Table 1.

Summary of “Right to Try” Act

Requirements for Patient   a. Life-threatening condition   b. Exhausted standard treatment options   c. Unable to participate in an ongoing trial   d. Provide informed consent Requirements for Drug   a. Phase I trial completed   b. Ongoing pivotal phase II or III trial   c. Active development plan to seek FDA approval   d. Not approved for any indication Requirement for the Physician   a. Be in good standing with licensing organization or board   b. Certify that patient is unable to participate in a clinical trial involving the drug in question   c. Accept written informed consent from patient or authorized representative.   d. Receive no compensation from the Sponsor/manufacturer Requirements for Sponsor/Manufacturer   a. Comply with standard procedures for investigational drug labeling, promotion, and recovery of direct costs.   b. Submit an annual summary of the use of the drug to the FDA, including number of doses supplied, number of patients treated, the uses for which the drug was made available, and any known serious adverse events. Liabilities and Mandates   a. No liability for a manufacturer’s decision not to provide drug   b. No liability for a physician’s decision not to prescribe drug   c. No mandate for any entity to provide coverage for drug or associated care   d. No positive right established to any individual