In his latest off-label use-related law review article in 2021, Bexis pointed out:

[A]lthough states have traditionally been recognized to have broad authority to regulate the practice of medicine, aside from occasional attempts to restrict use of abortifacients, state-law interventions restricting the off-label uses of prescription medical products have been infrequent.

James M. Beck, “Off-Label Use in the Twenty-First Century:  Most Myths and Misconceptions Mitigated,” 54 UIC J. Marshall L. Rev. 1, 10-11 (2021) (quotation marks and multiple footnotes omitted).  Indeed, at that point many more states had pro-off-label use statutes on the books (mostly concerning insurance coverage) than legislation seeking to restrict any such uses.  Id. at 11.

Any doubt about whether states have the authority to ban off-label uses was recently eliminated by United States v. Skrmetti, 145 S.Ct. 1816 (2025), which upheld a state ban on (among other things) the off-label use of FDA-approved drugs to treat gender dysphoria.  The state could rationally consider such treatment to be “experimental,” and some studies had found “the evidence on treatment efficacy and safety is still insufficient and inconclusive” and the “long-term risks . . . are largely unknown.”  Id. at 1825-26 (citations omitted).  But only Justice Thomas’ concurrence, of all the opinions, addressed off-label use as such.

For purposes of treating gender dysphoria . . ., puberty blockers generally are administered “off-label,” meaning without FDA authorization for the specific use.  Although it is neither unusual nor unlawful for drugs to be used off-label, the FDA has recognized that “just because a drug has been approved for one class of patients doesn’t mean it’s safe for another.”  That admonition is important here. . . .  The use of drugs to suppress normal puberty has multiple organ system effects whose long-term consequences have not been investigated.  This absence of evidence is a major drawback in assessing the effects of puberty blockers on children with gender dysphoria.

Id. at 1841-42 (citations and quotation marks omitted) (Thomas, J., concurring).

The basis for the Skrmetti decision thus was not the power of the states to ban this or that off-label use, but rather whether this particular ban violated the Equal Protection Clause by discriminating against those being treated off-label as a protected class subject to “intermediate scrutiny.”  Id. at 1829.  The court found no violation, as “[c]lassifications that turn on age or medical use are subject to only rational basis review,” id., and under that level of scrutiny defendants virtually always win (as was the case in Skrmetti).  See Id. at 1835-36.  Ironically, the on-label uses of these drugs were what saved the state’s off-label use ban:

[The statute] does not mask sex-based classifications. . . .  Under [the statute], no minor may be administered puberty blockers or hormones to treat gender dysphoria, gender identity disorder, or gender incongruence [the off-label uses]; minors of any sex may be administered puberty blockers or hormones for other purposes [those being the on-label uses].

Id. at 1831 (emphasis original).  Thus, the majority reasoned, “[a] law prohibiting the administration of specific drugs for particular medical uses does not” discriminate on the basis of sex – because the FDA-approved uses are available to all.  Id.

But just because states can ban off-label uses, doesn’t mean they should – particularly where, as in Skrmetti, the ban was motivated by political rather than medical reasons.  Justice Thomas celebrated the triumph of politics over medicine in his concurrence.  “[S]o-called experts have no license to countermand the wisdom, fairness, or logic of legislative choices.”  Id. at 1840.

[T]his case serves as a useful reminder that the American people and their representatives are entitled to disagree with those who hold themselves out as experts. . . .  The views of self-proclaimed experts do not shed light on the meaning of the Constitution.  Thus, whether major medical organizations agree with the result of Tennessee’s democratic process is irrelevant.  To hold otherwise would permit elite sentiment to distort and stifle democratic debate under the guise of scientific judgment.

Id. (citations and quotation marks omitted).  We disagree with this sort of populist anti-intellectualism, particularly when directed against the medical community.  “Scientific judgment” – especially medical science −  not politics, was responsible for average life expectancy in the United States rising from around 48 years in 1900 to over 78 years in 2023.  CSC, National Center for Health Statistics, “Life Expectancy,” & Figure 1.  Justice Thomas (age 77) is certainly a beneficiary of that trend.

