By: Kalie Pettit, AVMA extern, University of Minnesota-College of Veterinary Medicine
On June 13, President Obama signed into law the Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013 (S.622), reauthorizing ADUFA and AGDUFA, which were set to expire Oct. 31, until fiscal 2018. The programs will ensure that veterinarians, livestock and poultry producers, and pet owners have access to the drugs they need to keep their animals healthy.
U.S. Rep. Cory Gardner (R-Colo.), who helped champion the effort with House Environment and the Economy Subcommittee Chairman John Shimkus (R-Ill.), said: “Keeping our animals healthy and our food supply safe is crucial in ensuring our own health. This legislation gives producers throughout the country access to safe and effective animal drugs to treat their herds, keeping animals and our food healthy.”
ADUFA and AGDUFA allow the Food and Drug Administration to collect user fees from pharmaceutical companies to provide the agency with the resources needed to evaluate the effectiveness and safety of proposed new drugs. The legislation also helps expedite the FDA’s approval process by allowing for the use of electronic submissions and waivers for applications of drugs used in minor species.
The U.S. House had overwhelming support for this legislation, passing it by a vote of 390 to 12 on June 3 before sending it to the president’s desk.
AVMA has been advocating for this legislation because it will help ensure that more FDA-approved animal drugs are sent to the marketplace, giving veterinarians a greater ability to provide the best treatment for their animal patients.
For more information, read the House Energy and Commerce Committee’s press release from June 13 announcing the new law or watch video clips from the House hearing June 3 on the subcommittee’s website.