Guidelines for Off-label Communications Seven Steps to Safety
Off-label information distribution by pharmaceutical companies to physicians is legal and in common practice, though “off-label confusion” might be the better term. A clear picture of what is permitted in providing information to healthcare professionals about off-label use of approved prescription drugs is not available. It doesn’t exist. Food & Drug Administration has said some off-label drug information is acceptable. But it has not issued regulations or given firm guidance on dissemination of off-label information that may resolve concerns that manufacturers have.

This article is a summary of several presentations made by legal experts at a Washington, DC conference on Disseminating Off-Label Information. Several cases relating to false claims are reviewed and seven steps to safety for marketing a pharmaceutical product for an unapproved indication are presented.

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Issue: Vol. 2, No. 11: December 2003

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