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August 10, 2015

Proactive Off-Label Promotion Can Be Protected Speech

New York Federal Court Holds FDA Can't Punish Even Intentional Off-Label Promotion If It's Truthful and Non-Misleading

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Can the federal government punish a company for truthful, non-misleading commercial speech? It seems obvious the answer should be “no.” Yet, for decades, the Food and Drug Administration has declared that it may prohibit such speech when it comes to off-label (i.e., unapproved) uses of prescription drugs and devices. That position is under assault. In 2012's Caronia decision, the Second Circuit vacated the conviction of a pharmaceutical sales representative caught on tape making what the FDA didn’t dispute were truthful, non-misleading statements to promote off-label use of the drug Xyrem. 1 The FDA was undeterred. It insisted that Caronia was limited to its facts and did not imperil the agency’s longstanding prohibition against all off-label promotion. On Friday, however, a New York federal district court forcefully rejected the FDA’s effort “to marginalize” Caronia. Citing the company’s free speech rights, the court preliminarily enjoined the FDA from pursuing Amarin Pharma for making truthful, non-misleading statements promoting the off-label use of its anti-cholesterol drug Vascepa. 2

Amarin is by no means a “get out of jail free” card for drug and device companies accused of promoting (or which want to promote) off-label uses of their products. For one thing, the decision only grants preliminary relief and its precedential value is limited to a single district. More fundamentally, and as the decision itself makes apparent, determining what statements are and are not “truthful and non-misleading” is a tricky business indeed. Nonetheless, the court’s holding—extending potential First Amendment protection to proactive and intentional off-label promotion—is a major development in the ongoing debate over First Amendment limits on the FDA’s authority.  

Background—Vascepa’s On- and Off-Label Uses

Vascepa’s active ingredient is an omega-3 fatty acid derived from fish oil. The FDA has approved it to lower triglycerides (“bad” cholesterol) in patients with very high blood levels. Amarin sought approval to also market the drug for patients with lower—but still too high—levels of triglycerides who failed to respond to other drugs (persistently high triglyceride levels). A double-blind placebo controlled study already showed the drug significantly lowered levels in this population. But the FDA developed second thoughts about the correlation between lowering triglycerides and preventing cardiovascular disease. Pending completion of another study of that specific question, the FDA withheld approval of Vascepa to treat persistently high triglyceride levels (leaving in place the approval for treating very high levels). It forbade Amarin from proactively telling doctors about the results in this patient population. And though the FDA permits makers of over-the-counter fish oil supplements to tell consumers that “supportive but not conclusive” research shows a possible heart benefit, it prohibited Amarin from making that claim with respect to off-label use of Vascepa. 3

Amarin Files Suit and Wins

Amarin sought an injunction on the ground that the FDA cannot constitutionally penalize a company for truthful and non-misleading communications promoting off-label use of a drug. It challenged the FDA’s distinction between “proactive” off-label promotion—which the FDA categorically prohibits—and responding to a doctor’s query about off-label use, which the agency permits subject to strict limitations. For its part, the FDA contended that permitting proactive off-label promotion, truthful or not, was a “frontal assault . . . on the framework for new drug approval that Congress created in 1962” that could “eviscerate” the existing regime. It argued that the First Amendment doesn’t protect intentional off-label promotion any more than it protects “speech crimes” like jury tampering and blackmail. And employing somewhat tortuous logic, it interpreted Caronia to permit using evidence of truthful non-misleading statements to prove intent to engage in prohibited “misbranding” of a drug through off-label promotion.   

The court systematically rejected each argument put forth by the agency. No matter how important the FDA’s mission or how good its motives, government suppression of truthful commercial speech simply can’t be squared with the First Amendment, as interpreted in Caronia:

Caronia’s holding was that FDCA’s misbranding provisions cannot constitutionally criminalize, and therefore do not reach, the act of truthful and non-misleading speech promoting off-label use. 5

The court was equally unimpressed with the FDA’s doomsday predictions. It remarked that if the agency truly feared that truthful, non-misleading off-label promotion “gravely undermined” the drug approval process, it would have appealed Caronia to the Supreme Court. 6

The Limits of Amarin’s Holding

The Amarin court’s resolution of the constitutional question is straightforward. But it leads to two questions that are much harder to answer: when is off-label promotion “truthful and non-misleading” and who makes that call? In Amarin, the district court shouldered the burden of evaluating—in considerable depth—the truth and fairness of specific proposed statements about off-label use Vascepa as well as the FDA’s counter-proposals.  A detailed discussion of its analysis (largely agreeing with Amarin’s position) is beyond the scope of this summary. The point, though, is that Amarin may be something of an outlier. The court had the benefit of an “unusual and extensive regulatory history” that permitted it “to determine, at this early stage, the truthfulness of Amarin’s proposed statements regarding off-label use.” Absent that kind of record, a court might be reluctant to “bless” particular statements as true and not misleading. It might also be more likely to defer to the FDA’s opinion on the matter.   

The bottom line is that while Amarin is an encouraging development for drug and device companies, the extent of First Amendment protection for off-label promotion is far from clear. How courts will treat a dispute over the truthfulness of off-label promotion in a case with a less robust regulatory record—or in a case where the off-label use is alleged to be dangerous—remains to be seen. In such a case, a court may well give considerably more deference to the FDA’s position. Even the Amarin court observed that while the FDA “cannot require a manufacturer to choreograph its truthful promotional speech to conform to the agency’s specifications,” a wise company will vet any off-label promotional statements with the FDA in advance:

A manufacturer that leaves its sales force at liberty to converse unscripted with doctors about off-label use of an approved drug invites a misbranding action if false or misleading (e.g., one-sided or incomplete) representations result.

One more issue to keep in mind. The First Amendment doesn’t apply to conduct. Thus, it offers no protection to “non-communicative” activities—like providing doctors with golf trips or other perks in an effort to reward or encourage them to prescribe off-label. 8

[1]  United States v. Caronia, 703 F.3d 149 (2d Cir. 2012).

[2]  Amarin Pharma, Inc. v. United States Food & Drug Administration, No. 15 Civ. 3588 (PAE), slip. op. (S.D.N.Y. Aug. 7, 2015).

[3]  Slip Op. at 20-24.

[4]  Id. at 35, 45, 51.

[5]  Id. at 50.

[6]  Id. at 67.

[7] 54-65.

[8]  See Id. at 52.