid analgesics and opioids approved for medication assisted treatment (MAT) of opioid addiction including class-wide SLCs for immediate-release (IR) opioid pain medications, SLCs for methadone and buprenorphine products, and class-wide SLCs about the serious risks associated with the combined use of certain opioid medications with benzodiazepines or other central nervous system (CNS) depressants.

January: On January 9, FDA approved Arymo ER (morphine sulfate extended-release tablets), an extended-release (ER) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate. Arymo ER is the eighth ER opioid analgesic to be approved with labeling describing the product’s abuse-deterrent properties consistent with the FDA’s 2015 guidance for industry, Abuse-Deterrent Opioids – Evaluation and Labeling. Arymo ER is formulated to give it physicochemical properties expected to make abuse by injection difficult.

On January 17, FDA approved Vantrela ER (hydrocodone bitartrate extended-release tablets), an extended-release (ER) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate. Vantrela ER is the ninth ER opioid analgesic to be approved with labeling describing the product’s abuse-deterrent properties consistent with the FDA’s 2015 guidance for industry, Abuse-Deterrent Opioids – Evaluation and Labeling. The physical and chemical properties of Vantrela ER are expected to make intravenous (injection) abuse difficult and are expected to reduce, but not eliminate, abuse by nasal and oral routes. However, abuse of Vantrela ER by these routes is still possible.

April: On April 20, FDA announced the restricted the use of codeine and tramadol medicines in children because these medicines carry serious risks, including slowed or difficult breathing and death, which appear to be a greater risk in children younger than 12 years, and should not be used in these children. These medicines should also be limited in some older children. The FDA also recommended against the use of codeine and tramadol medicines in breastfeeding mothers due to possible harm to their infants.

On April 20, the FDA approved RoxyBond (oxycodone hydrochloride), an opioid analgesic indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. RoxyBond is the first immediate-release opioid analgesic approved with labeling describing its abuse-deterrent properties consistent with the FDA’s 2015 Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling. Based on laboratory studies, RoxyBond tablets are resistant to certain forms of manipulation such as crushing, grinding, or otherwise extracting oxycodone from the tablet that are typically used to make opioids easier to abuse by the nasal and intravenous routes.

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May: On May 9-10, FDA held a public meeting, Training Health Care Providers on Pain Management and Safe Use of Opioid Analgesics – Exploring the Path Forward, to obtain input on issues and challenges associated with Federal efforts to support training on pain management and the safe prescribing, dispensing, and patient use of opioids (safe use of opioids) for health care providers.

On May 10, FDA released the "FDA Education Blueprint for Health Care Providers Involved in the Management or Support of Patients with Pain" (draft revisions to the Blueprint), which broadens the current Blueprint to include information on pain management, including the principles of acute and chronic pain management non-pharmacologic treatments for pain and pharmacologic treatments for pain (both non-opioid analgesic and opioid analgesic).

June: On June 8, FDA requested that Endo Pharmaceuticals remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market based on its concern that the benefits of the drug may no longer outweigh its risks.

July: On July 6, the JAMA Viewpoint article by Dr. Scott Gottlieb and Dr. Janet Woodcock entitled, “Marshaling FDA Benefit-Risk Expertise to Address the Current Opioid Abuse Epidemic," was published.

On July 6, following the FDA’s request, Endo announced that it would voluntarily remove reformulated Opana ER from the market.

On July 10-11, FDA held a public meeting, Data and Methods for Evaluating the Impact of Opioid Formulations with Properties Designed to Deter Abuse in the Postmarket Setting: A Scientific Discussion of Present and Future Capabilities, to discuss ways to improve the analysis and interpretation of existing data, as well as to discuss opportunities and challenges for collecting and/or linking additional data to improve national surveillance and research capabilities in this area.

On July 13, the National Academies of Science, Engineering, and Medicine release the consensus report, commissioned by the FDA, which outline the state of the science regarding prescription opioid abuse and misuse, as well as the evolving role that opioids play in pain management.

September: On September 11, FDA held a Pediatric Advisory Committee meeting to discuss the use of prescription opioid products containing hydrocodone or codeine for the treatment of cough in pediatric patients. The discussion included current practice for the treatment of cough in children and benefit-risk considerations regarding the use of prescription opioid products in pediatric patients.

On September 20, FDA advised that the opioid addiction medications buprenorphine and methadone should not be withheld from patients taking benzodiazepines or other drugs that depress the central nervous system (CNS). The combined use of these drugs increases the risk of serious side effects however, the harm caused by untreated opioid addiction can outweigh these risks. Careful medication management by health care professionals can reduce these risks.

On September 28, after determining that a REMS is necessary for IR opioid analgesics to ensure that the benefits of these drugs continue to outweigh the risks, FDA sent letters to IR opioid analgesic manufacturers informing them that their products that are intended to be used in the outpatient setting will be subject to the same REMS requirements as the ER/LA opioid analgesics.

November: On November 21, FDA issued a final guidance titled “General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products.” This guidance recommends studies, including comparative in vitro and pharmacokinetic studies, that the potential abbreviated new drug application (ANDA) applicant should conduct and submit to FDA in an ANDA to demonstrate that a generic solid oral opioid drug product is no less abuse-deterrent than its reference listed drug with respect to all potential routes of abuse.

On November 30, FDA approved Sublocade, the first once-monthly injectable buprenorphine product for the treatment of moderate-to-severe opioid use disorder in adult patients who have initiated treatment with a transmucosal (absorbed through mucus membrane) buprenorphine-containing product. It is indicated for patients that have been on a stable dose of buprenorphine treatment for a minimum of seven days.

December: On December 11-12, FDA hosted a public workshop regarding the role of packaging, storage, and disposal options within the larger landscape of activities aimed at addressing abuse, misuse, or inappropriate access of prescription opioid drug products guiding principles and considerations for the design of packaging, storage, and disposal options for opioids integrating packaging, storage, and disposal options into existing health care and pharmacy systems, including both open and closed health care systems data needs and how to address challenges in assessing the impact of packaging, storage, and disposal options in both the premarket and postmarket settings and ways in which FDA could encourage the development and assessment of packaging, storage, and disposal options for opioids that have the potential to enhance opioid safety.

January: On January 11, FDA Commissioner, Scott Gottlieb, M.D., announced the 2018 Strategic Policy Roadmap, which provides an overview of some of the key priorities the agency will pursue advance FDA’s public health mission. Part of the Roadmap is reducing misuse and abuse of opioid drugs.

On January 11, FDA announced that it is requiring safety labeling changes for prescription cough and cold medicines containing codeine or hydrocodone to limit the use of these products to adults 18 years and older because the risks of these medicines outweigh their benefits in children younger than 18. The agency is also requiring the addition of safety information about the risks of misuse, abuse, addiction, overdose, death, and slowed or difficult breathing to the Boxed Warning of the drug labels for prescription cough and cold medicines containing codeine or hydrocodone.

On January 24, FDA and the Federal Trade Commission posted joint warning letters to the marketers and distributors of 12 opioid cessation products, for illegally marketing unapproved products with claims about their ability to help in the treatment of opioid addiction and withdrawal.

On January 30, FDA held a public hearing, “Opioid Policy Steering Committee: Prescribing Intervention—Exploring a Strategy for Implementation,” to receive stakeholder input on how FDA might, under its REMS authority, improve the safe use of opioid analgesics by curbing overprescribing to decrease the occurrence of new addictions and limit misuse and abuse of opioid analgesics.

