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The long wait is over.  Here is the Second Circuit’s decision in United States v. Caronia, No. 90-5006-cr, slip op. (2d Cir. Dec. 3, 2012).  By a 2-1 vote, Mr. Caronia’s conviction for off-label promotion is reversed on First Amendment grounds.  The ruling is unmistakable.  There was no question that off-label promotion had occurred.  Slip op. at 14-16.  The sole basis for vacating the conviction was the government’s failure to prove that any of the alleged promotion was false.
Interestingly, even the government tried to run for cover from the First Amendment, arguing on appeal that off-label promotion only “plays an evidentiary role” in a criminal prosecution for misbranding.  Slip op. at 27 (emphasis original). Thus:

The government contends that Caronia was not prosecuted for his speech, but that Caronia’s promotion of [an] off-label use served merely as “evidence of intent,” or evidence that the “off-label uses were intended ones[] for which [the drug’s] labeling failed to provide any directions.”

The majority in Caronia didn’t buy the change of tactics.  “[T]hat is not what happened in this case.”  Id. at 28.

[The government clearly prosecuted Caronia for his words − for his speech.  A pharmaceutical representative’s promotion of an FDA- approved drug’s off-label use is speech.  As the Supreme Court has held:  “Speech in aid of pharmaceutical marketing . . . is a form of expression protected by the Free Speech Clause of the First Amendment.”  Sorrell v. IMS Health, Inc., 131 S. Ct. 2653, 2659 (2011).  Here, the proscribed conduct for which Caronia was prosecuted was precisely his speech in aid of pharmaceutical marketing.

Caronia, slip op. at 31 (emphasis added).  As we pointed out in our very first Sorrell post, the First Amendment chickens are coming home to roost.
The Court then quite explicitly rejects an off-label  promotion ban as required by the FDCA, because to do so would be unconstitutional:

[W]e decline the government’s invitation to construe the FDCA’s misbranding provisions to criminalize the simple promotion of a drug’s off-label use by pharmaceutical manufacturers and their representatives because such a construction − and a conviction obtained under the government’s application of the FDCA − would run afoul of the First Amendment.

Caronia, slip op. at 33.
“Content-based” governmental restrictions on speech are “subject to strict scrutiny” and “presumptively invalid.  Id. at 34.  “Criminal regulatory schemes, moreover, warrant even more careful scrutiny.”  Id.  The Second Circuit then followed Sorrell‘s two-step First Amendment analysis.

First, we conclude that the government’s construction of the FDCA’s misbranding provisions imposes content- and speaker-based restrictions on speech subject to heightened scrutiny.  Second, we conclude the government cannot justify a criminal prohibition of off-label promotion even under [the] less rigorous intermediate test.

Caronia, slip op. at 39.
First, the FDA’s regime banning off-label promotion is “content based” − that is, based upon what is being discussed and thus not neutral:

[I]t distinguishes between “favored speech” and “disfavored speech on the basis of the ideas or views expressed.”  Under this construction, speech about the government-approved use of drugs is permitted, while certain speech about the off-label use of drugs − that is, uses not approved by the government − is prohibited, even though the off-label use itself is not.  Indeed, the content of the regulated speech drives this construction of the FDCA; as in Sorrell, the “express purpose and practical effect” of the government’s ban on promotion is to “diminish the effectiveness of [off-label drug] marketing by manufacturers.”

Caronia, slip op. at 40 (citing Sorrell, other citations omitted).  It is also speaker-based, as anybody no matter how medically ignorant, can advocate off-label uses, except the manufacturers:

[T]his construction is speaker-based because it targets one kind of speaker – pharmaceutical manufacturers − while allowing others to speak without restriction. . . .  B]ecause off-label prescriptions and drug use are legal, the government’s application of the FDCA permits physicians and academics, for example, to speak about off-label use without consequence, while the same speech is prohibited when delivered by pharmaceutical manufacturers.  This construction “thus has the effect of preventing [pharmaceutical manufacturers] − and only [pharmaceutical manufacturers] − from communicating with physicians in an effective and informative manner.”

