Sponsors (18)
Official title: To establish a special registration under the Controlled Substances Act for schedule I eligible investigational drugs under the Federal Right to Try law.
Introduced December 4, 2025 by Madeleine Dean · Last progress December 4, 2025
The bill creates a lawful, faster pathway for physicians to obtain and administer Schedule I investigational drugs—potentially improving patient access—at the cost of increased diversion/safety risks and new administrative and regulatory burdens that could limit participation and impose government costs.
Patients with serious or chronic conditions (and the physicians who treat them) can legally receive and administer Schedule I investigational drugs under a new federal registration pathway, creating a lawful route for access to investigational therapies.
Patients and providers gain faster, more predictable access because the bill sets firm review timelines (45 days for initial registration decisions; 30 days for supplemental approvals), which can accelerate delivery of investigational treatments.
Institutional physicians and hospitals can reduce administrative burden because a single registration may cover multiple related sites within the same city/county, simplifying compliance for health systems.
Patients and the broader healthcare system face increased diversion or misuse risk because the bill expands routine federal authorization for possession and use of Schedule I drugs, which could outpace effective oversight.
Physicians and small manufacturers may be deterred from participating because the law creates new administrative and compliance burdens (applications, documentation, training, and proof of state-law compliance), potentially limiting patient access in practice.
Taxpayers and government agencies could face added costs and workload because Justice Department and other regulators must meet compressed rulemaking deadlines and process registrations and supplements quickly.
Based on analysis of 2 sections of legislative text.
Creates a DEA special registration for physicians to obtain and administer Schedule I investigational drugs to eligible patients under federal right-to-try authority, with application requirements and regulatory deadlines.
Creates a new DEA special registration pathway that lets qualified physicians directly obtain and administer Schedule I investigational drugs to eligible patients under the federal “right to try” law. It sets application requirements, limits on possession quantities, timelines for agency action, and deadlines for interim and final regulations by the Attorney General. The measure requires physicians to prove existing DEA registration for Schedules II–V, obtain manufacturer documentation and agreement to supply and support administration, provide diversion-control and training information, and follow state law; the Attorney General must issue an interim final rule within 240 days and a final rule within two years after the interim rule is issued.