User Fees

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.

Funding advocates are bracing for possible cuts to health agencies and programs, and a possible government shutdown, after House Republican leadership postponed votes on a short-term funding measure Wednesday (Sept. 11). Political brinksmanship over the budget, including efforts to de-fund the Affordable Care Act, is taking center stage as the debate over whether to intervene in Syria is deferred, according to a funding source.

A key Senate appropriator is working to protect FDA user fees from sequestration and has included language in a report accompanying the agency funding bill that highlights the issue.

The top Democrat on the House FDA funding panel is trying to identify ways to pay for a measure that would allow FDA to access $85 million in sequestered user fees before he introduces language that could be tacked onto an agency funding bill, according to a congressional source.

FDA is in discussions with the White House Office of Management and Budget and congressional committees about gaining access to $85 million in sequestered industry fees, the agency's financial officials said, noting that the issue is starting to resonate on Capitol Hill.