Minimizing Legal Risks in

Drug Advertising and Promotion

Monday, March 13, 2006

About

Create compliant and effective drug advertising campaigns that will survive close scrutiny by enforcers, competitors, and plaintiffs

Fierce competition has resulted in a tremendous increase in the amount spent by the pharmaceutical industry on advertising and promoting its products over $4 billion last year as well as the aggressiveness of these campaigns. This increase in amount and intensity has brought about a corresponding increase in the level of scrutiny of the industry's advertising practices by the FDA, FTC, DOJ, State Attorneys General, Congress, and the plaintiffs' bar.

Direct-to-consumer advertising, in particular, is being examined closely on several fronts. The FDA recently has held a series of hearings on DTC advertising, PhRMA has published its DTC Guidelines, Congress has been considering some form of ban on new advertising, and the plaintiffs' bar continues to explore new theories of product liability and consumer fraud based on drug advertising.

The potential costs are great. A recent product liability judgment of over $250 million against a pharmaceutical company was significantly influenced, according to some jurors, by the company's marketing tactics. With so much at stake, it is critical for every counsel to a pharmaceutical company to have a sophisticated understanding of the exposures facing them and the most effective ways to mitigate these exposures.

American Conference Institute has developed a publication from the Fourth Annual Minimizing Legal Risks in Drug Advertising and Promotion to provide you with the practical information you need to understand and avoid the legal risk, both from government enforcers and the plaintiffs' bar, arising from your clients advertising and marketing campaigns. Leading pharmaceutical attorneys, in-house counsel, and regulatory professionals from companies such as Bristol-Myers Squibb Company, Solvay Pharmaceuticals, Pacific Pulmonary Services, Pfizer, PhRMA, Research Testing Laboratories as well as federal and state enforcers who are actively pursuing cases involving alleged inappropriate advertising and promotion practices, will provide you with their expert insight on the most critical advertising and promotion issues facing pharmaceutical companies.

Contents & Contributors

About

Create compliant and effective drug advertising campaigns that will survive close scrutiny by enforcers, competitors, and plaintiffs

Fierce competition has resulted in a tremendous increase in the amount spent by the pharmaceutical industry on advertising and promoting its products over $4 billion last year as well as the aggressiveness of these campaigns. This increase in amount and intensity has brought about a corresponding increase in the level of scrutiny of the industry's advertising practices by the FDA, FTC, DOJ, State Attorneys General, Congress, and the plaintiffs' bar.

Direct-to-consumer advertising, in particular, is being examined closely on several fronts. The FDA recently has held a series of hearings on DTC advertising, PhRMA has published its DTC Guidelines, Congress has been considering some form of ban on new advertising, and the plaintiffs' bar continues to explore new theories of product liability and consumer fraud based on drug advertising.

The potential costs are great. A recent product liability judgment of over $250 million against a pharmaceutical company was significantly influenced, according to some jurors, by the company's marketing tactics. With so much at stake, it is critical for every counsel to a pharmaceutical company to have a sophisticated understanding of the exposures facing them and the most effective ways to mitigate these exposures.

American Conference Institute has developed a publication from the Fourth Annual Minimizing Legal Risks in Drug Advertising and Promotion to provide you with the practical information you need to understand and avoid the legal risk, both from government enforcers and the plaintiffs' bar, arising from your clients advertising and marketing campaigns. Leading pharmaceutical attorneys, in-house counsel, and regulatory professionals from companies such as Bristol-Myers Squibb Company, Solvay Pharmaceuticals, Pacific Pulmonary Services, Pfizer, PhRMA, Research Testing Laboratories as well as federal and state enforcers who are actively pursuing cases involving alleged inappropriate advertising and promotion practices, will provide you with their expert insight on the most critical advertising and promotion issues facing pharmaceutical companies.

Contents & Contributors


PhRMA GUIDING PRINICIPLES ON DTC ADVERTISING
Diane Bieri, PhRMA

THE PhRMA GUIDING PRINCIPLES: DETERMINING HOW THEY FIT INTO YOUR COMPLIANCE PLAN
Mitzi G. Cole, Adkins, Plant & Cole, PLLC

PREVENTING LITIGATION INVOLVING DTC ADVERTISING
Lisa K. Brenner, Pfizer, Inc.

