User Fees

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.

The Pew Charitable Trusts and the Brookings Institution are pushing for medical device user fees to be used to beef-up postmarket surveillance like they are in the drug space.

Two House Republicans want FDA to waive or reduce generic drug user fees for some manufacturers that could be blocked from the market because of fee requirements, according to a bill introduced Monday (Dec. 2).

The generic drug industry is raising concerns with FDA that new user fee-mandated policies are disrupting review times, but FDA officials responded last week by saying the agency is not planning back off of these new restrictions on communication between the Office of Generic Drugs and sponsors.

FDA can accept and spend all fiscal 2014 user fees under a short-term spending measure passed this week but the agency may miss some goal dates associated with the biosimilar user fee program, which was the only user fee program halted during the 16-day government shutdown.