Reauthorization of FDA user fees is on track to be adopted well before the programs expire this fall following Senate passage of the Food and Drug Administration Safety and Innovation Act on May 24 and plans for the House to take up its version of the bill this week.
FDA User Fee Reauthorization Charges Along With Senate Passage
FDA user fee and reform bill sails through Senate on 96-1 vote. House plans to take up its similar legislation this week.
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Medical devices, diagnostics, and equipment face tariffs announced by President Donald Trump, despite industry pleas for exemption. The tariffs, ranging from 10%-49%, impact most countries trading with the US, potentially hindering innovation and increasing costs in the medtech sector.
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Energy and Commerce Health Subcommittee Democrats focus on criticizing HHS Secretary Kennedy’s RIF announcement, including 3,500 FDA jobs among cuts across HHS agencies. Representatives were left wondering if user fee programs would continue, even if reauthorized.
AdvaMed’s top priorities for the 119th Congress include modernizing US Medicare services and expanding patients’ access to the latest medical technologies.
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Product reviews for drugs, biologics, devices, tobacco and foods could be consolidated into one office at the FDA, as part of a restructuring plan circulating that was obtained by Pink Sheet.
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