H.R. 6434: Freedom to Heal Act of 2025

This bill, known as the Freedom to Heal Act of 2025, aims to amend the Controlled Substances Act to create a special registration process for physicians who wish to prescribe certain investigational drugs that are categorized as Schedule I substances. The bill specifically addresses the use of these drugs under the Federal Right to Try law, which allows patients with serious conditions to access experimental treatments that have not yet been fully approved by the Food and Drug Administration (FDA).

Key Provisions

• Special Registration for Physicians: The Attorney General will establish a process for physicians to get registered to directly administer eligible investigational Schedule I drugs to patients under specific conditions.
• Definition of Terms: The bill defines "eligible investigational drug" and "eligible patient" based on existing regulations outlined in the Federal Food, Drug, and Cosmetic Act.
• Application Requirements: Physicians must submit an application to the Attorney General, including:
  • Proof of a valid registration to dispense controlled substances from schedules II to V.
  • Compliance documentation confirming that the drug is an eligible investigational drug.
  • An agreement from the drug manufacturer to supply the drug along with administration guidance.
  • Assurances that treatment will follow the provided guidelines.
  • The quantity of the drug required for treatment.
  • State law compliance to treat patients with these drugs.
  • Evidence of relevant training and credentials.
  • A description of the site for drug storage and administration.
• Approval Process: The Attorney General must either register the physician or issue a show-cause order within 45 days of receiving the application.
• Electronic Submissions: The Attorney General is required to allow physicians to submit applications electronically.
• Restrictions on Amounts: Physicians can only possess the amounts of the drug specified in their application or an approved supplemental notification if they require additional amounts.
• Single Registration: Physicians are permitted to use a single registration to treat patients across multiple sites, provided these sites are within the same city or county and controlled by the same organization.
• Rulemaking Authority: The Attorney General is required to develop rules regarding the delivery, storage, security, and record maintenance for these drugs.
• Timeframes for Implementation: The Attorney General must issue an interim final rule within 240 days and a final rule within two years following the interim rule.

Implementation and Oversight

The bill places the responsibility of registration, approval, and regulation on the Attorney General and outlines a specific timeline for rulemaking to ensure that the law is effectively implemented. This provides a structure for how physicians can access and administer investigational drugs that may offer alternative treatment options to patients facing serious health conditions.

Relevant Companies

• ACAD (Acadia Pharmaceuticals) - May be impacted as a company developing investigational drugs for serious conditions, as the bill could provide a pathway for these products to be administered directly to patients.
• NUMN (Numinus Wellness) - Involved in psychedelic-assisted therapies, which may fall under the investigational drug use this legislation supports.