As those in attendance at ACC 2015 know, Jeff Popma of Beth Israel Deaconess asked publicly whether the 30-day data for Sapien 3 should suffice for approval of the device, but the story grew more interesting today (March 16). I was at a session at ACC dealing with translation of research into clinical practice, and Bram Zuckerman, director of the cardiovascular devices division at FDA’s Office of Device Evaluation, was on the dais. He talked a little about how FDA approaches evidence and so on, and really had little to say that he hasn’t said many times before.
Someone in the audience asked Zuckerman about whether the U.S. premarket review system should not look more like the system at work in Europe, and I followed with a question about whether an approval of Sapien 3 and other TAVR devices would be as a PMA supplement or as a PMA, and whether he could characterize his conversations with industry about PMA supplements for TAVR generally.
That didn’t sit well with Zuckerman, who said “this question is designed to obtain confidential information” about a device application. He went so far as to say that my presence was “an example of the kinds of people” who attend events like ACC 2015, and I suppose I should have been flattered when he described me as “a well-known member” of the press.
I wasn’t aware I am all that well known. After all, Medical Device Daily is a small-volume publication. If you want someone who is well known, try tracking down a name with the New York Times. They’re well known, but I doubt seriously whether more than 1,000 people in this world know who I am.
In any event, Zuckerman’s allegation that I was looking for confidential information is absurd. I asked for some idea of the conversations between FDA and industry on the notion of what might constitute a reasonable set of conditions for the use of a PMA supplement for TAVR. Zuckerman’s confusion about whether I was asking about Sapien 3 specifically is understandable, but he could have just said he couldn’t answer the question due to confidentiality.
That wasn’t good enough, though. He decided to go out of his way in an attempt to embarrass me. For the record, I was embarrassed alright, but not for myself. I found Zuckerman’s paranoia odd, not to mention unbecoming of his self-described status as a “humble public servant.”
I get that everyone has a bad day now and then, but this was way out of line. Bram Zuckerman needs to realize that the media have their place in this world. If he doesn’t like dealing with questions, maybe he should get a job that keeps him safe and sound in a place where no one has the temerity to challenge his authority. Until that day arrives, he might want to consider that it’s not the job of those in government to attempt to bully the press.