Trump Budget: FDA-Regulated Firms Should Pay 'Their Share' In User Fees
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.
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President Trump's eleventh-hour signature on the FDA Reauthorization Act puts into play about $1bn in device user-fee collections from industry through FY 2022, new US FDA performance goals and a range of device process enhancements and reforms supported by industry.
The White House expressed general support for the US House-passed user fee reauthorization bill while also demanding user fees be increased, creating some confusion in industry.
Scott Gottlieb was sworn in as US FDA commissioner May 11. Device-industry lobbyists say championing quick passage of user-fee reauthorization should be his near-term priority. Gottlieb is a well-known figure by some in industry, including AdvaMed chief Scott Whitaker, who served with him at HHS during the George W. Bush Administration.