Regulating Off-Label Communication | ZS

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Regulating Off-Label Communication



In the last decade, $20 billion in fines have been levied on pharmaceutical companies due to off-label communication infractions. Off-label communication has never been easy for pharmaceutical companies in the absence of clear guidance from regulatory authorities, so how can pharmaceutical companies make sure that they’re playing by the rules?

Recently, the U.S. Food and Drug Administration introduced initiatives to reduce the complexity of off-label communication. In this video, ZS Principal Aaron Mitchell weighs in on the challenges and the FDA’s efforts to clarify its policies and ensure patient safety.