President Donald Trump has chosen Scott Gottlieb to run the FDA. Gottlieb has a history of calling for faster approvals, greater regulatory transparency and a realignment of the balance of power between FDA and doctors, but as an industry insider is seen as a safer pair of hands than some of the other mooted candidates.
Having commented on FDA matters as a fellow at the American Enterprise Institute think tank for years—and continued to do so in the weeks before his nomination—Gottlieb has publicly set out his position on multiple regulatory topics.
Gottlieb is a believer in the potential for FDA actions to drive down the cost of drugs. This means the fast, flexible approach to evidence taken by FDA’s cancer division could spread throughout the agency, leading to the regulator waving through more applications and relying more on doctors to act as gatekeepers. And that Gottlieb could overhaul the aspects of generic drug regulation that prop up the prices of some products long after their patents have expired.
The commissioner elect, whose nomination still needs confirming by the Senate, also has a long history of arguing in favor of releasing complete response letters. Talking after an FDA task force floated the idea in 2010, Gottlieb said “we should have done this a long time ago,” adding that the “public deserves to see the agency’s explanations for its decisions.”
These proposals, while diverging from current FDA practices, are less extreme than the ideas put forward by other candidates who were reportedly in the running for the job. The relative restraint shown by Gottlieb, coupled to the understanding of FDA and the drug industry he accrued working for and with them, made him the first choice of many in biopharma.
Criticism of the pick has largely come from people outside the industry who are concerned about Gottlieb’s industry connections and position on the need for reform. Public Citizen blasted Gottlieb for his “dangerous deregulatory approaches” and “unprecedented web of Big Pharma ties”, while Harvard professor and FDA historian Daniel Carpenter told Vox Gottlieb will be “the most interest-conflicted commissioner in American history, by far.”
Robert Califf, M.D. was subject to criticism for his ties to the drug industry and, to a lesser extent, his comments about regulation being a barrier to innovation in the run up to his appointment as FDA commissioner, too.
Califf, who stepped down as commissioner in January, is still on leave from his position at Duke University. Since departing FDA, the cardiologist has defended the flexibility shown by the agency under the existing regulatory framework and poked holes in the idea that the regulator is impeding the availability of new drugs.
By Nick Paul Taylor
Source: Fierce Biotech
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