While the plaintiffs acknowledged the FDA’s authority to regulate drugs (they get no credit for that; it’s like Margaret Fuller’s announcement that she“accept[ed] the universe,” and Thomas Carlyle’s retort that“By Gad, she’d better!”), they argued that the FDA lacked authority to“prohibit, direct, or advise against off-label uses of drugs approved for human use.” The plaintiffs relied on 21 U.S.C. section 396, which provides that nothing in the federal Food, Drug and Cosmetic Act“shall be construed to limit or interfere with the full authority of a health practitioner to prescribe or administer any legally marketed device for any condition or disease within a legitimate health care practitioner-patient relationship.” Did you catch the word“device” in that quote? The plaintiffs did, but nevertheless contended that section 396 also applies to the prescription and administration of drugs. We have some sympathy with the overarching notion that the FDA does not regulate the practice of medicine, and we certainly have expressed some skepticism about some of the FDA’s efforts to limit off-label prescriptions (inasmuch as some of those off-label prescriptions are necessary and are within the standard of care), but we have little sympathy for the ivermectin pro-conspiracy and anti-vax crowd, and even less sympathy for the plaintiffs’ statutory construction inApter.Be that as it may, the plaintiffs

We pointed out that, if the FDA enforced either regulation in accordance with their literal terms, that would upset the well-established practice of off-label use by physicians, by potentially forcing manufacturers to police and deter the medical community’s off-label use. Indeed, after the enactment of 21 U.S.C. §396 (“[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 FDA probably lacks the authority to interpret §804.1 in this manner. Still, as our prior post illustrates, the FDA occasionally flirts with the literal implications of this “knows, or has knowledge” language in its intended use regulations.

gulated territory accidentally, and if they do, to be sure that such innovations are in compliance with FDA regulatory requirements. FDA, Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices, available athttps://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices. FDA, Guidance Document, Clinical Decision Support Software: Guidance for Industry and Food and Drug Administration Staff (Sept. 2022), available athttps://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-decision-support-software. 21 U.S.C. § 360j(O). 21 U.S.C. § 321 (emphasis added).https://www.thefdalawblog.com/2011/10/fda-continues-efforts-to-expand-power-over-intrastate-commerce/ Federation of State Medical Boards, Understanding Medical Regulation in the United States (last accessed Jan. 25, 2023), at https://www.fsmb.org/siteassets/education/pdf/best-module-text-intro-to-medical-regulation.pdf. 21 U.S.C. § 396. 21 C.F.R. § 807.65(d). FDA, Policy for Device Software Functions and Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff (last issued Sept. 28, 2022), available athttps://www.fda.gov/media/80958/download (citations omitted). 76 Fed. Reg. 8637, 8645 (Feb. 15, 2011) FDA, Requirements for Health Care Facilities and Manufacturers, available athttps://www.fda.gov/medical-devices/medical-device-data-systems/requirements-health-care-facilities-and-manufacturers. FDA Draft Guidance, “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” (October 2014), available athttps://www.fda.gov/media/89841/download.https://crsreports.congress.gov/product/pdf/IF/IF11389. FDA, Frequently-Asked-Questions about the Reprocessing and Reuse of Single-Use Devices by Third-Party and Hospital Reprocessors; Three Additional Questions, available athttps://www.fda.gov/media/71124/download. Medical Device User Fee and Modernization Act of 2002, Report 107-728

generally.”)See, Clinical Decision Support Software: Guidance for Industry and Food and Drug Administration Staff at 7.Id. at 11 (“Automation bias is the propensity of humans to over-rely on a suggestion from an automated system. In the context of CDS, automation bias can result in errors of commission (following incorrect advice) or omission (failing to act because of not being prompted to do so).”) (citing M.L. Cummings, Automation Bias in Intelligent Time Critical Decision Support Systems. American Institute of Aeronautics and Astronautics 1st Intelligent Systems Technical Conference, Vol. 2, 2004, pp. 557-62).Id. at 12.Id. at 12-13.Id. at 11.Id. at 12.Id.See, Miranda v. National Emergency Services, Inc, 35 Cal. App. 4th 897 (1995) (citing James v. St. Elizabeth Community Hospital, 30 Cal. App. 4th 73 (1994)) (“Physicians covering emergency rooms must make instantaneous decisions, often without the benefit of medical histories, consultation, or time for reflection”).See supra n. 9.21 USC § 396; see also e.g., Wash Legal Found. v. Friedman, 13 F. Supp. 2d 51 (D.D.C. 1998), at 66 (“FDA does not purport to regulate the practice of medicine, and the agency has long recognized that, in general, physicians may use an approved drug or device for an unapproved use”).21 USC § 360j(o)(1)(E)(iii); see also e.g., Judge Rotenberg Educ. Ctr., Inc. v. U.S. Food & Drug Admin., 3 F.4th 390 (D.C. Cir. 2021); United States v. California Stem Cell Treatment Center, Inc., No. EDCV 18-1005 JGV (C.D. Cal. Aug. 30, 2022). But see United States of America v. Regenerative Sciences, LLC, 741 F.3d 1314 (D.C. Cir. 2014).See, Clinical Decision Support Software: Guidance for Industry and Food and Drug Administration Staff at 14.See, e.g., United States v. Travia, 180 F. Supp. 2d, 115 (D.D.C. 2001) at 199 (“It is also well established that the ‘intended use’ of a product, within the meaning of the Act, is determined from its label, accompanying labeling, promotional claims, advertising, and any other rele

Does the case involve an off-label use?The FDA statute contemplates that a physician may choose to use a device for a purpose which has not been cleared with or approved by the FDA. 21 U.S.C. §396. Promotion of a device for an off-label use may, however, affect the availability of preemption defenses, and create a liability risk.12.

The powdered glove ban similarly targeted a particular use of a device, but was never challenged in court.[4] Section 1006 of the FD&C Act (21 U.S.C. § 396).

It is generally accepted that FDA’s authority under the Federal Food, Drug, and Cosmetic Act (FDCA) does not allow for FDA to regulate the practice of medicine. FDCA § 1006 (21 U.S.C. § 396) explicitly states that FDA may not interfere with the practice of medicine related to legally marketed medical devices. However, when it comes to the practice of medicine related to prescription drugs, this line is not always bright.

Id. (discussing 21 U.S.C. §396). Congress’ unqualified language thus “becomes all the harder to ignore, a sort of dog that didn’t bark.”

In their eyes, the FDA should be the only arbiter of whether information is backed by sufficient scientific evidence to justify permitted a manufacturer to disseminate it to physicians. These speakers argued that off-label uses backed by sufficient scientific evidence will not be kept a “secret” from physicians even if manufacturers are not permitted to disseminate information on these uses because physicians will learn of such uses from medical societies. At the most extreme, some speakers advocated for the FDA to insert itself into the doctor-patient relationship (something that is illegal under 21 U.S.C. §396) and require physicians to obtain separate informed consent (potentially even provided by the FDA) before prescribing or using a drug or device off-label. The FDA will be accepting written comments until January 9, 2017.

There can be no dispute that Congress did not intend FDA to regulate the practice of medicine via the FDC Act: “Nothing in this Act 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 within a legitimate health care practitioner-patient relationship.” 21 U.S.C. § 396. One of the reasons for this carve out was to recognize there are robust traditional means to redress harms caused by physicians, either through state medical boards or medical malpractice suits.