[Congressional Record Volume 149, Number 58 (Thursday, April 10, 2003)]
[Senate]
[Pages S5182-S5186]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. CORZINE (for himself, Ms. Snowe, Ms. Cantwell, Mr. Smith, 
        Mr. Dodd, Mr. Leahy, Mrs. Murray, Mr. Durbin, Mr. Lautenberg, 
        and Mr. Bingaman):
  S. 859. 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; to the Committee on Health, 
Education, Labor, and Pensions.
  Mr. CORZINE. Mr. President, I rise today to introduce legislation, 
the

[[Page S5183]]

Microbicides Development Act of 2003. I am very pleased to be 
introducing this bipartisan bill along with my colleagues, Senators 
Snowe, Cantwell, Gordon Smith, Dodd, Leahy, Murray, Durbin, and 
Lautenberg. I thank my colleagues for their support of this important 
legislation, which we believe is vital to the pursuit of combating the 
global HIV/AIDS crisis.
  As you know, recently released UN reports paint the most horrendous 
picture yet of the HIV epidemic, with AIDS continuing to kill more 
people worldwide than any other infectious disease, and sparing no 
corner of the world. According to the UN, China could have more than 10 
million HIV-infected people by 2010. Infection rates in Russia and 
Eastern Europe are rising faster than anywhere else. India may soon 
have the largest number of people living with HIV/AIDS in the world. 
And Sub-Saharan Africa remains devastated by an epidemic that has 
lowered life expectancy from 62 years on average to just 47. In hard-
hit countries like Botswana, where 45 percent of women attending 
prenatal clinics are HIV-positive, a 15-year old youth has an 80 
percent chance of dying of AIDS.
  The UN reports come on the heels of CIA assessments that the AIDS 
pandemic is entering a ``stage of substantial increases in size and 
scope.''
  Despite alarm bells ringing from the organizations as diverse in 
mandate as the UN and the CIA, little attention is paid to the reality 
that the face of the HIV epidemic both at home and abroad is 
increasingly female. As of the end of 2002, according to the Joint 
United Nations/World Health Organization Programme on HIV/AIDS, half of 
the world's HIV/AIDS-infected people were women. In Sub-Saharan Africa, 
58 percent of all adult HIV/AIDS cases were found in women, and in 
hard-hit nations such as Zambia, girls are five times more likely than 
boys to be HIV positive.
  Here in the United States, 30 percent of new HIV infections each year 
occur among women, most of whom, 64 percent, are African-American. The 
majority of U.S. women, 75 percent, acquire the disease through 
heterosexual transmission. My own State of New Jersey has the Nation's 
highest HIV/AIDS infection rate among women and the sixth highest 
infection rate among all adults. And here in our Nation's capital, one 
in three people with HIV now is a woman.
  Biologically, women are four times more vulnerable to HIV infection. 
Their vulnerability increases due to their lack of economic and social 
power in many societies, where women often cannot control sexual 
encounters or insist on protective measures such as abstinence or 
mutual monogamy. The typical woman who gets infected with HIV has only 
one partner--her husband. This trend devastates families and puts 
children at risk.
  This astounding reality bears restating: The single greatest risk 
factor for a woman in the developing world of contracting the HIV virus 
is being married.
  Women need HIV-prevention tools that they can control to safeguard 
their health and that of their families and communities. Unfortunately, 
there exists absolutely no HIV or STD prevention method that is within 
a woman's personal control. Condom use must be negotiated with a 
partner. We are all aware that for too many women, particularly low-
income women in the developing world and many in our own country who 
rely upon a male partner for economic support, there is no power of 
negotiation. We know these women are at risk--yet, we expect them to 
protect themselves without any tools.
  Today we have the opportunity to invest in groundbreaking research 
that can produce these tools, and ultimately, empower women. 
Microbicides are self-administered products that women could use to 
prevent transmission of STDs, including HIV/AIDS. I say ``could'' 
because due to insufficient research investments, no microbicides have 
been brought to market. This legislation would expand federal 
investments for microbicide research at the National Institutes for 
Health, NIH, the Centers for Disease Control and Prevention, CDC, and 
the United States Agency for International Development, USAID.
  In addition to encouraging new investments in microbicide research, 
the Microbicides Development Act will expedite the implementation of 
the NIH's five-year strategic plan for microbicide research, as well as 
expand coordination among Federal agencies already involved in this 
research, including NIH, CDC, and the United States Agency on 
International Development, USAID.
  Perhaps most importantly, the legislation calls for the establishment 
of a Microbicide Research and Development Branch within the National 
Institute of Allergy and Infectious Diseases.
  The National Institutes of Health, principally through the National 
Institute of Allergy and Infectious Diseases, NIAID, spends the 
majority of Federal dollars in this area. However, microbicide research 
at NIH is currently conducted with no single line of administrative 
accountability or specific funding coordination. In addition, other 
federal agencies such as CDC and USAID undertake microbicides research 
and development activities. Because there is no federal coordination, 
however, there is the risk that inefficiencies and duplication of 
effort could result. Through a variety of committees Congress has 
requested that NIH and its Office of AIDS Research provide Congress 
with a ``federal coordination plan'' for research and development in 
this area, but formal submission of this plan has been repeatedly 
delayed.
  A branch dedicated to microbicide research and development at the NIH 
is essential to providing the appropriate staff and funding for the 
coordination of these activities at the NIH and across agencies.
  I ask unanimous consent that the text of the bill be printed in the 
Record.
  There being no objection, the text of the bill was ordered to be 
printed in the Record, as follows:

