Off-Label Drug Promotion After Amarin - Webinar CD/Transcript

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Off-Label Drug Promotion After Amarin: From Settlement to Guidance and Beyond

The federal court ruling on in Amarin allows the drugmaker to make truthful and not misleading statements on Vascepa.

But the case raises questions about what truthful off-label promotion really means. FDA guidance recommends that manufacturers carefully vet and script advance statements for sales reps about a drug’s off-label use.  

Darshan Kulkarni — an expert on strategic regulatory and pharmaceutical counseling — discusses the impact of Amarin on off-label promotion.  He covers:

  • When does distributing information become promotion?
  • Six essential dos and don’ts for distributing scientific articles
  • Why the “safe harbor” turned out not to be so safe
  • Five practice scenarios to work through — how should you respond?
  • How and why off-label rules have evolved from 2008 to the present day
  • Six pivotal court cases and how they’ve shaped the law

Stay on top of the FDA’s latest rules on what speech is and is not protected.

  • Compliance officers
  • Consultants/service providers
  • Executive management
  • General/corporate counsel
  • Investigators
  • Managers
  • Manufacturing directors and supervisors
  • Regulatory/legislative affairs professionals
  • Risk management specialists
  • Sales/marketing personnel
  • Strategic planning and business development staff

Darshan Kulkarni of the Kulkarni Law Firm is a leading expert on strategic regulatory and pharmaceutical counseling.

With a background in both the law and hands-on healthcare experience (over 10 years as a pharmacist, including participation as a clinician in clinical trials), Mr. Kulkarni is versed in the needs of international device, pharmaceutical and biopharmaceutical companies and their service providers, including contract manufacturing organizations and contract research organizations.