I 
112TH CONGRESS 
2D SESSION 
H. R. 6342 
To allow the importation, distribution, and sale of investigational drugs and 
devices intended for use by terminally ill patients who execute an in-
formed consent document. 
IN THE HOUSE OF REPRESENTATIVES 
AUGUST 2, 2012 
Mr. PAUL (for himself, Mr. BROUN of Georgia, and Mr. HANNA) introduced 
the following bill; which was referred to the Committee on Energy and 
Commerce 
A BILL 
To allow the importation, distribution, and sale of investiga-
tional drugs and devices intended for use by terminally 
ill patients who execute an informed consent document. 
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 2012’’. 
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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 importation, distribution, or sale of an inves-
tigational 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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