HR-9186-119
Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Sponsored by Steve Cohen (D-TN)
What it does
This bill would amend the Controlled Substances Act (CSA) in two ways. First, it would add nine new statutory definitions — including "accepted medical use," "dependence liability," "abuse," "misuse," and "potential benefits to society" — to replace or clarify terms that currently lack precise legal meaning in the CSA. Second, it would require the Attorney General to defer to the Secretary of Health and Human Services' scientific and medical findings when scheduling drugs, and to place drugs only in the schedule whose controls are "reasonably tailored" to protect public health while preserving access for accepted medical uses.
Who benefits
Patients seeking access to substances with recognized medical uses that are currently in restrictive schedules (e.g., Schedule I). Researchers studying controlled substances, who would benefit from a broader statutory definition of "accepted medical use" that includes scientific research. Physicians and other healthcare practitioners in states that have authorized medical use of substances not yet federally approved. Pharmaceutical and biotech companies developing therapies involving controlled substances. States that have enacted medical or therapeutic use laws that conflict with federal scheduling. Drug policy reform advocates seeking a more science-driven scheduling process.
Who is hurt
Federal law enforcement agencies and the DEA, whose discretion in scheduling decisions would be formally subordinated to HHS scientific findings. Anti-drug-abuse organizations that favor stricter scheduling as a deterrent. Communities and public health advocates concerned that broader definitions of "accepted medical use" — including state-authorized uses — could make it harder to maintain tight controls on substances with high abuse potential. Insurers and payers who may face pressure to cover newly accessible substances. Existing pharmaceutical manufacturers whose products compete with substances that may gain easier access under revised scheduling criteria.
Supporters argue
Supporters argue that the CSA's current undefined terms — particularly "accepted medical use" and "potential for abuse" — have allowed scheduling decisions to lag far behind medical science, leaving patients without access to therapies with demonstrated benefit. They contend that codifying a science-first standard, where the Attorney General must defer to HHS's medical evaluation and tailor controls to actual risk, would correct a structural flaw that has kept substances like psilocybin and MDMA in Schedule I despite growing clinical evidence of therapeutic value. They further argue that recognizing state-authorized medical uses aligns federal law with the federalism principles that allow states to serve as laboratories of medical innovation.
Opponents argue
Opponents argue that expanding "accepted medical use" to include state-authorized substances — even without FDA approval — could effectively allow state legislatures to override federal drug controls, undermining the uniform national framework the CSA was designed to create. They contend that the bill's definition of "abuse" (limited to use that "will lead to a substance use disorder") and its narrow definition of "lack of accepted safety" set a high bar that could make it difficult to maintain Schedule I status for substances with significant public health risks. They further argue that mandating deference to HHS scientific findings removes a meaningful check on the scheduling process without guaranteeing that HHS evaluations will be timely, complete, or insulated from political pressure.
Constitutional context
Congress enacted the CSA under the Commerce Clause (Art. I, §8, cl. 3), authority affirmed in Gonzales v. Raich (2005). The bill's provision recognizing state-authorized medical uses raises Supremacy Clause (Art. VI, cl. 2) questions about whether federal law can formally incorporate state law as a trigger for federal scheduling criteria. Post-Loper Bright (2024), courts will independently review whether the bill's mandate that the Attorney General "defer" to HHS scientific findings is consistent with the CSA's statutory structure, rather than deferring to agency interpretation of that structure.
Checks and balances
The executive branch's DEA (within DOJ) loses independent scheduling discretion, as the bill would formally subordinate the Attorney General to HHS scientific findings; the primary check on this consolidated HHS authority would be judicial review of scheduling decisions under the APA and the post-Loper Bright independent statutory interpretation standard.
Historical precedent
The Controlled Substances Therapeutic Research Act of 1978 previously attempted to create a framework for medical access to Schedule I substances, and ongoing DEA rescheduling proceedings for marijuana (2024) have similarly tested the boundaries of "accepted medical use" under existing CSA criteria.