Health Subcommittee Advances Bipartisan Bills to Reauthorize Animal Drug User Fee Programs and Secure America’s Prescription Drug Supply Chain

May 8, 2013

WASHINGTON, DC – The Subcommittee on Health, chaired by Rep. Joe Pitts (R-PA), today advanced legislation reauthorizing two important drug user fee programs for new and generic animal drugs and a bill to secure America’s prescription drug supply chain.

The subcommittee first approved H.R. 1407 by voice vote, which would reauthorize and combine two successful user fee programs, 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. Reauthorization of these programs is essential to ensure that the Food and Drug Administration (FDA) can continue the timely review of new and generic animal drugs. The programs have ensured that veterinarians, livestock and poultry producers, and pet owners have access to the drugs they need to keep their animals healthy.

“ADUFA is important to many of my constituents in southern Illinois as well as rural and agriculture communities across the country,” stated Rep. John Shimkus (R-IL), author of the ADUFA reauthorization. “This bipartisan bill will provide the FDA with critical resources to improve the animal drug approval process and allow drug manufacturers to bring innovative products to the market improving food safety and animal health.”

Rep. Cory Gardner (R-CO), author of the AGDUFA reauthorization, stated, “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.” He added, “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.”

The subcommittee also advanced by voice vote bipartisan legislation to secure America’s pharmaceutical supply chain. The legislation would enhance the security of the pharmaceutical distribution supply chain for America’s patients while preventing duplicative federal and state requirements from saddling drug manufacturers, wholesale distributors, and pharmacies. Further, the legislation would establish a collaborative, transparent process between the Food and Drug Administration and stakeholders in order to better understand how and when to move to unit-level traceability.

"Legislation to secure our pharmaceutical supply chain is needed to protect Americans against counterfeit drugs while providing entities involved in the supply chain with more certainty by replacing duplicative regulations with a national standard,” stated Rep. Bob Latta (R-OH), co-author of the bill. “I was pleased to see the bill pass out of the Health Subcommittee, and I look forward to continuing to work with committee to advance this important legislation forward."
 

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