[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2635 Introduced in House (IH)]







106th CONGRESS
  1st Session
                                H. R. 2635

 To allow patients access to drugs and medical devices recommended and 
provided by health care practitioners that are not approved by the Food 
            and Drug Administration, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             July 29, 1999

   Mr. DeFazio (for himself, Mr. Burton of Indiana, Mr. Sanders, Mr. 
 Hinchey, Mr. Hayworth, Mr. Owens, Mr. Campbell, Mr. Rohrabacher, Mr. 
Andrews, Mr. Dreier, Mr. Wynn, Mr. Paul, Mr. Lipinski, Mrs. Myrick, Mr. 
 Filner, Mr. Stump, Mr. Rahall, Ms. Woolsey, Mr. Ackerman, Mr. Duncan, 
 Mr. Costello, Mr. Oberstar, Mr. Farr of California, and Mr. Taylor of 
 North Carolina) introduced the following bill; which was referred to 
                       the Committee on Commerce

_______________________________________________________________________

                                 A BILL


 
 To allow patients access to drugs and medical devices recommended and 
provided by health care practitioners that are not approved by the Food 
            and Drug Administration, 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 the following:
            (1) Avoiding regulation that lessens or impairs the health 
        status of the people of the United States is a priority of the 
        Federal Government.
            (2) The quality of health care in the United States depends 
        primarily on the freedom of each patient to choose a medical 
        treatment recommended by a health care practitioner and the 
        freedom of each health care practitioner to exercise 
        independent professional judgment in the selection and 
        recommendation of a treatment that the professional deems most 
        likely to satisfy the unique needs and tolerances of the 
        patient.
            (3) In the treatment of patients, health care practitioners 
        must be free to recommend drugs and medical devices not 
        approved by the Food and Drug Administration if in the 
        practitioner's independent professional judgment such drugs and 
        medical devices are necessary and offer hope of saving life, 
        reestablishing health, or alleviating suffering.
            (4) Certain diseases may not be cured by drugs or medical 
        devices approved by the Food and Drug Administration.
            (5) Drugs and medical devices approved by the Food and Drug 
        Administration are sometimes injurious to health when 
        administered to particular patients.
            (6) Patients sometimes prefer not to be treated with drugs 
        or medical devices approved by the Food and Drug 
        Administration.
            (7) In consultation with a health care practitioner, each 
        patient has a right to freedom of choice in deciding what drugs 
        to take and what medical devices to have applied to his or her 
        own body.
            (8) Although the Federal Government should act swiftly to 
        halt the manufacture, sale, and distribution of drugs and 
        medical devices that are adulterated within the meaning of this 
        Act, it should not take any action to interfere with a health 
        care practice regulated by the States.
            (9) Many drugs and medical devices not approved by the Food 
        and Drug Administration for manufacture, sale, and distribution 
        in the United States, including those marketed lawfully in 
        other countries, may be desired by patients and recommended by 
        health care practitioners.
            (10) Existing State laws governing the practice of medicine 
        and this Act provide adequate protection for practitioner-
        recommended patient use of drugs and medical devices not 
        approved by the Food and Drug Administration.

SEC. 3. DEFINITIONS.

    As used in this Act:
            (1) Advertising claims.--The term ``advertising claims'' 
        means proposals to engage in commercial transactions involving 
        the sale of an unapproved drug or medical device at a price 
        above costs.
            (2) Adulterated.--The term ``adulterated'' means any 
        unapproved drug or medical device that in whole or part 
        consists of any filthy, putrid, or decomposed substance or that 
        causes a danger to a patient.
            (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.
            (4) Danger.--The term ``danger'' means an adverse reaction 
        to an unapproved drug or medical device that--
                    (A) causes serious harm when used as directed;
                    (B) would not otherwise have occurred; and
                    (C) is more serious than contraindications 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 person authorized to 
        provide health care service in the State in which the service 
        is performed.
            (7) Legal representative.--The term ``legal 
        representative'' means a parent or other person who qualifies 
        as a legal guardian under State law.
            (8) Medical device.--The term ``medical device'' has the 
        same meaning given that term in section 201(h) of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 321(h)).
            (9) Unapproved drug or medical device.--The term 
        ``unapproved'', with respect to a drug or medical device, means 
        a new 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).
            (10) Patient.--The term ``patient'' means any person who 
        seeks medical treatment from a health care practitioner for a 
        disease or disease condition.
            (11) Secretary.--The term ``Secretary'' means the Secretary 
        of the Department of Health and Human Services.
            (12) Seller.--The term ``seller'' means a person, company, 
        or organization that receives payment for an unapproved drug or 
        medical device, except that this term does not apply to a 
        health care practitioner who receives payment from a patient or 
        legal representative of a patient for medical services, 
        including the administration of an unapproved drug or medical 
        device unless the health care practitioner is also the 
        manufacturer of the unapproved drug or medical device.

SEC. 4. ACCESS TO MEDICAL TREATMENT.

