[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[S. 1378 Introduced in Senate (IS)]







107th CONGRESS
  1st Session
                                S. 1378

 To allow patients access to drugs and medical devices recommended and 
provided by health care practitioners under strict guidelines, and for 
                            other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             August 3, 2001

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

_______________________________________________________________________

                                 A BILL


 
 To allow patients access to drugs and medical devices recommended and 
provided by health care practitioners under strict guidelines, 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 of 
2001''.

SEC. 2. DEFINITIONS.

    In this Act:
            (1) Adulterated.--The term ``adulterated'' means any 
        unapproved drug or medical device that in whole or part 
        consists of any filthy, putrid, or decomposed substance that 
        has been prepared, packed, or held under unsanitary conditions 
        where such drug or device may have been contaminated with such 
        filthy, putrid, or decomposed substance and be injurious to 
        health.
            (2) Advertising claim.--The term ``advertising claim'' 
        means any representation made or suggested by statement, word, 
        device, sound, or any combination thereof with respect to 
        medical treatment.
            (3) Costs.--The term ``costs'' means a charge to patients 
        equal to the amount necessary to recover expenses for making or 
        obtaining the unapproved drug or medical device and providing 
        for its transport to the health care practitioner. Such term 
        does not include the fees charged by a health care practitioner 
        for his or her professional services in administering, 
        providing, or counseling the patient concerning the unapproved 
        drug or medical device.
            (4) Danger.--The term ``danger'' means an adverse reaction, 
        to an unapproved drug or medical device, that used as 
        directed--
                    (A) causes serious harm to the patient in a case in 
                which such harm would not have otherwise occurred; or
                    (B) causes harm that is more serious than side 
                effects for drugs or medical devices approved by the 
                Federal Food and Drug Administration for the same 
                disease or condition.
            (5) Drug.--The term ``drug'' has the same meaning given 
        that term in section 201(g)(1) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 321(g)(1)).
            (6) Health care practitioner.--The term ``health care 
        practitioner'' means a physician or other individual who is a 
        provider of health care, who is authorized under applicable 
        Federal or State law to prescribe or dispense drugs or devices.
            (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) Legal representative.--The term ``legal 
        representative'' means a parent or other person who qualifies 
        as a legal guardian under State law.
            (9) 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)).
            (10) Patient.--The term ``patient'' means any person who 
        seeks medical treatment from a health care practitioner for a 
        disease or health condition.
            (11) Secretary.--The term ``Secretary'' means the Secretary 
        of the Department of Health and Human Services.
            (12) Unapproved drug or medical device.--The term 
        ``unapproved'', 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 360e) or under section 
        351 of the Public Health Service Act (42 U.S.C. 201).

SEC. 3. ACCESS TO MEDICAL TREATMENT.

