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On March 18, 2024, the Supreme Court heard argument in a matter, National Rifle Association of America v. Vullo, No. 22-842, that from its caption would seem to have nothing to do with our sandbox.

But it might.

One of the issues before the Supreme Court in NRA is whether administrative action, labeled only as “guidance” (in NRA, certain letters issued by the head of the New York State banking agency) were sufficiently coercive – despite not being presented as anything “final” – that they could unconstitutionally restrict speech in violation of the First Amendment.  Appellant NRA, represented by the American Civil Liberties Union (among others), contends that the defendant “issued formal guidance letters” that “promised enforcement leniency” and  “urged” the banks it regulated to cease doing business with the NRA for political reasons.  Petitioner’s Br., at 1.  Even though this “guidance” neither had nor claimed to have force of law, it had the desired effect – causing regulated entities to do what the government wanted for “fear of losing our license to do business.”  Id. at 8 (citation and quotation marks omitted).

To us, the analogy is obvious. The FDA also relies heavily on “guidance” that it likewise considers non-“final,” and has similarly done so in ways that impinge on First Amendment-protected speech.

NRA thus raises the question whether purported agency “guidance,” although supposedly only hortatory, was sufficiently coercive of protected speech to violate the First Amendment, based on:  (1) the agency’s “extensive regulatory authority over” the targeted entities, (2) similar instances in the agency had in fact “exercise[d] its authority” to take adverse regulatory action; (3) “timing,” (4) “the language of the guidance,” and (5) the “reactions of targeted entities” to comply with regulatory wishes.  Id. at 13-14.  The petitioner’s primary argument, as summarized is:

[I]nformal efforts to suppress or penalize speech by threatening private intermediaries violate the First Amendment just as much as direct censorship.

Id. at 15 (citing Bantam Books v. Sullivan, 372 U.S. 58 (1963)).  The agency in NRA allegedly “invoked [its] unparalleled authority” over a regulated industry to “penaliz[e] speakers based on [its] disagreement with the speakers’ views” by means of “threatening official retribution if the recipient does not comply.”  Id. at 16.  Since the case was decided on a motion to dismiss, those allegations are treated as true.

The agency in NRA claims that “because [it] did not directly impose a formal sanction on [the target entities], [its] actions are permissible” under the First Amendment.  Id. at 21.  But, by “act[ing] indirectly,” the agency thereby ‘eliminate[d] the safeguards’ associated with more formal and direct processes.” Id. at 24 (again quoting Bantam Books).  “The more power an [agency] has over those [it] addresses, the more likely [its] message will be coercive.”  Id. at 28 (citation omitted).  And in the NRA case:

Here, [the agency] wielded unparalleled direct authority over the entire [industry], supervising more than three thousand institutions.  [It] had enforcement discretion over a vast regulatory code.  And to enforce that code, [the agency] could inflict a range of punitive measures, including direct enforcement actions, . . ., millions of dollars in fines, and criminal referrals.

Id. at 29 (citations omitted).

To us, this sounds a lot like the FDA, and how the FDA is undertaking – both historically and right now – to suppress off-label speech in the context of First Amendment-protected product marketing, see Sorrell v. IMS Health Inc., 564 U.S. 552, 557 (2011), through use of supposedly informal agency “guidance” that it claims is insulated from judicial review.  But, if anything, the FDA’s resort to informal agency coercion of First Amendment-protected speech is a fortiori from NRA, since FDA agency coercion is directly against the speech of the regulated industry, rather than through third parties.

Our blogpost describing the FDA’s October, 2023 “draft guidance”:  “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers,” is here.  Bexis is also fresh off a presentation on the First Amendment problems with this draft guidance that he and Dan Troy gave at the March 11 Reed Smith annual Health Care Conference, so the issue is particularly salient.

Sure enough, like the informal agency action at issue in NRA, the FDA’s draft guidance is styled as a matter of agency “enforcement policy.”  Thus, like the agency actions in the NRA case, the FDA continues to leverage its authority over the industries it regulates to suppress truthful, and First Amendment protected, marketing of regulated products for off-label uses.

At least those are the parallels we see in what could be a monumental “sleeper” case (no FDA-related amici are of record) that could affect how the courts treat the FDA’s increasingly numerous “guidance” documents, at least as they affect First Amendment-protected speech, and possibly more generally as to whether “guidance” exposes an administrative agency to litigation.

According to SCOTUSblog, the Court in NRA was more “sympathetic” to the NRA’s First Amendment arguments than it was to somewhat similar arguments made in the more-publicized Murthy v. Missouri, No. 23-411, social media case that was argued on the same day. We’ll see what happens.