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[DOCID: f:h2405ih.txt]






107th CONGRESS
  1st Session
                                H. R. 2405

To amend the Public Health Service Act with respect to facilitating the 
  development of microbicides for preventing transmission of HIV and 
                  other sexually transmitted diseases.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             June 28, 2001

 Mrs. Morella (for herself, Ms. Eshoo, Ms. Pelosi, Mr. Greenwood, Mr. 
 Ganske, Mrs. Lowey, Mr. Sawyer, Ms. DeGette, Mr. Upton, Mrs. Thurman, 
   Ms. Slaughter, Mr. Jackson of Illinois, Mr. Waxman, Ms. Millender-
McDonald, Mrs. Maloney of New York, Ms. DeLauro, and Mr. George Miller 
of California) introduced the following bill; which was referred to the 
                    Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
To amend the Public Health Service Act with respect to facilitating the 
  development of microbicides for preventing transmission of HIV and 
                  other sexually transmitted diseases.

    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 ``Microbicide Development Act of 
2001''.

SEC. 2. FINDINGS.

    The Congress finds as follows:
            (1) Sexually transmitted diseases (``STDs'') and the human 
        immunodeficiency virus (``HIV'') are producing serious and 
        costly epidemics of infectious disease in populations 
        worldwide.
            (2) This year, 15,400,000 people in the United States will 
        acquire a new STD.
            (3) Globally, 36,100,000 people are infected with HIV, with 
        more than 15,000 new infections occurring daily.
            (4) Racial and ethnic minorities have been 
        disproportionately infected with STDs, especially HIV. For 
        example, although together African American and Latina women 
        represent roughly 25 percent of the total U.S. female 
        population, they account for 77 percent of all reported female 
        HIV cases.
            (5) STDs cause serious, costly, even deadly conditions for 
        women and their children: infertility, pregnancy complications, 
        cervical cancer, infant mortality, and higher risk of 
        contracting HIV.
            (6) Estimated annual costs of STDs and their complications 
        in the United States range from $8,400,000,000 in direct 
        medical costs to nearly $20,000,000,000, including out-of-
        pocket costs and lost productivity.
            (7) Microbicides are a promising new technology for STD and 
        HIV prevention.
            (8) Microbicides are user-controlled products that could 
        kill or inactivate the bacteria and viruses that cause STDs and 
        HIV.
            (9) Microbicides would fill a critical gap in the array of 
        STD-prevention technologies, first as an important backup or 
        alternative to the condom, and second, as a technology that, 
        unlike most vaccines, could offer protection against various 
        STDs, not just HIV.
            (10) Several potential microbicides are poised for 
        successful development; more than 20 products are in clinical 
        trials and nearly 35 promising compounds exist that could be 
        investigated further.
            (11) Studies into the market potential for microbicides 
        indicate that they would have broad appeal. One nationally 
        representative survey indicated that at least 21,000,000 
        sexually active women in the United States would be interested 
        in such products, if they were available.
            (12) Federal support for microbicide research and 
        development is crucial.
            (13) At present, there appear to be insufficient perceived 
        economic incentives for pharmaceutical companies to become 
        actively engaged in microbicide research and development.
            (14) Numerous small biotechnology companies and university 
        researchers are actively engaged in microbicide research, but 
        they are almost totally dependent on public-sector grants to 
        continue their work and test their products.
            (15) Despite public health need and tremendous scientific 
        opportunity, microbicide research and development currently 
        receives less than 1 percent of the Federal HIV research 
        budget--not nearly enough to keep pace with the raging STD and 
        HIV epidemics.
            (16) Existing public sector grants for microbicides are too 
        small and too short-term to move product leads forward, and the 
        availability of clinical trial sites is limited by funding 
        constraints.
            (17) There is a backlog in the research and development 
        pipeline, so that innovative and promising product concepts are 
        languishing, while infection rates are growing.
            (18) For significant progress to be made, the current 
        amount of Federal investment needs to increase to $75,000,000 
        in fiscal year 2002, to $100,000,000 in fiscal year 2003, with 
        $100,000,000 yearly in the successive out-years as required, in 
        order to sustain multiyear funding at a productive level.

   TITLE I--MICROBICIDE RESEARCH AT THE NATIONAL INSTITUTES OF HEALTH

SEC. 101. NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES; 
              PROGRAM REGARDING MICROBICIDES FOR PREVENTING 
              TRANSMISSION OF HIV AND OTHER SEXUALLY TRANSMITTED 
              DISEASES.

