User Fees

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.

The House passed by unanimous consent late Wednesday (Sept. 19) a measure that would allow FDA to collect all of the generic drug user fees authorized in the recently enacted FDA Safety and Innovation Act, but the bill does not address other user fees, including for medical devices and biosimilars.

An agreement on a federal drug track and trace measure is not likely to come before the August recess as initially hoped, but discussions among stakeholders, lawmakers and FDA are ongoing and will likely continue in September, with negotiators now hoping to conclude talks by the end of the year, according to a key stakeholder group.

Key FDA reforms -- such as tools to prevent drug shortages and antibiotic exclusivity incentives -- are immediately available following the July 9 enactment of the FDA Safety and Innovation Act mans, but the agency must also develop several policies in the coming years on a slew of hot-button issues ranging from social media regulation to antibiotic development.