I

103D CONGRESS

2D SESSION H. R. 4696

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 HOUSE OF REPRESENTATIVES

JUNE 30, 1994

Mr. DEFAZIO introduced the following bill; which was referred to the

Committee on Energy and Commerce

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.

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. FINDINGS.

7 The Congress finds that access to medical treatment

8 significantly affects interstate commerce in food, drugs,

9 and medical devices and that interference with medical
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1 treatments administered by licensed health care practi2 tioners is a burden on such commerce.

3 SEC. 3. DEFINITIONS.

4 As used in this Act:

5 (1) ADVERTISING OR LABELING CLAIMS.—The

6 term ‘‘advertising or labeling claims’’ means any

7 representations made or suggested by statement,

8 word, design, device, sound, or any combination

9 thereof with respect to treatment, including a rep10 resentation made or suggested by a label. The term

11 ‘‘advertising’’ has the meaning given such term by

12 the Federal Trade Commission under the Federal

13 Trade Commission Act.

14 (2) DEVICE.—The term ‘‘device’’ has the same

15 meaning given such term in section 201(h) of the

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

17 321(h)).

18 (3) DRUG.—The term ‘‘drug’’ means a drug as

19 defined in section 201(g)(1) of the Federal Food,

20 Drug, and Cosmetic Act (21 U.S.C. 321(g)(1)).

21 (4) FOOD.—The term ‘‘food’’ has the same

22 meaning given such term in section 201(f) of the

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

24 321(f)).
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1 (5) HEALTH CARE PRACTITIONER.—The term

2 ‘‘health care practitioner’’ means any properly li3 censed medical doctor, osteopath, chiropractor, or

4 naturopath and in the case of a health care practi5 tioner whose medical treatment involves the dispens6 ing of a controlled substance, such term means a

7 practitioner who is registered under such Act.

8 (6) LABEL AND LABELING.—The terms ‘‘label’’

9 and ‘‘labeling’’ have the same meaning given such

10 terms in sections 201(k) and 201(m) of the Federal

11 Food, Drug, and Cosmetic Act (21 U.S.C. 321(k),

12 (m)).

13 (7) LEGAL REPRESENTATIVE.—The term ‘‘legal

14 representative’’ means a parent or an individual who

15 qualifies as a legal guardian under State law.

16 (8) SERIOUS HARM.—The term ‘‘serious harm’’

17 means any serious negative reaction that—

18 (A) occurred as a result of a method of

19 treatment;

20 (B) would not otherwise have occurred;

21 and

22 (C) is more serious than reactions fre23 quently experienced with accepted treatments

24 for the same or similar health problems.
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1 (9) TREATMENT.—The term ‘‘treatment’’

2 means the use of any food, drug, device, or proce3 dure.

4 SEC. 4. ACCESS TO MEDICAL TREATMENT.

5 (a) IN GENERAL.—Notwithstanding any other provi6 sion of law, and except as provided in subsection (b), an

7 individual shall be permitted to be treated by a health care

8 practitioner with any method of medical treatment that

9 such individual desires or the legal representative of such

10 individual authorizes if—

11 (1) such practitioner agrees to treat such indi12 vidual; and

13 (2) the administration of such treatment falls

14 within the scope of the practice of such practitioner.

15 (b) TREATMENT REQUIREMENTS.—A health care

16 practitioner may provide any method of treatment to an

17 individual described in subsection (a) if—

18 (1) there is no evidence that such treatment it19 self, when taken as prescribed, is a serious harm to

20 such individual;

21 (2) in the case of an individual whose treatment

22 is the administration of a food (including a dietary

23 supplement), drug, or device that has not been ap24 proved by the Food and Drug Administration—
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1 (A) such individual has been informed that

2 such food, drug, or device has not yet been ap3 proved or certified by the Food and Drug Ad4 ministration for treating the medical condition

5 of such individual;

6 (B) such food, drug, or device (or informa7 tion accompanying the administration of such

8 food, drug, or device) contains the following

9 warning:

10 ‘‘WARNING: This food, drug, or de11 vice has not been proved safe and effective

12 by the Federal Government and any indi13 vidual who uses such food, drug, or device,

14 does so at his or her own risk.’’; and

15 (C) such drug is not a controlled substance

16 the use or prescription of which by a health

17 care practitioner would be in violation of the

18 Controlled Substances Act (21 U.S.C. 801 et

19 seq.);

20 (3) such individual has been informed of the

21 nature of the treatment, including—

22 (A) the contents of such treatment;

23 (B) any reasonably foreseeable side effects

24 that may result from such treatment; and
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1 (C) the results of past applications of such

2 treatment by the health care practitioner and

3 others;

4 (4) except as provided in subsection (c), there

5 have been no claims, including advertising and label6 ing claims, made with respect to the efficacy of such

7 treatment; and

8 (5) such individual—

9 (A) has been provided a written statement

10 that such individual has been fully informed

11 with respect to the information described in

12 paragraphs (1) through (4);

13 (B) desires such treatment; and

14 (C) signs such statement.

15 (c) CLAIM EXCEPTIONS.—Subsection (b)(4) shall not

16 apply to an accurate and truthful reporting by a practi17 tioner of the results of the practitioner’s administration

18 of a treatment described in section 2(9) in recognized jour19 nals or at seminars, conventions, or similar meetings, if

20 the only financial gain of such practitioner with respect

21 to such treatment is the payment received from an individ22 ual or representative of such individual for the administra23 tion of such treatment to such individual.
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1 SEC. 5. REPORTING OF A DANGEROUS TREATMENT.

2 If a practitioner, after administering such treatment,

3 discovers that the treatment itself (when taken as pre4 scribed) was a danger to the individual receiving the treat5 ment, the practitioner shall immediately report to the Sec6 retary of Health and Human Services the nature of the

7 treatment, the results of such treatment, the complete pro8 tocol of such treatment, and the source from which such

9 treatment or any part thereof was obtained.

10 SEC. 6. TRANSPORTATION OF MEDICATION AND EQUIP11 MENT.

12 Notwithstanding any other provision of the Federal

13 Food, Drug, and Cosmetic Act (21 U.S.C. 201 et seq.),

14 a person may introduce or deliver into interstate com15 merce medication or equipment for use in accordance with

16 this Act.

17 SEC. 7. RESTRICTIONS ON LICENSING BOARDS.

18 A licensing board that licenses health care practition19 ers may not impose on any health care practitioner any

20 disciplinary sanction, including revocation or suspension

21 of the license of the health care practitioner, or otherwise

22 punish such practitioner solely because such practitioner

23 provides treatment to which section 3 applies.

24 SEC. 8. PENALTY.

25 A health care practitioner who knowingly, willingly,

26 or with gross negligence violates any provisions under this
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1 Act shall not be covered by the protections under this Act

2 and shall be subject to all other applicable laws and regu3 lations.

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