In the Crosshairs

The case of congressmen getting in the middle of an approval for a knee-implant product raises the likelihood medical-device companies will get tougher oversight.

In a stunning admission, Food and Drug Administration officials say four New Jersey congressmen and the agency's former commissioner influenced the process that led to approval of ReGen Biologics Inc.'s Menaflex knee device last year. That decision is being reviewed by the agency.

The approval of Menaflex followed years of advice by the FDA's own scientific panels to keep the product off the market because of safety concerns. A report prepared by agency investigators not only questioned the decision to greenlight Menaflex, but also called for a review of the approval process.

Given that new FDA Commissioner Margaret Hamburg vowed to be more diligent challenging industry to protect consumers, the review of medical devices is going to get a very hard look. While drug approvals require human studies to show medicines work, devices like Menaflex often get an OK with less-rigorous data.

"It's a much easier process," says Miller Tabak analyst Les Funtleyder. "The problem with a much easier process is a lot of things get through. It's somewhat clear we probably should look at some of these things more strictly."

That will mean more costs for the industry, he says. How much depends on what type of added scrutiny government examiners add to the process.

The device industry argues that there doesn't need to be the thorough review of certain products. Indeed, the category is broad, including thousands of products from bandages and bedpans to pacemakers and implants. That's the challenge for regulators, determining which products require a more thorough review, Funtleyder says.

While changing the way these medical products are reviewed and approved has been talked about for years, "the chances are higher than they've ever been" that will happen, the analyst says. "But keep in mind this is an industry that will push back."

In a statement, the trade group Advanced Medical Technology Association says it likes the system just the way it is because the review process "gives robust protections to American patients and promotes medical innovation by providing the FDA the flexibility it needs to ensure the safety and effectiveness of low- and moderate-risk medical devices."