H.R. 6434House119th Congress (2025-2027)In Committee

Freedom to Heal Act of 2025

AI-Generated Summary

Updated January 6, 2026 at 4:01 PM UTC

The Freedom to Heal Act of 2025 creates a new special registration under the Controlled Substances Act that lets doctors directly give patients eligible investigational drugs classified as Schedule I, when those drugs are covered by the federal Right‑to‑Try law. The Attorney General would issue these registrations after physicians submit detailed applications showing they are qualified, have state approval, and have an agreement with the drug maker. The rule is aimed at patients with serious or life‑threatening conditions who have exhausted other treatment options.

Key Provisions

Adds a new subsection (p) to 21 U.S.C. 823 that defines a "special registration" for physicians to administer Schedule I investigational drugs under Right‑to‑Try.
Physicians must apply to the Attorney General, providing proof of a standard controlled‑substance license, compliance with Right‑to‑Try requirements, a supply agreement with the drug’s manufacturer, training credentials, and site details.
The Attorney General must act within 45 days to approve the registration or issue an order to show cause.
Applications can be submitted electronically, and physicians may only possess the drug quantities listed in their approved application (or a supplemental notification for additional amounts).
A single registration can cover multiple treatment sites if they are in the same city/county and under the same institution, provided the Attorney General is notified of each site.
The Attorney General must issue an interim final rule within 240 days and a final rule within two years to detail delivery, storage, record‑keeping, and enforcement procedures.

Legislative Activity

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1 earlier action

HouseIntro Referral Latest Action

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.

Energy and Commerce Committee

December 4, 2025

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HouseIntro Referral

Introduced in House

December 4, 2025

HouseIntro Referral

Energy and Commerce Committee

December 4, 2025

Floor Debate

1 member

What members said about H.R. 6434 on the floor

1 Republican

Rep. Monica De La CruzR-TX-15 · Dec 16, 2025

Under clause 7 of rule XII, sponsors were added to public bills and resolutions, as follows: H.R. 116: Mr. Jack. H.R. 154: Mr. Landsman. H.R. 158: Mr. Landsman. H.R. 220: Ms. Escobar. H.R. 251: Mr.…

Under clause 7 of rule XII, sponsors were added to public bills and resolutions, as follows:

H.R. 116: Mr. Jack.

H.R. 154: Mr. Landsman.

H.R. 158: Mr. Landsman.

H.R. 220: Ms. Escobar.

H.R. 251: Mr. Jack.

H.R. 253: Mr. Landsman.

H.R. 282: Ms. McDonald Rivet.

H.R. 349: Mr. Min and Ms. Escobar.

H.R. 397: Mr. Jeffries.

H.R. 429: Ms. McDonald Rivet.

H.R. 438: Mr. Riley of New York.

H.R. 485: Ms. McDonald Rivet.

H.R. 488: Ms. McDonald Rivet and Mr. Landsman.

H.R. 498: Mr. Davidson.

H.R. 516: Mr. Norman.

H.R. 520: Mr. Min.

H.R. 539: Mrs. Trahan.

H.R. 585: Mr. Riley of New York.

H.R. 718: Mr. Neguse.

H.R. 821: Ms. McDonald Rivet.

H.R. 865: Mr. Riley of New York.

H.R. 869: Ms. Budzinski.

H.R. 879: Mr. Vicente Gonzalez of Texas and Ms. Balint.

H.R. 921: Ms. McDonald Rivet.

H.R. 945: Ms. Bynum, Ms. McDonald Rivet, and Ms. Pingree.

H.R. 953: Mr. Min.

H.R. 1027: Mr. Subramanyam.

H.R. 1054: Ms. Budzinski.

H.R. 1055: Mr. Subramanyam.

H.R. 1078: Mr. Sessions and Mr. Davidson.

H.R. 1110: Ms. Perez.

H.R. 1162: Mr. Gill of Texas.

H.R. 1175: Ms. Balint.

