I

104TH CONGRESS

1ST SESSION H. R. 2019

To allow patients to receive any medical treatment they want under certain

conditions and for other purposes.

IN THE HOUSE OF REPRESENTATIVES

JULY 12, 1995

Mr. DEFAZIO (for himself, Mr. BARTON of Texas, Mr. DELAY, Mr. COX of

California, Mr. HINCHEY, Mr. PALLONE, Mr. KINGSTON, Ms. FURSE,

Ms. NORTON, Mr. OWENS, Mr. SMITH of New Jersey, Mr. LIPINSKI, Ms.

VELA ́ZQUEZ, Mr. EVANS, Mr. DELLUMS, Mr. DEUTSCH, Mr. FRAZER,

and Mr. HILLIARD) introduced the following bill; which was referred to

the Committee on Commerce

A BILL

To allow patients to receive any medical treatment they

want under certain conditions 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 As used in this Act:
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1 (1) ADVERTISING CLAIMS.—The term ‘‘adver2 tising claims’’ means any representations made or

3 suggested by statement, word, design, device, sound,

4 or any combination thereof with respect to a medical

5 treatment.

6 (2) DANGER.—The term ‘‘danger’’ means any

7 negative reaction that—

8 (A) causes serious harm;

9 (B) occurred as a result of a method of

10 medical treatment;

11 (C) would not otherwise have occurred;

12 and

13 (D) is more serious than reactions experi14 enced with routinely used medical treatments

15 for the same medical condition or conditions.

16 (3) DEVICE.—The term ‘‘device’’ has the same

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

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

19 321(h)).

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

21 meaning given such term in section 201(g)(1) of the

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

23 321(g)(1)).

24 (5) FOOD.—The term ‘‘food’’—
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1 (A) has the same meaning given such term

2 in section 201(f) of the Federal Food, Drug,

3 and Cosmetic Act (21 U.S.C. 321(f)); and

4 (B) includes a dietary supplement as de5 fined in section 201(ff) of such Act.

6 (6) HEALTH CARE PRACTITIONER.—The term

7 ‘‘health care practitioner’’ means a physician or an8 other person who is legally authorized to provide

9 health professional services in the State in which the

10 services are provided.

11 (7) LABEL.—The term ‘‘label’’ has the same

12 meaning given such term in section 201(k) of the

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

14 321(k)) and includes labeling as defined in section

15 201(m) of such Act (21 U.S.C. 321(m)).

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

17 representative’’ means a parent or an individual who

18 qualifies as a legal guardian under State law.

19 (9) SELLER.—The term ‘‘seller’’ means a per20 son, company, or organization that receives payment

21 related to a medical treatment of a patient of a

22 health practitioner, except that this term does not

23 apply to a health care practitioner who receives pay24 ment from an individual or representative of such in-
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1 dividual for the administration of a medical treat2 ment to such individual.

3 (10) MEDICAL TREATMENT.—The term ‘‘medi4 cal treatment’’ means any food, drug, device, or pro5 cedure that is used and intended as a cure, mitiga6 tion, treatment, or prevention of disease.

7 SEC. 3. ACCESS TO MEDICAL TREATMENT.

8 (a) IN GENERAL.—Notwithstanding any other provi9 sion of law, and except as provided in subsection (b), an

10 individual shall have the right to be treated by a health

11 care practitioner with any medical treatment (including a

12 medical treatment that is not approved, certified, or li13 censed by the Secretary of Health and Human Services)

14 that such individual desires or the legal representative of

15 such individual authorizes if—

16 (1) such practitioner has personally examined

17 such individual and agrees to treat such individual;

18 and

19 (2) the administration of such treatment does

20 not violate licensing laws.

21 (b) MEDICAL TREATMENT REQUIREMENTS.—A

22 health care practitioner may provide any medical treat23 ment to an individual described in subsection (a) if—

24 (1) there is no reasonable basis to conclude that

25 the medical treatment itself, when used as directed,
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1 poses an unreasonable and significant risk of danger

2 to such individual;

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

4 is the administration of a food, drug, or device that

5 has to be approved, certified, or licensed by the Sec6 retary of Health and Human Services, but has not

7 been approved, certified, or licensed by the Secretary

8 of Health and Human Services—

9 (A) such individual has been informed in

10 writing that such food, drug, or device has not

11 yet been approved, certified, or licensed by the

12 Secretary of Health and Human Services for

13 use as a medical treatment for the condition of

14 such individual; and

15 (B) prior to the administration of such

16 treatment, the practitioner has provided the pa17 tient a written statement that states the follow18 ing:

19 ‘‘WARNING: This food, drug, or de20 vice has not been declared to be safe and

21 effective by the Federal Government and

22 any individual who uses such food, drug, or

23 device, does so at his or her own risk.’’;
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1 (3) such individual has been informed in writ2 ing of the nature of the medical treatment, includ3 ing—

4 (A) the contents and methods of such

5 treatment;

