Freedom to Heal Act of 2025
- Bill Number
- S. 3346
- Origin Chamber
- Senate
- Congress
- 119th Congress, Session 1
- Policy Area
- Health
- Status
- Introduced
- Latest Action
- 2025-12-04: Read twice and referred to the Committee on the Judiciary.
- Last Updated
- 2026-02-12T12:03:24Z
AI-Generated Summary
Purpose of the legislation This bill creates a new special registration process under the Controlled Substances Act to allow physicians to directly administer certain schedule I investigational drugs to eligible patients under the existing Federal Right to Try law. The short title is the Freedom to Heal Act of 2025.
Key provisions
- The Attorney General must register physicians who submit an application showing they already hold a registration to handle controlled substances in schedules II through V.
- Applications must include proof of compliance with the Right to Try law, confirmation from the drug manufacturer or sponsor that the drug qualifies and will be supplied, the planned quantity, evidence of state law compliance, details on the physician’s training and the storage site, and other information to prevent misuse.
- The Attorney General has 45 days to approve the registration or issue an order to show cause.
- Physicians may submit supplemental notifications for additional quantities, which are automatically approved after 30 days unless challenged.
- A single registration can cover multiple treatment sites if they are in the same city or county and under the same institution.
- The Attorney General must issue an interim final rule within 240 days covering delivery, storage, security, record-keeping, and renewal or revocation procedures, followed by a final rule within two years.
Significant changes to existing law The bill adds a new subsection (p) to Section 303 of the Controlled Substances Act. This establishes a dedicated, streamlined registration pathway specifically for schedule I investigational drugs used under Right to Try, separate from the standard registration process that applies to other controlled substances.
Potential impacts
- Government agencies, particularly the Department of Justice and Drug Enforcement Administration, would gain new responsibilities for processing applications, issuing rules, and monitoring compliance to prevent diversion.
- Eligible patients with terminal illnesses could gain expanded access to certain investigational treatments.
- Drug manufacturers and sponsors would face additional documentation requirements when supplying these drugs.
- The changes would apply only within the United States and would not directly affect international relations.
Main stakeholders affected
- Physicians seeking to administer the drugs.
- Terminally ill patients eligible under the Right to Try law.
- Drug manufacturers and sponsors.
- The Attorney General and federal regulatory agencies.
- State governments, whose laws must be followed for treatment to occur.
Notable legal, constitutional, or political implications The bill requires applicants to demonstrate compliance with both federal Right to Try rules and applicable state laws, which could create coordination challenges between federal and state authorities. It also mandates expedited rulemaking outside normal notice-and-comment procedures for the initial interim rule.
This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.
Sponsor
Cosponsors (2)
Sen. Paul, Rand [R-KY], Sen. Heinrich, Martin [D-NM]
Recent Actions
- 2025-12-04: Read twice and referred to the Committee on the Judiciary.
- 2025-12-04: Introduced in Senate
Bill Versions
- Freedom to Heal Act of 2025 — issued 2025-12-04 — PDF (7 pages)