H.R. 1181: Mr. Nunn of Iowa and Mr. Davidson.

H.R. 1241: Mr. Jack and Ms. Mace.

H.R. 1246: Ms. McDonald Rivet.

H.R. 1254: Ms. Pingree.

H.R. 1277: Ms. McDonald Rivet.

H.R. 1285: Mr. Wied.

H.R. 1329: Ms. Strickland, Ms. McBride, Mrs. Hayes, Ms.

Ansari, Mr. Crow, Ms. Gillen, Mr. Landsman, and Mr. McDowell.

H.R. 1361: Mr. Tran.

H.R. 1369: Ms. McDonald Rivet.

H.R. 1394: Mr. Tonko.

H.R. 1398: Mrs. Kim.

H.R. 1404: Ms. Escobar.

H.R. 1412: Mr. Lawler.

H.R. 1421: Mr. Tran.

H.R. 1464: Mr. Thompson of California.

H.R. 1475: Mr. Neguse.

H.R. 1492: Mr. Smith of Nebraska.

H.R. 1502: Ms. McDonald Rivet.

H.R. 1522: Mr. McGarvey.

H.R. 1529: Ms. Balint.

H.R. 1546: Ms. McDonald Rivet.

H.R. 1564: Mr. Harder of California.

H.R. 1576: Mr. Landsman.

H.R. 1628: Ms. Salazar, Mr. Kelly of Pennsylvania, Mr.

Brecheen, Mr. Bell, and Mr. Norcross.

H.R. 1659: Mr. Riley of New York and Mr. Sorensen.

H.R. 1661: Ms. Balint and Mr. Keating.

H.R. 1695: Mr. Sorensen.

H.R. 1775: Mr. Moran.

H.R. 1810: Mr. Morelle.

H.R. 1960: Mr. Min.

H.R. 1983: Ms. Norton.

H.R. 1986: Ms. McDonald Rivet.

H.R. 1991: Ms. McDonald Rivet.

H.R. 1993: Mr. Crenshaw, Mrs. Hinson, and Ms. Davids of

Kansas.

H.R. 2028: Mr. Conaway.

H.R. 2036: Mr. Kean and Mr. Casten.

H.R. 2055: Ms. Morrison.

H.R. 2062: Mr. Moore of North Carolina.

H.R. 2068: Mr. Neguse.

H.R. 2094: Mr. Sorensen.

H.R. 2141: Ms. McDonald Rivet.

H.R. 2152: Ms. McDonald Rivet.

H.R. 2154: Mr. Landsman.

H.R. 2165: Mr. LaHood.

H.R. 2192: Mr. Nadler and Mr. Bera.

H.R. 2199: Mr. Feenstra.

H.R. 2232: Mr. Riley of New York.

H.R. 2244: Mr. Neguse.

H.R. 2253: Ms. Kamlager-Dove.

H.R. 2257: Ms. McDonald Rivet.

H.R. 2315: Mr. Jack.

H.R. 2370: Mr. Landsman.

H.R. 2402: Mr. Cisneros and Ms. Sewell.

H.R. 2467: Ms. Lofgren.

H.R. 2496: Mr. Messmer.

H.R. 2531: Mr. Casar.

H.R. 2672: Mr. Min.

H.R. 2678: Ms. Dean of Pennsylvania, Ms. Ross, and Mr.

McGovern.

H.R. 2680: Ms. Budzinski.

H.R. 2703: Mr. Quigley.

H.R. 2705: Mr. Jack and Ms. Mace.

H.R. 2716: Mrs. Miller-Meeks.

H.R. 2718: Mrs. Foushee.

H.R. 2727: Ms. Escobar.

H.R. 2728: Mr. Fields.

H.R. 2731: Ms. McDonald Rivet.

H.R. 2736: Ms. Johnson of Texas.

H.R. 2799: Mr. Evans of Pennsylvania.

H.R. 2829: Ms. Salinas.

H.R. 2878: Ms. McDonald Rivet.

