All Clarivate Analytics 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.

/images/Cortellis_Flagship_Logo_TM_RGB_Color.png
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
    • BioWorld
    • BioWorld MedTech
  • Special reports
    • Artificial intelligence
    • Coronavirus
    • Diagnosing and tracking COVID-19
    • Drugs to Watch 2020
    • The next pandemic
    • Premium reports
      • BioWorld Financings Reports
      • Disease Forecast Reports

BioWorld. Link to homepage.

  • Sign In
  • Sign Out
  • My Account
Subscribe
BioWorld - Friday, February 26, 2021
Home » Blogs » BioWorld MedTech Perspectives » Thank you government!

BioWorld MedTech Perspectives
BioWorld MedTech Perspectives RSS FeedRSS

BioWorld MedTech / CDRH / CMS

Thank you government!

Nov. 25, 2014
By Mark McCarty
No Comments

Guy Fawkes night; a different kind of Thanksgiving
Guy Fawkes night; a different kind of giving of thanks

November is not always a spicy month where federal agencies are concerned, but FDA and CMS have come through to give us something to talk about. Below are a couple of items to mull over as you enjoy a leisurely, stress-free drive or comfy, un-cramped flight to celebrate Thanksgiving with loved ones.

CMS makes a virtue of necessity

The final guidance for the Medicare coverage with evidence development (CED) program is a relatively brief document considering the impact it will have, but also considering the length of the draft that birthed it.

One thing CMS did make clear in the final is that Medicare administrative contractors (MACs) will not be issuing CEDs despite that the agency had floated such a notion in the draft. However, CMS was very un-specific about how to closeout a CED study in the final, stating little more than that it has its eye on the coverage transition between the termination of a study and the agency's decision about non-trial coverage.

One can understand how CMS might want to maintain flexibility, but the draft version raised more questions than it answered. Other than the MAC/CED thing, just what do we know now that we didn't know before? I guess brevity is the key virtue with this document.

FDA clamps down on morcellation

FDA announced November 24 that it will require that manufacturers apply a black box warning to power morcellators as well as contraindications, a move designed to eliminate the spread of uterine sarcomas and other cancers as a consequence of morcellation.

One cannot complain about FDA's concern over the potential for debilitating and lethal cases of cancer, but there are those who believe the agency has overreacted in requiring that labels convey a contraindication for peri-menopausal women. Understandably risk averse device makers have already pulled their offerings from the market, but at least one private-sector insurer has abandoned coverage of the procedure, and a number of hospitals have forbade use of these devices in their facilities as well.

When it comes to things like this, I always wonder why more people never get upset about device lag (cought*TAVR*cough), which has undoubtedly cost far more than the dozen lives FDA has attributed to morcellation. We should not want to actively do things that promote morbidity and mortality, but is benign neglect that leads to death and debilitation really any better?

As an aside, FDA used the immediately-in-effect (IIE) guidance mechanism to communicate its concerns about power morcellators without offering the 60-day comment period it had required of itself in the final standard operating procedure for these guidances. Unless I'm mistaken, the IIE is a tool for addressing urgent medical situations based on recent scientific or evidentiary developments. If FDA feels it can make this declaration without offering stakeholders 60 days to comment, why would it bother to ask for public comment any other time it wants to use the IIE mechanism?

Since it is quite apparent that the use of morcellation is already in sharp decline, we can reasonably conclude that FDA is of the do-as-I-say-not-as-I-do school of thought when it comes to its own regulations. And some people wonder why other people are skeptical of government.

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 outbreak. Note that we have added three critical tables which are...

  • Seniors with wooden puzzle

    Cassava’s simufilam improves AD patients’ cognition, behavior

    BioWorld
    When Cassava Sciences Inc.’s president and CEO, Remi Barbier, opened up the interim analysis of the company’s open-label study for Alzheimer’s disease candidate...
  • Vaxart COVID-19 vaccine tablets

    Vaxart shares shaken despite apparently positive early data for oral COVID-19 vaccine

    BioWorld
    Vaxart Inc. investors who stuck by company shares Feb. 3 had to swallow a bitter pill – watching shares of the oral vaccine developer (NASDAQ:VXRT) fall 57.8% to...
  • IPO money

    Lucira Health launches $153M IPO

    BioWorld MedTech
    Infectious diseases diagnostics company Lucira Health Inc. launched an IPO of 9 million shares of common stock at $17 per share, for expected gross proceeds of...
  • Today's news in brief

    BioWorld
    BioWorld briefs for Feb. 25.
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
    • About
    • Archives
    • Today's news
    • Search BioWorld Science
  • More
    • About
    • Archives
    • Article reprints and permissions
    • Contact us
    • Cookie policy
    • Copyright notice
    • Data methodology
    • Privacy policy
    • Share your news with BioWorld
    • Staff
    • Terms of use
A Clarivate Analytic solution. Link to Clarivate website.
Follow Us

Copyright ©2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing