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FDA Device Chief says Approval “Loophole” Should Be Closed

Posted on March 16, 2012

It has been said that those who don’t learn from history are doomed to repeat it — a lesson that Jeffrey Shuren, director of the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health, thinks the agency should take to heart.

On the heels of FDA approved hip implant and vaginal mesh products that have spurred a glut of patient injury complaints and hundreds of lawsuits, the device chief says that he agrees with some House democrats that the FDA should have more power to block unsafe products from coming to market.

At the heart of the debate is the agency’s 510(k) approval process, which is less stringent than its drug approval system, and allows devices to go to market without human testing as long as the FDA considers them “substantially equivalent” to previously approved versions, known as predicates.

And that is the crux of the problem, according to Shuren. He told Bloomberg News that by law, the FDA has to approve devices that “cite an eligible predicate.” The only exception is if the older product was subject to an FDA or court mandated recall. Since most manufacturers voluntarily recall products with safety issues, new products are still approved based on those older recalled products.

So some vaginal mesh implant products were approved by the agency despite the fact they traced their designs to a product that had been recalled by Boston Scientific Corp.

Four House Democrats proposed legislation last month that could give the FDA a firmer grip on this approval process. While Shuren hasn’t endorsed the bill, he does approve of a legislative fix that would assure “that if there is a problem with a new device, it gets addressed before it goes to market.”

The Tallahassee transvaginal mesh injury attorneys at Farah & Farah applaud these proposed FDA reforms and will be keeping track of these matters as they develop.

Source: http://www.businessweek.com/news/2012-02-29/fda-device-chief-says-approval-loophole-needs-to-be-closed.html