FDA Nominee Scott Gottlieb, MD, Advances to Senate Vote

April 27, 2017

Is a presidential nominee's experience in a particular industry constructive or compromising when the government assignment is to regulate that industry?

In the case of Scott Gottlieb, MD, the Republican-controlled Senate Health, Education, Labor, and Pensions (HELP) committee came down mostly on the side of constructive. Today it voted 14 to 9 to send Dr Gottlieb's nomination to be commissioner of the US Food and Drug Administration (FDA) to the full Senate for a confirmation vote.

President Donald Trump's pick to lead the FDA is a board director or adviser to a number of drug and medical device manufacturers such as GlaxoSmithKline and Tolero Pharmaceuticals. Dr Gottlieb also is a managing director of an investment banking firm that specializes in healthcare, and a venture partner in a venture capital firm that has invested in healthcare companies.

Dr Scott Gottlieb, President Donald Trump's nominee to head the FDA, appears at his confirmation hearing before the Senate HELP Committee on Wednesday, April 5, 2017.

Those are just some of the professional hats he's worn. He's practiced as a hospitalist, served in the FDA for a time as a deputy commissioner; and opined on healthcare policy as a resident fellow at the conservative-leaning American Enterprise Institute.

Dr Gottlieb's industry hats are the ones that have stirred up the most debate, however. Sen. Lamar Alexander (R-TN), who chairs the HELP committee, suggested that no one would question the nomination of a farmer to head the Department of Agriculture just because he or she was a farmer.

"We need people in government with experience in the types of industries and agencies and activities that they're in charge of," said Alexander. He noted that to avoid possible conflicts of interest, Dr Gottlieb had agreed to resign from his industry posts and recuse himself from decisions involving some 20 companies and institutions for 1 year. Those actions, said Alexander, persuaded the US Office of Government Ethics to give Dr Gottlieb a clean bill of health. He noted that the last three FDA commissioners, two of them nominated by Barack Obama, support Dr Gottlieb's nomination.

Democrats such as Sen. Patty Murray (D-WA), the ranking minority member of the HELP committee, were unconvinced.

"I have grown increasingly concerned whether [Dr Gottlieb] can lead the FDA in an unbiased way, given his unprecedented industry ties," said Murray. She noted that his promise of recusal does not apply to all the clients of the venture capital and investment firms where he works.

Murray's argument didn't win the day, however, even in her own party. Two of the 11 Democrats on the committee — Sen. Sheldon Whitehouse (D-RI) and Sen. Michael Bennet (D-CO) — joined the 12 Republican members to recommend Senate confirmation of Dr Gottlieb. A spokesperson for Senate Majority Leader Mitch McConnell (R-KY) told Medscape Medical News that he had nothing to announce about the date for the final vote.

Follow Robert Lowes on Twitter @LowesRobert.

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