II 

109TH CONGRESS 

2D SESSION S. 2618 

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 SENATE OF THE UNITED STATES 

APRIL 7, 2006 

Mr. HARKIN (for himself and Mr. GRASSLEY) introduced the following bill; 

which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

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 sugVerDate Aug 31 2005 22:33 Apr 12, 2006 Jkt 049200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S2618.IS S2618

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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 indiVerDate Aug 31 2005 22:33 Apr 12, 2006 Jkt 049200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S2618.IS S2618

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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 is within the 

25 scope of the practice of such practitioner; 


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1 (3) the health care practitioner complies with 

2 the requirements of subsection (b); and 

3 (4) it is a medical treatment that has not been 

4 approved, certified, or licensed by the Secretary, or 

5 is any medical treatment that has been approved by 

6 the designated governmental agency for a member 

7 country of the European Union or the European 

8 Free Trade Association, Canada, Australia, New 

9 Zealand, or Japan but not otherwise approved, cer10 tified, or licensed by the Secretary. 

11 (b) MEDICAL TREATMENT REQUIREMENTS.— 

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

13 may provide the medical treatment requested by an 

14 individual described in subsection (a) if— 

15 (A) there is no reason for the practitioner 

16 to conclude that, based on generally accepted 

17 principles and current information, the medical 

18 treatment requested, when used or provided as 

19 directed, will cause danger to the patient; 

20 (B) in the case of an individual whose 

21 treatment is the administration of a food, drug, 

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

23 licensed by the Secretary, but has not been so 

24 approved, certified, or licensed— 


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1 (i) such individual has been informed 

2 in writing that such food, drug, or device 

3 has not been approved, certified, or li4 censed by the Secretary for use as a med5 ical treatment of the medical condition of 

6 such individual; and 

7 (ii) prior to the administration of such 

8 treatment, the practitioner has provided 

9 the patient a written statement, which 

10 shall become part of the medical record of 

11 the patient, that includes the following pro12 vision: ‘‘WARNING: This food, drug, or 

13 device has not been declared to be safe and 

14 effective by the Federal Government and 

15 any individual who uses such food, drug, or 

16 device does so at his or her own risk.’’; 

17 (C) such individual has been informed in 

18 writing of the nature of the medical treatment, 

19 including— 

20 (i) the contents and methods of such 

21 treatment; 

22 (ii) the anticipated benefits of such 

23 treatment; 


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1 (iii) any reasonably foreseeable side 

2 effects that may result from such treat3 ment; 

4 (iv) the results of past application of 

5 such treatment by the health care practi6 tioner and others; and 

7 (v) any other information necessary to 

8 fully meet the requirements for informed 

9 consent of human subjects prescribed by 

10 regulations issued by the Food and Drug 

11 Administration; 

12 (D) except as provided in subsection (c), 

13 there have been no advertising claims made 

14 with respect to the efficacy of the medical treat15 ment by the practitioner, manufacturer, or dis16 tributor; 

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

18 or device that is a part of the requested medical 

19 treatment is not false or misleading; 

20 (F) such individual— 

21 (i) has been provided with a written 

22 statement that such individual has been 

23 fully informed with respect to the informa24 tion described in subparagraphs (A) 

25 through (D); 


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1 (ii) desires such treatment; and 

2 (iii) signs such statement; and 

3 (G) the health care practitioner provides 

4 the patient with a recommendation for the 

5 treatment involved under circumstances that 

6 give the patient sufficient opportunity to con7 sider whether or not to use such treatment. 

8 (2) BURDEN OF PROOF.—In any proceeding re9 lating to the enforcement of paragraph (1)(E) with 

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

11 in medical treatment covered under this subsection, 

12 the provisions of section 403B(c) of the Federal 

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

14 shall apply with respect to establishing the burden of 

15 proof that such label is false or misleading. 

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

17 section shall be construed to require informed con18 sent for the prescription of dietary supplements and 

19 foods not requiring such informed consent prior to 

20 the date of the enactment of this Act. 

21 (c) CLAIM EXCEPTIONS.— 

22 (1) REPORTING BY A HEALTH CARE PRACTI23 TIONER.—Subsection (b)(1)(D) shall not apply to an 

24 accurate and truthful reporting by a health care 

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1 ministration of a medical treatment in recognized 

2 journals, at seminars, conventions, or similar meet3 ings, or to others, so long as the reporting practi4 tioner has no direct or indirect financial interest in 

5 the reporting of the material and has received no fi6 nancial benefits of any kind from the manufacturer, 

7 distributor, or other seller for such reporting. Such 

8 reporting may not be used by a manufacturer, dis9 tributor, or other seller to advance the sale of such 

10 treatment. 

