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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‘‘(d) DEFINITION OF INVESTIGATIONAL DRUG OR 
DEVICE.—In this section, the term ‘investigational drug 
or device’ means a drug or device that— 
‘‘(1) has not yet been approved, licensed, or 
cleared for commercial distribution under section 
505, 510(k), or 515 of this Act or section 351 of the 
Public Health Service Act, and cannot otherwise be 
lawfully marketed in the United States; and 
‘‘(2) is or has been the subject of one or more 
clinical trials.’’. 
SEC. 3. LIABILITY PROTECTION. 
The Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 301 et seq.) is amended by inserting after section 
561A, as inserted by section 2 of this Act, the following: 
‘‘SEC. 561B. LIABILITY PROTECTION. 
‘‘Except in the case of gross negligence or willful mis-
conduct, any person who manufactures, imports, distrib-
utes, prescribes, dispenses, or administers an investiga-
tional drug or device in accordance with section 561A shall 
not be liable in any action under Federal or State law for 
any loss, damage, or injury arising out of, relating to, or 
resulting from— 
‘‘(1) the design, development, clinical testing 
and investigation, manufacturing, labeling, distribu-
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tion, sale, purchase, donation, dispensing, prescrip-
tion, administration, or use of the drug or device; or 
‘‘(2) the safety or effectiveness of the drug or 
device.’’. 
Æ 
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