Stay Up-To-Date With Industry Happenings

Our Client Alerts are our way of sharing current regulatory news and insights with our clients and friends of the firm. Our mailing list is huge and many of our Client Alerts are turned into trade press articles upon a media request to do so.

We pride ourselves in not publishing the pablum that everyone else says about a new law, regulation, guidance or regulatory initiative.

We bring to bear our experience, FDA relationships, our constant interface with FDA in meetings, phone calls and email communications to give you "inside baseball" insights into what it all means.

  • FDA Attempting To Rescind ReGen Clearance

    • Authored by: Mark DuVal
    • Published on: October 15, 2010

    Executive summary

    ReGen is the poster-child for FDA's never-ending attempts to tell us all how broken the 510(k) program is and how FDA will rescue society from all the bad devices out there today and in the future.

    The Agency, and in particular, CDRH Director Dr. Jeff Shuren, won't let this company go.

    On December 18, 2008, FDA granted 510(k) clearance to ReGen Biologic's Menaflex™ device. This week CDRH decided to "rescind" ReGen's clearance, although it's not clear they have the legal authority to do so. Is this a political maneuver or a new way of doing business at FDA or both?

  • The Department of Justice (DOJ), Office of Inspector General (OIG) and FDA plan to aggressively pursue misdemeanor prosecutions of CEOs, managers under ‚ÄúResponsible Corporate Officer Doctrine"

    • Authored by: Mark DuVal
    • Published on: October 15, 2010

    The Department of Justice (DOJ), Office of Inspector General (OIG) and FDA recently stated they plan to more aggressively pursue misdemeanor prosecutions of CEOs, managers and other executives under the long established but sporadically used "Responsible Corporate Officer Doctrine" ("RCO Doctrine") under the Food, Drug and Cosmetic Act to prosecute corporate officers for public welfare offenses. We feel this expanded view was not contemplated by the Congress that enacted these provisions.

    Coupled with that news, Deborah Wolf FDA's Regulatory Counsel in charge of device advertising and promotion compliance, was recently quoted as saying her organization was expanding from one person to three and they would be pursuing physicians and clinics who are promoting off-label. These two developments make it imperative that clients revisit their compliance programs and conduct reviews of their promotional activities to ensure they are in compliance. This Client Alert briefly discusses the RCO doctrine and provides recommendations about what a company can do to protect itself in this era of ramped up enforcement.

    Recent government threats

    As reported by Jessica Bylander in "The Gray Sheet" September 29, 2010, the Department of Justice ("DOJ"), Office of Inspector General ("OIG") and the FDA are setting their sites on prosecution of CEOs, executives and managers at device and drug companies for off-label promotion of drugs and devices.

  • Reporting Deadline For Medical Device And Drug Companies Approaches

    • Authored by: Mark DuVal
    • Published on: September 1, 2010

    Please be reminded that October 1, 2010 is the reporting deadline for medical device and drug companies filing 2009 marketing disclosures in Vermont (e.g. disclosures include things like CME grants, consulting fees, clinical expenditures, etc.). The deadline is approaching quickly. Failure to report in Vermont carries a fine of $10,000 per violation. A $500 filing fee and compliance declaration for Vermont were due July 1, 2010.

    Device and drug companies, additional state requirements:

  • FDA Town Hall Meeting With Dr. Shuren - May 18, 2010 - Minneapolis, MN

    • Authored by: Mark DuVal
    • Published on: May 19, 2010

    In this Client Alert, we offer our views on the FDA Town Hall meeting held May 18, 2010 in Minneapolis along with a battery of resources including a video of Congressman Erik Paulsen speaking yesterday from the House Floor about the Town Hall meeting.


    It is clear that we have a strong leader at the helm at CDRH. Dr. Jeff Shuren displayed a firm grasp on the issues and challenges and has a clear idea how to solve them. He has clarity of insight and vision. He openly, calmly and candidly addressed questions with warmth and well-placed humor. He is an effective leader and spokesman for the Agency and extremely organized and driven.

The information on our site is not intended to provide specific legal advice.
Helping clients be appropriately aggressive, yet compliant. TM