Sponsors (3)
The bill expands patient access and reduces provider paperwork for administration of eligible Schedule I investigational drugs, trading off increased access against heightened safety/diversion risks, uneven state-level availability, and added administrative costs.
Patients with serious or chronic conditions can obtain access to eligible Schedule I investigational drugs administered directly by physicians under an expanded Right-to-Try pathway, increasing treatment options when approved therapies are exhausted.
Physicians and healthcare facilities face less administrative friction and more predictable timelines because a single registration may cover treatment at multiple related sites and statutory decision deadlines (45-day initial decision; 30-day supplemental auto-approval) speed and standardize approvals.
Patients accessing Schedule I investigational drugs face substantial safety risks because these products lack full FDA approval and comprehensive safety and efficacy data.
Expanding a registration pathway for Schedule I drugs could increase the risk of diversion or misuse if diversion-control requirements and enforcement are inadequate.
Differences in state laws could limit or block access in some states, producing unequal access to investigational treatments across the country.
Based on analysis of 2 sections of legislative text.
Creates a DEA special registration pathway allowing qualified physicians to obtain authorization to possess and administer Schedule I investigational drugs to Right-to-Try patients, with documentation, timelines, and regulatory safeguards.
Introduced December 4, 2025 by Cory Anthony Booker · Last progress December 4, 2025
Creates a new federal registration pathway that lets qualifying physicians obtain permission from the Attorney General to possess and directly administer Schedule I investigational drugs to eligible patients under existing Right-to-Try law. The attorney general must approve or issue an order to show cause on applications within 45 days, accept electronic applications, limit possession to approved quantities, allow certain supplemental site notifications, and adopt implementing regulations on a set timetable.