The Center for Devices and Radiological Health may historically be the most interesting of all FDA’s branches, but the goings-on at CDRH since 2009, the year Jeff Shuren took the helm, have been nothing short of eye-popping. When one looks at the number of lawsuits and withdrawn guidances, it’s difficult to avoid the urge to characterize the past three years in terms of clichés, such as “a bull in a china shop.”
Perhaps the poster child for all this was the Menaflex 510(k), which we have discussed before. FDA’s rescission of this application was the most political move at FDA in decades as demonstrated by the agency’s explanation that the device, a collagen scaffold, was more effective at drawing in the patient’s own tissues than the clinical data indicated. So it’s too effective? That fails to address the fact that the device passed not one, but two advisory committee tests, not to mention that the device sent off no safety signals. There was also no indication the sponsor engaged in malfeasance or absent-mindedness in its filing, either, and the only two conditions under which a 510(k) can legally be rescinded are safety issues and inexhaustive application data … unless you’re Jeff Shuren, that is.
One of the really peculiar things about the Menaflex case was the number of media outlets calling on FDA to apologize for having cleared the Menaflex, which just shows a lot of people in my line of work have no idea what they’re talking about (stranger yet was that nobody in the media who criticized the device’s clearance had any problem with the towering hypocrisy displayed by New Jersey’s Rep. Frank Pallone, who first intervened on behalf of the application, then bashed FDA for having cleared it).
Regarding the 510(k) changes guidance, we note that CDRH held that it was still in force even after passage of the user fee bill in a Senate committee that shot the guidance down. That speaks of a kind of hubris that has a lot to do with the bureaucratic gridlock in Washington, but again, the media have no problem with it and the American public has no idea that device lag is a real thing and costs real lives.
Another one bites the dust: the Prevor case
The latest piece in this puzzle is the case of Prevor v. FDA, which dealt with a guidance that forced a lot of device applications to the Center for Drug Evaluation and Research. The thinking is that Shuren was behind the guidance, but it was signed by all the centers involved, so it wasn’t Shuren alone.
Let’s not forget the FDA commissioner in all this. Margaret Hamburg, MD, floated the idea of unilaterally disclosing confidential information from failed drug applications at a 2011 meeting of the Food and Drug Law Institute. So much for the notion of private property. This is a proposition that statist regimes such as Vladimir Putin’s Russia would have adored, but let’s hope that matters in the U.S. are not that far gone yet. If you think investor flight is bad now, just wait ‘til absurd notions like that start to gain traction in Washington.
The aggregate picture is not a pleasant one unless you’re a fan of command economies, and that’s a point to be taken up with firms that spend increasing amounts of time at the taxpayer-financed trough, or the highly selective device innovation program at CDRH. The word here is be careful what you wish for, because you can only eat at the trough or get a special break so many times before others begin trying to dictate everything you do, and you find yourself with progressively less wiggle room.
There’s a new world order coming yet more plainly into view at CDRH, and maybe even at FDA in general, but it’s still true that you might have to break a few things before you can make something new. That’s when a bull in a china shop is a very handy thing, indeed.