6 (B) the anticipated benefits of such treat7 ment;

8 (C) any reasonably foreseeable side effects

9 that may result from such treatment;

10 (D) the results of past applications of such

11 treatment by the health care practitioner and

12 others; and

13 (E) any other information necessary to

14 fully meet the requirements for informed con15 sent of human subjects prescribed by regula16 tions issued by the Food and Drug Administra17 tion;

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

19 have been no advertising claims made with respect

20 to the efficacy of the medical treatment by the prac21 titioner, manufacturer, or distributor;

22 (5) the label of any drug, device, or food used

23 in such treatment is not false or misleading; and

24 (6) such individual—
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1 (A) has been provided a written statement

2 that such individual has been fully informed

3 with respect to the information described in

4 paragraphs (1) through (4);

5 (B) desires such treatment; and

6 (C) signs such statement.

7 In any proceeding relating to the enforcement of para8 graph (5) with respect to the label of drugs, devices, or

9 food used in medical treatment covered under this sub10 section, the provisions of section 403B(c) of the Federal

11 Food, Drug, and Cosmetic Act (21 U.S.C. 343-2(c)) shall

12 apply to establishing the burden of proof that such label

13 is false or misleading.

14 (c) CLAIM EXCEPTIONS.—

15 (1) REPORTING BY A PRACTITIONER.—Sub16 section (b)(4) shall not apply to an accurate and

17 truthful reporting by a health care practitioner of

18 the results of the practitioner’s administration of a

19 medical treatment in recognized journals or at semi20 nars, conventions, or similar meetings or to others

21 so long as the reporting practitioner has no financial

22 interests in the reporting of the material and has re23 ceived no financial benefit of any kind from the

24 manufacturer, distributor, or other seller for such

25 reporting. Such reporting may not be used by a
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1 manufacturer, distributor, or other seller to advance

2 the sale of such treatment.

3 (2) STATEMENTS BY A PRACTITIONER TO A PA4 TIENT.—Subsection (b)(4) shall not apply to any

5 statement made in person by a health care practi6 tioner to an individual patient or an individual pro7 spective patient.

8 (3) DIETARY SUPPLEMENTS STATEMENTS.—

9 Subsection (b)(4) shall not apply to statements or

10 claims permitted under sections 403B and 403(r)(6)

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

12 U.S.C. 343-2 and 343(r)(6)).

13 SEC. 4. REPORTING OF A DANGEROUS MEDICAL TREAT14 MENT.

15 (a) HEALTH CARE PRACTITIONER.—If a health care

16 practitioner, after administering a medical treatment, dis17 covers that the treatment itself was a danger to the indi18 vidual receiving such treatment, the practitioner shall im19 mediately report to the Secretary of Health and Human

20 Services the nature of such treatment, the results of such

21 treatment, the complete protocol of such treatment, and

22 the source from which such treatment or any part thereof

23 was obtained.

24 (b) SECRETARY.—Upon confirmation that a medical

25 treatment has proven dangerous to an individual, the Sec-
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1 retary of Health and Human Services shall properly dis2 seminate information with respect to the danger of the

3 medical treatment.

4 SEC. 5 REPORTING OF A BENEFICIAL MEDICAL TREAT5 MENT.

6 If a health care practitioner, after administering a

7 medical treatment that is not a conventional medical treat8 ment for a life-threatening medical condition or condi9 tions, discovers that, in the opinion of the practitioner,

10 such medical treatment has positive effects on such condi11 tion or conditions that are significantly greater than the

12 positive effects that are expected from a conventional med13 ical treatment for the same condition or conditions, the

14 practitioner shall immediately make a reporting, which is

15 accurate and truthful, to the Office of Alternative Medi16 cine of—

17 (1) the nature of such medical treatment (which

18 is not a conventional medical treatment);

19 (2) the results of such treatment; and

20 (3) the protocol of such treatment.

21 SEC. 6. TRANSPORTATION AND PRODUCTION OF FOOD,

22 DRUGS, DEVICES, AND OTHER EQUIPMENT.

23 Notwithstanding any other provision of the Federal

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

25 a person may—
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1 (1) introduce or deliver into interstate com2 merce a food, drug, device, or any other equipment;

3 and

4 (2) produce a food, drug, device, or any other

5 equipment,

6 solely for use in accordance with this Act if there have

7 been no advertising claims by the manufacturer, distribu8 tor, or seller.

9 SEC. 7. VIOLATION OF THE CONTROLLED SUBSTANCES

10 ACT.

11 A health care practitioner, manufacturer, distributor,

12 or other seller may not violate any provision of the Con13 trolled Substances Act (21 U.S.C. 801 et seq.) in the pro14 vision of medical treatment in accordance with this Act.

15 SEC. 8. PENALTY.

16 A health care practitioner who knowingly violates any

17 provision of this Act shall not be covered by the protec18 tions under this Act and shall be subject to all other appli19 cable laws and regulations.

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