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Are sleepless nights ahead for US FDA in wake of off-label narcolepsy drug verdict?

This article was originally published in SRA

Executive Summary

US drug and device regulators kept quiet the day after a federal appeals court ruled that the "truthful" off-label promotion of US approved prescription drugs is not criminal activity and is protected speech under the First Amendment of the US Constitution, but Washington lawyer John R Fleder suspects there likely were quite a few nervous discussions and emails being circulated among officials at the Food and Drug Administration and the Department of Justice1-3.

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