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Free Speech

Journal of Free Speech Law: "FDA Regulation of Physicians' Professional Speech," by Prof. Barbara J. Evans

An early article from what will eventually be several on Information as Medicine.


A quick summary; the article is here:

Part I discusses First Amendment protection of physicians' professional speech, while also noting the strong framework of non-constitutional speech protections physicians long enjoyed under general health laws predating the emergence of modern First Amendment doctrine. These strong statutory protections may help explain the sparsity of First Amendment cases squarely addressing physicians' rights of access to the informational inputs of professional speech and their rights, as a profession, to exercise epistemic control of the medical evidence base in the sense of determining which sources of evidence are appropriate for a doctor to consider when advising a patient. Strongly protected by general health laws, these rights rarely are transgressed in ways that spark constitutional disputes. However, new medical technologies (and the government's attempts to regulate them) can exert new pressures that earlier health laws did not contemplate, leaving the First Amendment as physicians' only line of defense. CDS tools, I argue, have brought such a moment.

Part II describes the statutory basis for FDA's regulation of CDS [Clinical Decision Support] tools and explains how the Cures Act limits FDA's jurisdiction and requires procedural protections to avoid unjustified intrusions on physicians' free speech rights. Part III explains that the CDS Guidance deviates from the statute it purports to interpret in ways that impose a scheme of content-based regulation of physicians' professional speech. Part IV explains why ostensibly non-binding guidance documents, such as FDA's CDS Guidance, can nevertheless threaten immediate injuries to the rights of physicians and patients in their care. CDS tools offer great promise to improve health care, but they pose risks that call for careful oversight. The medical profession has a crucial role to play in that oversight, and the First Amendment keeps us safer by ensuring governmental agencies cannot oust them from that role.

And some more background, from the Introduction:

On September 28, 2022, after six years of effort and two draft guidance documents, the U.S. Food and Drug Administration (FDA) finalized its Guidance on Clinical Decision Support Software (CDS Guidance). Clinical Decision Support (CDS) tools are an important category of medical software designed to assist health care professionals. CDS tools process patient-specific health information along with various other sources of medical knowledge—such as clinical practice guidelines, drug labeling information, insights from published medical literature, or fresh insights derived by an artificial intelligence/machine learning (AI/ML) algorithm imbedded in the CDS tool itself—to offer a health care professional a set of patient-specific diagnostic or treatment recommendations for use in clinical health care.

The clinical care context distinguishes CDS tools from consumer-facing home health applications and other health-related software designed for use by medical laypeople. CDS tools have a trained medical professional in the loop to consider outputs from the software and formulate the final advice conveyed to patients. This context also positions CDS tools as the latest skirmish in a longstanding boundary dispute between the states' authority to regulate the practice of medicine and FDA's authority to regulate medical products such as the drugs and medical devices widely employed in modern medical practice.

The federal power to regulate medical practice—historically a focus of state regulation—was a fraught topic in the legislative debate preceding passage of the 1938 Food, Drug, and Cosmetic Actand flared up recently in connection with the Affordable Care Act.The states, through their medical practice acts, other statutes, and common law, define the scope of medical practice and regulate it. Arguments that FDA should not regulate the practice of medicine often invoke principles of federalism or the Tenth Amendment reservation of powers to the states. Courts have been unreceptive to those arguments, however.

The modern view is that the Constitution does not bar the federal government from touching medical practice issues—at least not as a matter of federalism—although Congress and federal agencies, as a policy matter, make efforts to respect the states' primacy in regulating the practice of medicine. Under this view, FDA's authority to regulate the practice of medicine is ultimately set by Congress subject to no real constitutional constraint, and FDA can expand this authority by petitioning Congress to amend FDA's enabling statutes.

This dynamic was seen in FDA's recent success in expanding its authority to regulate physicians' off-label uses of medical devices. The agency has long described its role as controlling which medical products are commercially available and ensuring that labeling accurately describes the uses for which the products have been shown safe and effective. However, "labeling is not intended to preclude the physician from using [his/her/their] best judgment in the interest of the patient, or to impose liability if [he/she/they] does not follow the package insert"—physicians, not FDA, set the standard of care. Congress codified this principle when expanding FDA's oversight of medical devices in 1976. Largely unnoticed in medical circles, President Biden signed legislation on December 29, 2022 repealing this pillar of physician autonomy in medical device regulation.

FDA sought this change after a federal court held, in 2021, that FDA interfered with the practice of medicine by selectively banning a particular off-label use while otherwise leaving a device on the market. The court held that FDA can ban a device altogether but cannot micromanage how physicians use devices it has not banned. The use in question was already receiving extensive state-level oversight requiring multiple physicians to certify, case-by-case, that no other treatment had worked and that the off-label use was in the patient's best interests. After losing this case, FDA pressed Congress in June 2022 to amend the medical device statutes to let the agency do what the court said it could not do. Congress declined, but the desired amendment reappeared deep in the 1,653-page December appropriations bill and was quietly enacted. Legal professionals with subject-matter expertise view this as opening the door to FDA oversight of medical practice. This change potentially affects CDS tools, which are subject to FDA regulation as medical devices.

This article challenges the modern view that there is no real constitutional constraint on FDA's authority to regulate the practice of medicine. The CDS Guidance is an intriguing counterexample where there is a meaningful constitutional constraint on FDA's power to regulate the practice of medicine, flowing not from principles of federalism but from the First Amendment.

FDA's September 2022 publication of the CDS Guidance sparked a flurry of adverse commentary alleging—with sound basis—that the guidance materially deviates from the statute it purports to interpret, Section 3060 of the 21st Century Cures Act (the Cures Act). In mapping a path forward, an important point for FDA to consider is that Congress has no power to grant FDA jurisdiction beyond what the U.S. Constitution allows. The constraint on FDA's authority to regulate CDS software is not merely a statutory constraint created by the Cures Act. Rather, it is a constitutional constraint imposed by the First Amendment. In the Cures Act, it appears Congress has already granted FDA as much jurisdiction to regulate CDS software as the First Amendment will allow. If FDA is displeased with that grant of jurisdiction, pressing Congress to grant FDA more jurisdiction is unlikely to be availing, because, in this case, Congress—like FDA—is up against a genuine constitutional constraint.