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 2015
This bill amends the Federal Food, Drug, and Cosmetic Act to declare that nothing in it or in the Public Health Service Act prevents or restricts, and the Food and Drug Administration (FDA) must not prevent or restrict, the manufacture, importation, distribution, or sale of investigational drugs or devices for terminally ill patients.
The FDA is prohibited from requiring the disclosure, collection, or reporting of certain information concerning such drugs or devices, except that the sponsor of a clinical trial may voluntarily disclose, collect, or report such information to the FDA.
Except in cases of gross negligence or willful misconduct, any person who manufactures, imports, distributes, prescribes, or administers an investigational drug or device is not liable under state or federal law for loss, damage, or injury from: (1) the development, testing, production, acquisition, or use of such drugs or devices; or (2) their safety or effectiveness.
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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