FDA’s thumb on the scale

February 22, 2016 – 8:38 PM | By Mark McCarty | No comments yet
Who is advising whom?

Who is advising whom?

It’s often interesting to see and hear the things that go on at FDA advisory hearings, and the Feb. 18 hearing for leadless pacemakers proved to be no exception. I’ll admit at the outset that I’ve always been of the view that these advisory committee members are charged with making up their own minds about the questions the agency poses to the panel, but maybe I’m just naïve, yes?

One of the questions the agency posed to the panel was whether a post-approval study for a leadless pacemaker could include patients who had participated in the pivotal study for that device. One member of the panel remarked that this was common practice, but FDA’s Bram Zuckerman, no model of reticence by any measure known to humankind, advised the panel that his “personal inclination would be no,” that pivotal study enrollees would not be permitted to participate in a PAS.

Now I’ll grant that this was in the context of a discussion about early adverse events associated with this class of devices, so the agency is perfectly at its right to want additional information on that score. And it’d require someone better versed in these matters than yours truly to assess whether there’s a legitimate need for a PAS with 1,700 fresh enrollees to sort out all the safety signals associated with this kind of device.

But let’s not forget that FDAers are also perfectly within their rights to ignore the advice of an advisory committee. Otherwise, the Boston Scientific Watchman would have made it to market quite a bit sooner than it actually did. Incidentally, representatives of Medtronic and St. Jude Medical were in attendance, too, and I seriously doubt whether they missed Zuckerman’s ham-fistedness.

Some might argue that this is small potatoes, but the problem I have with this is that Zuckerman’s conduct is akin to having a judge instruct a jury to find the defendant guilty. I doubt that Zuckerman’s expression of his “personal inclination” violated a law, but it is ethically out of bounds, or at the very least contrary to the whole idea of an advisory hearing.

After all, if what FDA wants is a rubber stamp, those can be had for a lot less money and inconvenience at the local office supply store. Otherwise, FDA should consider playing by the rules instead of introducing the kind of bias the agency purports to loathe in clinical trials.


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