H.R. 2902: Mrs. Hayes.

H.R. 2941: Mr. Sorensen.

H.R. 2947: Ms. Simon.

H.R. 2986: Mr. Quigley.

H.R. 3028: Ms. Johnson of Texas.

H.R. 3184: Ms. Lofgren and Mr. Turner of Ohio.

H.R. 3206: Mr. Reschenthaler.

H.R. 3246: Mr. Min.

H.R. 3261: Mr. Casar.

H.R. 3277: Mr. Vasquez.

H.R. 3316: Mr. Carson.

H.R. 3333: Mr. Thanedar.

H.R. 3337: Ms. McDonald Rivet.

H.R. 3350: Ms. McDonald Rivet.

H.R. 3367: Ms. Budzinski.

H.R. 3447: Mr. Cline and Mr. Landsman.

H.R. 3497: Mr. Correa, Ms. Salazar, Ms. Lois Frankel of

Florida, Ms. Lee of Florida, Mr. Schmidt, and Mr.

Fitzpatrick.

H.R. 3513: Mr. Larson of Connecticut.

H.R. 3514: Mr. Menendez.

H.R. 3526: Mrs. Miller-Meeks.

H.R. 3534: Mr. Landsman.

H.R. 3565: Ms. Salinas.

H.R. 3604: Mr. Goldman of New York.

H.R. 3629: Mr. Vasquez.

H.R. 3694: Mr. Case.

H.R. 3699: Mr. Huizenga.

H.R. 3740: Ms. Balint and Ms. Lofgren.

H.R. 3791: Mr. Neguse.

H.R. 3793: Mr. Goldman of New York.

H.R. 3858: Mr. Hunt.

H.R. 3867: Mr. Rutherford.

H.R. 3868: Mr. Neal.

H.R. 3885: Ms. Lee of Nevada.

H.R. 3931: Ms. Davids of Kansas.

H.R. 3959: Mr. Sessions.

H.R. 4083: Ms. McDonald Rivet.

H.R. 4130: Mr. Sessions.

H.R. 4141: Mr. Min.

H.R. 4151: Mr. Carter of Louisiana.

H.R. 4164: Ms. McDonald Rivet.

H.R. 4167: Mr. Mackenzie.

H.R. 4169: Ms. Perez.

H.R. 4176: Ms. Budzinski.

H.R. 4194: Mr. Williams of Texas.

H.R. 4206: Mr. Boyle of Pennsylvania, Mr. Rutherford, and

Ms. De La Cruz.

H.R. 4231: Mr. Smith of Washington.

H.R. 4242: Mr. Murphy.

H.R. 4291: Mr. Self.

H.R. 4299: Mr. Fitzpatrick.

H.R. 4317: Mr. Joyce of Pennsylvania, Mr. Babin, and Mr.

Davis of North Carolina.

H.R. 4464: Mr. Conaway.

H.R. 4521: Ms. McDonald Rivet.

H.R. 4582: Mr. Levin, Mr. Thompson of California, and Ms.

Escobar.

H.R. 4583: Mr. Levin, Mr. Thompson of California, and Ms.

Escobar.

H.R. 4585: Mr. Vasquez.

H.R. 4606: Mr. Crow.

H.R. 4611: Ms. Friedman.

H.R. 4640: Mr. Goldman of New York.

H.R. 4646: Mr. Davidson.

H.R. 4660: Mr. Harder of California and Mr. Davidson.

H.R. 4662: Mr. Takano, Mr. Whitesides, Mr. Vargas, Mr.

Lieu, Mr. Levin, Ms. Lofgren, and Ms. McDonald Rivet.

H.R. 4677: Ms. McDonald Rivet.

H.R. 4710: Mr. Moran.

H.R. 4721: Mr. Neguse.

H.R. 4810: Mr. Davidson.

H.R. 4821: Mr. Neal.

H.R. 4921: Mr. Cisneros.

