Some of us are old enough to remember when the Kessler-led FDA attacked off-label use of prescription medical products by using archaic language in the agency’s “intended use” regulations (21 C.F.R. §§201.128, 801.4) to claim that a regulated entity’s mere knowledge that its products were being used off-label by physicians meant that those products were “misbranded” or “adulterated.” He failed, and eventually those regulations were revised specifically to reject that reading. Since 2021, they have included the sentence: “provided, however, that a firm would not be regarded as intending an unapproved new use for an approved drug based solely on that firm’s knowledge that such drug was being prescribed or used by health care providers for such use.” Id. (emphasis added). In the course of the rulemaking leading to this amendment, the FDA expressly disclaimed any mere knowledge standard. 85 Fed. Reg. 59718, 59720 (FDA Sept. 23, 2020); 82 Fed. Reg. 14319, 14320 (FDA March 20, 2017). We discussed the process that led to that amendment several times, most recently here.
Unfortunately, the plaintiffs’ lawyers and other ideologues that are now running the DoJ, FDA (and other American health agencies) into the ground are at it again – despite the 2021 amendment. Apparently, they will argue anything and everything in their attempt to prohibit any doctor anywhere from offering “gender-affirming care.” Because such treatments involve off-label use of various drugs, the government is now offering absurd legal arguments seeking to prohibit doctors from using those FDA-regulated product off-label – without regard to how they would affect off-label use generally. Recall that the Supreme Court has held: “[O]ff-label use is generally accepted” under the law as a “necessary corollary of the FDA’s mission to regulate in this area without directly interfering with the practice of medicine.” Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341, 350 (2001). Interference with medical practice is precisely what the FDA is trying to do by reversing its off-label use positions.
Fortunately, the courts are rejecting this ideologically driven [b]administration regulatory flip-flop. Specifically, they are rejecting the government’s attempt to restrict off-label use in the context of pretextual subpoenas that the Justice Department (“DoJ”) has issued, ostensibly to investigate “off-label promotion.” In re Subpoena No. 25-1431-014, ___ F. Supp.3d ___, 2025 WL 3252648, at *17-19 (E.D. Pa. Nov. 21, 2025); QueerDoc, PLLC v. U.S. Dept. of Justice, 2025 WL 3013568, at *2 (W.D. Wash. Oct. 27, 2025); In re Administrative Subpoena No. 25-1431-019, 2025 WL 2607784, at *6-7 (D. Mass. Sept. 9, 2025). The most recent, No. 25-1431-014 decision is by far the most extensive, so we will focus on it.
These cases all involve intrusive and expensive DoJ subpoenas issued against hospitals and other healthcare providers that offer gender-affirming care in states where such treatments are legal under state law. The government’s position in No. 25-1431-014 was outlined by the DoJ’s Director of the Department of Justice’s Enforcement and Affirmative Litigation Branch, who asserted that:
a drug manufacturer or other person distributes a misbranded or unapproved drug simply by prescribing or administering an approved drug for an unapproved indication and to the extent these drugs are intended to treat gender dysphoria in minors, they constitute unapproved new drugs under federal law, and their distribution for that unapproved indication violates the [FDCA] and is a federal crime.”
2025 WL 3252648, at *18 (quotation marks omitted).
No way; no how. “The Director’s assertion is wrong as a matter of law.” Id. The federal government does not regulate the practice of medicine – states do, and the medical treatments being “investigated” were legal in the state in question:
The practice of off-label prescribing . . . is lawful in Pennsylvania and clinicians “are free to exercise their professional judgement [sic] to prescribe [FDA]-approved drugs for any use they see fit.”
Id. (quoting Sommers v. UPMC, 185 A.3d 1065, 1072 n.6 (Pa. Super. 2018)). “Even taken at face value, these concerns describe policy disagreements about the propriety of medical care left to the [states] since the Nation’s founding and not a federal crime under the Act.” Id. at *17.