On January 30, FDA announced limits to packaging for anti-diarrhea medicine Loperamide (Imodium) to encourage safe use.

On January 30, FDA posted the revised Blueprint, “Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain,” which broadens the current Blueprint to include information on pain management, including the principles of acute and chronic pain management non-pharmacologic treatments for pain and pharmacologic treatments for pain. (It is important to note that the revised Blueprint will not be considered final until the Opioid Analgesic Risk Evaluation and Mitigation Strategy is approved.)

February: On February 14, FDA held a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee to discuss the new drug application for Hydexor (proposed tradename), a fixed-dose combination oral tablet, submitted by Charleston Laboratories, Inc., that contains hydrocodone, acetaminophen, and promethazine, for the short-term management of acute pain severe enough to require an opioid analgesic while preventing and reducing opioid-induced nausea and vomiting. The committees also discussed the abuse potential of this non-abuse-deterrent product and whether it should be approved.

On February 15, through a cooperative agreement with the FDA, the Duke-Margolis Center hosted a public workshop, “Strategies for Promoting the Safe Use and Appropriate Prescribing of Prescription Opioids,” to examine the landscape of health system and payer interventions to promote safe and appropriate prescribing of opioids discuss how health systems and payers are using data and health IT tools to support interventions discuss how health system approaches were implemented, barriers to their adoption, and potential unintended consequences of adoption and discuss how to build an evidence base to support existing health system and payer interventions as well as how success may be defined and measured.

March: On March 27, FDA held a meeting of the Psychopharmacologic Drugs Advisory Committee to discuss the new drug application for lofexidine hydrochloride, submitted by US WorldMeds, LLC, for mitigation of symptoms associated with opioid withdrawal and facilitation of completion of opioid discontinuation treatment.

April: On April 17, FDA is hosting a public meeting on Patient-Focused Drug Development for Opioid Use Disorder (OUD), in collaboration with National Institute of Drug Abuse (NIDA). In addition to NIDA, FDA is also working closely with patient advocacy and community organizations to encourage participation from individuals with OUD. This meeting aligns with FDA’s ongoing work aimed at reducing the impact of opioid abuse and addiction.

On April 20, FDA issued the draft guidance, “Opioid Dependence: Developing Buprenorphine Depot Products for Treatment,” which reflects the agency’s current thinking regarding drug development and trial design issues relevant to the study of depot buprenorphine products (i.e. modified-release products for injection or implantation).

May: On May 16, FDA approved Lucemyra (lofexidine hydrochloride), the first non-opioid treatment for the mitigation of withdrawal symptoms associated with abrupt discontinuation of opioids.

On May 22, FDA convened a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee to discuss the new drug application for buprenorphine sublingual spray, submitted by INSYS Development Company, Inc., for the treatment of moderate-to-severe acute pain where the use of an opioid analgesic is appropriate. The committees will also be asked to discuss whether this product should be approved.

May: On May 30, FDA launched an innovation challenge to spur development of medical devices ‒ including digital health and diagnostics ‒ that target pain, addiction and diversion.

June: On June 1, FDA sent safety labeling change notification letters to drug companies with approved opioid analgesic products intended for use in an outpatient setting, which require the companies to include new safety information regarding the Opioid Analgesic REMS in the Boxed Warning and Warnings and Precautions sections of prescribing information due to a general lack of awareness of the REMS among all opioid analgesic prescribers.

June: On June 5, FDA took action against 53 websites marketing unapproved opioids as part of a comprehensive effort to target illegal online sales.

June: On June 26, FDA convened a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee to discuss the new drug application for oxycodone extended-release capsules, submitted by Pain Therapeutics, with the proposed indication of the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The product is intended to have abuse-deterrent properties based on its physicochemical properties. The committees will be asked to discuss whether the data submitted by the Applicant are sufficient to support labeling of the product with the properties expected to deter abuse.

June: On June 27, FDA convened internet stakeholders, government entities, academic researchers, and advocacy groups at a one-day Online Opioid Summit to discuss ways to collaboratively take stronger action in combatting the opioid crisis by reducing the availability of illicit opioids online.

July: On July 9, FDA hosted a public meeting on Patient-Focused Drug Development for chronic pain to hearing patients’ perspectives on chronic pain, views on treatment approaches, and challenges or barriers to accessing treatments for chronic pain.

August: On August 3, FDA convened a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee to discuss results from assessments of the transmucosal immediate-release fentanyl (TIRF) medicines’ risk evaluation and mitigation strategy (REMS), approved in December 2011. The TIRF REMS requires that healthcare providers who prescribe TIRF medicines for outpatient use are specially certified, that pharmacies that dispense TIRF medicines for inpatient and outpatient use are specially certified, and that completion of the prescriber-patient agreement form occurs prior to dispensing TIRF medicines for outpatient use. The Agency will seek the committees’ assessment as to whether this REMS with elements to assure safe use (ETASU) assures safe use, is not unduly burdensome to patient access to the drugs, and to the extent practicable, minimizes the burden to the healthcare delivery system. The Agency will also seek the committees’ input on any possible modifications to the TIRF REMS goals and requirements, as well as input on the adequacy of the evaluations conducted in the REMS assessments to determine whether the TIRF REMS goals are being met.

On August 6, FDA issued the draft guidance for industry, “Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment,” which is intended to assist sponsors in developing drugs for medication-assisted treatment of opioid use disorder (OUD) and addresses the clinical endpoints acceptable to demonstrate effectiveness of such drugs.

On August 22, FDA awarded a contract to the National Academies of Sciences, Engineering, and Medicine (NASEM) to help advance the development of evidence-based guidelines for appropriate opioid analgesic prescribing for acute pain resulting from specific conditions or procedures.

On August 28, FDA took action against 21 websites marketing unapproved opioids as part of agency’s effort to target illegal online sales.

September: On September 7, FDA approved a new dosage strength of buprenorphine and naloxone sublingual film as maintenance treatment for opioid dependence.

On September 18, FDA approved the Opioid Analgesic REMS.

On September 20, through a cooperative agreement with the FDA, the Duke Margolis Center for Health Policy convened a public workshop, “Expanding Access to Effective Treatment for Opioid Use Disorder: Provider Perspectives on Reducing Barriers to Evidence-Based Care.”

On September 27-28, FDA’s Office of Women’s Health, in collaboration with CDER and CTP, hosted a 2-day public meeting, “Opioid and Nicotine Use, Dependence, and Recovery: Influences of Sex and Gender.”

On October 11, FDA convened a meeting of the Anesthetic and Analgesic Drug Products Advisory Committee to discuss new drug application 210730, for oliceridine 1 milligram/milliliter injection, submitted by Trevena, Inc., for the management of moderate-to-severe acute pain in adult patients for whom an intravenous opioid is warranted. The committee also discussed the efficacy and safety data and benefit-risk considerations.

On October 12, FDA convened a meeting of the Anesthetic and Analgesic Drug Products Advisory Committee to discuss new drug application 209128, sufentanil sublingual tablets, submitted by AcelRx Pharmaceuticals, Inc., for the management of moderate-to-severe acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate, in adult patients in a medically supervised setting. The committee also discussed risk-benefit considerations and whether this product should be approved.

