I
103D CONGRESS
2D SESSION
H. R. 4696
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
JUNE 30, 1994
Mr. DEFAZIO 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. FINDINGS.
The Congress finds that access to medical treatment
significantly affects interstate commerce in food, drugs,
and medical devices and that interference with medical
treatments administered by licensed health care practi-
tioners is a burden on such commerce.
SEC. 3. DEFINITIONS.
As used in this Act:
(1) ADVERTISING OR LABELING CLAIMS.—The
term ‘‘advertising or labeling claims’’ means any
representations made or suggested by statement,
word, design, device, sound, or any combination
thereof with respect to treatment, including a rep-
resentation made or suggested by a label. The term
‘‘advertising’’ has the meaning given such term by
the Federal Trade Commission under the Federal
Trade Commission Act.
(2) DEVICE.—The term ‘‘device’’ has the same
meaning given such term in section 201(h) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
321(h)).
(3) DRUG.—The term ‘‘drug’’ means a drug as
defined in section 201(g)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321(g)(1)).
(4) FOOD.—The term ‘‘food’’ has the same
meaning given such term in section 201(f) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
321(f)).
(5) HEALTH CARE PRACTITIONER.—The term
‘‘health care practitioner’’ means any properly li-
censed medical doctor, osteopath, chiropractor, or
naturopath and in the case of a health care practi-
tioner whose medical treatment involves the dispens-
ing of a controlled substance, such term means a
practitioner who is registered under such Act.
(6) LABEL AND LABELING.—The terms ‘‘label’’
and ‘‘labeling’’ have the same meaning given such
terms in sections 201(k) and 201(m) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321(k),
(m)).
(7) LEGAL REPRESENTATIVE.—The term ‘‘legal
representative’’ means a parent or an individual who
qualifies as a legal guardian under State law.
(8) SERIOUS HARM.—The term ‘‘serious harm’’
means any serious negative reaction that—
(A) occurred as a result of a method of
treatment;
(B) would not otherwise have occurred;
and
(C) is more serious than reactions fre-
quently experienced with accepted treatments
for the same or similar health problems.
(9) 
TREATMENT.—The 
term 
‘‘treatment’’
means the use of any food, drug, device, or proce-
dure.
SEC. 4. ACCESS TO MEDICAL TREATMENT.
(a) IN GENERAL.—Notwithstanding any other provi-
sion of law, and except as provided in subsection (b), an
individual shall be permitted to be treated by a health care
practitioner with any method of medical treatment that
such individual desires or the legal representative of such
individual authorizes if—
(1) such practitioner agrees to treat such indi-
vidual; and
(2) the administration of such treatment falls
within the scope of the practice of such practitioner.
(b) TREATMENT REQUIREMENTS.—A health care
practitioner may provide any method of treatment to an
individual described in subsection (a) if—
(1) there is no evidence that such treatment it-
self, when taken as prescribed, is a serious harm to
such individual;
(2) in the case of an individual whose treatment
is the administration of a food (including a dietary
supplement), drug, or device that has not been ap-
proved by the Food and Drug Administration—
(A) such individual has been informed that
such food, drug, or device has not yet been ap-
proved or certified by the Food and Drug Ad-
ministration for treating the medical condition
of such individual;
(B) such food, drug, or device (or informa-
tion accompanying the administration of such
food, drug, or device) contains the following
warning:
‘‘WARNING: This food, drug, or de-
vice has not been proved 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.’’; and
(C) such drug is not a controlled substance
the use or prescription of which by a health
care practitioner would be in violation of the
Controlled Substances Act (21 U.S.C. 801 et
seq.);
(3) such individual has been informed of the
nature of the treatment, including—
(A) the contents of such treatment;
(B) any reasonably foreseeable side effects
that may result from such treatment; and
(C) the results of past applications of such
treatment by the health care practitioner and
others;
(4) except as provided in subsection (c), there
have been no claims, including advertising and label-
ing claims, made with respect to the efficacy of such
treatment; and
(5) such individual—
(A) has been provided a written statement
that such individual has been fully informed
with respect to the information described in
paragraphs (1) through (4);
(B) desires such treatment; and
(C) signs such statement.
(c) CLAIM EXCEPTIONS.—Subsection (b)(4) shall not
apply to an accurate and truthful reporting by a practi-
tioner of the results of the practitioner’s administration
of a treatment described in section 2(9) in recognized jour-
nals or at seminars, conventions, or similar meetings, if
the only financial gain of such practitioner with respect
to such treatment is the payment received from an individ-
ual or representative of such individual for the administra-
tion of such treatment to such individual.
SEC. 5. REPORTING OF A DANGEROUS TREATMENT.
If a practitioner, after administering such treatment,
discovers that the treatment itself (when taken as pre-
scribed) was a danger to the individual receiving the treat-
ment, the practitioner shall immediately report to the Sec-
retary of Health and Human Services the nature of the
treatment, the results of such treatment, the complete pro-
tocol of such treatment, and the source from which such
treatment or any part thereof was obtained.
SEC. 6. TRANSPORTATION OF MEDICATION AND EQUIP-
MENT.
Notwithstanding any other provision of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 201 et seq.),
a person may introduce or deliver into interstate com-
merce medication or equipment for use in accordance with
this Act.
SEC. 7. RESTRICTIONS ON LICENSING BOARDS.
A licensing board that licenses health care practition-
ers may not impose on any health care practitioner any
disciplinary sanction, including revocation or suspension
of the license of the health care practitioner, or otherwise
punish such practitioner solely because such practitioner
provides treatment to which section 3 applies.
SEC. 8. PENALTY.
A health care practitioner who knowingly, willingly,
or with gross negligence violates any provisions under this
Act shall not be covered by the protections under this Act
and shall be subject to all other applicable laws and regu-
lations.
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