[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4696 Introduced in House (IH)]
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 Representatives 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 practitioners 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
representation 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 licensed medical doctor,
osteopath, chiropractor, or naturopath and in the case of a
health care practitioner whose medical treatment involves the
dispensing 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 frequently
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 procedure.
SEC. 4. ACCESS TO MEDICAL TREATMENT.
(a) In General.--Notwithstanding any other provision 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 individual; 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 itself, 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 approved by the Food and Drug
Administration--
(A) such individual has been informed that such
food, drug, or device has not yet been approved or
certified by the Food and Drug Administration for
treating the medical condition of such individual;
(B) such food, drug, or device (or information
accompanying the administration of such food, drug, or
device) contains the following warning:
``WARNING: This food, drug, or device has
not been proved safe and effective by the
Federal Government and any individual 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 labeling 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 practitioner of the results of the
practitioner's administration of a treatment described in section 2(9)
in recognized journals 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 individual or
representative of such individual for the administration 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 prescribed) was a danger to
the individual receiving the treatment, the practitioner shall
immediately report to the Secretary of Health and Human Services the
nature of the treatment, the results of such treatment, the complete
protocol of such treatment, and the source from which such treatment or
any part thereof was obtained.
SEC. 6. TRANSPORTATION OF MEDICATION AND EQUIPMENT.
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 commerce medication or equipment for use in accordance
with this Act.
SEC. 7. RESTRICTIONS ON LICENSING BOARDS.
A licensing board that licenses health care practitioners 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 regulations.
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