The US Food and Drugs Administration (FDA) is gearing up to tighten the norms for approval of medical devices. The move comes in the backdrop of a couple of studies charging that while the agency pulled out all the stops when dealing with drugs, it allowed the device manufacturers get away lightly.
One of the articles, published Tuesday in the Journal of the American Medical Association, or JAMA, says many cardiovascular devices are approved based on a single study; whereas most drugs go through several layers of testing.
Advertisement"The bar for evidence of benefit should be higher for devices because they are implanted and cannot simply be discontinued, as drugs can," the researchers said in the JAMA paper.
The other study, published in the American Journal of Therapeutics, included as an author a medical reviewer in the FDA's cardiovascular device division. The authors concluded that studies submitted to get a cardiovascular device approved "frequently lack important details" such as information about the people used in research.
The researchers for both articles looked at about 80 cardiovascular devices that were approved from 2000 through 2007. The JAMA article, by researchers at the University of California, San Francisco, was based on publicly available FDA summaries of the safety and effectiveness of the devices.
Most of the approvals were based on a single study. Less than a third of the studies were randomized. And only about half of the primary measures in the studies were compared with outcomes from control groups. The authors, based at UC San Francisco, found that FDA approval was "often based on studies that lack adequate strength and may be prone to bias."
There have also been several incidents in which the agency acknowledged missteps, including the case of a knee device that was approved a year ago under political pressure.
The FDA publicly acknowledged only in September last that it approved a device to help with knee-replacement surgeries—a device the agency's own scientists said often failed—only after it received pressure from a cohort of Democratic congressmen from New Jersey, where the device's manufacturer, ReGen Biologics, is located.
The $3000 device was known as the Menaflex, a "collagen scaffold" that supported a damaged meniscus in the knee. It failed its initial reviews but received approval in December of last year anyway, during the waning days of the Bush Administration.
Jeffrey Shuren, acting director of the FDA's device division, acknowledged weaknesses in clinical trials used to approve some cardiovascular devices.
He said he wanted companies to work closely with the FDA in setting specific goals for their studies, which hasn't always been the case. "We want to be clear to manufacturers about what is expected of them," he said.
An official at AdvaMed, the device industry trade group, however, told the Wall Street Journal that the FDA spent 1,200 hours reviewing each device application, and companies too submitted large amounts of data before approval was granted. The official also said that the authors of the JAMA study didn't have access to all of the data companies submitted to the FDA.
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