Managing Legal Risks and Avoiding Conflicts of Interest in

Medical Affairs

Thursday, November 11, 2004

About

What is the proper role of your company's medical affairs department and how should its functions be defined?

Traditionally, a medical affairs department provides scientific support for a pharmaceutical company's marketing efforts with the caveat that the basis for this support be independently conceived and not in anyway influenced by a marketing campaign. However, increasing scrutiny over such matters as the duties of medical science liaisons, the dissemination of information on off-label use, CME requirements and medical ghostwriting - matters,all within the purview of medical affairs - have raised questions about the real borders between medical affairs and sales and marketing. The issues surrounding the recent Neurontin settlement illustrate this problem and the substantive financial and punitive consequences that result when the duties of medical affairs and sales and marketing are improperly co-mingled.

Last year's OIG Guidance was an attempt to clarify and delineate the respective roles and duties of medical affairs and sales and marketing in gray areas, yet confusion remains. Does your company have the necessary policies and procedures in place to ensure that the independence and integrity of its medical affairs department remain above reproach?

As counsel, executive or compliance officer for a medical affairs department of a pharmaceutical company, you need a complete understanding of the latest legal and regulatory developments affecting medical affairs today. This cutting-edge American Conference Institute event will bring you thoughtful and targeted commentary and in-depth analysis from an outstanding faculty of leading in-house pharmaceutical counsel, medical affairs specialists and compliance officers as well as expert attorneys. This comprehensive and unique program will give you the tools and strategies to reduce serious risks and skillfully navigate the gray areas that exist between medical affairs and sales and marketing.

Contents & Contributors

About

What is the proper role of your company's medical affairs department and how should its functions be defined?

Traditionally, a medical affairs department provides scientific support for a pharmaceutical company's marketing efforts with the caveat that the basis for this support be independently conceived and not in anyway influenced by a marketing campaign. However, increasing scrutiny over such matters as the duties of medical science liaisons, the dissemination of information on off-label use, CME requirements and medical ghostwriting - matters,all within the purview of medical affairs - have raised questions about the real borders between medical affairs and sales and marketing. The issues surrounding the recent Neurontin settlement illustrate this problem and the substantive financial and punitive consequences that result when the duties of medical affairs and sales and marketing are improperly co-mingled.

Last year's OIG Guidance was an attempt to clarify and delineate the respective roles and duties of medical affairs and sales and marketing in gray areas, yet confusion remains. Does your company have the necessary policies and procedures in place to ensure that the independence and integrity of its medical affairs department remain above reproach?

As counsel, executive or compliance officer for a medical affairs department of a pharmaceutical company, you need a complete understanding of the latest legal and regulatory developments affecting medical affairs today. This cutting-edge American Conference Institute event will bring you thoughtful and targeted commentary and in-depth analysis from an outstanding faculty of leading in-house pharmaceutical counsel, medical affairs specialists and compliance officers as well as expert attorneys. This comprehensive and unique program will give you the tools and strategies to reduce serious risks and skillfully navigate the gray areas that exist between medical affairs and sales and marketing.

Contents & Contributors

OIG GUIDANCE IMPACT
LaDonna L. Steiner, Purdue Pharma L.P.

WHAT IS THE APPROPRIATE ROLE OF MEDICAL AFFAIRS AT THE CLINICAL STAGE?
Jerrie Chiu, Bayer Pharmaceuticals
Jeffrey Wasserstein, Hyman, Phelps & McNamara, P.C.

DEVELOPING GUIDELINES FOR POST-MARKETING STUDIES
Seth B. Whitelaw, GlaxoSmithKline
Heather J. Stewart, Porter Wright Morris & Arthur LLP

ASSESSING AND REDUCING RISKS ASSOCIATED WITH THE PROVISION OF MEDICAL AND PRODUCT INFORMATION
Donna P. Bergeson, Alston & Bird
Lisa D'Agostino, Emory University School of Medicine

ANALYSIS AND IMPACT OF PROPOSED FDA SAFETY REPORTING REQUIREMENTS ON ADVERSE EVENTS REPORTING
Brian P. Waldman, Arent Fox PLLC

ESTABLISHING INTERNAL GUIDELINES FOR USING PHYSICIANS AS CONSULTANTS
Colleen M. Faddick, Faegre & Benson LLP
Sujata T. Dayal, Abbott Laboratories

MEDICAL SCIENCE LIAISONS IN PRACTICE
Geoffrey Levitt, Wyeth

SCIENTIFIC MEDICAL SCIENCE LIAISONS
Peter O. Safir, Covington & Burling

COUNSELING MEDICAL AFFAIRS AND SALES AND MARKETING ON APPROPRIATE INTERDEPARTMENTAL INTERFACES
Kelly B. Freeman, Ph.D., Eli Lilly and Company
Mark R. Lange, Eli Lilly and Company

AUTHORSHIP OF MEDICAL RESEARCH AND APPROPRIATE DISSEMINATION OF MEDICAL ARTICLES: HOW SCHOLARSHIP AND MARKETING CAN CO-EXIST IN THE PHARMACEUTICAL INDUSTRY
Howard L. Dorfman, Bayer Pharmaceuticals
Albert F. Cacozza, Jr., Ropes & Gray LLP

CONTINUING MEDICAL EDUCATION: THE ROLE OF INDUSTRY IN 2004 AND BEYOND
Marcia J. Coleman, M.D., M.B.A., Wyeth Pharmaceuticals

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



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