[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[S. 859 Introduced in Senate (IS)]







108th CONGRESS
  1st Session
                                 S. 859

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


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES



Mr. Corzine (for himself, Ms. Snowe, Ms. Cantwell, Mr. Smith, Mr. Dodd, 
 Mr. Leahy, Mrs. Murray, Mr. Durbin, Mr. Lautenberg, and Mr. Bingaman) 
introduced the following bill; which was read twice and referred to the 
          Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 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.

    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 
2003''.

SEC. 2. FINDINGS.

    Congress makes the following findings:
            (1) During 2002, AIDS caused the deaths of an estimated 
        3,100,000 people, including 1,200,000 women and 610,000 
        children under 15 years of age. An estimated 14,000,000 
        children living today have lost one or both parents due to 
        AIDS.
            (2) Worldwide, heterosexual transmission is accounting for 
        an increasing share of new HIV infections, with adolescents, 
        women, and disadvantaged people at particular risk.
            (3) In the United States, for example, African American and 
        Latina women account for 64 percent and 17 percent of all 
        reported HIV cases, respectively, even though they represent 
        only 25 percent of the total United States female population.
            (4) Half of the 38,600,000 adults living today with HIV/
        AIDS are women.
            (5) Biological, cultural, economic, and social factors 
        combine to make women and girls particularly vulnerable to HIV 
        and other sexually transmitted diseases (referred to in this 
        section as ``STDs''). In the hardest hit areas of Africa, 
        almost one-quarter of 15 to 19 year-old girls are already 
        infected with HIV, compared to 4 percent of their male peers.
            (6) In addition to HIV, other STDs can cause serious, 
        costly, even deadly conditions for women and their children, 
        including infertility, pregnancy complications, cervical 
        cancer, infant mortality, and higher risk of contracting HIV. 
        When women become infected with HIV, they risk passing along 
        the infection to their infants, either through pregnancy, 
        childbirth, or breastfeeding.
            (7) Regrettably, today's HIV prevention methods do not meet 
        the needs of the millions of women worldwide who, for cultural, 
        economic, and social reasons, cannot insist on protective 
        measures such as abstinence, condom use, or mutual monogamy.
            (8) A large majority of women become infected with HIV with 
        only one partner--their husbands. Women need prevention options 
        that they can use consistently within ongoing, long-term 
        relationships.
            (9) Microbicides are a promising new technology, 
        complementary to vaccines, that could put the power of 
        prevention into women's hands. Formulated as gels, creams, or 
        films, microbicides inactivate, block, or otherwise interfere 
        with the pathogens that cause HIV/AIDS and other STDs.
            (10) Even a moderately effective microbicide could have a 
        substantial impact on the HIV epidemic. The London School of 
        Hygiene and Tropical Medicine estimates that a 60 percent 
        efficacious microbicide introduced into the 73 poorest 
        countries could avert 2,500,000 HIV infections in men, women, 
        and children over 3 years.
            (11) Microbicides would also benefit men, because their 
        protective effect is likely to be bidirectional.
            (12) Numerous potential microbicides are poised for 
        successful development. Thirteen products are in clinical 
        trials and approximately 50 compounds exist that could be 
        investigated further. There is a backlog in the research and 
        development pipeline, however, so that innovative and promising 
        product concepts are languishing, while infection rates are 
        growing.
            (13) At present, there is insufficient economic incentive 
        for large pharmaceutical companies to become actively engaged 
        in microbicide research and development, thus, Federal support 
        is crucial. Three Federal agencies--the National Institutes of 
        Health, the Centers for Disease Control and Prevention, and the 
        United States Agency for International Development--have played 
        important roles in progress to date, but strong, effective, 
        well-coordinated, and visible public sector leadership will be 
        essential for the promise of microbicides to be realized.
            (14) A microbicide could be available within 5 to 7 years 
        if sufficient public sector funding were made available to 
        accelerate research and support the necessary clinical trials.
            (15) Microbicide research and development currently receive 
        only 2 percent of the AIDS research budget of the National 
        Institutes of Health, not nearly enough to keep pace with 
        public health need and scientific opportunity.
            (16) The United States Agency for International Development 
        sustains strong partnerships with public and private 
        organizations working on microbicide research, importantly 
        including clinical trials in developing countries where its 
        experience is extensive. The long experience of such Agency in 
        logistics management, service delivery, provider training, and 
        social marketing position it well to prepare for and implement 
        the introduction of microbicides once they are available.
            (17) The Centers for Disease Control and Prevention also 
        engages in critical microbicide research and clinical testing, 
        and has a long history of conducting field trials in developing 
        countries.
            (18) For the microbicide pipeline to advance significantly 
        and the essential clinical trials to be fielded soon, the 
current amount of Federal investment needs to increase to $130,000,000 
in fiscal year 2004 and to $160,000,000 in fiscal year 2005.

