II

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.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE.

4 This Act may be cited as the ‘‘Access to Medical

5 Treatment Act of 2001’’.

6 SEC. 2. DEFINITIONS.

7 In this Act:
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•S 1378 IS

1 (1) ADULTERATED.—The term ‘‘adulterated’’

2 means any unapproved drug or medical device that

3 in whole or part consists of any filthy, putrid, or de4 composed substance that has been prepared, packed,

5 or held under unsanitary conditions where such drug

6 or device may have been contaminated with such

7 filthy, putrid, or decomposed substance and be inju8 rious to health.

9 (2) ADVERTISING CLAIM.—The term ‘‘adver10 tising claim’’ means any representation made or sug11 gested by statement, word, device, sound, or any

12 combination thereof with respect to medical treat13 ment.

14 (3) COSTS.—The term ‘‘costs’’ means a charge

15 to patients equal to the amount necessary to recover

16 expenses for making or obtaining the unapproved

17 drug or medical device and providing for its trans18 port to the health care practitioner. Such term does

19 not include the fees charged by a health care practi20 tioner for his or her professional services in admin21 istering, providing, or counseling the patient con22 cerning the unapproved drug or medical device.

23 (4) DANGER.—The term ‘‘danger’’ means an

24 adverse reaction, to an unapproved drug or medical

25 device, that used as directed—
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1 (A) causes serious harm to the patient in

2 a case in which such harm would not have oth3 erwise occurred; or

4 (B) causes harm that is more serious than

5 side effects for drugs or medical devices ap6 proved by the Federal Food and Drug Adminis7 tration for the same disease or condition.

8 (5) DRUG.—The term ‘‘drug’’ has the same

9 meaning given that term in section 201(g)(1) of the

10 Federal Food, Drug, and Cosmetic Act (21 U.S.C.

11 321(g)(1)).

12 (6) HEALTH CARE PRACTITIONER.—The term

13 ‘‘health care practitioner’’ means a physician or

14 other individual who is a provider of health care,

15 who is authorized under applicable Federal or State

16 law to prescribe or dispense drugs or devices.

17 (7) INTERSTATE COMMERCE.—The term ‘‘inter18 state commerce’’ means commerce between any

19 State or Territory and any place outside thereof,

20 and commerce within the District of Columbia or

21 within any other Territory not organized with a leg22 islative body.

23 (8) LEGAL REPRESENTATIVE.—The term ‘‘legal

24 representative’’ means a parent or other person who

25 qualifies as a legal guardian under State law.
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1 (9) MEDICAL DEVICE.—The term ‘‘medical de2 vice’’ has the same meaning given the term ‘‘device’’

3 in section 201(h) of the Federal Food, Drug, and

4 Cosmetic Act (21 U.S.C. 321(h)).

5 (10) PATIENT.—The term ‘‘patient’’ means any

6 person who seeks medical treatment from a health

7 care practitioner for a disease or health condition.

8 (11) SECRETARY.—The term ‘‘Secretary’’

9 means the Secretary of the Department of Health

10 and Human Services.

11 (12) UNAPPROVED DRUG OR MEDICAL DE12 VICE.—The term ‘‘unapproved’’, with respect to a

13 drug or medical device, means a drug or medical de14 vice that is not approved or authorized for manufac15 ture, sale, and distribution in interstate commerce

16 under section 505, 513, or 515 of the Federal Food,

17 Drug, and Cosmetic Act (21 U.S.C. 355, 360c, and

18 360e) or under section 351 of the Public Health

19 Service Act (42 U.S.C. 201).

20 SEC. 3. ACCESS TO MEDICAL TREATMENT.

21 (a) IN GENERAL.—Notwithstanding sections

22 501(a)(2)(B), 501(e) through 501(h), 502(f)(1), 505,

23 513, and 515 of the Federal Food, Drug, and Cosmetic

24 Act (21 U.S.C. 351(a)(2)(B), 351(e) through 351(h),

25 352(f)(1), 355, 360c, and 360e) and section 351 of the
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1 Public Health Service Act (42 U.S.C. 201) or any other

2 provision of Federal law, a patient may receive, and a

3 health care practitioner may provide or administer, any

4 unapproved drug or medical device that the patient desires

5 or the legal representative of the patient authorizes if—

6 (1) such practitioner has personally examined

7 such patient and agrees to treat such patient;

8 (2) the unapproved drug or medical device is

9 recommended by a health care practitioner within

10 that practitioner’s scope of practice under State law;

11 (3) the provision or administration of the unap12 proved drug or medical device is not a violation of

13 the laws of the State or States in which the activity

14 is carried out; and

15 (4) the health care practitioner abides by all of

16 the requirements in subsection (b).