    Subpart 6 of part C of title IV of the Public Health Service Act 
(42 U.S.C. 285f et seq.) is amended by adding at the end the following 
section:

 ``microbicides for preventing transmission of hiv and other sexually 
                          transmitted diseases

    ``Sec. 447C. (a) Expansion and Coordination of Activities.--The 
Director of the Institute shall expand, intensify, and coordinate the 
activities of the Institute with respect to research on the development 
of microbicides to prevent the transmission of HIV and other sexually 
transmitted diseases (in this section referred to as `microbicide 
research').
    ``(b) Coordination With Other Institutes.--The Director of the 
Institute shall coordinate the activities under subsection (a) among 
all appropriate institutes and components of the National Institutes of 
Health to the extent such institutes and components have 
responsibilities that are related to the development of microbicides.
    ``(c) Research Plan.--
            ``(1) In general.--The Director of the Institute, acting in 
        consultation with the Director of the Office of AIDS Research, 
        shall develop a comprehensive research plan for the conduct and 
        support of research and development of microbicides (in this 
        section referred to as the `Research Plan'), and shall annually 
        review and as appropriate revise the plan.
            ``(2) Requirements.--The Research Plan shall--
                    ``(A) identify current microbicide research and 
                development activities conducted or supported by the 
                National Institutes of Health, including a description 
                of each current grant and contract mechanism explicitly 
                designed to facilitate microbicide research, including 
                support for preclinical product development and 
                clinical trial capacity; and
                    ``(B) describe microbicide research and development 
                opportunities for the five year period beginning six 
                months after the date of the enactment of the 
                Microbicide Development Act of 2001, including 
                professional judgment funding projections, description 
                of objectives with respect to microbicide research, 
                descr
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iption of the institutes involved and their role 
                in microbicide research, plans for enhancing the 
                capacity of such institutes to carry out the research 
                opportunities, including staffing and resources 
                necessary for carrying out the activities of this 
                section, and discussion of plans for increasing number 
                of investigators in this area of research.
            ``(3) Consultation.--In developing the Research Plan, the 
        Director of the Institute shall work in close consultation with 
        all appropriate institutes and components at the National 
        Institutes for Health that have responsibilities that are 
        related to the development of microbicides, with the 
        microbicide research community, and with health advocates.
            ``(4) Submission of initial plan to president and 
        congress.--
                    ``(A) In general.--The initial Research Plan shall 
                be developed not later than six months after the date 
                of the enactment of the Microbicide Development Act of 
                2001. The Director of the Institute shall transmit such 
                Plan to the Director of NIH, who shall submit the Plan 
                to the President and the Congress.
                    ``(B) Relation to requirement of biennial nih 
                report.--Subparagraph (A) shall be carried out 
                independently of the process of reporting that is 
                required in section 403.
    ``(d) Program for Microbicide Development.--
            ``(1) In general.--In carrying out subsection (a), the 
        Director of the Institute shall establish a program to support 
        research to develop microbicides that can substantially reduce 
        transmission of HIV and other sexually transmitted diseases. 
        Activities under such program shall provide for an expansion 
        and intensification of the conduct and support of--
                    ``(A) basic research on the initial mechanisms of 
                infection by sexually transmitted pathogens;
                    ``(B) development of appropriate animal models for 
                evaluating safety and efficacy of microbicides;
                    ``(C) development of formulation and delivery 
                approaches;
                    ``(D) research on targeted designs of microbicides;
                    ``(E) manufacture of candidate products for testing 
                in animals and humans;
                    ``(F) conduct of HIV incidence and microbicide 
                feasibility studies;
                    ``(G) evaluation of microbicides in clinical 
                trials, both domestically and internationally; and
                    ``(H) behavioral research on use, acceptability, 
                and adherence to microbicides.
            ``(2) Research branch.--The Director of the Institute shall 
        establish, within the Vaccine and Prevention Research Program 
        of the Division of AIDS in the Institute, an organizational 
        unit to be known as the Microbicide Research Branch. Such 
        Branch shall carry out the program under this subsection.
    ``(e) Construction of Facilities.--The Director of the Institute 
may make awards of grants and contracts to public and nonprofit private 
entities for the construction of facilities to conduct microbicide 
research, including clinical trials.
    ``(f) Centers for Microbicide Research and Development.--
            ``(1) In general.--The Director of the Institute, after 
        consultation with the advisory council for the Institute, and 
        in consultation with the Director of the Office of AIDS 
        Research, shall make awards of grants or contracts to public 
        and nonprofit private entities for the development and 
        operation of not less than four multidisciplinary research 
        centers to conduct microbicide research.
            ``(2) Requirements.--Each center assisted under this 
        subsection shall--
                    ``(A) use the facilities of a single institution, 
                or be formed from a consortium of cooperating 
                institutions, meeting such requirements as may be 
                prescribed by the Director of the Institute; and
                    ``(B) conduct basic research on muscosal 
                transmission to design novel microbicide strategies for 
                the prevention of HIV and STD infection, including 
                research into HIV and STD pathogenesis, reproductive 
                tract biology and toxicology, concept testing in animal 
models, and formulation and delivery design.
    ``(g) Report to Congress.--Not later than one year after the date 
of the initial submission of the Research Plan under subsection (c)(1), 
and annually thereafter, the Director of the Institute shall submit to 
the Committee on Energy and Commerce in the House of Representatives 
and the Committee on Health, Education, Labor and Pensions in the 
Senate a report that describes the activities of the Institute 
regarding microbicide research. Each such report shall include--
            ``(1) an updated Research Plan, including professional 
        judgment funding projections;
            ``(2) an assessment of the implementation of such plan;
            ``(3) a description and evaluation of the progress made, 
        during the period for which such report is prepared, in the 
        research on microbicides;
            ``(4) a summary and analysis of expenditures made, during 
        the period for which the report is made, for activities with 
        respect to microbicides research conducted and supported by the 
        National Institutes of Health, including the number of full-
        time equivalent employees; and
            ``(5) such comments and recommendations as the Director of 
        the Institute considers appropriate.
    ``(h) Coordination With Other Federal Agencies.--The Director of 
the Institute shall consult with the Director for the Centers for 
Disease Control and Prevention and the United States Agency for 
International Development in developing the Research Plan that takes 
into consideration research on HIV and other sexually transmitted 
diseases and microbicides carried out at the Centers for Disease 
Control and Prevention and the United States Agency for International 
Development.
    ``(i) Definition.--For purposes of this section, the term `HIV' 
means the human immunodeficiency virus. Such term includes acquired 
immune deficiency syndrome.
    ``(j) Authorization of Appropriations.--For the purposes of 
carrying out this section, there are authorized to be appropriated such 
sums as may be necessary for each of the fiscal years 2002 through 
2004.''.

