This past weekend, there was an NCAA Division I clash of athletic teams ranked #5 and #7, respectively, that included two children of two different authors of this Blog. To make things even weirder, one athlete is (cisgender) female and one athlete is (cisgender) male, and they come from opposite ends of the country, although their colleges are relatively close to each other. The authors, by contrast to their children, are far more, ahem, academic than athletic and neither has ever participated in this particular sport. Why do we mention this, albeit vaguely? Sometimes there are weird connections that you would not expect.
Cases on First Amendment protection of freedom of speech often create such connections. People on both ends of the political spectrum might want vigorous judicial protection of free speech, at least for their compatriots. Companies with very different business interests might advocate strongly for protection of commercial speech. State and local government entities from very different parts of the country might want leeway in regulating things like the volume or time of demonstrations. Those jurists who otherwise identify themselves as being strong proponents of federalism and “states’ rights” may favor strict limits against states or municipalities getting such leeway. Whereas those jurists who otherwise tout the importance of civil rights in our legal system may be inclined to afford local governments more deference in restricting speech. There seems to be a political angle to just about every contested regulation of speech and, of course, politics makes strange bedfellows.
The rules for what federal, state, or local governments can and cannot regulate when it comes to commercial speech by drug and device companies about their products, the conditions they treat, and competitors’ products are not less complex. As we have detailed at length previously (like here, here, and here, among many other posts), they are also changing. First Amendment cases typically turn on the level of scrutiny applied to a challenged government action, with the application of strict scrutiny almost always meaning the governmental restriction was unconstitutional. Cases on how to determine which level of scrutiny applies can also, of course, change the playing field. The Supreme Court decision in Reed v. Town of Gilbert, 576 U.S. 155 (2015), spelled out what makes a restriction on speech content-based and, thus, presumptively invalid. As we noted soon after Reed and since , these standards flow directly into whether and how FDA can restrict what drug and device manufacturers say about off-label use, the main recurring issue for these companies.
Without delving too far into hypotheticals, the rules on what is a content-based restriction of statements on off-label use might play out something like this. FDA could take the position, as it arguably did for decades, that a flat-out prohibition on all statements on off-label use was not content-based because FDA did not care which off-label use was at issue, what the company said about it, or whether the statement was well-supported by scientific evidence. The manufacturer could respond that even evaluating if the statement concerned an on-label use or an off-label use was enough of an evaluation of content to make any restriction of speech content-based. (On current law, the company would be right.)
In City of Austin v. Reagan Nat’l Adver. of Austin, __ S. Ct. __, 2022 U.S. LEXIS 2098 (U.S. Apr. 21, 2022) (“Austin”), the Supreme Court again waded into the murky waters of when local restrictions on advertising violate the free speech protections of the First Amendment. Those more focused on advertising law would surely take a deeper dive into the four separate opinions on Austin. We will start by recapping where the nine justices came down, reserving the labeling of political and doctrinal camps and the relative strangeness of bedfellowship for others. Justice Sotomayor delivered a fairly succinct opinion for the majority; she was joined by Chief Justice Roberts and Justices Breyer, Kagan, and Kavanaugh. Justice Breyer wrote a concurrence to emphasize that he thought Reed was wrongly decided, although controlling. Justice Alito wrote an opinion concurring in part and dissenting in part, urging that a determination of the facial (un)constitutionality of the local ordinance was all the Court had to address. Justice Thomas authored a long dissent—much longer than the Court’s opinion—that railed that the Court had established “an incoherent and malleable standard,” among other things; he was joined by Justices Gorsuch and Barrett.
The core issue was relatively straightforward: the city of Austin (Texas) like many other political subdivisions regulated billboards and other signs based on whether they advertised “a business, person, activity, goods, products, or services not located on the site where the sign is installed.” In other words, the regulation distinguished between on-site and off-site advertising, something apparently common since the Highway Beautification Act of 1965. Id. at *7. Going farther back, “[b]y some accounts, the proliferation of conspicuous patent-medicine advertisements on rocks and barns prompted States to begin regulating outdoor advertising in the late 1860s.” Id. at *6 (citations omitted). We told you there were would be some weird connections. For off-site advertising like that offered by the defendants, which owned billboards, the distinction in the regulation meant the defendants could not digitize their signs, something that would have been permitted for on-site advertising. After a bench trial, the district court found the local ordinances were content neutral and thus constitutional as written and applied. Id. at **9-10. The Fifth Circuit reversed, finding that resolving the on-site versus off-site distinction necessarily involved a content-based inquiry. Id. at **10-11.
