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Date: 5/23/2013

Title: ADUFA/AGDUFA Reauthorization Advances in the House

By Rep. Cory Gardner (R-Colo.)

Similar to human drugs, we have in place a process for ensuring that animal drugs distributed in our country are safe and effective. Keeping our animals healthy is crucial in insuring our own health. 

The Center for Veterinary Medicine and the Food and Drug Administration (FDA) are responsible for ensuring that animal drugs are safe and effective, and manufactured to the highest quality standards. Reauthorizing the programs that support the testing and review of new and generic animal drug applications will continue to secure a safe supply for our livestock and family pets.

On May 15, the House Energy and Commerce Committee approved by voice vote H.R. 1407, which would reauthorize the Animal Drug User Fee Act (ADUFA) and the Animal Generic Drug User Fee Act (AGDUFA) that expire at the end of Fiscal Year 2013. Reps. John Shimkus, of Illinois, and I led the effort to renew these important programs.

This legislation is essential to ensuring that producers throughout Colorado and the country have access to safe and effective animal drugs to treat their herds, keeping animals and our food healthy. Additionally, the American Veterinary Medical Association has maintained that animal drugs pose no risk to human health and make our food supply even safer. This legislation is also critical to the work of veterinarians and animal care givers who benefit from innovative medical advancements that help them treat, control and prevent animal diseases. 

Thus far, ADUFA/AGDUFA have been successful programs and the reauthorization makes them even more effective by streamlining the drug approval process. Companies dedicated to animal health rely on ADUFA/AGDUFA to provide a predictable and science-based review process for animal drugs. This reauthorization will allow them to benefit from a more stable process, so they can make decisions about where to invest research dollars. 

Without the ADUFA/AGDUFA reauthorization the FDA would not be able to continue running these important programs that ensure we have access to the drugs that keep our animals healthy. In fact, prior to the authorization of ADUFA/AGDUFA, there was a back log on the applications for animal drugs. This not only hurt the industry that manufactures these medications, but jeopardized livestock because herds didn't have access to these drugs. It is of the utmost importance that we send this legislation to the House floor for a vote and then to the President’s desk so the FDA can continue to provide these medications for our producers in a timely manner.   

For one of the leading agricultural district in the United States House of Representatives, it was an honor to lead this authorization through committee, so we can continue feeding the country and provide an economic boost to our rural communities.


Congressman Cory Gardner has been a leading conservative voice in Colorado where he served in the state legislature for five years prior to being elected to Congress to represent the state’s 4th Congressional District. Cory has always been a strong voice for rural families and small business. He has earned a reputation for fighting onerous government regulations that hurt farmers and hinder job growth.