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Trump nominates Gottlieb to head FDA

If confirmed he would take over from previous commissioner Robert Califf

US Food and Drug Administration (FDA)

President Donald Trump has named Scott Gottlieb as his choice for the new commissioner of the FDA, a choice that will be welcomed by pharma but is already making waves among those who believe his ties to the industry are a concern.

A medical doctor, former FDA deputy commissioner and health policy expert, Gottlieb has the credentials to take over from previous commissioner Robert Califf, who stepped down from the post on January 20 after Trump's inauguration.

He is certainly more of a mainstream choice than the other candidates mentioned in dispatches - tech capitalist Jim O'Neill, computational biology expert and tech investor Balaji Srinivasan and Joseph Gulfo, a healthcare technologist and outspoken FDA critic.

Gottlieb has close links with the pharma industry however, sitting on the board of several small biopharma companies as well as being an advisor to GlaxoSmithKline (GSK), and is a partner at venture capital fund New Enterprise Associates and managing director of investment banking firm TR Winston & Co.

Those ties to the commercial side of the drug industry have left some in the healthcare sector wary, particularly as he is an advocate of cutting regulations at the FDA – something Trump himself has said is a key reform goal – to make it easier to get new drugs and medical devices to market.

Some lawmakers have been making their reservations clear, with Senator Patty Murray (D-WA) tweeting: "There are concerns w/ Dr. Gottlieb's record & about how his views would impact our ability to maintain the "gold standard" of #FDA approval."

Meanwhile, a perusal of the comments below this Medscape article on the nomination suggests that the nomination is polarising doctors, much like Trump's choice of Tom Price to run the Department of Health and Human Services (DHHS), which was announced in December.

Industry body the Pharmaceutical Research and Manufacturers of America (PhRMA) welcomed the nomination, saying that Gottlieb's "extensive experience as a physician and breadth of healthcare knowledge will help ensure the FDA continues to play a vital role in protecting public health and innovation in the agency’s review and approval of new medicines for patients in need".

Consumer advocacy group Public Citizen is less enamoured. The group said in a statement that Gottlieb is "entangled in an unprecedented web of big pharma ties. He has spent most of his career dedicated to promoting the financial interests of the pharmaceutical industry".

"When Gottlieb served as FDA deputy commissioner, he was recused from many key meetings and decisions due to his close relationship with industry," it asserts.

The President's choice still has to win the backing of the Senate, and the confirmation process will kick off with a hearing in front of the Senate Health, Education, Labor and Pensions (HELP) committee, currently controlled by Republicans.

Article by
Phil Taylor

13th March 2017

From: Regulatory



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