Medical Device Loophole Needs Closing by Congress, FDA Device Chief Says

The Food and Drug Administration’s top medical-device regulator said the agency needs more power to block unsafe products and prevent repeats of faulty hip implants and vaginal mesh that sparked thousands of patient lawsuits.

House Democrats introduced legislation this month to let the FDA reject devices that have designs based on past products that were recalled for safety flaws. The agency now lacks that authority in many cases, creating a “loophole” that’s challenged the credibility of some device approvals, said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health.

The bill’s sponsors cited health complications caused by products like the hip replacements and vaginal implants made by New Brunswick, New Jersey-based Johnson & Johnson (JNJ), which they said were approved despite concerns with earlier versions of the technology. Shuren, while not endorsing the bill, said the agency supports a legislative fix.

“It’s good for patients and it’s good for companies and it assures that if there’s a problem with the new device, it gets addressed before it goes to market,” Shuren said by telephone. “The challenge now is if there’s a problem, it can get replicated” through future generations of devices.

An FDA researcher applies a stress test during device testing. By law, the FDA has to approve devices that cite an eligible predicate unless the older device has been ordered off the market by the agency or a court order, Jeffrey Shuren said. Close

An FDA researcher applies a stress test during device testing. By law, the FDA has to... Read More

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An FDA researcher applies a stress test during device testing. By law, the FDA has to approve devices that cite an eligible predicate unless the older device has been ordered off the market by the agency or a court order, Jeffrey Shuren said.

In October, Bloomberg News reported that the agency approved vaginal mesh implants even though some traced their designs to a product recalled by Boston Scientific Corp. (BSX), of Natick, Massachusetts. The devices, used by 300,000 women to treat weakened pelvic muscles, have sparked hundreds of lawsuits from patients who say they lead to internal injuries, incontinence and painful sex.

Trade Group Criticism

The device industry’s Washington, D.C. trade group, the Advanced Medical Technology Association, criticized the Democratic proposal in a statement on Feb. 2, saying the bill would add regulatory burdens for manufacturers who already struggle with long FDA reviews.

The agency already has “abundant authority to carry out its mandate’” and the legislation “will not contribute to patient safety,” according to the group, which represents device makers including J&J, Minneapolis-based Medtronic Inc. (MDT) and Abbott Laboratories (ABT), of Abbott Park, Illinois. The association stands by those concerns, a spokeswoman, Wanda Moebius, said in an e-mail yesterday.

Shuren said a change may make approvals easier by reducing the negotiations conducted by the FDA when it has concerns about a product’s design. Manufacturers could still show why a past device’s flaws had been corrected or aren’t relevant for a new application, he said.

Approval Program

The debate centers on the agency’s 510(k) program, the system used to clear 90 percent of medical products in the U.S. each year. The process can allow devices on the market without human testing if the FDA deems them “substantially equivalent” to previously approved versions, known as predicates.

By law, the FDA has to approve devices that cite an eligible predicate unless the older device has been ordered off the market by the agency or a court order, Shuren said. Because most companies opt for voluntary recalls before they reach that point, the devices can continue to serve as a basis for future products, Shuren said.

As a result, the FDA has approved items including drug- infusion pumps, heart and lung pumps and medical humidifiers for children despite concerns over predicates, Shuren said.

High-Profile Devices

On average, the agency clears 28 devices a year that cite a predicate known to be recalled, he said. While that’s “a small number” compared with the 3,000 devices reviewed annually through 510(k), it includes products like the vaginal meshes whose high-profile failures have shaken consumer faith, he said.

Changing the law “will bolster the strength of the 510(k) program, which repeatedly comes under criticism, and oftentimes, it’s for just a handful of cases,” Shuren said.

A device is five times as likely to be recalled with a design flaw if it was based on a predicate that was itself pulled for safety problems, Shuren said, citing FDA records.

The legislation, HR3847, was introduced Feb. 1 by four Democrats led by Representative Edward Markey of Massachusetts. Besides giving the FDA more power to reject devices, it would require manufacturers to submit information about recalls of predicates used in an application. The agency also would be required to review previously cleared products to see if any have safety issues in their “device lineage.”

While the FDA isn’t taking a position on Markey’s bill, “we would be glad to work with him to provide technical help,” an agency spokeswoman, Karen Riley, said in an e-mail.

To contact the reporter on this story: Alex Nussbaum in New York at anussbaum1@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net

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