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Medical Device Maker’s Brazen Manipulation of Approval Process Shows Need to Reform FDA

Peter Lurie, M.D., M.P.H., Deputy Director, Public Citizen’s Health Research Group

Today, The Wall Street Journal described how Regen Biologics manipulated the pre-market review process at the Food and Drug Administration (FDA) in order to win approval for its device, the Menaflex Collagen Scaffold, an implant that replaces damaged knee cartilage. Public Citizen was the only group to testify at the Nov. 14, 2008, FDA advisory committee meeting on this product. We recommended that the FDA not approve the device on the grounds that a clinical trial conducted by the company conclusively proved that the device has no clinical benefit. The company instead submitted bench testing data on the product’s tensile strength, for example. This is all very well but in the end how will a doctor justify to a patient implanting a device conclusively proven to do nothing clinically? Nonetheless, the device was approved on Dec. 18, 2008.  

In our testimony, we objected to the FDA reviewing the Menaflex under the less-stringent 510(k) process, rather than under the more-rigorous Pre-market Approval (PMA) mechanism. In fact, ReGen had initially sought PMA approval but after data collection in its negative, randomized-controlled trial was complete, shifted to the 510(k) process. In today’s Wall Street Journal, former FDA Commissioner Andrew von Eschenbach now admits that, “There’s something wrong with how that decision [to use the 510(k) pathway] was made … We fumbled that process.” Most patients will never know that the Menaflex only reached the market through the sponsor’s cunning manipulation of the regulatory process, aided and abetted by the FDA, leading to approval through this less-rigorous pathway.

According to the article, ReGen was permitted input into the makeup of the advisory committee, the questions posed to the advisory committee members and who would make the FDA presentation. One is hard pressed to remember manipulation of an FDA advisory committee so thorough and so brazen. 

The article clearly documents the extent to which senior FDA officials are willing to bend over backwards to appease industry, even going so far as to overrule the scientists with most intimate knowledge of the product. Until the agency puts itself back on a secure scientific footing, the public will continue to put little stock in its approval decisions.