H.R. 4945: Ms. McDonald Rivet.

H.R. 4950: Mr. Landsman.

H.R. 4982: Ms. McDonald Rivet.

H.R. 4989: Mr. Davidson.

H.R. 5068: Ms. Johnson of Texas.

H.R. 5106: Mr. Langworthy.

H.R. 5235: Ms. Perez.

H.R. 5263: Mr. Davidson.

H.R. 5269: Ms. Pou and Mr. Edwards.

H.R. 5271: Ms. Ross, Mr. Raskin, Mr. Swalwell, and Mr.

Beyer.

H.R. 5282: Mr. Neguse and Ms. McDonald Rivet.

H.R. 5309: Ms. Pressley, Ms. McDonald Rivet, Ms. Pingree,

and Ms. Rivas.

H.R. 5387: Mr. Min.

H.R. 5390: Ms. Pou and Mr. Meeks.

H.R. 5415: Mr. Harrigan, Mr. Kelly of Pennsylvania, Ms.

Ross, and Mr. Thompson of Pennsylvania.

H.R. 5434: Ms. Meng, Ms. Sewell, Mr. Soto, and Ms. Pingree.

H.R. 5438: Mrs. Harshbarger and Mr. Perry.

H.R. 5461: Ms. Friedman.

H.R. 5469: Ms. McDonald Rivet and Mr. Conaway.

H.R. 5509: Ms. Gillen, Mr. Krishnamoorthi, Mr. Davis of

North Carolina, Mr. Correa, and Mrs. Luna.

H.R. 5521: Ms. McDonald Rivet.

H.R. 5543: Mr. Whitesides.

H.R. 5638: Mr. Begich.

H.R. 5641: Ms. McDonald Rivet.

H.R. 5767: Mr. Williams of Texas and Mr. Babin.

H.R. 5791: Ms. DelBene.

H.R. 5835: Ms. Randall.

H.R. 5861: Mrs. Dingell.

H.R. 5867: Ms. Escobar.

H.R. 5870: Mr. Obernolte.

H.R. 5910: Ms. Ansari.

H.R. 5934: Ms. McDonald Rivet.

H.R. 5939: Ms. McDonald Rivet.

H.R. 5940: Ms. Pingree.

H.R. 5951: Mr. Thompson of California.

H.R. 5972: Mr. Cleaver.

H.R. 5983: Ms. Jayapal.

H.R. 5993: Ms. McDonald Rivet.

H.R. 6006: Ms. McDonald Rivet.

H.R. 6020: Ms. Budzinski.

H.R. 6056: Mr. Crow, Mr. Aguilar, Ms. Sewell, and Mr.

Morelle.

H.R. 6093: Ms. Budzinski.

H.R. 6099: Ms. McDonald Rivet.

H.R. 6108: Ms. Pingree.

H.R. 6109: Ms. Pingree.

H.R. 6110: Ms. Pingree.

H.R. 6111: Ms. Pingree.

H.R. 6119: Ms. McDonald Rivet.

H.R. 6121: Mr. Owens and Ms. Norton.

H.R. 6123: Ms. King-Hinds.

H.R. 6126: Ms. McDonald Rivet.

H.R. 6128: Mr. Soto.

H.R. 6130: Mr. Soto, Mr. Neguse, and Mrs. Hayes.

H.R. 6152: Mr. Min.

H.R. 6164: Mr. Aguilar.

H.R. 6170: Mr. Vindman.

H.R. 6181: Mr. Bera, Ms. Balint, Mr. Torres of New York,

and Mr. Aguilar.

H.R. 6182: Ms. Escobar.

H.R. 6213: Mr. Owens.

H.R. 6219: Mr. Smith of New Jersey.

H.R. 6228: Mr. Garcia of California.

H.R. 6231: Mr. Murphy and Ms. Brownley.

H.R. 6245: Ms. Escobar.

H.R. 6259: Ms. McDonald Rivet.

H.R. 6261: Mr. Vindman.

