[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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