March 10, 2017
By Alex Keown, BioSpace.com Breaking News Staff
WASHINGTON – Dr. Scott Gottlieb has inched closer to being named the new commissioner of the U.S. Food and Drug Administration (FDA), according to reports.
President Donald Trump is poised to tap Gottlieb, a former deputy commissioners at the FDA and conservative health policy specialist, to helm the regulatory agency, Reuters reported, citing unnamed sources. The decision could be made as soon as today, the wire service said. Gottlieb’s nomination was still being vetted as of this morning, a source told Reuters.
Gottlieb has been seen as the candidate most preferred by pharma executives. In a recent survey of 53 drug companies conducted by Mizuho Securities USA of Trump’s potential FDA choices, Gottlieb was the overwhelming favorite, garnering 72 percent of the vote.
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 (AEI), 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 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. 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.
It’s that experience that makes Gottlieb a palatable candidate for pharma leaders, particularly in light of Trump’s calls for overhauling the agency and his criticisms of what he called a “slow and burdensome” process of drug approval in the United States. According to Trump’s 100 Day 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.
If Gottlieb is tapped, Reuters said he is expected to encourage increased flexibility in clinical trial development. That will be made easier thanks to the 21st Century Cures Act, which was overwhelmingly passed by Congress earlier this month and signed into law by former President Barack Obama on Dec. 13. The Cures Act paves the way for streamlining FDA reviews of new medicines.
He has also talked about overhauling rules for approval of generic drugs as well as “injecting competition” into the market concerning situations where older drugs are controlled by one manufacturer and allowed to set the price at high levels, Bloomberg reported.
Many of Trump’s candidates for FDA commissioner were seen as radical choices who would dismantle or heavily de-regulate the agency. Some of those candidates included Jim O’Neill, who 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. Gottlieb would bring some reforms to the agency, but is not seen as someone who would throw out the baby with the bathwater in an attempt to cut through the proverbial red tape. Diana Zuckerman, president of the National Center for Health Research, told Bloomberg that Gottlieb has an anti-regulatory focus, but also “understands the agency and has some respect for it.”
