POLITICO: Adriel Bettelheim, Sarah Karlin-Smith, Sarah Owermohle, Helena Bottemiller Evich and Alice Miranda Ollstein contributed to this report.
FDA Commissioner Scott Gottlieb, an unusually activist regulator in the Trump administration whose agenda touched everything from tobacco to trans-fats, will step down in a month, leaving a void atop a $5 billion agency that regulates food, medicines and other products that comprise one-fifth of the U.S. economy.The 46-year-old libertarian physician’s announcement on Tuesday caught medical and food industries by surprise. Though he had tussles with some powerful interests and occasional clashes with other administration officials, he had strong backing from both President Donald Trump and Democrats in Congress, who supported many of his public health initiatives and his interest in bringing down drug prices.
In a resignation letter to HHS Secretary Alex Azar, Gottlieb noted his work to reduce tobacco use, discourage teen use of e-cigarettes, address the opioid epidemic and improve access to generic drugs.”I’m confident that the FDA will continue to advance all these efforts, and many other goals,” Gottlieb wrote.
He named Amy Abernethy, a respected physician and researcher whose medical career had touched many aspects of health care in academia and business, as his principal deputy in December. There was no immediate announcement of a successor, either on an interim or permanent basis.
Azar called Gottlieb an “exemplary public health leader, aggressive advocate for American patients, and passionate promoter of innovation.”Trump also praised Gottlieb’s service, tweeting he had done “an absolutely terrific job as commissioner of the FDA.
“The abrupt departure announcement caught many in Congress off guard. “I’m so disappointed,” said Sen. Tim Kaine (D-Va.).
“I was a skeptic but I think Scott did a good job,” said Sen. Patty Murray (D-Wash.). “I would’ve liked him to go further, but I thought he did an excellent job working with Congress.” Associates of Gottlieb said a big factor in his decision was that he has young children living back home in Connecticut.
Gottlieb, a former FDA and CMS official in the George W. Bush administration, was confirmed by the Senate in a 57-42 vote in May 2017 but went on to win bipartisan support for his public health initiatives. He was a key player in the Trump administration’s plans to revamp the drug approval process and reduce regulations and red tape, including in ways that fed into the president’s desire to lower drug prices and spur competition.
Gottlieb wasn’t afraid to speak on topics normally seen as a third rail for FDA commissioner, including drug pricing. He championed speeding up the drug review process to encourage more generics and biosimilar medicines to come to market. He also recently signaled that the agency would explore incorporating real-world data into new drug submissions, a move that could speed up clinical trials. It’s unclear how many of his unfinished priorities will be taken up by a successor — or whether some could be rolled back.
He was unusually transparent for a high-level government official, making frequent public appearances, blogging about the agency’s policy moves and spelling them out on Twitter. Gottlieb also at times candidly spoke about being diagnosed and successfully treated for Hodgkin’s lymphoma in his 30s.
His most high-profile advocacy came in the area of youth smoking, where he aggressively pressed e-cigarette manufacturers and retailers to halt marketing to teens. On Monday, he put 15 major retail chains on notice for underage tobacco sales while warning 40 manufacturers they could be marketing e-cigarette and tobacco products illegally. At the time, Gottlieb said more policy changes to restrict flavored tobacco and e-cigarettes were on their way soon. Those policies went further than some in the administration had advocated, creating tensions, sources within HHS said.
Gottlieb appeared on CNBC Tuesday morning, just hours before he gave notice, to discuss actions the agency was taking to fight underage cigarette sales.But Gottlieb got pushback from Sen. Richard Burr, a North Carolina Republican who has accused the agency of overreach on tobacco regulation and late last year put a hold on unrelated FDA legislation to flag his concerns. But even those tensions had limits: Burr on Tuesday called Gottlieb “potentially one of the best commissioners we’ve ever had at the FDA” and characterized their dispute as a difference of opinion.
The consumer group Public Citizen on Tuesday criticized Gottlieb for being cozy with industries he regulated and decisions such as the FDA’s approval of the potent opioid Dsuvia amid the addiction crisis last year.”It’s imperative, but sadly unlikely, that the next nominee for FDA commissioner be someone who is independent from industry ties and will make protection of public health the agency’s top priority,” the group’s president, Michael Carome, said in a statement.
Gottlieb also surprised the food industry and public health community by focusing on nutrition policy, something that’s usually a lower-profile issue for FDA commissioners.
During his tenure, the agency continued much of the Obama administration’s agenda on food, implementing calorie labeling on restaurant menus that was part of Obamacare, keeping a new requirement to label added sugars on Nutrition Facts labels, and finalizing a ban on trans fat — moves that were applauded by health advocates and frustrated industry leaders who thought they’d get more of a break during the Trump administration.
Gottlieb battled with the Agriculture Department on a handful of issues. The most public fight unfolded last summer over regulation of cell-based meats. The agency was unusually aggressive in asserting it had jurisdiction over the burgeoning sector, which grows meat tissue from cells to make sausages, chicken nuggets and other products. Ultimately, the administration decided that FDA and USDA will share jurisdiction.
The FDA has struggled with repeated foodborne illness outbreaks tied in particular to leafy greens on Gottlieb’s watch. After another E. coli outbreak cropped up last fall, the agency last year issue an unusually broad warning to consumers to avoid eating romaine lettuce. Investigators ultimately found the outbreak strain in a reservoir on a farm in Santa Barbara County, Calif., but that finding couldn’t explain the whole outbreak. Months later, FDA said the agency was still stumped about the root cause or causes of the outbreak, which sickened at least 62 people across 16 states and the District of Columbia last year.
The agency has long-delayed produce safety regulations targeted at preventing water contamination, which food safety advocates say would help prevent such outbreaks from happening.