Menaflex, made by Hackensack, N.J.-based RenGen Biologics, is designed to help patients who have severely torn meniscus tissue in their knee joint recover long-term mobility and avoid degenerative arthritis, according to the report.
A letter from the FDA said that controversy over the device’s approval raises concern over whether the review process and the agency’s decision were compromised. A 16-page letter from the House Energy and Commerce Committee raises the same concerns and cited issues specifically over “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,” according to the report.
RenGen officials said in the report that the FDA was right in ignoring objections from agency officials who made their decision based on an “illegal comparison of the device to a surgical procedure” rather than other devices.
Menaflex was approved using a fast-track method in which the FDA does not require clinical trials on safety or efficacy, according to the report. Congress is now investigating this approval process as many FDA doctors and former commissioners have said the process has been used too often in recent years.
Read about the FDA’s decision to review its Menaflex approval.
