• CMS's redrawn exemption for CME disallows sponsor choice of speaker

    • Published on: November 3, 2014
    • Category: FDA News

    Mark Gardner was quoted in a Medical Device Daily article written by Mark McCarty, Washington Editor, regarding 2015-2016 changes to the Sunshine Act.

    The Centers for Medicare & Medicaid Services released the Medicare physician fee schedule for calendar 2015 in a classic government data dump on Halloween, and among the items included in the MPFS is a revised exemption for sponsor payments made for continuing medical education. The final rule explains that when an applicable party funds a CME, but "does not either select or pay the covered recipient directly," that payment would be excluded so long as the sponsor did not provide the CME provider with "a distinct, identifiable set of covered recipients to be considered as speakers" at the event (Inside the Beltway).

    Read the full article here.

  • Op-Ed: What Do “The Hunger Games” and 510(k) Have in Common? More Than You’d Think.

    • Published on: April 29, 2013
    • Category: FDA News

    Op-Ed: What Do “The Hunger Games” and 510(k) Have in Common? More Than You’d Think.

    MDDI Device Talk Blog

    Posted: April 29, 2013

    Like the tributes thrust into the Hunger Games arena, medical device manufacturers want a fair shot at surviving the everchanging FDA 510(k) pathway.

    The FDA 510(k) program is beautiful and practical in its simplicity, and yet sophisticated in its ability to accommodate complexity and flexibility. It is as maligned as it is revered. But describing the nuanced process in detail is far too complex, as it requires an admixture of macro and micro politics, political philosophy being subtly carried out, and regulatory and administrative law, medicine, and science.
    By putting it into a caricature using the pop culture phenomenon The Hunger Games, however, I have tried to provide an amusing analogy to demonstrate what it’s like to take a client through the surprise-filled arena we call the 510(k) program as well as some tips on how to make it out alive.

  • Concerns heighten over the prospect of ‘responsible corporate officer’ prosecutions against drug and device manufacturers

    • Published on: January 18, 2011
    • Category: FDA News

    Concerns heighten over the prospect of ‘responsible corporate  officer’ prosecutions against drug and device manufacturers

    Westlaw article by Kim M. Schmid, Esq., and Molly J. Given, Esq., Bowman & Brooke, and Mark DuVal, J.D., and Mark Gardner J.D. DuVal & Associates

    JANUARY 18, 2011-VOLUME 17, ISSUE 24

    The recent announcement that the Department of Justice, Health and Human Services’ Office of Inspector General, and the Food and Drug Administration plan to aggressively pursue individual criminal charges against executives for illegal offlabel marketing deservedly caused a stir in the drug and medical device manufacturing community.

    High-ranking employees of pharmaceutical and medical device manufacturers are taking notice as they analyze the prospect of facing a personal criminal investigation under the “responsible corporate officer” doctrine of the Food, Drug and Cosmetic Act.  However, the concern over the government’s stated intent to use the RCO doctrine has implications greater than personal criminal liability because it may also provide fuel to the plaintiffs’ product liability tort bar.

    The results for manufacturers should government agencies forge ahead with these aggressive RCO prosecutions could be farreaching, affecting not only manufacturers and their executives and managers, but also medical industry insurers, shareholders and, ultimately, the health care consumer.

    This article outlines the contemplated enforcement actions and explores the impact that RCO prosecutions and convictions may have in the world of product liability lawsuits involving pharmaceuticals and medical devices.  Industry must anticipate the likely increase in RCO prosecutions and plan accordingly.


  • The Prosecutorial Prism: Are We All Felons?

    • Published on: March 1, 2005
    • Category: FDA News

    Update March/April 2005

    I appreciate this opportunity to comment on the role the First Amendment has—or, more accurately, has not—played in Department of Justice (DOJ) prosecutions undertaken in recent years. This commentary will focus on DOJ cases involving off-label uses of medical products, allegations of False Claims Act violations, DOJ’s announcement that it has over 500 drugs under investigation,1 and DOJ’s continued threats to prosecute more medical device companies.

    Prosecutors have a problem when they begin to look at everyone as a criminal. Industry has a problem when management turns a blind eye to programs and /or payments that might be illegal or fails to put into place effective compliance programs. Prosecutors look at the world through a prism partially of their own making and partially constructed from the bad actors they encounter. Industry must acknowledge that the vision of corporate managers can be clouded by the pressures of pleasing executive management and shareholders who want them to get the most out of their corporate assets. As such, companies must be diligent in policing themselves.

    This commentary, however, focuses on prosecutors and the recent prosecutions in the pharmaceutical and medical device sectors. There are four issues that need to be discussed “straight-up” with prosecutors and that may add an industry viewpoint not covered in the WLF correspondence above.

The information on our site is not intended to provide specific legal advice.
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