Tuesday, March 1, 2016

Grossman on AIDS Activists, the FDA, and the "Drug Constitution"

Lewis A. Grossman, American University, Washington College of Law, has posted AIDS Activists, FDA Regulation, and the Amendment of America's Drug Constitution:
This Article explores how AIDS activists, desperate for access to potentially life-saving pharmaceuticals, permanently transformed America’s “drug constitution.” Their advocacy altered the FDA’s interpretation and application of the federal Food, Drug, and Cosmetic Act (FDCA) so as to expedite the availability of new, unproven drugs for critical illnesses, thus enhancing individual patients’ autonomy to make therapeutic choices without government interference.

The FDCA is more than simple set of instructions to a federal agency — it is a source of vitally important and deeply entrenched institutional and normative frameworks. Like major civil rights, antitrust, and environmental statutes, the FDCA should be viewed as a quasi-constitutional “superstatute.” Therefore, the AIDS activists’ FDA reform campaign of the late 1980s and early 1990s should be understood as a “constitutional” movement, even though it rarely invoked the United States Constitution and pursued its goals entirely outside of court. As a result of the AIDS movement’s efforts, federal drug regulation today reflects not only the FDCA’s original foundational principle of protecting consumers from hazardous protects, but also the (often contrary) fundamental goal of promoting the expeditious release of potentially effective treatments for severe illnesses. The AIDS activists’ successful advocacy regarding drug access permanently shifted decision-making power previously exercised by the FDA to individual patients and their physicians.
In addition to linking the AIDS movement to other major civil rights campaigns focused on the implementation of statutes, this Article details a particularly remarkable advocacy effort that has gone mostly overlooked in the legal literature. The Article examines how a movement composed largely of members of a scorned and marginalized population — HIV-positive gay men — significantly altered a crucial body of law administered by one of the country’s most powerful federal agencies. As the Article describes, the AIDS movement achieved this success in a seemingly incongruous alliance with conservative libertarians. Rather than simply telling a triumphal story, however, this Article explores how the AIDS movement was ultimately torn apart by deep schisms that prevented it from ever coalescing around a fully coherent medical libertarian philosophy. The most profound of these divisions, rooted in the very nature of controlled clinical research, concerned the moral acceptability of limiting terminally ill people’s freedom to try experimental drugs to ensure the production of reliable data regarding the treatments’ effectiveness. Ambivalence about the proper resolution of this quandary — among activists and society as a whole — has inhibited a radical dissolution of the FDA’s gatekeeping power. Nevertheless, as this Article concludes, federal regulation of medical products is now very different than it would have been without the AIDS activists’ determined efforts.

No comments: