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.
Health Subcommittee, Energy and Commerce Committee
Introduced
In Committee
On Floor
Passed Chamber
Enacted
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.
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Timeline
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
Health
Business recordsCivil actions and liabilityDrug safety, medical device, and laboratory regulationDrug therapyHealth technology, devices, suppliesLong-term, rehabilitative, and terminal carePrescription drugsRetail and wholesale tradesTrade restrictions
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.
USA115th CongressHR-1020| House
| Updated: 2/17/2017
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.
Health Subcommittee, Energy and Commerce Committee
Health
Introduced
In Committee
On Floor
Passed Chamber
Enacted
Business recordsCivil actions and liabilityDrug safety, medical device, and laboratory regulationDrug therapyHealth technology, devices, suppliesLong-term, rehabilitative, and terminal carePrescription drugsRetail and wholesale tradesTrade restrictions