I 

108TH CONGRESS 

1ST SESSION H. R. 2085

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 

MAY 14, 2003

Mr. DEFAZIO (for himself and Mr. BURTON of Indiana) 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. DEFINITIONS. 

7 In this Act: 

8 (1) ADVERTISING CLAIM.—The term ‘‘adver9 tising claim’’ means any representation made or sug-
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1 gested by statement, word, design, device, sound, or 

2 any combination thereof with respect to a medical 

3 treatment. 

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

5 adverse reaction to an unapproved drug or medical 

6 device that, when used as directed—

7 (A) causes serious harm; 

8 (B) occurred as a result of the medical 

9 treatment; 

10 (C) would not otherwise have occurred; 

11 and 

12 (D) is more serious than reactions experi13 enced with routinely used medical treatments 

14 approved by the Food and Drug Administration 

15 for the same medical condition or conditions. 

16 (3) DEVICE.—The term ‘‘device’’ has the mean17 ing given such term in section 201(h) of the Federal 

18 Food, Drug, and Cosmetic Act (21 U.S.C.321(h)). 

19 (4) DRUG.—The term ‘‘drug’’ has the meaning 

20 given such term in section 201(g)(1) of the Federal 

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

22 (g)(1)). 

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

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

3 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 

8 other individual who is legally authorized to provide 

9 health care services in the State in which the serv10 ices are provided. 

11 (7) INTERSTATE COMMERCE.—The term ‘‘inter12 state commerce’’ means commerce between any 

13 State or territory and any place outside thereof, and 

14 commerce within the District of Columbia or within 

15 any other territory not organized with a legislative 

16 body. 

17 (8) LABEL.—The term ‘‘label’’ has the meaning 

18 given such term in section 201(k) of the Federal 

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

20 (9) LABELING.—The term ‘‘labeling’’ has the 

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

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

23 321(m)). 

24 (10) LEGAL REPRESENTATIVE.—The term 

25 ‘‘legal representative’’ means a parent or an indi-
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1 vidual who qualifies as a legal guardian under appli2 cable State law. 

3 (11) MEDICAL DEVICE.—The term ‘‘medical de4 vice’’ has the meaning given the term ‘‘device’’ in 

5 section 201(h) of the Federal Food, Drug, and Cos6 metic Act (21 U.S.C. 321(h)). 

7 (12) MEDICAL TREATMENT.—The term ‘‘med8 ical treatment’’ means any food, drug, device, or 

9 procedure that is used and intended as a cure, miti10 gation, treatment, or prevention of disease or a 

11 health condition. 

12 (13) PATIENT.—The term ‘‘patient’’ means any 

13 individual who seeks medical treatment from a 

14 health care practitioner for a disease or health con15 dition. 

16 (14) SECRETARY.—The term ‘‘Secretary’’ 

17 means the Secretary of Health and Human Services. 

18 (15) SELLER.—The term ‘‘seller’’ means an in19 dividual or organization that receives payment re20 lated to the medical treatment of a patient of a 

21 health practitioner, except that this term does not 

22 apply to a health care practitioner who receives pay23 ment from an individual or representative of such in24 dividual for the administration of a medical treat25 ment to such individual. 
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1 (16) UNAPPROVED DRUG OR MEDICAL DE2 VICE.—The term ‘‘unapproved drug or medical de3 vice’’ with respect to a drug or medical device, 

4 means a drug or medical device that is not approved 

5 or authorized for manufacture, sale, and distribution 

6 in interstate commerce under section 505, 513, or 

7 515 of the Federal Food, Drug, and Cosmetic Act 

8 (21 U.S.C 355, 360c, and 360(e)) or under section 

9 351 of the Public Health Service Act (42 U.S.C. 

10 262). 

11 SEC. 3. ACCESS TO MEDICAL TREATMENT. 

12 (a) IN GENERAL.—Notwithstanding any other provi13 sion of law, and except as provided in subsection (b), an 

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

15 care practitioner with any medical treatment (including a 

16 medical treatment that is not approved, certified, or li17 censed by the Secretary) that such individual desires, or 

18 that the legal representative of such individual authorizes, 

19 if—

20 (1) such practitioner has personally examined 

21 such individual and agrees to provide treatment to 

22 such individual; 

23 (2) the administration of such treatment does 

24 not violate applicable licensing laws; and 
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1 (3) the health care practitioner complies with 

2 the requirements of subsection (b). 

