[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5641 Introduced in House (IH)]








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.

    Be it enacted by the Senate and House of Representatives 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 device can 
        market its new product, the Food and Drug Administration (in 
        this section referred to as the ``FDA'') requires that the 
        manufacturer conduct laboratory and clinical trials to 
        ascertain the product's safety and effectiveness.
            (2) Federal regulations mandate that an Institutional 
        Review Board (IRB), which is comprised of scientists, 
        physicians, and lay people, review the protocol 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 endangered.
            (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 populations 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 benefits 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 participants 
        only need to conform to either international norms on clinical 
        investigations or the laws and regulations of the country in 
        which the research is to be conducted. However, neither 
        international nor most host-country standards meet the 
        stringent requirements of 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 practices.
            (8) Some researchers exploit the fragile regulatory 
        systems, high illiteracy rates, and public health failures of 
        developing countries to test their experimental drugs and 
        devices on misinformed and unwilling human participants.
            (9) 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.
            (10) In September 2001, the Office of the Inspector General 
        of the Department of Health and Human Services released the 
        report entitled ``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, including United 
        States regulatory agencies and the World Health Organization, 
        have raised concerns about the lack of experience and 
        insufficient monitoring practices of many foreign IRBs.
            (11) The Inspector General also recommended, among other 
        things, that the FDA collect more information on the 
        performance of foreign IRBs and the growth and location of 
        foreign clinical investigations.
            (12) 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 manufacturers to profit from the misery and pain of 
        uniformed, misinformed, and unwilling patients in developing 
        countries.
            (13) On June 10, 2004, the FDA issued a proposed rule that 
        would, among other things, replace the existing requirement 
        that foreign clinical studies be conducted in accordance with 
        the ethical principles which are contained in the Declaration 
        of Helsinki (described in section 312.120(c) of title 21, Code 
        of Federal Regulations), with a requirement that such studies 
        comply with good clinical practice (GCP).
            (14) Although pharmaceutical and biotechnology companies 
        and their lobbyists, in submitted public comment, generally 
        support the proposed rule, other organizations, such as the 
        AIDS Vaccine Advocacy Coalition and Public Citizen, have 
        objected to the proposed deletion of the Declaration of 
        Helsinki from applicable regulations because the removal may 
        result in the use of placebos or other drugs which are less 
        effective than established treatments in control groups facing 
        life-threatening medical conditions.
            (15) As of June 15, 2006, the FDA has not promulgated a 
        final version of the June 2004 proposed rule.

SEC. 3. STATEMENT OF POLICY.

    It is the policy of the United States 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 exercise 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 section.
    (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 such Act, the President shall require, as a prerequisite 
for approval of an export license for a test article required by 
subsection (a) of this section, that an applicant for such license--
            (1) identify each clinical investigation for which the test 
        article is intended;
            (2) secure a certification from an institutional review 
        board that each of the protocols for every clinical 
        investigation identified under paragraph (1) has been reviewed 
        by the institutional review board and has, at a minimum, met 
        substantially the same standards for the protection of the 
        rights and welfare of human subjects as the standards that 
        would be required for IRB approval of the protocol if the 
        protocol were for a clinical investigation of the test article 
        pursuant to the Federal Food, Drug, and Cosmetic Act ; and
            (3) submit the certification secured under paragraph (2) to 
        the President.
    (c) Reporting Requirement.--Not later than one year after the date 
of the enactment of this Act, and annually thereafter, the President 
shall prepare and submit to the appropriate congressional committees a 
report regarding the approval of export licenses required by subsection 
(a). Such report shall include--
            (1) the names of the applicants for such export licenses;
            (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 marketing permit.--The term 
        ``application for research 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 committees.--The term 
        ``appropriate congressional committees'' means the Committee on 
        International Relations 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 
                investigation'' means any experiment that--
                            (i) involves a test article and one or more 
                        human subjects; and
                            (ii)(I) the results of which are intended 
                        to be later submitted to, or held for 
                        inspection by, the Secretary of Health and 
                        Human Services as part of an application for 
                        research or marketing permit; or
                            (II) must meet the requirements for prior 
                        submission to such Secretary under section 
                        505(i) or 520(g) of the Federal Food, Drug, and 
                        Cosmetic Act (21 U.S.C. 355(i) or 360j(g)).
                    (B) Exclusion.--The term ``clinical investigation'' 
                does not include experiments that must meet the 
                requirements of part 58 of title 21, Code of Federal 
                Regulations, or successor regulations, regarding 
                nonclinical laboratory studies.
            (4) Destination country.--The term ``destination country'' 
        means the country into which test articles are being exported.
            (5) Human subject.--The term ``human subject'' means an 
        individual who is or becomes a participant 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 (including 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 designated by an institution 
        to review, to approve the initiation of, and to conduct 
        periodic review of, biomedical research involving human 
        subjects. The primary purpose of such review is to assure the 
        protection 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 institution 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 
        product, or any other article that would be subject to 
        regulation under the Federal Food, Drug, and Cosmetic Act if 
        introduced into interstate commerce.
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