Prosecutions for “off-label marketing” by manufacturers have become an important component of the government's health care initiative. “Off-label” usage of prescription drugs and medical devices refers to using a product for a purpose that is not specified in the labeling approved by the Food and Drug Administration (FDA).
Off-Label Marketing and the First Amendment
Pharmaceutical and medical device manufacturers have argued that FDA restrictions on off-label promotion infringe their First Amendments rights. While First Amendment defenses are difficult, two recent cases have placed this issue back in the spotlight.
By
Jonathan S. Feld And Laura BrakeThis premium content is locked for Business Crimes Bulletin subscribers only
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