Moreover, once governments start down this slippery slope, who knows where it will end.  Perhaps not coincidentally, in the same week that Skrmetti was decided, so was Culture of Life Family Services, Inc. v. Bonta, 2025 WL 1687929 (S.D. Cal. June 13, 2025).  California brought suit over another off-label use “abortion pill reversal (‘APR’) treatment,” which “consists of taking the hormone progesterone in order to counteract mifepristone.”  Id. at *1.  When the state instituted enforcement actions against various persons who promote that off-label use, those targeted sought “pre-enforcement relief.”  Id. at *2.  They claimed a First Amendment “Free Speech” right to engage in this particular off-label use.  Id. at *4.

They lost.  Their asserted right to engage in off-label use “failed to make a colorable claim and even if it has, the government has justified its restriction on speech.”  Id.  Once again, a court found that off-label use was not constitutionally protected.  The speech in question was commercial in nature:

Although [plaintiff] alleges that, as a religious nonprofit, it provides numerous free services, including “free APR treatment,” this belies the fact that it still accepts insurance and payment for APR treatments from women who do have the ability to pay. . . .  Thus, it seems apparent that [defendant] has an economic motivation behind its APR speech.

Id. at *6.

But why is that any different than our (and our clients’) position that truthful off-label speech is First Amendment protected under Central Hudson Gas & Electric Corp. v. Public Service Comm’n, 447 U.S. 557 (1980)?

Because the plaintiffs’ speech was rife with misrepresentations.  After a lengthy discussion of relevant, and competing, medical testimony on several points, id. at *7-9, 10-11, 12, 13 Culture of Life concluded:

• “[I]t would be at the very least potentially misleading to state that supplemental progesterone can ‘reverse’ an abortion.”  Id. at *10.
• “[G]iven the lack of robust scientific study on this issue, statements on the effectiveness of APR are potentially misleading.”  Id. at *12.
• “Due to the dearth of medical evidence on the effects of [the off-label use], the Court finds it potentially misleading to say that APR can only cause non-life-threatening side effects.”  Id. at *13.
• “Given the lack of scientific evidence on this specific question, the Court finds the statements on birth defects following APR to be potentially false and misleading.”  Id.
• It is “unclear what the actual aggregate success rate would be.  Statements purporting a 64-68% success rate are therefore inherently false and misleading.”  Id.
• Because “the 64% success rate is not a reliable statistic . . . and there is no reason to generalize this statistic to all women who started APR, . . . these kinds of statements [large number of “lives saved”] potentially false and misleading.”  Id. at *14.
• “[S]tatements that APR treatment could work in non-standard situations are inherently misleading.”  Id.

The court therefore concluded that plaintiffs were not entitled to First Amendment protection because:  (1) many of the statements were false and misleading, either inherently or potentially; (2) enforcement “directly advance[d] a substantial government interest” of “protecting consumers from misleading advertising by medical professionals,” particularly given “the special interest that states have in regulating professions”; and (3) “women, in exercising their reproductive rights, are also consumers who must be given the correct information.”  Id. at *13.

As Culture of Life points out, California had not actually banned the off-label use itself.  Id. at *14.  However, Skrmetti simultaneously established that states (unlike the FDA) have that power, and if California had done so the First Amendment outcome in Culture of Life would not have changed, although the Central Hudson analysis would have been much shorter.  “As a threshold question, Central Hudson specifies that if the regulated commercial speech concerns illegal activity or is misleading, the First Amendment extends no protection and the analysis ends.”  Culture of Life, 2025 WL 1687929, at *6 (citations and quotation marks omitted).  Next time maybe California will.

And the list could go on.  Off-label use of Ivermectin was controversial during the recent COVID-19 pandemic.  No state did at that time, but any state that wanted to – or still wants to – could ban it, either for the safety reasons that the FDA cited, or for purely political reasons.

Banning off-label uses is a slippery slope, and we don’t think states should start down it, particularly for the populist, anti-science motives that Justice Thomas espoused in Skrmetti.