I 
113TH CONGRESS 
2D SESSION 
H. R. 4475 
To allow the manufacture, importation, distribution, and sale of investiga-
tional drugs and devices intended for use by terminally ill patients 
who execute an informed consent document, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
APRIL 10, 2014 
Mr. GRIFFITH of Virginia (for himself and Mr. HANNA) introduced the 
following bill; which was referred to the Committee on Energy and Commerce 
A BILL 
To allow the manufacture, importation, distribution, and sale 
of investigational drugs and devices intended for use 
by terminally ill patients who execute an informed con-
sent document, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Compassionate Free-
dom of Choice Act of 2014’’. 
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SEC. 2. DRUGS AND DEVICES FOR USE BY TERMINALLY ILL 
PATIENTS. 
The Federal Food, Drug, and Cosmetic Act is amend-
ed by inserting after section 561 (21 U.S.C. 360bbb) the 
following: 
‘‘SEC. 561A. DRUGS AND DEVICES FOR USE BY TERMINALLY 
ILL PATIENTS. 
‘‘(a) IN GENERAL.—Nothing in this Act or section 
351 of the Public Health Service Act prevents or restricts, 
and the Food and Drug Administration shall not imple-
ment or enforce any provision of law preventing or re-
stricting, the manufacture, importation, distribution, or 
sale of an investigational drug or device intended for use 
by a terminally ill patient in accordance with subsection 
(b). 
‘‘(b) PATIENT REQUIREMENTS.—In order for an in-
vestigational drug or device to be intended for use in ac-
cordance with this subsection, such drug or device must 
be intended for use by a patient who has— 
‘‘(1) been diagnosed with a terminal illness by 
a licensed physician; 
‘‘(2) been informed by a licensed physician that 
no drug or device that is lawfully marketed in the 
United States is likely to cure the illness; and 
‘‘(3) executed a written informed consent docu-
ment that states— 
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‘‘(A) the known and potential risks and 
benefits of such drug or device; and 
‘‘(B) any indications of the illness for 
which a drug or device is lawfully marketed, or 
for which treatment is otherwise available, in 
the United States. 
‘‘(c) PROHIBITION ON REQUIRING THE DISCLOSURE, 
COLLECTION, AND REPORTING OF CERTAIN INFORMA-
TION BY FOOD AND DRUG ADMINISTRATION.— 
‘‘(1) IN GENERAL.—The Commissioner of Food 
and Drugs may not require the disclosure, collection, 
or reporting of— 
‘‘(A) any information related to the deliv-
ery, administration, or use of an investigational 
drug or device pursuant to this section; or 
‘‘(B) any information related to the clinical 
outcomes experienced by a terminally ill patient 
supplied an investigational drug or device pur-
suant to this section. 
‘‘(2) EXCEPTION.—Nothing in this subsection 
prevents the sponsor of a clinical trial from volun-
tarily disclosing, collecting, or reporting information 
to the Food and Drug Administration. 
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