FDA Hears Public Comments on Two Animal Drug Bills

By: Dr. Ashley Morgan, assistant director, Governmental Relations Division

The Food and Drug Administration held two public meetings this month to discuss recommendations for reauthorizing a pair of bills that will support user fees for new animal drug applications. AVMA participated in the meetings and submitted comments in support of the user fees, under the condition that the fees are directed toward the FDA expediting its review and approval process for animal drug products.

The two bills up for reauthorization next September are the Animal Drug User Fee Act (ADUFA) and the Animal Generic Drug User Fee Act (AGDUFA). Both bills give FDA the authority to collect user fees from the animal health industry, which allows the agency to expedite its review process for pioneer and generic new animal drugs without compromising the agency’s quality review process.

ADUFA, initially authorized in 2003, and AGDUFA, authorized in 2008, must be reauthorized by Congress every five years.

AVMA has been communicating to the FDA on both bills and submitted comments in November 2011 during a previous public meeting period. Since that time, the FDA has completed negotiations with industry and convened public meetings to hear the public’s views on the proposed recommendations for reauthorizing the programs.

Comments on the recommendations to reauthorize the bills can be submitted to the FDA electronically via http://www.regulations.gov1 or in writing to: Division of Dockets Management (HFA-305), FDA, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. When providing comments, reference docket number FDA-2011-N-0656 for ADUFA, and docket number FDA-2011-N-0655 for AGDUFA.

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