Federal RuleAug 21
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DOL Rewrites Disability Rules for 'Merit-Based Opportunity' Push
RuleLabor DepartmentFederal Contract Compliance Programs OfficeSignificant Wallet
119-hr-6434119th CongressWALLET
Freedom to Heal Act of 2025
Sponsored By: Representative Dean, Madeleine [D-PA-4]
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.
Show full summary
- 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.
Sponsors & CoSponsors
Sponsor
Dean, Madeleine [D-PA-4]
PA • D
Cosponsors
Rep. Suozzi, Thomas R. [D-NY-3]
NY • D
Sponsored 10/9/2026
Rep. Mace, Nancy [R-SC-1]
SC • R
Sponsored 12/4/2025
Rep. Correa, J. Luis [D-CA-46]
CA • D
Sponsored 12/4/2025
Rep. Khanna, Ro [D-CA-17]
CA • D
Sponsored 12/4/2025
Rep. Lieu, Ted [D-CA-36]
CA • D
Sponsored 12/4/2025
Rep. Crenshaw, Dan [R-TX-2]
TX • R
Sponsored 12/4/2025
Rep. Bergman, Jack [R-MI-1]
MI • R
Sponsored 12/4/2025
Rep. Luttrell, Morgan [R-TX-8]
TX • R
Sponsored 12/4/2025
Rep. Grothman, Glenn [R-WI-6]
WI • R
Sponsored 12/15/2025
Rep. Elfreth, Sarah [D-MD-3]
MD • D
Sponsored 12/15/2025
Rep. McBride, Sarah [D-DE-At Large]
DE • D
Sponsored 12/16/2025
Rep. Goldman, Daniel S. [D-NY-10]
NY • D
Sponsored 12/16/2025
Rep. Wied, Tony [R-WI-8]
WI • R
Sponsored 1/7/2026
Rep. Van Orden, Derrick [R-WI-3]
WI • R
Sponsored 1/12/2026
Rep. Fitzpatrick, Brian K. [R-PA-1]
PA • R
Sponsored 2/4/2026
Rep. Sorensen, Eric [D-IL-17]
IL • D
Sponsored 2/12/2026
Rep. Cohen, Steve [D-TN-9]
TN • D
Sponsored 2/23/2026
Rep. Johnson, Julie [D-TX-32]
TX • D
Sponsored 3/27/2026
Roll Call Votes
No roll call votes available for this bill.
View on Congress.gov