Sponsors (18)
The bill creates a federal pathway and faster timelines to let physicians obtain and administer Schedule I investigational drugs—expanding patient access—while increasing risks of diversion/misuse and imposing new administrative and enforcement burdens.
Patients with serious or chronic conditions and their physicians: a new federal registration pathway allows physicians to legally obtain and administer Schedule I investigational drugs, increasing access to experimental therapies.
Patients and healthcare-workers: the bill sets predictable review timelines (45 days for registration decisions; 30 days for supplemental approvals) that can speed access to investigational therapies.
Institutional physicians and hospitals: one registration can cover multiple related sites within the same city or county, reducing duplicative paperwork and administrative burden.
Patients with chronic conditions and healthcare-workers: expanding routine federal authorization for possession and use of Schedule I drugs increases the risk of diversion, misuse, or accidental exposure if oversight is insufficient.
Healthcare-workers and patients: deeming supplemental notifications approved after 30 days unless challenged may permit increases in possession or use before full federal review, weakening safety and accountability safeguards.
Physicians and small manufacturers: new application, documentation, training, and state-law proof requirements impose administrative and compliance costs that could limit participation.
Based on analysis of 2 sections of legislative text.
Creates a DEA special registration allowing physicians to obtain and administer Schedule I investigational drugs to eligible right-to-try patients, with application, oversight, and deadlines.
Creates a new DEA registration path that lets qualified physicians obtain and directly administer Schedule I investigational drugs to eligible patients under the federal "right to try" authority. It sets application requirements, timelines for Attorney General/DEA decisions, possession limits tied to approved applications, and deadlines for interim and final rules to implement the pathway. The law requires physicians to show existing DEA registration (for Schedules II–V), manufacturer documentation and agreement to supply the drug, training and site details, and diversion-prevention plans. The Attorney General must issue a registration or an order to show cause within 45 days, publish an interim final rule within 240 days of enactment, and a final rule within two years after the interim rule is issued.
Introduced December 4, 2025 by Madeleine Dean · Last progress December 4, 2025