II

106TH CONGRESS

1ST SESSION S. 1955

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 SENATE OF THE UNITED STATES

NOVEMBER 18, 1999

Mr. DASCHLE (for himself, Mr. HARKIN, Mr. INOUYE, Mr. REID, and Mr.

JOHNSON) 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 that

are not approved by the Food and Drug Administration,

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’’.

6 SEC. 2. DEFINITIONS.

7 In this Act:
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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.

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

20 adverse reaction, to an unapproved drug or medical

21 device, that used as directed—

22 (A) causes serious harm to the patient in

23 a case in which such harm would not have oth24 erwise occurred; or
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1 (B) causes harm that is more serious than

2 side effects for drugs or medical devices ap3 proved by the Federal Food and Drug Adminis4 tration for the same disease or condition.

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

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

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

8 321(g)(1)).

9 (6) HEALTH CARE PRACTITIONER.—The term

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

11 other individual who is a provider of health care,

12 who is authorized under the law of a State to pre13 scribe drugs or devices.

14 (7) INTERSTATE COMMERCE.—The term ‘‘inter15 state commerce’’ means commerce between any

16 State or Territory and any place outside thereof,

17 and commerce within the District of Columbia or

18 within any other Territory not organized with a leg19 islative body.

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

21 representative’’ means a parent or other person who

22 qualifies as a legal guardian under State law.

23 (9) MEDICAL DEVICE.—The term ‘‘medical de24 vice’’ has the same meaning given the term ‘‘device’’
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1 in section 201(h) of the Federal Food, Drug, and

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

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

4 person who seeks medical treatment from a health

5 care practitioner for a disease or health condition.

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

7 means the Secretary of the Department of Health

8 and Human Services.

9 (12) UNAPPROVED DRUG OR MEDICAL DE10 VICE.—The term ‘‘unapproved’’, with respect to a

11 drug or medical device, means a drug or medical de12 vice that is not approved or authorized for manufac13 ture, sale, and distribution in interstate commerce

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

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

16 360e) or under section 351 of the Public Health

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

18 SEC. 3. ACCESS TO MEDICAL TREATMENT.

19 (a) IN GENERAL.—Notwithstanding sections

20 501(a)(2)(B), 501(e) through 501(h), 502(f)(1), 505,

21 513, and 515 of the Federal Food, Drug, and Cosmetic

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

23 352(f)(1), 355, 360c, and 360e) and section 351 of the

24 Public Health Service Act (42 U.S.C. 201) or any other

25 provision of Federal law, a patient may receive, and a
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1 health care practitioner may provide or administer, any

2 unapproved drug or medical device that the patient desires

3 or the legal representative of the patient authorizes if—

4 (1) the unapproved drug or medical device is

5 recommended by a health care practitioner within

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

7 (2) the provision or administration of the unap8 proved drug or medical device is not a violation of

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

10 is carried out; and

11 (3) the health care practitioner abides by all of

12 the requirements in subsection (b).

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

14 recommend, provide or administer any unapproved drug

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

16 if that practitioner—

17 (1) does not violate State law by providing or

18 administering the unapproved drug or medical de19 vice;

20 (2) does not violate the Controlled Substances

21 Act (21 U.S.C. 801 et seq.) by providing or admin22 istering the unapproved drugs;

23 (3) has concluded based on generally accepted

24 principles and current information that the unap-
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1 proved drug or medical device, when used as di2 rected, will not cause a danger to the patient;

3 (4) provides the recommendation under cir4 cumstances that give the patient sufficient oppor5 tunity to consider whether or not to use such a drug

6 or medical device and that minimize the possibility

7 of coercion or undue influence by the health care

8 practitioner;

9 (5) discloses to the patient any financial inter10 est that such a practitioner may have in the drug or

11 medical device;

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

13 recommending, providing, or administering the un14 approved drug or medical device—

15 (A) that the unapproved drug or medical

16 device is not approved by the Secretary as safe

17 and effective for the condition of the patient

18 and is considered experimental;

19 (B) of the foreseeable risks and benefits of

20 the unapproved drug or medical device, includ21 ing any risk to an embryo or fetus, and ex22 pected possible side effects or discomforts that

23 the patient may experience and any medical

24 treatment available if side affects occur;
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1 (C) of any appropriate alternative proce2 dures or courses of treatment (including proce3 dures or courses of treatment that may involve

4 the use of a drug or medical device that has

5 been approved by the Food and Drug Adminis6 tration), if any, that may be advantageous for

7 the patient’s condition;

8 (D) of any interactions the unapproved

9 drug or medical device may have with other

10 drugs, if any;

11 (E) of the active and inactive ingredients

12 of the unapproved drug and the mechanism of

13 action of the medical device, if known;

14 (F) of the health condition for which the

15 unapproved drug or medical device is provided,

16 the method of administration that will be used,

17 and the unit dose;

18 (G) of the procedures that will be employed

19 by the health care practitioner in using such a

20 drug or medical device;

21 (H) of the extent, if any, to which con22 fidentiality of records identifying the patient

23 will be maintained;

24 (I) for use of such a drug or medical de25 vice involving more than minimal risk, of the
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1 treatments available if injury occurs, what such

