FDA Admits It Was Wrong to Approve a Knee Treatment

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In an unprecedented move, the Federal Drug Administration (FDA) admitted Thursday that it had made a mistake in approving a medical device against the repeated objections of its own scientific reviewers. The agency announced it would begin the process of rescinding market approval for the Menaflex Collagen Scaffold, an implantable device for knee injuries made by ReGen Biologics, Inc., based in New Jersey.

The Menaflex device, a collagen implant designed to support injured knees, was first approved in December 2008. In September 2009, an FDA report recommended that the agency re-evaluate the scientific evidence on which the device’s approval was based. It questioned the original FDA review of the Menaflex device and found that despite the fact that the agency’s scientific reviewers had repeatedly rejected ReGen’s application for approval, agency managers ignored those objections and approved the device under political pressure. The Washington Post reports:

FDA scientists had rejected ReGen’s application for approval for Menaflex three times, citing concerns that patients might suffer adverse impacts or that the product would do little to help them heal from a torn meniscus. The company sought a fast-track approval that is given to products which are substantially similar to other products already on the market. But several FDA reviewers believed it was, in fact, a new product, which would have required extensive clinical trials proving safety and efficacy.

In late 2008, ReGen appealed to then-FDA Commissioner Andrew von Eschenbach, who ordered an expedited review by a panel of independent advisers and allowed ReGen input about the composition of the panel. The internal probe found that ReGen executives had unusual access to von Eschenbach and approval came after von Eschenbach met several times with members of the New Jersey congressional delegation. In December, von Eschenbach approved the company’s application without any explanation for overruling the judgment of his staff.

The New York Times reports that the New Jersey congressional delegation included four Democrats: Senators Robert Menendez and Frank R. Lautenberg and Representatives Frank Pallone Jr. and Steven R. Rothman. According to the NYT, the lawmakers had received significant campaign contributions from ReGen. All four congressmen and Eschenbach said they acted properly. (More on Time.com: Figuring Out Food Labels)

An FDA press release clarified why the Menaflex device, which is designed to support an injured meniscus — the disk that acts as a cushion between the bones in the knee joint — should not have been fast-tracked for approval:

The FDA has now concluded that the Menaflex device is intended to be used for different purposes and is technologically dissimilar from devices already on the market, called “predicate devices.” These differences can affect the safety and effectiveness of the Menaflex device. For example, instead of simply repairing or reinforcing damaged tissue like predicate devices, Menaflex is intended to stimulate the growth of new tissue to replace tissue that was surgically removed. Because of these differences, the Menaflex device should not have been cleared by the agency.

The FDA says patients who already have the insert probably do not need to have it removed, since it is designed to be re-absorbed and replaced with new tissue. However, patients who have the device are advised to check with their doctors.

ReGen notes that its device has been approved in Europe for about a decade and used by some 3,000 patients with no adverse reactions; the company says it has been implanted in 50 patients in the U.S. The Washington Post cites FDA officials who say the agency has received two reports of adverse effects in U.S. patients.

The Menaflex device will remain on the market until the FDA revokes its approval or ReGen voluntarily recalls it.

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