Wednesday, 23 August, 2017

Trump's FDA pick Scott Gottlieb has deep ties to pharma industry

Endpoints News Endpoints News
Sammy Stanley | 16 March, 2017, 00:28

The White House announced the nomination of Gottlieb on March 10. He is a frequent contributor to The Wall Street Journal. He has also served as the deputy commissioner of the FDA under President George W. Bush, and held other roles at the agency.

The nominee is now a fellow at the American Enterprise Institute. Although we are always right to view political appointees with some skepticism, let us not lose sight of the ultimate mission here: to improve public health. Indeed, Dr. Gottlieb is decidedly not the kind of Washington "outsider" President Trump has gravitated toward during his first 2 months in office. That may be a bit much, but it is worth noting that President Trump is hardly the first to suggest the need for an accelerated approval process for novel therapies and/or vaccines for rare and/or troubling infectious diseases that now lack effective treatments and/or prophylaxis.

"Longer, larger trials that require drug makers to evaluate "hard" endpoints (like how long a cancer patient lives) rather than "surrogate" endpoints (like a drug's ability to shrink tumors) give FDA reviewers more statistical confidence".

"It's widely known that he's very conservative; that he's been sympathetic, if not complicit, with the pharmaceutical industry over many years, and so that raises some concerns", she noted. "If the Senate does not reject Gottlieb, he will have to be recused from key decisions time and time again, otherwise there is no way to be sure he will put the public's health over industry profits", said Michael Carome, MD, director of Public Citizen's Health Research Group in a press statement. "His nomination would confirm Trump's plans to move forward with a unsafe deregulatory agenda at the agency".

Paul Howard, a senior fellow with the Manhattan Institute, reportedly said, "Scott is an exceptional choice for FDA commissioner". The Cures Act paves the way for streamlining FDA reviews of new medicines. He is now a Partner at venture capital firm New Enterprise Associates and sits on the Board of and serves as an advisor to several pharmaceutical companies, including GlaxoSmithKline. He's also a senior principal at TR Winston, a health care-focused merchant and investment bank, and a senior adviser and partner to Arcoda Capital Management, a health care-focused hedge fund.

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