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Upton Hails House Passage of Critical Health Bills to Support Animal Drug Programs, Secure Prescription Drug Supply Chain

Local employers Zoetis, Perrigo, and MPI Research benefit from efficient federal review process for animal drugs

The House voted today to pass important legislation to renew the successful federal approval programs for new and generic animal drugs as well as legislation to secure the nation’s prescription drug supply chain. Congressman Fred Upton, R-St. Joseph, praised the passage of both bills, which were approved on May 15, 2013, by his Energy and Commerce Committee.

The Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013, 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 local employers like Zoetis, Perrigo, and MPI Research by ensuring that the Food and Drug Administration (FDA) can continue the timely review of new and generic animal drugs. A streamlined approval process helps Michigan manufacturers better compete, innovate, and create jobs by getting their drugs to veterinarians, livestock and poultry producers, and pet owners in a timely manner. 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 passed the House this evening by a vote of 390 to 12 and next heads to the President’s desk for approval.

“These programs ensure that veterinarians, livestock and poultry producers, and pet owners have access to the drugs they need to keep their animals healthy. In addition, they assist our drug manufacturers by fostering a predictable federal review process,” said Upton. “Timely reauthorization of these programs is important for companies like Zoetis, Perrigo, and MPI Research, which employ hundreds of folks in Southwest Michigan. These FDA programs give them the predictability they need to produce innovative drugs for pets and livestock, helping them better compete with overseas competitors.”

“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,” wrote Kathy R. Mitchell, Director of U.S. Government Relations at Zoetis, Inc, in a May 8, 2013, 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.

The Safeguarding America’s Pharmaceuticals Act 2013, H.R. 1919, seeks to enhance the security of the drug supply chain for U.S. patients without saddling drug manufacturers, wholesale distributors and pharmacies with duplicative federal and state requirements.  Further, H.R. 1919 establishes the process on how to trace individual units of pharmaceutical products and when that would begin. H.R. 1919 passed the House this afternoon by voice vote and now awaits consideration in the Senate.

“This bipartisan bill strengthens the prescription drug supply chain in order to protect Michigan families against counterfeit drugs. It also helps prevent increases in drug prices, avoid additional drug shortages, and eliminate hundreds of millions of dollars worth of government red tape on American businesses that is harming job growth,” said Upton.

“The prevalence of counterfeit prescription drugs is a threat to the safety and wellbeing of our communities.  A track and trace system is an effective way to help combat the actions of those who put our nation’s families at risk,” said Berrien County Sheriff Paul Bailey.  “The law enforcement community applauds Congressman Upton for his continued leadership to help keep our region safe.”

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