Posted on February 13, 2018
“Farmers often use animal drugs to prevent outbreaks of infectious disease, to treat pain, or prevent swelling of joints in animals. According to the Tennessee Department of Agriculture, the cattle and calves industry and the poultry industry are two of Tennessee’s largest agriculture sectors. So it is important that farmers and ranchers continue to have access to new medicines to keep their animals healthy and prevent and treat diseases, and help keep our food supply safe.”
WASHINGTON, February 13, 2018 — Senate health committee Chairman Lamar Alexander (R-Tenn.) today 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.”
“We know that the human medical products we use are safe because the Food and Drug Administration has approved them – and the way that farmers, ranchers, and veterinarians know drugs for animals are safe is the same – the FDA has approved them,” Alexander said. “And similar to the user fee agreements this committee reauthorized last year for human medical products, this year we need to reauthorize the Animal Drug and Generic Drug User Fee Agreements.”
The committee today held a hearing on reauthorizing the Food and Drug Administration (FDA) Animal Drug User Fee Agreements (ADUFA) and the Generic Animal Drug User Fee Agreements (AGDUFA). Last week, Chairman Alexander and Ranking Member Patty Murray (D-Wash.) and House Energy and Commerce Committee Chairman Greg Walden (R-OR.) and Ranking Member Frank Pallone, Jr. (D-N.J.) released a discussion draft of bipartisan legislation reauthorizing these agreements.
Alexander continued: “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 both animals that are common family pets as well as the livestock that is our food supply. These agreements help bring these 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.”
“According to the Tennessee Department of Agriculture, the cattle and calves industry and the poultry industry are two of Tennessee’s largest agriculture sectors. So it is important that farmers and ranchers continue to have access to new medicines to keep their animals healthy and prevent and treat diseases, and help keep our food supply safe.”
If Congress does not have a reauthorization in place by August 1, FDA will need to notify staff within 60 days of when funding is expected to terminate.
Alexander said: “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. 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.”
Alexander and Murray also announced last week the committee would mark up the ADUFA legislation on February 28.
Alexander’s full prepared remarks are here.