Knee Device Maker Snubs FDA’s Offer for New Hearing

So much for forgiving and forgetting.

Proving that resentment and hard feelings—as well as old habits—can indeed die hard, ReGen Biologics Inc. has rebuked an offer by the U.S. Food and Drug Administration (FDA) for one final hearing about the revocation of clearance for its Menaflex knee implant.

Vowing to bring the controversial product to the U.S. market by other means, Hackensack, N.J.-based ReGen called the FDA’s offer of a final hearing “futile.” In an unusually long news release, ReGen Biologics Chairman and CEO Gerald E. Bisbee Jr. said the company “believes that…any [such] hearing…would be a costly and futile exercise…ReGen has no interest in continuing to be a pawn in bureaucratic infighting aimed at reforming the FDA’s 510(k) review process.”

“The safety and effectiveness issues surrounding the clearance of our device were settled years ago, at a Nov. 14, 2008, advisory panel meeting,” Bisbee noted. “The independent experts on that panel were completely in Menaflex’s favor. The only issues that require remediation are the blatantly arbitrary and unfair processes of the FDA, and those aren’t on the table in a Part 16 review. Enough is enough.”

Last fall, the FDA decided to rescind the 510(k) clearance it granted ReGen in 2008 for its Menaflex Collagen Scaffold, an absorbable mesh implant designed to encourage the re-growth of damaged knee cartilage. As a result, ReGen must keep the device off the market until it can prove its safety and effectiveness to the FDA’s satisfaction. The FDA told the company that it wants to discuss the “appropriate marketing pathway for the device” as well as the kind of data needed to provide a “reasonable assurance of safety and effectiveness.”

Menaflex won FDA approval through the agency’s 510(k) premarket notification, a process in which a manufacturer needs only to show that its product substantially is the same as a “predicate” drug or device already approved by the FDA—and therefore is as safe and effective. The decision, however, soon came under fire by members of Congress who questioned whether the agency had properly followed its procedures and succumbed to undue pressure from the manufacturer. In September 2009, the FDA agreed to reevaluate its decision.

“There were in fact numerous departures from the review process,” Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health, said about the CDRH’s 2008 decision. “There is no adequate information in the record establishing why the device was approved.”

After reevaluating its decision, the FDA said it concluded that Menaflex was “technologically dissimilar” from other surgical-mesh devices the agency had approved, and it embodied differences that could affect its safety and effectiveness. Unlike predecessor products that repair or reinforce damaged tissue, for example, Menaflex helped the human body grow new meniscal tissue.

“Because of these differences, the Menaflex device should not have been cleared by the agency,” the FDA said in a news release.

The FDA’s about-face infuriated Bisbee, who called the move “totally unbelievable.” He blamed the agency’s change of heart on politics.

“The agency’s clearance of Menaflex has become a political football and the FDA is not playing by the rules,” Bisbee said in a statement last October following the FDA’s decision. “Regen has invested 58 months and more than $30 million to meet (the center’s) requirements only to have the agency reverse decisions made by previous officials by stating that they were in error with no substantial evidence that is true.”

In his 18-page letter to the FDA (dated March 21), Bisbee accuses the FDA of failing “repeatedly to provide ReGen with a fair and impartial review process related to the review of Menaflex. ReGen therefore has no reason to believe that the FDA will conduct a…hearing in an unbiased and impartial manner.”