Right to Try for Individualized Treatments Act

This bill significantly amends the Federal Food, Drug, and Cosmetic Act to expand patient access to investigational medical treatments. It specifically authorizes the use of investigational individualized medical treatments for patients diagnosed with a life-threatening disease or condition or a severely debilitating illness.

The legislation defines an "investigational individualized medical treatment" as a drug or biological product tailored to a patient's unique genomic profile. It broadens the definition of an eligible patient to include those with severely debilitating illnesses, in addition to life-threatening conditions, who have considered approved treatment options. Access requires certification by a physician in good standing and the patient's written informed consent, or additional informed consent for individualized treatments, which includes an explanation of approved treatments and potential outcomes.

Under this expanded framework, manufacturers operating within eligible healthcare facilities may make these specialized treatments available, and eligible patients can request them. However, the bill explicitly states that manufacturers are not required to provide such treatments to any patient.