Freedom to Heal Act of 2025
- Bill Number
- H.R. 6434
- Origin Chamber
- House
- Congress
- 119th Congress, Session 1
- Policy Area
- Health
- Status
- Introduced
- Latest Action
- 2025-12-04: Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
- Last Updated
- 2026-03-28T08:06:37Z
AI-Generated Summary
Purpose of the Legislation
The Freedom to Heal Act of 2025 aims to expand access to experimental drugs for seriously ill patients by creating a streamlined process for physicians to administer certain Schedule I controlled substances—drugs with high potential for abuse and no accepted medical use under current law—under the existing Federal Right to Try law. This law allows terminally ill patients to use investigational treatments outside of clinical trials without full FDA approval.
Key Provisions
- Definitions: Adopts the meanings of "eligible investigational drug" (an experimental drug in development for serious conditions) and "eligible patient" (a patient with a life-threatening disease who has exhausted approved treatments) from the Federal Food, Drug, and Cosmetic Act's Right to Try section.
- Special Registration Process: Physicians can apply to the Attorney General (who oversees the Drug Enforcement Administration, or DEA) for permission to directly administer these drugs to eligible patients. Applications must include:
- Proof of an existing license to handle less restricted controlled substances (Schedules II-V).
- Documentation from the drug's manufacturer confirming eligibility, an agreement to supply the drug with usage guidance, and a physician's pledge to follow that guidance.
- Details on drug quantities needed, state law compliance, physician qualifications, storage/administration sites, and measures to prevent illegal diversion (e.g., the drug being misused or sold illicitly).
- Approval Timeline: The Attorney General must approve or issue a "show cause" order (requiring the applicant to justify their request) within 45 days of receiving a complete application.
- Electronic Applications and Quantity Limits: Applications can be submitted online. Physicians are limited to possessing only the approved amounts of the drug, with options to request more via a supplemental notice (automatically approved after 30 days unless challenged).
- Multi-Site Flexibility: A single registration covers multiple treatment sites if they are in the same city or county and controlled by the same entity, provided sites are pre-notified.
- Rulemaking Requirements: The Attorney General must issue an interim final rule within 240 days of enactment to cover logistics like drug delivery, storage, record-keeping, and registration renewals/revocations. A full final rule follows within two years, using standard public comment procedures.
Significant Changes to Existing Law
- Amends the Controlled Substances Act (CSA) by adding a new subsection (p) to Section 303, which previously had no specific pathway for Schedule I drugs in Right to Try scenarios. This creates an exception to the CSA's general prohibition on physicians handling Schedule I substances outside research settings, while maintaining safeguards against abuse.
- Bypasses some standard administrative procedures for the initial rule (e.g., no required public notice and comment for the interim rule), allowing faster implementation.
Potential Impacts
- On Government Agencies: Increases workload for the Department of Justice and DEA in processing applications, monitoring compliance, and developing rules to prevent diversion. This could strain resources but also aligns federal drug policy with patient access goals.
- On Citizens: Enables terminally ill patients faster access to promising experimental treatments that might otherwise be blocked by federal drug scheduling, potentially improving end-of-life care options without affecting routine drug enforcement.
- On International Relations: Minimal direct impact, though it may influence how U.S. policies on controlled substances are viewed in global health and drug control treaties (e.g., UN conventions on narcotics).
Main Stakeholders Affected
- Physicians and Healthcare Providers: Gain a legal pathway to use experimental Schedule I drugs, but must meet new documentation and training requirements.
- Eligible Patients: Benefit from expanded treatment options under Right to Try, particularly those with conditions unresponsive to approved therapies.
- Drug Manufacturers and Sponsors: Required to provide drugs, guidance, and verifications, potentially accelerating compassionate use programs.
- Federal Agencies: The Attorney General/DEA handles registrations and rulemaking; indirect involvement from the FDA (via Right to Try definitions).
Notable Legal, Constitutional, or Political Implications
- Legal: Strengthens the Right to Try framework by integrating it with the CSA, reducing conflicts between drug safety/enforcement laws and patient autonomy. Includes anti-diversion measures to comply with federal controlled substances regulations, potentially limiting legal risks for physicians.
- Constitutional: Supports individual rights to pursue life-saving treatments (implied under due process or liberty interests), but balances this with public health protections against drug abuse.
- Political: Bipartisan sponsorship reflects broad support for patient access reforms; could set precedent for further deregulation of experimental therapies, though critics might argue it risks unsafe drug use without full oversight. No major challenges to separation of powers, as it directs executive rulemaking within statutory bounds.
This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.
Sponsor
Cosponsors (17)
Rep. Mace, Nancy [R-SC-1], Rep. Correa, J. Luis [D-CA-46], Rep. Khanna, Ro [D-CA-17], Rep. Lieu, Ted [D-CA-36], Rep. Crenshaw, Dan [R-TX-2], Rep. Bergman, Jack [R-MI-1], Rep. Luttrell, Morgan [R-TX-8], Rep. Grothman, Glenn [R-WI-6], Rep. Elfreth, Sarah [D-MD-3], Rep. McBride, Sarah [D-DE-At Large], Rep. Goldman, Daniel S. [D-NY-10], Rep. Wied, Tony [R-WI-8], Rep. Van Orden, Derrick [R-WI-3], Rep. Fitzpatrick, Brian K. [R-PA-1], Rep. Sorensen, Eric [D-IL-17], Rep. Cohen, Steve [D-TN-9], Rep. Johnson, Julie [D-TX-32]
Recent Actions
- 2025-12-04: Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
- 2025-12-04: Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
- 2025-12-04: Introduced in House
- 2025-12-04: Introduced in House
Bill Versions
- Freedom to Heal Act of 2025 — issued 2025-12-04 — PDF (7 pages)