Pharmaceutical & Medical Device Counsel's Guide to

Off-Label Communications

Overcoming uncertainty in an era of heightened scrutiny

Monday, April 24, 2006

About

Ensure That Your Company Is Not the Next Potential Target for Claims of Off-Label Promotion

With heightened scrutiny by various government enforcers, the need to interpret varied and vague guidelines, the lack of clear case law, and an alarmingly aggressive plaintiffs' bar, off-label communications continue to be an unresolved issue for drug and medical device companies. As investigations and lawsuits continue to grow exponentially, no company is immune from becoming the next potential target.

Being aware of the current case law and guidelines that regulate and govern off-label communications is the bare minimum you must do. To manage such communications with confidence and mitigate potential liability, you must implement and monitor proper compliance and training programs and be ready to defend against any investigation or claim.

The publication for the American Conference Institute's 2nd National Pharmaceutical and Medical Device Counsel's Guide to Off-Label Communications will provide you with presentations that include the most up-to-date information for tackling the latest legal and regulatory developments. Presentations with in this publication will provide you with useful and thorough information on:

  • Navigating the complexities of off-label communications in the face of differing interpretations and standards by government bodies
  • Developing effective methods to monitor the sales force
  • Evaluating your First Amendment rights in the wake of the WLF trilogy of cases
  • Clarifying the proper role of MSLs when communicating off-label uses
  • Recognizing the risks of securities fraud and shareholder derivative suits
  • Ensuring proper Internet communications
  • Preparing for new off-label issues with emerging personalized medicine

Contents & Contributors

About

Ensure That Your Company Is Not the Next Potential Target for Claims of Off-Label Promotion

With heightened scrutiny by various government enforcers, the need to interpret varied and vague guidelines, the lack of clear case law, and an alarmingly aggressive plaintiffs' bar, off-label communications continue to be an unresolved issue for drug and medical device companies. As investigations and lawsuits continue to grow exponentially, no company is immune from becoming the next potential target.

Being aware of the current case law and guidelines that regulate and govern off-label communications is the bare minimum you must do. To manage such communications with confidence and mitigate potential liability, you must implement and monitor proper compliance and training programs and be ready to defend against any investigation or claim.

The publication for the American Conference Institute's 2nd National Pharmaceutical and Medical Device Counsel's Guide to Off-Label Communications will provide you with presentations that include the most up-to-date information for tackling the latest legal and regulatory developments. Presentations with in this publication will provide you with useful and thorough information on:

  • Navigating the complexities of off-label communications in the face of differing interpretations and standards by government bodies
  • Developing effective methods to monitor the sales force
  • Evaluating your First Amendment rights in the wake of the WLF trilogy of cases
  • Clarifying the proper role of MSLs when communicating off-label uses
  • Recognizing the risks of securities fraud and shareholder derivative suits
  • Ensuring proper Internet communications
  • Preparing for new off-label issues with emerging personalized medicine

Contents & Contributors


MEDICARE PART D, OFF-LABEL PROMOTION, AND THE FALSE CLAIMS ACT
Martin F. Murphy, Foley Hoag LLP

DEVELOPING, IMPLEMENTING, AND MAINTAINING A COMPLIANCE PROGRAM
William J. Hrubes, Jr., Gambro, Inc.
Jeanine Jiganti, Takeda Pharmaceuticals North America, Inc.
Keith M. Korenchuk, McGuireWoods LLP

TRAINING, MONITORING AND DISCIPLINING YOUR SALES FORCE TO MITIGATE EXPOSURE TO OFF-LABEL CLAIMS
Tanya Dobash, Taro Pharmaceuticals
Richard Shupack, InterMune, Inc.

ASSESSING YOUR FIRST AMENDMENT RIGHTS AGAINST FDA POSITION ON OFF-LABEL COMMUNICATIONS
Marc J. Scheineson, Alston & Bird LLP

ENSURING INDEPENDENCE AND VALUE IN SUPPORT OF CME PROGRAMS AND OTHER EDUCATIONAL ACTIVITIES
Heather J. Stewart, Bristol-Myers Squibb Co.
Bruce S. Manheim, Jr., Ropes & Grays

CREATING EFFECTIVE AND COMPLIANT RELATIONSHIPS WITH HEALTH CARE PROFESSIONALS
Sean Fahey, Pepper Hamilton LLP
Albert P. Parker, II, Wyeth Pharmaceuticals North America

PRODUCT LIABILITY AND OFF-LABEL USE: AN OVERVIEW
James Beck, Dechert LLP
Karl Dahlquist, Medtronic, Inc.

COMBATING ECONOMIC LOSS CONSUMER FRAUD CLAIMS IN THE PROMOTION AND SALE OF PHARMACEUTICALS
Steven P. Benenson, Porzio, Bromberg & Newman, P.C.

UNDERSTANDING THE LINK BETWEEN OFF-LABEL SALES/PROMOTION AND SECURITIES FRAUD/SHAREHOLDER DERIVATIVE SUITS
Michael Kichline, Dechert LLP
David A. Kotler, Dechert LLP

INTERNET ADVERTISING OF DRUGS AND BIOLOGICS
James M. Wood, Reed Smith LLP



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