President Obama today signed into law S.622, the Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013. This important legislation has been a top priority for Congressman Fred Upton, R-St. Joseph, who serves as Chairman of the House Committee on Energy and Commerce. The much-anticipated legislation creates a more efficient federal review process for new and generic animal drugs. A streamlined approval process helps Michigan employers like Zoetis and Perrigo better compete, innovate, and create jobs by getting their drugs to veterinarians, livestock and poultry producers, and pet owners in a timely manner.
"Today we have good news for American families and farmers," said Upton. "These programs that help keep animals healthy and bring new drugs to market will continue without interruption. Further, this bipartisan measure also protects local jobs because ADUFA and AGDUFA provide companies like Zoetis and Perrigo -- which account for hundreds of Southwest Michigan jobs -- with the predictability they need to produce innovative drugs for pets and livestock."
More specifically, S. 622 reauthorizes and combines two existing user fee programs -- the Animal Drug User Fee Act (ADUFA) and the Animal Generic Drug User Fee Act (AGDUFA) -- that are set to expire at the end of Fiscal Year 2013. Renewing these important programs benefits Southwest Michigan manufacturers by ensuring that the Food and Drug Administration (FDA) can continue the timely review of new and generic animal drugs. S. 622 is the near-identical Senate version of the Animal Drug User Fee Amendments of 2013, H.R. 1407, which Upton's committee approved by voice vote last month. S. 622 recently passed the House by a vote of 390 to 12.
"Both ADUFA and AGDUFA help provide the framework for the Federal Drug Administration (FDA) to thoroughly evaluate the safety and efficiency of animal drugs, giving veterinarians and livestock producers the tools they need to protect animal health and the safety of animal food products," Kathy R. Mitchell, Director of U.S. Government Relations at Zoetis, wrote in a recent letter to Upton.
"The reauthorization of these important programs will enable the FDA to continue its timely review of animal drugs, critical to protecting the health and wellness of U.S. livestock and companion animals, through September 2018," continued Mitchell.
Last Congress, Upton led the way in the House for the successful, bipartisan reauthorization of the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Act (MDUFA), which streamlined the federal approval process for new prescription drugs and medical devices. These commonsense reforms enable Michigan manufacturers like Perrigo, Pfizer, and Stryker to better compete, innovate, and create jobs. The reauthorizations also significantly improve patient care by ensuring that lifesaving American-made products are brought to market in a safe and timely matter.