Congress created a comprehensive framework for regulating psychoactive drugs when it enacted the CSA in 1970. The statute sets out five schedules of legal controls for the hundreds of drugs that it covers, along with instructions for the Executive Branch about how to decide which drugs belong in which schedules (5). Critics have long accused the government of “overscheduling” marijuana, psilocybin, MDMA (3,4-methylenedioxymethamphetamine), and other popular substances, often pointing out that alcohol and tobacco are not scheduled at all (6). The more fundamental problem, however, is that both the list of schedules and the criteria for making scheduling decisions are incomplete.

The CSA tasks the attorney general with choosing among three basic models for regulating any given potentially addictive drug (see the table). The attorney general, in turn, has “subdelegated” these choices to the DEA ever since 1973. The DEA can prohibit medical and commercial access altogether, as well as most research, by placing the drug in Schedule I. Alternatively, the DEA can permit access only for medical uses by placing the drug in Schedule II, III, IV, or V. Finally, the DEA can decline to schedule the drug, leaving it free to be purchased, sold, manufactured, and consumed without the special strictures or penalties of federal controlled substances law. Although attorneys general retain some discretion when implementing particular schedules for particular drugs, they lack any discretion to modify the CSA’s scheduling framework.

Within this framework, there is no schedule that permits the lawful, nonmedical sale of a drug subject to reasonable restrictions, such as limits on marketing to children. An unscheduled substance may still be subject to other federal laws, such as the Food, Drug, and Cosmetic Act, which is administered by the FDA. But as the controversy around kratom reveals, those laws generally only have bite if and to the extent that the substance is promoted as a food additive or dietary supplement. For more dangerous drugs, there is also no schedule that permits lawful access to overdose prevention programs that have proven effective at reducing morbidity and mortality around the world, such as safe injection sites (7). The DEA is left with the option of imposing some sort of criminal ban (either across the board or for any nonmedical use) or leaving a drug completely unregulated by the CSA.

The result, as we explain in a recent article (8), is that US drug policy relies far too much on criminal prohibitions and far too little on what might be called capitalism controls. Criminal prohibitions have been shown time and again to be ineffective for widely used, habit-forming products. Worse than ineffective, they can lead illegal sellers to develop more-potent variants of, or substitutes for, whichever drug is the latest law enforcement priority. And yet, these prohibitions are a central pillar of the CSA and its state-level counterparts, with enormous costs in terms of arrests, imprisonments, and the undermining of racial justice and civil liberties.

Capitalism controls, on the other hand, have a well-studied track record both inside the United States and abroad. According to the World Health Organization (WHO), the three most cost-effective means of regulating the harmful use of a drug such as alcohol are restrictions on “commercial and public availability,” restrictions on “advertising and promotions,” and “pricing policies such as excise tax increases” [(9), p. 67]. Tobacco researchers have identified two other important categories of controls: checks on political lobbying by industry and restrictions on additives and other product designs that promote initiation or addiction (10). None of these capitalism controls are present in the CSA.

In addition, the CSA tells the Executive Branch to consider only medical benefits when deciding whether to expand access to a drug. What about the nonmedical benefits that the drug might have, be they religious, creative, social, or recreational? And what about the fact that expanding options for lawful use means spending less money on law enforcement and putting fewer individuals behind bars? Those benefits, and those people, do not count under the CSA today.

No matter how wisely the DEA might implement the statute, then, the agency cannot reach a sensible outcome for a popular drug such as marijuana. The same goes for more lethal substances, such as injectable opioids. The absence of appropriate schedules helps explain why both drug incarceration rates and drug overdose death rates have experienced exponential growth since the 1970s (11).

These fundamental flaws in the CSA can be fixed in two basic ways. First, decisions about how to schedule drugs should reflect a wider range of interests and perspectives, with explicit attention given to the experiences of people who use or prescribe the drug in question. Just as it does in other areas of rulemaking, the government ought to take into account all relevant impacts of its drug policies—medical and otherwise. This is already a familiar practice for issues such as pollution control; the Environmental Protection Agency has incorporated “recreation activities,” “aesthetics,” and other “hedonic” considerations into its economic benefits analyses for years (8). An expanded decision-making process along these lines is best left to a public health agency rather than a law enforcement outfit, such as the DEA.

Second, to thread the needle between overcriminalization and overcommercialization, the scheduling system must provide a means to legalize or decriminalize drugs while protecting consumers. The law should enable the Executive Branch to place highly dangerous drugs in a new “harm reduction” schedule, unlocking evidence-based measures to prevent overdoses and severe health harms. Heroin and fentanyl, for example, might belong in this schedule. The law should also contain an option to place drugs deemed relatively benign in a new “managed market access” schedule, focused on preventing underage use and corporate exploitation. Marijuana and psilocybin would be candidates for such placement.

Under this latter schedule, marijuana sellers could be subject to a range of capitalism controls, including limits on potency, additives, marketing tactics, coordinated lobbying, and more. Research on state marijuana regimes has found that the most effective measures at reducing problematic use are “business-oriented policies,” under which firms suffer penalties for failure to comply with restrictions on product design, advertising, retail availability, and the like (12). In the best tradition of federalism, Congress can learn from state legalization strategies that have curbed public health risks while surviving constitutional challenges brought by industry actors. To minimize conflict with state regulatory regimes that meet or exceed federal standards, Congress could further instruct that any firms operating within these regimes qualify for the managed market access schedule—and thus for all of the benefits of federal legal status—either indefinitely or for a transitional period.

