FDA Asked to Overhaul its Medical Device Testing System
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Finally, reform may be coming to the Food and Drug Administration's medical device testing system. On Thursday, the Government Accountability Office released a report requiring the FDA to take "immediate steps" to fix this system.
The New York Times reported that the FDA has been promising this change for decades, but has failed time and time again to act on those promises. Congress's Accountability Office has been criticizing the FDA, in recent years, for failing to protect our food supply, failing to adequately inspect foreign drug plants that provide our medicines and failing to detect certain drug dangers.
While the FDA has mostly agreed with Congress's criticisms, this time, nine scientists within the FDA's medical device branch are also sounding the alarm on the faulty review process. These scientists have written letters to both Congress and President-elect Obama seeking the changes needed to improve this system.
The current medical device approval system allows medical devices that are similar in operation to older devices already on the market to be approved more quickly with minimal testing requirements.
"So on the one hand, the manufacturer wheels in their new Ferrari to the F.D.A. and says, 'Look, it's a car just like the Model T,'" said Dr. Peter B. Bach, a pulmonary physician at Memorial Sloan-Kettering Cancer Center in New York and a former senior adviser to Medicare and Medicaid. "Then they go out in the marketplace and say to doctors, 'Why would you drive anything but a Ferrari?' This drives up the cost of care without any necessary actual improvement in outcomes."
This system was created by the FDA in 1976 and divides products into three classes. Class I devices, like forceps, are mostly exempt from the review process. Class II devices, for example, a Mercury thermometer, get quick reviews. Class III devices, including pacemakers and heart valves, are able to receive expedited review if they are found to be similar enough to devices already on the market.
In 1990, the FDA was instructed to write rules that would provide for more rigorous testing for these Class III devices, but the agency never followed through. The Accountability Office told the FDA that they still needed to write those new rules.
Dr. Susan Alpert of Medtronic explained that many of the devices currently designated as Class III would, once the system is fixed, be reclassified as Class II, or less risky, devices.
If you or someone you know is dependent on a medical device, here is some information. For information on the FDA and prescription drugs, click here.