Amy-Klobuchar_12132010_001.txt

Washington, D.C. – Following the release of a new medical report today, U.S. Senator Amy Klobuchar continued to press the Food and Drug Administration (FDA) to reform the approval process for medical devices to maintain safety and encourage innovation. The report surveyed over 200 medical technology companies and found that confusing and contradictory regulations are threatening innovation in this key industry.  Last week, Klobuchar and U.S. Senator Scott Brown (R-MA) led a bipartisan letter to FDA Commissioner Margaret Hamburg, pushing her to make reforms that protect patients and ensure continued innovation.

“Good policies begin with the people who are out in the field – thinking, inventing, and making new products,” Klobuchar said. “This report confirms what many companies in the medical device industry already know – innovation is at risk. That’s why I will continue to push for common-sense reforms that encourage innovation and patient safety and do not impose confusing and burdensome regulations on Minnesota businesses.”

The report outlined key challenges facing the med-tech industry and the effect it has on innovation and patients.  Specifically, the findings showed that U.S. companies have to wait at least 10 months to approve a device and on average 31 months if there is a clinical trial.  In Europe, the entire approval process averages seven months.

The report also highlighted how U.S. medical device companies are being negatively impacted by the lengthy approval process which requires companies to spend $31 million on average to approve a low-to-moderate risk device. Of that total, $24 million – or 77 percent – goes towards covering FDA and FDA-related compliance expenses. The high costs are starting to negatively affect investment in the medical device industry with venture capital funding dropping by one-third nationally over the last two years.

In addition to leading the bipartisan letter with Brown last week, Klobuchar held a hearing earlier this summer with leading Minnesota innovators in the med-tech industry. Klobuchar credited Minnesota’s medical device investors, entrepreneurs, and innovators for raising awareness about the need to streamline the approval process. Minnesota has over 400 medical device companies that employ over 35,000 Minnesotans. 

The FDA is currently evaluating the 510 (k) approval process and is reviewing comments received from the medical device industry, academic experts, and numerous health care providers, and it plans to release a list of reforms it can make by the end of the year. The Institute of Medicine will release its recommendations on the 510 (k) process next summer.

Klobuchar is the chair of the Senate Commerce Subcommittee on Competitiveness, Innovation, and Export Promotion, and recently met with Commissioner Hamburg to discuss the medical device approval process.