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.
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
Publication Details