Generic User Fee Waivers Created In Draft House Bill, Breaking FDA-Industry Agreement

FDA says it likely will oppose the provision because it would create more administrative complexity and increase fees paid by individual firms, but many provider and professional associations think waivers could help prevent and alleviate drug shortages.

A small provision in the proposed House user fee package that would allow generic drug user fee waivers runs counter to the technical agreement negotiated by the FDA and industry to create the program.

A group of provider and professional associations is already urging adoption of the provision, though, because they believe it could...