Freedom to Heal Act of 2025
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Progress
Where this bill stands in the legislative process.
- Introduced
- Passed House
- Passed Senate
- To President
- Became Law
Overview
The Freedom to Heal Act of 2025 creates a special registration process under the Controlled Substances Act to allow physicians to directly administer schedule I investigational drugs to patients through the ‘Right to Try’ law. This registration requires physicians to demonstrate compliance with federal regulations, obtain agreements from drug manufacturers, and adhere to specific storage and handling requirements. The Attorney General will review applications and can issue orders to show cause if necessary, establishing a streamlined process for accessing these medications for eligible patients.
Key provisions
- Establishes a special registration for schedule I investigational drugs under the Right to Try law.
- Requires physicians to demonstrate compliance with the Federal Food, Drug, and Cosmetic Act.
- Mandates agreements with drug manufacturers for supply and administration guidance.
- Limits physician possession to amounts specified in applications or supplemental notifications.
- Allows a single registration for treatment at multiple sites within the same city or county under common control.
- Requires physicians to notify the Attorney General of each treatment site.
- Directs the Attorney General to issue interim and final rules to implement the registration process.
- Provides a mechanism for physicians to submit applications electronically.
Who is affected
- Physicians
- Drug Manufacturers
Bill text
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Sponsors
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18 on record
Primary sponsor
Cosponsors
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