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Trump Budget: FDA-Regulated Firms Should Pay 'Their Share' In User Fees

 
• By Sue Darcey and David Filmore

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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A budget "blueprint" from the Trump administration asks for a major increase in user fees collected from medical-product companies in FY 2018 compared to what firms have agreed to. Meanwhile, the proposal appears to seek a significant reduction in funds provided by Congress to the agency for pre-market reviews, but details are lacking.

As is, the proposal could be a source of complication as the industry pushes for speedy reauthorization of the device user-fee program based on an agreement inked with the Obama administration’s FDA last summer

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