- Bloomberg

12/15/2011 - Medical implants that have sparked thousands of patient lawsuits, from Johnson & Johnson (JNJ)’s artificial hips to vaginal meshes made by Boston Scientific Corp., would face new tracking requirements under a bill introduced by three U.S. senators.

Under the legislation, the Food and Drug Administration could order companies to conduct safety studies of devices even after they’re approved and could grant conditional approvals pending the result of ongoing trials. That would raise the bar for products approved through the so-called 510(k) system, which now requires companies only to show their devices are similar to those already on the market.

The system was used to clear failing hip implants recalled in 2010 by J&J, the world’s largest maker of medical devices, and vaginal meshes that spurred an FDA warning earlier this year. In July, the Institute of Medicine, a U.S. advisory group, urged the FDA to replace 510(k), saying it didn’t ensure safety.

“Faulty medical devices, especially those implanted in the body, can have disastrous health impacts on patients,” said U.S. Senator Herb Kohl, one of the bill’s three sponsors, in a statement today. “This legislation will help ensure that FDA can act quickly and decisively when there’s a problem and that the drive toward getting new technologies to market won’t come at the risk of patient safety.”

The legislation was introduced by Kohl, a Wisconsin Democrat, Charles Grassley, a Republican of Iowa, and Democrat Richard Blumenthal, of Connecticut.

Letters to Companies

The senators have sent letters to five companies that recalled faulty medical devices requesting information about how the companies conduct post-market surveillance and manage recalls, including New Brunswick, New Jersey-based J&J, Minneapolis, Minnesota-based Medtronic Inc. (MDT) and Murray Hill, New Jersey-based CR Bard Inc. (BCR)

Jeffrey Shuren, director of the FDA’s device-review center, declined to comment on the legislation in an interview, saying he hadn’t yet seen the bill.

While the agency can order some post-approval reviews now, its authority has limits, said Christy Foreman, director of the FDA’s Office of Device Evaluation. Studies like those it ordered earlier this year by Johnson & Johnson and other hip-implant makers can’t last longer than three years, Foreman said. And the agency can’t require long-term studies as part of 510(k) approvals, she said in an interview.

Lobby Response

The Advanced Medical Technology Association, the device industry lobby group in Washington, opposes expanding FDA’s post-market device authority because it is unnecessary, said Janet Trunzo, executive vice president for technology and regulatory affairs at the group.

“It is important for the America public to realize that the medical technology industry has a well-documented safety record,” Trunzo said in a statement. “Several recent studies have shown that for the vast majority of products cleared by the FDA, less than 0.5 percent are involved in a serious recall.”

The legislation should be included in reauthorization of the FDA’s medical device user fee program that helps fund the review process, Grassley said. The program must be reauthorized by October. While consumer advocates have criticized the FDA as too lax, the agency’s also come under fire this year from device makers who say reviews are taking too long.

Shuren, in a meeting with investors in New York today, said the FDA had heard the complaints and is instituting a series of reforms to make the process faster and more consistent.

Rising Decision Rate

The percentage of 510(k) applications granted a final decision has risen to 78 percent this year, after four years of declines. The percentage of initial reviews in which the FDA has sought more information may fall for the first time since 2002, he said. The meeting was held by Wells Fargo & Co.

“Our mission is to protect the public health,” Shuren said. “But it’s also to promote public health by promoting innovation. There’s this misperception out there that the two are inconsistent but we think they are very compatible.”

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