Trump Chooses Gottlieb to Head FDA

14.03.2017 -

US President Donald Trump has chosen Scott Gottlieb to head the Food and Drug Administration. The 44-year-old former physician, who served as deputy FDA commissioner of medical and scientific affairs at the FDA between 2005 and 2007 under President George W. Bush, is described as conservative and in the past sometimes critical of the drug regulatory authority but not one who would take a wrecking ball to the agency he has been named to lead. Gottlieb’s appointment must still be confirmed by the US Senate.

The nominee, said to have strong ties to Wall Street and the pharmaceutical industry, is currently a resident fellow at the conservative think-tank American Enterprise Institute and a partner in the venture capital firm New Enterprise Associates. Since leaving the FDA in 2007, he has served as a board member or adviser to at least nine pharmaceutical or medical technology companies and at present is a consultant to GlaxoSmithKline's product investment board, among other positions.

Trump has said he wants the new head to “cut red tape” at the agency, in order to speed up the drug approval process. In a January meeting with pharmaceutical industry executives, the then president-elect said he aimed to slash regulation by 75-80%, “a level no one has seen before.”  At a speech to Congress on Feb. 28, the newly sworn in chief executive called the FDA’s decision-making “slow and burdensome,” despite last year’s passage of the 21st Century Cures Act, a wide-ranging law designed to accelerate the review process for new drugs and devices.

Some of those commenting on Trump’s remarks said the review process at the FDA is relatively fast compared with health regulators in other countries.  Although 2016 saw only 22 new medicines approved, the lowest number since 2010, the two preceding years saw near-record highs. Altogether 45 new drug were approved in 2015.

Pharma industry observers told the journal Xconomy that of the candidates regarded to be in line for the FDA job, Gottlieb was the sector’s “clear favorite.” In a recent survey of drug company managers conducted by biotech analyst Salim Syed of Mizuho Securities, 72% of the 53 polled said he would be their choice. One of the executives who spoke to Xconomy said Gottlieb was 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.”

In recent remarks to the BIO CEO & Investor Conference in New York, a partner in Deerfield Management reportedly said it would become “exceedingly difficult to invest” in biotech stocks if the stance of a hedge fund manager who believed the FDA should only review whether drugs are safe, leaving it to the market to decide whether they actually work, prevailed. 

While Gottlieb is seen as generally supporting reduced FDA regulation, particularly for health apps and wearable devices like the Apple Watch, ,” the biotech publications said he has “never embraced libertarian-leaning proposals that would have the FDA abandon its effectiveness reviews of drugs and medical products.”