User Fees

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.

The ranking Republican on the Senate appropriations subcommittee with jurisdiction over FDA raised the possibility of exempting agency user fees from sequester cuts during a hearing on Thursday (April 18), with FDA Commissioner Margaret Hamburg also expressing concern that sequestration of user fees could harm future negotiations with industry.

The Obama administration is asking Congress to give FDA more funding to implement the new food safety law, finish upgrades of new laboratories and strengthen inspections in China, while also seeking savings in drug and device programs.

Just last year, Congress and the Obama Administration came together on a bipartisan basis to reauthorize for the fourth time the very successful Prescription Drug User Fee program (PDUFA). Under this important legislation, companies seeking approval for their new cures and treatments pay user fees to the Food and Drug Administration (FDA) for the review of their therapies.