ReGen Biologics Takes FDA to Court over Menaflex Knee Device Debacle

ReGen Biologics has filed a lawsuit against the U.S. Food & Drug Administration (FDA) over the agency’s decision to revoke approval for its <"">Menaflex knee repair device. The FDA decided to rescind the Menaflex approval last year, after concluding it never should have occurred in the first place.

The Menaflex Collagen Scaffold was cleared for marketing by the FDA in December 2008 for the repair and reinforcement of the meniscal tissue in the knee. The meniscus is a C-shaped disk of fibrocartilage that acts as a cushion between the ends of bones in the joint and also helps lubricate the joint. Menaflex is intended to stimulate the growth of new tissue to replace surgically removed tissue.

As we’ve reported previously, ReGen’s 510(K) application for Menaflex was rejected by FDA scientists on three occasions, with the agency’s staff asserting it wasn’t eligible for the process. But FDA managers ultimately overruled the scientists and approved Menaflex anyway. A 2009 review conducted by FDA scientists who were not involved in the earlier Menaflex reviews found that its approval was influenced by outside pressure, including lobbying by lawmakers from the ReGen’s home state of New Jersey.

In March 2010, the FDA said it was reconsidering its approval of Menaflex, and convened an advisory panel to look at the device. Then in October, the FDA announced that it had concluded that the Menaflex device did not qualify for 510(K) approval, which is intended for devices that are substantially similar to products already on the market. At the time, the FDA said it had determined that the Menaflex device was meant for different purposes and was technologically dissimilar from earlier devices. As a result of the FDA’s decision, Menaflex can’t be marketed in the U.S. at this time.

According to an Associated Press report, ReGen’s lawsuit claims the FDA overstepped its authority by removing Menaflex from the market after it had already been cleared. It further calls the agency’s rescission of approval “arbitrary and capricious.” It asks the court to set aside the Menaflex rescission, and seeks a court judgment declaring that its product can be legally marketed in the U.S, as well as costs and expenses including attorneys’ fees.

The lawsuit, which was filed in U.S. District Court for the District of Columbia, names the FDA and the heads of that agency and the Department of Health and Human Service as defendants.

According to The Wall Street Journal, ReGen filed for bankruptcy in April 2010, just days after receiving a letter from the FDA confirming that approval or Menaflex would be rescinded.

Incidentally, the FDA has embarked on an effort to overhaul the 510(k) approval process, which has received a great deal of criticism in recent years. Last fall, an internal FDA review found numerous flaws with the process. Just this past February, a study published in the Archives of Internal Medicine said most high risk medical device recalls over the past five years involved products subject to the streamlined 510(K) process.

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