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See today's BioWorld MedTechSee today's BioWorld
Home » WLF sees First Amendment issues in US FDA draft off-label guidance
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WLF sees First Amendment issues in US FDA draft off-label guidance

Jan. 10, 2024
By Mark McCarty
The U.S. FDA’s latest draft guidance on discussions of off-label uses with doctors revisits a controversial subject that has previously migrated into the courts, and by some accounts, may do so yet again. In comments to the docket, the Washington Legal Foundation (WLF) argued that this latest attempt to regulate commercial speech is another example of the agency’s “flagrant disregard for drug and device manufacturers’ free speech rights,” which WLF seemed to suggest is an actionable violation of the First Amendment.
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