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Advertising and Promotion Regulatory Affairs Conference


Session 6: Legal Update

    Session Chair(s)
      Coleen  Klasmeier, JD

      Coleen Klasmeier, JD

      • Partner and Global Coordinator, Food, Drug and Medical Device Reg Practice
      • Sidley Austin, LLP, United States
    Advertising and promotion issues continue to arise in a wide range of legal contexts, from civil litigation brought by injured plaintiffs to state and local authorities acting under general consumer protection statutes and nuisance principles and a variety of civil and criminal investigations and settlement agreements arising under the False Claims Act. At the same time, the Food and Drug Administration’s implementation of the advertising and promotion provisions of the Federal Food, Drug, and Cosmetic Act has continued to develop in response to First Amendment pressures and other shifts in the external environment. This session will identify and summarize key developments in the law affecting manufacturer communications, with a focus on characterizing the enforcement and litigation risks confronting regulated entities. Our focus will include practical risk mitigation techniques and effective tools to remain up-to-date as the legal landscape continues to shift in this important area of manufacturer activity.
    Learning Objective : At the conclusion of this session, participants should be able to:
    • Identify the key Supreme Court cases from the past five years influencing FDA’s interpretation of its ad promo authorities under the FD&C
    • Characterize the principal shifts in FDA policy and enforcement reflecting the evolving legal landscape
    • Articulate at a high-level the most significant types of legal risk that can arise out of manufacturer communication activities
    Speaker(s)
      Coleen  Klasmeier, JD

      Key Developments and FDA Implications

      Coleen Klasmeier, JD

      • Partner and Global Coordinator, Food, Drug and Medical Device Reg Practice
      • Sidley Austin, LLP, United States
      Michael J Hulka

      Civil Litigation Developments

      Michael J Hulka

      • Senior Director, Assistant General Counsel
      • Eli Lilly and Company , United States
      Margaret  Sparks

      Criminal Enforcement and State AG Activity

      Margaret Sparks

      • Associate Vice President
      • Sanofi US, United States

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