On November 1, FDA convened a joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee to discuss efficacy, safety and risk-benefit profile of new drug application 210417 for buprenorphine and samidorphan sublingual tablets, submitted by Alkermes, Inc., for adjunctive treatment of major depressive disorder.

On November 2, FDA approved first oral sufentanil pain medication for use in a medically supervised setting.

On November 14, FDA convened a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee to discuss new drug application 209774, for an immediate-release oral tablet formulation of oxycodone, which is intended to resist common methods of physical or chemical manipulation and to deter intravenous and intranasal abuse, submitted by SpecGx Inc., for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. The committees also determined whether the Applicant adequately demonstrated that the abuse-deterrent properties of the proposed product are sufficient to include this information in the product label, and whether the product should be approved.

November 15, FDA convened a meeting of the Anesthetic and Analgesic Drug Products Advisory Committee to discuss the assessment of opioid analgesic sparing outcomes in clinical trials of acute pain. The committee also commented on the trial design and endpoints of these studies and how to determine the clinical relevance of the results.

January: On January 17, FDA announced the results of unprecedented work to design, test, and validate the key labeling requirements necessary to approve an over-the-counter (OTC) version of naloxone, including posting two model Drug Facts labels (DFLs) and the supporting FDA review. Overall, the study demonstrated that the model DFL was well-understood by consumers and is acceptable for use by manufacturers in support of their OTC naloxone development programs.

February: On February 6, FDA issued the final guidance, “Opioid Use Disorder: Developing Depot Buprenorphine Products for Treatment,” which reflects the agency’s current thinking regarding drug development and trial design issues relevant to the study of depot buprenorphine products (i.e. modified-release products for injection or implantation).

On February 12, FDA announced ongoing efforts to stop the spread of illicit opioids, further secure the U.S. drug supply chain and forcefully confront opioid epidemic.

March: On March 19, FDA took action against marketer of unapproved products claiming to treat addiction, chronic pain and other serious conditions.

On March 27, FDA announced new steps to strengthen agency’s safety requirements aimed at mitigating risks associated with transmucosal immediate-release fentanyl products.

April: On April 2, FDA took new enforcement actions as part of the agency’s ongoing effort to combat the illegal online sales of opioids.

On April 2, FDA hosted internet stakeholders, thought leaders, government entities, academic researchers, and advocacy groups at its second Online Opioid Summit.

On April 9, FDA announced harm reported from sudden discontinuation of opioid pain medicines and required label changes to guide prescribers on gradual, individualized tapering.

On April 19, FDA approved first generic naloxone nasal spray to treat opioid overdose.

On April 25, FDA launched a public education campaign to encourage safe removal of unused opioid pain medicines from homes.

May: On May 30, FDA opened a public docket to request information on requiring fixed-quantity blister packaging for certain opioid pain medicines to help decrease unnecessary exposure to opioids.

On September 30, 2019 FDA and DEA warned website operators illegally selling opioids

October: On October 24, FDA outlined the agency’s first year accomplishments implementing SUPPORT Act authorities to address the opioids crisis

November: On November 26, FDA issues warning letter for products illegally marketed for the treatment of health conditions, including opioid withdrawal symptoms

December: On December 11, FDA issued warning letter for not including the most serious risks in advertisement for medication-assisted treatment drug

On December 19, the National Academies of Sciences, Engineering, and Medicine released a consensus report, commissioned by the FDA, on framing opioid prescribing guidelines for acute pain.

January: On January 14, FDA convened a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee to discuss the new drug application (NDA) for oxycodegol, a new molecular entity full mu-opioid receptor agonist, submitted by Nektar Therapeutics, for the management of chronic low back pain in adult patients with pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The committees were asked to discuss the safety and efficacy data as well as the overall risk-benefit profile of the product.

January: On January 15, FDA convened a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee. During the morning session, the committees discussed the NDA for tramadol 44 milligrams (mg) and celecoxib 56 mg tablet, which contains a fixed-dose combination of an opioid and a non-steroid anti-inflammatory drug, submitted by Esteve Pharmaceuticals, S.A., for the management of acute pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate. The committees were asked to discuss the safety and efficacy data as well as the overall risk-benefit profile of the product.

During the afternoon session, the committees discussed the NDA for an extended-release oral tablet formulation of oxycodone, submitted by Intellipharmaceutics Corp., for the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. The product has been formulated with properties intended to deter abuse, and the applicant has submitted data to support these abuse-deterrent properties for this product. The committees were asked to discuss whether the applicant has demonstrated abuse-deterrent properties for their product that would support labeling, as well as the overall risk-benefit profile of the product.

June: On June 8, FDA and the National Telecommunications and Information Administration (NTIA) are launching a 120-day pilot to help reduce the availability of unapproved opioids illegally offered for sale online.

July: On July 23, the FDA issued a Drug Safety Communication announcing that the agency is requiring the drug manufacturers for all opioid pain relievers and medicines to treat OUD to add new recommendations about naloxone to the prescribing information to help ensure that health care professionals discuss the availability of naloxone and assess each patient’s need for a naloxone prescription when opioid pain relievers or medicines to treat OUD are being prescribed or renewed. In addition, the agency recommended that health care professionals consider prescribing naloxone to patients at increased risk of opioid overdose, regardless of whether they are receiving a prescription for an opioid pain reliever or medicine to treat OUD. These may include people with a current or past diagnosis of OUD or who have experienced a previous opioid overdose.

August: On August 7, the FDA approved Olinvyk (oliceridine), an opioid agonist for the management of moderate to severe acute pain in adults, where the pain is severe enough to require an intravenous opioid and for whom alternative treatments are inadequate.

September:On September 10-11, the FDA convened a joint meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee to discuss the results of required postmarketing studies (Postmarketing Requirements 3051-1, 3051-2, 3051-3, and 3051-4) that evaluated the effect of the reformulation of OxyContin (oxycodone hydrochloride extended-release tablets, manufactured by Purdue Pharma L.P., NDA 022272) on abuse, misuse, and fatal and non-fatal overdose, associated with OxyContin. The committees discussed whether these studies, in concert with other information from the published literature, have demonstrated that the reformulated OxyContin product has resulted in a meaningful reduction in these outcomes. The committees also discussed the broader public health impact of OxyContin’s reformulation.

October: On October 2, the FDA published the final guidance for industry, Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Treatment, which is intended to help sponsors develop drugs for treatment of opioid use disorder (OUD). This guidance addresses clinical endpoints acceptable for demonstrating effectiveness of such drugs.

November: On November 2, the FDA convened a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee to discuss the new drug application for Hydexor, a fixed-dose combination oral tablet, submitted by Õlas Pharma, Inc., that contains hydrocodone, acetaminophen, and promethazine, for the short-term (not to exceed 3 days) management of acute post-operative pain severe enough to require an opioid analgesic and the prevention of opioid-induced nausea and vomiting in patients who are at risk for or have a history of nausea and vomiting.

December: On December 23, the FDA finalized modifications to the transmucosal immediate-release fentanyl (TIRF) Risk Evaluation and Mitigation Strategy (REMS) to address the persistence of concerning prescribing practices and improve the agency’s ability to monitor for adverse events and ensure safe use of these medicines.

February: On February 1, the FDA provided an update on the pilot program with the National Telecommunications and Information Administration (NTIA) and three domain name registries to help reduce the availability of unapproved opioids illegally offered for sale online.

