The U.S. Food and Drug Administration issued a draft guidance for manufacturers regarding distributing information about off-label uses for their products.
The draft guidance issues recommendations for communicating information about new, unapproved uses for approved drugs and devices in medical and scientific journals, medical and scientific reference texts and clinical practice guidelines.
The guidance offers suggestions for each of the three publication types separately. Here is a sample of the guidelines.
A medical or scientific article or journal distributed by the manufacturer should be:
• In accordance with the peer review procedures of the system.
• Unabridged
• Distributed separate from any promotional materials
A medical or scientific reference text distributed by the manufacturer should be:
• Published by an independent publisher
• Peer reviewed
• The most current version
Clinical practice guidelines should:
• Be developed by a multidisciplinary panel of experts
• Consider patient preference and patient subgroups
• Explain relationships between alternate care options and health outcomes
The draft guidance also discusses practices to avoid regarding these materials.
The FDA is accepting comments on the draft guidance until May 2.
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