[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[S. 2207 Introduced in Senate (IS)]







107th CONGRESS
  2d Session
                                S. 2207

  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 SENATE OF THE UNITED STATES

                             April 18, 2002

Mr. Daschle (for himself, Mr. Harkin, and Mr. Grassley) introduced the 
 following bill; which was read twice and referred to the Committee on 
                 Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 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. DEFINITIONS.

    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 approved by the Food 
                and Drug Administration 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 care services in the State 
        in which the services are provided.
            (7) Interstate commerce.--The term ``interstate 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 same 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 same 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 individual who qualifies 
        as a legal guardian under State law.
            (11) Medical device.--The term ``medical device'' has the 
        same meaning given the term ``device'' in section 201(h) of the 
        Federal Food, Drug and Cosmetic Act (21 U.S.C. 321(h)).
            (12) 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.
            (13) Patient.--The term ``patient'' means any person who 
        seeks medical treatment from a health care practitioner for a 
        disease or health condition.
            (14) Secretary.--The term ``Secretary'' means the Secretary 
        of Health and Human Services.
            (15) 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.
            (16) Unapproved drug or medical device.--The term 
        ``unapproved drug or medical device'' 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 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) 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.--
            (1) In general.--A health care practitioner may provide any 
        medical treatment to an individual described in subsection (a) 
        if--
                    (A) there is no reason to conclude that, based on 
                generally accepted principles and current information, 
                the medical treatment itself, when used as directed, 
                will cause a 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 approved, certified, or 
                licensed by the Secretary--
                            (i) such individual has been informed in 
                        writing that such food, drug, or device has not 
                        yet been approved, certified, or licensed by 
                        the Secretary for use as a medical 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 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.'';
                    (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 treatment;
                            (iv) the results of past applications of 
                        such treatment by the health care practitioner 
                        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 treatment by the 
                practitioner, manufacturer, or distributor;
                    (E) the label or labeling of a food, drug, or 
                device that is a medical treatment is not false or 
                misleading; and
                    (F) such individual--
                            (i) has been provided a written statement 
                        that such individual has been fully informed 
                        with respect to the information described in 
                        subparagraphs (A) through (D);
                            (ii) desires such treatment; and
                            (iii) signs such statement.
            (2) Burden of proof.--In any proceeding relating 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 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 consent 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 practitioner.--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 
        administration of a medical treatment in recognized journals, 
        at seminars, conventions, or similar meetings, or to others, so 
        long as the reporting practitioner has no direct or indirect 
        financial interest in the reporting of the material and has 
        received no financial benefits 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)(1)(D) shall not apply to any statement made in person by a 
        health care practitioner to an individual patient or an 
        individual prospective patient. No health care practitioner 
        shall be held liable for any advertising claims made by others 
        unless the practitioner is a party to the dissemination of the 
        information.
            (3) Dietary supplements statements.--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 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 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 individuals, the Secretary 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 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 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 make a monthly reporting, which 
is accurate and truthful, to the National Center for Complementary and 
Alternative Medicine at the National Institutes of Health of--
            (1) the nature of such medical treatment (which is not a 
        conventional medical treatment);
            (2) the general results of such treatment administered in 
        the month involved; 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.

    Nothing in this Act shall be construed to apply to the manufacture, 
distribution, possession, or use of any drug that is a controlled 
substance under the Controlled Substances Act (21 U.S.C. 801 et seq.).

SEC. 8. PENALTY.

    A health care practitioner who knowingly 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.
                                 <all>