February: On February 16, the FDA issued a warning letter to AcelRx Pharmaceuticals, Inc. for the false and misleading promotion of Dsuvia (sufentanil sublingual tablet), a potent opioid analgesic.

March: On March 1, the FDA approved Hydrocodone bitartrate (reference listed drug: Hysingla ER), the first FDA-approved generic opioid with an abuse-deterrent formulation (ADF)—meaning the product has properties that are expected to reduce, though not totally prevent, abuse of the drug when chewed and then taken orally or crushed and snorted or injected.

March: On March 24, the FDA issued a white paper, Introduction to FDA’s Opioid Systems Model, which introduces FDA’s opioid systems modeling effort, discusses potential uses of the model, provides an overview of the model’s scope and structure, highlights preliminary areas for potential policy analysis and outlines on-going work.​

Summary Timeline

1995. OxyContin (oxycodone controlled-release) approved first formulation of oxycodone that allowed dosing every 12 hours instead of every 4 to 6 hours.

1998. Actiq (fentanyl) approved first pain medicine approved to treat cancer breakthrough pain, but with additional safety measures.

Early 2000s. Reports of overdose and death from prescription pain drugs, especially OxyContin, began to rise sharply.

2001. OxyContin label was changed to add and strengthen warnings about the drug’s potential for misuse and abuse.

2003. FDA issued a Warning Letter (PDF - 149KB) to OxyContin’s manufacturer for misleading advertisements.

2007. FDA Amendments Act granted FDA authority to require for certain drugs specified safety measures known as Risk Evaluation and Mitigation Strategies (REMS).

2009. FDA held several public and stakeholder meetings, including May 27-28 public meeting and December 4 stakeholder meeting, to discuss opioid risks, misuse, and abuse.

FDA partnered with U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) to launch an initiative to help ensure the safe use of the opioid methadone.

FDA launched the Safe Use Initiative to reduce preventable harm by medications, including opioids.

FDA began working with U.S. Drug Enforcement Administration (DEA) and others to help educate the public on safe disposal of opioids.

2010. FDA approved a new formulation of OxyContin.

FDA held joint advisory committee meeting to discuss its proposal for a class-wide REMS for Extended-Release (ER)/Long acting (LA) opioids, such as OxyContin.

2011. FDA approved REMS for transmucosal immediate-release fentanyl (TIRF) products, such as Actiq.

2012. FDA implemented the ER/LA opioids REMS program, which includes voluntary training for prescribers.

2013. January: On January 9, FDA issued a draft guidance to assist industry in developing new formulations of opioid drugs with abuse-deterrent properties: Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling (PDF - 463KB).

FDA held a January 24-25 meeting of its Drug Safety and Risk Management Advisory Committee (PDF - 69KB) to discuss the public health benefits and risks, including the potential for abuse, of drugs containing hydrocodone either combined with other analgesics or as an antitussive.

February: FDA held a public hearing on February 7-8 to obtain information on issues pertaining to the use of opioid drugs in the treatment of chronic pain. Impact of Approved Drug Labeling on Chronic Opioid Therapy: Part 15 Hearing.

In an open letter to prescribers on March 1, FDA and health professional organizations asked all prescribers of opioids to ensure they have thorough knowledge of the FDA-approved product labeling for the opioids they prescribe, and to ensure they have adequate training in opioid therapy. FDA also encouraged all prescribers to help curb our nation's opioid epidemic.

April: On April 16, FDA took multiple actions related to OxyContin.

May: On May 10, FDA responded to a petition and decided that the original formulation of Opana ER (oxymorphone hydrochloride) Extended-Release Tablets was not withdrawn from the market for reasons of safety or effectiveness. As a result, generic versions of the original formulation can continue to be approved and marketed.

FDA held the Clinical Development Programs for Opioid Conversion Public Workshop Request for Comments on July 29. The scientific workshop was held to address public health concerns associated with the inclusion of equianalgesic opioid conversion tables in opioid product labeling.

September: On September 10, FDA announced a set of significant measures to enhance the safe and appropriate use of extended-release and long-acting (ER/LA) opioids, including class-wide safety labeling changes and new post-marketing requirements for all ER/LA opioid analgesics. FDA also responded to two citizen petitions regarding labeling of opioids.

2014. April: On April 3, FDA approved Evzio (naloxone hydrochloride injection) for the emergency treatment of known or suspected opioid overdose. Naloxone is a medication that rapidly reverses the effects of opioid overdose. Evzio is the first auto-injector designed to deliver a dose of naloxone outside of a healthcare setting.

On April 14, FDA finalized the proposed class-wide safety labeling changes for all extended-release and long-acting (ER/LA) opioid analgesics, and responded to two citizen petitions regarding labeling for neonatal opioid withdrawal syndrome (NOWS).

July: On July 23, FDA approved Targiniq ER, an extended-release pain reliever that contains a combination of oxycodone and naloxone. Targiniq ER is the second extended-release/long-acting (ER/LA) opioid analgesic with FDA-approved labeling describing the product’s abuse-deterrent properties.

August: On August 19, FDA approved revisions to the ER/LA Opioid Analgesics REMS to incorporate information from the ER/LA opioid analgesic safety labeling changes (SLCs) announced on September 10, 2013, and approved on April 16, 2014. The most significant changes were to clarify the approved indications for use and limitations of use, and to revise warnings, including boxed warnings.

October: On October 17, FDA approved new labeling for Embeda (morphine sulfate and naltrexone hydrochloride), an extended-release (ER) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Embeda is the third ER opioid analgesic to be approved with labeling describing the product’s abuse-deterrent properties consistent with the FDA’s 2013 draft guidance, Abuse- Deterrent Opioids – Evaluation and Labeling. The new labeling includes a claim indicating that Embeda has properties that are expected to reduce oral and intranasal abuse when the product is crushed.

November: On November 20, FDA approved Hysingla ER (hydrocodone bitartrate), an extended-release (ER) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Hysingla ER is the fourth ER opioid analgesic to be approved with labeling describing the product’s abuse-deterrent properties consistent with the FDA’s 2013 draft guidance for industry, Abuse-Deterrent Opioids – Evaluation and Labeling. Hysingla ER has properties that are expected to reduce, but not totally prevent, abuse of the drug when chewed and then taken orally, or crushed and snorted or injected.

2015. January: January: On January 30, FDA approved a modified formulation of Zohydro ER (hydrocodone bitartrate extended-release capsules). The FDA has not approved an abuse-deterrent labeling claim for Zohydro ER.

April: On April 1, FDA issued a final guidance to assist industry in developing opioid drug products with potentially abuse-deterrent properties. Guidance for Industry: Abuse-Deterrent Opioids” (PDF - 227KB) explains the FDA’s current thinking about the studies that should be conducted to demonstrate that a given formulation has abuse-deterrent properties, makes recommendations about how those studies should be performed and evaluated, and discusses what labeling claims may be approved based on the results of those studies.

August: On August 13, FDA approved OxyContin for certain pediatric patients for pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. This approval is limited to opioid-tolerant pediatric patients 11 and up who are already taking and tolerating a minimum daily dose of at least 20 mg oxycodone orally or its equivalent. These patients can be expected to remain on treatment with an opioid for several weeks or more.

