HR6434119th CongressWALLET

Freedom to Heal Act of 2025

Sponsored By: Representative Dean (PA)

Introduced

Summary

Creates a special federal registration for doctors to administer certain Schedule I investigational drugs under Right To Try. This bill would set a defined application process, possession limits, and anti‑diversion rules so eligible patients can receive these drugs from registered physicians.

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  • Physicians: Doctors could apply for a special registration to directly give Schedule I eligible investigational drugs to eligible patients. Applications must include proof of existing controlled‑substance registration, manufacturer verification and supply agreement, training and site details, and the Attorney General would approve or deny applications within 45 days and supplemental quantity requests would be deemed approved after 30 days unless challenged.
  • Patients and manufacturers: Eligible patients under the Food, Drug, and Cosmetic Act’s Right To Try framework would gain a clearer pathway to care, and manufacturers or sponsors must verify drug eligibility, agree to supply the drug, and provide administration guidance to the treating physician.
  • Oversight and controls: The Attorney General would have to allow electronic submissions, permit a single registration to cover related sites in the same city or county under one institution, and issue an interim final rule within 240 days and a final rule within 2 years to set delivery, storage, recordkeeping, renewal, suspension, and other anti‑diversion safeguards.

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Bill Overview

Analyzed Economic Effects

1 provisions identified: 1 benefits, 0 costs, 0 mixed.

New physician registry for investigational drugs

This bill would create a special Attorney General registration so physicians could directly give certain Schedule I investigational drugs to eligible patients. Physicians would apply electronically and must show a valid Schedules II–V registration, manufacturer verification and supply agreement, quantity requested, state-law permission, relevant training, and a storage site description. The Attorney General would register or issue an order to show cause within 45 days of a complete application. Physicians could possess only the amounts listed, and supplemental requests for more drug would be deemed approved after 30 days unless challenged. A single registration could cover related sites in the same city or county under one institution. The Attorney General would issue an interim final rule within 240 days and a final rule within two years.

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Sponsors & CoSponsors

Sponsor

Dean (PA)

PA • D

Cosponsors

  • Mace

    SC • R

    Sponsored 12/4/2025

  • Correa

    CA • D

    Sponsored 12/4/2025

  • Khanna

    CA • D

    Sponsored 12/4/2025

  • Lieu

    CA • D

    Sponsored 12/4/2025

  • Crenshaw

    TX • R

    Sponsored 12/4/2025

  • Bergman

    MI • R

    Sponsored 12/4/2025

  • Luttrell

    TX • R

    Sponsored 12/4/2025

  • Grothman

    WI • R

    Sponsored 12/15/2025

  • Elfreth

    MD • D

    Sponsored 12/15/2025

  • McBride

    DE • D

    Sponsored 12/16/2025

  • Goldman (NY)

    NY • D

    Sponsored 12/16/2025

  • Wied

    WI • R

    Sponsored 1/7/2026

  • Van Orden

    WI • R

    Sponsored 1/12/2026

  • Fitzpatrick

    PA • R

    Sponsored 2/4/2026

  • Sorensen

    IL • D

    Sponsored 2/12/2026

  • Cohen

    TN • D

    Sponsored 2/23/2026

  • Johnson (TX)

    TX • D

    Sponsored 3/27/2026

Roll Call Votes

No roll call votes available for this bill.

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