A video of Upton’s morning remarks can be viewed here.
A video of the full press conference can be viewed here.
Congressman Fred Upton (R-St. Joseph) joined House Republican Leadership this morning to discuss the continued efforts of House Republicans to support American job creation and economic growth. Upton highlighted last evening’s House passage of the Food and Drug Administration (FDA) Reform Act of 2012 (H.R. 5651), which passed by an overwhelmingly bipartisan vote of 387 to 5. H.R. 5651 will reauthorize and expand the FDA’s user fee programs for medical products and includes major reforms to help U.S. manufacturers bring their life-saving products to patients and healthcare providers faster while maintaining the highest levels of patient safety. Michigan manufacturers like Perrigo, Pfizer, and Stryker have been put a competitive disadvantage because of the lack of predictability in the current FDA evaluation and approval process. H.R. 5651 will help these and other U.S. companies continue to lead the world in medical innovation and job creation. Reform will also significantly improve U.S. patient care by ensuring lifesaving products are brought to market in a timely manner.
“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.
“House passage of the FDA Reform Act of 2012 is a great step for Stryker, the med tech industry, and patients,” said Curt Hartman, Interim CEO and Vice President and CFO, Stryker Corporation. “This legislation, which includes reauthorization of the Medical Device User Free program, should bring greater consistency, predictability and efficiency to the medical device review process at the FDA and help provide more timely access to safe and effective medical devices for patients. Stryker appreciates the strong bipartisan support for this important legislation.”
“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.”
