Topper testifies in favor of animal drug user fees

Congress considers reauthorizing ADUFA, AGDUFA
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AVMA President Michael Topper was among the witnesses on a panel testifying at a March 14 congressional hearing in support of reauthorizing user fee programs for new and generic animal drugs.

Dr. Topper
​AVMA President Michael Topper tells a House subcommittee that veterinary access to FDA-approved medications for use in numerous, diverse species is critical. (Courtesy of the House Committee on Energy and Commerce)

Two provisions of the Federal Food, Drug, and Cosmetic Act—the Animal Drug User Fee Act and the Animal Generic Drug User Fee Act—have, for the past five years, allowed the Food and Drug Administration's Center for Veterinary Medicine to collect fees from drug sponsors to expedite the review of new treatments for animals.

Those provisions are set to expire Oct. 1, 2018.

Legislation under consideration by the House Committee on Energy and Commerce Subcommittee on Health would renew the FDA's authority for another five years.

"Timely reauthorization is needed to ensure FDA's ability to deliver continued high levels of performance and help ensure there are no disruptions to these important programs," Dr. Steven Solomon, FDA CVM director, told the subcommittee.

Among other things, user fees help fund the CVM's timely review of animal drug applications, market surveillance of animal drugs' safety and efficacy, and quality assurance measures for animal food as well as food products derived from animals.

In recent years, the FDA has approved a number of innovative treatment options, including two treatments for navicular disease in horses, which, for the first time, target bone changes commonly caused by the disease, according to Dr. Solomon. The agency has also approved new oncology treatments that target canine-specific tumors as well as the first generic version of a heartworm treatment, alleviating a drug shortage and providing a safe, effective, and more affordable alternative for pet owners.

As an alternative to antimicrobial use, the FDA approved a treatment to prevent mastitis in dairy cows. Another innovative approval was for the first drug to reduce pain in food-producing animals.

User fees provide new animal drugs with a predictable pathway to market, Dr. Topper testified, resulting in veterinarians having access to drugs that can potentially improve treatment outcomes, provide alternatives to existing treatments, fill unmet medical needs in veterinary medicine, and ultimately improve patient care.

User fees collected from sponsors of new animal drugs and generic animal drugs go toward expediting review of these treatments, so they are crucial, Dr. Topper said, especially because too few FDA-approved animal drugs are currently available to address the diversity of species and disease conditions that veterinarians treat.

"Comparisons show there are 23 times as many approved labeled indications for human use (as) there are for animal use," Dr. Topper said. "With seven major species and innumerable minor species, all of which have many varied diseases and conditions to treat, veterinary access to FDA-approved medications for use in numerous diverse species is critical."

During the hearing, Rep. Michael C. Burgess, chair of the health subcommittee, noted that the bulk of user fee programs were renewed last year with the FDA Reauthorization Act. "Our focus today on reauthorizing the Animal Drug User Fee Act and the Animal Generic Drug User Fee Act is equally important for the millions of American families and businesses that rely on the critical functions of FDA's Center for Veterinary Medicine," Burgess said.

Since its launch in 2004, ADUFA has been reauthorized four times. As part of the proposed legislation, program funding would increase by approximately $6 million annually, and all requests would have to be submitted electronically. The CVM would be required to begin implementation of the U.S.–European Union Mutual Recognition Agreement for good manufacturing practice inspections of pharmaceutical facilities. Review time for drug combinations for use in feed would also be shortened to 60 days when no additional data are required.

The generic animal drug provision, AGDUFA, has been reauthorized twice since 2008. In addition to increasing its funding by approximately $10 million annually, the proposed agreement would shorten the review time for abbreviated new animal drug applications (for generic drugs) to 60 days.

"From pet owners and veterinarians to farmers and animal food producers, updating these user fee agreements (is) essential in ensuring animal drugs are safe and effective for farm animals and our pets, while keeping our food supply safe," Burgess said. "Reauthorizing these agreements also includes the new commitments between FDA and industry on performance goals and procedures."