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.
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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.
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.
The Trump transition team is considering Jim O'Neill, a Silicon Valley investment manager, to head US FDA, according to news reports. Previous comments from O'Neill – who has some HHS experience – suggest, he favors substantially reducing FDA's role in assessing product effectiveness. While some experts are highly skeptical about O'Neill, others suggest he could champion much-needed change at the agency.