H.R.2368 - Right to Try Act115th Congress (2017-2018) |
|Sponsor:||Rep. Fitzpatrick, Brian K. [R-PA-8] (Introduced 05/04/2017)|
|Committees:||House - Energy and Commerce; Judiciary|
|Latest Action:||House - 06/07/2017 Referred to the Subcommittee on Crime, Terrorism, Homeland Security, and Investigations. (All Actions)|
This bill has the status Introduced
Here are the steps for Status of Legislation:
- Passed House
- Passed Senate
- To President
- Became Law
Summary: H.R.2368 — 115th Congress (2017-2018)All Information (Except Text)
Introduced in House (05/04/2017)
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.