Senate committee approves Animal Drug User Fee Act

Published on: Mar 21, 2013

The Senate Health, Education, Labor and Pensions Committee, passed the reauthorization of the Animal Drug User Fee Act and Animal Generic Drug User Fee Act. The authority for these programs expires on October 1, 2013 unless reauthorized by Congress.

The U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) completed its recommendations for the reauthorization of the act and sent it to Congress at the end of February. FDA’s recommendations for ADUFA III and AGDUFA II were developed in consultation both with drug industry representatives and with veterinary medicine stakeholders.

Sen. Lamar Alexander (R., Tenn.), said "these programs have reduced the average waiting time for the FDA to approve generic animal drugs by 450 days and eliminated a backlog of applications, meaning farmers get faster access to cheaper and better medicines, and people are healthier."

Dr. Ashley Morgan, assistant director in American Veterinarian Medical Assn. (AVMA) governmental relations division, said AVMA is still reviewing the language of the bill, but was supportive of the package negotiated between the Food and Drug Administration and the drug manufacturers. "AVMA supports user fees for new animal drug applications only if such fees are directed toward expediting the review and approval process for animal drug products."

An attempt failed by Sens. Kirsten Gillibrand (D., N.Y.) and Dianne Feinstein (D., Calif.) that would require FDA to annually report antibiotic sales for use on farms. Morgan said, "AVMA is opposed to attaching any amendments to ADUFA which relate to data collection.”

Laura Rogers, project director, The Pew Charitable Trusts, vowed to again attempt to attach the data collection provision when it comes up on the full Senate floor.