October: On October 2, FDA approved MorphaBond (morphine sulfate), an extended-release (ER) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate. MorphaBond is the fifth ER opioid analgesic to be approved with labeling describing the product’s abuse-deterrent properties consistent with the FDA’s 2015 guidance for industry, Abuse-Deterrent Opioids – Evaluation and Labeling. MorphaBond has properties that are expected to reduce, but not eliminate, abuse of the drug when crushed and snorted or injected.

November On November 18, FDA approved Narcan nasal spray, the first FDA-approved nasal spray version of naloxone hydrochloride, a life-saving medication that can temporarily stop or reverse the effects of an opioid overdose, including an overdose from heroin.

2016. February: On February 4, FDA leaders, in response to the opioid abuse epidemic, called for a far-reaching action plan to reassess the agency’s approach to opioid medications. The plan will focus on policies aimed at reversing the epidemic, while still providing patients in pain access to effective relief.

On February 4, FDA released five postmarketing (PMR) requirements announced on September 13, 2013, and replaced them with 11 PMRs (10 postmarketing studies and one clinical trial) because the 10 postmarketing observational studies and one clinical trial include refined measures for assessing the known serious risks of misuse, abuse, addiction, overdose, and death.

On February 19 the FDA announced that during the April 12th meeting of the Pediatric Advisory Committee (PAC) they will present a framework of current plans for a 2-day joint meeting of the PAC, the Anesthetic and Analgesic Drug Products Advisory Committee, and the Drug Safety and Risk Management Advisory Committees. This joint meeting is scheduled for September 15 and 16, 2016 and during this meeting the FDA will be calling on a broad range of independent experts with real-world experience to provide recommendations on how to address the unique needs of children in pain.

March: On March 1, the FDA convened the Science Board to hear about and discuss a range of pressing issues related to the current opioid epidemic, including: (1) the role of opioids in pain management (2) scientific challenges facing FDA in supporting the development of pain medications (3) scientific challenges facing FDA in seeking to understand the real-world use of opioids to treat pain (4) the role that FDA plays as a part of a larger Federal, State and local response to the challenges of providing appropriate pain treatment while reducing opioid abuse and (5) postmarket surveillance activities related to opioids.

On March 22, FDA announced required class-wide safety labeling changes for immediate-release (IR) opioid pain medications. Among the changes, the FDA is requiring a new boxed warning about the serious risks of misuse and abuse, which can lead to addiction, overdose and death. The FDA is also requiring several additional safety labeling changes across all prescription opioid products to include additional information on the risk of these medications.

On March 24, FDA issued a draft guidance titled “General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products.” This guidance recommends studies a generic applicant should conduct so FDA can evaluate the abuse deterrence of certain generic opioid drug products and help ensure that generic versions of approved opioids with abuse-deterrent formulations (ADFs) are no less abuse-deterrent than the brand named drug.

April: On April 26, FDA approved Xtampza ER (oxycodone), an extended-release (ER) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate. Xtampza ER is the sixth ER opioid analgesic to be approved with labeling describing the product’s abuse-deterrent properties consistent with the FDA’s 2015 guidance for industry, Abuse-Deterrent Opioids – Evaluation and Labeling. Xtampza ER has properties that are expected to reduce, but not eliminate, abuse of the drug when crushed and snorted or injected.

May: On May 3-4, FDA convened a joint meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee to discuss results from assessments of the extended-release and long-acting (ER/LA) Opioid Analgesics Risk Evaluation and Mitigation Strategies (REMS). The committees provided comments as to whether this REMS with Elements to Assure Safe Use (ETASU) assures safe use, is not unduly burdensome to patient access to the drugs, and to the extent practicable, minimizes the burden to the healthcare delivery system.

On May 26, FDA announced required safety labeling changes for methadone and buprenorphine products when used by pregnant women for medication-assisted treatment (MAT) of opioid use disorder to ensure providers have complete information about the benefits and risks of these products.

On May 26, FDA approved Probuphine, the first buprenorphine implant for the maintenance treatment of opioid dependence. Probuphine, an implant designed to provide a constant, low level of buprenorphine for six months, should be used in patients who are already stable on low-to-moderate doses of other forms of buprenorphine and as part of a complete treatment program that includes counseling and psychosocial support.

August: On August 19, FDA approved Troxyca ER (oxycodone hydrochloride and naltrexone hydrochloride extended-release capsules), an extended-release (ER) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate. Troxyca ER is the seventh ER opioid analgesic to be approved with labeling describing the product’s abuse-deterrent properties consistent with the FDA’s 2015 guidance for industry, Abuse-Deterrent Opioids – Evaluation and Labeling. Troxyca ER has properties that are expected to reduce, but not eliminate, abuse of the drug when crushed and then taken orally, snorted, or injected.

On August 31, FDA announced required class-wide changes to drug labeling to help inform health care providers and patients of the serious risks associated with the combined use of certain opioid medications and a class of central nervous system depressant drugs called benzodiazepines. Among the changes, the FDA is requiring boxed warnings and Medication Guides for prescription opioid analgesics, opioid-containing cough products, and benzodiazepines with information about the serious risks, including extreme sleepiness, respiratory depression, coma and death, associated with using these medications at the same time.

September: On September 15-16, the FDA convened a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee, the Drug Safety and Risk Management Advisory Committee, and the Pediatric Advisory Committee to discuss the appropriate development plans for establishing the safety and efficacy of prescription opioid analgesics for pediatric patients, including obtaining pharmacokinetic data and the use of extrapolation.

October: On October 5, the FDA convened a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management to discuss naloxone products intended for use in the community, specifically the most appropriate dose or doses of naloxone to reverse the effects of life-threatening opioid overdose in all ages, and the role of having multiple doses available in this setting. The committees also discussed the criteria prescribers will use to select the most appropriate dose in advance of an opioid overdose event and the labeling to inform this decision, if multiple doses are available.

On October 31 – November 1, the FDA held a public meeting, Pre-Market Evaluation of Abuse-Deterrent Properties of Opioid Drug Products, to discuss scientific and technical issues relating to formulation development and pre-market evaluation of opioid drug products with abuse-deterrent properties. The meeting was intended to give FDA the opportunity to discuss, and seek public input from stakeholders on, the approach to testing FDA recommended in its draft guidance General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products. The meeting also provided an opportunity to discuss FDA’s efforts to develop standardized in vitro testing methodologies for evaluating the abuse deterrence of opioid drug products.

December: On December 16, the FDA approved several safety labeling changes (SLCs) about the serious risks of prescription opioid analgesics and opioids approved for medication assisted treatment (MAT) of opioid addiction including class-wide SLCs for immediate-release (IR) opioid pain medications, SLCs for methadone and buprenorphine products, and class-wide SLCs about the serious risks associated with the combined use of certain opioid medications with benzodiazepines or other central nervous system (CNS) depressants.

2017. January: On January 9, FDA approved Arymo ER (morphine sulfate extended-release tablets), an extended-release (ER) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate. Arymo ER is the eighth ER opioid analgesic to be approved with labeling describing the product’s abuse-deterrent properties consistent with the FDA’s 2015 guidance for industry, Abuse-Deterrent Opioids – Evaluation and Labeling. Arymo ER is formulated to give it physicochemical properties expected to make abuse by injection difficult.

