ReGen Biologics (Hackensack, New Jersey) has filed suit against FDA over the agency's rescission of the firm's Menaflex application, a slugfest that is certain to draw intense interest everywhere, from Capitol Hill to the boondocks of the medical device industry. This might be a lawsuit that wends its way quietly into history, but it could also rupture whatever cohesiveness there might be at the agency's Center for Devices and Radiological Health. At the very least, it will serve as a huge distraction for CDRH officials and impose yet more drag on operations there. Unfortunately, there may be no happy ending to this story, whatever the outcome.
My sympathies have generally run toward ReGen in this fight for several reasons. One of these reasons is that the device, a collagen scaffold for patients undergoing partial removal of knee cartilage, passed not one but two advisory committees. It's unusual to say the least to see a 510(k) at an advisory hearing, but it is certainly unprecedented for a 510(k) device to have two goes at it.
I also found it conspicuous that the Centers for Medicare & Medicaid Services unilaterally moved to review coverage for the Menaflex. While CMS might justifiably claim orthopedists would want to implant the device in Medicare beneficiaries, it's also true that insurers tend to follow CMS's lead, and the non-coverage decision at CMS almost surely shut the device out of most of the U.S. market due to the consequent lack of private coverage. The agency could have at the very least consulted with ReGen before opening the analysis, which ReGen claims they did not bother to do. Frankly, CMS needs to understand how badly this one stinks. That kind of collusion in industry routinely results in jail terms, and everyone at the Department of Health and Human Services who thinks this is a good idea should spend time working for an entity that's not immune from prosecution.
Opponents of the Menaflex like to complain about the firm's use of a predicate not specific to the anatomy in question, but that's rather commonplace for meshes and scaffolds, and the complaint reflects either ignorance or disingenuousness. So let's toss that one out right now.
The complaints about the firm bringing in members of the New Jersey congressional delegation are understandable, but the idea that this the first time such a thing has gone on is quite a stretch. I'd also point out that it's not just corporate America that lobbies in the hallowed halls of Congress on such matters. Just ask health advocates who think the 510(k) program is too lax. If they tell you they spend no time in House and Senate offices trying to get politicians to prod FDA into toughening up, they're pulling your leg to put it nicely.
On the other hand, the documents recently filed for ReGen's lawsuit disclose another side of the dynamic. As reported in the June 2 edition of Medical Device Daily, those documents include a memo penned by Dan Schultz, MD, who at the time was the CDRH director. In a memo to the clearance document for the Menaflex, Schultz wrote that ReGen officials "repeatedly expressed their disdain for the FDA review process and the individuals involved in the review." Schultz also alleged that ReGen managers "demonize[d] the staff” and attempted to “circumvent the process," which he states "did nothing but complicate and delay this decision."
I should point out that while I've had limited contact with Dan Schultz, my impression of him is that he's very even-tempered. I have also had a lot of contact with device makers in the five years I've been with Medical Device Daily, and I've never heard a word of complaint about Schultz. If the folks at ReGen behaved idiotically, they have themselves to blame for at least some of their problems.
One possible effect of this lawsuit is that the agency will drop its plan to tinker with its rescission authority, whatever the intent or explanation. The key in this court case may be whether FDA is seen as having gone too far, which may prove to be the case given that rescissions are statutorily limited to cases in which there is a safety problem and to instances in which the sponsor deliberately misinformed FDA on the application. Neither has been alleged, and FDA's rationale appears to hinge on the notion that the Menaflex invokes more in-filling of the patient's own tissues than data in the application suggested.
FDA's argument here is not particularly strong because it comes across as a case of splitting fine hairs, but the underlying weakness of the agency's defense – the absence of a safety signal or evidence of malfeasance – is a good sign that this is a fight FDA should not have taken on. If FDA wins this lawsuit, a Republican majority in Congress will respond with endless oversight and a GOP president will simply dial back many of the changes. If FDA loses, the agency will have squandered tremendous resources for nothing.
Either way, everyone loses, including patients who could benefit from this device. Like the Thompson memo and Sarbanes-Oxley, this is suggestive of government not by, of and for the people, but government by, of and for the notion that government always knows best despite mounting evidence that government routinely gets it horribly wrong.