User Fees

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.

Drug Risk Evaluation and Mitigation Strategies' inefficiencies highlighted recently by the HHS Office of Inspector General will help shape the dialogue at FDA's upcoming prescription drug stakeholder meetings, according to sources focused on the issue.

Implementation of the new generic drug user fee act is complicated by uncertainty over the budget and the looming cuts mandated by sequestration, according to FDA Commissioner Margaret Hamburg, who acknowledged at a recent meeting with generic drug industry executives that the agency was off to a slow start in reducing the backlog of abbreviated new drug applications.

The Senate early Saturday morning approved a six-month continuing resolution and a bill allowing FDA to collect all generic drug user fees, sending both measures to the president for his signature.

The pharmaceutical industry is concerned that the administration's inclusion of FDA user fees among programs to be hit by the upcoming budget sequestration could permanently divert the industry-paid funding away from FDA, the head of the drug industry's trade group said Thursday (Sept. 20), a view echoed by the Biotechnology Industry Organization.

Mandatory across-the-board government funding cuts might apply to FDA user fees and as a result lead to a bigger agency impact that initially thought, FDA funding advocates said in advance of an administration report set for release this week that will detail cuts to occur under the budget act's sequestration.