Minimizing Legal Risks in

Drug Advertising and Promotion

Practical strategies for compliance & defense

Monday, June 13, 2005

About


Is Your Client the Next to Suffer Legal Consequences from Its Promotional Practices?

Pharmaceutical companies are now a favorite target of plaintiff firms, media pundits and politicians. Armed with the knowledge that pharmaceutical companies spent roughly $110 million, or nearly 29% of all ad revenue from January though September of 2004, the foes of the industry are hoping to increase pressure to affect a sea change in the content of advertising and even impact the fate of direct-to consumer ("DTC") advertising. Further, plaintiff lawyers are continuing to use advertising and promotional practices of drug companies as fodder for product liability and consumer fraud lawsuits.

It is critical that every in-house pharma counsel and the outside firms advising them have a sophisticated understanding of the exposures facing these companies along with the most effective ways to mitigate these exposures. American Conference Institute's Third Annual Forum on Minimizing Legal Risks in Drug Advertising and Promotion publication is designed specifically to provide the latest legal theories and strategies in this arena.

You'll learn from leading pharmaceutical attorneys, in-house counsel at major pharmaceutical companies and the government enforcers that are actively pursuing pharmaceutical companies for alleged inappropriate advertising and promotion practices.* Get insight on critical issues, including:

  • How the recent trends in Lanham Act and consumer fraud cases will impact your client
  • Changing the public's negative perception of the industry-why it matters and how to do it in a productive manner
  • The latest guidance on avoiding conflicts in sponsoring CME
  • How will recent product recalls impact pharmaceutical product liability litigation?
  • Raising a red flag: what is government looking for to build a prosecution for off-label promotion?
  • The impact on the pharmaceutical industry of the perception of increasing FDA oversight of physicians
*American Conference Institute cannot guarantee that every presentation will be included in the publication.

Contents & Contributors

About


Is Your Client the Next to Suffer Legal Consequences from Its Promotional Practices?

Pharmaceutical companies are now a favorite target of plaintiff firms, media pundits and politicians. Armed with the knowledge that pharmaceutical companies spent roughly $110 million, or nearly 29% of all ad revenue from January though September of 2004, the foes of the industry are hoping to increase pressure to affect a sea change in the content of advertising and even impact the fate of direct-to consumer ("DTC") advertising. Further, plaintiff lawyers are continuing to use advertising and promotional practices of drug companies as fodder for product liability and consumer fraud lawsuits.

It is critical that every in-house pharma counsel and the outside firms advising them have a sophisticated understanding of the exposures facing these companies along with the most effective ways to mitigate these exposures. American Conference Institute's Third Annual Forum on Minimizing Legal Risks in Drug Advertising and Promotion publication is designed specifically to provide the latest legal theories and strategies in this arena.

You'll learn from leading pharmaceutical attorneys, in-house counsel at major pharmaceutical companies and the government enforcers that are actively pursuing pharmaceutical companies for alleged inappropriate advertising and promotion practices.* Get insight on critical issues, including:

  • How the recent trends in Lanham Act and consumer fraud cases will impact your client
  • Changing the public's negative perception of the industry-why it matters and how to do it in a productive manner
  • The latest guidance on avoiding conflicts in sponsoring CME
  • How will recent product recalls impact pharmaceutical product liability litigation?
  • Raising a red flag: what is government looking for to build a prosecution for off-label promotion?
  • The impact on the pharmaceutical industry of the perception of increasing FDA oversight of physicians
*American Conference Institute cannot guarantee that every presentation will be included in the publication.

Contents & Contributors


REGULATION OF DIRECT-TO-CONSUMER ADVERTISING FOR PRESCRIPTION MEDICATIONS
Joseph K. Hetrick, Dechert
Tessie Corbin, Dechert

UPDATE ON THE PRACTICE OF DTC ADVERTISING: BOON OR BANE TO THE INDUSTRY?
Charlene A. Gallagher, Wyeth Pharmaceuticals
Joseph K. Hetrick, Dechert

OVERPROMOTION: WHAT ARE PLAINTIFFS ALLEGING AND HOW WILL IT IMPACT YOUR CLIENT?
R. Bruce Dickson, Manatt, Phelps & Phillips LLP

SUPPORTING/ATTACKING COMPARATIVE ADVERTISING CLAIMS
Patrick J. Osinski, Organon USA Inc.
Stuart M. Feinblatt, Sills Cummis Epstein & Gross
Elisa M. Pagano, Sills Cummis Epstein & Gross

THE CLASS ACTION FAIRNESS ACT OF 2005: OVERVIEW, HISTORICAL PERSPECTIVE, AND SETTLEMENT REQUIREMENTS
Linda Pissott Reig, Porzio, Bromberg & Newman, PC
Charles E. Erway, III, Porzio, Bromberg & Newman, PC
Brian P. Sharkey, Porzio, Bromberg & Newman, PC

DISSEMINATION OF CLINICAL TRIAL RESULTS: SCIENTIFIC EXCHANGE VS. PRODUCT PROMOTION
Mark R. Lange, Eli Lilly and Company

DISSEMINATION OF CLINICAL TRIAL RESULTS: SCIENTIFIC EXCHANGE VS. PRODUCT PROMOTION
Lori Cohen, Greenberg Traurig, LLP
Darcy E. Coty, Greenberg Traurig, LLP

THE ROLE OF THE FDA V. PHYSICIAN DISCRETION: ARE THE LINES CHANGING?
Elizabeth Gobeil, Thompson Hine LLP
Walt Addison Linscott, Thompson Hine LLP

THE ROLE OF THE FDA V. PHYSICIAN DISCRETION: ARE THE LINES CHANGING
Joseph J. Leghorn, Nixon Peabody LLP

UPDATE ON GOVERNMENT ENFORCEMENT ACTIVITY
Judith Whiting, Office of the Attorney General

OFF-LABEL PROMOTION: MARKETING PHARMACEUTCALS IN AN ERA OF SCRUTINY AND PROSECUTION
Harvey Kaplan, Shook, Hardy & Bacon
Jon A. Strongman, Shook, Hardy & Bacon

MANAGING THE RISKS AND EXPOSURES OF WEB-BASED MARKETING
Howard L. Dorfman, Bayer Pharmaceuticals Corporation

MANAGING THE RISKS AND EXPOSURES OF WEB-BASED MARKETING
Joseph McMenamin, M.D., J.D., McGuire Woods

MAPPING THE MINEFIELD: MINIMIZING THE RISKS IN THE CHANGING WORLD OF CME
Susan Hart-White, Sanofi-Synthelabo Inc., a member of the sanofi-aventis Group
Keith Korenchuk, McGuire Woods

THE FDA TANGLE: DTC AND THE FDA
Tessie Corbin, Dechert
Tammi Markowitz, Dechert



DOCUMENT TYPES: PRESENTATIONS AVAILABLE: 0