Animal Drug and Animal Generic Drug User Fee Reauthorization Act
Floor Speech
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Mr. GARDNER. Mr. Speaker, I thank the gentleman for yielding time.
I rise today in support of Senate Bill 622, the Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013.
This legislation will reauthorize two very important programs at the Food and Drug Administration that will provide farmers, ranchers, pet owners, and veterinarians with speedy access to medications that they need for the treatment of herds and pets.
I would like to thank Senator Harkin for leading its passage in the U.S. Senate, and I would also like to thank Congressman Shimkus for his leadership with the House version of H.R. 1407.
These programs have been a success story at the FDA, and this legislation will ensure that drug approvals are done efficiently and to the highest quality standards. ADUFA and AGDUFA expire at the start of September, and we will need to pass this reauthorization today to assure there is no delay for animal caretakers and livestock producers. This bill will also help companies that develop and manufacture animal drugs by providing predictable time lines. It will also help them to benefit from a more stable review process so they can make decisions about where to invest research dollars.
Colorado has a thriving livestock industry which supports rural communities and economic strength for the entire State. I said this during the committee markup of H.R. 1407: there is more livestock in my district than people, or at least that's what I'm told. Colorado is also home to one of the Nation's premier schools of veterinary medicine at Colorado State University. Keeping livestock animals healthy, in particular, is crucial to ensuring our own health, not to mention the health of our family pets. The ADUFA and AGDUFA program keeps our food healthy and safe, while the application of animal drugs poses no risk to animal health.
I had the honor of introducing, with bipartisan support, H.R. 1408, the Animal Generic Drug User Fee Act, or AGDUFA. The bill was later incorporated into H.R. 1407. This program at FDA has achieved noteworthy success since first being authorized in 2008. The FDA has decreased a backlog of applications and reduced the review time for new generic drug applications. The reauthorization of this program will continue this success and allow our animal caretakers and livestock producers to utilize cost savings associated with generic medications.
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