For Immediate Release:
May 26, 2010

Joint letter to FDA calls for regulatory review to consider impact on small businesses

Washington, D.C. – U.S. Senator Amy Klobuchar and Congressman Erik Paulsen and today sent a letter to the Commissioner of the Food and Drug Administration (FDA), urging a regulatory framework that supports medical innovation and jobs as the FDA reviews and plans the approval process for medical devices.   Noting Minnesota’s role as a national leader in the medical device industry, Klobuchar and Paulsen expressed concerns over proposed changes to the process, while advocating for sensible regulations that will protect patients without stifling new health care breakthroughs in the future.  

“For decades, the FDA and the medical device industry enjoyed a successful partnership -- one that allowed them to ensure new products were appropriately vetted, and innovative technologies were adequately supported,” Klobuchar and Paulsen wrote.  “We urge the FDA to maintain that tradition of cooperation today, and to reject proposals that unduly burden small businesses and suppress the development of promising medical breakthroughs.”

The FDA is currently reviewing the 510(k) approval process for medical devices, and last week held a town hall meeting in Bloomington, MN to solicit comments and concerns on the process.

Klobuchar is the chair of the Senate Commerce Subcommittee on Competitiveness, Innovation and Export Promotion and Paulsen is the co-chair of the Medical Technology Caucus.    

Full text of the letter is below.

May 25, 2010

Dr. Margaret Hamburg
Commissioner
Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993-0002

Dear Dr. Hamburg,

          Thank you for your service in your role as Commissioner of the Food and Drug Administration (FDA).  We are writing to express concerns regarding the FDA’s proposed changes to the 510 (k) approval process for medical devices.

This is an issue of particular importance to our home state of Minnesota.  Our state has led medical innovation for more than 60 years and boasts more than 400 medical device companies that together employ over 50,000 people.  In the last few weeks, we’ve had the opportunity to speak with a number of medical device companies, many of which attended the FDA’s town hall meeting on May 18, 2010 in Bloomington, Minnesota regarding recent changes in the FDA’s approval process.

We support your agency’s goal to improve the FDA’s policies and procedures to ensure only safe and effective devices reach the marketplace.  We also applaud your willingness to meet personally with our state’s medical device industry to discuss how they can have the most productive collaboration.  This is essential for American patients to continue to have access to the best, most advanced medical technology possible.

However, we are concerned that some policy changes under consideration by the FDA would add new and unnecessary regulations, resulting in an even longer and more complicated approval process. 

In addition to creating an undue regulatory burden, these changes would increase the time, cost and risk associated with developing new medical technology.

Bringing a new medical device to market typically involves millions, sometimes hundreds of millions, of dollars in upfront research and development costs. The suggested changes could threaten the availability of often relied on equity investments.  Already, FDA’s increasingly slow and inconsistent approval system has dampened investment in small medical device firms. In the last two years, venture capital funding alone dropped by one-third.  Efforts to further restrict the approval process would only compound those declines, jeopardizing 83% of jobs in the medical technology sector and threatening our nation’s $5.4 billion trade surplus in medical device exports.

For decades, the FDA and the medical device industry enjoyed a successful partnership-- one that allowed them to ensure new products were appropriately vetted, and innovative technologies were adequately supported.  We urge the FDA to maintain that tradition of cooperation today, and to reject proposals that unduly burden small businesses and suppress the development of promising medical breakthroughs. 

Thank you for your consideration of this important issue.

                                                Sincerely,

Amy Klobuchar
United States Senator

Erik Paulsen
United States Representative

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