[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 2618 Introduced in Senate (IS)]








109th CONGRESS
  2d Session
                                S. 2618

  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 7, 2006

  Mr. Harkin (for himself 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 claim.--The term ``advertising claim'' 
        means any representation 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 an adverse reaction 
        to an unapproved drug or medical device that, when used as 
        directed--
                    (A) causes serious harm;
                    (B) occurred as a result of the 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 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 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 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 other individual 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 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 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 applicable State law.
            (11) Medical device.--The term ``medical device'' has the 
        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 or a health condition.
            (13) Patient.--The term ``patient'' means any individual 
        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 an individual or 
        organization that receives payment related to the 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 that the legal representative of such individual authorizes, if--
            (1) such practitioner has personally examined such 
        individual and agrees to provide treatment to such individual;
            (2) the administration of such treatment does not violate 
        applicable licensing laws and is within the scope of the 
        practice of such practitioner;
            (3) the health care practitioner complies with the 
        requirements of subsection (b); and
            (4) it is a medical treatment that has not been approved, 
        certified, or licensed by the Secretary, or is any medical 
        treatment that has been approved by the designated governmental 
        agency for a member country of the European Union or the 
        European Free Trade Association, Canada, Australia, New 
        Zealand, or Japan but not otherwise approved, certified, or 
        licensed by the Secretary.
    (b) Medical Treatment Requirements.--
            (1) In general.--A health care practitioner may provide the 
        medical treatment requested by an individual described in 
        subsection (a) if--
                    (A) there is no reason for the practitioner to 
                conclude that, based on generally accepted principles 
                and current information, the medical treatment 
                requested, when used or provided as directed, will 
                cause 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 so approved, certified, or 
                licensed--
                            (i) such individual has been informed in 
                        writing that such food, drug, or device has not 
                        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, which shall become 
                        part of the medical record of the patient, that 
                        includes the following provision: ``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 application 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 any food, drug, or 
                device that is a part of the requested medical 
                treatment is not false or misleading;
                    (F) such individual--
                            (i) has been provided with 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; and
                    (G) the health care practitioner provides the 
                patient with a recommendation for the treatment 
                involved under circumstances that give the patient 
                sufficient opportunity to consider whether or not to 
                use such treatment.
            (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 with respect 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 health care 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 by a health 
        care practitioner directly to a patient or prospective patient. 
        A health care practitioner shall not be held liable for any 
        advertising claims made by others unless the practitioner is a 
        party in the dissemination of the information in such claims.
            (3) Dietary supplements statement.--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--
            (1) immediately cease the use of such treatment;
            (2) refrain from recommending the use of any unapproved 
        drug or medical device that was a part of such treatment;
            (3) report to the manufacturer and the Director of the 
        Centers for Disease Control and Prevention--
                    (A) the nature of such treatment;
                    (B) the results of such treatment;
                    (C) the complete protocol of such treatment; and
                    (D) the source from which such treatment or any 
                part thereof was obtained; and
            (4) include as part of the reporting under paragraph (3), 
        an affidavit pursuant to section 1746 of title 28, United 
        States Code, confirming that all statements made in the report 
        under such paragraph are accurate.
    (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 an approved drug or medical device for a life-
threatening medical condition or conditions, discovers that such 
medical treatment has, in the opinion of the health care practitioner, 
positive effects on such condition or conditions that are significantly 
greater than the positive effects that are expected from an approved 
medical treatment for the same condition or conditions, the 
practitioner shall--
            (1) make a monthly reporting to the National Center for 
        Complementary and Alternative Medicine at the National 
        Institutes of Health of--
                    (A) the nature of such medical treatment (which is 
                not a conventional medical treatment);
                    (B) the general results of such treatment 
                administered in the month involved; and
                    (C) the protocol of such treatment; and
            (2) provide an affidavit pursuant to section 746 of title 
        28, United States Code, confirming that all statements made in 
        the monthly reporting under paragraph (1) are accurate and 
        truthful.

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

    (a) In General.--Notwithstanding any other provision of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 201 et seq.), an individual 
may--
            (1) introduce or deliver into interstate commerce a food, 
        drug, device, or any other equipment; and
            (2) produce, transport, receive and hold 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 of the 
food, drug, device, or equipment involved.
    (b) Notification.--If an individual imports a shipment of a food, 
drug, device, or any other equipment, the individual shall notify the 
Secretary of any such shipment.
    (c) Production of Unapproved Drugs, Devices, and Other Equipment.--
In the case of unapproved drugs, devices, or other equipment, except 
those approved by a country listed in section 3(a)(4), a manufacturer 
shall provide notice the Secretary of the intent of such manufacturer 
to deliver the product into interstate commerce.
    (d) Rule of Construction.--Nothing in this Act shall be construed 
to limit or interfere with the authority of a health care practitioner 
to prescribe, recommend, provide, or administer to a patient for any 
medical condition or disease any unapproved drug or medical device that 
is lawful under the law of the State or States in which the health care 
practitioner practices.

SEC. 7. OTHER LAWS NOT AFFECTED BY THIS ACT.

    Nothing in this Act shall be construed to--
            (1) apply to the manufacture, distribution, possession, 
        administration, recommendation, prescription, or provision, or 
        support the use of any drug that is a controlled substance 
        under the Controlled Substances Act (21 U.S.C. 801 et seq.);
            (2) apply to statements or claims permitted or authorized 
        under sections 403 and 403B of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 343, 343-2); or
            (3) in any way adversely affect the distribution or sale of 
        dietary supplements (as defined in section 201(f) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(f)).

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.
                                 <all>