User Fees

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.

FDA singled out a facility in Germany for neither identifying itself with the agency nor paying generic drug facility fees, according to the first public warning letter the agency issued under the new user fee program created by last year's FDA Safety and Innovation Act.

Physician lobbyists say their chances of replacing the Medicare Sustainable Growth Rate formula are slipping away as Congress gets caught up in a standoff over funding the government and raising the debt ceiling. But there's also another problem: House freshmen conservatives don't consider SGR a priority, and, if lobbyists can't convince them that it is, GOP leadership is not inclined to include a fix to the Medicare physician pay formula in debt ceiling talks, sources say.