Today we discuss a couple of developments involving (actually or potentially) the application of the First Amendment to the FDA’s increasingly battered prohibition against truthful promotion of off-label use.
First, we’ve mentioned Pacira Pharmaceuticals v. FDA before as the latest First Amendment follow-up action to Amarin Pharma, Inc. v. FDA, ___ F. Supp.3d ___, 2015 WL 4720039 (S.D.N.Y. Aug. 7, 2015). What we have for you now are the two industry-side amicus briefs filed in support of Pacira’s First Amendment motion against the FDA. This one was filed by PhRMA, and this one was filed by something called the Medical Information Working Group, which is a consortium consisting of Amgen, Bayer, Boehringer, Lilly, Genentech, GSK, J&J, Novartis, Novo Nordisk, Pfizer, and Sanofi. Impressive lineup. And to think we can remember when nobody was willing to take on the FDA about truthful off-label promotion for fear of retaliation…. What a difference a few wins make.
We’ve read through the two amicus briefs and we heartily recommend them to anyone interested in bringing the FDA’s reign of (t)error in this area to long-overdue end. Briefly, the MIWG brief makes the following points: (1) the FDA’s ban is an “ambiguous tangle of regulations, nonbinding guidance documents, and severe enforcement practices”; (2) pharmaceutical promotion is First Amendment protected speech under Sorrell v. IMS Health, Inc., 131 S. Ct. 2653 (2011); (3) truthful off-label promotion provides valuable information to physicians and patients alike; (4) what FDA claims is “misbranding” is the same information it has pledged in other contexts to “work hard to address”; (5) Pacira’s speech is really on-label promotion that the FDA has attempted to suppress through an improperly crabbed reading of the drug’s intended use; (6) off-label use is legal, common-place, medically valuable, and sometimes the medical standard of care; (7) more truthful speech about off-label use is better than less; (8) the FDA’s ban unconstitutionally discriminates on the basis of both speaker and content; (9) the basis for the FDA’s ban is unconstitutionally vague and ambiguous; (10) FDA’s “safe harbors” are arbitrary and constitutionally inadequate; (11) the FDA has taken inconsistent positions on what off-label promotion is allowed; (12) the FDA has never even defined “promotion”; (13) the FDA’s vagueness and contradictory policies chills protected speech − truthful pharmaceutical promotion; and (14) because of this chilling effect there is both standing and justiciability.
PhRMA’s brief argues: (1) the FDA gave this drug a broad approval, and can’t narrow the scope of that approval after the fact by threatening prosecution via an informal warning letter; (2) the First Amendment requires that the FDA “scrupulously observe” its procedures that might chill protected speech; (3) “regulation through warning letter” is unconstitutionally vague; (4) the dispositive inquiry is whether speech is truthful, not whether it is “promotional” as opposed to “scientific”; (5) disclosure and disclaimers are less restrictive than the FDA’s administrative ban; (5) the FDA’s “substantial evidence” (two controlled clinical trials) yardstick for efficacy and comparative claims does not transform truthful speech into something that is “false or misleading” for First Amendment purposes; and (6) the FDA’s “substantial evidence” threshold is unconstitutional if applied to otherwise truthful speech that has adequate disclosures and disclaimers of its being based on less than two controlled clinical trials.
As these briefs indicate, one of the major problems that the FDA faces is that, well after approving this drug for surgery generally, it sent a warning letter seeking to restrict its approval to only the specific surgical sites evaluated in the studies on which its approval was based. Not a good move. Indeed, now that it’s been sued, the FDA has (without any public announcement) taken the almost unprecedented step of depublishing that warning letter and removing it from its website. We’re frankly not surprised that something like this has happened. We warned back in 2010 that the FDA was making a big mistake when it changed its policies and permitted its non-lawyer staffers to issue warning letters without requiring that those letters first be vetted by actual FDA lawyers. Now, the ill-conceived Pacira letter has the FDA back on its heels in significant First Amendment litigation. What goes around, comes around.