17 (b) REQUIREMENTS.—A health care practitioner may

18 recommend, provide or administer any unapproved drug

19 or medical device for a patient, pursuant to subsection (a),

20 if that practitioner—

21 (1) does not violate Federal or State law by

22 providing or administering the unapproved drug or

23 medical device;
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1 (2) does not violate the Controlled Substances

2 Act (21 U.S.C. 801 et seq.) by recommending, pro3 viding or administering the unapproved drugs;

4 (3) has concluded based on generally accepted

5 principles and current information that the unap6 proved drug or medical device, when used as di7 rected, will not cause a danger to the patient;

8 (4) provides the recommendation under cir9 cumstances that give the patient sufficient oppor10 tunity to consider whether or not to use such a drug

11 or medical device and that minimize the possibility

12 of coercion or undue influence by the health care

13 practitioner;

14 (5) discloses to the patient any financial inter15 est that such a practitioner may have in the drug or

16 medical device;

17 (6) has informed the patient in writing, prior to

18 recommending, providing, or administering the un19 approved drug or medical device—

20 (A) that the unapproved drug or medical

21 device is not approved by the Secretary as safe

22 and effective for the condition of the patient

23 and is considered experimental;

24 (B) of the foreseeable risks and benefits of

25 the unapproved drug or medical device, includ-
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1 ing any risk to an embryo or fetus, and ex2 pected possible side effects or discomforts that

3 the patient may experience and any medical

4 treatment available if side affects occur;

5 (C) of any appropriate alternative proce6 dures or courses of treatment (including proce7 dures or courses of treatment that may involve

8 the use of a drug or medical device that has

9 been approved by the Food and Drug Adminis10 tration), if any, that may be advantageous for

11 the patient’s condition;

12 (D) of any interactions the unapproved

13 drug or medical device may have with other

14 drugs, if any;

15 (E) of the active and inactive ingredients

16 of the unapproved drug and the mechanism of

17 action of the medical device, if known;

18 (F) of the health condition for which the

19 unapproved drug or medical device is provided,

20 the method of administration that will be used,

21 and the unit dose;

22 (G) of the procedures that will be employed

23 by the health care practitioner in using such a

24 drug or medical device;
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1 (H) of the extent, if any, to which con2 fidentiality of records identifying the patient

3 will be maintained;

4 (I) for use of such a drug or medical de5 vice involving more than minimal risk, of the

6 treatments available if injury occurs, what such

7 treatments involve, and where additional infor8 mation regarding such treatments may be ob9 tained;

10 (J) of any anticipated circumstances under

11 which the patient’s use of such a drug or med12 ical device may be terminated by the health

13 care practitioner without regard to the patient’s

14 consent;

15 (K) that the use of an such a drug or med16 ical device is voluntary and that the patient

17 may suspend or terminate treatment at any

18 time;

19 (L) of the consequences of a patient’s deci20 sion to withdraw from the use of such a drug

21 or medical device;

22 (M) if any information described in sub23 paragraphs (A) through (L) cannot be provided

24 by the health care practitioner because such in25 formation is not known at the time the practi-
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1 tioner provides or administers such drug or

2 medical device, that such information cannot be

3 provided by the practitioner; and

4 (N) of any other information or disclosures

5 required by applicable State law for the admin6 istration of experimental drugs or medical de7 vices to human subjects;

8 (7) has not made, except as provided in sub9 section (d), any advertising claims for the unap10 proved drug or medical device;

11 (8) does not impose a charge for the unap12 proved drug or medical device in excess of costs;

13 (9) complies with requirements for reporting a

14 danger in section 4; and

15 (10) has received a signed affidavit from the

16 patient or the patient’s legal representative con17 firming that the patient or the legal representative—

18 (A) has received the written information

19 required by this subsection and understands it;

20 and

21 (B) desires treatment with the unapproved

22 drug or medical device as recommended by the

23 health care practitioner.

24 The provisions of paragraph (8) shall not be construed to

25 apply to dietary supplements.
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1 (c) MANDATORY DISCLOSURE.—Any manufacturer of

2 an unapproved drug or medical device shall disclose, to

3 any health care practitioner that has received such drug

4 or medical device from such manufacturer, all information

5 available to such manufacturer regarding such drug or

6 medical device to enable such practitioner to comply with

7 the requirements of subsection (b)(3) and make a deter8 mination regarding the danger posed by such drug or med9 ical device. Compliance with this subsection shall not con10 stitute a violation of the Federal Food, Drug, and Cos11 metic Act (21 U.S.C. 301 et seq.).

