Par vs. USA - Off-label Promotion And The First Amendment

Playing the Back 9 - FDA may need to take a Mulligan (or two) in its definition of off-label promotion

More than ten years after the District Court in DC invalidated FDA regulations concerning promotional activities as violative of the First Amendment to the US Constitution in Washington Legal Foundation v. Henney, and as the judge who presided over that case predicted, the First Amendment challenge to FDA regulations prohibiting truthful and non-misleading speech has resurfaced.

In Par Pharmaceutical, Inc. et al v US, Par brought suit for declaratory relief in the District of Columbia to prohibit FDA from, among other things, enforcing "FDA's unconstitutional and invalid regulations" restricting truthful non-misleading speech. Par's complaint seeks declaratory and injunctive relief concerning the following:

FDA's intended use regulations "as applied" violate the first Amendment by prohibiting truthful non-misleading "on-label" speech. FDA cannot "deem intent" to market off-label based on knowledge that a manufacturer knows that physicians are using a product off-label. To the extent on-label speech is "deemed" to relate to an off-label use, declare that FDA's regulations violate the First Amendment to the extent they prohibit truthful and non-misleading speech concerning off-label use. To the extent on-label speech is "deemed" to relate to an off-label use, declare FDA's definition of labeling violates the First Amendment "as applied" to prohibit truthful non-misleading speech concerning off-label use. 32 CFR 201.100(c)(1) is invalid as contrary to 21 USC §353(b)(2). FDA's definition of labeling 21 CFR § 201.1(1)(2) is invalid as contrary to 21 USC § 321(m). Enter a preliminary injunction during the pendency of this case prohibiting enforcement of the foregoing regulations. Enter a permanent injunction to prevent enforcement of invalid regulations to prohibit truthful and non-misleading speech. Request for costs and attorneys' fees. In seeking to dismiss this case, FDA argues that the claims are not ripe and has submitted the declaration of the Associate Director of Medical Policy and Director of the Office of Medical Policy (OMP) at the Center for Drug Evaluation and Research (CDER) at FDA. At this juncture in the case, FDA is not yet tackling Par's First Amendment challenge but is attacking what it perceives as false assumptions and misinterpretations of the marketing regulations. FDA's Declaration starts off recognizing that an...