Much has been made of the slow-down in device approvals at FDA's Center for Devices and Radiological Health, and the explanations range from a preoccupation with scientific and statistical minutia to a paranoia that yet another incident will subject the agency to another lashing in the court of public opinion.
But let's face it, FDA gets some pretty shabby treatment on Capitol Hill, too. I recall a hearing in which then-Senator Hillary Clinton (D-New York) grilled incoming FDA commissioner Andrew von Eschenbach, MD, like a common criminal. She and Sen. Patty Murray (D-Washington) never allowed von Eschenbach to completely answer a question. It was like an interrogation from a movie about the KGB, and it was an embarrassment.
It hasn't been that bad for FDA on the Hill lately, but the media never miss a chance to hammer the agency. If FDA approves a drug that has a problem that didn't emerge in a clinical trial, it's FDA's fault. The explanation in the mainstream media is never “you can't demand drug makers enroll a million patients in a trial.” The explanation is always malfeasance by industry or just plain stupidity at FDA.
On the other end of things, FDA is accused of stonewalling if it doesn't approve things quickly enough, and patient groups are almost as bad as industry on this score. Again, there are instances in which I think the reviewers at the Office of Device Evaluation (ODE) blew it, but some of the criticism is nothing short of nuts.
A point I like to bring up in conversation is that FDA's resources have been known to be deficient for decades, and one idea that sometimes bubbles to the surface in such chats is that more cash at FDA means more regulatory overkill. That thought has occurred to me, but I'm starting to wonder.
After all, one way to beat someone into paranoia at work is to heap more and more work on them and take away resources, and then treat them like criminals in the nation's media every time something goes wrong. And when it comes to medicine, something is bound to go wrong sooner or later, isn't it?
Would a fully loaded checking account fix what's ailing FDA? Not in the short term, and the Cult of Thalidomide might never work its way out of the agency. I'm also not recommending that industry roll over on the user fee issue. Still, anyone who thinks that starving FDA into submission on device applications is a reasonable approach is forgetting one thing: It's already been tried.
As Dr. Phil might say, “how's that working for you?”