SB3346, titled the Freedom to Heal Act of 2025, would create a new special registration process under the Controlled Substances Act for physicians who want to directly administer certain Schedule I investigational drugs to eligible patients under the federal Right to Try framework. The bill is aimed at patients seeking access to experimental treatments that have been designated as eligible investigational drugs and that are supplied by a manufacturer or sponsor for use in treatment.
Under the bill, the Attorney General would be required to register physicians who meet specified criteria, including holding an existing controlled-substances registration for schedules II through V, showing compliance with the federal Right to Try law, documenting the drug’s eligibility, identifying the treatment site, and demonstrating relevant training or experience. The application process would have to be handled within 45 days, and the Attorney General would also have to provide an electronic submission option. Physicians could possess only the amount of drug identified in the application or later supplemental notifications, and the bill allows a single registration for related treatment sites within the same city or county and under the same institutional control.
The bill would amend Section 303 of the Controlled Substances Act, adding a new subsection specifically governing Schedule I eligible investigational drugs used under Right to Try. It would also require the Department of Justice to issue an interim final rule within 240 days and a final rule within two years, addressing delivery, storage, security, recordkeeping, registration renewal or revocation, and other anti-diversion controls. In practical terms, the measure would create a federal pathway for tightly regulated physician access to certain experimental Schedule I substances for treatment purposes, while preserving federal oversight through registration and diversion-prevention requirements.
The available context shows no committee transcript, vote record, or recorded amendments, so there is little direct evidence of legislative debate. Based on the bill’s sponsors and structure, the general sentiment appears supportive of expanding patient access to experimental therapies while maintaining controlled-substance safeguards. The bill’s design suggests an attempt to balance compassionate use and medical innovation with law-enforcement concerns.
The main points of potential contention are likely to be the use of Schedule I substances, the scope of physician access, and the extent of federal discretion in approving or denying registrations. Supporters would likely emphasize patient access, physician flexibility, and a clearer legal pathway for Right to Try treatments, while critics may focus on diversion risks, the adequacy of evidence for investigational drugs, and whether the bill could weaken existing controlled-substances protections.
SB3346 would amend the Controlled Substances Act by adding a new special registration category for physicians administering Schedule I eligible investigational drugs under the federal Right to Try law. It would impose new federal application, approval, storage, quantity, and reporting requirements, and it would require DOJ rulemaking to implement the program. The bill would also interact with the Federal Food, Drug, and Cosmetic Act’s Right to Try provisions by tying eligibility to the definitions in that law and by requiring state-law authorization for treatment where applicable.
There is no recorded committee discussion or vote history in the provided materials, so no formal legislative sentiment can be measured from debate or roll call. The bill’s sponsorship by Senators Booker and Paul suggests bipartisan interest in expanding access to experimental treatments, and the text reflects a generally pro-access, pro-patient approach paired with regulatory controls. Overall, the bill appears to be framed positively as a medical access measure rather than a punitive or restrictive one.
The likely areas of contention are the federal handling of Schedule I drugs, the risk of diversion, and the degree of oversight given to the Attorney General in approving registrations and setting implementation rules. Supporters are likely to argue that the bill creates a necessary legal pathway for patients with serious conditions to receive investigational therapies, while opponents may question whether the safeguards are sufficient and whether the bill could normalize use of highly restricted substances outside traditional approval pathways. Because no transcript or vote data are provided, specific named objections or supporters are not available.