[Congressional Bills 104th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2019 Introduced in House (IH)]







104th CONGRESS
  1st Session
                                H. R. 2019

  To allow patients to receive any medical treatment they want under 
               certain conditions and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             July 12, 1995

 Mr. DeFazio (for himself, Mr. Barton of Texas, Mr. DeLay, Mr. Cox of 
  California, Mr. Hinchey, Mr. Pallone, Mr. Kingston, Ms. Furse, Ms. 
     Norton, Mr. Owens, Mr. Smith of New Jersey, Mr. Lipinski, Ms. 
  Velazquez, Mr. Evans, Mr. Dellums, Mr. Deutsch, Mr. Frazer, and Mr. 
  Hilliard) introduced the following bill; which was referred to the 
                         Committee on Commerce

_______________________________________________________________________

                                 A BILL


 
  To allow patients to receive any medical treatment they want under 
               certain conditions 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. DEFINITIONS.

    As used in this Act:
            (1) Advertising claims.--The term ``advertising claims'' 
        means any representations made or suggested by statement, word, 
        design, device, sound, or any combination thereof with respect 
        to a medical treatment.
            (2) Danger.--The term ``danger'' means any negative 
        reaction that--
                    (A) causes serious harm;
                    (B) occurred as a result of a method of medical 
                treatment;
                    (C) would not otherwise have occurred; and
                    (D) is more serious than reactions experienced with 
                routinely used medical treatments for the same medical 
                condition or conditions.
            (3) 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)).
            (4) Drug.--The term ``drug'' has the same 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 same 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 defined in 
                section 201(ff) of such Act.
            (6) Health care practitioner.--The term ``health care 
        practitioner'' means a physician or another person who is 
        legally authorized to provide health professional services in 
        the State in which the services are provided.
            (7) Label.--The term ``label'' has the same meaning given 
        such term in section 201(k) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 321(k)) and includes labeling as 
        defined in section 201(m) of such Act (21 U.S.C. 321(m)).
            (8) Legal representative.--The term ``legal 
        representative'' means a parent or an individual who qualifies 
        as a legal guardian under State law.
            (9) Seller.--The term ``seller'' means a person, company, 
        or organization that receives payment related to a medical 
        treatment of a patient of a health practitioner, except that 
        this term does not apply to a health care practitioner who 
        receives payment from an individual or representative of such 
        individual for the administration of a medical treatment to 
        such individual.
            (10) Medical treatment.--The term ``medical treatment'' 
        means any food, drug, device, or procedure that is used and 
        intended as a cure, mitigation, treatment, or prevention of 
        disease.

SEC. 3. ACCESS TO MEDICAL TREATMENT.

    (a) In General.--Notwithstanding any other provision 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 licensed by the Secretary of Health and Human Services) 
that such individual desires or the legal representative of such 
individual authorizes if--
            (1) such practitioner has personally examined such 
        individual and agrees to treat such individual; and
            (2) the administration of such treatment does not violate 
        licensing laws.
    (b) Medical Treatment Requirements.--A health care practitioner may 
provide any medical treatment to an individual described in subsection 
(a) if--
            (1) there is no reasonable basis to conclude that the 
        medical treatment itself, when used as directed, poses an 
        unreasonable and significant risk of danger to such individual;
            (2) 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 of Health and 
        Human Services, but has not been approved, certified, or 
        licensed by the Secretary of Health and Human Services--
                    (A) such individual has been informed in writing 
                that such food, drug, or device has not yet been 
                approved, certified, or licensed by the Secretary of 
                Health and Human Services for use as a medical 
                treatment for the condition of such individual; and
                    (B) prior to the administration of such treatment, 
                the practitioner has provided the patient a written 
                statement that states the following:
                            ``WARNING: This food, drug, or device has 
                        not been declared to be 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.'';
            (3) such individual has been informed in writing of the 
        nature of the medical treatment, including--
                    (A) the contents and methods of such treatment;
                    (B) the anticipated benefits of such treatment;
                    (C) any reasonably foreseeable side effects that 
                may result from such treatment;
                    (D) the results of past applications of such 
                treatment by the health care practitioner and others; 
                and
                    (E) 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;
            (4) except as provided in subsection (c), there have been 
        no advertising claims made with respect to the efficacy of the 
        medical treatment by the practitioner, manufacturer, or 
        distributor;
            (5) the label of any drug, device, or food used in such 
        treatment is not false or misleading; and
            (6) 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.
In any proceeding relating to the enforcement of paragraph (5) with 
respect to the label of drugs, devices, 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 to establishing the burden of proof that such label 
is false or misleading.
    (c) Claim Exceptions.--
            (1) Reporting by a practitioner.--Subsection (b)(4) shall 
        not apply to an accurate and truthful reporting by a health 
        care practitioner of the results of the practitioner's 
        administration of a medical treatment in recognized journals or 
        at seminars, conventions, or similar meetings or to others so 
        long as the reporting practitioner has no financial interests 
        in the reporting of the material and has received no financial 
        benefit of any kind from the manufacturer, distributor, or 
        other seller for such reporting. Such reporting may not be used 
        by a manufacturer, distributor, or other seller to advance the 
        sale of such treatment.
            (2) Statements by a practitioner to a patient.--Subsection 
        (b)(4) shall not apply to any statement made in person by a 
        health care practitioner to an individual patient or an 
        individual prospective patient.
            (3) Dietary supplements statements.--Subsection (b)(4) 
        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 TREATMENT.

    (a) Health Care Practitioner.--If a health care practitioner, after 
administering a medical treatment, discovers that the treatment itself 
was a danger to the individual receiving such treatment, the 
practitioner shall immediately report to the Secretary of Health and 
Human Services the nature of such 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.
    (b) Secretary.--Upon confirmation that a medical treatment has 
proven dangerous to an individual, the Secretary of Health and Human 
Services shall properly disseminate information with respect to the 
danger of the medical treatment.

SEC. 5 REPORTING OF A BENEFICIAL MEDICAL TREATMENT.

    If a health care practitioner, after administering a medical 
treatment that is not a conventional medical treatment for a life-
threatening medical condition or conditions, discovers that, in the 
opinion of the practitioner, such medical treatment has positive 
effects on such condition or conditions that are significantly greater 
than the positive effects that are expected from a conventional medical 
treatment for the same condition or conditions, the practitioner shall 
immediately make a reporting, which is accurate and truthful, to the 
Office of Alternative Medicine of--
            (1) the nature of such medical treatment (which is not a 
        conventional medical treatment);
            (2) the results of such treatment; and
            (3) the protocol of such treatment.

SEC. 6. TRANSPORTATION AND PRODUCTION OF FOOD, DRUGS, DEVICES, AND 
              OTHER EQUIPMENT.

    Notwithstanding any other provision of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 201 et seq.), a person may--
            (1) introduce or deliver into interstate commerce a food, 
        drug, device, or any other equipment; and
            (2) produce 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, distributor, or seller.

SEC. 7. VIOLATION OF THE CONTROLLED SUBSTANCES ACT.

    A health care practitioner, manufacturer, distributor, or other 
seller may not violate any provision of the Controlled Substances Act 
(21 U.S.C. 801 et seq.) in the provision of medical treatment in 
accordance with this Act.

SEC. 8. PENALTY.

    A health care practitioner who knowingly violates any provision of 
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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