3 (b) MEDICAL TREATMENT REQUIREMENTS.—

4 (1) IN GENERAL.—A health care practitioner 

5 may provide the medical treatment requested by an 

6 individual described in subsection (a) if—

7 (A) there is no reason for the practitioner 

8 to conclude that, based on generally accepted 

9 principles and current information, the medical 

10 treatment requested, when used or provided as 

11 directed, will cause danger to the patient; 

12 (B) in the case of an individual whose 

13 treatment is the administration of a food, drug, 

14 or device that has to be approved, certified, or 

15 licensed by the Secretary, but has not been so 

16 approved, certified, or licensed—

17 (i) such individual has been informed 

18 in writing that such food, drug, or device 

19 has not been approved, certified, or li20 censed by the Secretary for use as a med21 ical treatment of the medical condition of 

22 such individual; and 

23 (ii) prior to the administration of such 

24 treatment, the practitioner has provided 

25 the patient a written statement that in-
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1 cludes the following provision: ‘‘WARN2 ING: This food, drug, or device has not 

3 been declared to be safe and effective by 

4 the Federal Government and any indi5 vidual who uses such food, drug, or device 

6 does so at his or her own risk.’’; 

7 (C) such individual has been informed in 

8 writing of the nature of the medical treatment, 

9 including—

10 (i) the contents and methods of such 

11 treatment; 

12 (ii) the anticipated benefits of such 

13 treatment; 

14 (iii) any reasonably foreseeable side 

15 effects that may result from such treat16 ment; 

17 (iv) the results of past application of 

18 such treatment by the health care practi19 tioner and others; and 

20 (v) any other information necessary to 

21 fully meet the requirements for informed 

22 consent of human subjects prescribed by 

23 regulations issued by the Food and Drug 

24 Administration; 
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1 (D) except as provided in subsection (c), 

2 there have been no advertising claims made 

3 with respect to the efficacy of the medical treat4 ment by the practitioner, manufacturer, or dis5 tributor; 

6 (E) the label or labeling of any food, drug, 

7 or device that is a part of the requested medical 

8 treatment is not false or misleading; 

9 (F) such individual—

10 (i) has been provided with a written 

11 statement that such individual has been 

12 fully informed with respect to the informa13 tion described in subparagraphs (A) 

14 through (D); 

15 (ii) desires such treatment; and 

16 (iii) signs such statement; and 

17 (G) the health care practitioner provides 

18 the patient with a recommendation for the 

19 treatment involved under circumstances that 

20 give the patient sufficient opportunity to con21 sider whether or not to use such treatment. 

22 (2) BURDEN OF PROOF.—In any proceeding re23 lating to the enforcement of paragraph (1)(E) with 

24 respect to the label of a drug, device, or food used 

25 in medical treatment covered under this subsection, 
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1 the provisions of section 403B(c) of the Federal 

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

3 shall apply with respect to establishing the burden of 

4 proof that such label is false or misleading. 

5 (3) RULE OF CONSTRUCTION.—Nothing in this 

6 section shall be construed to require informed con7 sent for the prescription of dietary supplements and 

8 foods not requiring such informed consent prior to 

9 the date of the enactment of this Act. 

10 (c) CLAIM EXCEPTIONS.—

11 (1) REPORTING BY A HEALTH CARE PRACTI12 TIONER.—Subsection (b)(1)(D) shall not apply to an 

13 accurate and truthful reporting by a health care 

14 practitioner of the results of the practitioner’s ad15 ministration of a medical treatment in recognized 

16 journals, at seminars, conventions, or similar meet17 ings, or to others, so long as the reporting practi18 tioner has no direct or indirect financial interest in 

19 the reporting of the material and has received no fi20 nancial benefits of any kind from the manufacturer, 

21 distributor, or other seller for such reporting. Such 

22 reporting may not be used by a manufacturer, dis23 tributor, or other seller to advance the sale of such 

24 treatment. 
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1 (2) STATEMENTS BY A PRACTITIONER TO A PA2 TIENT.—Subsection (b)(1)(D) shall not apply to any 

3 statement made by a health care practitioner di4 rectly to a patient or prospective patient. A health 

5 care practitioner shall not be held liable for any ad6 vertising claims made by others unless the practi7 tioner is a party in the dissemination of the informa8 tion in such claims. 

