[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3854 Introduced in House (IH)]







109th CONGRESS
  1st Session
                                H. R. 3854

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


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           September 21, 2005

  Mr. Shays (for himself, Ms. Schakowsky, Mr. Davis of Illinois, Mr. 
George Miller of California, Mr. Brown of Ohio, Ms. Millender-McDonald, 
Mr. Payne, Mr. Leach, Ms. Lee, Mr. Evans, Ms. Schwartz of Pennsylvania, 
    Mr. Crowley, Mr. Waxman, Mr. Kirk, Mr. Emanuel, Mr. Berman, Mr. 
Grijalva, Mr. Jackson of Illinois, Mr. Larson of Connecticut, Ms. Bean, 
   Mr. McNulty, Mr. Owens, Mr. Wexler, Mr. Rush, Mr. Gutierrez, Mr. 
  McDermott, Mr. McGovern, Mr. Van Hollen, Mr. Stark, and Mr. Honda) 
 introduced the following bill; which was referred to the Committee on 
Energy and Commerce, and in addition to the Committee on International 
 Relations, for a period to be subsequently determined by the Speaker, 
 in each case for consideration of such provisions as fall within the 
                jurisdiction of the committee concerned

_______________________________________________________________________

                                 A BILL


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

    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''.

SEC. 2. FINDINGS.

    Congress makes the following findings:
            (1) Women and girls are the new face of HIV/AIDS, and are 
        increasingly affected by the disease in each region of the 
        world. Women account for nearly \1/2\ of the 37,000,000 adults 
        living with HIV and AIDS worldwide as of 2005. Approximately 
        7,000 women are newly infected with HIV each day.
            (2) Because of their social and biological vulnerabilities, 
        young women are particularly at risk. In Sub-Saharan Africa, 76 
        percent of the young people (between ages 15 and 24) with HIV 
        are girls under 20.
            (3) When women become infected with HIV, they can pass 
        along the infection to their children during pregnancy, labor 
        and delivery, or breast-feeding. The most effective way to halt 
        mother-to-child transmission is to ensure that mothers are not 
        infected in the first place.
            (4) An increasing number of women who become infected with 
        HIV have only 1 sexual partner, their husband. Unfortunately, 
        marriage is not necessarily effective protection against HIV, 
        because to protect themselves from HIV, women have to rely on 
        their male partners to be faithful or to use condoms. Many 
        women in the developing world are unable to insist on mutual 
        monogamy or negotiate condom use, especially in long-term 
        relationships.
            (5) Scientists are working on a promising new prevention 
        tool that could slow down the spread of the HIV/AIDS epidemic, 
        microbicides. Formulated as gels, creams, or rings, 
        microbicides inactivate, block, or otherwise interfere with the 
        transmission of the pathogens that cause AIDS and other 
        sexually transmitted diseases (``STD''s). Microbicides could 
        allow a woman to protect herself from disease.
            (6) Married couples need a method of HIV protection that 
        will allow them to conceive a child and start a family. No 
        existing HIV prevention method also allows conception. Some 
        microbicides are being developed with the objective that they 
        will allow conception while protecting from disease.
            (7) Households in developing countries often dissolve when 
        a mother dies. In the hardest hit countries, the number of 
        children who are orphaned by AIDS is increasing dramatically.
            (8) Women in the United States also need HIV prevention 
        tools like microbicides. AIDS is now the number 1 cause of 
        death among African-American women between the ages of 25 and 
        34.
            (9) In addition to HIV, other STDs continue to be a major 
        health threat in the United States. The United States has the 
        highest rates of sexually transmitted diseases of any 
        industrialized nation. Nineteen million STD infections occur 
