The Food and Drug Administration is receiving criticism from both sides of the debate about the way it approves medical devices. Some critics say the agency takes too long, while others complain that the FDA doesn’t adequately scrutinize products before giving them the green light.
As the Associated Press reports, last week members of a House subcommittee heard from consumer advocates who cited a recent study that shows that 71 percent of recalled devices were approved through a speedier FDA process for items considered relatively low risk. They argued that the FDA’s streamlined process puts patients at risk.
“There’s a serious problem here when 112 million devices were recalled in less than five years,” Dr. Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic, told lawmakers.
On the other side of the fight are representatives of the $120 billion medical device industry, who say that cumbersome review procedures send patients abroad in search of the most advanced care.
“Investment is drying up, companies are moving overseas or closing their doors, and U.S. patients are being denied timely access to safe and effective new medical products,” said Josh Makower, an inventor of medical devices who teaches at Stanford University.
Dr. Jeffrey Shuren, who heads the FDA’s Center for Devices and Radiological Health, pointed the finger at device manufacturers themselves for submitting shoddy applications. He said that half of the applications in recent years have lacked key information, which lead to delays. Shuren also rejected the idea that the way his agency deals with medical products makes Europe a better place to be a patient.
“Just because a technology is available in another country doesn’t mean it works or even that it’s necessarily safe,” he said. He also mentioned that a handful of products that were rejected in the U.S. were initially approved in Europe, only to be recalled there later on because of safety concerns.
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