ReGen Sues FDA Seeking Restoration Of Knee-Device Approval

ReGen Biologics Inc. (RGBOQ) has sued the U.S. Food and Drug Administration while seeking to restore approval for a knee-repair device.

The FDA recently rescinded its prior approval for the key ReGen product, called Menaflex, blocking the company's access to the U.S. market. Although the FDA cleared that device in December 2008, the agency determined after a later review that the product didn't meet criteria for the approval pathway that was used.

ReGen filed for Chapter 11 bankruptcy protection in April, days after the FDA pulled approval for Menaflex. In a suit filed Tuesday, the company said it seeks an order setting aside the FDA's March 30 rescission letter.

That rescission move was "arbitrary, capricious, an abuse of discretion and not in accordance with law," ReGen said in its complaint, filed in the U.S. District Court for the District of Columbia.

The Hackensack, N.J., company named the FDA and the heads of that agency and the Department of Health and Human Service as defendants. An FDA spokeswoman said the agency doesn't comment on pending litigation.

ReGen wants the court to set aside the FDA's decision to pull approval for Menaflex. The company also seeks a court judgment declaring that its product can be legally marketed in the U.S., and to recover costs and expenses including attorneys' fees.

The Menaflex product--a collagen-based surgical mesh used to reinforce damaged or weakened soft tissue in knees--gained marketing approval under the most commonly used FDA approval pathway for medical devices. That process is intended for products that are similar to already approved devices, but the FDA later decided Menaflex was "technologically dissimilar from devices already on the market."

The Wall Street Journal reported that 2008 approval came amid political and lobbying pressure on the agency.

ReGen has said its product is safe and effective while challenging the legitimacy of the FDA's review used to re-examine its earlier decision. The FDA in January offered ReGen a chance to request a hearing on the proposed approval rescission, but ReGen declined in March while saying it would "seek an unbiased review of Menaflex's approval status under U.S. law."

The FDA is engaged in a broad overhaul of its so-called 510(k) device-approval process amid a mix of outside complaints that the rules have been too lax and inconsistently applied.

   -By Jon Kamp, Dow Jones Newswires; 617-654-6728; 
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