H.R. 6268: Mr. Krishnamoorthi.

H.R. 6293: Mr. Davidson.

H.R. 6366: Mr. Obernolte and Ms. Ross.

H.R. 6422: Mr. LaLota.

H.R. 6425: Ms. McDonald Rivet.

H.R. 6432: Ms. McDonald Rivet.

H.R. 6434: Ms. McBride and Mr. Goldman of New York.

H.R. 6436: Mr. Vindman.

H.R. 6440: Mr. Garcia of Illinois and Ms. DelBene.

H.R. 6444: Mr. Vindman.

H.R. 6448: Ms. Plaskett.

H.R. 6449: Ms. McDonald Rivet.

H.R. 6450: Mr. Vindman.

H.R. 6468: Mr. Vindman.

H.R. 6475: Mr. Vindman.

H.R. 6498: Mr. Vindman.

H.R. 6501: Ms. Wilson of Florida.

H.R. 6521: Mr. Vargas.

H.R. 6529: Mr. Thanedar.

H.R. 6541: Mr. Davidson.

H.R. 6543: Mr. Vindman.

H.R. 6546: Mr. Davidson.

H.R. 6547: Mr. Foster and Mr. Rose.

H.R. 6550: Mr. Rose, Mr. Sessions, and Mr. Davidson.

H.R. 6551: Mr. Gottheimer.

H.R. 6552: Mr. Gottheimer, Mr. Sessions, and Mr. Davidson.

H.R. 6553: Mr. Sessions and Mr. Nunn of Iowa.

H.R. 6554: Mr. Sessions and Mr. Nunn of Iowa.

H.R. 6555: Mr. Gottheimer.

H.R. 6556: Mr. Gottheimer.

H.R. 6574: Mr. Goldman of New York, Ms. DelBene, Mr.

Subramanyam, Ms. Meng, Ms. Plaskett, Mrs. Dingell, Ms.

Pingree, Ms. Titus, and Mr. Evans of Pennsylvania.

H.R. 6597: Mrs. McClain Delaney.

H.R. 6608: Mr. Bacon.

H.R. 6624: Mr. Gill of Texas and Mrs. McClain Delaney.

H.R. 6670: Mr. Haridopolos and Mr. Goldman of New York.

H.R. 6675: Mr. Gill of Texas.

H.R. 6677: Mr. Case.

H.R. 6678: Mr. Fitzpatrick.

H.R. 6707: Mrs. Miller of West Virginia.

H.R. 6724: Mr. Mannion.

H.J. Res. 13: Ms. Bonamici.

H. Con. Res. 12: Mr. Dunn of Florida and Mr. Tran.

H. Con. Res. 64: Ms. Goodlander, Mr. Espaillat, and Ms.

Hoyle of Oregon.

H. Res. 297: Ms. Budzinski.

H. Res. 381: Mr. Conaway.

H. Res. 704: Mr. Thanedar.

H. Res. 733: Mr. Conaway.

H. Res. 843: Mr. Smith of New Jersey.

H. Res. 931: Ms. McDonald Rivet.

Bill Text

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Introduced in HouseIssued December 4, 2025

119th CONGRESS

1st Session

H. R. 6434

IN THE HOUSE OF REPRESENTATIVES

December 4, 2025

Ms. Dean of Pennsylvania (for herself, Ms. Mace, Mr. Correa, Mr. Khanna, Mr. Lieu, Mr. Crenshaw, Mr. Bergman, and Mr. Luttrell) introduced the following bill; which was 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

A BILL

To establish a special registration under the Controlled Substances Act for schedule I eligible investigational drugs under the Federal Right to Try law.

Short title

This Act may be cited as the Freedom to Heal Act of 2025.

Special registration requirements related to right to try

Section 303 of the Controlled Substances Act (21 U.S.C. 823) is amended by adding at the end the following:

(p)

Special registration for schedule I eligible investigational drugs under right To try

(1)

Definitions

In this subsection, the terms eligible investigational drug and eligible patient have the meanings given those terms in section 561B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–0a).

