I
107TH CONGRESS
2D SESSION
H. R. 5249
To promote safe and ethical clinical trials of drugs and other test articles
on people overseas.
IN THE HOUSE OF REPRESENTATIVES
JULY 26, 2002
Mr. LANTOS (for himself, Mr. BROWN of Ohio, Mr. SMITH of New Jersey,
Mr. HILLIARD, Ms. WATSON of California, Ms. LEE, Mr. PALLONE, Mr.
STUPAK, Mrs. NAPOLITANO, Mr. BERMAN, Mr. ACKERMAN, Mr. PAYNE,
Mr. MEEKS of New York, Mr. HOEFFEL, Mr. SHERMAN, Ms. WOOLSEY,
Ms. BERKLEY, Ms. MCKINNEY, and Ms. ROS-LEHTINEN) introduced the
following bill; which was referred to the Committee on International Rela-
tions
A BILL
To promote safe and ethical clinical trials of drugs and
other test articles on people overseas.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Safe Overseas Human
Testing Act’’.
SEC. 2. FINDINGS.
The Congress finds the following:
(1) Before a manufacturer of a new drug or de-
vice can market its new product, the Food and Drug
Administration (FDA) requires that the manufac-
turer conduct laboratory and clinical trials to ascer-
tain the product’s safety and effectiveness.
(2) Federal regulations mandate that an Insti-
tutional Review Board (IRB), which is comprised of
scientists, physicians, and lay people, review the pro-
tocol or research plan and the informed consent
form of the proposed clinical trial to ensure, among
other things, that the health and safety of the
human participants are not unnecessarily endan-
gered.
(3) Institutional Review Boards also verify that
the manufacturer’s clinical researchers implement
appropriate additional safeguards to protect the
rights and welfare of potentially vulnerable popu-
lations, such as women, children, the elderly, the
physically or mentally disabled, and persons who are
economically or educationally disadvantaged.
(4) Most importantly, the IRBs help assure the
FDA that manufacturers of new drugs and medical
devices adequately inform human participants of the
anticipated risks and the likelihood of projected ben-
efits derived from their participation in the clinical
trials, and then secure the voluntary consent of the
participants.
(5) For the purpose of supporting the safety
and efficacy of the test article, the FDA, however,
may accept the results of clinical trials with human
participants which are conducted outside of the
United States and do not meet United States IRB
and ethical requirements.
(6) Foreign clinical trials involving human par-
ticipants only need to conform to either international
norms on clinical investigations or the laws and reg-
ulations of the country in which the research is to
be conducted. However, neither international nor
most host-country standards meet the stringent re-
quirements in the United States.
(7) International and most foreign-country legal
protections do not adequately shield participants in
clinical investigations of a new drug or device from
unethical, dangerous, or unscrupulous research prac-
tices.
(8) According to the Department of Health and
Human Services (HHS), the number of countries in
which clinical investigators conduct drug research
for FDA-approval purposes mushroomed from 29 in
1990 to 79 in 1999. Russia and countries in East-
ern Europe and Latin America experienced the larg-
est growth of clinical research.
(9) Some researchers exploit the fragile regu-
latory systems, high illiteracy rates, and public
health failures of developing countries to test their
experimental drugs and devices on misinformed and
unwilling human participants.
(10) On December 17, 2000, the Washington
Post began a six-part series of articles which docu-
mented the abuses and unethical practices of some
United States-based pharmaceutical companies con-
ducting clinical investigations of drugs and other
test articles on human participants overseas.
(11) The Washington Post articles chronicled
numerous cases where individuals in clinical trials
had not given informed consent, researchers did not
follow protocols for investigation and falsified re-
sults, and poor people were paid to participate in
trials without fully understanding the risks of their
participation.
(12) On April 30, 2001, the National Bioethics
Advisory Commission (NBAC) presented to the
President a report, entitled ‘‘Ethical and Policy
Issues in International Research: Clinical Trials in
Developing Countries’’, which discussed the ethical
issues generated by research on human participants
in developing countries and recommended ways to
help ensure the health and safety of these human
participants. The NBAC highlighted the inadequate
regulatory protections which are afforded to human
participants in many clinical trials abroad.
(13) In September 2001, the Office of the In-
spector General within HHS released the report
‘‘The Globalization of Clinical Trials: A Growing
Challenge in Protecting Human Subjects’’. In the
report, the Inspector General acknowledged that key
entities which oversee or study foreign research, in-
cluding United States regulatory agencies and the
World Health Organization, have raised concerns
about the lack of experience and insufficient moni-
toring practices of many foreign IRBs.