The government’s attack on off-label use:
rests on an admittedly unprecedented interpretation of the [FDCA]. The Department seeks to transform Congress’s regulation of the manufacture, distribution, and labeling of drugs into a vehicle for federal oversight of how physicians diagnose, treat, and counsel child patients.
Id. As Buckman held, there is nothing illegal about off-label use:
Both the [FDA] and our colleagues long recognized off-label prescribing − the use of an approved drug for an unapproved indication − is lawful and beyond the Act’s reach. Although the Act regulates a manufacturer’s distribution of drugs, it does not go further by regulating a doctor’s practice of medicine.” Congress likewise expressly preserved state authority over medical practice, providing in part, “[n]othing in this chapter shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease.” The Food and Drug Administration can only regulate the marketing and labelling of devices. It cannot regulate what physicians do with the devices with respect to their patients.
2025 WL 3252648, at *17 (footnotes omitted). In addition to citing Buckman and quoting 21 U.S.C. §396, these footnotes provide extensive additional authority. That authority, and much more, on every off-label use-related point the No. 25-1431-014 opinion is found in James M. Beck, “Off-Label Use in the Twenty-First Century: Most Myths & Misconceptions Mitigated,” 54 UIC J. Marshall L. Rev. 1 (2021).
Another error in the government’s position was “stretch[ing] the concept of ‘labeling’ to suggest ordinary clinical documents may qualify as ‘false or misleading labeling.” This argument lacked any legal basis, since “labeling” is only issued by entities, such as “manufacturers, packers, or distributors,” that the FDA regulates, and the FDA does not regulate hospitals or doctors. No. 25-1431-014, at *18. Nor are medical care providers “part of the ‘chain of distribution’ of a drug.” Id. That was crazy talk:
This theory has no cognizable bounds; it defies both law and logic. Accepting this interpretation would transform every act of treatment into a potential federal offense. And be directly contrary to Congress’s mandate.
* * * *
[T]he first clause simply restates [DoJ’s] assertion using an approved drug for an unapproved indication renders it an “unapproved new drug” and the second echoes the misbranding provision which requires manufacturer labeling to include “adequate directions for use.” Neither theory governs physicians acting within their state-regulated scope of practice − prescribing or administering [FDA]-approved drugs in the exercise of professional medical judgment. Misbranding liability, as Congress structured it, attaches to those who design, control, or disseminate a drug’s labeling − such as manufacturers and distributors − not to physicians engaged in patient-specific treatment. Clinicians neither create a drug’s labeling nor define its “intended use” under the Act.
Id. (more footnotes omitted). The DoJ’s position was an unprecedented, big-government power grab against the states’ authority to regulate the medical profession:
The prescription-drug framework rests on licensed practitioners exercising medical judgment rather than layperson-directed labeling. Nothing in the Act treats a physician’s diagnosis, counseling, or prescription decisions as misbranding. The DoJ’s disavowal of criminal intent thus conflicts with (and does not cure) the premise underlying [DoJ’s] belief off-label medical practice itself violates the Act. We again cannot fathom where [DoJ’s] theory would lead in prosecutions of clinicians who exercise their learned judgment to find these drugs will help their child patients and the Commonwealth agrees with them.
Id.
Further, the DoJ attack on off-label use was indeed unprecedented. The only authority DOJ offered in No. 25-1431-014 was completely inapposite – involving prosecutions of physicians for prescribing “drug[s] the Food and Drug Administration had not approved as safe for any use.” Id. at *19 (emphasis original). In sum:
The [DoJ] hopes to reinterpret Congress’s longstanding mandate in the Act to reach lawful clinical care. Extending it so far would subvert Congress’s design, erase the long-recognized boundary between drug regulation and the practice of medicine, and intrude upon Pennsylvania’s sovereign authority to oversee the medical profession in the Commonwealth guaranteed under the Tenth Amendment. Such an interpretation would seem to disregard the limits of Congress’s intent and risk undermining the physician-patient relationship and open, evidence-based communication about care − a result at odds with both Congress’s direction . . . and sound medical practice set by the Commonwealth.