9 (3) DIETARY SUPPLEMENTS STATEMENT.—

10 Subsection (b)(1)(D) shall not apply to statements 

11 or claims permitted under sections 403B and 

12 403(r)(6) of the Federal Food, Drug, and Cosmetic 

13 Act (21 U.S.C. 343–2 and 343(r)(6)). 

14 SEC. 4. REPORTING OF A DANGEROUS MEDICAL TREAT15 MENT. 

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

17 practitioner, after administering a medical treatment, dis18 covers that the treatment itself was a danger to the indi19 vidual receiving such treatment, the practitioner shall—

20 (1) immediately cease the use of such treat21 ment; 

22 (2) refrain from recommending the use of any 

23 unapproved drug or medical device that was a part 

24 of such treatment; 
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1 (3) report to the manufacturer and the Director 

2 of the Centers for Disease Control and Prevention—

3 (A) the nature of such treatment; 

4 (B) the results of such treatment; 

5 (C) the complete protocol of such treat6 ment; and 

7 (D) the source from which such treatment 

8 or any part thereof was obtained; and 

9 (4) include as part of the reporting under para10 graph (3), an affidavit pursuant to section 1746 of 

11 title 28, United States Code, confirming that all 

12 statements made in the report under such paragraph 

13 are accurate. 

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

15 treatment has proven dangerous to individuals, the Sec16 retary shall properly disseminate information with respect 

17 to the danger of the medical treatment and prohibit the 

18 further use of such treatment. 

19 SEC. 5. REPORTING OF A BENEFICIAL MEDICAL TREAT20 MENT. 

21 If a health care practitioner, after administering a 

22 medical treatment that is not an approved drug or medical 

23 device for a life-threatening medical condition or condi24 tions, discovers that such medical treatment has, in the 

25 opinion of the health care practitioner, positive effects on 
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1 such condition or conditions that are significantly greater 

2 than the positive effects that are expected from an ap3 proved medical treatment for the same condition or condi4 tions, the practitioner shall—

5 (1) make a monthly reporting to the National 

6 Center for Complementary and Alternative Medicine 

7 at the National Institutes of Health of—

8 (A) the nature of such medical treatment 

9 (which is not a conventional medical treatment); 

10 (B) the general results of such treatment 

11 administered in the month involved; and 

12 (C) the protocol of such treatment; and 

13 (2) provide an affidavit pursuant to section 746 

14 of title 28, United States Code, confirming that all 

15 statements made in the monthly reporting under 

16 paragraph (1) are accurate and truthful. 

17 SEC. 6. TRANSPORTATION AND PRODUCTION OF FOOD, 

18 DRUGS, DEVICES, AND OTHER EQUIPMENT. 

19 (a) IN GENERAL.—Notwithstanding any other provi20 sion of the Federal Food, Drug, and Cosmetic Act (21 

21 U.S.C. 201 et seq.), an individual may—

22 (1) introduce or deliver into interstate com23 merce a food, drug, device, or any other equipment; 

24 and 
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1 (2) produce, transport, receive and hold a food, 

2 drug, device, or any other equipment, 

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

4 been no advertising claims by the manufacturer, dis5 tributor, or seller of the food, drug, device, or equipment 

6 involved. 

7 (b) RULE OF CONSTRUCTION.—Nothing in this Act 

8 shall be construed to limit or interfere with the authority 

9 of a health care practitioner to prescribe, recommend, pro10 vide, or administer to a patient for any medical condition 

11 or disease any unapproved drug or medical device that is 

12 lawful under the law of the State or States in which the 

13 health care practitioner practices. 

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

15 Nothing in this Act shall be construed to—

16 (1) apply to the manufacturer, distribution, 

17 possession, or use of any drug that is a controlled 

18 substance under the Controlled Substances Act (21 

19 U.S.C. 801 et seq.); 

20 (2) apply to statements or claims permitted or 

21 authorized under sections 403 and 403B of the Fed22 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

23 3443, 343–2); or 

24 (3) in any way adversely affect the distribution 

25 or sale of dietary supplements (as defined in section 
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1 201(f) of the Federal Food, Drug, and Cosmetic Act 

2 (21 U.S.C. 321 (ff)). 

3 SEC. 8. PENALTY. 

4 A health care practitioner who knowingly violates any 

5 provision of this Act shall not be covered by the protec6 tions under this Act and shall be subject to all other appli7 cable laws and regulations.

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