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March 6, 2019

Gottlieb is leaving FDA. Here's the legacy he'll leave behind.

Daily Briefing

    By Heather Bell, Managing Editor

    FDA Commissioner Scott Gottlieb sent waves through the health care industry and Capitol Hill on Tuesday when he announced he will resign from his position within the next month.

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    Gottlieb—a physician and cancer survivor who spent much of his career working in the pharmaceutical and health care industries—told the Washington Post, "I'm leaving because I need to spend time with my family. I get home late Friday, work on weekends, and come back to Washington on Sunday. I did the job 100%." According to the Post, Gottlieb has been commuting to Washington D.C. from Connecticut, where his wife and three daughters live.

    A senior White House official told the Post that President Trump did not seek Gottlieb's resignation. In a tweet, Trump said, Gottlieb "has helped us to lower drug prices, get a record number of generic drugs approved and onto the market, and so many other things. He and his talents will be greatly missed!"

    Gottlieb's health care record

    Gottlieb's time as FDA commissioner was marked by a focus on the opioid epidemic, significant changes to drug approval processes, and an emphasis on stemming e-cigarette use by U.S. teenagers. Among other highlights, Gottlieb:

    Accelerated generic drug approvals—and laid the groundwork for a new drug evaluation office: Under Gottlieb, FDA has taken steps to increase generic drug competition, approving a record 781 generic drugs in FY 2018, breaking the agency's previous record of 763 generic drug approvals in FY 2017. In January, Gottlieb announced plans to more broadly restructure the drug approval process. Gottlieb said FDA would begin that process by creating the Office of Drug Evaluation Science to develop a more structured approach to data analysis for drug approvals.

    Modernized the review process for new gene and cell therapies: Under Gottlieb, FDA in November 2017 unveiled a new risk-based framework designed to accelerate the approval of promising gene and cell therapy treatments. At the same time, FDA took aim at "bad actors" that offer stem cell injections they claim can treat dozens of medical conditions, such as Alzheimer's disease, arthritis, and multiple sclerosis.

    Spoke out against drug costs: While FDA commissioners in the past have steered clear of drug cost debates (in part because FDA has no regulatory authority over costs and isn't supposed to consider cost in approval decisions), Gottlieb has been a vocal critic of the United States' rebate system. In May, Gottlieb floated that the administration could consider revising safe harbor for drug rebates under the Anti-Kickback Statue—and in February HHS proposed a rule that would do just that.

    Led the crackdown on tobacco and e-cigarette makers: Gottlieb has called youth vaping an "epidemic" that could cause yet another generation of teens to become addicted to nicotine. Last year, Gottlieb unveiled a five-step plan to lower e-cigarette use among children and teens, and he took steps to implement several of those initiatives, such as launching a nearly $60 million education campaign and investigating the marketing tactics behind more than 40 e-cigarette products. In November, the agency unveiled a long-rumored proposal to limit the sale of most flavored e-cigarettes. According to the Post, the White House Office of Management and Budget currently is reviewing that proposal.

    Sought to make medical devices safer: Under Gottlieb, FDA formed new partnerships intended to better understand and respond to confirmed and potential cybersecurity threats to medical devices. For instance, FDA in October announced it had entered a memorandum of agreement (MOA) with the Department of Homeland Security to implement a formal framework for the agencies to coordinate on medical device-related cybersecurity threats. The agency for the first time ever also teamed up with ethical hackers to identify medical device vulnerabilities.

    Oversaw new opioid approvals—and a first-of-its kind removal: Under Gottlieb, FDA in 2017 took the unprecedented step of getting the opioid medication Opana ER pulled from the market because of concerns the drug's addictiveness outweighed its benefits. FDA said efforts by Endo Pharmaceuticals to make the drug harder to crush and snort had made it more appealing as an injectable—and contributed to a major outbreak of HIV and hepatitis C in Indiana in 2015. The following year, FDA approved US WorldMeds' Lucemyra, the first non-opioid treatment for managing opioid withdrawal. But a few months later, the agency made the controversial decision to approve a powerful new opioid called Dsuvia.

    How Gottlieb silenced (most of) his critics

    While some industry observers initially expected Gottlieb, who's had financial ties to major pharmaceutical firms, to protect Big Pharma's interests, he largely quieted those concerns and established himself as a rarity in the Trump administration: an official who garnered support from lawmakers and policymakers on both sides of the aisle, as well as health care industry stakeholders and observers. 

