User Fees

FDA will hold a public meeting on June 10 to explore setting up a user fee program to help fund reviews of over-the-counter (OTC) drug monographs, saying the agency's OTC program is severely under resourced and reviews could stall.

FDA's drug regulatory policy chief Jane Axelrad will step down the end of April after serving at the agency for 25 years and playing an integral role in FDA reform and user fee negotiations.

FDA drug center chief Janet Woodcock told the Senate health committee Thursday (Jan. 28) that the agency will “absolutely” have the generic drug application application backlog cleared out when the current Generic Drug User Fee Amendments (GDUFA) expire at the end of September 2017.

Drug industry stakeholders floated the idea of offering “third-party support” to help implement improvements to FDA's hiring system that would positively impact the sixth iteration of the Prescription Drug User Fee Act (PDUFA), and the agency said it would consider the suggestion, an FDA document reveals.

FDA coordinated with the medical device lobby on a CEO survey of policies in play under the third device user fee law, according to internal documents and emails obtained by Inside Health Policy through the Freedom of Information Act.

Key issues are starting to emerge as FDA and the medical device industry gear up to present their user fee proposals next Wednesday (Nov. 18) at a closed-door meeting that is expected to jump-start preliminary discussions on reauthorization of the user fee agreement set to expire in 2017.

As uncertainty grows around the Senate health committee's effort to move its own parallel version of the House Cures legislation, the drug and device industries are increasingly looking to upcoming user fee reauthorization bills as vehicles for policy changes to FDA, industry sources say.

FDA officials repeatedly have said some provisions of the House's 21st Century Cures bill would be better left to the Prescription Drug User Fee Act (PDUFA) reauthorization process without giving specifics, but sources say while the two inform each other industry is addressing each separately.

Acting FDA Commissioner Stephen Ostroff told the agency’s Science Board that user fee negotiations cannot occur in isolation from the ongoing debate surrounding the House-passed 21st Century Cures bill and the Senate’s complimentary medical innovation effort, saying the congressional initiatives directly impinge upon user fee talks.