THE CONSUMER FRAUD CLASS ACTION SUIT, ITS INPACT ON PHARMACEUTICAL AND MEDICAL DEVICE PRODUCTS BASED LITIGATION, FRAMEWORKS FOR AN AGGRESSIVE DEFENSE
Joseph J. Leghorn, Nixon Peabody LLP
Christopher Allen, Jr., Nixon Peabody LLP
Tavares Brewington, Nixon Peabody LLP

DEFENDING FALSE ADVERTISING AND CONSUMER FRAUD CLASS ACTIONS
Thomas A. Smart, Kaye Scholer LLP
Richard A. De Sevo, Kaye Scholer LLP

FDA UPDATE ON ADVERTISING AND PROMOTION OF PRESCRIPTION DRUGS
Lesley R. Frank, Ph.D., J.D., Food and Drug Administration

TRENDS IN FDA & FTC REGULATION AND ENFORCEMENT
Lesley Fair, Federal Trade Commission

MISLEADING USES OF MEDICAL DATA, OMISSIONS, AND CONSUMER BEHAVIOR
Robert Schiff, Ph.D., RAC, CQA, Schiff & Company, Inc.

RECENT TRENDS IN FDA UNTITLED AND WARNING LETTERS & AVOIDANCE OF MISLEADING USE OF MEDICAL DATA
Joseph Barone, MD, Solvay Pharmaceuticals, Inc. RECENT TRENDS IN FDA UNTITLED & WARNING LETTERS & AVOIDANCE OF MISLEADING USE OF MEDICAL DATA
Linda Pissott-Reig, Porzio, Bromberg & Newman, P.C.

MINIMIZING DRUG ADVERTISING AND PROMOTION
Kathleen Meriwether, United States Attorney's Office, Eastern District of Pennsylvania

PLANNING FOR INCREASED STATE BY STATE REGULATION
Keith M. Korenchuk, McGuire Woods LLP
Janice Toran, Astellas US LLC

MARKETING CLAIMS: OVER PROMOTION
Joseph K. Hetrick, Dechert LLP

CLAIMS OF OVERPROMOTION IN PRODUCT LIABILITY TRIALS
William Hoffman, Kaye Scholer LLP

NEW RULES OF THE ROAD FOR CLINICAL TRIALS: BALANCING TRANSPARENCY REQUIREMENTS AGAINST PRE-APPROVAL PROMOTIONAL AND OTHER LEGAL RESTRCTIONS
Leigh-Ann Durant, Nixon Peabody LLP

THE LIABILITY RISKS OF OFF-LABEL PROMOTION AND AVOIDING THOSE RISKS Harvey L. Kaplan, Shook, Hardy & Bacon L.L.P.
Beverly Baughman, Pfizer Inc.
Jon A. Strongman, Shook, Hardy & Bacon L.L.P.

THE GOVERNMENT AND OFF LABEL PROMOTION
Carolyn McElroy, Pacific Pulmonary Services

COMPLYING WITH INTERNATIONAL PHARMACEUTICAL MARKETING REGULATION
Eileen Erdos, Ernst & Young LLP
Keith M. Korenchuk, McGuire Woods LLP

USING HEALTH CARE PROFESSIONALS AS CONSULTANTS - CHANGING THE PARADIGM
Ann E. Lewis, Bristol-Myers Squibb Company

ISSUES ARISING IN CONTINUING MEDICAL EDUCATION AND OTHER THIRD-PARTY EDUCATIONAL ACTIVITIES: AN UPDATE
Connie Matteo, Porzio, Bromberg & Newman, P.C.
Elizabeth A. Brophy, Porzio, Bromberg & Newman, P.C.
Genevieve M. Spires, Porzio, Bromberg & Newman, P.C.

OVERCOMING THE UNIQUE CHALLENGES OF INTERNET-BASED MARKETING
Joseph P. McMenamin, McGuire Woods LLP



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