Ever since Congress created it, the CSA’s scheduling system has prioritized, and sought to balance, law enforcement, medical, and pharmaceutical interests (while keeping the alcohol and tobacco lobbies at bay). The punitive politics of the war on drugs, together with deferential modes of judicial review, effectively entrenched this system, even as evidence of its biases and blind spots mounted (6). These interests and their ideas would remain important under our proposed framework, as would drug pharmacology. But they would no longer crowd out other forms of expertise. Conversely, social science and public health research into the expected effects of drug controls would move from the sidelines toward the center of analysis. The result would be a broader form of evidence-based policy-making that takes into account the full range of costs and benefits associated with any given scheduling decision.

Although our focus is on the United States, incomplete drug schedules are a problem worldwide. The 1961 Single Convention on Narcotic Drugs and the 1971 Convention on Psychotropic Substances establish their own scheduling frameworks, which, like the CSA, make no provision for harm reduction or managed market access. For example, the WHO is currently reconsidering the international legal status of the coca leaf, in part because the existing rules defy the evidence on its safety and in part because they impinge on religious use (13). Yet even if the WHO recommends relaxing these rules, the UN Commission on Narcotic Drugs will not have the option of reassigning coca leaf to a schedule that imposes noncriminal controls on nonmedical use.

Against this backdrop, the reforms that we propose to the CSA would be valuable internationally as well as domestically. A managed market access schedule would depart from Portugal’s pioneering experiment with drug decriminalization, allowing for instructive comparisons. Insofar as this new schedule supports “prevention of abuse of drugs,” a key phrase in the Single Convention, it would arguably allow the United States and other countries to legalize a substance such as marijuana without running afoul of the UN drug conventions (14). More generally, revisions to the US scheduling framework could inform and inspire critical assessments of its UN counterpart—a particularly pressing need given a historic vote by the Commission on Narcotic Drugs in March 2025 to conduct an independent review of the international regimes governing narcotic drugs and psychotropic substances.

The gaps in the CSA’s scheduling framework have not only done immense damage—they also limit possibilities for pursuing evidence- based reform any other way. The CSA framework creates an information problem by restricting the very research into drugs’ benefits that might support their reclassification (15). The CSA framework simultaneously creates a coordination problem, as state efforts to work around it through ad hoc legalizations are complicated by the challenges of developing and regulating an industry that violates federal law. Repealing or narrowing the CSA, meanwhile, would give rise to even more difficult problems of international law compliance and interjurisdictional coordination. By contrast, the addition of a harm reduction schedule and a managed market access schedule would mitigate both problems, as explained above, while creating new private sector incentives for research into the benefits necessary to support shifting a drug (or particular formulations of a drug) into a more permissive regulatory model.

Although the prospect of Congress revising the scheduling system in such a pragmatic fashion might seem to be a pipe dream, there are reasons to believe that these reforms may be politically viable. By targeting excessive criminalization and excessive commercialization in one swoop, the reforms have the potential to mobilize a broad swath of civil society. And pursuing so-called upstream changes to the CSA’s structural design, instead of picking fights over specific drugs, has been a winning legislative strategy in the past, as with the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 and the Protecting Patient Access to Emergency Medications Act of 2017.

Although the changes that we propose would improve the process through which drug regulatory decisions are made, decisions about which drugs will be placed in which schedules can be left entirely to agency officials. This allows Congress and the president to show initiative and make genuine progress on drug harms, without themselves resolving hot-button questions that divide their constituencies, such as whether to legalize marijuana at the federal level. By the same token, upstream reform dilutes pharmaceutical companies’ incentives to defend the existing rules because the addition of more-flexible schedules to the CSA may create new opportunities for revenue generation even though it threatens others. Our proposal also retains the CSA’s approach to “preemption,” which leaves states free to impose additional controls within their borders. This all but ensures that some states will maintain stricter controls on drugs that are moved into the federal harm reduction schedule or managed market access schedule, giving members of Congress an additional layer of insulation against any political blowback that these moves might elicit in some quarters.

Still, pragmatic drug reform is always an uphill battle, given the ideological, institutional, and material forces invested in the status quo. It is hard to imagine congressional action absent engagement by researchers, clinicians, and patients. Drug scheduling under the CSA profoundly affects public health, medical practice, and quality of life for millions of people. Individuals with professional expertise and personal experience regarding particular drugs have sought to inform past rescheduling decisions, as they are seeking to do with the current marijuana rulemaking. But no matter how compelling this advocacy might be, it cannot redeem a broken system. Concerns about the gap between evidence and policy in the regulation of marijuana and other drugs should be directed not only toward the DEA but also, and more fundamentally, toward Congress and the UN.

From the opioid crisis to the prison population boom to the ongoing marijuana mess, the prevailing framework for scheduling psychoactive drugs is a root cause of repeated failure. To address this failure, the scientific community needs to stop fighting so much over the classification of specific substances and start focusing on the classificatory and regulatory framework itself. Enlighted and effective drug policies will never be realized unless the schedules are straightened out.

M.L. served as senior adviser to the US Drug Enforcement Administration, in the office of the deputy administrator, from 2022 to 2023. The views and analysis presented in this Policy Forum are the authors’ own and do not represent the perspective of their employers. For helpful comments, the authors thank three anonymous reviewers.