   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 expedite the development and implementation of a 
        Federal strategic plan for the conduct and support of 
        microbicide research and shall biannually review and as 
        appropriate revise the plan.
            ``(2) Coordination.--In developing, implementing, and 
        reviewing the plan, 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 on the development of 
microbicides to prevent the transmission of HIV and other sexually 
transmitted diseases.
    ``(c) Microbicide Development Branch.--In carrying out subsection 
(b), the Director of the National Institute of Allergy and Infectious 
Diseases shall establish within the Vaccine and Prevention Research 
Program of the Division of AIDS in the Institute, a branch charged with 
carrying out microbicide research and development. In establishing such 
branch, the Director shall ensure that there are a sufficient number of 
employees dedicated to carry out the mission of the branch.
    ``(d) Report to Congress.--
            ``(1) In general.--Not later than 1 year after the date on 
        which the initial Federal strategic plan is developed under 
        subsection (a), and biannually 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. Each such report shall 
        include--
                    ``(A) a description of activities with respect to 
                microbicides conducted and supported by the Federal 
                Government;
                    ``(B) a summary and analysis of expenditures, 
                during the period for which the report is prepared, for 
                activities with respect to microbicide-specific 
                research and development, including the number of 
                employees involved in these activities within each 
                agency;
                    ``(C) a description and evaluation of the progress 
                made, during the period for which such report is 
                prepared, towards the development of effective, 
                reliable, and acceptable microbicides;
                    ``(D) a review of the remaining scientific and 
                programmatic obstacles with respect to microbicides; 
                and
                    ``(E) an updated Federal Strategic Plan, including 
                professional judgment funding projections.
            ``(2) Appropriate congressional committees definition.--For 
        the purposes of this subsection, the term `appropriate 
        committees of Congress' means the Committee on Energy and 
        Commerce and the Committee on Appropriations of the House of 
        Representatives and the Committee on Health, Education, Labor, 
        and Pensions and the Committee on Appropriations of the Senate.
    ``(e) HIV Definition.--For purposes of this section, the term `HIV' 
means the human immunodeficiency virus. Such term includes acquired 
immune deficiency syndrome (AIDS).
    ``(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 fiscal years 2004 and 2005, and 
such sums as may be necessary in subsequent fiscal years to sustain 
multiyear funding at a productive level.''.

 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--
            (1) by transferring section 317R so as to appear after 
        section 317Q; and
            (2) by inserting after section 317R (as so transferred) the 
        following:

``SEC. 317S. 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 the Centers' 5-year 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 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) 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) Staffing.--In carrying out the microbicide agenda, the 
Centers for Disease Control and Prevention shall ensure that there are 
sufficient numbers of dedicated employees for carrying out the agenda 
under subsection (a).
    ``(c) Report to Congress.--
            ``(1) In general.--Not later than 1 year after the date of 
        enactment of this section, and biannually 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. 
        Such report shall include--
                    ``(A) a description of activities with respect to 
                microbicides conducted and supported by the Centers for 
                Disease Control and Prevention;
                    ``(B) a summary and analysis of expenditures, 
                during the period for which the report is prepared, for 
                activities with respect to microbicide-specific 
                research and development, including the number of 
                employees involved in these activities;
                    ``(C) a description and evaluation of the progress 
                made, during the period for which such report is 
                prepared, towards the development of effective, 
                reliable, and acceptable microbicides; and
                    ``(D) a review of the remaining scientific and 
                programmatic obstacles with respect to microbicides.
            ``(2) Appropriate congressional committees definition.--For 
        the purposes of this subsection, the term `appropriate 
        committees of Congress' means the Committee on Energy and 
        Commerce and the Committee on Appropriations of the House of 
        Representatives and the Committee on Health, Education, Labor, 
        and Pensions and the Committee on Appropriations of the Senate.
    ``(d) Definition.--For the purposes of this section, the term `HIV' 
means the human immunodeficiency virus. Such term includes acquired 
immune deficiency syndrome (AIDS).
    ``(e) 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 fiscal years 2004 and 2005, and 
such sums as may be necessary in subsequent fiscal years to sustain 
multiyear funding at a productive level.''.

