Key Takeaways
- • Rep. Steve Cohen (D-Tenn.) has proposed the Public Health and Research Reforms in Controlled Substances Act of 2026, which would substantially overhaul federal drug scheduling and shift key scheduling decisions from the DEA to HHS.
- • The bill would replace the current single-track schedule with two classifications: a Roman numeral I through IV for misuse risk and a letter A through E for therapeutic value.
- • Marijuana and THCs would be removed from the controlled substance schedules, with the change applied retroactively to past offenses, pending cases, convictions, and juvenile adjudications.
- • The bill would eliminate quantity-based five- and 10-year mandatory minimum trafficking provisions and expand the researcher registration pathway under HHS.
- • The commentary author argues the bill preserves significant prohibition infrastructure, including simple-possession penalties, HHS production quotas, and FDA authority over cannabis products, and calls for amendments.
Summary
Under current law, the Drug Enforcement Administration makes the ultimate legal determination of whether a drug has a "currently accepted medical use," even though the Department of Health and Human Services evaluates the underlying scientific and medical evidence, as the Justice Department explained in a 2024 legal opinion. Cohen's bill would move the assessment of medical usefulness and drug-related risks, and the scheduling decisions themselves, to HHS. Substances would receive a Roman numeral reflecting misuse risk and a letter reflecting therapeutic value, allowing a drug to be classified as high risk while still recognized for medical benefits. The commentary cites fentanyl as an example.
The bill would replace the "potential for abuse" standard with one based on the potential to develop a substance use disorder, excluding isolated or occasional nontherapeutic use. It would also require officials to consider whether scheduling a substance could itself harm public health, including by prompting substitution with other drugs. The commentary notes this provision could be significant in disputes over kratom and its alkaloids, such as 7-hydroxymitragynine. An expert committee would publish its evidence and reasoning for each scheduling decision. HHS would also take over researcher registration, with an expedited pathway for qualifying researchers and faster decisions for small preclinical pilot studies.
Cohen's bill sets a two-year deadline for reconsidering 32 named substances and an eight-year deadline for most others, with statutory fallback classifications if deadlines are missed. It would repeal the legal obligation of the ONDCP director to oppose specified legalization efforts. Marijuana and THCs would be removed from the schedules, retroactively. Sentencing reforms would eliminate quantity-based trafficking mandatory minimums and certain death or serious-injury penalties, narrow repeat-offender enhancements to prior "serious drug felony" convictions, and direct the Bureau of Prisons to identify and move to reduce sentences for eligible prisoners.
The commentary identifies significant shortcomings. The bill would retain criminal penalties for simple possession, including mandatory minimums for repeat offenses. The expert committee would be appointed by the HHS secretary in consultation with the drug czar, without expressly reserving seats for pain patients, consumers, or civil liberties advocates. Emergency and temporary scheduling would bypass committee review and be exempt from judicial review. The bill would transfer production quotas to HHS rather than abolish them, and the author argues quotas have contributed to injectable opioid shortages in hospitals. Maximum fines would rise, with the ceiling for individuals convicted of Schedule I or II trafficking without a qualifying prior rising from $1 million to $10 million. Finally, the bill preserves FDA authority over cannabis products and offers no explicit protection for a recreational market.
The author notes Cohen is retiring at the end of his term and is unlikely to see the bill pass in the post-election lame duck session, but argues it could serve as a benchmark for the next Congress.
Go deeper than the headline
Research every firm in this story, track the ones that matter and get the daily briefing — free for 7 days.