The Truth Is Out There, But Not Always On The Label
Manufacturers suffer significant civil and criminal penalties when they communicate truthful scientific information concerning off-label use of their products. The U.S. Food and Drug Administration has been successful in defeating First Amendment challenges by arguing that (1) its regulation of communications concerning off-label use of FDA-regulated products is commercial regulation, and (2) off-label communications, i.e., speech, are conduct and evidence of intent to misbrand.
But a new day is dawning on the First...
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