December 13, 2016
By Alex Keown, BioSpace.com Breaking News Staff
WASHINGTON – Another name has surfaced as a potential candidate to helm the U.S. Food and Drug Administration under the presidential administration of Donald Trump. Reuters is reporting Dr. Scott Gottlieb, a former deputy commissioners at the FDA is now a leading candidate.
Gottlieb previously served in the FDA under the administration of President George W. Bush. He is currently a venture partner at New Enterprise Associates and resident fellow at the American Enterprise Institute, a conservative think tank, Reuters said. Gottlieb earned his medical degree from Mount Sinai School of Medicine and holds a bachelor’s degree in economics from Wesleyan University. In addition to his roles at AEI, Gottlieb advises the U.S. Department of Health and Human Services as a member of the Federal Health Information Technology Policy Committee, Reuters said.
Gottlieb has strong ties to the pharmaceutical industry and currently serves as an adviser to several companies, including GlaxoSmithKline , Reuters said.
Gottlieb is the latest in possible candidates for the FDA’s top spot under Trump. Earlier this month, Donald Trump supporter Peter Thiel recommended Jim O’Neill, a longtime aide and investment partner, as a potential candidate to helm the FDA or take a leadership role at Health and Human Services. Like Gottlieb, O’Neill served in the Bush administration, as principal associate deputy secretary at the Department of Health and Human Services. O’Neill currently serves as a managing director of Thiel’s Mithril Capital Management.
If O’Neill were to be tapped, he would be the first FDA head in more than 50 years without a background in science or medicine. O’Neill has a history of calling for reforms at the FDA, including allowing for the approval of drugs after they have been proven safe, but have not yet necessarily proven efficacy. O’Neill also argued for a free-market approach to medication. In 2009, he said that kind of approach would drive drug prices lower and allow for innovation in terms of drugs and drug delivery.
It’s those radical and disruptive ideas about the FDA that make Gottlieb a more palatable choice, Michael Gaba, federal policy leader of law firm Holland & Knight‘s national Healthcare & Life Sciences Team, told Reuters.
Gottlieb served several years at the FDA and has a strong understanding of the agency’s role. From 2003 to 2004, Gottlieb was a senior adviser to the FDA commissioner and then the agency’s director of medical policy development, Reuters said. In 2004, Gottlieb took on a role as senior adviser to the Centers for Medicare and Medicaid Services. And then from 2005-2007, he served as the FDA’s deputy commissioner for medical and scientific affairs.
During the presidential campaign, Trump was critical of the FDA and called for more efficiency when it comes to approving new drugs. In his 100 Day Plan, Trump said one FDA-specific reform he intends to undertake is to “cut the red tape at the FDA.” According to Trump’s plan, there are “over 4,000 drugs awaiting approval, and we especially want to speed the approval of life-saving medications.” Trump has also called for easing restrictions for drugs that have been approved by foreign regulatory agencies to be available in the United States, which would bypass the FDA’s regulatory authority over drugs available in the U.S.