Our other point is something that we didn’t see in either amicus brief in the Pacira litigation. That’s the Supreme Court’s First Amendment decision in Reed v. Town of Gilbert, 135 S. Ct. 2218 (2015). While Reed is not a drug case, it is an interesting application of the Court’s precedent in Sorrell, with potentially broad application. In Reed the Court declared unconstitutional a town’s regulation of temporary advertising signs because it discriminated on the basis of content between “ideological signs,” “political signs,” and “temporary directional signs.” Id. at 2224-25. Citing primarily Sorrell, the Court held that “[g]overnment regulation of speech is content based” – and therefore subject to strict First Amendment scrutiny – “if a law applies to particular speech because of the topic discussed or the idea or message expressed.” Id. at 2227. “A law that is content based on its face is subject to strict scrutiny regardless of the government’s benign motive, content-neutral justification, or lack of animus toward the ideas contained in the regulated speech.” Id. at 2228 (citation and quotation marks omitted). The key is not “viewpoints” but “topics”:
[I]t is well established that the First Amendment’s hostility to content-based regulation extends not only to restrictions on particular viewpoints, but also to prohibition of public discussion of an entire topic. Thus, a speech regulation targeted at specific subject matter is content based even if it does not discriminate among viewpoints within that subject matter.
Id. at 2230 (citation and quotation marks omitted) (emphasis added). Likewise, a government restriction aimed at a particular “topic” cannot escape strict scrutiny because it does not turn on the identity of the speaker:
[J]ust as with speaker-based laws, the fact that a distinction is event based does not render it content neutral. . . . As we have explained, a speech regulation is content based if the law applies to particular speech because of the topic discussed or the idea or message expressed. A regulation that targets a sign because it conveys an idea about a specific event is no less content based than a regulation that targets a sign because it conveys some other idea.
Id. at 2231 (emphasis added). See also Id. at 2233 (“[l]imiting speech based on its ‘topic’ or ‘subject’ favors those who do not want to disturb the status quo”) (Alito, Kennedy, and Sotomayor, concurring).
Because the governmental defendant’s “topic”-based restrictions on signs were content-based, and therefore subject to strict scrutiny, the signage regulations had to satisfy a tough “compelling interest” and “narrowly tailored” constitutional standard. Id. Not surprisingly they flunked. Id. at 2231-32. The particular reasons don’t concern us, only the holding in Reed that because the governmental restriction targeted a “topic” it was subject to strict scrutiny as content-based.
Now, consider the Reed standard as applied to the FDA’s off-label promotion ban. Off-label use certainly seems as much of a defined “topic” as those discussed in Reed, which included “church services” and “elections.” 135 S. Ct. 2230. Thus, under Reed’s “topic”-based approach, there doesn’t seem to be the need any longer to go through the “commercial speech” rigmarole of Central Hudson Gas & Electric Corp. v. Public Service Commission, 447 U.S. 557 (1980), to come to the conclusion that the First Amendment doesn’t permit the FDA to place the entire topic of off-label use off limits to truthful speech by those marketing FDA-regulated products. Rather, this is a job for strict scrutiny.
Think we’re off the wall? One of the justices who decided Reeddoesn’t:
Nor can the majority avoid the application of strict scrutiny to all sorts of justifiable governmental regulations by relying on this Court's many subcategories and exceptions to the rule. The Court has said, for example, that we should apply less strict standards to “commercial speech” . . . . [T]he Court has applied the heightened “strict scrutiny” standard even in cases where the less stringent “commercial speech” standard was appropriate. [citing Sorrell]
Reed, 135 S. Ct. at 2235 (citation omitted) (Breyer, J., concurring in the result). That’s right; the example used is Sorrell. Sorrell, of course, held that pharmaceutical promotion was First Amendment protected speech, as we discussed here. It’s not for nothing that we put Sorrell in our top ten list of best drug/medical device decisions of 2011. Perhaps not coincidentally, Sorrell was decided by the same six justices (Alito, Kennedy, Roberts, Scalia, Sotomayor, and Thomas) as Reed. Justice Breyer, at least, thinks that Reed can apply to drug/device promotion. He doesn’t like that, but we do.
In the Second Circuit, with the Caronia precedent, drug and device companies pursuing First Amendment challenges to the FDA’s off-label promotion ban probably don’t need the extra added strict scrutiny oomph of Reed’s “topic” analysis. But in cases venued outside Caronia’s protective umbrella, we recommend that those using the First Amendment to defend against the FDA’s ban think about adding Reed to their constitutional armamentarium.