FDA to Review Its Approval of Knee Device

The Food and Drug Administration said it will re-examine its decision to approve a knee-surgery device last December over the objections of several scientists and managers at the agency, according to a letter from the FDA that the Senate Finance Committee reviewed Monday.

The letter, signed by acting FDA Commissioner Joshua Sharfstein and reviewed by The Wall Street Journal, said the controversy over the decision raises “legitimate concerns about whether the agency’s review process and decision…were compromised.”

The device, called Menaflex, is made by ReGen Biologics Inc. of Hackensack, N.J. It is designed to help patients who have severely torn meniscus tissue in their knee joint recover long-term mobility and avoid degenerative arthritis.

The House Energy and Commerce Committee on Monday, in a separate action, asked the FDA to re-examine the ReGen decision. In a 16-page letter to the FDA, committee leaders said that agency documents “raise concerns” about an advisory panel of orthopedic-surgery experts convened by the agency last November.

The House committee’s letter cited issues “such as the exclusion of FDA experts who had raised concerns previously about the device, the propriety of ReGen’s input into the selection of advisory committee members, and the failure to hold a formal vote on whether the device should be approved.”

Gary Bisbee, ReGen’s chief executive, said through a spokeswoman that the FDA made the right move in overruling the negative views of some agency officials and approving the device in December. He said the FDA’s earlier rejections were based on an “illegal comparison of the device to a surgical procedure” instead of other cleared medical devices. ReGen says Menaflex is safe and effective.

Dr. Sharfstein’s letter was sent to the Senate in response to questions from Sen. Charles Grassley of Iowa, the ranking Republican on the Finance Committee. The Wall Street Journal carried a page-one article on the Menaflex approval process in March.

Menaflex was cleared by the FDA using a fast-track method that doesn’t require major clinical trials on safety and efficacy. That process is now under scrutiny by Congress because of allegations from FDA doctors and former FDA commissioners that it has been used too often in recent years to approve devices that need more clinical trial information.

Rep. Bart Stupak (D., Mich.), who is chairman of the investigations subcommittee of the House Energy and Commerce panel, has been looking into allegations involving the FDA’s device division. He signed the committee’s letter to the FDA along with its chairman, Democrat Henry Waxman of California, and Frank Pallone (D., N.J), the health subcommittee leader.

On Tuesday, Mr. Pallone will hold a hearing in his subcommittee on legislation he has co-sponsored which would allow victims of flawed medical devices broader latitude to sue their makers.

Source:  The Wall Street Journal

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