(2)

Special registration process

The Attorney General shall register physicians to directly administer eligible investigational drugs in schedule I to eligible patients under section 561B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–0a) in accordance with paragraphs (3) through (8) of this subsection.

(3)

Requirements

(A)

Application

A physician desiring a registration to directly administer an eligible investigational drug as described in paragraph (2) shall submit to the Attorney General an application containing—

(i)

evidence of a valid registration to dispense or administer controlled substances in schedules II through V;

(ii)

evidence of compliance with section 561B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–0a), including—

(I)

documentation from the manufacturer or sponsor verifying the investigational drug in schedule I is an eligible investigational drug;

(II)

an agreement from the manufacturer or sponsor to supply the eligible investigational drug, along with guidance on its administration, to the requesting physician for the treatment of eligible patients; and

(III)

an affirmation that the physician will only directly administer the eligible investigational drug to treat eligible patients in a manner consistent with the guidance provided by the manufacturer or sponsor;

(iii)

the quantity of the eligible investigational drug to be supplied by the manufacturer or sponsor to the physician to treat eligible patients;

(iv)

evidence that the physician may treat eligible patients with eligible investigational drugs under the laws of the State in which the treatment will take place;

(v)

evidence of training, credentials, or experience relevant to treating patients with the eligible investigational drug;

(vi)

a description of the site at which the physician intends to store and administer the eligible investigational drug; and

(vii)

any additional information the Attorney General determines necessary to prevent diversion.

(B)

Approval

Not later than 45 days after receiving an application containing the information required under subparagraph (A), the Attorney General shall—

(i)

(ii)

serve an order to show cause upon the applicant in accordance with section 304(c).

(4)

Electronic submissions

The Attorney General shall provide a means for a physician to submit an application under paragraph (3)(A) electronically.

(5)

Limitation on amounts

A physician treating eligible patients with an eligible investigational drug in schedule I under this subsection may only possess the amounts of the eligible investigational drug identified in—

(A)

the application submitted to the Attorney General under paragraph (3)(A); or

(B)

a supplemental notification that the physician may submit to the Attorney General if the physician needs additional amounts of the eligible investigational drug for the treatment of eligible patients, which supplemental notification—

(i)

shall include—

(I)

the name of the physician;

(II)

the additional quantity of the eligible investigational drug needed; and

(III)

an attestation that the treatment with the eligible investigational drug is consistent with the scope of treatment that was the subject of the application under paragraph (3)(A); and

(ii)

shall be deemed approved on the date that is 30 days after the date on which the physician submits the supplemental notification to the Attorney General, unless the Attorney General serves an order to show cause upon the applicant in accordance with section 304(c).

(6)

Single registration for related treatment sites

A physician may treat eligible patients with an eligible investigational drug in schedule I under a single registration under this subsection if—

(A)

the treatment occurs exclusively on sites all of which are—

(i)

within the same city or county; and

(ii)

under the control of the same institution, organization, or agency; and

(B)

before commencing the treatment, the physician notifies the Attorney General of each site where the eligible investigational drug will be stored or administered in accordance with paragraph (3)(A)(vi).

(7)

Rulemaking

Notwithstanding the requirements of section 553 of title 5, United States Code, not later than 240 days after the date of enactment of this subsection, the Attorney General shall issue an interim final rule to implement this subsection, including with respect to—

(A)

the manner in which an eligible investigational drug may be delivered to an approved registrant;

(B)

the storage and security of an eligible investigational drug;

(C)

the maintenance of records for an approved registrant;

(D)

the process for renewal, suspension, or revocation of a registration; and

(E)

any other matters necessary to ensure effective controls against diversion.

(8)

Final rule

Not later than 2 years after issuing an interim final rule under paragraph (7), the Attorney General shall issue a final rule to implement this subsection in accordance with section 553 of title 5, United States Code.