Q&A: Mark McClellan Discusses Gottlieb, Cures And More
Former FDA Commissioner Mark McClellan talked with Medtech Insight about FDA Commissioner-nominee Scott Gottlieb, who he has worked closely with in the past at FDA and CMS. He also discussed 21st Century Cures Implementation, President Trump's budget blueprint and more.
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President Trump's initial budget plan for US FDA would, it appears, make industry-paid user fees a much larger proportion of the agency's budget, but details are lacking. As is, the plan could complicate agreements that came out of FDA-industry user-fee negotiations last summer, but observers say this is just the first step in a process and Congress will ultimately decide. Trump would also shave 22% from the National Institutes of Health.
FDA Confirmation Watch: Gottlieb Likely To Face Questions About Approval Standards, Ties To Industry
Top HELP Committee Democrat Patty Murray tweeted concerns about Gottlieb's positions on the "gold standard" of FDA approval; Pubic Citizen's Michael Carome ultimately thinks Gottlieb will be approved.
After months of waiting on whether President Trump would pick a conventional FDA commissioner candidate or go off the beaten path, the White House appears to be taking the former approach. Trump is expected to nominate Scott Gottlieb, a George W. Bush administration FDA alum, physician and long-time conservative voice on health policy. Gottlieb will favor reduced regulatory burdens, and industry hopes he will help push forward a device user-fee reauthorization agreement.