I 

109TH CONGRESS 

2D SESSION H. R. 5641 

To promote safe and ethical clinical trials of drugs and other test articles 

on people overseas. 

IN THE HOUSE OF REPRESENTATIVES 

JUNE 20, 2006 

Mr. LANTOS (for himself and Mr. BROWN of Ohio) introduced the following 

bill; which was referred to the Committee on International Relations 

A BILL 

To promote safe and ethical clinical trials of drugs and 

other test articles on people overseas. 

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 ‘‘Safe Overseas Human 

5 Testing Act’’. 

6 SEC. 2. FINDINGS. 

7 The Congress finds the following: 

8 (1) Before a manufacturer of a new drug or de9 vice can market its new product, the Food and Drug 

10 Administration (in this section referred to as the 


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1 ‘‘FDA’’) requires that the manufacturer conduct 

2 laboratory and clinical trials to ascertain the prod3 uct’s safety and effectiveness. 

4 (2) Federal regulations mandate that an Insti5 tutional Review Board (IRB), which is comprised of 

6 scientists, physicians, and lay people, review the pro7 tocol or research plan and the informed consent 

8 form of the proposed clinical trial to ensure, among 

9 other things, that the health and safety of the 

10 human participants are not unnecessarily endan11 gered. 

12 (3) Institutional Review Boards also verify that 

13 the manufacturer’s clinical researchers implement 

14 appropriate additional safeguards to protect the 

15 rights and welfare of potentially vulnerable popu16 lations and persons who are economically or educa17 tionally disadvantaged. 

18 (4) Most importantly, the IRBs help assure the 

19 FDA that manufacturers of new drugs and medical 

20 devices adequately inform human participants of the 

21 anticipated risks and the likelihood of projected ben22 efits derived from their participation in the clinical 

23 trials, and then secure the voluntary consent of the 

24 participants. 


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1 (5) For the purpose of supporting the safety 

2 and efficacy of the test article, the FDA, however, 

3 may accept the results of clinical trials with human 

4 participants which are conducted outside of the 

5 United States and do not meet United States IRB 

6 and ethical requirements. 

7 (6) Foreign clinical trials involving human par8 ticipants only need to conform to either international 

9 norms on clinical investigations or the laws and reg10 ulations of the country in which the research is to 

11 be conducted. However, neither international nor 

12 most host-country standards meet the stringent re13 quirements of the United States. 

14 (7) International and most foreign-country legal 

15 protections do not adequately shield participants in 

16 clinical investigations of a new drug or device from 

17 unethical, dangerous, or unscrupulous research prac18 tices. 

19 (8) Some researchers exploit the fragile regu20 latory systems, high illiteracy rates, and public 

21 health failures of developing countries to test their 

22 experimental drugs and devices on misinformed and 

23 unwilling human participants. 

24 (9) On April 30, 2001, the National Bioethics 

25 Advisory Commission (NBAC) presented to the 


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1 President a report, entitled ‘‘Ethical and Policy 

2 Issues in International Research: Clinical Trials in 

3 Developing Countries’’, which discussed the ethical 

4 issues generated by research on human participants 

5 in developing countries and recommended ways to 

6 help ensure the health and safety of these human 

7 participants. The NBAC highlighted the inadequate 

8 regulatory protections which are afforded to human 

9 participants in many clinical trials abroad. 

10 (10) In September 2001, the Office of the In11 spector General of the Department of Health and 

12 Human Services released the report entitled ‘‘The 

13 Globalization of Clinical Trials: A Growing Chal14 lenge in Protecting Human Subjects’’. In the report, 

15 the Inspector General acknowledged that key entities 

16 which oversee or study foreign research, including 

17 United States regulatory agencies and the World 

18 Health Organization, have raised concerns about the 

19 lack of experience and insufficient monitoring prac20 tices of many foreign IRBs. 

21 (11) The Inspector General also recommended, 

22 among other things, that the FDA collect more in23 formation on the performance of foreign IRBs and 

24 the growth and location of foreign clinical investiga25 tions. 


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1 (12) While Federal regulation should accelerate, 

2 whenever possible, the delivery from laboratory to 

3 patients of new drugs which are designed to treat 

4 devastating illnesses, existing law permits manufac5 turers to profit from the misery and pain of uni6 formed, misinformed, and unwilling patients in de7 veloping countries. 

8 (13) On June 10, 2004, the FDA issued a pro9 posed rule that would, among other things, replace 

10 the existing requirement that foreign clinical studies 

11 be conducted in accordance with the ethical prin12 ciples which are contained in the Declaration of Hel13 sinki (described in section 312.120(c) of title 21, 

14 Code of Federal Regulations), with a requirement 

15 that such studies comply with good clinical practice 

16 (GCP). 

17 (14) Although pharmaceutical and bio18 technology companies and their lobbyists, in sub19 mitted public comment, generally support the pro20 posed rule, other organizations, such as the AIDS 

21 Vaccine Advocacy Coalition and Public Citizen, have 

22 objected to the proposed deletion of the Declaration 

23 of Helsinki from applicable regulations because the 

24 removal may result in the use of placebos or other 

25 drugs which are less effective than established treatVerDate Aug 31 2005 22:45 Jun 21, 2006 Jkt 049200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H5641.IH H5641

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1 ments in control groups facing life-threatening med2 ical conditions. 

3 (15) As of June 15, 2006, the FDA has not 

4 promulgated a final version of the June 2004 pro5 posed rule. 

