To allow the manufacture, importation, distribution, and sale of investigational drugs and devices intended for use by terminally ill patients who execute an informed consent document, and for other purposes.
Compassionate Freedom of Choice Act of 2017
This bill amends the Federal Food, Drug, and Cosmetic Act to declare that nothing in that Act or in the Public Health Service Act prevents or restricts, and the Food and Drug Administration (FDA) may not prevent or restrict, the manufacture, importation, distribution, or sale of drugs or medical devices that are intended for terminally ill patients, have been the subject of a clinical trial, and have not been approved by the FDA.
The FDA may not require the disclosure, collection, or reporting of certain information concerning such drugs or devices. The sponsor of a clinical trial may voluntarily disclose, collect, or report such information to the FDA.
Except in the case of gross negligence or willful misconduct, a person who manufactures, imports, distributes, prescribes, or administers such a drug or device is not liable under state or federal law for loss, damage, or injury from the development, testing, production, acquisition, use, safety, or effectiveness of the drug or device.
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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