1. Pink Sheet

Off-Label Communication Principles From PhRMA, BIO Aim For Reg Changes

 
• By Cathy Kelly

Manufacturer communications with providers and payers could include real-world evidence and pharmacoeconomic information, associations urge.

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The Pharmaceutical Research and Manufacturers of America and Biotechnology Innovation Organization released a set of principles on disseminating drug information to health care professionals and payers July 27 in the hopes of spurring the release of regulations from FDA that will enable the practice.

The “Principles on Responsible Sharing of Truthful and Non-Misleading Information About Medicines with Health Care Professionals and Payers” are “intended to establish responsible, science-based parameters for accurate and trusted information sharing,” the

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