National Forum on

Off-Label Promotion of Pharmaceuticals

Thursday, September 22, 2005

About

ARE YOUR COMPANY'S SALES AND PROMOTIONAL EFFORTS MAKING IT A TARGET FOR CLAIMS OF OFF-LABEL PROMOTION?

Controversy continues to swirl around "off-label" promotion of pharmaceutical products. The challenge of various FDA strictures on First Amendment and other grounds continues to fan the flames of debates about dissemination of information and appropriate promotional and marketing tactics. Yet, government scrutiny continues to trigger numerous and varied lawsuits by enforcers and plaintiff attorneys alike. The current legal atmosphere poses challenges for even the most vigilant in-house counsel and compliance officers.

With these numerous and complex challenges to promoting pharmaceutical products in mind, American Conference Institute has developed this publiction to provide in-house counsel, compliance officers, sales mangers and marketing executives in pharmaceutical companies with the practical tools necessary to ensure continued compliance with the myriad of regulations and guidelines regarding off-label promotion of product and the appropriate dissemination of information regarding a product.

Get insights on critical issues, including:

  • Lessons learned in negotiating and implementing CIAs
  • When does alleged inappropriate promotion raise a claim under the False Claims Act?
  • After WLF how plaintiffs and regulators are hoping to avoid First Amendment protections
  • When is support of CME appropriate?
  • Inappropriate promotion v. transparency in disclosure- maneuvering the minefield of reporting clinical trial results
  • Tactics for monitoring the sales representatives-controlling the dissemination of information
  • What is the role of the Medical Liaison in the wake of the Neurontin case?

Contents & Contributors

About

ARE YOUR COMPANY'S SALES AND PROMOTIONAL EFFORTS MAKING IT A TARGET FOR CLAIMS OF OFF-LABEL PROMOTION?

Controversy continues to swirl around "off-label" promotion of pharmaceutical products. The challenge of various FDA strictures on First Amendment and other grounds continues to fan the flames of debates about dissemination of information and appropriate promotional and marketing tactics. Yet, government scrutiny continues to trigger numerous and varied lawsuits by enforcers and plaintiff attorneys alike. The current legal atmosphere poses challenges for even the most vigilant in-house counsel and compliance officers.

With these numerous and complex challenges to promoting pharmaceutical products in mind, American Conference Institute has developed this publiction to provide in-house counsel, compliance officers, sales mangers and marketing executives in pharmaceutical companies with the practical tools necessary to ensure continued compliance with the myriad of regulations and guidelines regarding off-label promotion of product and the appropriate dissemination of information regarding a product.

Get insights on critical issues, including:

  • Lessons learned in negotiating and implementing CIAs
  • When does alleged inappropriate promotion raise a claim under the False Claims Act?
  • After WLF how plaintiffs and regulators are hoping to avoid First Amendment protections
  • When is support of CME appropriate?
  • Inappropriate promotion v. transparency in disclosure- maneuvering the minefield of reporting clinical trial results
  • Tactics for monitoring the sales representatives-controlling the dissemination of information
  • What is the role of the Medical Liaison in the wake of the Neurontin case?

Contents & Contributors


MASTERING THE COMPLIANCE GUIDELINES TO ENSURE BEST PRACTICES AND TO MITIGATE EXPOSURE TO OFF-LABEL PROMOTION CLAIMS
Keith M. Korenchuk, McGuire Woods
Susan Hart-White, Sanofi-Aventis

A DEFENSE PERSPECTIVE: UNDERSTANDING THE LATEST TOOLS USED BY ENFORCERS TO PROSECUTE ALLEGED INAPPROPRIATE PROMOTION
Nathan Sheers, Sidley Austin Brown & Wood LLP

POTENTIAL OFF-LABEL ISSUES IN REPORTING CLINICAL TRIALS RESULTS
Elizabeth Gobeil, Thompson Hine LLP
Eric R. Green, Quintiles Transnational Corp.

REDUCING LIABILITY EXPOSURES CREATED BY PROMOTION OF PRESCRIPTION AND OTC DRUGS BY SALES REPRESENTATIVES
R. Bruce Dickson Manatt, Phelps & Phillips LLP
Walt Addison Linscott, Thompson Hine LLP
Stephen J. McConnell, Dechert

THE ROLE OF SALES REPRESENTATIVES IN LITIGATION
Stephen J. McConnell, Dechert

A PRACTICAL GUIDE TO SPOTTING THE POTENTIAL
Walt Addison Linscott, Thompson Hine LLP

THE ANATOMY OF A HEALTH CARE FRAUD INVESTIGATION ABOUT ALLEGED OFF-LABEL PROMOTIONAL ACTIVITIES
Lisa M. Goldman, Pfizer Inc
Lynn Shapiro Snyder, Epstein Becker & Green P.C.

IMPACT OF FIRST AMENDMENT ON PHARMACEUTICAL PROMOTION
James D. Arden, Sidley Austin Brown & Wood LLP

STRIKING THE BALANCE: SUPPORT OF CME AND OTHER THIRD-PARTY EDUCATIONAL ACTIVITY
Sondra Moylan, MS, RN, American Academy of CME, Inc.

THE ROLE OF THE MEDICAL LIAISON: HOW TO DISSEMINATE MEDICAL INFORMATION WITHOUT INCURRING LIABILITY
Howard L. Dorfman, Bayer Pharmaceuticals Corporation

LITIGATING THE OFF-LABEL CASE
Connie A. Matteo, Porzio, Bromberg & Newman, P.C.

STATE LAW UPDATE GIFTS, ADVERTISING AND MARKETING COMPLIANCE
Retta M. Riordan, Organon Pharmaceuticals USA Inc.

STATE LAW UPDATE: CLINICAL TRIAL REGISTRIES, SAMPLING (MID-LEVEL PRACTITIONERS & THEFT/LOSS REPORTING), PRICE DISCLOSURES & ADVERTISING COST DISCLOSURES
Linda Pissott Reig, Porzio, Bromberg & Newman, P.C.

DEFEATING OFF-LABEL CLAIMS IN PHARMACEUTICAL LITIGATION LORI G. COHEN, GREENBERG TRAURIG, LLP
Christiana C. Jacxsens, Greenberg Traurig, LLP

TRAINING SALES FORCE TO COMPLY WITH OFF-LABEL GUIDANCE
Melissa Tearney, Nixon Peabody LLP
David Ryan, Nixon Peabody LLP

TRAINING THE SALES FORCE TO CONSISTENTLY COMPLY WITH OFF-LABEL GUIDANCE
Kimberly Banks MacKay, Novartis Pharmaceuticals Corporation



DOCUMENT TYPES: PRESENTATIONS AVAILABLE: 0