    (a) In General.--Notwithstanding sections 501(a)(2)(B), 501(e) 
through 501(h), 502(f)(1), 505, 513, and 515 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 351(a)(2)(B), 351(e) through 351(h), 
352(f)(1), 355, 360c, and 360e) and section 351 of the Public Health 
Service Act (42 U.S.C. 201) or any other provision of Federal law, a 
patient may receive, and a health care practitioner may provide or 
administer, any unapproved drug or medical device that the patient 
desires or the legal representative of the patient authorizes if--
            (1) such practitioner has personally examined such patient 
        and agrees to treat such patient;
            (2) the unapproved drug or medical device is recommended by 
        a health care practitioner within that practitioner's scope of 
        practice under State law;
            (3) the provision or administration of the unapproved drug 
        or medical device is not a violation of the laws of the State 
        or States in which the activity is carried out; and
            (4) the health care practitioner abides by all of the 
        requirements in subsection (b).
    (b) Requirements.--A health care practitioner may recommend, 
provide or administer any unapproved drug or medical device for a 
patient, pursuant to subsection (a), if that practitioner--
            (1) does not violate Federal or State law by providing or 
        administering the unapproved drug or medical device;
            (2) does not violate the Controlled Substances Act (21 
        U.S.C. 801 et seq.) by recommending, providing or administering 
        the unapproved drugs;
            (3) has concluded based on generally accepted principles 
        and current information that the unapproved drug or medical 
        device, when used as directed, will not cause a danger to the 
        patient;
            (4) provides the recommendation under circumstances that 
        give the patient sufficient opportunity to consider whether or 
        not to use such a drug or medical device and that minimize the 
        possibility of coercion or undue influence by the health care 
        practitioner;
            (5) discloses to the patient any financial interest that 
        such a practitioner may have in the drug or medical device;
            (6) has informed the patient in writing, prior to 
        recommending, providing, or administering the unapproved drug 
        or medical device--
                    (A) that the unapproved drug or medical device is 
                not approved by the Secretary as safe and effective for 
                the condition of the patient and is considered 
                experimental;
                    (B) of the foreseeable risks and benefits of the 
                unapproved drug or medical device, including any risk 
                to an embryo or fetus, and expected possible side 
                effects or discomforts that the patient may experience 
                and any medical treatment available if side affects 
                occur;
                    (C) of any appropriate alternative procedures or 
                courses of treatment (including procedures or courses 
                of treatment that may involve the use of a drug or 
                medical device that has been approved by the Food and 
                Drug Administration), if any, that may be advantageous 
                for the patient's condition;
                    (D) of any interactions the unapproved drug or 
                medical device may have with other drugs, if any;
                    (E) of the active and inactive ingredients of the 
                unapproved drug and the mechanism of action of the 
                medical device, if known;
                    (F) of the health condition for which the 
                unapproved drug or medical device is provided, the 
                method of administration that will be used, and the 
                unit dose;
                    (G) of the procedures that will be employed by the 
                health care practitioner in using such a drug or 
                medical device;
                    (H) of the extent, if any, to which confidentiality 
                of records identifying the patient will be maintained;
                    (I) for use of such a drug or medical device 
                involving more than minimal risk, of the treatments 
                available if injury occurs, what such treatments 
                involve, and where additional information regarding 
                such treatments may be obtained;
                    (J) of any anticipated circumstances under which 
                the patient's use of such a drug or medical device may 
                be terminated by the health care practitioner without 
                regard to the patient's consent;
                    (K) that the use of an such a drug or medical 
                device is voluntary and that the patient may suspend or 
                terminate treatment at any time;
                    (L) of the consequences of a patient's decision to 
                withdraw from the use of such a drug or medical device;
                    (M) if any information described in subparagraphs 
                (A) through (L) cannot be provided by the health care 
                practitioner because such information is not known at 
                the time the practitioner provides or administers such 
                drug or medical device, that such information cannot be 
                provided by the practitioner; and
                    (N) of any other information or disclosures 
                required by applicable State law for the administration 
                of experimental drugs or medical devices to human 
                subjects;
            (7) has not made, except as provided in subsection (d), any 
        advertising claims for the unapproved drug or medical device;
            (8) does not impose a charge for the unapproved drug or 
        medical device in excess of costs;
            (9) complies with requirements for reporting a danger in 
        section 4; and
            (10) has received a signed affidavit from the patient or 
        the patient's legal representative confirming that the patient 
        or the legal representative--
                    (A) has received the written information required 
                by this subsection and understands it; and
                    (B) desires treatment with the unapproved drug or 
                medical device as recommended by the health care 
                practitioner.
The provisions of paragraph (8) shall not be construed to apply to 
dietary supplements.
    (c) Mandatory Disclosure.--Any manufacturer of an unapproved drug 
or medical device shall disclose, to any health care practitioner that 
has received such drug or medical device from such manufacturer, all 
information available to such manufacturer regarding such drug or 
medical device to enable such practitioner to comply with the 
requirements of subsection (b)(3) and make a determination regarding 
the danger posed by such drug or medical device. Compliance with this 
subsection shall not constitute a violation of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 301 et seq.).
    (d) Advertising Claims Exception.--Subsection (b)(7) shall not 
apply to a health care practitioner's dissemination of information on 
the results of the practitioner's administration of the unapproved drug 
or medical device in a peer-reviewed journal, through academic or 
professional forums, or through statements by a practitioner to a 
patient. Subsection (b)(7) shall not apply to any accurate and truthful 
statement made in person by a health care practitioner to an individual 
or a prospective patient.

