Congressman Fred Upton (R-St. Joseph) made the following statement in support of today’s Energy and Commerce Committee passage of the bipartisan Food and Drug Administration (FDA) Reform Act of 2012 (H.R. 5651).  The legislation reauthorizes 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) – that are set to expire in September.  The bill also establishes user fee programs for generic drugs and biosimilars, and reforms the FDA’s evaluation and approval process for medical products.  Reauthorization and FDA reform will enable U.S. manufacturers to get their breakthrough products to market faster while maintaining the highest levels of patient safety.  Last week, Upton visited with employees of local medical industry leaders Pfizer and Stryker, who will benefit from a more efficient, transparent, and consistent FDA.  Apart from U.S. jobs and global competitiveness, reform will significantly improve patient care by ensuring lifesaving products are brought to market in a timely manner.  H.R. 5651 passed full committee by a unanimous vote of 46 to 0 and now awaits consideration before the full House.

“The medical device and drug industries employ thousands here in Michigan – jobs that are now being threatened by the lack of predictability in the FDA approval process,” said Upton.  “A slow and uncertain approval process is detrimental to American jobs and competitiveness, putting U.S. companies like Perrigo, Pfizer, and Stryker at a severe disadvantage with foreign competitors.  The United States has long been the global leader in medical innovation, but that position could soon be jeopardized if reforms are not enacted.  What’s more, ongoing delays at the FDA have come at a serious cost to American patients whose lives depend upon the availability of these new drugs and medical technologies.  Today’s vote demonstrates that the best policymaking gets done when both sides of the aisle come together and focus on the issues that matter.”

“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.”

“Your 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 your 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.”