S. 3346: Freedom to Heal Act of 2025

The Freedom to Heal Act of 2025 proposes to create a special registration process for physicians who want to administer certain investigational drugs classified as Schedule I under the Controlled Substances Act. Here’s a breakdown of what the bill entails:

Purpose of the Bill

The main goal of the bill is to allow eligible patients to access investigational drugs that are currently not widely available, particularly those classified as Schedule I drugs. Schedule I drugs are substances considered to have a high potential for abuse and have no accepted medical use in treatment in the U.S.

Definitions

• Eligible Investigational Drug: A drug being tested in clinical trials that has not yet been approved by the FDA but meets specific criteria.
• Eligible Patient: A patient who meets certain conditions to qualify for treatment with an investigational drug under the Federal Right to Try law.

Registration Process for Physicians

To administer Schedule I investigational drugs, physicians must undergo a special registration process with the Attorney General. The key components of this process are:

• Application Submission: Physicians must submit an application that includes:
• Proof of a valid registration to dispense controlled substances.
• Compliance documentation with regulations regarding investigational drugs.
• Details on the quantity of the drug to be supplied by the manufacturer.
• Evidence that the treatment is permissible under state laws.
• Documentation of the physician's relevant training and experience.
• A proposed site for storing and administering the drug.
• Approval Timeline: The Attorney General must act on the application within 45 days, either registering the physician or issuing a notice to explain any objections.

Limits on Drug Amounts

Physicians are permitted to possess only the amounts of investigational drugs that they apply for or that are authorized by the Attorney General. If more supplies are needed, physicians can submit a supplemental notification to request additional quantities.

Single Registration for Multiple Sites

Physicians can treat patients at multiple sites under one registration if all sites are within the same local area and controlled by the same institution. They must notify the Attorney General of each site where the drug will be used.

Implementation Timeline

The Attorney General is required to implement this bill with various regulations within specified timeframes, including issuing an interim final rule within 240 days of the bill's enactment and a final rule within two years after that.

Additional Regulations

The interim rule will cover:

• The delivery method for investigational drugs to registered physicians.
• Storage and security requirements for these drugs.
• Record maintenance protocols for physicians.
• Rules for renewing or revoking a given registration.

Relevant Companies

• None found