February 6, 2017
By Alex Keown, BioSpace.com Breaking News Staff
WASHINGTON – During a meeting with pharma executives last week President Donald Trump said he was close to naming a “fantastic” new head of the U.S. Food and Drug Administration who would streamline the agency and cut regulations to allow products a quicker route to market.
Multiple names have been bandied about, including Joseph Gulfo, the former chief executive officer of Mela Sciences and Jim O’Neill, a longtime colleague of Trump transition team scientific adviser Peter Thiel. But, industry leaders have their own preference for a new FDA commissioner—Dr. Scott Gottlieb, a former deputy commissioners at the FDA. Gottlieb has strong ties to the pharmaceutical industry and currently serves as an adviser to several companies, including GlaxoSmithKline (GSK).
This morning, Endpoints reported that Mizuho Securities USA conducted a survey of 53 drug companies asking which of Trump’s potential FDA commissioner candidates was preferable. Gottlieb was the overwhelming favorite, garnering 72 percent of the vote, Endpoints noted. O’Neill received 8 percent of the vote and Gulfo took in 9 percent. Another potential candidate, Balaji Srinivasan, the co-founder of Counsyl Inc., received 2 percent of the vote, Endpoints said.
Gottlieb earned his medical degree from Mount Sinai School of Medicine and holds a bachelor’s degree in economics from Wesleyan University. He is currently a venture partner at New Enterprise Associates and resident fellow at the American Enterprise Institute, a conservative think tank. 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. Gottlieb served several years at the FDA and has a strong understanding of the agencies role. From 2003 to 2004, Gottlieb was a senior adviser to the FDA commissioner and then the agency’s director of medical policy development. 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.
With his resume, Gottlieb seems as if he would be an ideal choice to helm the FDA. However, Gottlieb’s strong credentials could actually hurt him when it comes to garnering favor with the president, who has shown a knack for selecting some advisers and cabinet leaders with little experience for those roles. Trump has shown a decided interest in having his administration play the role of disruptor when it comes to several agencies and the FDA is likely no exception given some of his comments made during and after the campaign. 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. During the meeting with pharma heads last week Trump said one thing about the FDA that has always bothered him was the slowness to approve new drugs.