SEC. 4. CESSATION OF USE, AND REPORTING OF, DANGEROUS DRUGS AND MEDICAL 
              DEVICES.

    (a) Duty To Protect Patient.--If a health care practitioner 
discovers that an unapproved drug or medical device causes a danger to 
a patient, the practitioner shall immediately cease use and 
recommendation of the unapproved drug or medical device and provide to 
the manufacturer of the unapproved drug or medical device and the 
Director of the Centers for Disease Control and Prevention--
            (1) a written evaluation of the patient's medical condition 
        before and after administration of the unapproved drug or 
        medical device;
            (2) a written evaluation of the adverse reaction, including 
        its physiological manifestations, duration, and the effect of 
        cessation of treatment upon the patient's condition;
            (3) any other information the health care practitioner 
        deems pertinent to an evaluation of the adverse reaction;
            (4) the name, occupation, business address, and business 
        telephone number of the physician;
            (5) the name of the unapproved drug or medical device and a 
        description of the method of administration and operation, 
        dosage, and duration of treatment;
            (6) the lot number, if any, of the unapproved drug or 
        medical device; and
            (7) an affidavit pursuant to section 1746 of title 28, 
        United States Code, confirming that all statements made to the 
        manufacturer are accurate.
    (b) Manufacturer's Duty To Report.--Any manufacturer of an 
unapproved drug or medical device that receives information provided 
under subsection (a) shall immediately--
            (1) cease sale and distribution of the unapproved drug or 
        medical device pending completion of an investigation to 
        determine the actual cause of the danger;
            (2) notify all health care practitioners to whom the 
        manufacturer has provided the unapproved drug or medical device 
        of the information provided to the manufacturer under 
        subsection (a); and
            (3) report to the Secretary in writing that an unapproved 
        drug or medical device (identified by name, known method of 
        operation, unit dose, and intended use) that the manufacturer 
        provided to a health care practitioner for administration under 
        this Act has been reported to be a danger to a patient and 
        confirming that the manufacturer--
                    (A) has ceased sale and distribution of the 
                unapproved drug or medical device pending completion of 
                an investigation to determine the actual cause of the 
                danger; and
                    (B) has notified health care practitioners to which 
                the unapproved drug or medical device has been sent of 
                the information it has received.
    (c) Investigation.--
            (1) In general.--The Director of the Centers for Disease 
        Control and Prevention, upon receipt of the information 
        described in subsection (a), shall conduct an investigation of 
        the unapproved drug or medical device that a health care 
        practitioner has determined to cause a danger to a patient in 
        order to make a determination of the actual cause of such 
        danger.
            (2) Report to secretary.--The Director of the Centers for 
        Disease Control and Prevention shall prepare and submit a 
        report to the Secretary regarding the determination made under 
        paragraph (1), including a determination concerning whether the 
        unapproved drug or medical device is or is not the actual cause 
        of danger or whether the actual cause of danger cannot be 
        determined.
            (3) Duty of secretary.--Upon receipt of the report 
        described in paragraph (2), the Secretary shall--
                    (A) if the Director of the Centers for Disease 
                Control and Prevention determines that the cause of 
                such danger is the unapproved drug or medical device, 
                direct the manufacturer of such drug or medical device 
                to--
                            (i) cease manufacture, sale, and 
                        distribution of such drug or medical device; 
                        and
                            (ii) notify all health care practitioners 
                        to whom the manufacturer has provided such drug 
                        or medical device to cease using or 
                        recommending such drug or medical device, and 
                        to return such drug or medical device to the 
                        manufacturer as part of a complete recall;
                    (B) if the Director of the Centers for Disease 
                Control and Prevention determines that the cause of 
                such danger is not such drug or medical device, direct 
                the manufacturer of such drug or medical device to 
                inform all health care practitioners to whom the 
                manufacturer has provided such drug or medical device 
                of such a determination; and
                    (C) if the Director of the Centers of Disease 
                Control and Prevention cannot determine the cause of 
                the danger, direct the manufacturer of the drug or 
                medical device to inform all health care practitioners 
to whom the manufacturer has provided such drug or medical device of 
such a determination.
    (d) Secretary's Duty To Inform.--Upon receipt of the report 
described in subsection (b)(3), the Secretary shall promptly 
disseminate information concerning the danger to all health care 
practitioners in the United States, to the Director of the National 
Center for Complementary and Alternative Medicine, and to agencies of 
the States that have responsibility for regulating unsafe or 
adulterated drugs and medical devices.

