Sept. 24, 2009
FDA Internal Review Slams Knee Device’s Approval Process
Statement of Peter Lurie, MD, MPH, Deputy Director, Health Research Group at Public Citizen
The Food and Drug Administration’s preliminary internal investigation of the 2008 approval of ReGen Biologics’s collagen scaffold device, Menaflex, has confirmed the corruption of FDA procedures Public Citizen always believed was at the root of the case. The report documents an unprecedented degree of interference from the company and members of Congress. Moreover, then-FDA Commissioner Andrew von Eschenbach was involved in the approval process in a fashion that departed dramatically from customary FDA practices. And the advisory committee process was undermined to effect the makeup of the advisory committee, the questions posed to advisory committee members and who would make the FDA presentation.
While this report unmasks the massive procedural irregularities in the approval of this device, the device remains on the market and patients continue to be treated with a useless device The report recommends that the approval of the device itself be reconsidered. This would not be a moment too late. The essential fact about this device is that it doesn’t work. A gold standard, randomized, controlled trial of the product versus a placebo showed absolutely no clinical benefit from this device.
For this reason, Public Citizen opposed the approval of this device – the only group to do so – and provided testimony to Congress about the device in June in which we highlighted both the procedural and scientific problems with the device.