Proper care of animals, whether livestock or companion animals, is a concern of owners and the veterinarians who provide necessary medical care.
When animals are ill, much like humans they sometimes require medication, and like with human drugs research is required to bring animal care medications to market and to get approval by the Food and Drug Administration (FDA). Funding is necessary for the research, which is why the U.S. Senate Committee on Health, Education, Labor and Pensions held a hearing Feb. 13 to discuss the Animal Drug User Fee Reauthorization Act of 2018.
The Act renews FDA’s authority to collect user fees from the makers of new animal drugs and generic drugs. A press release from the Senate and House health committees explained that the 2014 Animal Drug User Fee Amendments (ADUFA) and Animal Generic Drug User Fee Amendments (AGDUFA) must be reauthorized and updated by Congress to reflect the new commitments between FDA and industry before the current user fee agreements expire on Sept. 30, 2018.
When the draft discussion document was released Feb. 8, Sen. Lamar Alexander (R-TN), chairman of the Senate Committee on Health, Education, Labor and Pensions, said, “A timely reauthorization of these updated agreements will help speed safe and effective new animal drugs to farmers and ranchers, veterinarians, families, and animal food and feed producers to keep their animals healthy. It is important that Congress do its job and reauthorize these critical programs by late summer to ensure FDA can continue its work to review new animal drugs. These agreements are essential to ensure that animal drugs on the market are safe and effective for farm animals and pets and help keep our food supply safe.”
In opening statements before the hearing, Alexander explained, “We know that human medical products we use are safe because the Food and Drug Administration has approved them. The way the farmer knows the drug he has given to his calf is safe is the same—the FDA has approved it.”
He went on to say that the legislation involves agreements between the FDA and the animal drug industry to pay user fees to help speed the approval of new drugs that are used by farmers, ranchers, families and veterinarians to keep their animals and pets safe and healthy. If funding is not obtained it could lead to staff layoffs and delays in research.
Additionally, he said, this funding is important because the revenue FDA receives from the animal drug user fees is only about 3 percent of the revenue FDA receives from the human drug program. Under consideration are two agreements—one for new brand animal drugs, which the FDA calls “pioneer drugs,” and one for generic new animal drugs. He noted that last year the applications for review included 780 applications for new pioneer animal drugs, and 240 applications for generic new animal drugs.
Another important goal of the agreements is to reduce the approval time in certain areas. The user fees, Alexander said, provide critical funding for FDA to do its job to expedite the review of safe and effective treatment for animals.
In additional remarks, Alexander said that, on average, the animal drug industry spends over $30 million a year to develop new products for farm animals, and over $22 million a year for new treatments for our pets. And according to the animal drug industry, it can take up to eight years for a drug intended for use in farm animals to be available for veterinarians and farmers, and over six years for new pet medicines.
“And while these agreements are important to our family pets, we also want to ensure the farmers and ranchers raising our food supply are able to treat animals with the safe drugs they need,” said Alexander. He went on to say, “I have carefully reviewed the agreements and believe they are good for FDA and good for farmers, ranchers, veterinarians, farm animals and our pets.”
Also speaking before the committee hearing was Steven Solomon, DVM, MPH, director of the Center for Veterinary Medicine at the FDA, who explained the need for the reauthorization, echoing some of Alexander’s comments regarding funding for timely research.
He addressed the need for safe drugs in food producing animals saying, “FDA plays a vital role in animal agriculture by reviewing the safety and efficacy of new drugs for food producing animals such as cattle, pigs and chickens.” He noted that when reviewing new animal drugs for food producing animals, “FDA also evaluates whether edible products derived from treated animals are safe for human consumption.”
He touched briefly on concerns over antimicrobial resistance and said increased public awareness has led to important changes in animal agriculture and innovative new products.
Solomon said, “FDA considers timely review of the safety and effectiveness of new animal drug applications to be central to the agency’s mission to protect and promote human and animal health.” He added that ADUFA and AGDUFA are successful programs that help facilitate approval of drugs and have eliminated backlogs and reduced the amount of time needed to review animal drug applications.
Animal health is a priority area for the National Cattlemen’s Beef Association (NCBA). Colin Woodall, NCBA’s senior vice president of government affairs, said, “America’s ranchers and beef producers dedicate their lives to looking after the animals in their care. Modern veterinary technology helps make that possible, which is why NCBA supports a swift reauthorization of the Animal Drug User Fee Act. Swift ADUFA reauthorization will ensure a stable and predictable drug review process, helping bring innovative products to market and ensuring that veterinarians and producers have access to the best possible tools for keeping animals healthy.”
Alexander said the committee hopes to complete its debate by the end of the month and move the bill to the Senate floor for full consideration. He concluded, saying, “These agreements are essential to ensure the animal drugs on the market are safe and effective and keep farm animals and pets healthy, and help keep our food supply safe.” — Rae Price, WLJ editor
