Guidelines for Off-label Communications

SUMMARY

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 safely for marketing a pharmaceutical product for an unapproved indication are presented.

Order and pay for this reprint now using your credit card…

ONLY $9.95
Download PDF file immediately after paying:

Add to Cart

View Cart ]]>

PMN211-05
Issue: Vol. 2, No. 11: December 2003
ARTICLE CATEGORIES: CONFERENCE HIGHLIGHT | BEST PRACTICES | REGULATORY & COMPLIANCE