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BioPharmaceutical United States Legal Issues

Off-Label Enforcement, Not Promotion, May See First Changes After Free Speech Ruling

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Executive Summary

In a watershed decision, a federal appeals court declares that manufacturers cannot be prosecuted under the FD&C Act’s misbranding provisions solely for speech promoting off-label use of a drug. Industry attorneys predict the decision, if it stands, will change the government’s approach to pursuing such cases.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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