Minimizing Legal Risks in

Drug Advertising and Promotion

The Latest Enforcement Activity, Caselaw, Compliance and Defense Strategies

Monday, June 02, 2003

About

Are you up-to-date on the legal risks posed by your company's advertising?

Pharmaceutical companies are under increasing pressure to get a better bang for their advertising buck. While advertising spends tripled between 1997 and 2002, the sales per dollar declined by 25%. DTC campaigns and promotional practices have become more aggressive - and are increasingly catching the attention of the FDA, the FTC, the DOJ and the plaintiffs' bar.

The FDA has vowed to act faster to stop misleading drug advertisements and has said that it will engage in more aggressive action to do so. The plaintiffs' bar is exploring new avenues of attack, with increasing focus on statutes that allow for significant damages and a lesser burden of proof.

With expensive ad campaigns at increased risk of, at best, being pulled, and at worst, being the subject of a multi-million dollar lawsuit, it is more critical than ever that counsel to pharma understand and anticipate the current and emerging legal issues while supporting marketing's objective to get the best ROI on its advertising dollar.

American Conference Institute developed Minimizing Legal Risks in Drug Advertising and Promotion to provide you with the practical tools, information and insights you need to effectively review your client's promotional campaign, limit exposures and succeed in defending against allegations of inappropriate promotion of drugs or medical devices.

This was a unique opportunity to hear about the most pressing issues from those on the front lines: experienced in-house counsel from Bayer, Pfizer, Wyeth, Alcon Labs, Pharmacia and Boehringer Ingelheim. The faculty also included leading attorneys from the firms that are in the trenches of the advertising and promotional campaigns… and fighting the battles against the FDA, FTC and plaintiffs' bar. You will get practical insight on:

  • The latest FDA targets - reducing exposure in your advertising
  • Working within the First Amendment protections in drug advertising
  • Policing the sales force - preventing misleading claims and fraudulent activity through effective sales strategies
  • Ensuring the legal department interfaces with the web master - minimizing online exposures
  • Critical update on DTC advertising caselaw and the learned intermediary doctrine
  • Staying "within the lines" when promoting to physicians
  • Successful defense techniques for the latest allegations and theories of liability by the plaintiffs' bar
  • Understanding…and minimizing the real risks of HIPAA
  • Using the preemption doctrine to successfully oppose claims to ban advertising
  • Maneuvering through the minefield of CME seminars and scientific journals
Be sure to take advantage of this opportunity to get the answers to your most pressing questions on pharmaceutical advertising and promotion…from the leaders in the industry.

Contents & Contributors

About

Are you up-to-date on the legal risks posed by your company's advertising?

Pharmaceutical companies are under increasing pressure to get a better bang for their advertising buck. While advertising spends tripled between 1997 and 2002, the sales per dollar declined by 25%. DTC campaigns and promotional practices have become more aggressive - and are increasingly catching the attention of the FDA, the FTC, the DOJ and the plaintiffs' bar.

The FDA has vowed to act faster to stop misleading drug advertisements and has said that it will engage in more aggressive action to do so. The plaintiffs' bar is exploring new avenues of attack, with increasing focus on statutes that allow for significant damages and a lesser burden of proof.

With expensive ad campaigns at increased risk of, at best, being pulled, and at worst, being the subject of a multi-million dollar lawsuit, it is more critical than ever that counsel to pharma understand and anticipate the current and emerging legal issues while supporting marketing's objective to get the best ROI on its advertising dollar.

American Conference Institute developed Minimizing Legal Risks in Drug Advertising and Promotion to provide you with the practical tools, information and insights you need to effectively review your client's promotional campaign, limit exposures and succeed in defending against allegations of inappropriate promotion of drugs or medical devices.

This was a unique opportunity to hear about the most pressing issues from those on the front lines: experienced in-house counsel from Bayer, Pfizer, Wyeth, Alcon Labs, Pharmacia and Boehringer Ingelheim. The faculty also included leading attorneys from the firms that are in the trenches of the advertising and promotional campaigns… and fighting the battles against the FDA, FTC and plaintiffs' bar. You will get practical insight on:

  • The latest FDA targets - reducing exposure in your advertising
  • Working within the First Amendment protections in drug advertising
  • Policing the sales force - preventing misleading claims and fraudulent activity through effective sales strategies
  • Ensuring the legal department interfaces with the web master - minimizing online exposures
  • Critical update on DTC advertising caselaw and the learned intermediary doctrine
  • Staying "within the lines" when promoting to physicians
  • Successful defense techniques for the latest allegations and theories of liability by the plaintiffs' bar
  • Understanding…and minimizing the real risks of HIPAA
  • Using the preemption doctrine to successfully oppose claims to ban advertising
  • Maneuvering through the minefield of CME seminars and scientific journals
Be sure to take advantage of this opportunity to get the answers to your most pressing questions on pharmaceutical advertising and promotion…from the leaders in the industry.

