Questions about FDA Oversight of Medical Devices Leave Patients Vulnerable

Yesterday, the U.S. Energy and Commerce Subcommittee on Health held a hearing on the Food and Drug Administration’s (FDA) oversight of medical devices. While the hearing was cut short for floor votes, a few interesting things did come up.

Marcia Crosse, health care director for the nonpartisan Government Accountability Office (GAO), testified that the FDA does not review all class III devices through the premarket approval process as Congress had intended. Instead, many class III devices are being reviewed through the 510(K) process, a much less stringent process of review, which often does not even require clinical trial data.

As we said in our press statement, this is just more evidence that FDA approval does not necessarily guarantee the safety of medical devices, and even more reason why we need the Medical Device Safety Act (MDSA) passed.

The MDSA would restore the right of medical device victims to hold manufacturers accountable in state court when a device has been found to be defective and cause harm. The civil justice system offers consumers an added layer of protection by giving manufacturers an additional incentive to ensure their products are safe and effective.

Earlier this year, GAO had issued a report citing problems with the FDA’s approval process of medical devices and had named FDA oversight of medical products as a “high-risk” area of concern to the agency.

The FDA’s oversight of medical devices has been called into question not only by the GAO, but members of Congress, and even the FDA’s own physicians and scientists. In April, they sent a letter to President Obama outlining numerous instances where “wrongdoing and cover-up is nothing new but is part of a longstanding pattern of behavior.”

The hearing comes a week after another Medtronic device – 37,000 pacemakers – were recalled because the devices were found to seriously, even fatally, injure patients. Removal of the pacemakers is the recommended course of action, further putting patients’ health at risk by subjecting them to invasive surgery.

Testimony from the hearing is available on the House Energy and Commerce website.