Pharma Marketing News
PMN Home | Advertising Information | FAQs
About Us | Contact Us | Privacy Policy
Subscribe Glossary
Pharma Marketing Blog Pharmaguy Audio Podcasts Event Calendar PReader Surveys

Share |

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.

Read this article now. It's FREE...

Download PDF file

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

Find other articles in related Topic Areas:

Vol 2, #11 Contents

Contact Information
Pharma Marketing News

Pharma Marketing News | Subscribe | Industry Insights | Podcasts | Pharmaguy | Blog
Surveys | Glossary | Conference Calendar | Advertising Information | FAQs | About Us | Privacy Policy

© 2014. Pharma Marketing Network. All rights reserved.