ReGen's Menaflex "Likely Safe"; FDA Weighing Next Steps
BY LAUREN UZDIENSKI, MARCH 24, 2010
A CDRH panel convened yesterday to review the science behind the beleaguered Menaflex collagen meniscus implant, which has been the subject of near-constant scrutiny since its 510(k) clearance in December of 2008. The panel determined that the device was "likely safe" at its highly unusual meeting, but the big questions about what will happen to ReGen - whether their market status is in jeopardy - and how this case could set a precedent for re-reviewing device approvals remained largely unanswered.
For the past year, ReGen has been dogged by allegations that they unfairly influenced the Menaflex clearance decision, which started with criticism of the review process from a group of FDA scientists. The WSJ later cited questionable campaign donations and the company's role in selecting its review panel. The FDA concluded, after an internal review, that the ReGen application represented several "deviations" from standard procedure and was a "threat" to the 510(k) process, and the agency decided to look again at the science behind Menaflex.
Which brings us to yesterday's meeting. ReGen defended the quality of their data (and claimed to have completed more testing and submitted more data than applicants manufacturing similar devices), though the panel generally seemed to agree that it contained shortcomings. The WSJ reports that the panel's chairman found the efficacy data inadequate and low-quality and argued that there wasn't enough safety data. Questions about the studies seemed to concern design, missing data and potential bias.
What's next? In comments to reporters, CDRH director Jeff Shuren outlined three possible outcomes from the meeting: doing nothing, implementing special controls or reclassifying Menaflex into a higher-risk category. The latter points could result in additional data collection or even a new application. This is where the ReGen case could reverberate far beyond the individual company and test the limits of the agency's authority. No particular safety issues have been raised with Menaflex, which implies that the agency's ongoing review may occur somewhere outside its typical domain of safety and efficacy.
Whatever happens with ReGen, strengthening the scientific rigor of the 510(k) program has become a key priority for the new FDA administration. Jeff Shuren has promised some guidance changes to come as early as September, and the IOM is currently conducting a review of the 510(k) process that is expected to lead to additional changes. That review is due next spring.
