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March 6, 2019

Gottlieb Resigns from FDA; the Future of Vaping Remains Uncertain

FDA Commissioner Scott Gottlieb resigned yesterday after less than two years on the job, and will leave office next month. In January, Gottlieb denied that he was quitting the job, telling his Twitter followers, “I want to be very clear – I’m not leaving. We’ve got a lot important policy we’ll advance this year. I look forward to sharing my 2019 strategic roadmap soon.”

Gottlieb is well known to vapers, both for postponing the 2018 deadline for FDA marketing approval — which saved the industry from certain death — and later for legitimizing the coordinated attacks on JUUL that have led to a nationwide moral panic over teenage vaping.

Gottlieb announced in July 2017 that the FDA would launch an initiative that would reduce the nicotine in cigarettes below addictive levels, and at the same time encourage smokers to switch to e-cigarettes and other safer nicotine products. For the first time, Americans heard an FDA commissioner admit that vapor products could have a public health benefit.

Rumors are swirling in D.C. over the resignation, including one story that Gottlieb was forced out of office after conservative groups pressured the White House to reject his proposed ban on flavored vaping products in convenience stores. He has also recently been pilloried on the floor of the Senate by North Carolina Republican Richard Burr, a longtime tobacco industry ally, who objected to Gottlieb’s proposal to ban menthol cigarettes.

But Gottlieb denied the rumors and instead cited personal reasons. He has commuted weekly between his Washington, D.C.-area office and his home in Westport, CT for two years, and has had little time to spend with his wife and three young children. He did not explain why he announced six weeks ago that he would not quit.

He told the Times he will remain in office long enough to advance his c-store flavor ban, and other tobacco regulatory initiatives that are in the pipeline. That could include e-liquid flavor regulations, which the FDA has been considering for about seven months. Prohibition of most flavors could kill the independent vaping industry.

Unnamed sources in the Trump administration told the Washington Post that Gottlieb was not fired. Two White House officials said that Trump doesn’t want Gottlieb to leave the FDA, and that he might even be asked to take another job.

President Trump reacted on Twitter: “Scott Gottlieb, who has done an absolutely terrific job as Commissioner of the FDA, plans to leave government service sometime next month. Scott 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!”

No successor has been named. Vaping industry stakeholders who are tempted to throw parties should probably consider that the next commissioner may not be an improvement by their standards. Previous FDA commissioners have left much of the vaping regulatory decisions to the FDA Center for Tobacco Products and that office’s director Mitch Zeller. It was Zeller that led the creation of the Deeming Rule.

Gottlieb, 46, had worked at the FDA previously, during the George W. Bush administration. Since then he has worked as a venture capitalist, a fellow at the conservative American Enterprise Institute, and an assistant professor and practicing M.D. at New York University School of Medicine. He also owned stock in many pharmaceutical and biotech companies, and was on the board of vape shop franchiser Kure. (He divested all his stocks after he was approved.)

Because of his libertarian politics and industry ties, he got some pointed questions from skeptical Democrats during his confirmation hearing, but once approved by the Senate he set about becoming one of the most active and hands-on FDA commissioners in history, taking actions that were generally applauded by both sides in the hyperpartisan Congress.

In his resignation letter, sent to Department of Health and Human Services Secretary Alex Azar, Gottlieb ticked off the FDA’s accomplishments during his watch:

Dear Mr. Secretary:

With this letter, I hereby tender my resignation as Commissioner of Food and Drugs, effective in one month.

Over the past 23 months, I’ve been privileged to work with an outstanding team at the Food and Drug Administration, and to collaborate with the professional staff on the implementation of many meaningful initiatives that have advanced the public health. I’m fortunate for the opportunity that the President of the United States afforded me to lead this outstanding team, at this time, in this period of wonderful scientific advances. I’m deeply grateful for your support and the support of the President and his team in advancing many critical public health goals.

In the last two years, the FDA set out to advance major new policies to reduce the morbidity associated with tobacco use; to confront teen use of e-cigarettes; to decrease the rate of new opioid addiction; to improve access to affordable generic drugs; to modernize the development process for novel medical technologies like gene therapy and targeted medicines; to implement measures to improve food safety and our ability to identify and track outbreaks of foodborne illness; and to reduce the burden of chronic disease through better information and diets.

Working together, my colleagues and I achieved all of these goals, and much more.

We approved a record number of generic medicines, novel drugs, and novel devices in 2017 and then topped our own achievements with new records we set in 2018. We set in motion a historic modernization of the Office of New Drugs and of the Office of the Commissioner.

We advanced new approaches for the modern and efficient regulation of cell based regenerative medicine, complex generics, targeted cancer drugs, dietary supplements, digital health tools, and personal genetic tests. We forged a new breakthrough pathway for novel devices that promote safety, and undertook historic modernizations of the 510(k) process. We expanded opportunities for patients with terminal illness to access investigative medicines.

We’ve taken notable enforcement actions to confront bad actors that put Americans at risk. We cracked down on bogus stem cell therapies, on sham homeopathy, on unsafe medical device products, on tobacco sales to minors, on unsafe dietary supplements, and on kratom.

The agency helped support major legislative efforts to secure a more modern framework for the efficient regulation of diagnostic tests and over-the-counter drugs; to advance animal health through a new pathway that makes the development of drugs targeting unmet animal health needs more efficient; to support our efforts to address the opioid crisis with historic new authorities and resources; to more efficiently advance safe and effective medical priorities for our troops; and to sharply expand our interdiction work inside the International Mail Facilities.”

We were strong in moments of crisis.

We dedicated ourselves to the recovery of Puerto Rico and mitigated and averted drug and device shortages in its aftermath. We led a global investigation into impurities found in a class of critical medicines. We restored critical functions and protected the public during a historic government shutdown. We were transparent with the public in these and all our endeavors. All of these efforts were broad undertakings. They took the collective dedication of the professional staff of the FDA, whose commitment to the public health drove these and many other objectives on behalf of Americans.

All of these efforts will have palpable impacts on the health of patients and the safety of families. We did all this, and much more, through the hard work, scientific prowess, and public spiritedness of one of the most talented workforces in the Federal government. I’m grateful to have shared these opportunities with my FDA colleagues. I’m thankful for their support and commitment to our shared mission. And I’m thankful to my family for their support in enabling me to take on the privilege of serving in this role. I’m confident that the FDA will continue to advance all these efforts, and many other goals.

Sincerely,

Scott Gottlieb, MD

Commissioner of Food and Drugs

Smokers created vaping without any help from the tobacco industry or anti-smoking crusaders, and vapers have the right to keep innovating to help themselves. My goal is to provide clear, honest information about the challenges vaping faces from lawmakers, regulators, and brokers of disinformation. I recently joined the CASAA board, but my opinions aren’t necessarily CASAA’s, and vice versa. You can find me on Twitter @whycherrywhy

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