Freedom to Heal Act of 2025
- Sponsor
- Rep. Dean, Madeleine [D-PA-4]
- Committees
- Judiciary Committee (primary)
- Last action
- Dec 4, 2025
Bottom line
The bill aims to expand access for terminally ill patients to certain Schedule I investigational drugs by creating a dedicated, less burdensome regulatory pathway for physicians under the existing Right to Try Act.
What it actually does
This bill establishes a special registration process under the Controlled Substances Act (CSA) for physicians to directly administer Schedule I investigational drugs to eligible patients under the federal Right to Try law. It streamlines the regulatory pathway for these drugs, which are typically subject to the highest level of federal control, by creating specific application and approval procedures for their use in terminally ill patients.
Proponents argue
Supporters argue this bill removes a significant bureaucratic hurdle, allowing terminally ill patients to access potentially life-saving or palliative treatments that are currently restricted by Schedule I classifications, thereby fully realizing the intent of the Right to Try law. They contend it provides a compassionate pathway for patients with no other treatment options.
Opponents contend
Opponents might express concerns about potential risks associated with less stringent oversight of Schedule I drugs, even for investigational use, citing the potential for diversion, misuse, or unforeseen patient safety issues. They may argue that the existing regulatory framework for Schedule I drugs is necessary to protect public health and safety.
The bill is concise and can be read quickly, allowing ample time for a thorough evaluation of its specific provisions and their implications.
Section 2, new CSA Section 303(p)(2)
Establishment of Special Registration Process
This provision mandates the Attorney General to register physicians specifically for the purpose of directly administering eligible investigational Schedule I drugs to eligible patients under the federal Right to Try law. This creates a distinct regulatory pathway separate from the standard, more restrictive Schedule I registration requirements, specifically for compassionate use cases.
Supporters argue
Supporters argue this provision is crucial for fulfilling the promise of the Right to Try Act, as it directly addresses the unique regulatory challenges posed by Schedule I drugs, which are otherwise extremely difficult to access even for investigational use.
Critics contend
Critics may contend that creating a special registration for Schedule I drugs, even for compassionate use, could inadvertently weaken the overall control framework for these substances, potentially increasing risks of diversion or misuse.
Tradeoffs
This provision balances the desire for expanded patient access to experimental treatments against the federal government's interest in maintaining strict control over Schedule I substances due to their high potential for abuse and lack of accepted medical use.
Section 2, new CSA Section 303(p)(3)(A)
Application Requirements for Special Registration
This section details the specific information physicians must submit to the Attorney General to obtain the special registration. Requirements include evidence of existing controlled substance registration, compliance with the Right to Try Act, manufacturer documentation and agreement to supply the drug, state law compliance, physician training, and a description of the drug storage and administration site. It also allows the Attorney General to request additional information to prevent diversion.
Section 2, new CSA Section 303(p)(3)(B)
Application Approval Timeline
This provision sets a 45-day deadline for the Attorney General to either approve a complete application for special registration or issue an order to show cause for denial. This ensures a relatively swift decision-making process for physicians seeking to administer these investigational drugs.
Section 2, new CSA Section 303(p)(5)
Limitation on Drug Amounts and Supplemental Notifications
This provision limits a physician to possessing only the quantity of the investigational drug specified in their initial application. However, it also creates a streamlined process for physicians to request additional amounts through a 'supplemental notification,' which is deemed approved after 30 days unless the Attorney General issues an order to show cause. This allows for flexibility in treatment needs while maintaining oversight.
Section 2, new CSA Section 303(p)(6)
Single Registration for Related Treatment Sites
This provision allows a physician to use a single special registration to administer Schedule I investigational drugs at multiple sites, provided all sites are within the same city or county and under the control of the same institution, organization, or agency. The physician must notify the Attorney General of each site. This reduces administrative burden for physicians practicing across multiple closely related locations.
Section 2, new CSA Section 303(p)(7) and (8)
Rulemaking Authority and Timelines
This provision directs the Attorney General to issue an interim final rule within 240 days of enactment to implement the special registration subsection, covering aspects like drug delivery, storage, security, record maintenance, and registration renewal/suspension/revocation. A final rule must then be issued within 2 years after the interim rule. This ensures that detailed operational guidelines are established quickly and then finalized through a standard rulemaking process.
This subsection defines 'eligible investigational drug' and 'eligible patient' by referencing section 561B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-0a).
Section 2, new CSA Section 303(p)(1)
Why it matters:This is standard legislative practice to avoid redundancy and ensure consistency with existing law (the Right to Try Act). It's not evasive, but requires a reader to consult external legal text for full understanding.
Case for: Supporters would argue that referencing existing definitions ensures legal consistency and avoids creating conflicting or redundant definitions, streamlining the legislative process.
Case against: Critics might argue that relying on external definitions makes the bill less self-contained and harder for a casual reader to fully comprehend without cross-referencing other statutes, potentially obscuring the full scope of the bill.
Estimated impact: This reference ensures that the special registration process aligns precisely with the existing scope of the federal Right to Try law, covering drugs that have completed a Phase 1 clinical trial and are for patients with life-threatening diseases who have exhausted approved treatment options.