(16) UNAPPROVED
DRUG
OR
MEDICAL
DE-
VICE.—The term ‘‘unapproved drug or medical de-
vice’’ with respect to a drug or medical device, 
means a drug or medical device that is not approved 
or authorized for manufacture, sale, and distribution 
in interstate commerce under sections 505, 510, or 
515 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C 355, 360c, and 360(e)) or under section 
351 of the Public Health Service Act (42 U.S.C. 
262). 
SEC. 3. ACCESS TO MEDICAL TREATMENT. 
(a) IN GENERAL.—Notwithstanding any other provi-
sion of law, and except as provided in subsection (b), an 
individual shall have the right to be treated by a health 
care practitioner with any medical treatment (including a 
medical treatment that is not approved, certified, or li-
censed by the Secretary) that such individual desires, or 
that the legal representative of such individual authorizes, 
if— 
(1) such practitioner has personally examined 
such individual and agrees to provide treatment to 
such individual; 
(2) the administration of such treatment does 
not violate applicable licensing laws; 
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(3) the health care practitioner complies with 
the requirements of subsection (b); and 
(4) it is a medical treatment that has not been 
approved, certified, or licensed by the Secretary, or 
is any medical treatment that has been approved by 
the designated governmental agency for a member 
country of the European Union or the European 
Free Trade Association, Canada, Australia, New 
Zealand, or Japan but not otherwise approved, cer-
tified, or licensed by the Secretary. 
(b) MEDICAL TREATMENT REQUIREMENTS.— 
(1) IN GENERAL.—A health care practitioner 
may provide the medical treatment requested by an 
individual described in subsection (a) if— 
(A) there is no reason for the practitioner 
to conclude that, based on generally accepted 
principles and current information, the medical 
treatment requested, when used or provided as 
directed, will cause danger to the patient; 
(B) in the case of an individual whose 
treatment is the administration of a food, drug, 
or device that has to be approved, certified, or 
licensed by the Secretary, but has not been so 
approved, certified, or licensed— 
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(i) such individual has been informed 
in writing that such food, drug, or device 
has not been approved, certified, or li-
censed by the Secretary for use as a med-
ical treatment of the medical condition of 
such individual; and 
(ii) prior to the administration of such 
treatment, the practitioner has provided 
the patient a written statement that in-
cludes the following provision: ‘‘WARN-
ING: This food, drug, or device has not 
been declared to be safe and effective by 
the Federal Government and any indi-
vidual who uses such food, drug, or device 
does so at his or her own risk.’’; 
(C) such individual has been informed in 
writing of the nature of the medical treatment, 
including— 
(i) the contents and methods of such 
treatment; 
(ii) the anticipated benefits of such 
treatment; 
(iii) any reasonably foreseeable side 
effects that may result from such treat-
ment; 
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(iv) the results of past application of 
such treatment by the health care practi-
tioner and others; and 
(v) any other information necessary to 
fully meet the requirements for informed 
consent of human subjects prescribed by 
regulations issued by the Food and Drug 
Administration; 
(D) except as provided in subsection (c), 
there have been no advertising claims made 
with respect to the efficacy of the medical treat-
ment by the practitioner, manufacturer, or dis-
tributor; 
(E) the label or labeling of any food, drug, 
or device that is a part of the requested medical 
treatment is not false or misleading; 
(F) such individual— 
(i) has been provided with a written 
statement that such individual has been 
fully informed with respect to the informa-
tion 
described 
in 
subparagraphs 
(A) 
through (D); 
(ii) desires such treatment; and 
(iii) signs such statement; and 
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(G) the health care practitioner provides 
the patient with a recommendation for the 
treatment involved under circumstances that 
give the patient sufficient opportunity to con-
sider whether or not to use such treatment. 
(2) BURDEN OF PROOF.—In any proceeding re-
lating to the enforcement of paragraph (1)(E) with 
respect to the label of a drug, device, or food used 
in medical treatment covered under this subsection, 
the provisions of section 403B(c) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 343–2(c)) 
shall apply with respect to establishing the burden of 
proof that such label is false or misleading. 
(3) RULE OF CONSTRUCTION.—Nothing in this 
section shall be construed to require informed con-
sent for the prescription of dietary supplements and 
foods not requiring such informed consent prior to 
the date of the enactment of this Act. 
(c) CLAIM EXCEPTIONS.— 
(1) REPORTING BY A HEALTH CARE PRACTI-
TIONER.—Subsection (b)(1)(D) shall not apply to an 
accurate and truthful reporting by a health care 
practitioner of the results of the practitioner’s ad-
ministration of a medical treatment in recognized 
journals, at seminars, conventions, or similar meet-
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