By: Zachary Kern, student at the University of Pennsylvania-School of Veterinary Medicine, extern in AVMA’s Governmental Relations Division
On April 9, a House subcommittee heard testimony on two bills that will allow the Food and Drug Administration to collect fees from pharmaceutical companies to facilitate the approval process of new animal drugs.
ADUFA, the Animal Drug User Fees Act (H.R. 1407), and AGDUFA, the Animal Generic Drug User Fees Act (H.R. 1408), were introduced by Rep. John Shimkus (R-Ill.) and Rep. Cory Gardner (R-Colo.) respectively earlier this month. The bills would reauthorize the programs, which are set to expire Oct. 1, through fiscal 2018. The bills will allow the FDA to collect roughly $21.6 million per year through fiscal 2018, which will give the agency the adequate resources it needs to evaluate proposed drugs’ effectiveness and safety, thereby expediting the approval process.
The House Energy and Commerce’s Health Subcommittee heard testimony from Dr. Bernadette Dunham, director of the Food and Drug Administration’s Center for Veterinary Medicine; Dr. Richard Carnevale, vice president of scientific, regulatory and international affairs at the Animal Health Institute; Dr. Mike Apley, professor of production medicine and clinical pharmacology at Kansas State University-College of Veterinary Medicine; and Dr. Lance Price, professor of occupational and environmental health at George Washington University.
According to Dr. Dunham, ADUFA has helped to greatly shorten the drug approval process and complete new drug applications. Prior to ADUFA’s institution, the drug approval process at the FDA averaged more than 500 days to completion, but now it only requires 180 days. In addition, the agency cleared a backlog of 833 new animal drug applications within the first five years of ADUFA’s enactment.
The new bill will continue to improve upon this approval process by introducing procedural changes, such as electronic submissions, which will further decrease the review times for resubmissions and reactivations and involve stakeholders earlier on in the rule change process. It will also allow the FDA to take steps to promote innovation and increase applications from small businesses by continuing to offer waivers for applications for drugs used in minor species, as well as bring sponsors in earlier—often before the applications are submitted—to help their approvals take less time and cost less money.
Dr. Dunham commended AVMA’s efforts to improve the drug approval process by opening the dialogue between veterinarians, the FDA, and food animal production organizations. As an additional example of increased stakeholder input, the FDA will be holding public meetings in five cities across the United States over the next two months to bring together livestock producers and veterinarians in rural and underserved areas to discuss the impact of strategies to combat antimicrobial resistance.
Though ADUFA and AGDUFA hold broad bipartisan support as-is, the subcommittee still heard testimony on other issues with regard to data collection and the use of antimicrobials in food-producing animals.
Dr. Price, in his testimony, called for increased monitoring, not restriction, of antibiotic use in animals, to mirror the current changes taking place in human hospitals that have introduced antibiotic stewardship programs. He stated that the United States needs more information on the types of antibiotics that are used on food animals and on the situations in which they are used. Collecting detailed data would not only help limit and monitor antimicrobial resistance, he said, but also bolster the industry’s and the FDA’s claims that antibiotics are being used with less frequency.
AVMA does not support any amendments to ADUFA and AGDUFA with regard to data collection. ADUFA and AGDUFA deal with expediting the approval process of new animal drugs on the front-end and should not be used as vehicles to manage how end users dispense these products.
The bills will be voted on by the subcommittee on April 19. To watch the webcast of the hearing, visit the committee’s website.