I 
108TH CONGRESS 
1ST SESSION H. R. 2085
To permit an individual to be treated by a health care practitioner with 
any method of medical treatment such individual requests, and for other 
purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 14, 2003
Mr. DEFAZIO (for himself and Mr. BURTON of Indiana) introduced the 
following bill; which was referred to the Committee on Energy and Commerce 
A BILL 
To permit an individual to be treated by a health care 
practitioner with any method of medical treatment such 
individual requests, 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 ‘‘Access to Medical 
Treatment Act’’. 
SEC. 2. DEFINITIONS. 
In this Act: 
(1) ADVERTISING
CLAIM.—The term ‘‘adver-
tising claim’’ means any representation made or sug-
gested by statement, word, design, device, sound, or 
any combination thereof with respect to a medical 
treatment. 
(2) DANGER.—The term ‘‘danger’’ means an 
adverse reaction to an unapproved drug or medical 
device that, when used as directed—
(A) causes serious harm; 
(B) occurred as a result of the medical 
treatment; 
(C) would not otherwise have occurred; 
and 
(D) is more serious than reactions experi-
enced with routinely used medical treatments 
approved by the Food and Drug Administration 
for the same medical condition or conditions. 
(3) DEVICE.—The term ‘‘device’’ has the mean-
ing given such term in section 201(h) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C.321(h)). 
(4) DRUG.—The term ‘‘drug’’ has the meaning 
given such term in section 201(g)(1) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321 
(g)(1)). 
(5) FOOD.—The term ‘‘food’’—
(A) has the meaning given such term in 
section 201(f) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321(f)); and 
(B) includes a dietary supplement as de-
fined in section 201(ff) of such Act. 
(6) HEALTH CARE PRACTITIONER.—The term 
‘‘health care practitioner’’ means a physician or 
other individual who is legally authorized to provide 
health care services in the State in which the serv-
ices are provided. 
(7) INTERSTATE COMMERCE.—The term ‘‘inter-
state commerce’’ means commerce between any 
State or territory and any place outside thereof, and 
commerce within the District of Columbia or within 
any other territory not organized with a legislative 
body. 
(8) LABEL.—The term ‘‘label’’ has the meaning 
given such term in section 201(k) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321(k)). 
(9) LABELING.—The term ‘‘labeling’’ has the 
meaning given such term in section 201(m) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
321(m)). 
(10) 
LEGAL
REPRESENTATIVE.—The 
term 
‘‘legal representative’’ means a parent or an indi-
vidual who qualifies as a legal guardian under appli-
cable State law. 
(11) MEDICAL DEVICE.—The term ‘‘medical de-
vice’’ has the meaning given the term ‘‘device’’ in 
section 201(h) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 321(h)). 
(12) MEDICAL TREATMENT.—The term ‘‘med-
ical treatment’’ means any food, drug, device, or 
procedure that is used and intended as a cure, miti-
gation, treatment, or prevention of disease or a 
health condition. 
(13) PATIENT.—The term ‘‘patient’’ means any 
individual who seeks medical treatment from a 
health care practitioner for a disease or health con-
dition. 
(14) 
SECRETARY.—The 
term 
‘‘Secretary’’ 
means the Secretary of Health and Human Services. 
(15) SELLER.—The term ‘‘seller’’ means an in-
dividual or organization that receives payment re-
lated to the medical treatment of a patient of a 
health practitioner, except that this term does not 
apply to a health care practitioner who receives pay-
ment from an individual or representative of such in-
dividual for the administration of a medical treat-
ment to such individual.
(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 section 505, 513, 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; and
(3) the health care practitioner complies with 
the requirements of subsection (b). 
(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—
(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; 
(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 
(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-
ings, or to others, so long as the reporting practi-
tioner has no direct or indirect financial interest in 
the reporting of the material and has received no fi-
nancial benefits of any kind from the manufacturer, 
distributor, or other seller for such reporting. Such 
reporting may not be used by a manufacturer, dis-
tributor, or other seller to advance the sale of such 
treatment.
(2) STATEMENTS BY A PRACTITIONER TO A PA-
TIENT.—Subsection (b)(1)(D) shall not apply to any 
statement made by a health care practitioner di-
rectly to a patient or prospective patient. A health 
care practitioner shall not be held liable for any ad-
vertising claims made by others unless the practi-
tioner is a party in the dissemination of the informa-
tion in such claims. 
(3) DIETARY
SUPPLEMENTS
STATEMENT.—
Subsection (b)(1)(D) shall not apply to statements 
or claims permitted under sections 403B and 
403(r)(6) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 343–2 and 343(r)(6)). 
SEC. 4. REPORTING OF A DANGEROUS MEDICAL TREAT-
MENT. 
(a) HEALTH CARE PRACTITIONER.—If a health care 
practitioner, after administering a medical treatment, dis-
covers that the treatment itself was a danger to the indi-
vidual receiving such treatment, the practitioner shall—
(1) immediately cease the use of such treat-
ment; 
(2) refrain from recommending the use of any 
unapproved drug or medical device that was a part 
of such treatment;
(3) report to the manufacturer and the Director 
of the Centers for Disease Control and Prevention—
(A) the nature of such treatment; 
(B) the results of such treatment; 
(C) the complete protocol of such treat-
ment; and 
(D) the source from which such treatment 
or any part thereof was obtained; and 
(4) include as part of the reporting under para-
graph (3), an affidavit pursuant to section 1746 of 
title 28, United States Code, confirming that all 
statements made in the report under such paragraph 
are accurate. 
(b) SECRETARY.—Upon confirmation that a medical 
treatment has proven dangerous to individuals, the Sec-
retary shall properly disseminate information with respect 
to the danger of the medical treatment and prohibit the 
further use of such treatment. 
SEC. 5. REPORTING OF A BENEFICIAL MEDICAL TREAT-
MENT. 
If a health care practitioner, after administering a 
medical treatment that is not an approved drug or medical 
device for a life-threatening medical condition or condi-
tions, discovers that such medical treatment has, in the 
opinion of the health care practitioner, positive effects on
such condition or conditions that are significantly greater 
than the positive effects that are expected from an ap-
proved medical treatment for the same condition or condi-
tions, the practitioner shall—
(1) make a monthly reporting to the National 
Center for Complementary and Alternative Medicine 
at the National Institutes of Health of—
(A) the nature of such medical treatment 
(which is not a conventional medical treatment); 
(B) the general results of such treatment 
administered in the month involved; and 
(C) the protocol of such treatment; and 
(2) provide an affidavit pursuant to section 746 
of title 28, United States Code, confirming that all 
statements made in the monthly reporting under 
paragraph (1) are accurate and truthful. 
SEC. 6. TRANSPORTATION AND PRODUCTION OF FOOD, 
DRUGS, DEVICES, AND OTHER EQUIPMENT. 
(a) IN GENERAL.—Notwithstanding any other provi-
sion of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 201 et seq.), an individual may—
(1) introduce or deliver into interstate com-
merce a food, drug, device, or any other equipment; 
and
(2) produce, transport, receive and hold a food, 
drug, device, or any other equipment, 
solely for use in accordance with this Act if there have 
been no advertising claims by the manufacturer, dis-
tributor, or seller of the food, drug, device, or equipment 
involved. 
(b) RULE OF CONSTRUCTION.—Nothing in this Act 
shall be construed to limit or interfere with the authority 
of a health care practitioner to prescribe, recommend, pro-
vide, or administer to a patient for any medical condition 
or disease any unapproved drug or medical device that is 
lawful under the law of the State or States in which the 
health care practitioner practices. 
SEC. 7. OTHER LAWS NOT AFFECTED BY THIS ACT. 
Nothing in this Act shall be construed to—
(1) apply to the manufacturer, distribution, 
possession, or use of any drug that is a controlled 
substance under the Controlled Substances Act (21 
U.S.C. 801 et seq.); 
(2) apply to statements or claims permitted or 
authorized under sections 403 and 403B of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 
3443, 343–2); or 
(3) in any way adversely affect the distribution 
or sale of dietary supplements (as defined in section