All Clarivate websites use cookies to improve your online experience. They were placed on your computer when you launched this website. You can change your cookie settings through your browser.

More information on our cookie policy.

BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
    • BioWorld
    • BioWorld MedTech
  • Special reports
    • Aging
    • Artificial intelligence
    • Coronavirus
    • IVDs on the rise
    • Top Biopharma Trends of 2021
    • Top Med-tech Trends of 2021
    • Premium reports
      • BioWorld Financings Reports
      • Disease Incidence & Prevalence Summaries

BioWorld. Link to homepage.

  • Sign In
  • Sign Out
  • My Account
Subscribe
BioWorld - Thursday, August 11, 2022
Home » Blogs » BioWorld MedTech Perspectives » Public accusations and paranoia at FDA

BioWorld MedTech Perspectives
BioWorld MedTech Perspectives RSS FeedRSS

BioWorld MedTech

Public accusations and paranoia at FDA

March 16, 2015
By Mark McCarty
No Comments

200px-Food_and_Drug_Administration_logo.svgAs 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.

You must login or register in order to post a comment.

Report Abusive Comment

Popular Stories

  • Free access to BioWorld coronavirus articles

    BioWorld
    The articles in this collection are from BioWorld’s ongoing coverage of the COVID-19 coronavirus pandemic. They are available for free with registration. Note...
  • Today's news in brief

    BioWorld
    BioWorld briefs for Aug. 11, 2022.
  • Today's news in brief

    BioWorld MedTech
    BioWorld MedTech briefs for Aug. 11, 2022.
  • Amvuttra

    Alnylam’s Amvuttra rare disease drug among positive recommendations from Europe’s CHMP

    BioWorld
    Alnylam Pharmaceuticals Inc.’s Amvuttra (vutrisiran), a treatment for the rare disease hereditary transthyretin-mediated amyloidosis, was among medicines...
  • Pig organ cells

    Whole body cellular function recovery in pigs after death

    Science
    A new system for restoring cell function and tissues in mammals after death could expand the availability of organs for transplantation. The research also opens...
black cortellis ad

BioWorld Premium

Enjoy extended coverage for the most complete market view with BioWorld, BioWorld MedTech, and BioWorld Asia in a single, easy to access subscription.

Subscribe
  • BioWorld
    • Today's news
    • Analysis and data insight
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Newco news
    • Opinion
    • Regulatory
    • Science
  • BioWorld MedTech
    • Today's news
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Newco news
    • Opinion
    • Regulatory
    • Science
  • BioWorld Asia
    • Today's news
    • Analysis and data insight
    • Australia
    • China
    • Clinical
    • Deals and M&A
    • Financings
    • Newco news
    • Regulatory
    • Science
  • BioWorld Science
    • Archives
    • Today's news
    • Search BioWorld Science
    • About
  • More
    • About
    • Archives
    • Article reprints and permissions
    • Contact us
    • Cookie policy
    • Copyright notice
    • Data methodology
    • Podcasts
    • Privacy policy
    • Share your news with BioWorld
    • Staff
    • Terms of use
Follow Us

Copyright ©2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing