Congressman Fred Upton (R-St. Joseph), Chairman of the House Energy and Commerce Committee, issued the following statement for this morning’s Oversight and Investigations Subcommittee hearing regarding the impact of Food and Drug Administration (FDA) medical device regulation on patient access, innovation, and job creation.  Upton has called for streamlining the FDA approval process of unnecessary and duplicative regulations that are currently forcing medical device research, development, and jobs overseas. 

There are an estimated 420,000 Americans working in the medical device industry, with some 1,700 jobs in Upton’s district and 9,000 jobs in the State of Michigan.  Early last month, Upton joined leading industry representatives at Kalamazoo, Michigan based Stryker to discuss an agenda for American medical device competitiveness.

The full text of Upton’s remarks prepared for delivery follow below:

Let me begin by thanking the Chairman for holding this important hearing on the need for improvements to medical device regulation by the Food and Drug Administration.  The United States’ leadership position in the global medical device industry is in jeopardy. American medical device companies are launching their products overseas and taking American jobs with them because of regulatory delays and uncertainty at FDA.  In some instances, companies actually based in the U.S. are exiting the U.S. market entirely, largely due to the long delays and regulatory red tape at the FDA.  This issue hits close to home since the device industry provides nearly 1,700 jobs in my district and 9,000 jobs in the entire state of Michigan.

Review times have dramatically increased under this administration.  This is not due to a decrease in funding.  In fact, medical device review process appropriations increased from $275 million in 2008 to $368 million in 2010.  The lagging approval time is a huge problem for patients and our economy.  Our witnesses today will paint a compelling picture of how inefficiency and indecision affect patients, physicians, and innovative job-creators, particularly small businesses.           

Let me be very clear: patient safety is our utmost priority.  The goal is not a lower safety threshold for the approval of medical devices.  Nor should FDA implement a European-style review system.  What we are advocating is greater transparency and predictability; timely and consistent guidance for industry; and less burdensome data requests – the FDA should actually follow the requirements of the “least burdensome” rule.  Congress enshrined these principles and processes into the law.  FDA leadership must follow the law and instill these principles and processes in its review staff.  Only then will the medical device industry start moving again, create more jobs, and as a result, help our struggling economy. The overly burdensome regulations that are stifling American innovation and job creation must end. It is imperative that America maintains its leadership in this vital industry.

I look forward to hearing from Dr. Shuren [Director, Center for Devices and Radiological Health, Food and Drug Administration] on why the FDA has failed so far to provide the predictability and certainty that will help create jobs and provide our citizens access to life-saving innovations, and what the FDA intends to do going forward to fix it.