On January 17, FDA approved Vantrela ER (hydrocodone bitartrate extended-release tablets), an extended-release (ER) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate. Vantrela ER is the ninth ER opioid analgesic to be approved with labeling describing the product’s abuse-deterrent properties consistent with the FDA’s 2015 guidance for industry, Abuse-Deterrent Opioids – Evaluation and Labeling. The physical and chemical properties of Vantrela ER are expected to make intravenous (injection) abuse difficult and are expected to reduce, but not eliminate, abuse by nasal and oral routes. However, abuse of Vantrela ER by these routes is still possible.

April: On April 20, FDA announced the restricted the use of codeine and tramadol medicines in children because these medicines carry serious risks, including slowed or difficult breathing and death, which appear to be a greater risk in children younger than 12 years, and should not be used in these children. These medicines should also be limited in some older children. The FDA also recommended against the use of codeine and tramadol medicines in breastfeeding mothers due to possible harm to their infants.

On April 20, the FDA approved RoxyBond (oxycodone hydrochloride), an opioid analgesic indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. RoxyBond is the first immediate-release opioid analgesic approved with labeling describing its abuse-deterrent properties consistent with the FDA’s 2015 Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling. Based on laboratory studies, RoxyBond tablets are resistant to certain forms of manipulation such as crushing, grinding, or otherwise extracting oxycodone from the tablet that are typically used to make opioids easier to abuse by the nasal and intravenous routes.

On April 27, FDA held an expert roundtable for healthcare professionals to discuss their experiences with the use of cough suppressants in children (<18 years of age), particularly opioid containing antitussive products, as well as the data available to support recommendations made by various professional societies regarding the treatment of cough in children.

May: On May 9-10, FDA held a public meeting, Training Health Care Providers on Pain Management and Safe Use of Opioid Analgesics – Exploring the Path Forward, to obtain input on issues and challenges associated with Federal efforts to support training on pain management and the safe prescribing, dispensing, and patient use of opioids (safe use of opioids) for health care providers.

On May 10, FDA released the "FDA Education Blueprint for Health Care Providers Involved in the Management or Support of Patients with Pain" (draft revisions to the Blueprint), which broadens the current Blueprint to include information on pain management, including the principles of acute and chronic pain management non-pharmacologic treatments for pain and pharmacologic treatments for pain (both non-opioid analgesic and opioid analgesic).

June: On June 8, FDA requested that Endo Pharmaceuticals remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market based on its concern that the benefits of the drug may no longer outweigh its risks.

July: On July 6, the JAMA Viewpoint article by Dr. Scott Gottlieb and Dr. Janet Woodcock entitled, “Marshaling FDA Benefit-Risk Expertise to Address the Current Opioid Abuse Epidemic," was published.

On July 6, following the FDA’s request, Endo announced that it would voluntarily remove reformulated Opana ER from the market.

On July 10-11, FDA held a public meeting, Data and Methods for Evaluating the Impact of Opioid Formulations with Properties Designed to Deter Abuse in the Postmarket Setting: A Scientific Discussion of Present and Future Capabilities, to discuss ways to improve the analysis and interpretation of existing data, as well as to discuss opportunities and challenges for collecting and/or linking additional data to improve national surveillance and research capabilities in this area.

On July 13, the National Academies of Science, Engineering, and Medicine release the consensus report, commissioned by the FDA, which outline the state of the science regarding prescription opioid abuse and misuse, as well as the evolving role that opioids play in pain management.

September: On September 11, FDA held a Pediatric Advisory Committee meeting to discuss the use of prescription opioid products containing hydrocodone or codeine for the treatment of cough in pediatric patients. The discussion included current practice for the treatment of cough in children and benefit-risk considerations regarding the use of prescription opioid products in pediatric patients.

On September 20, FDA advised that the opioid addiction medications buprenorphine and methadone should not be withheld from patients taking benzodiazepines or other drugs that depress the central nervous system (CNS). The combined use of these drugs increases the risk of serious side effects however, the harm caused by untreated opioid addiction can outweigh these risks. Careful medication management by health care professionals can reduce these risks.

On September 28, after determining that a REMS is necessary for IR opioid analgesics to ensure that the benefits of these drugs continue to outweigh the risks, FDA sent letters to IR opioid analgesic manufacturers informing them that their products that are intended to be used in the outpatient setting will be subject to the same REMS requirements as the ER/LA opioid analgesics.

November: On November 21, FDA issued a final guidance titled “General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products.” This guidance recommends studies, including comparative in vitro and pharmacokinetic studies, that the potential abbreviated new drug application (ANDA) applicant should conduct and submit to FDA in an ANDA to demonstrate that a generic solid oral opioid drug product is no less abuse-deterrent than its reference listed drug with respect to all potential routes of abuse.

On November 30, FDA approved Sublocade, the first once-monthly injectable buprenorphine product for the treatment of moderate-to-severe opioid use disorder in adult patients who have initiated treatment with a transmucosal (absorbed through mucus membrane) buprenorphine-containing product. It is indicated for patients that have been on a stable dose of buprenorphine treatment for a minimum of seven days.

December: On December 11-12, FDA hosted a public workshop regarding the role of packaging, storage, and disposal options within the larger landscape of activities aimed at addressing abuse, misuse, or inappropriate access of prescription opioid drug products guiding principles and considerations for the design of packaging, storage, and disposal options for opioids integrating packaging, storage, and disposal options into existing health care and pharmacy systems, including both open and closed health care systems data needs and how to address challenges in assessing the impact of packaging, storage, and disposal options in both the premarket and postmarket settings and ways in which FDA could encourage the development and assessment of packaging, storage, and disposal options for opioids that have the potential to enhance opioid safety.

2018. January: On January 11, FDA Commissioner, Scott Gottlieb, M.D., announced the 2018 Strategic Policy Roadmap, which provides an overview of some of the key priorities the agency will pursue advance FDA’s public health mission. Part of the Roadmap is reducing misuse and abuse of opioid drugs.

On January 11, FDA announced that it is requiring safety labeling changes for prescription cough and cold medicines containing codeine or hydrocodone to limit the use of these products to adults 18 years and older because the risks of these medicines outweigh their benefits in children younger than 18. The agency is also requiring the addition of safety information about the risks of misuse, abuse, addiction, overdose, death, and slowed or difficult breathing to the Boxed Warning of the drug labels for prescription cough and cold medicines containing codeine or hydrocodone.

On January 24, FDA and the Federal Trade Commission posted joint warning letters to the marketers and distributors of 12 opioid cessation products, for illegally marketing unapproved products with claims about their ability to help in the treatment of opioid addiction and withdrawal.

On January 30, FDA held a public hearing, “Opioid Policy Steering Committee: Prescribing Intervention—Exploring a Strategy for Implementation,” to receive stakeholder input on how FDA might, under its REMS authority, improve the safe use of opioid analgesics by curbing overprescribing to decrease the occurrence of new addictions and limit misuse and abuse of opioid analgesics.

On January 30, FDA announced limits to packaging for anti-diarrhea medicine Loperamide (Imodium) to encourage safe use.

On January 30, FDA posted the revised Blueprint, “Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain,” which broadens the current Blueprint to include information on pain management, including the principles of acute and chronic pain management non-pharmacologic treatments for pain and pharmacologic treatments for pain. (It is important to note that the revised Blueprint will not be considered final until the Opioid Analgesic Risk Evaluation and Mitigation Strategy is approved.)

