User Fees

FDA is focusing on the review of generic drug prior approval supplements for medications in shortage and has set up a new “attack team” to whittle down the supplement application backlog as it works to meet commitments agreed to under the Generic Drug User Fee Act, an agency official recently said.

Pioneer and generic animal drug user fee legislation easily cleared the House Energy and Commerce Committee's health panel Wednesday (May 8) as lawmakers instead focused on debating separate drug traceability legislation, which was marked up in the same session.

House appropriators with jurisdiction over FDA debated reducing the impact of sequestration on the agency, as it has recently done for others, so that FDA could fulfill commitments it made to the drug and device industries during user fee negotiations last year.

House Energy and Commerce members questioned FDA's top veterinary official and other experts about the connection between the use of animal antibiotics and growing antibiotic resistance in humans during a hearing on the reauthorization of pioneer and animal drug user fee programs.

Industry groups are looking to free up medical product user fees that have been withheld from FDA due to sequestration and to exempt user fees from future budget cuts, changes sources said could happen in next year's spending bill but may not be likely this fiscal year.

The Senate health committee Wednesday (March 20) by a voice vote cleared animal drug user fee legislation that mirrored the agreement negotiated between FDA and industry, clearing the way for floor consideration where animal antibiotics are expected to enter the debate.

FDA plans to spend $700,000 this fiscal year to establish a cooperative agreement with Brookings Institution's Engelberg Center for Health Care Reform to conduct research, workshops and meetings related to Prescription Drug User Fee Act goals such as those for rare diseases, Risk Evaluation and Mitigation Strategies and patient-reported outcomes.

The Obama administration is asking appropriators to include in upcoming funding legislation a provision allowing FDA to fully collect user fees associated with medical devices, generic drugs, biosimilars, animal drugs and tobacco products, according to a document obtained by Inside Health Policy that lists “anomalies” the White House Office of Management and Budget recently sent to lawmakers.

FDA officials said Friday (Sept. 21) they plan to start the generic drug user fee program regardless of the outcome of congressional efforts to allow fee collection, as the lack of an appropriations measure affects when -- not if -- the fees will be collected.