6 SEC. 3. STATEMENT OF POLICY. 

7 It is the policy of the United States to control the 

8 export of test articles which are intended for clinical inves9 tigations involving human participants in order to— 

10 (1) foster public health and safety; 

11 (2) prevent injury to the foreign policy of the 

12 United States; and 

13 (3) preserve the credibility of the United States 

14 as a responsible trading partner. 

15 SEC. 4. MEASURES TO PROTECT THE PUBLIC HEALTH. 

16 (a) IN GENERAL.—In order to carry out the policy 

17 set forth in section 3, test articles intended for clinical 

18 investigations may be exported only pursuant to an export 

19 license approved by the President. The President may ex20 ercise the authorities of the Export Administration Act of 

21 1979, as continued in effect pursuant to the International 

22 Emergency Economic Powers Act, to carry out this sec23 tion. 

24 (b) CRITERIA FOR EXPORT LICENSE.—In addition to 

25 any other requirements that may apply, including under 


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1 the Federal Food, Drug, and Cosmetic Act, the Public 

2 Health Service Act, and regulations issued under either 

3 such Act, the President shall require, as a prerequisite for 

4 approval of an export license for a test article required 

5 by subsection (a) of this section, that an applicant for such 

6 license— 

7 (1) identify each clinical investigation for which 

8 the test article is intended; 

9 (2) secure a certification from an institutional 

10 review board that each of the protocols for every 

11 clinical investigation identified under paragraph (1) 

12 has been reviewed by the institutional review board 

13 and has, at a minimum, met substantially the same 

14 standards for the protection of the rights and wel15 fare of human subjects as the standards that would 

16 be required for IRB approval of the protocol if the 

17 protocol were for a clinical investigation of the test 

18 article pursuant to the Federal Food, Drug, and 

19 Cosmetic Act ; and 

20 (3) submit the certification secured under para21 graph (2) to the President. 

22 (c) REPORTING REQUIREMENT.—Not later than one 

23 year after the date of the enactment of this Act, and annu24 ally thereafter, the President shall prepare and submit to 

25 the appropriate congressional committees a report regardVerDate Aug 31 2005 22:45 Jun 21, 2006 Jkt 049200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H5641.IH H5641

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1 ing the approval of export licenses required by subsection 

2 (a). Such report shall include— 

3 (1) the names of the applicants for such export 

4 licenses; 

5 (2) the names of approved applicants for such 

6 export licenses; and 

7 (3) the destination country or countries for 

8 each application for such export licenses. 

9 (d) DEFINITIONS.—In this section: 

10 (1) APPLICATION FOR RESEARCH OR MAR11 KETING PERMIT.—The term ‘‘application for re12 search or marketing permit’’ has the meaning given 

13 that term in section 56.102(b) of title 21, Code of 

14 Federal Regulations, or successor regulations. 

15 (2) APPROPRIATE CONGRESSIONAL COMMIT16 TEES.—The term ‘‘appropriate congressional com17 mittees’’ means the Committee on International Re18 lations of the House of Representatives and the 

19 Committee on Banking, Housing, and Urban Affairs 

20 of the Senate. 

21 (3) CLINICAL INVESTIGATION.— 

22 (A) IN GENERAL.—The term ‘‘clinical in23 vestigation’’ means any experiment that— 

24 (i) involves a test article and one or 

25 more human subjects; and 


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1 (ii)(I) the results of which are in2 tended to be later submitted to, or held for 

3 inspection by, the Secretary of Health and 

4 Human Services as part of an application 

5 for research or marketing permit; or 

6 (II) must meet the requirements for 

7 prior submission to such Secretary under 

8 section 505(i) or 520(g) of the Federal 

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

10 355(i) or 360j(g)). 

11 (B) EXCLUSION.—The term ‘‘clinical in12 vestigation’’ does not include experiments that 

13 must meet the requirements of part 58 of title 

14 21, Code of Federal Regulations, or successor 

15 regulations, regarding nonclinical laboratory 

16 studies. 

17 (4) DESTINATION COUNTRY.—The term ‘‘des18 tination country’’ means the country into which test 

19 articles are being exported. 

20 (5) HUMAN SUBJECT.—The term ‘‘human sub21 ject’’ means an individual who is or becomes a par22 ticipant in research, either as a recipient of a test 

23 article or as a control. A subject may be either a 

24 healthy individual or a patient. 


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1 (6) INSTITUTION.—The term ‘‘institution’’ 

2 means any public or private entity or agency (includ3 ing Federal, State, and other agencies), either in the 

4 United States or other country. 

5 (7) INSTITUTIONAL REVIEW BOARD; IRB.—The 

6 terms ‘‘institutional review board’’ and ‘‘IRB’’ mean 

7 any board, committee, or other group formally des8 ignated by an institution to review, to approve the 

9 initiation of, and to conduct periodic review of, bio10 medical research involving human subjects. The pri11 mary purpose of such review is to assure the protec12 tion of the rights and welfare of the human subjects. 

13 (8) IRB APPROVAL.—The term ‘‘IRB approval’’ 

14 means the determination of an IRB made pursuant 

15 to part 56 of title 21, Code of Federal Regulations, 

16 or successor regulations, that a clinical investigation 

17 has been reviewed and may be conducted at an insti18 tution within the constraints set forth by the IRB 

19 and by other institutional and Federal requirements. 

20 (9) TEST ARTICLE.—The term ‘‘test article’’ 

21 means any drug for human use, biological product 

22 for human use, medical device for human use, 

23 human food additive, color additive, electronic prod24 uct, or any other article that would be subject to 


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1 regulation under the Federal Food, Drug, and Cos2 metic Act if introduced into interstate commerce. 

Æ 


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