Physician Registration for Schedule I Treatments

Summary#

The Freedom to Heal Act of 2025 would amend the Controlled Substances Act to create a special federal registration for physicians who directly administer certain Schedule I investigational drugs to eligible patients under the Federal Right to Try law. Its stated goal is to establish a registration process for that treatment. The bill has been introduced but is not law; passage is uncertain.

  • The Attorney General must register a physician who applies, or serve an order to show cause, within 45 days after receiving a complete application.
  • An application must include, among other things, the physician’s controlled-substance registration for Schedules II through V, evidence the treatment is allowed under state law, and the manufacturer’s or sponsor’s agreement to supply the drug and provide administration guidance.
  • A physician may possess only the quantity listed in the application or in a later notice. That additional quantity is deemed approved after 30 days unless the Attorney General serves an order to show cause.
  • A physician may use one registration for multiple treatment sites only if they are in the same city or county and under the control of the same institution, organization, or agency, and the physician notifies the Attorney General of each site before treatment.
  • The Attorney General must issue an interim final rule within 240 days of enactment and a final rule within two years after that. The rules must address delivery, storage and security, records, and renewal, suspension, or revocation.

What it means for you#

  • Physicians: A physician seeking to administer a qualifying Schedule I investigational drug would have to apply and meet the bill’s requirements. The bill requires electronic application submission to be available. It does not create an exemption from state law.
  • Eligible patients: The bill creates a federal registration process for physicians; it does not require a manufacturer or sponsor to provide a drug, or guarantee that a patient will receive one.
  • Manufacturers and sponsors: Their agreement to supply the drug and provide administration guidance must be included in a physician’s application. The bill does not require them to make that agreement.
  • Institutions and treatment sites: A physician can use one registration for related sites only under the bill’s location and shared-control conditions.
  • Attorney General: Must set the application and drug-control rules and act on complete applications within the stated deadline.

Money#

No cost estimate is included in the supplied material; no publicly available information is provided about the bill’s cost.

  • The bill requires the Attorney General to create and run the registration process, accept electronic applications, and issue two sets of rules. It gives no staffing or cost estimate.
  • The bill sets no fee, fine, or new tax.

What is unclear#

  • The bill refers to “eligible investigational drug” and “eligible patient” as defined in the Federal Food, Drug, and Cosmetic Act, but that Act’s relevant text was not supplied, so those definitions and the current Right to Try process could not be verified.
  • The Controlled Substances Act being amended was not supplied. The bill’s effect alongside current registration rules could not be verified.
  • The bill does not specify the information or process for an order to show cause, or how a physician may challenge one.
  • The Attorney General’s required rules will supply important details on delivery, security, records, and registration renewal, suspension, or revocation.
  • The bill does not say how quickly a physician’s initial registration must take effect after approval, or how the process works if the Attorney General does not act within 45 days.

Case for#

  • The bill appears intended to provide a specific federal registration route for physicians administering certain Schedule I drugs under Right to Try.
  • Requiring evidence of state-law authority, relevant training or experience, a supply agreement, and a treatment site could help limit registration to specified treatment settings.
  • Quantity limits, site notices, recordkeeping rules, and security rules could help guard against diversion (drug use outside the approved purpose).
  • The 45-day deadline and electronic applications could make the process more predictable for physicians.

Case against#

  • Access still depends on a manufacturer or sponsor agreeing to supply the drug; the bill does not require that agreement.
  • The application requirements and later rules could make the process demanding, and the bill provides no cost or staffing estimate.
  • The bill gives the Attorney General authority to request additional information to prevent diversion, without defining how much additional information may be required.
  • A physician may have to wait 30 days for additional quantities to be deemed approved, and the bill does not explain what happens if treatment needs change sooner.