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U.S. Department of Health and Human Services

Animal & Veterinary

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President Bush Signs Bill Reauthorizing ADUFA, Authorizing AGDUFA

by Shannon Cameron, Assistant Editor, and Jon F. Scheid, Editor
FDA Veterinarian Newsletter May / June 2008 Volume XXIII, No III

On August 14, 2008, President Bush signed a bill reauthorizing the Animal Drug User Fee Act (ADUFA) and authorizing the Animal Generic Drug User Fee Act (AGDUFA), which will provide the Food and Drug Administration with more funding for timely animal drug reviews. The reauthorized ADUFA also begins a new “end-review amendment process” that gives FDA additional flexibility in dealing with new animal drug applications. The plan to implement the reauthorized ADUFA also is designed to improve communication with industry.

Congress initially approved ADUFA legislation in 2003. Under that law, FDA collected $43 million in user fees over the 5 years of the first ADUFA program. Under the reauthorized program, FDA expects to collect approximately $98 million over the 5-year life of the program.

The AGDUFA program calls for user fees to generate a total of $27 million for generic animal drug review over the 5-year life of the measure, beginning in FY 2009. AGDUFA is FDA’s first user fee program to cover generic animal drugs. Currently, the generic animal drug review process is entirely funded through appropriations. Under both ADUFA and AG-DUFA, FDA will collect funds through application fees, product fees, and sponsor fees. The fees will supplement appropriated resources for drug review.

Under a plan developed by CVM and the animal drug industry for implementing the reauthorized ADUFA, CVM and sponsors will be able to use a new end-review amendment process for a drug application. The process gives the Center the option of allowing a sponsor more time to submit additional, non-substantial data or information that CVM needs to finish reviewing an animal drug submission. Previously, when data were missing, CVM typically had to issue an “incom-plete” letter to the sponsor, which meant the entire review process had to start again, once the sponsor submitted the missing information.

Among the new provisions in the ADUFA reauthorization are plans to improve the timeliness and predictability of for-eign pre-approval inspections and conduct 10 public workshops during the program’s 5-year life. The workshop topics will be mutually agreed upon by FDA and the regulated industry. CVM also plans to develop an electronic submission tool for industry submissions which will have online review capability. In addition, CVM and sponsors will discuss the applicable use of pharmacokinetic/pharmacodynamic data.

FDA has promised to meet specific performance goals for generic animal drug review as it begins to collect generic animal drug user fees. For example, FDA has agreed to review 90 percent of non-administrative Abbreviated New Animal Drug Applications in fiscal year 2009, the first year of generic animal drug user fees, within 700 days. The review time-frame is reduced over the life of the program to 270 days by fiscal year 2013.

Antimicrobial drug distribution reports

Under the ADUFA reauthorization, drug sponsors must report annually the amount of an antimicrobial active ingredient sold or distributed for use in food-producing animals the previous calendar year. The new law requires the reports to spec-ify the amount by “container size, strength, and dosage form” of the antimicrobial active ingredient. Domestic as well as export sales must be reported.

The measure requires drug sponsors to submit the information to the Secretary of Health and Human Services. The Secretary is directed to make summaries of the information available publicly. The public summaries will present the in-formation by class of antimicrobial, but only if three or more sponsors produce that class of antimicrobial.

The reports will be due March 31 each year, with the first report due in 2010.