The Food and Drug Administration (FDA) should tighten regulations that permit high-risk medical devices to be used in patients following only a cursory safety review by regulators, according to a report issued Thursday by a government watchdog office.
The 64-page report by the Government Accountability Office (GAO) was long anticipated in medical technology circles. It provides ammunition for critics who claim the FDA is too cozy with makers of medical devices, allowing potentially unsafe products to be used on patients.
"The report certainly confirms our suspicions that FDA uses a variety of means to lessen the regulatory burden on industry,'' said Dr. Peter Lurie, of the consumer advocacy group Public Citizen.
The GAO report comes a week after a group of FDA career scientists sent a letter to President-elect Barack Obama's transition team claiming that the agency has "corrupted and distorted" the scientific review process. The unnamed scientists said managers within the FDA's device division ordered, intimidated and coerced FDA experts to modify scientific data in violation of the law.
At issue in the GAO report is the FDA's 510k process, which clears a medical device for sale if the manufacturer proves it is "substantially equivalent" to an existing product on the market. The process was intended for more rudimentary and less-invasive types of devices, such as examination gloves or infusion pumps.
Sophisticated products, or Class III devices, require extensive clinical studies in patients to prove they are safe and effective. In recent years, Class III products approved have included heart defibrillators and artery-clearing cardiac stents.
Many companies opt for the 510k process because it takes less time and is relatively inexpensive, generally not requiring clinical testing. In fiscal 2005, the average cost for the agency to review a 510k application was about $18,200, compared with $870,000 for a more sophisticated Class III device.
Janet Trunzo, a spokeswoman for the med-tech industry group AdvaMed, said the "510k process is a well-defined, science-driven method used by FDA as part of a comprehensive regulatory framework to meet the needs of patients and the diversity of medical technology.''
But the GAO report indicates that the lines between the two kinds of FDA review can blur. The report highlights 20 Class III medical devices currently in use that were cleared through the 510k process by the FDA between 2003 and 2007.
Those products -- including metal hip joints, pacemaker electrodes and pedicle screws used in spine surgery -- were supposed to be reviewed again by the agency to see if they required more extensive studies in patients. But the GAO report states "that process is incomplete."
The FDA has not acted on reviewing some of those devices, despite requesting information from manufacturers as far back as 1997. "This just allows products to elude stringent review that Congress has mandated,'' said Public Citizen's Lurie.
GAO spokeswoman Karen Riley said the agency is committed to completing these reviews and is working on a process to get the job done.
Janet Moore • 612-673-7752