Market approval and the right to health: a human rights perspective on MDMA-assisted therapy

The FDA's 2024 rejection of MDMA-assisted therapy sparked debate about ethics in drug regulation. This paper examines that debate through a human rights lens, particularly the right to health. It argues that drug approval decisions must consider the interdependent relationships among patients, regulators, pharmaceutical sponsors, and the public. While acknowledging the ethical concerns raised, the analysis suggests that typical arguments for rejection insufficiently considered the costs to patients who would have benefited. The paper also argues that a human rights-based approach supports expanding unlicensed use programs under certain conditions and that evidentiary standards for approval may need reconsideration if double-blind trials are practically infeasible in psychedelic research.

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Abstract

The application for MDMA-assisted therapy (MDMA-AT) and its rejection by the FDA in 2024 prompted a debate about ethical aspects in drug regulation. This paper examines central issues raised in that debate through the lens of human rights, especially the right to health. It argues that drug approval decisions must take into account the multipolar constellation of and dependencies between patients, regulators, pharmaceutical sponsors and members of the public whose health interests may be affected. With an eye on future applications of psychedelics expected soon, the paper analyses key ethical arguments brought forward for rejecting the MDMA-AT application. While acknowledging the importance of the ethical concerns raised, the analysis suggests that typical arguments for rejection insufficiently considered the costs imposed on patients who would have benefitted from the therapy. These ethical arguments, taken by themselves, are insufficient to justify the rejection. The paper further situates market authorisation within broader considerations of access to medicines and argues that, under certain empirical conditions, a human rights-based approach supports expansions of unlicensed use programmes. Finally, it examines the ethical implications of evidentiary standards for market approval in light of the problem of functional unblinding in psychedelic trials, suggesting that double-blind randomised controlled trial requirements warrant reconsideration should they prove practically infeasible.