The Mifepristone Litigation: Untangling the Implications of the Fifth Circuit's Decision for Abortion Access and the U.S. Food and Drug Administration.

In August 2023, a federal appeals court issued an opinion in Alliance for Hippocratic Medicine v FDA, a case wherein a group of antiabortion medical organizations and physicians have challenged U.S. Food and Drug Administration (FDA) approval and regulation of mifepristone. This opinion contained some good news for the FDA, drug makers, and patients: the appeals court declined to halt the marketing of mifepristone altogether (as the trial court judge would have). But the court also decided that the FDA's 2016 and 2021 actions expanding the indication for mifepristone, lowering the drug's dose, and loosening restrictions on its distribution and use were likely unlawful, and it thus affirmed the trial court's order staying these actions. In this article, we explain key aspects of the opinion to health care professionals and consider the ways in which the appeals court's reasoning and conclusions, if followed by the Supreme Court, could undermine abortion access and public health going forward.

Pressing regulatory challenges for psychedelic medicine.

Policy must support generation of evidence on safety and effectiveness.

The origins of American health libertarianism.

This Article examines Americans' enduring demand for freedom of therapeutic choice as a popular constitutional movement originating in the United States' early years. In exploring extrajudicial advocacy for therapeutic choice between the American Revolution and the Civil War, this piece illustrates how multiple concepts of freedom in addition to bodily freedom bolstered the concept of a constitutional right to medical liberty. There is a deep current of belief in the United States that people have a right to choose their preferred treatments without government interference. Modern American history has given rise to movements for access to abortion, life-ending drugs, unapproved cancer treatments, and medical marijuana. Recently, cries of "Death Panels" have routinely been directed against health care reform proposals that citizens believe would limit the products and procedures covered by government health insurance. Some of the most prominent contemporary struggles for health freedom have been waged in court. But other important recent battles for freedom of therapeutic choice have taken place in other forums, from legislative hearings to Food and Drug Administration advisory committee meetings to public demonstrations. This attitude of therapeutic libertarianism is not new. Drawing mainly on primary historical sources, this Article examines arguments in favor of freedom of therapeutic choice voiced in antebellum America in the context of battles against state licensing regimes. After considering some anti-licensing arguments made before independence, it discusses the views and statements of Benjamin Rush, an influential founding father who was also the most prominent American physician of the early national period. The Article then analyzes the Jacksonian-era battle against medical licensing laws waged by the practitioners and supporters of a school of botanical medicine known as Thomsonianism. This triumphant struggle was waged in explicitly constitutional terms, even though it occurred entirely outside of the courts. The Thomsonian campaign thus offers one of the most striking examples of a successful popular constitutional movement in American history. This article shows that, at its origin, the American commitment to freedom of therapeutic choice was based on notions of not only bodily freedom, but also economic freedom, freedom of conscience, and freedom of injury. Finally, this Article considers ways in which this early history helps illuminate the nature of current struggles for freedom of therapeutic choice.

Food, drugs, and droods: a historical consideration of definitions and categories in American food and drug law.

This Article explores the evolution and interaction of the legal and cultural categories "food" and "drug" from the late nineteenth century to the present. The federal statutory definitions of "food" and "drug" have always been ambiguous and plastic, providing the FDA with significant regulatory flexibility. Nevertheless, the agency is not necessarily free to interpret the definitions however it chooses. "Food" and "drug" are not only product classes defined by food and drug law, but also fundamental cultural concepts. This Article demonstrates that the FDA, as well as Congress and the courts, have operated within a constraining cultural matrix that has limited their freedom to impose their preferred understandings of these categories on American society. Nonetheless, history also provides ample evidence that lawmakers possess substantial power to mold the legal categories of "food" and "drug" so as to advance desired policies. One explanation for this regulatory flexibility in the face of deep-seated cultural conceptions is the indeterminate nature of the extralegal notions of "food" and "drug." The terms, as commonly understood, embrace nebulous, overlapping, and constantly evolving realms. Moreover, the relationship between culture and law is not a one-way street with respect to these categories. Although the regulatory apparatus has always had to take into account the extralegal understandings of "food" and "drug," the law in turn has exerted significant influence over their meaning in broader culture.