Publication Details

Publication Categories

Browse C5 Companies

C5 Group
www.C5groupinc.com

Canadian Institute
www.canadianinstitute.com

C5 (UK)
www.C5-online.com
ACI : Conference-Papers : 2007 : Off-Label Communications

3rd NationalMedical Device & Pharmaceutical Counsel's Guide to

Off-Label Communications

Staying within the bounds of lawful scientific exchange

Wednesday, September 13, 2006

About

Don't Be the Next Target of Off-Label Promotion Claims!

Heightened scrutiny by various government enforcers combined with vague and conflicting guidelines, unclear case law, and an alarmingly aggressive plaintiffs' bar has only led to increased controversy and confusion with respect to off-label communications. As investigations and lawsuits continue to grow exponentially it has become evident that 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 from the American Conference Institute's 3rd National Medical Device & Pharmaceutical Counsel's Guide to Off-Label Communications will provide you with the most up-to-date tools for tackling the latest legal and regulatory developments. Have access to presentations about how to build about successful compliance plans, effective business practices, and winning litigation tactics from leading in-house counsel, compliance and regulatory officers, and expert attorneys who represent the drug and medical device industries. The publication will provide you with useful and thorough information on:

  • Maintaining compliance in the face of differing interpretations and standards by government bodies pertaining to off-label communications
  • Preserving all useful defenses in the event of a product liability suit
  • Developing effective methods for monitoring the activities of your sales force
  • Clarifying the proper role of MSLs when communicating off-label uses

Contents & Contributors

About

Don't Be the Next Target of Off-Label Promotion Claims!

Heightened scrutiny by various government enforcers combined with vague and conflicting guidelines, unclear case law, and an alarmingly aggressive plaintiffs' bar has only led to increased controversy and confusion with respect to off-label communications. As investigations and lawsuits continue to grow exponentially it has become evident that 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 from the American Conference Institute's 3rd National Medical Device & Pharmaceutical Counsel's Guide to Off-Label Communications will provide you with the most up-to-date tools for tackling the latest legal and regulatory developments. Have access to presentations about how to build about successful compliance plans, effective business practices, and winning litigation tactics from leading in-house counsel, compliance and regulatory officers, and expert attorneys who represent the drug and medical device industries. The publication will provide you with useful and thorough information on:

  • Maintaining compliance in the face of differing interpretations and standards by government bodies pertaining to off-label communications
  • Preserving all useful defenses in the event of a product liability suit
  • Developing effective methods for monitoring the activities of your sales force
  • Clarifying the proper role of MSLs when communicating off-label uses

Contents & Contributors


TACKLING THE REIMBURSEMENT ISSUES ASSOCIATED WITH OFF-LABEL USES
Judy Waltz, Foley & Lardner LLP

OFF-LABEL COMMUNICATIONS: ISSUES FOR SALES REPRESENTATIVES
Jack Cinquegrana, Choate, Hall & Stewart LLP

TRAINING AND POLICING SALES REPRESENTATIVES
Vernon Francis, Dechert LLP

ENSURING THAT MSLS STICK TO THE SCIENCE
Wayne L. Pines, Scientific Advantage LLC

PERMISSIBLE DISSEMINATION OF OFF-LABEL DRUG AND MEDICAL DEVICE INFORMATION
Sandra J.P. Dennis, Esq., Morgan, Lewis & Bockius LLP

THE INTERNET: OPPORTUNITIES AND RISKS IN PROMOTIONAL AND EDUCATIONAL COMMUNICATIONS
R. Bruce Dickson, Manatt, Phelps & Phillips LLP

"GHOST-WRITING" LANDMINES AND STEPS TO AVOID THEM
Sean P. Wajert, Dechert LLP

MODIFYING COMPLIANCE ACTIVITIES IN RESPONSE TO TRENDS IN GOVERNMENT ENFORCEMENT ACTIVITY
Kathy Harris, DePuy Orthopaedics Inc.
Michael Koon, Shook Hardy & Bacon LLP

POTENTIAL OFF-LABEL ISSUES IN REPORTING CLINICAL TRIAL RESULTS
Elizabeth D. Gobeil, Thompson Hine LLP

AUDITING AND MONITORING OFF-LABEL COMMUNICATIONS IN THE WAKE OF RECENT CIAS
Lynn Shapiro Snyder, Epstein Becker & Green P.C.
John Rah, Epstein Becker & Green P.C.

OFF-LABEL USE AND PRODUCT LIABILITY: A SWORD OR A SHIELD
Stephen J. McConnell, Dechert LLP

OFF-LABEL IN THE COURTROOM
Kirby Griffis, Spriggs & Hollingsworth