Managing Legal Risks and Avoiding Conflicts of Interests in

Medical Affairs

Monday, May 16, 2005

About

Is Your Medical Affairs Department Putting Your Company at Risk?

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 - all matters within the traditional purview of medical affairs - have raised questions about the real borders between medical affairs and sales and marketing. The issues surrounding last year's settlement illustrate this problem and the substantial financial and punitive consequences that result when the duties of medical affairs and sales and marketing are improperly co-mingled.

The OIG Guidance of 2003 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 to, 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 publication 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. The publication will provide you with valuable information on:

  • The impact of the OIG guidance in defining the duties of medical affairs
  • How the OIG guidance and PhRMA Code have impacted post marketing studies
  • Effective risk management techniques in MI/PI communications
  • The impact of new FDA guidelines for pharmacovigilance and the EU's push for international harmonization
  • Proper reimbursement structures for physician-consultants
  • The role of MSLs with respect to the dissemination of information regarding off-label use and other compliance issues
  • Criteria for the authorship of medical articles
  • Strategies for avoiding conflicts of interest for industry v. non-industry sponsored CME events

  • Contents & Contributors

    About

    Is Your Medical Affairs Department Putting Your Company at Risk?

    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 - all matters within the traditional purview of medical affairs - have raised questions about the real borders between medical affairs and sales and marketing. The issues surrounding last year's settlement illustrate this problem and the substantial financial and punitive consequences that result when the duties of medical affairs and sales and marketing are improperly co-mingled.

    The OIG Guidance of 2003 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 to, 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 publication 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. The publication will provide you with valuable information on:

  • The impact of the OIG guidance in defining the duties of medical affairs
  • How the OIG guidance and PhRMA Code have impacted post marketing studies
  • Effective risk management techniques in MI/PI communications
  • The impact of new FDA guidelines for pharmacovigilance and the EU's push for international harmonization
  • Proper reimbursement structures for physician-consultants
  • The role of MSLs with respect to the dissemination of information regarding off-label use and other compliance issues
  • Criteria for the authorship of medical articles
  • Strategies for avoiding conflicts of interest for industry v. non-industry sponsored CME events

  • Contents & Contributors


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

    WHAT IS THE APPROPRIATE ROLE OF MEDICAL AFFAIRS AT THE CLINICAL STAGE?
    William Bertrand, MedImmune
    Jeffrey Wasserstein, Hyman, Phelps & McNamara, P.C.

    POST-MARKETING STUDIES: HOW TO FORM A SQUARE
    Alison M. Duncan, Porter Wright Morris & Arthur LLP

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

    GOOD PHARMACOVIGILANCE AND SAFETY PRACTICES: US AND INTERNATIONAL PERSPECTIVES
    MC Ragsdale , Sidley Austin Brown & Wood LLP

    GOOD PHARMACOVIGILANCE AND SAFETY PRACTICES: US AND INTERNATIONAL PERSPECTIVES
    Robert Reder, MD, Purdue Pharma L.P.

    MEDICAL SCIENCE LIAISONS ("MSLS"): QUALIFICATIONS, DUTIES AND FUNCTIONS
    Peter O. Safir, Covington & Burling

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

    COMPLYING WITH NEW STANDARDS IN CONTINUING MEDICAL EDUCATION
    Paul Minicozzi, RPh, PhD, 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

    COUNSELING MEDICAL AFFAIRS AND SALES AND MARKETING ON APPROPRIATE INTERDEPARTMENTAL INTERFACES
    Kelly B. Freeman, Ph.D., Eli Lilly and Company
    Charlene A. Gallagher, Wyeth Pharmaceuticals



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