Trump pick Gottlieb likely to speed FDA nods without tossing agency's risk-benefit model: analysts

Scott Gottlieb is likely to get President Donald Trump's nod to run the FDA, according to Reuters. (Photo courtesy of the American Enterprise Institute)

President Donald Trump has picked former agency insider Scott Gottlieb to head up the FDA in a move that's already drawing kudos from industry analysts and execs hoping for faster, more streamlined drug approvals.

The president decided on Gottlieb for the position over venture capitalist and contrarian thinker Jim O’Neill, who was said to be under consideration late last year.

It’s a decision the industry appears to support, as a recent Mizuho Securities survey of biopharma execs showed that 72% of the 53 respondents favored the former FDA deputy commissioner for the agency’s top job. 

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"I believe Scott Gottlieb is the least likely to rail for the obliteration of the current efficacy, safety, risk-benefit model that is a foundation for advancement of new treatments in the United States," one of those execs told Mizuho in the anonymous survey.

And there are clues about what Gottlieb might do if confirmed. According to a recent note from Bernstein analyst Ronny Gal, the "(presumably) pharma-friendly" Gottlieb would like to see a faster drug approval process, and that may have built him some favor with Trump.

In a move less favored by the industry, the nominee may also open up some previously secret agency information. Gottlieb has said the FDA should publish its complete response letters (CRLs) when it rejects an application, one idea that has the backing of analysts at Piper Jaffray. The letters are currently confidential.

Both Gal and RBC Capital Markets analyst Randall Stanicky believe Gottlieb will specifically push for faster generic approvals as one way to lower costs. Just days before making the appointment, Trump tweeted that he wants to increase “competition” in the industry, Stanicky pointed out.

That's a pledge the president has made several times during the campaign and since the election. Back in January, before taking office, he said pharma was “getting away with murder,” adding that he wants to see new competitive “bidding” to bring prices down.

Trump backed off that tone during a meeting with the industry weeks later when he and top CEOs talked about regulations, jobs, and importantly, prices.

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During his career, Gottlieb has served as a practicing physician and as a governmental health policy adviser in several roles. In addition to his current position as a resident fellow at the conservative think tank American Enterprise Institute, he's a clinical assistant professor at New York University and a health information technology adviser for the Department of Health and Human Services.

At the FDA, he served as a deputy commissioner for medical and scientific affairs under President George W. Bush. He's praised the leadership of FDA oncology czar Richard Pazdur, whose efforts have significantly sped up the review time for lifesaving cancer meds.

One exec polled by Mizuho said the prospective nominee "understands that a consistent, higher bar must be preserved while attempting to streamline innovation like that shown in the oncology division under Dr. Pazdur."

Though Gottlieb might be pharma's preferred candidate, nonprofit Public Citizen isn't a fan of the pick. Michael Carome, health research director at the group, said in a statement that Gottlieb "is entangled in an unprecedented web of Big Pharma ties" that "span decades."

Back in December, Bloomberg reported that Trump was considering nominating O’Neill, a name that sent shock waves through the industry as experts dug into the venture capitalist’s past statements on FDA regulations.

Among those statements was an endorsement for a “progressive approval” system, in which patients could use drugs after companies have established safety, but before they’ve ironed out efficacy. Just 8% of biopharma execs supported O'Neill in Mizuho's poll.