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