        every year. It is estimated that by age 25, \1/2\ of all 
        sexually active people in the United States can expect to be 
        infected with an STD.
            (10) HIV and AIDS represent a threat to national security 
        and economic well being, with direct medical costs of up to 
        $15,500,000,000 per year. The pandemic undermines armies, 
        foments unrest, and burdens the United States military.
            (11) As the Nation's largest single provider of HIV/AIDS 
        care, the Veterans Affairs health care system spent 
        $359,000,000 to provided care to more than 20,000 American 
        veterans with HIV/AIDS in fiscal year 2004.
            (12) The microbicide field has achieved an extraordinary 
        amount of scientific momentum, with several first-generation 
        candidates now in large scale human trials around the world. At 
        same time, new products, based upon recent advances in HIV 
        treatment, have advanced into early safety trials.
            (13) Microbicides are a classic public health good for 
        which the social benefits are high but the economic incentive 
        to private investment is low. Like other public health goods, 
        such as vaccines, public funding must fill the gap. Microbicide 
        research depends in large part on Government leadership and 
        investment.
            (14) The Federal Government needs to make a strong 
        commitment to microbicide research and development. Three 
        agencies--the National Institutes of Health (``NIH''), the 
        Centers for Disease Control and Prevention (``CDC''), and the 
        United States Agency of International Development (``USAID'')--
        have played important roles in the progress to date, but 
        further strong, well-coordinated, and visible public sector 
        leadership will be essential for the promise of microbicides to 
        be realized.
            (15) As of 2005, microbicide research at NIH is conducted 
        under several institutes with no single line of administrative 
        accountability, no specific funding coordination, and highly 
        variable levels of interest and commitment across institute 
        leadership. Only a few NIH staff can claim microbicides as 
        their sole focus.
            (16) The President's Emergency Plan for AIDS Relief 
        (``PEPFAR'') recognizes the urgency of developing safe and 
        effective microbicides to prevent HIV. In addition, NIH 
        documents state that ``the US government is firmly committed to 
        accelerating the development of safe and effective microbicides 
        to prevent HIV,'' recognizing that microbicides may provide 
        ``one of the most promising preventative interventions given 
        that could be inexpensive, readily available, and widely 
        acceptable''. But as of 2005, NIH spends barely 2 percent of 
        its HIV/AIDS research budget on microbicides. As more 
        microbicide candidates are advanced into later-stage clinical 
        trials and development costs rise correspondingly, 2005 funding 
        levels are simply inadequate.
            (17) USAID and the CDC have expanded their microbicide 
        portfolios, but without overall Federal coordination, costly 
        inefficiencies and unproductive duplication of effort may 
        result. USAID sustains strong partnerships with public and 
        private organizations working on microbicide research, 
        importantly including clinical trials in developing countries 
        where its experience is extensive. USAID is well positioned to 
        facilitate the introduction of microbicides once they are 
        available. The CDC also engages in critical microbicide 
        research and clinical testing, and has a long history of 
        conducting field trials in developing countries.
            (18) HIV prevention options available as of 2005 are not 
        enough. HIV prevention strategies must recognize women's needs 
        and vulnerabilities. If women are to have a genuine opportunity 
        to protect themselves, their best option is the rapid 
        development of new HIV-prevention technologies like 
        microbicides, which women can initiate.

