The House Energy and Commerce Committee, chaired by Congressman Fred Upton, R-St. Joseph, today advanced bipartisan 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.  Both measures passed by voice vote and await consideration before the full House of Representatives.

The Animal Drug User Fee Amendments of 2013, H.R. 1407, 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.

“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.”

Upton’s committee also passed the bipartisan Safeguarding America’s Pharmaceuticals Act 2013, H.R. 1919, which seeks to enhance the security of the drug supply chain for U.S. patients while preventing duplicative federal and state requirements from saddling drug manufacturers, wholesale distributors, and pharmacies.  Further, H.R. 1919 would establish a collaborative, transparent process between the FDA and stakeholders in order to better understand how and when to move to unit-level traceability.

“This bill would work to protect American families against counterfeit drugs and eliminate hundreds of millions of dollars worth of duplicative government regulations.”