The Food and Drug Administration failed to follow its own rules when it approved a knee-repair product last year against the recommendation of its own scientists, according to an internal probe.
FDA disregarded own rules in approving device
The report, requested by recently appointed FDA Deputy Commissioner Josh Sharfstein, found the approval of ReGen Biologics' Menaflex device raises serious questions about whether agency leadership caved to pressure from the company. It details a series of problems which “constitutes a clear deviation from the principles of integrity used in this review.”
FDA leaders said they are reviewing the decision to approve the device, but are not pulling it off the market. “This device has been cleared by FDA and we have no basis to question the safety," said Jeffrey Shuren, acting director for medical devices. Sharfstein stressed to patients that the report is “not a reason to panic.” Hackensack, N.J.-based ReGen stood by the safety and effectiveness of its device, saying in a statement that the FDA's review involves “procedural irregularities” at the agency.
FDA scientists twice rejected ReGen's device between 2006 and 2008. The agency approved the device in December after support from New Jersey lawmakers. The announcement came one day after the FDA said it is asking the Institute of Medicine to review the agency's fast-track 510k approval system.
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