This afternoon, President Barack Obama signed into law the bipartisan Food and Drug Administration (FDA) Safety and Innovation Act (S.3187), which among other things streamlines the federal approval process for U.S. prescription drugs and medical devices. Congressman Fred Upton (R-St. Joseph) has led the way in the House for these commonsense reforms, which will enable Michigan manufacturers like Perrigo, Pfizer, and Stryker to better compete with companies overseas, innovate, and create jobs. Reform will also significantly improve patient care by ensuring that lifesaving American-made products are brought to market in a safe and timely manner.
“Through this bipartisan legislation, U.S. drug and device manufacturers will soon be able to compete on a level playing field with the rest of the world – that is very good news for jobs, medical innovation, and patient care here in southwest Michigan,” said Upton. “Local employers like Perrigo, Pfizer, and Stryker have long led the world in medical innovation, and will continue to do so through improved predictability, transparency, and efficiency at the FDA. This is an important bipartisan accomplishment, and I congratulate all of my colleagues who helped get the bill across the finish line.”
S. 3187 is the product of an agreement reached between the Senate-passed FDA Safety and Innovation Act and Upton’s FDA Reform Act of 2012 (H.R. 5651), which passed the House earlier this year by a vote of 387 to 5 and the House Energy and Commerce Committee by a unanimous vote of 46 to 0.
This spring, Upton visited with employees of local medical industry leaders Pfizer and Stryker who have been put at a competitive disadvantage because of current delays and inefficiencies at the FDA.
“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.”
Like H.R. 5651, this bicameral agreement reauthorizes for five years the FDA evaluation and approval processes for prescription drugs and medical devices that are set to expire at the end of September. The bill also improves the evaluation and approval processes 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), S. 3187 will reduce the federal deficit by $311 million over ten years.
“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. “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. “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.”