Quick summary; article here:
Part One discusses First Amendment protections for physicians’ professional speech, while also pointing to the strong framework of non-constitutional speech protections physicians have long enjoyed under general health laws that predate the emergence of modern First Amendment principles. These strong legal protections may help explain the sparseness of First Amendment cases that directly address physicians’ rights to input into professional speech and their rights as a profession to exercise cognitive control over the medical evidence base. That is, determine what rights are. These rights are vigorously protected by general health laws and are rarely infringed upon giving rise to constitutional disputes. However, new medical technologies (and government attempts to regulate them) may impose new pressures not contemplated by earlier health laws, leaving the First Amendment as a physician’s only line of defense. I think CDS tools bring about such a moment.
Part 2 describes the statutory basis for FDA’s regulation of CDS [Clinical Decision Support] Tools and explain how the Cures Act limits FDA’s jurisdiction and requires procedural protections to avoid undue infringements on physicians’ free speech rights. Part Three explains that the CDS Guidelines depart from the regulations they are intended to interpret by imposing a content-based regulatory scheme on physicians’ professional speech. Part IV explains why ostensibly non-binding guidance documents, such as the FDA’s CDS guidance, may immediately undermine the rights of physicians and patients in their care. CDS tools offer great promise for improving health care, but they also carry risks that require careful oversight. The medical community plays a vital role in this oversight, and the First Amendment makes us safer by ensuring that government agencies cannot expel them from this role.
And some more background information, from the introduction:
On September 28, 2022, after six years of hard work and two draft guidance documents, the U.S. Food and Drug Administration (FDA) finalized the Clinical Decision Support Software Guidance (CDS Guidance). Clinical decision support (CDS) tools are an important class of medical software designed to assist healthcare professionals. CDS tools process patient-specific health information as well as a variety of other sources of medical knowledge, such as clinical practice guidelines, drug labeling information, insights from the published medical literature, or new insights derived from artificial intelligence/machine learning (AI/ML) algorithms Embedded within the CDS tool itself, it provides healthcare professionals with a set of patient-specific diagnostic or treatment recommendations for use in clinical healthcare.
The clinical care environment differentiates CDS tools from consumer-facing home health applications and other health-related software designed for use by those in the medical community. CDS tools have trained medical professionals in the loop considering the software’s output and formulating the final recommendations that are conveyed to the patient. The backdrop also makes the CDS tool the latest in a long-running border dispute between states’ authority to regulate the practice of medicine and the FDA’s authority to regulate medical products such as drugs and medical devices widely used in modern medical practice.
Federal authority to regulate medical practices — historically the focus of state regulation — was a fraught topic in legislative debates before passage of the Food, Drug, and Cosmetic Act of 1938, and more recently with the Affordable Care Act dispute. Arguments that the FDA should not regulate medical practices often invoke federal principles or the Tenth Amendment’s reservation of state power. However, the courts have not accepted these arguments.
Modern wisdom holds that the Constitution does not prohibit the federal government from touching medical practice issues—at least not federalism issues—despite efforts by Congress and federal agencies on policy matters to respect the primacy of states in regulating medical practice. According to this view, the FDA’s authority to regulate the practice of medicine is ultimately established by Congress and is not subject to a true constitution, and the FDA can expand this authority by petitioning Congress to amend the FDA’s authorizing regulations.
The FDA’s recent success in expanding its authority to regulate off-label use of medical devices by physicians is exemplifying this dynamic. The agency has long described its role as controlling which medical products are available on the market and ensuring labels accurately describe the uses for which the products have been shown to be safe and effective. However, “the label is not intended to prevent physicians from using [his/her/their] Use your best judgment in the interests of the patient or assume responsibility if: [he/she/they] Failure to follow package insert”—Doctors, not the FDA, set standards of care. Congress codified this principle in 1976 when it expanded FDA oversight of medical devices. With the medical community largely unnoticed, President Biden on December 29, 2022 signed legislation repealing this pillar of physician autonomy in medical device regulation.
The FDA sought the change after a federal court ruled in 2021 that the agency interfered with the practice of medicine by selectively banning specific off-label uses while leaving a device on the market. The court held that the FDA can ban a device outright but cannot micromanage how doctors use a device it has not banned. The use is already subject to extensive oversight at the state level, requiring multiple doctors to certify on a case-by-case basis that other treatments are ineffective and that off-label use is in the best interest of the patient. After losing the case, the FDA pressured Congress in June 2022 to change medical device regulations to allow the agency to do things the court ruled it couldn’t do. Congress refused, but the required amendments appeared again in a 1,653-page December appropriations bill and were quietly enacted. Legal professionals with relevant expertise believe this opens the door for the FDA to oversee medical practices. This change may affect CDS tools, which are regulated by the FDA as medical devices.
This article challenges the modern view that there are no real constitutional limits to the FDA’s authority to regulate the practice of medicine. The CDS guidance is an interesting counterexample where there are meaningful constitutional limits on the FDA’s power to regulate the practice of medicine, not from federal principles but from the First Amendment.
The FDA’s release of CDS guidance in September 2022 prompted a flurry of negative comments, with well-founded claims that the guidance materially departed from the provisions of the 21st Century Cures Act (the Cures Act) that it was intended to interpret. 3060 Regulations. An important point for FDA to consider when planning a path forward is that Congress does not have the authority to grant FDA jurisdiction beyond what is permitted by the U.S. Constitution. Limitations on FDA’s authority to regulate CDS software are not just statutory limits created by the Cures Act. Rather, it is a constitutional constraint imposed by the First Amendment. In the Cures Act, Congress appears to have given the FDA as much jurisdiction over CDS software as the First Amendment allows. If FDA is dissatisfied with the granting of jurisdiction, urging Congress to grant FDA more jurisdiction is unlikely to be effective, because in such a case Congress (like FDA) faces real constitutional constraints.
