Second Annual Minimizing Legal Risks in

Drug Advertising and Promotion

New Guidelines - New Exposures - Practical Strategies for Compliance & Defense

Monday, June 21, 2004

About

Are you equipped to effectively counsel your client on its newest promotions?

More aggressive promotions. More comparative claims. New guidance issued by the FDA. New enforcement collaborations being established between the FDA and the SEC. In this constantly changing arena, it's imperative that counsel to pharma and the outside attorneys advising them, be up-to-date on the risks, the consequences and practical strategies for staying in compliance.

American Conference Institute has developed the Second Annual Forum on Minimizing Legal Risks in Drug Advertising and Promotion publication. This information-packed publcation will provide you the up-to-the-minute information you need to advise your sales and marketing clients on current and emerging risks and how to avoid them.

You'll learn from the FDA, the FTC, the DOJ, and the SEC. You'll also get practical insights into how to handle sales and marketing legal issues from experienced in-house counsel from Bayer, Fujisawa, Solvay, Pfizer and Organon.

The expert faculty also includes leading attorneys from the national firms that are in the trenches of the advertising and promotional campaigns... and fighting the battles against the FDA, FTC, DOJ and plaintiffs' bar. They covered the critical issues facing drug advertisers today, including:

  • The latest from FDA on print ads and other areas of focus
  • FTC's authority and recent enforcement activity
  • What DOJ is currently scrutinizing... and what's on their radar screen
  • FDA's collaboration with SEC: what will the practical impact be for manufacturers?
  • Supporting or attacking comparative advertising
  • Exposures to manufacturers from internet pharmacies
  • Pre-approval communication regarding clinical trials
  • Safely maximizing the health care professional's role in promotion
  • First Amendment protections
  • Effectively sponsoring CME and other educational forums

Contents & Contributors

About

Are you equipped to effectively counsel your client on its newest promotions?

More aggressive promotions. More comparative claims. New guidance issued by the FDA. New enforcement collaborations being established between the FDA and the SEC. In this constantly changing arena, it's imperative that counsel to pharma and the outside attorneys advising them, be up-to-date on the risks, the consequences and practical strategies for staying in compliance.

American Conference Institute has developed the Second Annual Forum on Minimizing Legal Risks in Drug Advertising and Promotion publication. This information-packed publcation will provide you the up-to-the-minute information you need to advise your sales and marketing clients on current and emerging risks and how to avoid them.

You'll learn from the FDA, the FTC, the DOJ, and the SEC. You'll also get practical insights into how to handle sales and marketing legal issues from experienced in-house counsel from Bayer, Fujisawa, Solvay, Pfizer and Organon.

The expert faculty also includes leading attorneys from the national firms that are in the trenches of the advertising and promotional campaigns... and fighting the battles against the FDA, FTC, DOJ and plaintiffs' bar. They covered the critical issues facing drug advertisers today, including:

  • The latest from FDA on print ads and other areas of focus
  • FTC's authority and recent enforcement activity
  • What DOJ is currently scrutinizing... and what's on their radar screen
  • FDA's collaboration with SEC: what will the practical impact be for manufacturers?
  • Supporting or attacking comparative advertising
  • Exposures to manufacturers from internet pharmacies
  • Pre-approval communication regarding clinical trials
  • Safely maximizing the health care professional's role in promotion
  • First Amendment protections
  • Effectively sponsoring CME and other educational forums

Contents & Contributors

FDA UPDATE ON PROMOTION OF PRESCRIPTION DRUGS
Carol H. Barstow, J.D., Food and Drug Administration

HEALTH CARE FRAUD ENFORCEMENT
Stuart A. Minkowitz, Office of the U.S. Attorney for the District of New Jersey
Viveca Parker, United States Attorney's Office, Eastern District of Pennsylvania

NEW RULES OF THE ROAD: THE NEW FDA-SEC COLLABORATION ON PRE-APPROVAL PROMOTIONAL STATEMENTS
Leigh-Ann M. Patterson, Nixon Peabody

PRE-APPROVAL EDUCATION: HOW TO DO IT LEGALLY
David G. Adams, Venable

LEGALLY GETTING THE WORD OUT: USE OF PRESS RELEASES & WEBSITES TO PUBLICIZE SCIENTIFIC ADVANCES BEFORE FDA APPROVAL OF NEW DRUGS OR NEW INDICATIONS"
Linda Pissott Reig, Porzio, Bromberg & Newman, P.C.

MINIMIZING THE RISKS OF PRE-APPROVAL PROMOTION AND COMMUNICATION ABOUT CLINICAL TRIALS
David G. Adams, Venable
Howard L. Dorfman, Bayer Pharmaceuticals Corporation
Linda Pissott Reig, Porzio, Bromberg & Newman, P.C.

SUPPORTING/ATTACKING COMPARATIVE ADVERTISING CLAIMS
Patrick J. Osinski, Organon USA Inc.
R. Bruce Dickson, Paul Hastings Janofsky & Walker LLP
Stuart M. Feinblatt, Sills Cummis Epstein & Gross P.C.
Elisa M. Pagano, Sills Cummis Epstein & Gross P.C.

PROMOTION OF DRUGS THROUGH INTERNET PHARMACIES: WHAT YOU DON'T KNOW CAN HURT YOU
Joseph J. Leghorn, Nixon Peabody
Vivian Quinn, Nixon Peabody
Jacob Herstek, Nixon Peabody

OFF-LABEL PROMOTION: AN UPDATE
Harvey L. Kaplan, Shook, Hardy & Bacon

MAINTAIN REGULATORY COMPLIANCE IN PROMOTION ACTIVITIES: FOCUS ON OFF LABEL PROMOTION
Carolyn McElroy, Mintz Levin
Theresa Claffey Carnegie, Mintz Levin

PROMOTION OF PRESCRIPTION DRUGS BY SALES REPRESENTATIVES: GUIDANCE FOR REPS IN THE FIELD
Presented by:
Diane Sullivan, Dechert
Written by:
Eben S. Flaster, Dechert
Luke A. Meisner, Dechert
Erin Fisher, Dechert

HEALTH CARE PROFESSIONALS AS PROMOTIONAL CONSULTANTS FOR PHARMACEUTICAL MANUFACTURERS
Elizabeth Gobeil, Solvay Pharmaceuticals, Inc.
Sandra K. Herron, Powell, Goldstein, Frazer & Murphy LLP

ASSAULTS ON THE LEARNED INTERMEDIARY DOCTRINE
Alice S. Johnston, Buchanan Ingersoll

PLAINTIFF'S ATTACK UPON THE LEARNED INTERMEDIARY DOCTRINE
William M. Corley, Marks Gray, PA

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

THE WHAT NOTS AND WHY NOTS OF CME PROGRAMS: ENSURING COMPLIANCE WITH FDA, OIG AND ACCME GUIDELINES
Debra Dunne, RPh, Segal McCambridge Singer & Mahoney

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
Will W. Sachse, Dechert
Jennifer K. Green, Dechert



DOCUMENT TYPES: PRESENTATIONS AVAILABLE: 0