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Tuesday, April 14 • 1:00pm - 4:00pm
Workshop C: The Challenges and Opportunities in Disseminating Medical Information: Do We Need a Redesign of the Role of Medical Affairs in Ensuring Compliant and Effective HCP Interactions?

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While the role of pharmaceutical companies to provide accurate scientific information to HCPs and the global medical community is well established, regulatory and compliance oversight continue. Pharmaceutical companies must consider a range of regulatory and enforcement statutes as well as actions taken by various government agencies with overlapping authority and often differing enforcement perspectives. The Medical Affairs function is being called upon to take a more proactive approach in helping to develop and implement policies regarding medical communication with both the external medical community as well as internal stakeholders (including Commercial, R&D, HEOR). This presentation will review the basic provisions of the FDCA as regulatory guidance's issued by the FDA and actions taken by the Office of the Inspector General (OIG) in enforcing the False Claims Act 
(FCA) and the Anti-Kickback statute, among others, and discuss the need for a new paradigm relating to the role of Medical Affairs.

  • Understand the evolution of the current enforcement environment 
  • Discuss the interpretation and importance of FDA guidance documents including the FDA Reprint Guidance, the Draft Guidance on Unsolicited Requests for Off-Label Information, Drug and Medical Device Manufacturers Communications with Payers and Formulary Committees, and Medical Product Communications Consistent with FDA-Required Labeling 
  • Identify areas of concern for FDA and OIG as revealed through enforcement letters and Corporate Integrity Agreements (CIAs) as affecting company policies 
  • Craft new policies to respond to current and future enforcement initiatives 

avatar for Howard Dorfman

Howard Dorfman

Distinguished Visiting Practitioner and Adjunct Professor, Seton Hall University School of Law

Tuesday April 14, 2020 1:00pm - 4:00pm EDT