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FDA Publishes Final Guidance For Communicating Off-Label Uses. First Amendment Questions Remain

 
• By Brian Bossetta

The US FDA final guidance uses a Q&A format to help manufacturers navigate the regulatory landscape for communicating the off-label uses of their medical products to health care professionals. However, some say the final document fails to address potential free speech concerns.

Manufacturers looking to stay out of regulatory hot water for conveying the off-label uses of their medical products to health care professionals (HCPs) should consult new final guidance from the Food and Drug Administration.

The agency’s document offers manufacturers a series of Q&As that seek to clarify the regulatory parameters for describing off-label uses...

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