Some investigational drugs, such as ketamine, psychedelics, and cannabis, exist simultaneously in regulated clinical trials and unregulated street or online markets, where they are accessible without clinician oversight. The authors propose the term "parallel-access compounds" for this category and argue that research ethics should formally recognize these substances. Non-psychoactive examples also exist, like retatrutide, an investigational weight-loss drug that has been illicitly manufactured and sold despite being intended only for trial participants.
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.