11 (2) STATEMENTS BY A PRACTITIONER TO A PA12 TIENT.—Subsection (b)(1)(D) shall not apply to any 

13 statement made by a health care practitioner di14 rectly to a patient or prospective patient. A health 

15 care practitioner shall not be held liable for any ad16 vertising claims made by others unless the practi17 tioner is a party in the dissemination of the informa18 tion in such claims. 

19 (3) DIETARY SUPPLEMENTS STATEMENT.— 

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

21 or claims permitted under sections 403B and 

22 403(r)(6) of the Federal Food, Drug, and Cosmetic 

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


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1 SEC. 4. REPORTING OF A DANGEROUS MEDICAL TREAT2 MENT. 

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

4 practitioner, after administering a medical treatment, dis5 covers that the treatment itself was a danger to the indi6 vidual receiving such treatment, the practitioner shall— 

7 (1) immediately cease the use of such treat8 ment; 

9 (2) refrain from recommending the use of any 

10 unapproved drug or medical device that was a part 

11 of such treatment; 

12 (3) report to the manufacturer and the Director 

13 of the Centers for Disease Control and Prevention— 

14 (A) the nature of such treatment; 

15 (B) the results of such treatment; 

16 (C) the complete protocol of such treat17 ment; and 

18 (D) the source from which such treatment 

19 or any part thereof was obtained; and 

20 (4) include as part of the reporting under para21 graph (3), an affidavit pursuant to section 1746 of 

22 title 28, United States Code, confirming that all 

23 statements made in the report under such paragraph 

24 are accurate. 

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

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1 retary shall properly disseminate information with respect 

2 to the danger of the medical treatment and prohibit the 

3 further use of such 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 an approved drug or medical 

8 device for a life-threatening medical condition or condi9 tions, discovers that such medical treatment has, in the 

10 opinion of the health care practitioner, positive effects on 

11 such condition or conditions that are significantly greater 

12 than the positive effects that are expected from an ap13 proved medical treatment for the same condition or condi14 tions, the practitioner shall— 

15 (1) make a monthly reporting to the National 

16 Center for Complementary and Alternative Medicine 

17 at the National Institutes of Health of— 

18 (A) the nature of such medical treatment 

19 (which is not a conventional medical treatment); 

20 (B) the general results of such treatment 

21 administered in the month involved; and 

22 (C) the protocol of such treatment; and 

23 (2) provide an affidavit pursuant to section 746 

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


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1 statements made in the monthly reporting under 

2 paragraph (1) are accurate and truthful. 

3 SEC. 6. TRANSPORTATION AND PRODUCTION OF FOOD, 

4 DRUGS, DEVICES, AND OTHER EQUIPMENT. 

5 (a) IN GENERAL.—Notwithstanding any other provi6 sion of the Federal Food, Drug, and Cosmetic Act (21 

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

8 (1) introduce or deliver into interstate com9 merce a food, drug, device, or any other equipment; 

10 and 

11 (2) produce, transport, receive and hold a food, 

12 drug, device, or any other equipment, 

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

14 been no advertising claims by the manufacturer, dis15 tributor, or seller of the food, drug, device, or equipment 

16 involved. 

17 (b) NOTIFICATION.—If an individual imports a ship18 ment of a food, drug, device, or any other equipment, the 

19 individual shall notify the Secretary of any such shipment. 

20 (c) PRODUCTION OF UNAPPROVED DRUGS, DEVICES, 

21 AND OTHER EQUIPMENT.—In the case of unapproved 

22 drugs, devices, or other equipment, except those approved 

23 by a country listed in section 3(a)(4), a manufacturer shall 

24 provide notice the Secretary of the intent of such manufac25 turer to deliver the product into interstate commerce. 


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1 (d) RULE OF CONSTRUCTION.—Nothing in this Act 

2 shall be construed to limit or interfere with the authority 

3 of a health care practitioner to prescribe, recommend, pro4 vide, or administer to a patient for any medical condition 

5 or disease any unapproved drug or medical device that is 

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

7 health care practitioner practices. 

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

9 Nothing in this Act shall be construed to— 

10 (1) apply to the manufacture, distribution, pos11 session, administration, recommendation, prescrip12 tion, or provision, or support the use of any drug 

13 that is a controlled substance under the Controlled 

14 Substances Act (21 U.S.C. 801 et seq.); 

15 (2) apply to statements or claims permitted or 

16 authorized under sections 403 and 403B of the Fed17 eral Food, Drug, and Cosmetic Act (21 U.S.C. 343, 

18 343–2); or 

19 (3) in any way adversely affect the distribution 

20 or sale of dietary supplements (as defined in section 

21 201(f) of the Federal Food, Drug, and Cosmetic Act 

22 (21 U.S.C. 321(f)). 

23 SEC. 8. PENALTY. 

24 A health care practitioner who knowingly violates any 

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1 tions under this Act and shall be subject to all other appli2 cable laws and regulations. 

Æ 


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