GAO Report Suggests FDA Changes

GAO Advises Immediate Changes Be Made in FDA Review Process of High Risk Medical Devices

A report issued on January 15, 2009 by the Government Accountability Office (GAO), the investigative arm of Congress responsible for enhancing the performance of all federal government agencies, concludes that the FDA has approved many medical devices that have never been shown to be safe or effective. The GAO report advises that immediate steps be taken to modify the review policy for medical devices defined as "higher risk." Specifically, the "FDA should take steps to ensure that high-risk device types are approved through the most stringent premarket review process."

Less than one-tenth of the devices that underwent premarket evaluation by the FDA from 2003 to 2007 were approved under the more extensive review process according to the GAO report. Some of the devices cleared without extensive testing included metal hip joints, external defibrillators, and electrodes for pacemakers.

Congress passed the Medical Device Act of 1976 which requires that all medical devices be classified into three distinct groups, each requiring its own level of scrutiny. The highest risk devices (Class III), e.g. replacement heart valves and implantable pacemakers, undergo the tightest review process that generally includes a clinical evaluation of safety.

The problem with safeguarding medical devices stems from a loophole in the 1976 law. Although Congress envisioned that Class III devices would be approved through the more stringent review process, certain types of these devices can be cleared for marketing with a lower level of review. The Safe Medical Devices Act of 1990 attempted to close that loophole by requiring that, for each Class III device, the FDA either reclassify the device to a lower class or establish a schedule for requiring the higher level of review. The goal was to ensure that no Class III devices would be approved via a less stringent evaluation. However, this process remains incomplete. The recent review by the GAO found that 228 Class III devices had been cleared with only the lower level of review despite the 1976 and 1990 laws that required all new products in this category to undergo strict reviews.

The FDA has not disagreed with the criticisms. Outgoing commissioner Dr. von Eschenbach agreed that the agency is not doing all it should. He argued that the agency needs greater funds and staff in order to better meet its mission.

The GAO report follows on the heels of other concerns about FDA operations. Nine scientists from the FDA's Center for Devices and Radiological Health wrote letters to Congress and then President-Elect Obama outlining charges of a "corrupted and distorted" review process and requesting changes in FDA operations. The scientists said they were pressured to modify scientific evaluations and to make approvals against their professional judgment.

Representative Henry Waxman, chair of the House Energy and Commerce Committee, said in an emailed statement, "Americans deserve to have confidence that when FDA allows a medical device to go on the market it will be safe and effective." Representative Frank Pallone (D, NJ) has announced his intention to hold hearings on the FDA's oversight of medical devices.