Is the Supreme Court on a path to legalize truthful off-label communication?
Manufacturers suffer significant civil and criminal penalties when they communicate truthful scientific information concerning off-label use of their products. The Food and Drug Administration ("FDA") 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 Amendment, and the government's old arguments may not endure.
In Washington Legal Foundation v Friedman, 13 F. Supp. 2d 51 (D.D.C. 1998), the Court issued an injunction prohibiting FDA and the Department of Health and Human Services from enforcing any regulation, guidance, policy, order or other official action to prohibit, restrict, sanction, or otherwise seek to limit any pharmaceutical or medical device manufacturer from the dissemination of information concerning unapproved uses for its products. After the Fourth Circuit vacated the injunction stating "as a result of the government's clarification at oral argument, the dispute between the parties has disappeared before our eyes." Washington Legal Foundation v Henney, 202 F. 3d 331, 334 (D.C Cir. 2000), the case went back to the trial court to enforce whatever was left of the injunction and the trial court stated:
This year, the Court of Appeals was poised to finally galvanize a rule of law in this area. Yet, for whatever reason, the opportunity was spent debating not the U.S. Constitution's First Amendment, but its Article III case or controversy requirement. In fact, after the Court of Appeals' opinion, we...