Caronia, slip op. at 40-41 (again citing Sorrell, with other citations omitted).  Finally, Caronia was worse than Sorrell, from a First Amendment standpoint, because “this case involves a criminal regulatory scheme subject to more careful scrutiny.  Id. at 41.
Caronia goes on to invalidate the FDA’s off-label speech ban under the less strict Central Hudson commercial speech test.  The first two prongs were easy:  “promoting off-label drug use concerns lawful activity (off-label drug use), and the promotion of off-label drug use is not in and of itself false or misleading.”   Slip op. at 42 (there’s a footnote that the dissent suggests that off-label promotion is inherently misleading, but even the government did not so argue).
The third prong is also satisfied, since the government has “substantial” interests “in preserving the effectiveness and integrity of the FDCA’s drug approval process, and . . . in reducing patient
exposure to unsafe and ineffective drugs.”  Id. at 42-43.  Again, that’s not something that this blog has ever disputed, either.  It all comes down to whether the FDA’s ban on truthful speech is a legitimate way, under the First Amendment, to pursue those interests.

  • “As off-label drug use itself is not prohibited, it does not follow that prohibiting the truthful promotion of off-label drug usage by a particular class of speakers would directly further the government’s goals.”  Caronia, slip op. at 44.
  • “[P]rohibiting off-label promotion by a pharmaceutical manufacturer while simultaneously allowing off-label use ‘paternalistically’ interferes with the ability of physicians and patients to receive potentially relevant treatment information; such barriers to information about off-label use could inhibit, to the public’s detriment, informed and intelligent treatment decisions.”  Id.
  • “While some off-label information could certainly be misleading or unhelpful, this case does not involve false or misleading promotion.  Moreover, in the fields of medicine and public health, ‘where information can save lives,’ it only furthers the public interest to ensure that decisions about the use of prescription drugs, including off-label usage, are intelligent and well-informed.”  Id. at 46.
  • “If the government’s objective is to shepherd physicians
    to prescribe drugs only on-label, criminalizing manufacturer promotion of
    off-label use while permitting others to promote such use to physicians is an
    indirect and questionably effective means to achieve that goal.”  Id. at 47
  • “[T]he government’s construction of the FDCA to impose a complete and criminal ban on off-label promotion by pharmaceutical manufacturers is more extensive than necessary to achieve the government’s substantial interests.”  Id. at 48.
  • The government has plenty of non-infringing alternatives:  FDA warnings about off-label uses; disclaimers; safety tiers between various off-label uses (like Medicare does), listing known or suspected off-label uses in the approval process; and ceilings or caps on the number of off-label prescriptions before FDA approval is mandatory, and even prohibitions of some off-label uses.  Id. at 48-50.
  • “In the absence of any support, such conclusory assertions are insufficient to sustain the government’s burden of demonstrating that the proposed alternatives are less effective than its proposed construction of the FDCA.”  Id. at 50-51.

Thus the FDA’s off-label promotion ban, even if construed as involving only commercial speech, is unconstitutional under the First Amendment.  The court therefore construes the FDCA as allowing truthful promotion of off-label uses.

[W]e decline to adopt the government’s construction of the FDCA’s misbranding provisions to prohibit manufacturer promotion alone as it would unconstitutionally restrict free speech.  We construe the misbranding provisions of the FDCA as not prohibiting and criminalizing the truthful off-label promotion of FDA-approved prescription drugs.

Caronia, slip op. at 51.
If adopted by the Supreme Court (and this is one of the few cases that a grant of certiorari can be described as “likely”), the analysis in Caronia will kill the FDA’s speech-specific ban on off-label promotion – and along with it the government’s monetization of that ban to collect billions of dollars in fines for what is First-Amendment protected activity.  The states and their accompanying False Claims Act relators should see the money spigot shut off as well.  Finally, in our product liability cases – in the Second Circuit immediately, and in other circuits once this rationale is adopted – plaintiffs will no longer be able to assert off-label promotion, in and of itself, as something that’s tortious.  Ever since New York Times v. Sullivan, tort litigation cannot be based on First-Amended protected conduct.
A great day today for the good guys!
PS:  There’s a “sky is falling” dissent that we’ll discuss in the future, but right now, we have to get back to our paying work.