Contents & Contributors

FDA REPORT
David G. Adams, Venable

FEDERAL TRADE COMMISSION ADVERTISING ENFORCEMENT
Thomas B. Pahl, Federal Trade Commission
Lesley A. Fair, Federal Trade Commission

FEDERAL TRADE COMMISSION REGULATION OF PHARMACEUTICAL ADVERTISING AND PROMOTION
Steven E. Bizar, Buchanan Ingersoll, PC
Thomas P. Manning, Buchanan Ingersoll, PC

DOCTOR STILL KNOWS BEST: THE CONTINUED VIABILITY OF THE LEARNED INTERMEDIARY DOCTRINE
Connie A. Matteo, Porzio, Bromberg & Newman, P.C.
Diane M. Fleming, Porzio, Bromberg & Newman, P.C.

THE LATEST CLAIMS AND THE LATEST DEFENSES
Alice S. Johnston, Buchanan Ingersoll, PC

PLAINTIFFS' ALTERNATIVE LEGAL THEORIES IN PHARMACEUTICAL LITIGATION
Sol H. Weiss, Anapol, Schwartz, Weiss, Cohan, Feldman and Smalley, P.C.
Lawrence R. Cohan, Anapol, Schwartz, Weiss, Cohan, Feldman and Smalley, P.C.
Daniel J. Siegel, Anapol, Schwartz, Weiss, Cohan, Feldman and Smalley, P.C.
Tracy A. Finken, Anapol, Schwartz, Weiss, Cohan, Feldman and Smalley, P.C.
Gregory S. Spizer, Anapol, Schwartz, Weiss, Cohan, Feldman and Smalley, P.C.

PROMOTION OF PRESCRIPTION DRUGS BY LOCAL REPS: CAVEATS AND PREVENTIVE TECHNIQUES
Debra D. O'Gorman, Dechert LLP
Erin C. Fisher, Dechert LLP
Cheri R. Tolin, Dechert LLP
Presented by: Diane P. Sullivan, Dechert LLP

AVOIDING THE PITFALLS OF ONLINE DRUG ADVERTISING
William M. Corley, Marks Gray, P.A.

WHAT EVERY IN-HOUSE COUNSEL NEEDS TO KNOW ABOUT HIPAA'S RESTRICTIONS ON PROMOTIONAL ACTIVITIES
Leigh-Ann Patterson, Nixon Peabody
Dina L. Michels, Ropes and Gray

WHAT EVERY IN-HOUSE COUNSEL NEEDS TO KNOW ABOUT HIPAA'S RESTRICTIONS ON PROMOTIONAL ACTIVITIES
William T. Fitzgerald, Alcon Laboratories, Inc.
Dina L. Michels, Ropes and Gray
Leigh-Ann Patterson, Nixon Peabody

FIRST AMENDMENT PROTECTIONS IN PHARMACEUTICAL ADVERTISING AND PROMOTION
James D. Arden, Sidley Austin Brown & Wood, LLP

PRESCRIPTION FOR SUCCESS: MASTERING THE PREEMPTION DOCTRINE
Joseph K. Hetrick, Dechert LLP
Will W. Sachse, Dechert LLP

OFF-LABEL PROMOTION OF DRUGS: THE RISKS AND HOW TO MINIMIZE THEM
Harvey L. Kaplan, Shook, Hardy & Bacon, LLP

REGULATORY ISSUES IN CME
Geoffrey M. Levitt, Wyeth

WALKING THE FINE LINE: INDUSTRY SUPPORT OF CONTINUING MEDICAL EDUCATION
Lori Baer, Alston & Bird LLP
Christiana P. Callahan, Alston & Bird LLP

AVOIDING LEGAL AND ETHICAL PITFALLS OF INDUSTRY-SPONSORED RESEARCH AND "GHOSTWRITTEN" ARTICLES: HOW SCHOLARSHIP AND MARKETING CAN COEXIST IN THE PHARMACEUTICAL INDUSTRY
Howard L. Dorfman, Bayer Pharmaceuticals Corporation
Linda Pissott Reig, Porzio, Bromberg & Newman, PC


DOCUMENT TYPES: PRESENTATIONS AVAILABLE: 0