Are sleepless nights ahead for FDA in wake of off-label narcolepsy drug verdict?
This article was originally published in Scrip
Although US regulators remained mum 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, Washington lawyer John R Fleder suspected there likely were quite a few nervous discussions and emails being circulated among officials at the US FDA and the Department of Justice.
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