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March 13, 2017

Trump to Nominate Gottlieb for FDA Commissioner

  • Scott Gottlieb, M.D., a former FDA deputy commissioner during the administration of George W. Bush, has been named by President Donald Trump as his nominee to run the agency.

    “@POTUS has announced his intent to nominate Scott Gottlieb as next Commissioner of the FDA,” White House Press Secretary Sean Spicer tweeted Friday at 10:02 p.m.

    The FDA is now led by acting commissioner Stephen Ostroff, M.D., pending U.S. Senate confirmation of Dr. Gottlieb. If confirmed as expected, he would be permanent successor to Robert M. Califf, M.D., who was nominated by Trump’s predecessor Barack Obama and left office the day Trump was sworn in.

    Trump’s announcement of intent to nominate Dr. Gottlieb comes nearly 2 weeks after Trump criticized the FDA’s approach to reviewing new drugs during his address to Congress. The president cited 20-year-old Megan Crowley, a Notre Dame sophomore whose life was saved through a Pompe disease treatment developed by Novazyme Pharmaceuticals, the drug developer founded by her father John F. Crowley, now chairman and CEO of Amicus Therapeutics.

    “Our slow and burdensome approval process at the Food and Drug Administration keeps too many advances, like the one that saved Megan’s life, from reaching those in need,” Trump said. “If we slash the restraints, not just at the FDA, but across our government, then we will be blessed with far more miracles like Megan.”

    Trump has also spoken out several times against sky-high-and-rising drug prices, tweeting March 7: “I am working on a new system where there will be competition in the Drug Industry. Pricing for the American people will come way down!”

    Last month, Trump committed to overhauling the FDA and shortening the approval time for new treatments—as well as restated his call for lower drug prices—during a meeting with biopharma industry leaders. Following the meeting, the industry’s two key trade groups, the Biotechnology Innovation Organization (BIO) and Pharmaceutical Research and Manufacturers of America (PhRMA), pledged to cooperate with Trump.

    That touched off criticism from a group long critical of the industry, which contended that rolling back FDA regulations would be a deadly mistake: “Destroying medication and device approval standards at the FDA will have devastating, life-and-death consequences for hundreds of thousands of Americans. It will also, incidentally, hurt the industry,” Public Citizen president Robert Weissman said in a statement.

    However, in one widely quoted survey of 53 biopharma executives by Mizuho Securities USA, Dr. Gottlieb emerged the clear favorite with 72% support among those surveyed. Over the past year, he has asserted that faster approvals could help lower drug prices, especially for generic drugs, since in many cases a single supplier holds rights to a treatment.

    A panel of industry leaders and observers agreed last month that a Trump administration can be expected to redirect the FDA.

    Dr. Gottlieb is a resident fellow with the American Enterprise Institute, a think tank which in part espouses free-enterprise approaches to policy issues. He also holds positions with two venture capital firms, serving as a managing partner with T.R. Winston and as a venture partner with New Enterprise Associates. NEA is the world’s largest venture capital firm with an active portfolio of more than 300 active tech and healthcare businesses and more than $17 billion in capital committed across 15 funds.

    Dr. Gottlieb served as FDA deputy commissioner for medical and scientific affairs during 2005–2007  and as senior advisor to the FDA commissioner and director of medical policy development during 2003–2004. In between both stints with the agency, he worked on implementing the Medicare Part D drug benefit as a senior adviser to the Administrator of the Centers for Medicare and Medicaid Services.

    Dr. Gottlieb’s tenue with the agency gives him a more traditional background than other people Trump was reported to have been considering for the FDA’s helm. Most widely reported among those was Jim O’Neill, managing director at Mithril Capital Management, the investment firm co-founded by Trump ally Peter Thiel, a co-founder of PayPal. O’Neill in 2014 called for “progressive” approval of new drugs after their safety has been established, but before efficacy has been proven.

    Other people speculated as Trump’s choice for the FDA were the former CEO of Mela Sciences, Joseph Gulfo, and Silicon Valley entrepreneur Balaji Srinivasan, co-founder of DNA screening provider Counsyl. Srinivasan has been a critic of FDA actions he has said hinder the adoption of innovative technologies.

     

     

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