12 (d) ADVERTISING CLAIMS EXCEPTION.—Subsection

13 (b)(7) shall not apply to a health care practitioner’s dis14 semination of information on the results of the practi15 tioner’s administration of the unapproved drug or medical

16 device in a peer-reviewed journal, through academic or

17 professional forums, or through statements by a practi18 tioner to a patient. Subsection (b)(7) shall not apply to

19 any accurate and truthful statement made in person by

20 a health care practitioner to an individual or a prospective

21 patient.

22 SEC. 4. CESSATION OF USE, AND REPORTING OF, DAN23 GEROUS DRUGS AND MEDICAL DEVICES.

24 (a) DUTY TO PROTECT PATIENT.—If a health care

25 practitioner discovers that an unapproved drug or medical
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1 device causes a danger to a patient, the practitioner shall

2 immediately cease use and recommendation of the unap3 proved drug or medical device and provide to the manufac4 turer of the unapproved drug or medical device and the

5 Director of the Centers for Disease Control and

6 Prevention—

7 (1) a written evaluation of the patient’s medical

8 condition before and after administration of the un9 approved drug or medical device;

10 (2) a written evaluation of the adverse reaction,

11 including its physiological manifestations, duration,

12 and the effect of cessation of treatment upon the pa13 tient’s condition;

14 (3) any other information the health care prac15 titioner deems pertinent to an evaluation of the ad16 verse reaction;

17 (4) the name, occupation, business address, and

18 business telephone number of the physician;

19 (5) the name of the unapproved drug or med20 ical device and a description of the method of ad21 ministration and operation, dosage, and duration of

22 treatment;

23 (6) the lot number, if any, of the unapproved

24 drug or medical device; and
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1 (7) an affidavit pursuant to section 1746 of

2 title 28, United States Code, confirming that all

3 statements made to the manufacturer are accurate.

4 (b) MANUFACTURER’S DUTY TO REPORT.—Any

5 manufacturer of an unapproved drug or medical device

6 that receives information provided under subsection (a)

7 shall immediately—

8 (1) cease sale and distribution of the unap9 proved drug or medical device pending completion of

10 an investigation to determine the actual cause of the

11 danger;

12 (2) notify all health care practitioners to whom

13 the manufacturer has provided the unapproved drug

14 or medical device of the information provided to the

15 manufacturer under subsection (a); and

16 (3) report to the Secretary in writing that an

17 unapproved drug or medical device (identified by

18 name, known method of operation, unit dose, and in19 tended use) that the manufacturer provided to a

20 health care practitioner for administration under

21 this Act has been reported to be a danger to a pa22 tient and confirming that the manufacturer—

23 (A) has ceased sale and distribution of the

24 unapproved drug or medical device pending
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1 completion of an investigation to determine the

2 actual cause of the danger; and

3 (B) has notified health care practitioners

4 to which the unapproved drug or medical device

5 has been sent of the information it has received.

6 (c) INVESTIGATION.—

7 (1) IN GENERAL.—The Director of the Centers

8 for Disease Control and Prevention, upon receipt of

9 the information described in subsection (a), shall

10 conduct an investigation of the unapproved drug or

11 medical device that a health care practitioner has

12 determined to cause a danger to a patient in order

13 to make a determination of the actual cause of such

14 danger.

15 (2) REPORT TO SECRETARY.—The Director of

16 the Centers for Disease Control and Prevention shall

17 prepare and submit a report to the Secretary re18 garding the determination made under paragraph

19 (1), including a determination concerning whether

20 the unapproved drug or medical device is or is not

21 the actual cause of danger or whether the actual

22 cause of danger cannot be determined.

23 (3) DUTY OF SECRETARY.—Upon receipt of the

24 report described in paragraph (2), the Secretary

25 shall—
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1 (A) if the Director of the Centers for Dis2 ease Control and Prevention determines that

3 the cause of such danger is the unapproved

4 drug or medical device, direct the manufacturer

5 of such drug or medical device to—

6 (i) cease manufacture, sale, and dis7 tribution of such drug or medical device;

8 and

9 (ii) notify all health care practitioners

10 to whom the manufacturer has provided

11 such drug or medical device to cease using

12 or recommending such drug or medical de13 vice, and to return such drug or medical

14 device to the manufacturer as part of a

15 complete recall;

16 (B) if the Director of the Centers for Dis17 ease Control and Prevention determines that

18 the cause of such danger is not such drug or

19 medical device, direct the manufacturer of such

20 drug or medical device to inform all health care

21 practitioners to whom the manufacturer has

22 provided such drug or medical device of such a

23 determination; and

24 (C) if the Director of the Centers of Dis25 ease Control and Prevention cannot determine
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1 the cause of the danger, direct the manufac2 turer of the drug or medical device to inform all

3 health care practitioners to whom the manufac4 turer has provided such drug or medical device

5 of such a determination.

