Product Promotion Webinar: The Fine Line Between What’s Right and What’s Wrong

Event Details

Schedule

November 10, 2004

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Location

Internet

A Web Conference


Learn more about the legal and regulatory issues concerning product promotion and compliance.


CLE Credit (1.5 Hours) Available for Georgia Attorneys


Topics Covered:


“Isn’t a Warning Letter the Worst that Could Happen?” – What You Don’t Know About Product Promotion Legal and Regulatory Issues Could Hurt You
Alan Minsk, Esq., Chair of the Food and Drug Practice, Arnall Golden Gregory LLP – Atlanta, Georgia



  • Latest FDA Statements on Off-Label Dissemination and Enforcement

  • Overview of the False Claims Act and the Federal Anti-Kickback Statute

  • Important Takeaways from the Office of the Inspector General’s Guidelines

  • Where the Government Might Be Headed with Enforcement

  • The Neurontin Case

Working With (Not Against) Sales & Marketing Organizations
Roger Louis, Esq., Chief Compliance Officer, Genzyme Corporation – Cambridge, Massachusetts



  • “Dollars to Doctors” and The Anti-Kickback Statute

  • False Claims Act Evolution

  • Sampling & Other Free Drug Programs

  • Product Pricing

  • The Art of Writing: Intention & (Mis)Interpretation

  • Selling Compliance: Rules are Not Self-Executing

Product Promotion Concerns in the Medical Research Context
Mark R. Lange, Esq., Counsel, Global Medical and Regulatory Affairs, Eli Lilly and Company -Indianapolis, Indiana



  • Application of Concerns to Medical Research and Off-label Promotion

  • Challenges of Providing Counsel to Researchers

  • Moving Forward: Synergies of Law, Ethics and Patient Benefits