No. 25-1431-014, at *19.
Yet another bogus legal proposition is lurking beneath the surface in No. 25-1431-014. The DoJ also demanded production of individual “informed consent” documents in the subpoena. Id. at *7. It claimed these files were “relevant” to “prove . . . informed consent, and disclosure of off-label use is key to assessing whether the [target of the subpoena] concealed or downplayed risks.” Id. at 13 (emphasis added). While not addressed in the No. 25-1431-014 opinion, that’s also legally incorrect. Federal informed consent standards only exist in the context of FDA-regulated clinical trials, and off-label use is not FDA regulated. For authority on that point, see Bexis’ article, 54 UIC J. Marshall L. Rev. at 35-37, 92-93 & nn. 167-75, 481-84. Like off-label use itself, the applicable informed consent standards are also a matter of state law, and state law overwhelmingly requires discussion of medical risks and benefits – not FDA regulatory status – in informed consent discussions. The target in No. 25-1431-014 was a Pennsylvania hospital, and Pennsylvania’s informed consent law follows the majority view:
We see no reason to expand the information that surgeons traditionally impart to their patients to encompass a device’s FDA regulatory status. We agree . . . that the FDA labels given to a medical device do not speak directly to the medical issues surrounding a particular surgery. The category into which the FDA places the device for marketing and labeling purposes simply does not enlighten the patient as to the nature or seriousness of the proposed operation, the organs of the body involved, the disease sought to be cured, or the possible results. The FDA administrative label does not constitute a material fact, risk, complication or alternative to a surgical procedure. It follows that a physician need not disclose a device’s FDA classification to the patient in order to ensure that the patient has been fully informed regarding the procedure.
Southard v. Temple University Hospital, 781 A.2d 101 (Pa. 2001). The same decision also calls out the misconception that, somehow, informed consent standards only applicable to federally regulated clinical trial standards should control:
[Plaintiffs] further rely on a line of cases involving clinical investigations which are conducted pursuant to FDA regulations (“Investigational Device Exemptions”, or “IDEs”). The FDA permits such investigations in order to encourage the discovery of useful medical devices. In turn, physicians who participate in an IDE voluntarily agree to abide by numerous procedures, including obtaining a patient’s informed consent of the proposed clinical testing. [Plaintiff] was not a patient in one of these investigations. [Plaintiffs] argue that surgeons who perform “experimental surgery” outside of these FDA-monitored investigations should not be held to a lesser standard of disclosure; rather, they too should be required to disclose the “investigational nature of the procedure” [They] improperly equate the two situations. Merely because a device is deemed “investigational” for purposes of an IDE does not establish that the device is “experimental” or “investigational” for all medical purposes. . . . We therefore decline to subject those physicians who do not voluntarily participate in FDA clinical investigations to the purview of the FDA’s requirements for such investigations.
Id. at 107-08 (citations, footnotes, and quotation marks omitted). For other decisions reaching the same result in numerous state-law informed consent cases, see 54 UIC J. Marshall L. Rev. at 84-86 & nn. 443-53, and several prior posts. This argument, as well, represents a massive attempted federal encroachment on state law.
Because the legal underpinnings of DoJ’s attempt to subpoena patient records from health care providers under the pretext of investigating off-label promotion” that was “illegal” under the FDCA was 100% invalid, the subpoenas in question were invalid and stricken. No. 25-1431-014, at *19.
Note: for anyone who is interested, No. 25-1431-014 also conducted a detailed, six-factor analysis of the applicable privacy-related balancing test for subpoenas generally, under the Third Circuit’s controlling United States v. Westinghouse Electric Corp., 638 F.2d 570 (3d Cir. 1980), decision, and ruled against the government on that basis as well. See No. 25-1431-014, at *19-33.