FDA, Politics

Scott Gottlieb likes his job running the FDA, but he isn’t ruling out a big HHS promotion

Exactly 5 months after Scott Gottlieb was sworn in as the new commissioner of the FDA, he’s a top candidate to replace his old boss Tom Price as head of Health and Human Services. And even as he demurs about the idea of taking the high profile Cabinet post, he isn’t exactly refusing to consider it.

“I feel like I want to continue to follow through on the policies we’ve put out [at FDA] and it’s where I think I can be most effective,” the diplomatic Gottlieb told Reuters in an interview.

Has he been fielding any inquiries on the HHS job? He’s a bit more coy about that.

“I‘m not going to get into private discussions I might have had around that.”

The Hill has been handicapping the lineup of top candidates, which definitely includes Gottlieb, who’s seen as the pragmatic choice for HHS, which Price had to vacate after landing in a vat of boiling hot political water for his use of pricey private jets.

CMS director Seema Verma, who played a big role in lobbying for recent legislation for a new system to replace Obamacare, has been mentioned as the candidate most likely to fit the ideological qualifications needed to continue the fight against Obamacare. And then politicians like Louisiana’s Bobby Jindal could make it with the backing of allies in Congress.

Gottlieb has been earning widespread praise in the biotech world for his campaign to push more generics into the market, clearing a backlog of applications while tailoring the FDA to ease up on the approval process with a more receptive regulatory approach — without actually dumping the gold standard on safety and efficacy.

There are two big test cases on that score, with big Eli Lilly and little Amicus both steering new applications for top drugs back to the FDA after being told initially they needed to pursue new studies that would consume years and added costs.

Gottlieb proved an adroit player in Washington, DC during his confirmation hearings, skirting the most controversial fields and offering to assist lawmakers waging war on opioids. If he does wind up with the HHS nomination — a thought that would have been laughed at just months ago — you can expect plenty of fretting in biopharma about his replacement.

President Donald Trump, who’s been overseeing the rapid turnover of his top team, has alternately attacked biopharma and embraced it. In the latest encounter, as top pharma chiefs like Merck’s Ken Frazier bailed on the president in the wake of the controversy over Trump’s response to the Charlottesville protests, Trump was slapping back hard.

Image: Scott Gottlieb Getty

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
Marketing Associate - Demand Generation
Catalytic Data Science Charleston, SC
Associate Principal, Life Sciences Partnerships
Flatiron Health New York City or San Francisco

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