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Off-Label Communication: Pfizer Highlights Burdens Of FDA Policy

 
• By Sue Sutter

Seeking relaxation of US agency restrictions, Pfizer cites three examples where company delayed or decided against distributing medically relevant information beyond the product labeling; PhRMA survey shows almost half of all requests for information by prescribers and payers relate to off-label use.

At a recent US FDA hearing Pfizer Inc. highlighted three types of product-related communications that could become more prevalent if the agency revises its regulatory framework governing industry communications about off-label uses.

In two of the cases, Pfizer delayed distributing information about uses within the approved indication due to a lack of...

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