Speaking at this afternoon's Health Subcommittee hearing, Congressman Fred Upton (R-St. Joseph) praised the success of the federal government's animal drug review programs and stated his commitment to see these programs renewed by this summer. Similar to Food and Drug Administration's (FDA) programs for human drugs and medical devices, under these programs the FDA collects funds to help expedite the new animal drug and generic drug approval processes. U.S. employers like Zoetis and MPI Research, which employ hundreds of people in Southwest Michigan, benefit from a reduced FDA application backlog, enabling them to get products to market faster, better compete with companies overseas, and create jobs here at home. Last renewed in 2008, the Animal Drug User Fee Act (ADUFA) and the Animal Generic Drug User Fee Act (AGDUFA) are currently set to expire on September 30, 2013, without congressional action.
"Together, these programs have yielded many benefits for the American people. They've ensured that veterinarians, livestock producers, poultry producers, and pet owners have access to new and affordable animal drugs to keep their animals healthy," said Upton in his opening remarks. "They've assisted animal drug producers by fostering a stable and predictable FDA review process. And finally, they've helped American consumers by keeping that food supply safe. For companies like Zoetis, which employs over 700 people in my district, these programs are essential for them to keep producing top-of-the line drugs for pets and livestock."
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.