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

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

    Chapter 1 of part I of the Foreign Assistance Act of 1961 (22 
U.S.C. 2151 et seq.) is amended by inserting after section 104 the 
following:

``SEC. 104A. MICROBICIDES FOR PREVENTING TRANSMISSION OF HIV AND OTHER 
              DISEASES.

    ``(a) Development and Implementation of the Microbicide Agenda 
Supported by the Agency for International Development.--The Office of 
HIV/AIDS of the Agency for International Development, in conjunction 
with other offices within the Agency for International Development, 
shall fully implement the Agency's microbicide agenda to support the 
development of microbicides, and facilitate wide-scale introduction 
once microbicide products are available. Such an agenda shall include--
            ``(1) support for the discovery, development, and 
        preclinical evaluation of topical microbicides;
            ``(2) support for the conduct of clinical studies of 
        candidate microbicides to assess safety, acceptability, and 
        effectiveness in reducing HIV and other sexually transmitted 
        diseases;
            ``(3) support for behavioral and social science research 
        relevant to microbicide development, testing, acceptability, 
        and use;
            ``(4) support for preintroductory and introductory studies 
        of safe and effective microbicides in developing countries; and
            ``(5) facilitation of access to microbicides as they become 
        available to women at highest risk of HIV and other sexually 
        transmitted diseases as soon as possible.
    ``(b) Staffing.--The Office of HIV/AIDS of the Agency for 
International Development shall ensure that there are sufficient 
numbers of dedicated employees for purposes of carrying out the agenda 
under subsection (a).
    ``(c) Report to Congress.--
            ``(1) In general.--Not later than 1 year after the date of 
        enactment of this section, and biannually thereafter, the 
        Administrator of the Agency for International Development shall 
        submit to the appropriate committees of Congress a report on 
        the strategies being implemented by the Agency for 
        International Development 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. Such report 
        shall include--
                    ``(A) a description of activities with respect to 
                microbicides conducted and supported by the Agency for 
                International Development;
                    ``(B) a summary and analysis of expenditures, 
                during the period for which the report is prepared, for 
                activities with respect to microbicide-specific 
                research and development, including the number of 
                employees involved in these activities;
                    ``(C) a description and evaluation of the progress 
                made, during the period for which such report is 
                prepared, towards the development of effective, 
                reliable, and acceptable microbicides;
                    ``(D) a review of the remaining scientific and 
                programmatic obstacles with respect to microbicides; 
                and
                    ``(E) a description of the steps being taken to 
                increase access and availability of approved 
                microbicides to prevent HIV and other sexually 
                transmitted diseases.
            ``(2) Appropriate congressional committees definition.--For 
        the purposes of this subsection, the term `appropriate 
        committees of Congress' means the Committee on International 
        Relations and the Committee on Appropriations of the House of 
        Representatives and the Committee on Foreign Relations and the 
        Committee on Appropriations of the Senate.
    ``(d) Definition.--For the purposes of this section, the term `HIV' 
means the human immunodeficiency virus. Such term includes acquired 
immune deficiency syndrome (AIDS).
    ``(e) 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 fiscal years 2004 and 2005, and 
such sums as may be necessary in subsequent fiscal years to sustain 
multiyear funding at a productive level.''.
                                 <all>