In an act of overwhelming bipartisanship, the House of Representatives today passed legislation authored by Congressman Fred Upton (R-St. Joseph) that reauthorizes and expands the Food and Drug Administration’s (FDA) user fee programs for medical products.  The FDA Reform Act of 2012 (H.R. 5651) includes major reforms to the FDA’s current evaluation and approval processes for prescription drugs and medical devices, enabling U.S. companies to bring their breakthrough products to market faster while maintaining the highest levels of patient safety.  Earlier this month, Upton visited with employees of local medical industry leaders Pfizer and Stryker, who will benefit from a more efficient, transparent, and consistent FDA.  Under current law, U.S. companies have been put at a competitive disadvantage with overseas manufacturers who already benefit from a more streamlined approval process.  Reform will also significantly improve U.S. patient care by ensuring lifesaving products are brought to market in a timely manner.  H.R. 5651 passed the House by a vote of 387 to 5, having recently passed the House Energy and Commerce Committee by a unanimous vote of 46 to 0.  Upton expects a final bill to reach the President’s desk by early summer.

“Michigan manufacturers have been severely disadvantaged by the lack of predictability in the current FDA approval process – at a cost to jobs, innovation, and patient care,” said Upton.  “Michigan employers like Perrigo, Pfizer, and Stryker have long led the world in medical innovation, but that position could be jeopardized if commonsense reforms are not enacted.  Through this bipartisan legislation, we put our manufacturers on a level playing field with the rest of the world, allowing them to safely bring their lifesaving products to the doctors and patients who need them.  I applaud House Democrats and Republicans for coming together on this issue to get the job done – this is how policymaking should work.”

H.R. 5651 reauthorizes for five years the FDA user fee programs for prescription drugs and medical devices – the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Act (MDUFA), respectively – that are set to expire at the end of September.  Under these user fee agreements, the FDA collects fees directly from medical manufacturers to fund the agency’s drug and device approval processes. Upton’s bill also establishes new user fee programs for generic drugs and biosimilars, takes steps to prevent drug shortages, and encourages the development of treatment options for children with rare diseases.  According to the non-partisan Congressional Budget Office (CBO), H.R. 5651 would reduce the federal deficit by $370 million over ten years. 

“Pfizer appreciates Fred’s leadership on PDUFA,” said Frank Foley, site leader of Kalamazoo operations for Pfizer, Inc. “This bill is vital to ensure the FDA has the resources it needs to review our products and inspect our manufacturing facilities.”

“This bipartisan legislation comes at a critical time, ensuring that there is a well-defined pathway for future products that will improve the health of those with diabetes, including 750,000 people with diabetes in Michigan,” said Cathy Coury, Executive Director of the Juvenile Diabetes Research Foundation’s Michigan Great Lakes West Chapter, upon passage of the bill. “We believe this legislation will better enable the FDA to effectively review and approve future products of similar significance in a timely manner.”

“Reauthorization is not only critical to the patients of our state, it is vital to Michigan’s economy,” wrote Michigan Governor Rick Snyder in a May 9th letter to Upton concerning PDUFA. “In order for the United States and the State of Michigan to remain competitive in [the pharmaceutical] industry, we must work to provide a business environment that provides a level of certainty and predictability.”