The Court’s first substantive paragraph of its decision fairly encapsulates its analysis, so we will paste it here:
A regulation of speech is facially content based under the First Amendment if it “target[s] speech based on its communicative content”—that is, if it “applies to particular speech because of the topic discussed or the idea or message expressed.” Reed, 576 U.S. at 163. The Court of Appeals interpreted Reed to mean that if “[a] reader must ask: who is the speaker and what is the speaker saying” to apply a regulation, then the regulation is automatically content based. 972 F.3d at 706. This rule, which holds that a regulation cannot be content neutral if it requires reading the sign at issue, is too extreme an interpretation of this Court’s precedent. Unlike the regulations at issue in Reed, the City’s off-premises distinction requires an examination of speech only in service of drawing neutral, location-based lines. It is agnostic as to content. Thus, absent a content-based purpose or justification, the City’s distinction is content neutral and does not warrant the application of strict scrutiny.
Id. at *12. The city ordinance required “reading a billboard to determine whether it directs readers to the property on which it stands or to some other offsite location,” but the “sign’s substantive message itself is irrelevant to the application of the provisions.” Id. at *15. “Reed does not require strict scrutiny to this kind of location-based regulation.” Id. (citations omitted). The Court thus remanded the case to determine if the ordinance could survive intermediate scrutiny, which would focus on whether there was an impermissible purpose or justification. Id. at *22. Again, this seems like a relatively straightforward analysis that did not upset the approach by many jurisdictions in regulating signs and billboards.
First, though, the Court took aim at the Thomas dissent, noting that it also did not “embrace the read-the-sign rule” from the Fifth Circuit. Id. at **20-21. The dissent, it said, falsely accused the Court of creating a “novel ‘specificity test’” when it had “merely appl[ied] those precedents [from Reed and other cases] to reach the ‘commonsense’ result that a location-based and content-agnostic on-/off-premises distinction does not, on its face, ‘singl[e] out specific subject matter for differential treatment.’” Id. at *21 (citations omitted). Instead, “[i]t is the dissent that would upend settled understandings of the law.” Id. For a majority opinion of the Supreme Court, this is pretty wild stuff.
The dissent brought at least as much venom. The Austin “off-premises restriction . . . discriminates against certain signs based on the message they convey—e.g., whether they promote an on- or off-site event, activity, or service.” Id. at *36. The dissent claimed the majority had replaced the standard from Reed with “an incoherent and malleable standard.” Id. It then cited an older case not discussed in the Court’s opinion, which we think provides some insight into the intensity of the disagreement:
In so doing, the majority’s reasoning is reminiscent of this Court’s erroneous decision in Hill v. Colorado, 530 U.S. 703 (2000), which upheld a blatantly content-based prohibition on “counseling” near abortion clinics on the ground that it discriminated against “an extremely broad category of communications.” Id. at 723. Because I would adhere to Reed rather than echo Hill’s long-discredited approach, I respectfully dissent.
Id. at **36-37. This caused us to look up Hill, which had a majority opinion authored by Justice Stevens and joined by, among others, Chief Justice Rehnquist. It also did not concern a “content-based” restriction focused on abortion clinics. The Colorado statute at issue concerned all healthcare facilities and instituted a bubble around people entering or exiting those facilities to further obvious public safety goals. So, without re-litigating all the Supreme Court freedom of speech cases over the last twenty-plus years, we can say the decisions setting the standards for evaluating local restrictions on signs or FDA limits on statements on off-label use will remain contentious and driven by shifting concerns and alliances.
As for FDA limits on statements by drug and device companies, did Austin change anything compared to Reed and the rest of the cases examined in Austin? Not really. If anything, Austin emphasized that any such restrictions would be subject to strict scrutiny. At least for now. As the Breyer concurrence noted, there are many federal, state, and local laws that “turn, often necessarily, on the content of speech.” Id. at *26. One of his examples was FDA’s regulation of prescription drug labeling under 21 U.S.C. § 353(b)(4)(A). He was not arguing, however, that such regulation should be subject to strict scrutiny, but that Reed “too rigidly ties content discrimination to strict scrutiny (and, consequently, to ‘almost certain legal condemnation’).” Id. at **27-28 (citation omitted). As for us, our views on the differential treatment of statements about off-label and on-label uses are well known, but we certainly do not argue that the entire regulatory scheme for the labeling of medical products should be toppled. With the shifting slate on standards and the implications of applying strict scrutiny to certain limits on commercial speech, however, it is not hard to see how the broader and vigorously partisan fights on freedom of speech could have the unintended consequence of creating major changes to that scheme.