Jeffrey A. Singer
Earlier this week, the office of Representative Steve Cohen (D‑TN), who serves on the House Judiciary Committee, announced that he introduced HR 9186, “The Controlled Substances Act (CSA) Clarification in Sciences Act.”
Under the CSA, the Drug Enforcement Administration (DEA) has established five schedules of controlled substances. The DEA defines Schedule I drugs as follows:
Schedule I drugs, substances, or chemicals are defined as drugs with no currently accepted medical use and a high potential for abuse. Some examples of Schedule I drugs are: heroin, lysergic acid diethylamide (LSD), marijuana (cannabis), 3,4‑methylenedioxymethamphetamine (ecstasy), methaqualone, and peyote.
Federal law prohibits the manufacture, sale, transportation, or personal possession of Schedule I drugs. Clinical researchers who want to study Schedule I drugs must go through a lengthy and discouraging approval process. Psychedelic drugs were placed on Schedule I in 1970, setting back promising research for half a century and driving most therapeutic research underground. Lawmakers and policymakers are only recently beginning to appreciate the therapeutic potential of psychedelics, which might have been helping patients decades ago.
The DEA considers drugs in Schedules II through V to have “accepted medical use(s).” The higher schedule numbers reflect decreasing “potential for abuse, with use potentially leading to severe psychological or physical dependence.”
The current scheduling regime relies on narrow definitions of “accepted medical use” and expansive concepts of abuse that can keep potentially beneficial substances under highly restrictive controls long after scientific understanding has evolved. Critics contend that the system has impeded research, restricted patient access, and allowed political considerations to influence scheduling decisions. H.R. 9186 attempts to correct these problems by updating key definitions, distinguishing dependence from abuse, recognizing a broader range of medical evidence, and giving greater weight to scientific and medical expertise in scheduling determinations.
Specifically, the bill recognizes that dependence is not synonymous with abuse, broadens the concept of accepted medical use beyond FDA approval alone, and gives greater weight to scientific and medical evaluations in scheduling decisions. It also raises the threshold for concluding that a substance lacks accepted safety, requiring regulators to consider both public health risks and legitimate medical uses when determining the appropriate level of control.
The bill also raises the threshold for concluding that a substance lacks accepted safety. Rather than focusing primarily on the presence of risks, it requires regulators to weigh those risks against potential medical benefits and determine whether “a reasonable practitioner would conclude that the risks of death or significant irreversible physical or psychological harm to the user would clearly outweigh any medical benefit to the user.”
H.R. 9186 does not eliminate the underlying problem that the Controlled Substances Act places physicians and researchers within a system in which law-enforcement agencies retain substantial authority over medical decisions. In that respect, it still leaves cops practicing medicine. But by modernizing key definitions and placing greater emphasis on scientific and medical evidence, the bill would move federal drug policy in a more evidence-based direction. If enacted, these reforms could reduce barriers to research and improve clinicians’ ability to care for patients—including those in pain—while leaving broader questions about the role of law enforcement in drug policy unresolved.
