Conflicts Between Government Regulation of Off-Label Communications and The First Amendment
The FDA takes the position that a drug manufacturer may not promote its drug for an unapproved use, and that any such promotion is false and misleading simply because it is not FDA-approved. However, many off-label uses are in fact effective and safe, as is evidenced by subsequent FDA approval of such uses for numerous drug products. The Supreme Court has in recent terms begun to address the boundaries between government regulation of pharmaceuticals and the First Amendment free speech guarantee. Some legal observers have suggested that the trend in the Court's decisions may ultimately reduce the ability of FDA to prevent broader dissemination of off-label information about approved drug products.
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