On February 14, FDA held a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee to discuss the new drug application for Hydexor (proposed tradename), a fixed-dose combination oral tablet, submitted by Charleston Laboratories, Inc., that contains hydrocodone, acetaminophen, and promethazine, for the short-term management of acute pain severe enough to require an opioid analgesic while preventing and reducing opioid-induced nausea and vomiting. The committees also discussed the abuse potential of this non-abuse-deterrent product and whether it should be approved.

February: On February 15, through a cooperative agreement with the FDA, the Duke-Margolis Center hosted a public workshop, “Strategies for Promoting the Safe Use and Appropriate Prescribing of Prescription Opioids,” to examine the landscape of health system and payer interventions to promote safe and appropriate prescribing of opioids discuss how health systems and payers are using data and health IT tools to support interventions discuss how health system approaches were implemented, barriers to their adoption, and potential unintended consequences of adoption and discuss how to build an evidence base to support existing health system and payer interventions as well as how success may be defined and measured.

March: On March 27, FDA held a meeting of the Psychopharmacologic Drugs Advisory Committee to discuss the new drug application for lofexidine hydrochloride, submitted by US WorldMeds, LLC, for mitigation of symptoms associated with opioid withdrawal and facilitation of completion of opioid discontinuation treatment.

April: On April 17, FDA is hosting a public meeting on Patient-Focused Drug Development for Opioid Use Disorder (OUD), in collaboration with National Institute of Drug Abuse (NIDA). In addition to NIDA, FDA is also working closely with patient advocacy and community organizations to encourage participation from individuals with OUD. This meeting aligns with FDA’s ongoing work aimed at reducing the impact of opioid abuse and addiction.

On April 20, FDA issued the draft guidance, “Opioid Dependence: Developing Buprenorphine Depot Products for Treatment,” which reflects the agency’s current thinking regarding drug development and trial design issues relevant to the study of depot buprenorphine products (i.e. modified-release products for injection or implantation).

May: On May 16, FDA approved Lucemyra (lofexidine hydrochloride), the first non-opioid treatment for the mitigation of withdrawal symptoms associated with abrupt discontinuation of opioids.

On May 22, FDA convened a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee to discuss the new drug application for buprenorphine sublingual spray, submitted by INSYS Development Company, Inc., for the treatment of moderate-to-severe acute pain where the use of an opioid analgesic is appropriate. The committees will also be asked to discuss whether this product should be approved.

May: On May 30, FDA launched an innovation challenge to spur development of medical devices ‒ including digital health and diagnostics ‒ that target pain, addiction and diversion.

June: On June 1, FDA sent safety labeling change notification letters to drug companies with approved opioid analgesic products intended for use in an outpatient setting, which require the companies to include new safety information regarding the Opioid Analgesic REMS in the Boxed Warning and Warnings and Precautions sections of prescribing information due to a general lack of awareness of the REMS among all opioid analgesic prescribers.

June: On June 5, FDA took action against 53 websites marketing unapproved opioids as part of a comprehensive effort to target illegal online sales.

June: On June 26, FDA convened a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee to discuss the new drug application for oxycodone extended-release capsules, submitted by Pain Therapeutics, with the proposed indication of the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The product is intended to have abuse-deterrent properties based on its physicochemical properties. The committees will be asked to discuss whether the data submitted by the Applicant are sufficient to support labeling of the product with the properties expected to deter abuse.

June: On June 27, FDA convened internet stakeholders, government entities, academic researchers, and advocacy groups at a one-day Online Opioid Summit to discuss ways to collaboratively take stronger action in combatting the opioid crisis by reducing the availability of illicit opioids online.

July: On July 9, FDA hosted a public meeting on Patient-Focused Drug Development for chronic pain to hearing patients’ perspectives on chronic pain, views on treatment approaches, and challenges or barriers to accessing treatments for chronic pain.

August: On August 3, FDA convened a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee to discuss results from assessments of the transmucosal immediate-release fentanyl (TIRF) medicines’ risk evaluation and mitigation strategy (REMS), approved in December 2011. The TIRF REMS requires that healthcare providers who prescribe TIRF medicines for outpatient use are specially certified, that pharmacies that dispense TIRF medicines for inpatient and outpatient use are specially certified, and that completion of the prescriber-patient agreement form occurs prior to dispensing TIRF medicines for outpatient use. The Agency will seek the committees’ assessment as to whether this REMS with elements to assure safe use (ETASU) assures safe use, is not unduly burdensome to patient access to the drugs, and to the extent practicable, minimizes the burden to the healthcare delivery system. The Agency will also seek the committees’ input on any possible modifications to the TIRF REMS goals and requirements, as well as input on the adequacy of the evaluations conducted in the REMS assessments to determine whether the TIRF REMS goals are being met.

On August 6, FDA issued the draft guidance for industry, “Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment,” which is intended to assist sponsors in developing drugs for medication-assisted treatment of opioid use disorder (OUD) and addresses the clinical endpoints acceptable to demonstrate effectiveness of such drugs.

On August 22, FDA awarded a contract to the National Academies of Sciences, Engineering, and Medicine (NASEM) to help advance the development of evidence-based guidelines for appropriate opioid analgesic prescribing for acute pain resulting from specific conditions or procedures.

On August 28, FDA took action against 21 websites marketing unapproved opioids as part of agency’s effort to target illegal online sales.

September: On September 7, FDA approved a new dosage strength of buprenorphine and naloxone sublingual film as maintenance treatment for opioid dependence.

On September 18, FDA approved the Opioid Analgesic REMS.

On September 20, through a cooperative agreement with the FDA, the Duke Margolis Center for Health Policy convened a public workshop, “Expanding Access to Effective Treatment for Opioid Use Disorder: Provider Perspectives on Reducing Barriers to Evidence-Based Care.”

On September 27-28, FDA’s Office of Women’s Health, in collaboration with CDER and CTP, hosted a 2-day public meeting, “Opioid and Nicotine Use, Dependence, and Recovery: Influences of Sex and Gender.”

On October 11, FDA convened a meeting of the Anesthetic and Analgesic Drug Products Advisory Committee to discuss new drug application 210730, for oliceridine 1 milligram/milliliter injection, submitted by Trevena, Inc., for the management of moderate-to-severe acute pain in adult patients for whom an intravenous opioid is warranted. The committee also discussed the efficacy and safety data and benefit-risk considerations.

On October 12, FDA convened a meeting of the Anesthetic and Analgesic Drug Products Advisory Committee to discuss new drug application 209128, sufentanil sublingual tablets, submitted by AcelRx Pharmaceuticals, Inc., for the management of moderate-to-severe acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate, in adult patients in a medically supervised setting. The committee also discussed risk-benefit considerations and whether this product should be approved.

On November 1, FDA convened a joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee to discuss efficacy, safety and risk-benefit profile of new drug application 210417 for buprenorphine and samidorphan sublingual tablets, submitted by Alkermes, Inc., for adjunctive treatment of major depressive disorder.

On November 2, FDA approved first oral sufentanil pain medication for use in a medically supervised setting.

On November 14, FDA convened a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee to discuss new drug application 209774, for an immediate-release oral tablet formulation of oxycodone, which is intended to resist common methods of physical or chemical manipulation and to deter intravenous and intranasal abuse, submitted by SpecGx Inc., for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. The committees also determined whether the Applicant adequately demonstrated that the abuse-deterrent properties of the proposed product are sufficient to include this information in the product label, and whether the product should be approved.

