Newsflash: “Speech In Aid Of Pharmaceutical Marketing [is] Protected By The First Amendment.”

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 have even less First Amendment law than before; this is because the Court vacated all of this Court’s previous constitutional rulings on the matter.

As for this Court’s part in the controversy, the Court is confident that it has done its best…[i]t has decided the [Constitutional] issue at least twice, and senses it will be called on to do so again before the controversy is concluded. For now, however, the issue must be given a temporary rest.

Washington Legal v Henney, 128 F. Supp. 2d 11, 15 (D.D.C. 2000).

The “temporary rest” may be coming to an end as off-label speech cases join a rising tide of First Amendment jurisprudence.

In Sorrell v. IMS Health Inc., 564 U.S. _, 131 S. Ct. 2653_(2011), the Supreme Court stated that “[s]peech in aid of pharmaceutical marketing, however, is a form of expression protected by the Free Speech Clause of the First Amendment“:

[t]he First Amendment requires heightened scrutiny whenever the government creates a “regulation of speech because of disagreement with the message it conveys”…. Facts, after all, are the beginning point for much of the speech that is most essential to advance human knowledge and to conduct human affairs. There is thus a strong argument that prescriber-identifying information is speech for First Amendment purposes.

Id at 2666.

The Court went on to state:

Those who seek to censor or burden free expression often assert that disfavored speech has adverse effects. But the “fear that people would make bad decisions if given truthful information” cannot justify content-based burdens on speech. The First Amendment directs us to be especially skeptical of regulations that seek to keep people in the dark for what the government perceives to be their own good. These precepts apply with full force when the audience, in this case prescribing physicians, consists of “sophisticated and experienced consumers.”…That the State finds expression too persuasive does not permit it to quiet the speech or to burden its messengers.

131 S. Ct. at 2670-71.

In U.S. v. Caronia, 576 F. Supp. 2d 385, (E.D.N.Y. 2008), a case pending in the Second Circuit, Mr. Caronia, his employer and others were indicted as a result of a sting operation. Unfortunately for Mr. Caronia, his employer admitted to a conspiracy to misbrand and paid a hefty penalty. In denying Mr. Caronia’s motion to dismiss, the trial court recognized that the Constitutional question at issue remained “unsettled”:

Reduced to its essence, Caronia’s argument is that the government cannot restrict truthful, non-misleading promotion by a pharmaceutical manufacturer (or its employees) to a physician of the off-label uses of an FDA-approved drug…squarely, Caronia’s constitutional attack calls into questions America’s regulatory regime for the approval and marketing of prescription drugs.…[T]he Constitutional issues raised in Caronia’s motion are very much unsettled, not only in the circuit but nationwide…. ”With that the overture ends and the play begins. Enter on stage the essential question – can government satisfy the fourth prong of Central Hudson?” (i.e. the less intrusive means)…. [H]ere, the FDA’s maintaining through the FDCA’s misbranding provisions some control over the off-label promotion of manufacturers does appear essential to maintaining the integrity of the FDA’s new drug approval process…this Court is unable to identify non-speech restrictions that would likely constrain in any effective way manufacturers from circumventing that approval process.

Id. at 393. The case was tried to verdict against Mr. Caronia, and he was convicted on one count of “conspiracy to introduce or deliver for introduction into interstate commerce a drug…that was misbranded.”

Caronia’s appeal has been joined by amici who have battled the First Amendment issue since the days when it was “laughed out of court.” U.S. v. Caputo, 517 F.3d 935, 937 (7th Cir. 2008). Only now, no one is laughing. Before going to the Supreme Court,Sorrell was decided by the Second Circuit. In finding that the Vermont statute at issue in Sorrell infringed on First Amendment rights, the Second Circuit stated: “[t]he statute is therefore clearly aimed at influencing the supply of information, a core First Amendment concern…the First Amendment teaches that courts should assume that truthful commercial information ‘is not in itself harmful.’” 630 F.3d 263, 272 (2d Cir. 2010). The Court went on to conclude that the state could achieve its goals with less restrictive means:

In other words the statute seeks to alter the marketplace of ideas by taking out some truthful information that the state thinks could be used too effectively. The state’s approach to regulating the interaction between detailers and doctors is premised on limiting the information available to physicians as a means of impacting their conduct. This approach is antithetical to a long line of Supreme Court cases stressing that courts must be very skeptical of government efforts to prevent the dissemination of information in order to affect conduct.

Id. at 277-278. Sorrell was not a case directly involving off-label communications but the Court’s reasoning may apply equally in the context of off-label communications.