FDA Encouraged by Generics Proposal Heading Into User Fee Talks

Generic-drug makers appear to be uniting behind a broad user-fee proposal that would be based on more than just FDA reviews of their applications. The proposal would combine the traditional “sponsor and review-based” model used by brand-drug makers with a new model that would heighten the importance of funding for FDA inspections, Peter Beckerman, a senior policy adviser in the FDA Office of the Commissioner, said at a generic user fee stakeholder meeting Wednesday. Agency officials have called for such funding in recent weeks, saying that a lack of resources to conduct inspections outside of the U.S. is largely to blame for the agency’s backlog in ANDAs.
Drug Industry Daily