FDA to Review Its Approval of Knee Device

WASHINGTON — 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.”

Josh Sandberg

Josh Sandberg is the President of Ortho Spine Partners and Partner for The De Angelis Group. He also serves as Co-Founder and Editor of OrthoSpineNews.

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