Hudson's Legislation Passes Congress in Animal Drug User Fee Agreements Reauthorization
August 1, 2018
FOR IMMEDIATE RELEASE
August 1, 2018
Hudson’s Legislation Passes Congress in Animal Drug User Fee Agreements Reauthorization
WASHINGTON, D.C.– Today U.S. Representative Richard Hudson (NC-08), Chairman of the Agriculture and Rural America Task Force, released the following statement after the Senate sent the House-passed Animal Drug and Animal Generic Drug User Fee Amendments of 2018 (H.R. 5554) to President Donald Trump’s desk to be signed into law. This bill includes his legislation, the Animal Health and Innovation Act of 2018 (H.R. 5599), which will expand the innovative conditional approval pathway to major uses and major species, such as dogs, cats, horses, swine, and poultry.
“This legislation will make a huge difference for our farmers,” said Rep. Hudson. “It gives them the tools they need to keep animals healthy while improving the gold standard we have for food safety. I’m pleased to see this bill head to President Trump’s desk, and I’ll continue to work to support our farmers and rural communities.”
H.R. 5554 will amend the Federal Food, Drug, and Cosmetic Act to reauthorize user fee programs relating to new animal drugs (Animal Drug User Fee Act or ADUFA) and new generic animal drugs (Animal Generic Drug User Fee Act or AGDUFA). H.R. 5554 passed the House on July 16, by voice vote.
Included in the reauthorization was an amendment by Rep. Hudson to expand conditional approval to major uses and major species so innovative veterinary drugs can help pets and livestock have a higher quality of life and prolonged lifespans. Currently, conditional approval allows certain animal drug products for unmet medical needs in minor uses and minor species to come to market on a conditional, year by year basis for up to five years to prove efficacy. Conditional approval is only granted to veterinary drug products that have been demonstrated to be safe to use and have a reasonable expectation of effectiveness. This pathway is critical in circumstances where there is unmet veterinary medical need, but a clinical efficacy trial is difficult to construct.
Current standards for major uses and major species require substantial evidence of efficacy in order to gain approval. Two examples, degenerative joint disease in dogs, cats and horses and Blackhead Disease in turkeys, paint the picture for why conditional approval is necessary for both companion animals and agricultural livestock. Degenerative joint disease is a crippling condition that develops over time in dogs, cats and horses. Currently, treatments exist to treat the pain and inflammation once the disease has presented itself, but there is no treatment to slow the progression of the disease. Because the disease develops slowly, it is almost impossible to collect the clinically required data necessary to demonstrate efficacy of a treatment that stops or slows the onset of the disease within a reasonable timeframe. Expanding conditional approval would allow collection of clinical efficacy data over time, creating opportunities for drug development.
Blackhead Disease is a random biological event that can wipe out an entire turkey flock within weeks, resulting in a devastating setback to any farmer across the country it strikes. Because Blackhead Disease is a random biological event, it is impossible to design a full scale clinical trial to gather the necessary data to prove efficacy. Expanding conditional approval would allow a drug that is proven safe to collect efficacy data when Blackhead Disease pops up, helping farmers save their flocks.
In 2004, Congress granted the Food and Drug Administration (FDA) the authority to conditionally approve drugs for minor uses and minor species through the Minor Use and Minor Species Animal Health Act of 2003. This law demonstrated the benefits of conditional use for veterinary medicine and FDA agreed in the March 18th hearing on Reauthorization of Animal Drug User Fees that expanding conditional approval to major uses and major species will help meet current unmet medical needs.
Rep. Hudson’s amendment will help companion pet owners and farmers gain access to innovative new treatments that will help save pets and livestock from hardship, pain and possible death.