SEC. 5. REPORTING OF RESULTS OF UNAPPROVED DRUGS AND MEDICAL DEVICES.

    (a) Reporting of Results.--If a health care practitioner provides 
or administers an unapproved drug or medical device, that in the 
opinion of the health care practitioner, produces results that are more 
beneficial than results produced from any drug or medical device 
approved by the Food and Drug Administration, or produces other results 
regarding the effectiveness of the treatment relative to treatments 
approved by the Food and Drug Administration for the same condition, 
the practitioner shall provide to the manufacturer--
            (1) the results of the administration of the drug or 
        device;
            (2) a written evaluation of the patient's medical condition 
        before and after administration of the unapproved drug or 
        medical device;
            (3) the name, occupation, business address, and business 
        telephone number of the physician;
            (4) the name of the unapproved drug or medical device and a 
        description of the method of operation and administration, 
        dosing, and duration of treatment; and
            (5) an affidavit pursuant to section 1746 of title 28, 
        United States Code, confirming that all statements made to the 
        manufacturer are accurate.
    (b) Manufacturer's Duty To Report.--Any manufacturer of an 
unapproved drug or medical device that receives information under 
subsection (a) shall provide to the Director of the National Center for 
Complementary and Alternative Medicine--
            (1) a complete copy of the information;
            (2) the name, business address, and business telephone 
        number of the manufacturer;
            (3) the name, business address, and business telephone 
        number of the health care practitioner who supplied information 
        to the manufacturer;
            (4) the name of the unapproved drug or medical device;
            (5) the known method of operation and administration of the 
        unapproved drug or medical device;
            (6) the per unit dose; and
            (7) the intended use of the unapproved drug or medical 
        device.
    (c) Director's Duty To Make Public.--The Director of the National 
Center for Complementary and Alternative Medicine shall review and 
analyze information received pursuant to subsection (b) about an 
unapproved drug or medical device and make available, on an Internet 
website and in writing upon request by any individual, an annual review 
and analysis of such information, and include a statement that such 
drug or medical device is not approved by the Food and Drug 
Administration.

SEC. 6. OTHER LAWS NOT AFFECTED BY THIS ACT.

    This Act--
            (1) shall not be construed--
                    (A) to have any effect on section 503A of the 
                Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353a);
                    (B) to have any effect on the Controlled Substances 
                Act (21 U.S.C. 801 et seq.); or
                    (C) to supersede any law of a State or political 
                subdivision of a State, including laws governing rights 
                and duties among health care practitioners and 
                patients;
            (2) shall not 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); and
            (3) shall not in any way adversely affect the distribution 
        or sale of dietary supplements (as defined in section 201(ff) 
        of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        321(ff)).

SEC. 7. AUTHORIZED ACTIVITIES OF HEALTH CARE PRACTITIONERS.

    (a) Introduction in Interstate Commerce.--To the extent necessary 
to comply with this Act, a health care practitioner may--
            (1) introduce an unapproved drug or medical device into 
        interstate commerce;
            (2) deliver an unapproved drug or medical device for 
        introduction into such commerce;
            (3) transport an unapproved drug or medical device in such 
        commerce;
            (4) receive an unapproved drug or medical device in such 
        commerce and deliver the unapproved drug or medical device; and
            (5) hold an unapproved drug or medical device for sale 
        after shipment of the unapproved drug or medical device in such 
        commerce.
    (b) Rule of Construction.--This Act shall not 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 
condition or disease any unapproved drug or medical device lawful under 
the law of the State or States in which the health care practitioner 
practices.

SEC. 8. PENALTY.

    A health care practitioner or manufacturer found to have knowingly 
violated this Act shall be denied coverage under this Act.
                                 <all>