FDA Commissioner Scott Gottlieb was an outlier in the Trump administration, with an activist agenda touching everything from medical device regulation to youth smoking.
His departure puts it all in jeopardy.
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“Legacies are hard to measure at this point, even if the next commissioner shares Dr. Gottlieb’s agenda,” said Steven Grossman, a health policy consultant specializing in FDA matters. “Whoever comes next is going to be far more dependent than Dr. Gottlieb on the priorities set by HHS and the White House.”
Gottlieb’s initiatives on nutrition and vaping, along with overhauling regulation of dietary supplements, often were at odds with Republican orthodoxy and the Trump administration’s anti-regulatory zeal.
That means whoever replaces the 46-year-old libertarian physician will be hard pressed to get buy-in from the HHS Secretary, the White House and both parties in Congress.
“We’ve developed very firm administrative records to support what we’re doing and the other thing is, we built consensus,” Gottlieb told POLITICO in an interview. “We did the hard work to get political consensus, not just broadly across Capitol Hill but within the administration. We went through the hard process of policymaking and we did it in an open and transparent fashion.”
But much of his work is only partly finished. Gottlieb said early Wednesday that he expects to finalize parts of his tobacco agenda, including curbing e-cigarettes sales and restricting flavored vapors, before leaving about a month from now. The agency continues to work out other regulatory questions, such as how to regulate meats grown from cells to make sausages, chicken nuggets and other products. Gottlieb repeatedly denied that his departure was connected to any policy disputes with others in the administration.
Other initiatives such as fleshing out how to regulate cannabidiol, a popular hemp-derived product recently legalized under the farm bill, could be stalled. And some of his policies could be reshaped in a way that loses bipartisan support.
Gottlieb’s efforts in traditional areas, such as changes to FDA’s new drug office or speeding up generic drug approvals, are likely to endure. “It’s the new technology, new areas the FDA is wading into, that could create challenges,” said Michael Werner, co-founder and senior policy counsel of the Alliance for Regenerative Medicine and partner at Holland & Knight LLP.
Areas like cannabis or dietary supplements “where there isn’t really sort of that political constituency yet or an established program … I think that’s where strong leadership and thoughtful leadership at the top really make a difference. Those are the spaces to watch,” he said.
Gottlieb himself conceded the most controversial area probably is tobacco and e-cigarette regulation. Plans like restricting e-cigarette sales in convenience stores are nearing completion: Gottlieb met with the White House Office of Management and Budget last week and told POLITICO he is “very confident” that the guidance will be issued soon. But his even more controversial tobacco proposals — which call for banning menthol cigarettes and flavored cigars entirely and instituting lower nicotine levels — are still being drafted and have never enjoyed much backing among conservatives.
“I can’t predict what’s going to happen six months down the road,” Gottlieb said. “But I think that a lot of the key elements of what we’re seeking to do here have broad support.”
Others are less certain. Sen. Richard Burr (R-N.C.) hasthe potential menthol cigarette ban and long criticized Gottlieb’s approach to the tobacco industry, even holding up unrelated legislation to protest tobacco user fees. Conservative groups like Americans for Tax Reform have vocally opposed virtually all the tobacco plans.
Still, Gottlieb pushed back on reports that the tobacco agenda was a source of tension within the administration, saying he had buy-in from both the White House and HHS Secretary Alex Azar.
And some Republicans in Congress quickly pledged to carry on Gottlieb’s initiatives.
Senate Finance Chairman Chuck Grassley (R-Iowa) told reporters Wednesday that he was ready to carry the legacy on aggressive tobacco and vaping policy, along with ambitious drug policy proposals. “I just hope the president will appoint somebody with the same approach as Gottlieb … we’ve got to refine the process in FDA for all drugs in particular for generics, and he was headed down that road and I hope that his successor will follow,” Grassley said.
Rank-and-file FDA officials were taken aback by Gottlieb’s departure. Throughout his tenure, the commissioner issued an unusual steady stream of new policy pronouncements, guidance documents and press statements on everything from food safety to opioids. The frequent communication, which was markedly different from past leadership, helped raise the profile of the agency in Washington and beyond.
“There were a lot of people at FDA staring at their computer screens sort of comatose,” said Stuart Pape, a lawyer at Polsinelli who specializes in food regulatory issues. “It certainly throws a monkey wrench into lots of initiatives across all the regulated products.”
The FDA divisions that handle nutrition and food safety have customarily had lower profiles than those dealing with drugs and medical devices but Gottlieb took a particular interest in food policy issues and raised their profile. The agency fought to continue much of the Obama administration’s nutrition agenda, implementing menu labeling and keeping on track a mandate to label added sugars on food packages — moves that pleasantly surprised public health advocates.
The FDA has also kept working on voluntary sodium reduction targets for processed foods — a controversial policy that was first proposed under the Obama administration that has not yet been finalized.
Gottlieb last year laid out a broad,, with plans for a consumer education campaign and a big update to food labeling standards, among other things. But much of this work is just beginning and supporters worry the momentum will be difficult to continue under new leadership.
“He had a big picture vision of the importance of nutrition and he had a big vision of the potential benefit,” said a former FDA official. “The question is: Will there be continued support for that?”
The official noted that anything controversial tends to need strong political backing from the commissioner and the White House in order to advance: “You’re only as strong as the support you get from above.”
Gottlieb, for his part, disputed the idea that the food side of FDA could languish after he leaves.
“The nutrition agenda and what we do to try to use nutrition as a vehicle to try to reduce the burden of chronic disease in this country is key part of the agency’s overall approach to public health,” he told POLITICO. “I don’t see that changing.”
But Gottlieb may underestimate how much his personality — particularly his communication skills — brought success.
HIs departure will create a “public health messaging gap,” given that “he centralized more than any commissioner the communication role to himself,” another former FDA official said.
“Gottlieb is a genius at offering a constant stream of newsy updates, packaging almost any FDA guidance or workshop into a larger more gripping narrative. In the absence of the constant, agency-directed messaging, those outside groups could start to reshape the narrative,” Rick Weissenstein of Cowen Washington Research Group wrote in a note to clients.
“Gottlieb is in many ways a singular figure,” Weissenstein added. “His political instincts, personal relationships and media savvy have changed the way the agency does business. So while we don’t think there will be a significant change in direction, it may be fair to say that we have seen the peak and maintaining that level will be a challenge for whoever takes over the agency.”
Adam Cancryn contributed to this report.