2 treatments involve, and where additional infor3 mation regarding such treatments may be ob4 tained;

5 (J) of any anticipated circumstances under

6 which the patient’s use of such a drug or med7 ical device may be terminated by the health

8 care practitioner without regard to the patient’s

9 consent;

10 (K) that the use of an such a drug or med11 ical device is voluntary and that the patient

12 may suspend or terminate treatment at any

13 time;

14 (L) of the consequences of a patient’s deci15 sion to withdraw from the use of such a drug

16 or medical device;

17 (M) if any information described in sub18 paragraphs (A) through (L) cannot be provided

19 by the health care practitioner because such in20 formation is not known at the time the practi21 tioner provides or administers such drug or

22 medical device, that such information cannot be

23 provided by the practitioner; and

24 (N) of any other information or disclosures

25 required by applicable State law for the admin-
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1 istration of experimental drugs or medical de2 vices to human subjects;

3 (7) has not made, except as provided in sub4 section (d), any advertising claims for the unap5 proved drug or medical device;

6 (8) does not impose a charge for the unap7 proved drug or medical device in excess of costs;

8 (9) complies with requirements for reporting a

9 danger in section 4; and

10 (10) has received a signed affidavit from the

11 patient or the patient’s legal representative con12 firming that the patient or the legal representative—

13 (A) has received the written information

14 required by this subsection and understands it;

15 and

16 (B) desires treatment with the unapproved

17 drug or medical device as recommended by the

18 health care practitioner.

19 (c) MANDATORY DISCLOSURE.—Any manufacturer of

20 an unapproved drug or medical device shall disclose, to

21 any health care practitioner that has received such drug

22 or medical device from such manufacturer, all information

23 available to such manufacturer regarding such drug or

24 medical device to enable such practitioner to comply with

25 the requirements of subsection (b)(3) and make a deter-
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1 mination regarding the danger posed by such drug or med2 ical device. Compliance with this subsection shall not con3 stitute a violation of the Federal Food, Drug, and Cos4 metic Act (21 U.S.C. 301 et seq.).

5 (d) ADVERTISING CLAIMS EXCEPTION.—Subsection

6 (b)(7) shall not apply to a health care practitioner’s dis7 semination of information on the results of the practi8 tioner’s administration of the unapproved drug or medical

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

10 professional forums, or through statements by a practi11 tioner to a patient. Subsection (b)(7) shall not apply to

12 any accurate and truthful statement made in person by

13 a health care practitioner to an individual or a prospective

14 patient.

15 SEC. 4. CESSATION OF USE, AND REPORTING OF, DAN16 GEROUS DRUGS AND MEDICAL DEVICES.

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

18 practitioner discovers that an unapproved drug or medical

19 device causes a danger to a patient, the practitioner shall

20 immediately cease use and recommendation of the unap21 proved drug or medical device and provide to the manufac22 turer of the unapproved drug or medical device and the

23 Director of the Centers for Disease Control and

24 Prevention—
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1 (1) a written evaluation of the patient’s medical

2 condition before and after administration of the un3 approved drug or medical device;

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

5 including its physiological manifestations, duration,

6 and the effect of cessation of treatment upon the pa7 tient’s condition;

8 (3) any other information the health care prac9 titioner deems pertinent to an evaluation of the ad10 verse reaction;

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

12 business telephone number of the physician;

13 (5) the name of the unapproved drug or med14 ical device and a description of the method of ad15 ministration and operation, dosage, and duration of

16 treatment;

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

18 drug or medical device; and

19 (7) an affidavit pursuant to section 1746 of

20 title 28, United States Code, confirming that all

21 statements made to the manufacturer are accurate.

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

23 manufacturer of an unapproved drug or medical device

24 that receives information provided under subsection (a)

25 shall immediately—
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1 (1) cease sale and distribution of the unap2 proved drug or medical device pending completion of

3 an investigation to determine the actual cause of the

4 danger;

5 (2) notify all health care practitioners to whom

6 the manufacturer has provided the unapproved drug

7 or medical device of the information provided to the

8 manufacturer under subsection (a); and

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

10 unapproved drug or medical device (identified by

11 name, known method of operation, unit dose, and in12 tended use) that the manufacturer provided to a

13 health care practitioner for administration under

14 this Act has been reported to be a danger to a pa15 tient and confirming that the manufacturer—

16 (A) has ceased sale and distribution of the

17 unapproved drug or medical device pending

18 completion of an investigation to determine the

19 actual cause of the danger; and

20 (B) has notified health care practitioners

21 to which the unapproved drug or medical device

22 has been sent of the information it has received.

23 (c) INVESTIGATION.—

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

25 for Disease Control and Prevention, upon receipt of
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1 the information described in subsection (a), shall

2 conduct an investigation of the unapproved drug or

3 medical device that a health care practitioner has

4 determined to cause a danger to a patient in order

5 to make a determination of the actual cause of such

6 danger.

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

8 the Centers for Disease Control and Prevention shall

9 prepare and submit a report to the Secretary re10 garding the determination made under paragraph

11 (1), including a determination concerning whether

12 the unapproved drug or medical device is or is not

13 the actual cause of danger or whether the actual

14 cause of danger cannot be determined.

