FDA Says Approval of Menaflex Knee-Surgery Device May Have Violated Agency Rules

The Food and Drug Administration is taking another look at a knee-surgery device it approved last year after hearing concerns about how the product was rushed through safety reviews.

The product, called Menaflex, is made by ReGen Biologics Inc. of Hackensack, N.J. It is used to help patients recovering from surgery to repair severely torn meniscus tissue in the knee avoid the formation of degenerative arthritis in the injured joint and encourage long-term mobility.

The FDA approved Menaflex in December 2008, but the agency now says it is going to reexamine that ruling based on evidence that raises concerns about how the device received the go-ahead from the FDA. The House Energy and Commerce Committee asked the FDA to re-examine the Menaflex decision in light of questions about the FDA advisory panel of medical experts that recommended the device’s approval.

House Committee Raises Questions

According to the House committee’s letter, the advisory panel excluded experts who had raised questions about the safety of the device, included members who were placed there by ReGen, and did not take a formal vote in recommending Menaflex’s approval.

Concerns about the propriety of the FDA approvals for Menaflex were exposed in a March 2009 front-page report in The Wall Street Journal, prompting the House committee to get involved.

ReGen stands by the device and says Menaflex is safe.

Is FDA Abusing Fast-Track Approvals Process?

The FDA approved Menaflex using a fast-track process that did not require ReGen to complete major clinical trials to determine whether the product is safe and effective. Congressional leaders are now looking into whether that process should be used to rush medical devices and new drugs through the approvals.

Some critics accuse the FDA of abusing the expedited approvals by using it on products that need more intensive pre-marketing clinical trials.

During the approvals process, ReGen complained that FDA officials were biased against the company and top Democratic leaders reportedly pushed for speedy consideration of the Menaflex application.

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