H.R. 2368

Right to Try Act

This bill requires the federal government to allow unrestricted manufacturing, distribution, prescribing, and dispensing of experimental drugs, biological products, and medical devices that are authorized by state law and intended to treat terminally ill patients. Patients receiving these treatments must be certified by a physician as having exhausted all other treatment options and as being at greater risk from their medical condition than the treatment. The physician must explain the treatment to the patient, including that the treatment is experimental, and the patient, or the patient's legal representative, must acknowledge the explanation.

A manufacturer, distributor, prescriber, dispenser, possessor, or user of such a treatment has no liability regarding the treatment.

The outcome of manufacture, distribution, prescribing, dispensing, possession, or use of such a treatment may not be used by a federal agency to adversely impact review or approval of the treatment.

The treatment must: (1) have successfully completed a phase 1 (initial, small scale) clinical trial; (2) remain under investigation in a clinical trial approved by the Food and Drug Administration (FDA); and (3) not be approved, licensed, or cleared for sale by the FDA.