President Donald Trump has nominated Scott Gottlieb, MD, to be commissioner of the FDA. Gottlieb, in addition to being a physician, is a fellow at the American Enterprise Institute, a conservative think tank, and is a partner in a venture capital fund.
Gottlieb served as deputy commissioner for medical and scientific affairs at the FDA during the George W. Bush administration. Before that, he was a policy advisor at the Centers for Medicare and Medicaid Services (CMS).
Gottlieb has written extensively on health policy issues and has frequently testified in congressional committee hearings on issues including drug pricing. He has advocated for loosening requirements needed for approving new medical drugs and devices, according to a Reuters report.
According to DrugChannels.net, Gottlieb is seen as someone who could significantly change the ways prescription drugs are priced and paid for. The website noted that he has a “keen understanding of the potentially dysfunctional aspects of this system.”
“I’ve been a big fan of Dr. Gottlieb’s for some time and think he is an outstanding choice,” said Adam Fein, PhD, President of Pembroke Consulting, Inc., and CEO of Drug Channels Institute, in an email to Drug Topics.
President Trump has talked of lowering the high prices of drugs. The FDA has no authority over drug prices, but “Dr. Gottlieb understands drug channels well enough to know that it's misleading to focus solely on a drug's list price. That list price may have no relationship to a drug's net price to a payer, a patient's out-of-pocket cost, and the drug's impact on healthcare spending.”
His familiarity with members of Congress may help him gain approval for his nomination, but he may be hurt by accusations that he is overly close with drug companies and with those who invest in drug companies. Gottlieb has worked as a consultant to or has served on the boards of several companies, including GlaxoSmithKline. He received more than $400,000 in payments from pharmaceutical companies between 2013 and 2015, according to a CMS database. These financial ties are expected to be a feature of his nomination hearings.
Gottlieb, 44, is trained as an internist and hospitalist.
The FDA has regulatory power over about a quarter of the U.S. economy when you add up pharmaceuticals, drugs, food safety, and cosmetics. Although President Trump has promised to make big changes at the FDA and to reduce government regulation in general, Gottlieb is seen to be a relatively conventional choice for commissioner. This is true especially when compared to another top candidate for the job, Jim O’Neill. O’Neill had called for approving drugs if they have been shown to be safe, but have not yet been shown to be effective.