We've been watching the evolution of the Supreme Court's thinking on First Amendment review of "speaker" and "content" specific prior restraints since we first noticed that emerging doctrine in the pharmaceutical detailing case, Sorrell v. IMS Health, Inc., 564 U.S. 552 (2011). In Sorrell, however, it was unclear how much (if any) more searching this form of review would be than the "intermediate" scrutiny to which commercial speech has long been entitled. Sorrell held:
In the ordinary case it is all but dispositive to conclude that a law is content based and, in practice, viewpoint discriminatory. The State argues that a different analysis applies here because [the statute] at most burdens only commercial speech. As in previous cases, however, the outcome is the same whether a special commercial speech inquiry or a stricter form of judicial scrutiny is applied.
Id. at 571 (citations omitted). So the Court was not specific exactly how much scrutiny was actually being applied.
Sorrell was followed by a classic "sleeper" case, Reed v. Town of Gilbert, 576 U.S. 155 (2015), which crystallized the "topic"-based aspect of First Amendment doctrine:
[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 169 (citations and quotation marks omitted). Thus, a directional sign prohibition. "fails strict scrutiny" where it imposed a "content-based" speech restriction. Id. at 172.
The end of the 2020 Supreme Court term brought the concept of content/speaker based speech restrictions home to the federal government. The Court in Barr v. American Assn. of Political Consultants, Inc, ___ S. Ct. ___, 2020 WL 3633780 (U.S. July 6, 2020), was rather splintered, producing four opinions. But much of the disagreement in Barr had to do with whether the unconstitutional aspect of a federal statute (the Telephone Consumer Protection Act) was severable from the rest of the statute. On the core First Amendment issue of strict scrutiny of content/speaker based speech restrictions (having to do with robocalls in Barr), a majority explicitly embraced "strict scrutiny." Four justice joined the lead opinion in Barr:
[Our] precedents restrict the government from discriminating in the regulation of expression on the basis of the content of that expression. Content-based laws are subject to strict scrutiny.
2020 WL 3633780, at *5 (citing, inter alia Reed) (emphasis added) (Kavanaugh, joined by Roberts, C.J., Thomas, & Alito, JJ.). And again:
[T]hat a distinction is speaker based does not automatically render the distinction content neutral. Indeed, the Court has held that laws favoring some speakers over others demand strict scrutiny when the legislature's speaker preference reflects a content preference.
Id. (citing both Reed and Sorrell) (emphasis added).
On the question of strict scrutiny, these four justices were joined in Barr by Justice Gorsuch – who would have struck down the entire TCPA as non-severable (a minority position). On strict scrutiny of content/speaker based speech restrictions, Gorsuch stated:
TCPA's rule against cellphone robocalls is a content-based restriction that fails strict scrutiny. The statute is content-based because it allows speech on a subject the government favors (collecting its debts) while banning speech on other disfavored subjects (including political matters).
Id. at *21 (Gorsuch, J.) (emphasis added). That's five votes for strict scrutiny in the context of federal statutory regulation of speech.
Nor have these votes been cast without full awareness of the effect that strict scrutiny might have on the administrative state. Justice Breyer's dissent on this point was quite explicit – "drug labels" were his prime example:
Consider prescription drug labels, securities forms, and tax statements. A government agency might reasonably specify just what information the form or label must contain and further provide that the form or label may not contain other information. . . . No one would think that the exclusion of political speech, say, from a drug label, means that courts must examine all other regulatory exceptions with strict scrutiny.
Id. at *17 (Breyer, J., joined by (Ginsburg & Kagan, JJ.). Justice Breyer used "political" speech as an example of something that could be banned from drug labels, but as we've discussed until we're blue in the face, the primary information actually banned from FDA-regulated labeling (very broadly defined for both drugs and medical devices) has to do with off-label uses.
Now, all that is subject to strict scrutiny.
And it continues to matter. Right now, largely because of off-label use concerns, the FDA is seeking to ban consumer access to pharmacogenomic testing. We've discussed pharmacogenomics for years, before it became "a thing." One aspect of pharmacogenomics is so-called "personalized medicine" – because not everybody metabolizes drugs (and other things) the same way. Thus, the results of individualized pharmacogenomic testing may indicate that particular patients should take a greater, or a lesser, amount of a drug than the labeled dosage – and that's off-label use. Or as the FDA put it in a recent warning letter:
Further, according to your website, the . . . tests may be ordered by a lab physician in which case test results are provided directly to patients. This could lead to patients inappropriately increasing, decreasing, or stopping their medication without their physician's involvement, which poses significant risks to patient safety.
FDA warning letter, dated 4/4/2019. Rather than deal with that issue (which is a legitimate concern), in a nuanced fashion to require physician involvement, the FDA seeks to ban such tests altogether, by forcing them for the first time to go through pre-market approval. Id. (asserting the "tests are adulterated . . . because your firm does not have an approved application for premarket approval (PMA)").
Once again, however, the FDA is acting in an overtly content (information on individualized dosing) and speaker (the manufacturer)-based fashion, which in light of the prior discussion should properly be subject to strict First Amendment scrutiny. Indeed, the FDA's current attempt to suppress pharmacogenomically-based off-label use is extremely ironic – and even more blatantly speaker-based – since as to hundreds of actual drugs (as opposed to genomic tests) the FDA actually encourages the inclusion of similar pharmacogenomic information in product labeling.
This article is presented for informational purposes only and is not intended to constitute legal advice.