Gardner to Introduce Reauthorization of FDA Program that Approves Generic Animal Drugs
WASHINGTON D.C. – Congressman Cory Gardner (CO-04) announced today that he will be introducing legislation to reauthorize the Animal Generic Drug User Fee Act (AGDUFA), which supports the testing and review of generic animal drug applications by the Food and Drug Administration.
“Colorado’s 4th Congressional District has over 2.8 million cattle and calves, 450,000 hogs and pigs, and close to 160,000 sheep and goats. This legislation is essential to ensuring that producers in Colorado and throughout the country have access to safe and effective animal drugs to treat their herds,” Gardner said. “Colorado is also home to one of the nation's premier veterinary medicine schools, Colorado State University. This legislation is critical to the work of veterinarians and animal care givers across the state and nationwide.”
Congressman John Shimkus (IL-15) is introducing companion legislation to reauthorize the Animal Drug User Fee Act (ADUFA), which deals with the approval process for brand name drugs. Gardner’s bill covers generic drugs. A legislative hearing on these bills will be held in the Energy and Commerce Subcommittee on Health on Tuesday, April 9.
The Center for Veterinary Medicine and the FDA are responsible for ensuring that animal drugs are safe and effective, and manufactured to the highest quality standards. This legislation allows them to continue collecting user fees from drug manufacturers to pay for the program.