 TITLE II--MICROBICIDE RESEARCH AT THE CENTERS FOR DISEASE CONTROL AND 
                               PREVENTION

SEC. 201. MICROBICIDES FOR PREVENTING TRANSMISSION OF HIV AND OTHER 
              SEXUALLY TRANSMITTED DISEASES.

    Part B of title III of the Public Health Service Act (42 U.S.C. 243 
et seq.) is amended by inserting after section 317P the following 
section:

 ``microbicides for preventing transmission of hiv and other sexually 
                          transmitted diseases

    ``Sec. 317Q. (a) Expansion and Coordination of Microbicide Research 
Activities.--The Secretary, acting through the Director of the Centers 
for Disease Control and Prevention, shall expand, intensify, and 
coordinate the activities of such Centers with respect to research on 
microbicides to prevent the transmission of HIV and other sexually 
transmitted diseases.
    ``(b) Grants Regarding Microbicide Research.--In order to 
contribute to the rapid evaluation of safe and effective microbicides 
for the prevention of HIV and other sexually transmitted diseases, the 
Secretary may in carrying out subsection (a) make grants to public and 
nonprofit private entities for the purpose of--
            ``(1) laboratory research in 
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preparation for, and support 
        of, clinical microbicide trials;
            ``(2) conducting behavioral research in preparation for, 
        and support of, clinical microbicide trials;
            ``(3) developing and characterizing domestic populations 
        and international cohorts appropriate for Phase I, II, and III 
        clinical trials of candidate topical microbicides;
            ``(4) conducting Phase I and II clinical trials to assess 
        the safety and acceptability of candidate microbicides;
            ``(5) conducting Phase III clinical trials to assess the 
        efficacy of candidate microbicides;
            ``(6) provide technical assistance to, and consultation 
        with, a wide variety of domestic and international entities 
        involved in developing and evaluating topical microbicides, 
        including health agencies, extramural researchers, industry, 
        health advocates, and non-profit organizations; and
            ``(7) developing and evaluating the diffusion and effects 
        of implementation strategies for use of effective topical 
        microbicides.
    ``(c) Selection of Agents and Trial Designs; Coordination With 
Other Agencies.--In coordination and collaboration with the Director of 
the National Institutes of Health and the Administrator of the United 
States Agency for International Development, the Secretary shall select 
agents and trial designs, develop clinical trial capacity as described 
in subsection (b), share experience, and avoid duplication of effort.
    ``(d) Annual Reports.--Not later than six months after the date of 
the enactment of the Microbicide Development Act of 2001, and annually 
thereafter, the Secretary shall submit to the Energy and Commerce 
Committee in the House of Representatives and the Health, Education, 
Labor and Pensions Committee in the Senate a report on the activities 
carried out under this section by the Secretary. Each such report shall 
include--
            ``(1) description of research with respect to microbicide 
        research and development;
            ``(2) description and evaluation of the progress made, 
        during the period for which such report is prepared, in the 
        research on microbicides; and
            ``(3) summary and analysis of expenditures made, during the 
        period for which the report is made, for activities with 
        respect to microbicides conducted and supported by the Centers 
        for Disease Control and Prevention.
    ``(e) Definition.--For the purposes of this section, the term `HIV' 
means the human immunodeficiency virus. Such term includes acquired 
immune deficiency syndrome.
    ``(f) Authorization of Appropriations.--For the purposes of 
carrying out this section, there are authorized to be appropriated such 
sums as may be necessary for each of the fiscal years 2002 through 
2004.''.
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