(14) Also, the Inspector General recommended,
among other things, that the FDA collect more in-
formation about the performance of foreign IRBs,
and the growth and location of foreign clinical inves-
tigations.
(15) While Federal regulation should accelerate,
whenever possible, the delivery from laboratory to
patients of new drugs which are designed to treat
devastating illnesses, existing law permits manufac-
turers to profit from the misery and pain of uni-
formed, misinformed, and unwilling patients in de-
veloping countries.
SEC. 3. STATEMENT OF POLICY.
It is the policy of Congress to control the export of
test articles which are intended for clinical investigations
involving human participants in order to—
(1) foster public health and safety;
(2) prevent injury to the foreign policy of the
United States; and
(3) preserve the credibility of the United States
as a responsible trading partner.
SEC. 4. MEASURES TO PROTECT THE PUBLIC HEALTH.
(a) IN GENERAL.—In order to carry out the policy
set forth in section 3, test articles intended for clinical
investigations may be exported only pursuant to an export
license approved by the President. The President may ex-
ercise the authorities of the Export Administration Act of
1979, as continued in effect pursuant to the International
Emergency Economic Powers Act, to carry out this sec-
tion.
(b) CRITERIA FOR EXPORT LICENSE.—In addition to
any other requirements that may apply, including under
the Federal Food, Drug, and Cosmetic Act, the Public
Health Service Act, and regulations issued under either
(2) the names of approved applicants for such
export licenses; and
(3) the destination country or countries for
each application for such export licenses.
(d) DEFINITIONS.—In this section:
(1) APPLICATION
FOR
RESEARCH
OR
MAR-
KETING
PERMIT.—The term ‘‘application for re-
search or marketing permit’’ has the meaning given
that term in section 56.102(b) of title 21, Code of
Federal Regulations, or successor regulations.
(2) APPROPRIATE
CONGRESSIONAL
COMMIT-
TEES.—The term ‘‘appropriate congressional com-
mittees’’ means the Committee on International Re-
lations of the House of Representatives and the
Committee on Banking, Housing, and Urban Affairs
of the Senate.
(3) CLINICAL INVESTIGATION.—
(A) IN GENERAL.—The term ‘‘clinical in-
vestigation’’ means any experiment that in-
volves a test article and one or more human
subjects, and that either must meet the require-
ments for prior submission to the Food and
Drug Administration under section 505(i),
507(d), or 520(g) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(i), 357(d), or
360j(g)), or need not meet the requirements for
prior submission to the Food and Drug Admin-
istration under those sections, but the results of
which are intended to be later submitted to, or
held for inspection by, the Food and Drug Ad-
ministration as part of an application for a re-
search or marketing permit.
(B) EXCLUSION.—The term ‘‘clinical in-
vestigation’’ does not include experiments that
must meet the provisions of part 58 of title 21,
Code of Federal Regulations, or successor regu-
lations, regarding nonclinical laboratory studies.
(4) DESTINATION COUNTRY.—The term ‘‘des-
tination country’’ means the country into which test
articles are being exported.
(5) HUMAN SUBJECT.—The term ‘‘human sub-
ject’’ means an individual who is or becomes a par-
ticipant in research, either as a recipient of a test
article or as a control. A subject may be either a
healthy individual or a patient.
(6) 
INSTITUTION.—The 
term 
‘‘institution’’
means any public or private entity or agency (includ-
ing Federal, State, and other agencies), either in the
United States or other country.
(7) INSTITUTIONAL REVIEW BOARD; IRB.—The
terms ‘‘institutional review board’’ and ‘‘IRB’’ mean
any board, committee, or other group formally des-
ignated by an institution to review, to approve the
initiation of, and to conduct periodic review of, bio-
medical research involving human subjects. The pri-
mary purpose of such review is to assure the protec-
tion of the rights and welfare of the human subjects.
(8) IRB APPROVAL.—The term ‘‘IRB approval’’
means the determination of an IRB made pursuant
to part 56 of title 21, Code of Federal Regulations,
or successor regulations, that a clinical investigation
has been reviewed and may be conducted at an insti-
tution within the constraints set forth by the IRB
and by other institutional and Federal requirements.
(9) TEST
ARTICLE.—The term ‘‘test article’’
means any drug for human use, biological product
for human use, medical device for human use,
human food additive, color additive, electronic prod-
uct, or any other article that would be subject to
regulation under the Federal Food, Drug, and Cos-
metic Act if introduced into interstate commerce.
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