    Gottlieb was named to the No. 19 spot on Modern Healthcare's 2018 list of the Most Influential People in Healthcare for his work to speed up generic drug approvals and calls for price transparency. The American Journal of Managed Care readers in 2018 similarly named Gottlieb the Most Influential Person in Healthcare in 2018, citing his public health initiatives to limit teens' access to flavored tobacco products. That same year, TIME selected Gottlieb to appear on its annual list of the 50 people transforming health care for "grounding his tough policies in scientific evidence."

    As statements from lawmakers, industry stakeholders, and observers flooded the internet Tuesday, it became clear that many viewed Gottlieb's resignation as a loss to the health care community.

    According to Modern Healthcare's Susannah Luthi, several lawmakers were "surprise[d]" by the resignation and learned about the news only when reporters sought comment.  Sen. Richard Burr (R-N.C.), who has disagreed with some of Gottlieb's tobacco initiatives, told Luthi he thinks Gottlieb "is potentially one of the best commissioners we've ever had at the FDA."

    Joshua Sharfstein—a former principal deputy commissioner at the FDA under former President Barack Obama's administration, who is now a professor at Johns Hopkins Bloomberg School of Public Healthtold the New York Times' Sheila Kaplan and Jan Hoffman that Gottlieb "surprised a lot of people in his willingness to take some risks for public health." He added that Gottlieb "was remarkably successful at keeping the agency moving forward at a difficult time and really focused on public health challenges, including the opioid epidemic and drug prices."

    AdvaMed President and CEO Scott Whitaker praised Gottlieb for being a "tireless advocate for improved patient care" and for supporting medical technology to combat the opioid epidemic.

    John Maraganore—CEO of Alnylam Pharmaceuticals, which under Gottlieb received FDA approval of a novel medicine that uses technology called RNA interference—told STAT News' Matthew Herper that Gottlieb was "a terrific commissioner" and he's "very disappointed to see him go."

    Scott Melville—president and CEO of Consumer Healthcare Products Association, which includes manufacturers and distributors of over-the-counter drugs and nutritional supplements—said Gottlieb oversaw "tremendous progress" modernizing over-the-counter drug regulations.

    Several health care groups—including the American Heart Association and the American Cancer Society Action Network—praised Gottlieb's tenure, along with patient advocacy groups like Friend of Cancer Research and Center for Science in the Public Interest.

    On the other hand, Public Citizen's Michael Carome was one of the few to maintain his criticism of Gottlieb and his industry ties. Carome in a statement bid Gottlieb "good riddance."

    And there were also those who said Gottlieb could have done more. Pieter Cohen, an associate professor at Harvard Medical School who conducts research into the safety of dietary supplements, told the Post Gottlieb should have done more to address the major safety problems involving dietary supplements. Gottlieb last month sent warning letters to several companies selling supplements containing unapproved drugs, but Cohen argued FDA should have pursued recalls.

    In addition, Andrew Kolodny, co-director of the Heller School at Brandeis University's Opioid Policy Research, said Gottlieb could have taken more action on opioids. He tweeted, "Gottlieb's public comments on opioids were much better than his predecessors [and] he had some new ideas, but behind scenes little changed."

    What comes next

    Several media outlets reported that Gottlieb's departure could leave many of the initiatives he oversaw without a champion to see them through. As STAT News' Matthew Herper and Adam Feuerstein write, "He took personal ownership of every initiative, and pushed them forward with his own personal brand."

    For example, the Post reports that some initiatives—such as Gottlieb's controversial plan to ban menthol cigarettes—are still in the early planning stages and could face opposition without Gottlieb.

    Sen. Bill Cassidy (R-La.) separately told Luthi he hopes Gottlieb's departure won't slow the agency's progress on generic-drug approvals. "I hope that he's put in systems that will outlast him, because that's obviously the goal," Cassidy said.

    As for Gottlieb himself, he told the Post the decision to step down was "very hard." He added, "This is the best job I will ever have (McGinley et al., Washington Post, 3/5; Luthi, Modern Healthcare, 3/5; Roza, Inside Health Policy, 3/5 [subscription required]; Owermohle et al., Politico, 3/5; Herper, STAT News, 3/5; Kaplan/Hoffman, New York Times, 3/5).

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