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ReGen's 510(k) Clearance Under the Microscope at the WSJ BY LAUREN UZDIENSKI, MARCH 5, 2009

When ReGen Biologics received 510(k) clearance last December for its meniscal repair product, Menaflex, it looked like a happy ending for the company after two failed FDA submissions and a long back-and-forth with the agency. Now it appears the story of Menaflex's journey to the U.S. market isn't over yet, at least not in the eyes of the media. The Wall Street Journal is reporting that ReGen's political angling may have had a hand in attaining product clearance.

ReGen's relationship with the FDA began in 2004, when the company, planning to submit a PMA for Menaflex, started a clinical trial. The PMA effort was scrapped in 2005 in favor of a 510(k) after the trial ran into trouble: a warning letter was issued from the FDA regarding record-keeping. The agency later raised conflict-of-interest concerns about the study's oversight in one of ReGen's two 510(k) rejection letters.

510(k) applications were submitted and rejected in 2006 and 2007.

After the second 510(k) rejection in the fall of 2007, ReGen reportedly turned to a number of New Jersey Democrats for help: Sen. Robert Menendez, Rep. Frank Pallone, chairman of the Health Subcommittee of the House Energy and Commerce Committee, Rep. Steve Rothman and Sen. Frank Lautenberg. Menendez, Lautenberg and Rothman requested that Andrew von Eschenbach, then the FDA commissioner, review the submission personally. This apparently resulted in a meeting between the company and Dr. von Eschenbach, after which ReGen asked that their case be referred to the head of the FDA's device division, Daniel Schultz, and that FDA staffers who previously opposed Menaflex be excluded from future review of the product.

In July of 2008, ReGen published clinical data from its study and submitted its third 510(k) application. FDA reviewers raised concerns over revision rates, which ReGen said came from incorrect analysis of the data. Still, these reviewers recommended the 510(k) be rejected.

Instead Dr. Schultz formed a special committee to review the application. ReGen reportedly helped select the members of this committee, voicing a preference that knee surgeons be excluded in favor of sports medicine specialists. The justification ReGen gave was that the success of Menaflex could lead to fewer total knee replacements, so these surgeons would be motivated to reject the application. This created a debate at the agency, for fear that it would appear that ReGen was getting preferential treatment, so references to ReGen's panel choices were, per the WSJ, excised from the record. The panel convened, with five of the eight members identified as sports medicine specialists. None of Menaflex's former critics spoke at the meeting.

The outcome, per Dr. Schultz, was that the panel unanimously voted to clear the product. The Journal disputes this with quotes from panel members who had "reservations."

It wasn't only the physicians on the panel who had reservations. ReGen named surgical meshes used in shoulder and hernia repair as predicate devices, though ex-FDA official Larry Kessler concluded that Menaflex was not substantially equivalent to these devices. He wrote that Menaflex will "undergo weight-bearing forces that are not comparable to those experienced by . . . products with which we are familiar."

Despite Dr. Kessler's findings, Menaflex was cleared for sale. Dr. von Eschenbach was later quoted, "There's something wrong with how that decision was made."

von Eschenbach also said the 510(k) process at the agency "has gotten out of control," strong criticism that has nonetheless been echoed elsewhere in recent months. The FDA has been facing allegations of corruption as well as general concerns over the rigor of the 510(k) pathway.

President Obama is likely to address these concerns during the current administration, though no successor to Dr. von Eschenbach has been nominated as yet, and there have been no firm plans announced regarding FDA reform.

As for ReGen, the company is in the midst of the U.S. launch for its product and recently raised $9.0 million to support the launch. Though it's unclear what ramifications the Journal's allegations will have on the company, ReGen has proven they're nothing if not resilient.

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