November 15, FDA convened a meeting of the Anesthetic and Analgesic Drug Products Advisory Committee to discuss the assessment of opioid analgesic sparing outcomes in clinical trials of acute pain. The committee also commented on the trial design and endpoints of these studies and how to determine the clinical relevance of the results.

January: On January 17, FDA announced the results of unprecedented work to design, test, and validate the key labeling requirements necessary to approve an over-the-counter (OTC) version of naloxone, including posting two model Drug Facts labels (DFLs) and the supporting FDA review. Overall, the study demonstrated that the model DFL was well-understood by consumers and is acceptable for use by manufacturers in support of their OTC naloxone development programs.

February: On February 6, FDA issued the final guidance, “Opioid Use Disorder: Developing Depot Buprenorphine Products for Treatment,” which reflects the agency’s current thinking regarding drug development and trial design issues relevant to the study of depot buprenorphine products (i.e. modified-release products for injection or implantation).

On February 12, FDA announced ongoing efforts to stop the spread of illicit opioids, further secure the U.S. drug supply chain and forcefully confront opioid epidemic.

March: On March 19, FDA took action against marketer of unapproved products claiming to treat addiction, chronic pain and other serious conditions.

On March 27, FDA announced new steps to strengthen agency’s safety requirements aimed at mitigating risks associated with transmucosal immediate-release fentanyl products.

April: On April 2, FDA took new enforcement actions as part of the agency’s ongoing effort to combat the illegal online sales of opioids.

On April 2, FDA hosted internet stakeholders, thought leaders, government entities, academic researchers, and advocacy groups at its second Online Opioid Summit.

On April 9, FDA announced harm reported from sudden discontinuation of opioid pain medicines and required label changes to guide prescribers on gradual, individualized tapering.

On April 19, FDA approved first generic naloxone nasal spray to treat opioid overdose.

On April 25, FDA launched a public education campaign to encourage safe removal of unused opioid pain medicines from homes.

May: On May 30, FDA opened a public docket to request information on requiring fixed-quantity blister packaging for certain opioid pain medicines to help decrease unnecessary exposure to opioids.

On September 30, 2019 FDA and DEA warned website operators illegally selling opioids

October: On October 24, FDA outlined the agency’s first year accomplishments implementing SUPPORT Act authorities to address the opioids crisis

November: On November 26, FDA issues warning letter for products illegally marketed for the treatment of health conditions, including opioid withdrawal symptoms

December: On December 11, FDA issued warning letter for not including the most serious risks in advertisement for medication-assisted treatment drug

On December 19, the National Academies of Sciences, Engineering, and Medicine released a consensus report, commissioned by the FDA, on framing opioid prescribing guidelines for acute pain.

January: On January 14, FDA convened a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee to discuss the new drug application (NDA) for oxycodegol, a new molecular entity full mu-opioid receptor agonist, submitted by Nektar Therapeutics, for the management of chronic low back pain in adult patients with pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The committees were asked to discuss the safety and efficacy data as well as the overall risk-benefit profile of the product.

On January 15, FDA convened a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee. During the morning session, the committees discussed the NDA for tramadol 44 milligrams (mg) and celecoxib 56 mg tablet, which contains a fixed-dose combination of an opioid and a non-steroid anti-inflammatory drug, submitted by Esteve Pharmaceuticals, S.A., for the management of acute pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate. The committees were asked to discuss the safety and efficacy data as well as the overall risk-benefit profile of the product.

During the afternoon session, the committees discussed the NDA for an extended-release oral tablet formulation of oxycodone, submitted by Intellipharmaceutics Corp., for the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. The product has been formulated with properties intended to deter abuse, and the applicant has submitted data to support these abuse-deterrent properties for this product. The committees were asked to discuss whether the applicant has demonstrated abuse-deterrent properties for their product that would support labeling, as well as the overall risk-benefit profile of the product.

June: On June 8, FDA and the National Telecommunications and Information Administration (NTIA) are launching a 120-day pilot to help reduce the availability of unapproved opioids illegally offered for sale online.

July: On July 23, the FDA issued a Drug Safety Communication announcing that the agency is requiring the drug manufacturers for all opioid pain relievers and medicines to treat OUD to add new recommendations about naloxone to the prescribing information to help ensure that health care professionals discuss the availability of naloxone and assess each patient’s need for a naloxone prescription when opioid pain relievers or medicines to treat OUD are being prescribed or renewed. In addition, the agency recommended that health care professionals consider prescribing naloxone to patients at increased risk of opioid overdose, regardless of whether they are receiving a prescription for an opioid pain reliever or medicine to treat OUD. These may include people with a current or past diagnosis of OUD or who have experienced a previous opioid overdose.

August: On August 7, the FDA approved Olinvyk (oliceridine), an opioid agonist for the management of moderate to severe acute pain in adults, where the pain is severe enough to require an intravenous opioid and for whom alternative treatments are inadequate.

September: On September 10-11, the FDA convened a joint meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee to discuss the results of required postmarketing studies (Postmarketing Requirements 3051-1, 3051-2, 3051-3, and 3051-4) that evaluated the effect of the reformulation of OxyContin (oxycodone hydrochloride extended-release tablets, manufactured by Purdue Pharma L.P., NDA 022272) on abuse, misuse, and fatal and non-fatal overdose, associated with OxyContin. The committees discussed whether these studies, in concert with other information from the published literature, have demonstrated that the reformulated OxyContin product has resulted in a meaningful reduction in these outcomes. The committees also discussed the broader public health impact of OxyContin’s reformulation.

October: On October 2, the FDA published the final guidance for industry, Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Treatment, which is intended to help sponsors develop drugs for treatment of opioid use disorder (OUD). This guidance addresses clinical endpoints acceptable for demonstrating effectiveness of such drugs.

November: On November 2, the FDA convened a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee to discuss the new drug application for Hydexor, a fixed-dose combination oral tablet, submitted by Õlas Pharma, Inc., that contains hydrocodone, acetaminophen, and promethazine, for the short-term (not to exceed 3 days) management of acute post-operative pain severe enough to require an opioid analgesic and the prevention of opioid-induced nausea and vomiting in patients who are at risk for or have a history of nausea and vomiting.

December: On December 23, the FDA finalized modifications to the transmucosal immediate-release fentanyl (TIRF) Risk Evaluation and Mitigation Strategy (REMS) to address the persistence of concerning prescribing practices and improve the agency’s ability to monitor for adverse events and ensure safe use of these medicines.

February: On February 1, the FDA provided an update on the pilot program with the National Telecommunications and Information Administration (NTIA) and three domain name registries to help reduce the availability of unapproved opioids illegally offered for sale online.

February: On February 16, the FDA issued a warning letter to AcelRx Pharmaceuticals, Inc. for the false and misleading promotion of Dsuvia (sufentanil sublingual tablet), a potent opioid analgesic.

March: On March 1, the FDA approved Hydrocodone bitartrate (reference listed drug: Hysingla ER), the first FDA-approved generic opioid with an abuse-deterrent formulation (ADF)—meaning the product has properties that are expected to reduce, though not totally prevent, abuse of the drug when chewed and then taken orally or crushed and snorted or injected.

March: On March 24, the FDA issued a white paper, Introduction to FDA’s Opioid Systems Model, which introduces FDA’s opioid systems modeling effort, discusses potential uses of the model, provides an overview of the model’s scope and structure, highlights preliminary areas for potential policy analysis and outlines on-going work.​


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