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

16 report described in paragraph (2), the Secretary

17 shall—

18 (A) if the Director of the Centers for Dis19 ease Control and Prevention determines that

20 the cause of such danger is the unapproved

21 drug or medical device, direct the manufacturer

22 of such drug or medical device to—

23 (i) cease manufacture, sale, and dis24 tribution of such drug or medical device;

25 and
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1 (ii) notify all health care practitioners

2 to whom the manufacturer has provided

3 such drug or medical device to cease using

4 or recommending such drug or medical de5 vice, and to return such drug or medical

6 device to the manufacturer as part of a

7 complete recall;

8 (B) if the Director of the Centers for Dis9 ease Control and Prevention determines that

10 the cause of such danger is not such drug or

11 medical device, direct the manufacturer of such

12 drug or medical device to inform all health care

13 practitioners to whom the manufacturer has

14 provided such drug or medical device of such a

15 determination; and

16 (C) if the Director of the Centers of Dis17 ease Control and Prevention cannot determine

18 the cause of the danger, direct the manufac19 turer of the drug or medical device to inform all

20 health care practitioners to whom the manufac21 turer has provided such drug or medical device

22 of such a determination.

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

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

25 shall promptly disseminate information concerning the
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1 danger to all health care practitioners in the United

2 States, to the Director of the National Center for Com3 plementary and Alternative Medicine, and to agencies of

4 the States that have responsibility for regulating unsafe

5 or adulterated drugs and medical devices.

6 SEC. 5. REPORTING OF RESULTS OF UNAPPROVED DRUGS

7 AND MEDICAL DEVICES.

8 (a) REPORTING OF RESULTS.—If a health care prac9 titioner provides or administers an unapproved drug or

10 medical device, that in the opinion of the health care prac11 titioner, produces results that are more beneficial than re12 sults produced from any drug or medical device approved

13 by the Food and Drug Administration, or produces other

14 results regarding the effectiveness of the treatment rel15 ative to treatments approved by the Food and Drug Ad16 ministration for the same condition, the practitioner shall

17 provide to the manufacturer—

18 (1) the results of the administration of the drug

19 or device;

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

21 condition before and after administration of the un22 approved drug or medical device;

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

24 business telephone number of the physician;
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1 (4) the name of the unapproved drug or med2 ical device and a description of the method of oper3 ation and administration, dosing, and duration of

4 treatment; and

5 (5) an affidavit pursuant to section 1746 of

6 title 28, United States Code, confirming that all

7 statements made to the manufacturer are accurate.

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

9 manufacturer of an unapproved drug or medical device

10 that receives information under subsection (a) shall pro11 vide to the Director of the National Center for Com12 plementary and Alternative Medicine—

13 (1) a complete copy of the information;

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

15 telephone number of the manufacturer;

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

17 telephone number of the health care practitioner who

18 supplied information to the manufacturer;

19 (4) the name of the unapproved drug or med20 ical device;

21 (5) the known method of operation and admin22 istration of the unapproved drug or medical device;

23 (6) the per unit dose; and

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

25 medical device.
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1 (c) DIRECTOR’S DUTY TO MAKE PUBLIC.—The Di2 rector of the National Center for Complementary and Al3 ternative Medicine shall review and analyze information

4 received pursuant to subsection (b) about an unapproved

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

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

7 annual review and analysis of such information, and in8 clude a statement that such drug or medical device is not

9 approved by the Food and Drug Administration.

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

11 This Act shall not be construed to have any effect

12 on section 503A of the Federal Food, Drug, and Cosmetic

13 Act (21 U.S.C. 353a) nor does this Act supersede any law

14 of a State or political subdivision of a State, including laws

15 governing rights and duties among health care practi16 tioners and patients. This Act shall also not apply to state17 ments or claims permitted or authorized under sections

18 403 and 403B of such Act (21 U.S.C. 343, 343–2). This

19 Act shall not in any way adversely affect the distribution

20 and marketing of vitamins and supplements.

21 SEC. 7. AUTHORIZED ACTIVITIES OF HEALTH CARE PRAC22 TITIONERS.

23 (a) INTRODUCTION IN INTERSTATE COMMERCE.—To

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

25 practitioner may—
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1 (1) introduce an unapproved drug or medical

2 device into interstate commerce;

3 (2) deliver an unapproved drug or medical de4 vice for introduction into such commerce;

5 (3) transport an unapproved drug or medical

6 device in such commerce;

7 (4) receive an unapproved drug or medical de8 vice in such commerce and deliver the unapproved

9 drug or medical device; and

10 (5) hold an unapproved drug or medical device

11 for sale after shipment of the unapproved drug or

12 medical device in such commerce.

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

14 construed to limit or interfere with the authority of a

15 health care practitioner to prescribe, recommend, provide

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

17 unapproved drug or medical device lawful under the law

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

19 practices.

20 SEC. 8. PENALTY.

21 A health care practitioner or manufacturer found to

22 have knowingly violated this Act shall be denied coverage

23 under this Act.

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