6 (d) SECRETARY’S DUTY TO INFORM.—Upon receipt

7 of the report described in subsection (b)(3), the Secretary

8 shall promptly disseminate information concerning the

9 danger to all health care practitioners in the United

10 States, to the Director of the National Center for Com11 plementary and Alternative Medicine, and to agencies of

12 the States that have responsibility for regulating unsafe

13 or adulterated drugs and medical devices.

14 SEC. 5. REPORTING OF RESULTS OF UNAPPROVED DRUGS

15 AND MEDICAL DEVICES.

16 (a) REPORTING OF RESULTS.—If a health care prac17 titioner provides or administers an unapproved drug or

18 medical device, that in the opinion of the health care prac19 titioner, produces results that are more beneficial than re20 sults produced from any drug or medical device approved

21 by the Food and Drug Administration, or produces other

22 results regarding the effectiveness of the treatment rel23 ative to treatments approved by the Food and Drug Ad24 ministration for the same condition, the practitioner shall

25 provide to the manufacturer—
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1 (1) the results of the administration of the drug

2 or device;

3 (2) a written evaluation of the patient’s medical

4 condition before and after administration of the un5 approved drug or medical device;

6 (3) the name, occupation, business address, and

7 business telephone number of the physician;

8 (4) the name of the unapproved drug or med9 ical device and a description of the method of oper10 ation and administration, dosing, and duration of

11 treatment; and

12 (5) an affidavit pursuant to section 1746 of

13 title 28, United States Code, confirming that all

14 statements made to the manufacturer are accurate.

15 (b) MANUFACTURER’S DUTY TO REPORT.—Any

16 manufacturer of an unapproved drug or medical device

17 that receives information under subsection (a) shall pro18 vide to the Director of the National Center for Com19 plementary and Alternative Medicine—

20 (1) a complete copy of the information;

21 (2) the name, business address, and business

22 telephone number of the manufacturer;

23 (3) the name, business address, and business

24 telephone number of the health care practitioner who

25 supplied information to the manufacturer;
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1 (4) the name of the unapproved drug or med2 ical device;

3 (5) the known method of operation and admin4 istration of the unapproved drug or medical device;

5 (6) the per unit dose; and

6 (7) the intended use of the unapproved drug or

7 medical device.

8 (c) DIRECTOR’S DUTY TO MAKE PUBLIC.—The Di9 rector of the National Center for Complementary and Al10 ternative Medicine shall review and analyze information

11 received pursuant to subsection (b) about an unapproved

12 drug or medical device and make available, on an Internet

13 website and in writing upon request by any individual, an

14 annual review and analysis of such information, and in15 clude a statement that such drug or medical device is not

16 approved by the Food and Drug Administration.

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

18 This Act—

19 (1) shall not be construed—

20 (A) to have any effect on section 503A of

21 the Federal Food, Drug, and Cosmetic Act (21

22 U.S.C. 353a);

23 (B) to have any effect on the Controlled

24 Substances Act (21 U.S.C. 801 et seq.); or
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1 (C) to supersede any law of a State or po2 litical subdivision of a State, including laws gov3 erning rights and duties among health care

4 practitioners and patients;

5 (2) shall not apply to statements or claims per6 mitted or authorized under sections 403 and 403B

7 of the Federal Food, Drug, and Cosmetic Act (21

8 U.S.C. 343, 343–2); and

9 (3) shall not in any way adversely affect the

10 distribution or sale of dietary supplements (as de11 fined in section 201(ff) of the Federal Food, Drug,

12 and Cosmetic Act (21 U.S.C. 321(ff)).

13 SEC. 7. AUTHORIZED ACTIVITIES OF HEALTH CARE PRAC14 TITIONERS.

15 (a) INTRODUCTION IN INTERSTATE COMMERCE.—To

16 the extent necessary to comply with this Act, a health care

17 practitioner may—

18 (1) introduce an unapproved drug or medical

19 device into interstate commerce;

20 (2) deliver an unapproved drug or medical de21 vice for introduction into such commerce;

22 (3) transport an unapproved drug or medical

23 device in such commerce;
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1 (4) receive an unapproved drug or medical de2 vice in such commerce and deliver the unapproved

3 drug or medical device; and

4 (5) hold an unapproved drug or medical device

5 for sale after shipment of the unapproved drug or

6 medical device in such commerce.

7 (b) RULE OF CONSTRUCTION.—This Act shall not be

8 construed to limit or interfere with the authority of a

9 health care practitioner to prescribe, recommend, provide

10 or administer to a patient for any condition or disease any

11 unapproved drug or medical device lawful under the law

12 of the State or States in which the health care practitioner

13 practices.

14 SEC. 8. PENALTY.

15 A health care practitioner or manufacturer found to

16 have knowingly violated this Act shall be denied coverage

17 under this Act.

Æ