Pharma Fights Back: Combating Heightened Prosecution of Off-Label Promotion with Claims of First Amendment Violations

Abstract

The FD&C Act and FDA-promulgated regulations work together to bar off-label promotion by pharmaceutical companies. This regulatory framework is often confusing and ambiguous, and FDA “guidance” on the issue has done relatively little to provide clarity. There was a series of trials and appeals in the late 1990s on the constitutionality of such speech restrictions, in which the plaintiff claimed that by prohibiting commercial speech, the First Amendment rights of pharmaceutical companies were being violated. But ultimately confusion perpetuated: although the cases culminated in an injunction against the FDA, the agency reinterpreted their guidance as merely safe harbors that provided no independent prosecutorial basis, rendering the court’s injunction moot. Prosecution of pharmaceutical companies for off-label promotion has increased over the past five years; recently, some pharmaceutical companies have responded by raising anew the First Amendment claims of a decade ago. This time, however, the claims are more narrowly focused, and if the recent oral arguments in front of the Second Circuit are any indication, carry a strong chance of winning.