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FDA Again Criticized for Medical Device Oversight
Thousands of medical devices are approved annually in the United States with no proof of efficacy. Now, the Government Accountability Office (GAO) finds that high-risk medical devices are among those approved without appropriate proof of safety by the same regulators that are also not mandated to monitor recalls when problems arise.
The U.S. Food and Drug Administration (FDA) defends a practice commonly known as known as 510(k) approvals, claiming it promotes innovation. According to Bloomberg.com, the FDA has given expedited reviews to nearly 70 devices, including pacemakers and hip joints since January 2009, when the GAO called for “immediate steps” to strengthen standards or reclassify risks, citing testimony by Marcia Crosse, director of health care at the GAO. The Senate Special Committee on Aging will be discussing its findings at a hearing today in Washington.
The FDA’s policy of fast-tracking medical devices contrasts greatly with its process for drug approvals in which the FDA requires new medications be studied in thousands of people to determine safety and efficacy prior to approval for market release. By contrast, medical device makers must simply demonstrate a device does what they claim, and that it poses no undue safety risks. Unlike a new drug, a device approved under 510(k) does not have to prove efficacy.
Consider the global recall of defective DePuy hip replacement devices that involved 93,000 hip devices manufactured by the Johnson & Johnson unit, which led to deeper review of the FDA review process. That review pointed to a 1976 law that is not strictly followed and that calls for high-risk devices to undergo more stringent review, said the GAO, wrote Bloomberg.com. The GAO is Congress’ investigational unit.
“Concerns persist about the effectiveness of the 510(k) process in general, including its ability to provide adequate assurance that devices are safe and effective,” Crosse said in written testimony, quoted Bloomberg.com. The 510(k) program clears some 3,800 to 4,000 products annually and is, according to senior executive vice president for the Advanced Medical Technology Association, David Nexon, “critical to a vibrant and successful device industry,” quoted Bloomberg.com, citing testimony. The program, “has an exemplary record of protecting the public from unsafe devices,” he added.
While industry, as expected, argues that fast-tracking is needed to match technology, many disagree, saying the fast-tracking process is over-used. For instance, we recently wrote that advocacy group Public Citizen revealed eight significant loopholes in how the FDA approves medical devices, allowing potentially unsafe, ineffective, dangerous products on the market.
The recalled DePuy hip joint devices are not the only fast-tracked devices found to be defective. Protegen, a synthetic sling implanted under a woman’s bladder to prevent stress incontinence was granted 510(k) approval in 1996, but was recalled three years later due to a high rate of complications. Medtronic Inc. recalled its Sprint Fidelis defibrillator lead, approved under the 510(k) process, after it was found to have a higher-than-normal facture rate and was implicated in five deaths. Sadly, notes Bloomberg.com, the FDA only mandates thorough testing for less than one-tenth of all devices
The GAO only looked at high-risk devices, such as implantable or life-sustaining device and found that 26 of 27 products mentioned in the 2009 report are undergoing “less stringent” FDA reviews, said Crosse. Of 113 withdrawn devices that were classified as high-risk recalls by the FDA from 2005 to 2009—81 percent—were fast-tracked, said Bloomberg.com. Of the recalls, one-third were cardiovascular devices, including defibrillators manufactured by Medtronic Inc., Zoll Medical Corp., and Welch Allyn Inc., wrote Bloomberg.com.
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