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US HR2368

US HR2368
Right to Try Act


summary

Introduced
05/04/2017
In Committee
06/07/2017
Crossed Over
Passed
Dead
12/31/2018

Introduced Session

115th Congress

Bill Summary

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.

AI Summary

This bill, the Right to Try Act, requires the federal government to allow the 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 must be certified by a physician as having exhausted all other treatment options and being at greater risk from their medical condition than the experimental treatment. The physician must explain the experimental nature of the treatment to the patient, who must acknowledge the explanation. The bill also exempts manufacturers, distributors, prescribers, dispensers, possessors, or users of such treatments from liability, and prohibits federal agencies from using the outcomes of these treatments to adversely impact the approval of the experimental drug, biological product, or device.

Committee Categories

Business and Industry, Health and Social Services, Justice

Sponsors (6)

Last Action

Referred to the Subcommittee on Crime, Terrorism, Homeland Security, and Investigations. (on 06/07/2017)

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