    (a) In General.--Notwithstanding sections 501(a)(2)(B), 501(e) 
through 501(h), 502(f)(1), 513, 505, and 515 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321(a)(2)(B), 351(c) through 351(h), 
351(e), 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, 
any unapproved drug or medical device that the patient desires or the 
legal representative of the patient authorizes if--
            (1) the unapproved drug or medical device is recommended by 
        a health care practitioner within that practitioner's scope of 
        practice under State law;
            (2) the 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
            (3) the health care practitioner abides by all of the 
        recommendation requirements in subsection (b).
    (b) Recommendation Requirements.--A health care practitioner may 
recommend and provide any unapproved drug or medical device to a 
patient, pursuant to subsection (a), if that practitioner--
            (1) does not violate State law by providing or 
        administering the unapproved drug or medical device;
            (2) does not violate the Controlled Substances Act by 
        providing or administering the unapproved drug;
            (3) has concluded that the unapproved drug or medical 
        device, used as directed, will not pose a danger to the 
        patient;
            (4) has informed the patient in writing, prior to 
        recommending or providing 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) that the patient may suspend or terminate 
                treatment at any time;
                    (C) the currently indicated and generally accepted 
                treatment or treatments for the patient's condition, if 
                any;
                    (D) interactions the unapproved drug or medical 
                device may have with other drugs, if any;
                    (E) the active and inactive ingredients of the 
                unapproved drug and the mechanism of action, if known;
                    (F) the mechanism of action of the medical device;
                    (G) the health condition for which the unapproved 
                drug or medical device is provided, the method of 
                administration that the patient should or the health 
                care practitioner will use, and the unit dose;
                    (H) the opinion of the health care practitioner 
                concerning the risks and benefits of the unapproved 
                drug or medical device, including any expected possible 
                side effects; and
                    (I) any other information or disclosures required 
                by applicable State law for the administration of 
                experimental drugs or medical devices to human 
                subjects;
            (5) has not made, except as provided in subsection (c), any 
        advertising claims for the unapproved drug or medical device;
            (6) does not impose a charge for the unapproved drug or 
        medical device in excess of costs;
            (7) complies with requirements for reporting a danger in 
        section 5; and
            (8) 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 subsection (b)(4)(A)-(I) and understands it; and
                    (B) desires treatment with the unapproved drug or 
                medical device as recommended by the health care 
                practitioner.
    (c) Advertising Claims Exception.--
            (1) Reporting by a health care practitioner.--Subsection 
        (b)(5) 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 unless the health care practitioner makes an offer to 
        sell the unapproved drug or medical device in connection with 
        the dissemination of that information.
            (2) Dietary supplement statements.--Subsection (b)(5) 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 and 343-2).

SEC. 5. 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 creates 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--
            (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, 
        dosing, 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 by the 
        manufacturer 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 by the manufacturer 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) Manufacturer's Duty To Investigate.--Upon receipt of the 
information described in subsection (a), the manufacturer shall 
commence an investigation to determine the actual cause of the danger, 
and shall carry out the following, as applicable:
            (1) If the actual cause is determined to be the unapproved 
        drug or medical device, the manufacturer shall cease 
        manufacture, sale, and distribution of the unapproved drug or 
        medical device; shall notify all health care practitioners to 
        whom the manufacturer has provided the unapproved drug or 
        medical device to cease use and recommendation of the 
        unapproved drug or medical device and return the unapproved 
        drug or medical device to the manufacturer for a complete 
        recall; and shall notify the Secretary that it has taken each 
        of the foregoing steps.
            (2) If the actual cause is determined not to be the 
        unapproved drug or medical device, the manufacturer shall 
        inform all health care practitioners to whom the manufacturer 
        has provided the unapproved drug or medical device of that 
        determination and of any recommendations on use or 
        modifications of the unapproved drug or medical device the 
        manufacturer deems appropriate and shall notify the Secretary 
        that it has taken each of the foregoing steps.
            (3) If the actual cause is not determined, the manufacturer 
        shall inform all health care practitioners to whom the 
        manufacturer has provided the unapproved drug or medical device 
        of that finding; shall make any recommendations on use or 
        modifications of the unapproved drug or medical device the 
        manufacturer deems appropriate; and shall notify the Secretary 
        that it has taken each of the foregoing steps.
    (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. 6. REPORTING OF BENEFICIAL DRUGS AND MEDICAL DEVICES.

    (a) Reporting of Beneficial Results.--If a health care practitioner 
discovers that an unapproved drug or medical device used in the 
treatment of a life threatening medical condition produces results 
that, in the opinion of the practitioner, are significantly more 
beneficial than results produced from a drug or medical device approved 
by the Food and Drug Administration for the same condition or 
conditions, the practitioner shall provide to the manufacturer of the 
unapproved drug or medical device--
            (1) a written evaluation of the patient's medical condition 
        before and after administration of the unapproved drug or 
        medical device;
            (2) the name, occupation, business address, and business 
        telephone number of the physician;
            (3) 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
            (4) 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) Notice to Congress of Beneficial Results.--Each year on the 
fifteenth day of January after the date of enactment of this Act, the 
Director of the National Center for Complementary and Alternative 
Medicine shall submit to Congress a report accurately summarizing all 
information it has received under subsection (b). The Director and the 
Congress shall make the Director's report available to the public.

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

    This Act does not have any effect on section 503A of the Federal 
Food, Drug, and Cosmetic Act nor does this Act supersede any law of a 
State or political subdivision of a State, including laws governing 
rights and duties among health care practitioners and patients.

SEC. 8. AUTHORIZED ACTIVITIES OF HEALTH CARE PRACTITIONERS.

    In conformity with the provisions of this Act, a health care 
practitioner may introduce an unapproved drug or medical device into 
interstate commerce; deliver an unapproved drug or medical device for 
introduction into such commerce; transport an unapproved drug or 
medical device in such commerce; receive an unapproved drug or medical 
device in such commerce and deliver the unapproved drug or medical 
device; and hold an unapproved drug or medical device for sale after 
shipment of the unapproved drug or medical device in such commerce. 
This Act shall not be construed to limit or interfere with the 
authority of a health care practitioner to prescribe, recommend, 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. 9. PENALTY.

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