PDF _ RL34459 - Animal Drug User Fee Program
4-Aug-2008; Sarah A. Lister; 29 p.

Update: Previous Releases:
August 4, 2008

Abstract: The Animal Drug User Fee Act of 2003 (ADUFA I, P.L. 108-130) gave the Food and Drug Administration (FDA) initial authority to collect user fees from sponsors for the review of animal drug applications. ADUFA mirrors fee programs for human drugs and medical devices. Program authority sunsets October 1, 2008, and FDA would have to lay off staff in its review program if the program were not reauthorized by then. ADUFA supporters — including companies that make brandname animal drugs, and livestock producer groups — considered ADUFA reauthorization to be “must pass” legislation in the 110th Congress. A coalition of consumer groups opposed the program and its reauthorization, citing, in particular, concerns about the safety of animal drugs used in livestock production.

After negotiations with brand-name animal drug companies, FDA made several proposals for the reauthorization of ADUFA (ADUFA II), including a near-doubling of the total amount of fees to be collected in the future. The proposed increase would support continued enhancements of FDA’s review program, further improvements in the timeliness of reviews, and the elimination of a backlog of pre-approval inspections of foreign manufacturing facilities. FDA presented draft reauthorizing legislation to Congress in April 2008. H.R. 6432, the Animal Drug User Fee Amendments of 2008, a bill to reauthorize the program, was introduced on July 8, 2008. Subsequently, the bill was forwarded without amendment to the full committee by the House Energy and Commerce Subcommittee on Health, and was marked up by the full committee on July 16, 2008.

ADUFA does not cover generic animal drugs. FDA has not been able to maintain the statutory requirement for timeliness of generic animal drug reviews since ADUFA was enacted. FDA presented a draft Animal Generic Drug User Fee Act (AGDUFA) to Congress in April 2008, separate from the ADUFA II draft bill. H.R. 6433, the Animal Generic Drug User Fee Act of 2008, was introduced on July 8, 2008. Subsequently, the bill was forwarded without amendment to the full committee by the House Energy and Commerce Subcommittee on Health, and was marked up by the full committee on July 16, 2008.

On July 30, 2008, the House passed H.R. 6432, as amended, under suspension. The engrossed (House-passed) bill incorporated an amended version of H.R. 6432 (ADUFA reauthorization), as reported, and H.R. 6433 (AGDUFA), as reported, without amendment. On August 1, 2008, the Senate took up the House-passed measure and passed it by unanimous consent. The measure has been sent to the President, who is expected to sign it.

This report discusses aspects of ADUFA I, including funding and program performance; FDA’s ADUFA II and AGDUFA proposals; congressional activity; and relevant issues. Appendix A provides a summary of ADUFA I. Appendix B describes the FDA process for approval of animal drugs. This report will be updated to incorporate legislative actions and other events as they unfold.

 [read report]

Topics: Natural Resources, Legislative, General Interest

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