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

SEC. 101. OFFICE OF AIDS RESEARCH; PROGRAM REGARDING MICROBICIDES FOR 
              PREVENTING TRANSMISSION OF HIV AND OTHER DISEASES.

    Subpart I of part D of title XXIII of the Public Health Service Act 
(42 U.S.C. 300cc-40 et seq.) is amended by inserting after section 2351 
the following:

``SEC. 2351A. MICROBICIDES FOR PREVENTING TRANSMISSION OF HIV AND OTHER 
              DISEASES.

    ``(a) Federal Strategic Plan.--
            ``(1) In general.--The Director of the Office of AIDS 
        Research shall--
                    ``(A) expedite the implementation of a Federal 
                strategic plan for the conduct and support of 
                microbicide research and development; and
                    ``(B) annually review and, as appropriate, revise 
                such plan, to prioritize funding and activities in 
                terms of their scientific urgency.
            ``(2) Coordination.--In implementing, reviewing, and 
        prioritizing elements of the plan described under paragraph 
        (1), the Director of the Office of AIDS Research shall 
        coordinate with--
                    ``(A) other Federal agencies, including the 
                Director of the Centers for Disease Control and 
                Prevention and the Administrator of the United States 
                Agency for International Development, involved in 
                microbicide research;
                    ``(B) the microbicide research community; and
                    ``(C) health advocates.
    ``(b) Expansion and Coordination of Activities.--The Director of 
the Office of AIDS Research, acting in coordination with other relevant 
institutes and offices, shall expand, intensify, and coordinate the 
activities of all appropriate institutes and components of the National 
Institutes of Health with respect to research and development of 
microbicides to prevent the transmission of the human immunodeficiency 
virus (`HIV') and other sexually transmitted diseases.
    ``(c) Microbicide Development Unit.--In carrying out subsection 
(b), the Director of the National Institute of Allergy and Infectious 
Diseases shall establish within the Division of AIDS in the Institute, 
a clearly defined organizational unit charged with carrying out 
microbicide research and development. In establishing such unit, the 
Director shall ensure that there are a sufficient number of employees 
dedicated to carrying out the mission of the unit.
    ``(d) Microbicide Clinical Trials.--In carrying out subsection (c), 
the Director of the National Institute of Allergy and Infectious 
Diseases shall assign priority to ensuring adequate funding and support 
for the integration of basic science and clinical research, with 
particular emphasis on implementation of trials leading to product 
licensure.
    ``(e) Reports to Congress.--
            ``(1) In general.--Not later than 6 months after the date 
        of enactment of the Microbicide Development Act, and annually 
        thereafter, the Director of the Office of AIDS Research shall 
        submit to the appropriate committees of Congress a report that 
        describes the strategies being implemented by the Federal 
        Government regarding microbicide research and development.
            ``(2) Contents of reports.--Each report submitted under 
        paragraph (1) shall include--
                    ``(A) a description of activities with respect to 
                microbicide research and development conducted and 
                supported by the Federal Government;
                    ``(B) a summary and analysis of the expenditures 
                made by the Director of the Office of AIDS Research 
                during the preceding year for activities with respect 
                to microbicide-specific research and development, 
                including basic research, preclinical product 
                development, clinical trials, and process development 
                and production;
                    ``(C) a description and evaluation of the progress 
                made, during the preceding year, toward the development 
                of effective and acceptable microbicides; and
                    ``(D) a review of scientific and programmatic 
                obstacles to expediting the commercial availability of 
                microbicide products.
            ``(3) Appropriate committees of congress defined.--In this 
        subsection, the term `appropriate committees of Congress' means 
        the Committee on Health, Education, Labor, and Pensions and the 
        Committee on Appropriations of the Senate and the Committee on 
        Energy and Commerce and the Committee on Appropriations of the 
        House of Representatives.
    ``(f) Authorization of Appropriations.--There are authorized to be 
appropriated such sums as may be necessary for each fiscal year to 
carry out this section.''.

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

SEC. 201. MICROBICIDES FOR PREVENTING TRANSMISSION OF HIV AND OTHER 
              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 317S the following:

``SEC. 371T. MICROBICIDES FOR PREVENTING TRANSMISSION OF HIV AND OTHER 
              DISEASES.

    ``(a) Development and Implementation of the Microbicide Agenda 
Supported by the Centers for Disease Control and Prevention.--The 
Director of the Centers for Disease Control and Prevention shall fully 
implement such Centers' topical microbicide agenda to support 
microbicide research and development. Such an agenda shall include--
            ``(1) conducting laboratory research in 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 Phases I, II, and III 
        clinical trials of candidate topical microbicides;
            ``(4) conducting Phases 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) providing technical assistance to, and consulting 
        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 nonprofit organizations; and
            ``(7) developing and evaluating the diffusion and effects 
        of implementation strategies for use of effective topical 
        microbicides.
    ``(b) Personnel.--The Centers for Disease Control and Prevention 
shall ensure that there are sufficient numbers of dedicated employees 
for carrying out the microbicide agenda under subsection (a).
    ``(c) Report to Congress.--
            ``(1) In general.--Not later than 1 year after the date of 
        enactment of the Microbicide Development Act, and annually 
        thereafter, the Director of the Centers for Disease Control and 
        Prevention shall submit to the appropriate committees of 
        Congress, a report on the strategies being implemented by the 
        Centers for Disease Control and Prevention with respect to 
        microbicide research and development. Such report shall be 
        submitted alone or as part of the overall Federal strategic 
        plan on microbicides compiled annually by the National 
        Institutes of Health Office of AIDS Research as required under 
        section 2351A.
            ``(2) Contents of report.--Such report shall include--
                    ``(A) a description of activities with respect to 
                microbicides conducted or supported by the Director of 
                the Centers for Disease Control and Prevention;
                    ``(B) a summary and analysis of the expenditures 
                made by such Director during the preceding year, for 
                activities with respect to microbicide-specific 
                research and development, including the number of 
                employees of such Centers involved in such activities;
                    ``(C) a description and evaluation of the progress 
                made, during the preceding year, toward the development 
                of effective and acceptable microbicides; and
                    ``(D) a review of scientific and programmatic 
                obstacles to expediting the commercial availability of 
                microbicide products.
            ``(3) Appropriate committees of congress defined.--For the 
        purposes of this subsection, the term `appropriate committees 
        of Congress' means the Committee on Health, Education, Labor, 
        and Pensions and the Committee on Appropriations of the Senate 
        and the Committee on Energy and Commerce and the Committee on 
        Appropriations of the House of Representatives.
    ``(d) Authorization of Appropriations.--There are authorized to be 
appropriated such sums as may be necessary for each fiscal year to 
carry out this section.''.

