HIV/AIDS Treatment Regulation

Author: Nicholas Stubblefield Edited by: Nora Lewis

Suggested Citation:

Stubblefield, N., Lewis, N. (2026). HIV/AIDS treatment regulation. Technology Assessment Project Case Study Library, University of Michigan. https://stpp.fordschool.umich.edu/tap-case-study-library/hivaids-treatm…

HIV/AIDS Treatment Regulation

Key Takeaways

• Grassroots organizing can drive decisionmakers to defer to community knowledge and concerns, shaping policies to realize public benefits more fully.
• This community experience is a form of expertise, and incorporating it into formal institutions can further legitimize these organizations in the eyes of the public.

The U.S. AIDS epidemic of the 1980s provides an important window into how government regulation changes in response to different political stimuli. By 1987, over 50,000 people—primarily gay men—had died of AIDS since the first cases were reported in 1981 (U.S. Centers for Disease Control and Prevention, 2001). From 1981 to 1989, two such stimuli emerged, and they differed wildly in motivation, scope, and representation. AIDS activists developed a savvy grassroots campaign advocating for better AIDS treatment. They targeted the U.S. Food and Drug Administration (FDA) and demanded an overhaul of regulation practice in service of patients. Simultaneously, the Reagan administration, motivated by partisan ideology, also sought to change the FDA's regulatory burden in service of private drug developers (Tolchin & Tolchin, 1983). Both groups left lasting marks on the FDA, chiseling their respective thumbprints on transformed regulatory practices. Though they each pursued some form of deregulation, the two camps advocated different frameworks consistent with their motivations.

AIDS Activists: ACTUP

Prior to the AIDS epidemic, existing regulatory practice at the FDA required rigorous testing and trials before drugs could be used in humans, a far more stringent method than in many places in the world. In the context of the AIDS epidemic, an FDA AIDS coordinator stated that it would be "unethical to release these new AIDS drugs before they've been properly evaluated" (Rodraza, 1993).

The AIDS Coalition to Unleash Power (ACTUP) was formed in the wake of the epidemic, made up of grassroots activists, many of whom belonged to the queer community and suffered from AIDS themselves or had lost friends and family to the disease. They protested the government's inaction in dealing with AIDS and contested both the framework and ethical evaluations of the FDA. They felt that to withhold treatment, even that in its experimental stages, from someone with AIDS who could possibly benefit, was itself unethical.

ACTUP's demands of the FDA included shortening the drug approval process and providing access to drugs after a safe completion of Phase 1 trials. They opposed double-blind placebo studies, arguing it was unethical to give a placebo to someone actively suffering from a life-ending disease, and called for changing the experimental criterion for testing a drug accordingly. They also demanded that clinical trials be more representative, with all demographics studied in clinical trials in accordance with the diverse demographics dealing with AIDS, and that insurance must cover these costs (Schulman, 2021; Schulman & Ciesemier, 2023). ACTUP further called on the government to "recognize every AIDS death as an act of Racist, Sexist, and Homophobic violence" (Crimp, 2011).

Reagan Administration

Executive Order 12291, signed in 1981, gave the President's Office of Management and Budget (OMB) direct oversight and decision-making authority over executive regulatory bodies, including the FDA (Executive Order 12291, 1981). This brought the FDA closer to the President's direct agenda, including deference to private drug companies. The OMB was now empowered to shape regulation according to its own motivations and values: perceived economic value and cost-benefit analysis. The OMB required an economic analysis for any proposed regulation, a political tool many saw as a move to stymie regulatory action and research capacity around AIDS (Grossman, 2016).

What is clear in this case?

ACTUP used empirical experience to build a case against the FDA's 1980 regulation scheme, and that direct-use experience constituted a form of expertise (Tolchin & Tolchin, 1983). The coalition highlights the importance of patient and user advocacy and alternative avenues for establishing and using novel expertise.

By 1987, the FDA had created new accelerated approval regulations for lifesaving drugs including AIDS treatments, giving sick patients access to promising experimental drugs outside clinical trials and demonstrating deference to communities (Food and Drug Administration, 2019). The ACTUP coalition was ultimately successful in transforming the U.S. government's response to the AIDS crisis through political activism and civil disobedience, but also by developing credible expertise that challenged scientific authority (Epstein, 1996).

Relevance to Advanced Nuclear Energy

The HIV/AIDS crisis acts as a relevant analogous technology to advanced nuclear in that it shows the role that grassroots organizing and community knowledge can play in shaping regulatory processes. Advanced nuclear reactors, particularly small modular reactors and microreactors, are often touted by proponents as conducive to community governance given their scale. This presents an opportunity for the lived experiences and expertise of communities to govern the operation of advanced nuclear reactors, just as HIV/AIDS activists directly pushed for policy reforms using their lived experiences. The case presents an example of how communities may organize to shape advanced nuclear energy governance, and how public benefits can be more wide-reaching when this expertise is incorporated.

Key References

Crimp, D. (2011, December 6). Before occupy: How AIDS activists seized control of the FDA in 1988. The Atlantic.

Epstein, S. (1996). Impure science: AIDS, activism, and the politics of knowledge (1st ed.). University of California Press.

Schulman, S. (2021). Let the record show: A political history of ACT UP New York, 1987–1993. Farrar, Straus and Giroux.

References

Crimp, D. (2011, December 6). Before occupy: How AIDS activists seized control of the FDA in 1988. The Atlantic.

Epstein, S. (1996). Impure science: AIDS, activism, and the politics of knowledge (1st ed.). University of California Press.

Exec. Order No. 12291, 3 C.F.R. 124 (1981). https://www.archives.gov/federal-register/codification/executive-order/12291.html.

Food and Drug Administration. (2019, March 14). The history of FDA's role in preventing the spread of HIV/AIDS.

Grossman, L. (2016, February 27). AIDS activists, FDA regulation, and the amendment of America's drug constitution. American Journal of Law and Medicine, 42(4).

Rodraza, R. (1993). The FDA's response to AIDS: Paradigm shift in new drug policy? Food and Drug Law Journal, 48(3), 351–375.

Schulman, S. (2021). Let the record show: A political history of ACT UP New York, 1987–1993. Farrar, Straus and Giroux.

Schulman, S. & Ciesemier, K. (Hosts). (2023, October 19). How ACT UP changed the face of AIDS and activism [Audio Podcast Episode]. In At Liberty. ACLU.

Tolchin, M. & Tolchin, S. J. (1983, August 21). The rush to deregulate. The New York Times.

U.S. Centers for Disease Control and Prevention. (2001). HIV and AIDS: United States, 1981–2000. Morbidity and Mortality Weekly Report, 50(21), 430–434.

Photo: 1970s AIDS activist lapel badge. Michael James Papers / Hall-Carpenter Archives.