S. 4698: Right to Try for Individualized Treatments Act

This bill would expand the federal “Right to Try” framework to include not just certain investigational drugs, but also investigational individualized medical treatments for some seriously ill patients.

What kinds of patients could use it

The bill would allow access for patients who have been diagnosed with a:

• life-threatening disease or condition, or
• severely debilitating illness.

For these individualized treatments, the patient would need to have considered approved treatment options, and a physician would have to certify the patient’s condition. The physician must be in good standing and cannot be paid directly by the manufacturer just for making that certification.

What counts as an “individualized medical treatment”

The bill defines this as a drug or biological product made for a specific patient based on that patient’s unique genomic profile. That could include information from:

• genomic sequence,
• chromosomes,
• DNA,
• genes,
• gene products such as enzymes or proteins, or
• metabolites.

How access would work

A manufacturer could choose to make an individualized treatment available if it is following applicable federal human-subject protection rules and is operating through an eligible health care facility. The bill says the manufacturer would not be required to provide the treatment to every patient.

An eligible patient could request access from either the health care facility or the manufacturer, but access would still depend on the bill’s requirements being met.

Consent requirements

The bill would keep informed-consent protections and add a special “additional informed consent” process for individualized treatments. That written consent, signed by the physician and a witness, would need to include:

• an explanation of currently approved treatments,
• the patient’s statement that the approved and conventionally recognized treatments are unlikely to prolong or improve life,
• clear identification of the proposed individualized treatment, and
• a description of possible outcomes based on the physician’s knowledge of the treatment and the patient’s disease.

Other legal changes

The bill would update the existing Right to Try law so its exemptions and references also apply to individualized medical treatments, not just investigational drugs. It would also make conforming wording changes throughout the section of federal law being amended.

Relevant Companies

None found