E&C: #SubHealth Reviews ADUFA and AGDUFA Discussion Draft Ahead of Fall Reauthorization Deadline

Statement

The Health Subcommittee, chaired by Rep. Michael C. Burgess, M.D. (R-TX), today held a hearing to review a discussion draft of bipartisan legislation reauthorizing the Food and Drug Administration's (FDA) Animal Drug User Fee Act (ADUFA) and the Animal Generic Drug User Fee Act (AGDUFA). The discussion draft was released by bipartisan leaders of the Energy and Commerce Committee and the Senate Health, Education, Labor, and Pensions (HELP) Committee.

"This will be ADUFA's fourth authorization, and since its launch in 2004 [FY2004], we have seen review times reduced significantly," stated #SubHealth Chairman Burgess in his opening remarks. "Under the proposed agreement, funding for the program would increase by approximately $6 million annually, all submissions must be electronic, the Center for Veterinary Medicine is required to begin implementation of the U.S.-E.U. good manufacturing practice Mutual Recognition Agreement for inspections of pharmaceutical manufacturing facilities, and review time for drug combinations for use in feed is shortened to 60 days when no additional data is required."

"In rural and agriculture communities across the country, ADUFA and its generic version, AGDUFA, are critical for farmers, ranchers, and veterinarians," said Rep. Mullin. "Moreover, it's vital for the food supply of all American consumers. The reauthorization of these animal user fee agreements between the FDA and the animal drug industry help speed the approval of new drugs so that farmers, ranchers, families, and veterinarians can keep their animals and pets safe and healthy. As the sponsor of ADUFA, I hope to see the House move swiftly on reauthorization of ADUFA and AGDUFA for the health and safety of our animals and our food supply."

Dr. Steven Solomon, Director, Center for Veterinary Medicine (CVM), FDA, spoke to the successes and goals of the reauthorizations, testifying, "ADUFA IV builds on the success of prior ADUFA achievements. The negotiated recommendations propose changes to current performance goals to further enhance review. FDA agrees to maintain the ADUFA III performance goals regarding review of most original and administrative NADAs [new animal drug applications], investigational new animal drug studies, non-manufacturing supplemental NADAs, and reactivations."

Dr. Rachel Cumberbatch, Director, Regulatory Affairs, Animal Drugs, Animal Health Institute, highlighted the animal health industry and its role in the economy, stating, "Fueled by $9.9 billion in sales of medicines, the U.S. animal health industry employs 21,257 workers, accounts for more than $1.2 billion in wages and $1.2 billion in taxes and maintains a positive balance in trade."

Dr. Bill Zollers, Chairman, Generic Animal Drug Alliance (GADA), stressed the importance of generic animal drugs and past reauthorizations, saying, "In conclusion, the GADA supports the proposed legislation for reauthorization of AGDUFA. Without timely reauthorization, we will return to the untenable situation pre-AGDUFA when lengthy application reviews served as a disincentive to companies pursuing generic animal drugs. It remains critical for the continued viability of the veterinary generic drug industry that the FDA/CVM review process maintains and improve predictability and efficiency. Reauthorization of AGDUFA is critical to continuing to make the pursuit of generic animal drug approvals viable and to increase the number of safe and effective generic animal drugs on the market."

Dr. Michael Topper, President, American Veterinary Medical Association, concluded his statement to the subcommittee by focusing on the impact these reauthorizations will have, remarking, "We appreciate the attention Congress is giving to this legislation to reauthorize user fees and provide veterinarians with more important tools with which to treat their patients. …We look forward to working with the committee and FDA CVM to increase the number of approved animal drugs for the benefit of our patients, their owners, and our communities."

"We don't often think of the FDA when it comes to animal drugs, but these programs are critically important to the pet owners of America and our farmers that we rely on to produce the food that feeds our country," said #FullCmte Chairman Greg Walden (R-OR). "This is important must-pass legislation and we are committed to getting it done on time before these user fee programs expire in September."

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