As is widely known by now, FDA lost the second round of the legal struggle over the Menaflex 510(k), but the decision at the Court of Appeals for the District of Columbia sends the application back to FDA, where the device awaits an uncertain fate. Will FDA appeal to a higher court? I doubt it.
The Menaflex story is one of the more convoluted med tech stories of the recent past. The first sponsor of the product, the now-shuttered ReGen Biologics, initially filed it as a PMA, but switched to a 510(k) after similar devices were cleared for other parts of the human anatomy.
Staff at the Office of Device Evaluation chipped in to the melodrama by declaring the device not substantially equivalent on the first pass, which everyone at ODE knows is a no-no. On the other hand, ReGen’s management was not the easiest to get along with by some accounts.
Pressure to clear, pressure to rescind?
Then of course there’s the involvement by the New Jersey congressional delegation, with which the latest court decision evinces no discomfort at all. And let’s not be outraged by that. It wasn’t the first time and most certainly will not be the last, and there’s a reason the private sector can complain to Congress about FDA. It’s their right to complain to Congress, so please, no sniveling over that one.
The Centers for Medicare & Medicaid Services already decreed it would not pay for the Menaflex, which immediately removed a huge chunk of the potential market for use in knee osteoarthritis. That wouldn’t stop private payers from covering the device, although they would have a tough time doing so given that efficacy data for the collagen scaffold were iffy. So why not just let the market decide?
One of the problems with the optics for FDA is that the Menaflex was one of the devices targeted by the FDA whistleblowers in letters to Congress and the White House in 2008 and 2009, which casts the Menaflex as the easy target for proving that FDA does its job. Another “optical” issue is that both advisory committees recommended FDA allow the device on the market, in part because of an impending wave of knee replacements as the Baby Boom ages. If memory serves, ReGen had priced the Menaflex at about $2,000, which is a lot cheaper than a knee revision surgery.
Congress provides an out
I wrote three years ago that FDA may find itself on the losing end of this debate, but all that changes with the Food and Drug Administration Safety and Innovation Act, which gives FDA greater leeway in up-classifying medical devices. Prior to FDASIA, the statute did not give the agency the right to just summarily rescind the clearance because to do so amounted to an up-classification, which required rulemaking.
Here in the post-FDASIA world, however, FDA can use its administrative leverage to say “class III” and that will pretty much be that. Still, the agency was part of the reason this turned into such a nightmare to begin with, and it has yet to acknowledge the primacy of its role in this mess. Instead of standing up and saying “we needlessly put a company out of business,” FDA continues to insist that it acted properly in rescinding the clearance. FDA’s continued gamesmanship is ironic because it always postures itself as the morally upright guardian of the public health. It turns out FDAers are just as political as anyone else in Washington.
There’s one conclusion that is difficult to avoid in all this and it’s that FDA’s handling of the Menaflex was nothing but a cheap piece of regulatory railroading on the agency’s part. The public deserves better.