6th Annual Corporate Counsel Forum on

Advertising & Promotions for the Pharmaceutical Industry

Tuesday, January 22, 2008

About

In the wake of new legislation regulating DTC advertising, and the limited availability of defenses such as preemption and learned intermediary, the pharmaceutical advertising and promotions industry is experiencing significant regulatory and legal changes. Whether advertising on television, print, online, or through other means, the only way to ensure optimal compliance is with a thorough understanding of how governing bodies such as FDA, FTC, and the state attorney general offices work together to regulate pharmaceutical advertising. It is your duty to stay abreast of these industry-wide changes and advise your clients on how to adapt.

Ensure best practices in pharmaceutical advertising and marketing that will benefit your company and most importantly, the health of your consumers.

As always, careful, in-depth training of sales representatives and MSLs is necessary to ensure proper promotional practices. Now is the time to re-examine in-house programs and uncover the areas that need work. Make sure that the right information is shared and hear what other companies are doing to keep inappropriate information from being disseminated.

American Conference Institute has specifically tailored this publication to provide you with a thorough understanding of advertising and promotions law for your industry. You will hear from leading pharmaceutical attorneys who are entrenched in advertising and marketing law, and representatives from the regulatory bodies who are called upon to review ads for improper advertising and promotional practices. Specific highlights include:

  • Understanding the implications of FDARA on DTC advertising
  • Mapping the regulatory landscape to ensure proper claim substantiation
  • Crafting effective disease awareness advertisements without overstepping regulatory boundaries
  • Creating an efficient system to map, track, and update advertising practices in compliance with state laws
  • Promoting to managed care groups in light of Medicare Part D Changes and other recent developments
  • Limiting promotional missteps with calculated sales-force and MSL training
  • Clarifying the FDA's rules for off-label promotions

Contents & Contributors

About

In the wake of new legislation regulating DTC advertising, and the limited availability of defenses such as preemption and learned intermediary, the pharmaceutical advertising and promotions industry is experiencing significant regulatory and legal changes. Whether advertising on television, print, online, or through other means, the only way to ensure optimal compliance is with a thorough understanding of how governing bodies such as FDA, FTC, and the state attorney general offices work together to regulate pharmaceutical advertising. It is your duty to stay abreast of these industry-wide changes and advise your clients on how to adapt.

Ensure best practices in pharmaceutical advertising and marketing that will benefit your company and most importantly, the health of your consumers.

As always, careful, in-depth training of sales representatives and MSLs is necessary to ensure proper promotional practices. Now is the time to re-examine in-house programs and uncover the areas that need work. Make sure that the right information is shared and hear what other companies are doing to keep inappropriate information from being disseminated.

American Conference Institute has specifically tailored this publication to provide you with a thorough understanding of advertising and promotions law for your industry. You will hear from leading pharmaceutical attorneys who are entrenched in advertising and marketing law, and representatives from the regulatory bodies who are called upon to review ads for improper advertising and promotional practices. Specific highlights include:

  • Understanding the implications of FDARA on DTC advertising
  • Mapping the regulatory landscape to ensure proper claim substantiation
  • Crafting effective disease awareness advertisements without overstepping regulatory boundaries
  • Creating an efficient system to map, track, and update advertising practices in compliance with state laws
  • Promoting to managed care groups in light of Medicare Part D Changes and other recent developments
  • Limiting promotional missteps with calculated sales-force and MSL training
  • Clarifying the FDA's rules for off-label promotions

Contents & Contributors

FDA AMENDMENTS ACT OF 2007: PROMOTION-RELATED PROVISIONS
Coleen Klasmeier, Sidley Austin LLP (Washington, DC)

MAPPING THE REGULATORY LANDSCAPE
Tanya D. Berlage, Saul Ewing LLP (Baltimore, MD)

THE FTC, THE FDA, AND THE ABCS OF TRUTH IN ADVERTISING
Lesley Fair, Federal Trade Commission (Washington, DC)

DISEASE AWARENESS ADS: GETTING THEM RIGHT
Stefanie Solomon, Hogan & Hartson LLP (Washington, DC)

PREEMPTION: RECENT DEVELOPMENTS AND ITS IMPACT ON PHARMACEUTICAL ADVERTISING
Lisa Baird, Reed Smith LLP (Los Angeles, CA)

HOW TO ENSURE YOUR NATIONAL ADVERTISING & MARKETING PRACTICES ARE IN COMPLIANCE WITH STATE LAWS
Linda Pisott Reig, Porzio Bromberg & Newman P.C. (Morristown, NJ)

PROMOTING PRESCRIPTION DRUGS IN A MANAGED CARE ENVIRONMENT
Coleen Klasmeier, Sidley Austin LLP (Washington, DC)

WHAT THE ABSENCE OF THE LEARNED INTERMEDIARY DOCTRINE MEANS FOR PHARMACEUTICAL COMPANIES
Michael Imbroscio, Covington & Burling LLP (Washington, DC)

LIMITING PROMOTIONAL MISSTEPS THROUGH EFFECTIVE SALES FORCE AND MSL TRAINING
Perry Goldman, Elan Pharmaceuticals, Inc. (San Francisco, CA)

Brian French, Nixon Peabody LLP (Washington, DC)

IMPLEMENTING CONTROLS TO MONITOR DRUG ADVERTISING ON THE WEB IN THE ABSENCE OF A REGULATORY SCHEMATIC
Howard Dorfman, Bayer Healthcare LLC (West Haven, CT)

PHARMA ON THE WEB
Joseph Mcmenamin, Mcguirewoods LLP (Richmond, VA)

DEFINING HOW THE DRUG LABEL & ASSOCIATED WARNINGS CONTROL SCOPE OF ADVERTISING & PROMOTION: INDUSTRY PERSPECTIVE
Mitzi Cole, Wyeth Pharmaceuticals (Collegeville, PA)

DEFINING HOW THE DRUG LABEL AND ASSOCIATED WARNINGS CONTROL THE SCOPE OF POST MARKET ADVERTISING AND PROMOTION
Brian Waldman, Arent Fox LLP (Washington, DC)

WORKING TOWARDS A CLEARER DEFINITION OF “OFF-LABEL” PROMOTION
Vernon, Francis, Dechert LLP (Philadelphia, PA)
Joseph Leghorn, Nixon Peabody LLP (Boston, MA)



DOCUMENT TYPES: PRESENTATIONS AVAILABLE: 0