Sponsors (18)
The bill expands and streamlines physician access to investigational Schedule I drugs for seriously ill patients but does so at the cost of increased safety risks, added compliance burdens, and potential federal–state legal uncertainty.
Patients with serious or chronic conditions (and their treating physicians) can receive investigational Schedule I drugs directly under the Right to Try pathway, increasing access to experimental treatments when other options are exhausted.
Physicians and healthcare facilities face a 45-day statutory decision deadline and may use electronic applications, reducing administrative delay and speeding provider requests for access to investigational treatments.
Patients and providers benefit from a streamlined supply process: supplemental notifications to increase supply are automatically approved after 30 days absent objection, helping ensure continuity of treatment.
Patients, providers, and communities face increased risk of diversion, misuse, or other safety harms from broader access to Schedule I substances if safeguards and controls fail.
Physicians, manufacturers, and sponsors confront added administrative and compliance burdens (detailed applications, supply agreements, storage and recordkeeping) that may deter participation and limit availability of treatments.
Patients and state health systems may face delays or conflicting outcomes where the federal approval pathway intersects with state laws or state treatment authority, creating legal complexity that can impede access in some jurisdictions.
Based on analysis of 2 sections of legislative text.
Establishes a federal special registration for physicians to directly administer certain Schedule I investigational drugs under Right to Try, with application requirements and decision timelines.
Creates a new federal registration pathway that lets qualified physicians directly give certain Schedule I investigational drugs to eligible patients under the existing Right to Try law. The Attorney General must approve physician applications that show existing controlled-substance registration, state legal authority to treat, manufacturer documentation of the investigational drug and supply, training and storage plans, and other anti-diversion measures, with set timelines for decisions and rulemaking. The bill requires electronic filing, allows a single registration to cover multiple related sites in the same city/county with notice, permits supplemental supply notifications that are deemed approved after 30 days unless challenged, and orders the Attorney General to issue an interim final rule within 240 days and a final rule within two years of that interim rule.
Introduced December 4, 2025 by Madeleine Dean · Last progress December 4, 2025