DeLauro Calls for Improved Process for Medical Devices in Response to GAO Findings

Washington, DC— Congresswoman Rosa DeLauro (CT-3), Ranking Member on the Labor, Education, Health, and Human Services Appropriations Subcommittee, sent a letter to Margaret Hamburg, M.D., Commissioner of the U.S. Food and Drug Administration, to express her concern about the approval process for medical devices.

Congresswoman DeLauro's letter comes in the wake of findings presented today by the Government Accountability Office (GAO), which highlight the continued risks to the public because of a lax approval process for medical devices implanted during surgery, such as hip and knee replacement procedures. These devices are not subject to adequate testing procedures, due to the faulty approval process at the FDA. Congresswoman DeLauro asks for information on how this process will be improved and monitored.

The text of the letter appears below.

April 13, 2011

Margaret Hamburg, M.D. Commissioner U.S. Food and Drug Administration U.S. Department of Health and Human Services 10903 New Hampshire Ave Silver Spring, MD 20993-0002

Dear Commissioner Hamburg:

I am writing to express my continued concern about the Food and Drug Administration's (FDA) approval process for medical devices in light of today's Government Accountability Office (GAO) testimony. The National Institutes of Health estimates that more than 770,000 Americans have a hip or knee replaced each year. These patients have surgery and work with their health care team to have a successful recovery and improved quality of life. It is simply unacceptable that their outcome should continue to rely on an inadequate approval process of the devices that are implanted during the surgery.

Though I am encouraged by the proposed reviews announced in 2010, I am concerned that the health and safety of patients are still at risk. Understanding that the Institute of Medicine review should be issued later this year, I strongly urge the FDA to continue their efforts to reform the approval process for medical devices in the meantime to protect the public health.

As the series of GAO studies clearly illustrate, the 510(k) approval process needs improvement to ensure the safety of Americans. Reform of this process should not overlook the devices that have slipped through a loophole in the regulation of devices and may risk patient safety. A 2009 GAO review found that 66% of these class III devices cleared by the 510(k) approval process between 2003 and 2007 were implantable, life sustaining, or of significant risk.

The same 2009 review recommended that the FDA take prompt action to issue regulations pertaining to 27 types of devices. GAO testimony provided today notes that a final regulation has been issued for only 1 of those 27 device types. In fact, the FDA has not even proposed classification for 21 of those devices. Considering the impact of these devices on both patient outcome and cost, it is clear that such an accelerated approval process is not appropriate for these high-risk devices.

In addition to the general concerns outlined above, I am requesting responses to the following questions.

• How will the FDA protect the public from unsafe class III devices while considering a more complete reform of the approval of medical devices?

• What is the anticipated timeline for implementing reform across the approval of medical devices by the FDA?

• Will this reform close the existing loophole that allows some high-risk products to enter the market, and thus be used in hospitals and surgery centers across the country, without going through the pre-market approval process that Congress intended? Or will these products continue to be approved through the 510(k) approval process that Congress did not intend?

• What changes does the FDA currently have the authority to implement to improve the recall of ineffective or unsafe medical devices? Is additional authority needed and would a database of implanted medical devices assist in improving such recalls?

Thank you for your attention to this critical public health issue. I look forward to your response to these questions and to our continued work to protect Americans from unsafe medical devices. Sincerely,

ROSA L. DeLAURO Member of Congress