The Senate Committee on Health, Education, Labor & Pensions conducted a hearing on the reauthorization of the Animal Drug User Fee Act (ADUFA) and the Animal Generic Drug User Fee Agreements (AGDUFA). Set to expire in October, both grant the U.S. Food & Drug Administration permission to collect fees from the makers of new animal drugs, including generic animal drugs, which are used to support the agency’s approval and market introduction programs.
Senate Health Committee chairman Lamar Alexander (R., Tenn.) said, “The timely reauthorization of the animal drug and generic animal drug user fee agreements is critical to help keep our farm animals and pets healthy, prevent outbreaks of disease and keep our food supply safe.”
While animal drugs may be used to treat almost every animal species, much of the drug development focuses on the seven major species: horses, cattle, pigs, dogs, cats, chickens and turkeys. These include animals that are common family pets as well as livestock that are raised for food.
Alexander explained that these agreements help bring new medicines to the veterinarians who write prescriptions for families to care for their pets and treat diseases such as cancer or heartworm disease.
“We also want to ensure the farmers and ranchers raising our food supply are able to treat their animals with the safe drugs they need. Farmers often use animal drugs to prevent outbreaks of infectious disease, to treat pain or prevent swelling of joints in animals. Having safe and effective animal drugs is important to both the consumer – that food-producing animals are safe to eat – and the farmer or rancher – that he has a product to treat his animals and prevent outbreaks,” Alexander added.
Dr. Steven Solomon, director of FDA’s Center for Veterinary Medicine (CVM), testified to the committee that the laws have alleviated the backlog of requests for approving new animal drugs and increased the efficiency of FDA’s approval process.
Solomon noted that ADUFA and AGDUFA are highly successful programs that facilitate the availability of approved products for food-producing and other animals and foster a flexible, risk-based review framework to accommodate innovative approaches to drug development. “Prior to initiating these user fee programs, FDA’s CVM had a large backlog of overdue submissions, and sponsors had to wait, on average, 500 days for pioneer drug review responses and 700 days for generic drug review responses,” he said. “As a result of ADUFA and AGDUFA user fees, CVM eliminated the backlog in applications and has dramatically reduced the time needed to review animal drug applications and other submissions. Both programs help FDA to maintain a stable scientific and technical workforce, improve timely communications with drug sponsors and achieve other efficiencies in the drug approval process while maintaining science-based regulatory standards for drug safety and efficacy."
Recently, Alexander and ranking committee member Sen. Patty Murray (D., Wash.) released a draft of bipartisan legislation for reauthorizing ADUFA and AGDUFA that includes a requirement that all requests for new animal drugs be submitted electronically beginning Oct. 1. The committee plans to mark up the ADUFA legislation on Feb. 28.
If Congress does not have reauthorization in place by Aug. 1, FDA will need to notify staff within 60 days of when funding is expected to be terminated.
“These user fees are a critical funding source for FDA to do its job to expedite the review of safe and effective treatments for animals. They fund over one-third of all activities related to pioneer animal drug reviews and over half of generic new animal drug review activities,” Alexander said. “If Congress does not do its job to reauthorize these critical programs, more than 115 people who work on reviewing these drugs will lose their job. This inaction would lead to delays in approving new animal drugs and bringing new treatments to farmers, ranchers, veterinarians and families.”
The National Pork Producers Council (NPPC) and National Cattlemen’s Beef Assn. said their organizations support the reauthorization of ADUFA and AGDUFA, which are crucial for ensuring that animal health, human health and food safety are protected.
“Failure to renew the laws by the deadline will result in a major disruption for the livestock production industry,” NPPC said.