    TITLE III--MICROBICIDE RESEARCH AT THE UNITED STATES AGENCY FOR 
                       INTERNATIONAL DEVELOPMENT

SEC. 301. MICROBICIDES FOR PREVENTING TRANSMISSION OF HIV AND OTHER 
              DISEASES.

    Section 104A of the Foreign Assistance Act of 1961 (22 U.S.C. 
2151b-2) is amended--
            (1) by redesignating subsection (g) as subsection (h); and
            (2) by inserting after subsection (f) the following:
    ``(g) Microbicides for Preventing Transmission of HIV and Other 
Diseases.--
            ``(1) Development and implementation of the microbicide 
        agenda.--The head of the Office of HIV/AIDS of the United 
        States Agency for International Development, in conjunction 
        with other offices of such Agency, shall develop and implement 
        a program to support the development of microbicides products 
        for the prevention of the transmission of HIV and other 
        diseases, and facilitate wide-scale availability of such 
        products after such development. The program shall be known as 
        the `microbicide agenda' and shall include--
                    ``(A) support for the discovery, development, and 
                preclinical evaluation of topical microbicides;
                    ``(B) support for the conduct of clinical studies 
                of candidate microbicides to assess the safety, 
                acceptability, and effectiveness of such microbicides 
                in reducing the transmission of HIV and other sexually 
                transmitted diseases;
                    ``(C) support for behavioral and social science 
                research relevant to microbicide development, testing, 
                acceptability, and use;
                    ``(D) support for preintroductory and introductory 
                studies of safe and effective microbicides in 
                developing countries; and
                    ``(E) facilitation of access to microbicides by 
                women at highest risk of contracting HIV or other 
                sexually transmitted diseases, at the earliest possible 
                time.
            ``(2) Staffing.--The head of the Office of HIV/AIDS shall 
        ensure that the Agency has a sufficient number of dedicated 
        employees to carry out the microbicide agenda.
            ``(3) Reports to congress.--
                    ``(A) In general.--Not later than 1 year after the 
                date of enactment of the Microbicide Development Act, 
                and annually thereafter, the Administrator of the 
                Agency shall submit to the appropriate committees of 
                Congress a report on the activities of the 
                Administrator to carry out the microbicide agenda and 
                on any other activities carried out by the 
                Administrator related to microbicide research and 
                development.
                    ``(B) Contents of report.--Each report submitted 
                under subparagraph (A) shall include--
                            ``(i) a description of activities with 
                        respect to microbicides conducted or supported 
                        by the Administrator;
                            ``(ii) a summary and analysis of the 
                        expenditures made by the Administrator during 
                        the preceding year for activities with respect 
                        to microbicide-specific research and 
                        development, including the number of employees 
                        of the Agency who are involved in such 
                        activities;
                            ``(iii) a description and evaluation of the 
                        progress made during the preceding year toward 
                        the development of effective and acceptable 
                        microbicides;
                            ``(iv) a review of scientific and 
                        programmatic obstacles to expediting the 
                        commercial availability of microbicide 
                        products; and
                            ``(v) a description of the activities 
                        carried out to increase the availability of 
                        microbicides approved to prevent the 
                        transmission of HIV or other sexually 
                        transmitted diseases.
                    ``(C) Appropriate committees of congress defined.--
                In this paragraph, the term `appropriate committees of 
                Congress' means the Committee on Foreign Relations and 
                the Committee on Appropriations of the Senate and the 
                Committee on International Relations and the Committee 
                on Appropriations of the House of Representatives.
            ``(4) Authorization of appropriations.--There are 
        authorized to be appropriated such sums as may be necessary for 
        each fiscal year to carry out this subsection.''.
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