                                 S. 859

       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

[[Page S5184]]

     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 Center's 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

[[Page S5185]]

     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--
       ``(1) a description of activities with respect to 
     microbicides conducted and supported by the Agency for 
     International Development;
       ``(2) 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;
       ``(3) 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;
       ``(4) a review of the remaining scientific and programmatic 
     obstacles with respect to microbicides; and
       ``(5) 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.''.
  Mr. DURBIN. Mr. President, I am honored to be a cosponsor of the 
Microbicides Development Act of 2003. The legislation calls for a 
redoubling of the effort at the National Institutes of Health and the 
Centers for Disease Control to develop microbicides, a class of 
products that can prevent transmission of HIV and other sexually 
transmitted diseases in women and their partners.
  As this Congress continues to fight AIDS, taking tiny steps in 
pursuit of a challenge racing away from us, I see the development of 
microbicides as another ``tiny'' step forward. I believe microbicides 
are an important addition to the arsenal to fighting AIDS, and indeed 
the Global AIDS bill I introduced, The Global CARE Act of 2003, S. 250, 
includes microbicides among the preventative measures the U.S. should 
support.
  I, and the other cosponsors of this important legislation, see a real 
need and urgency to expand the range of preventive interventions for 
HIV transmission. The ABC options for preventing HIV infection, which 
remain a key part of our response and contribute to the world's ability 
to slow the spread of HIV/AIDS, have not changed since the 1980s: A, 
abstinence when it comes to sexual activity; B, be faithful to one 
partner; C, if you are going to ignore the other two, use a condom. 
Despite the effectiveness of the ABCs in many areas, HIV/AIDS continues 
to spread. We urgently need more prevention options.
  Microbicides, defined as antimicrobial products that can be applied 
topically for the prevention of sexually transmitted diseases, STDs, 
including HIV, may offer one of the most promising preventive 
interventions. They could prove to be safe, effective, inexpensive, 
readily available, and widely acceptable. Microbicides will add to the 
range of options available. Most importantly, microbicides offer an 
additional method of prevention that can be controlled by women.
  Notwithstanding the knowledge of successful HIV prevention 
strategies--condom use, reduction in the number of sexual partners, 
diagnosis and treatment of sexually transmitted infections--HIV 
continues to spread at an alarming rate especially among women in 
developing countries.
  In sub-Saharan Africa, the area hardest hit by the pandemic, women 
and girls account for 58 percent of those living with AIDS. Worldwide, 
women represent 50 percent of those infected, an increase of 9 percent 
in five years. In some of the hardest hit countries in southern Saharan 
Africa, HIV prevalence among girls aged 15 to 19 is four to seven times 
higher than among boys their age. Attitudes, beliefs, and taboos 
surrounding sex, the status of women and children, and the source and 
causes of AIDS also complicate attempts to control transmission and 
provide appropriate prevention and treatment.
  In the United States, more than 30 percent of newly reported HIV 
cases diagnosed are occurring in women, according to the most recent 
data collected by the Centers of Disease Control. As in the rest of the 
world, the majority of these reported HIV infections among U.S. women 
result from heterosexual transmission, and the data suggest that 
younger women are disproportionately at risk for acquiring HIV.
  Microbicides will be particularly attractive to those who do not wish 
to draw attention to the fact that they are using a prevention method. 
Unlike male or female condoms, microbicides are a potential preventive 
option that women can easily control and that does not require the 
cooperation, consent or even knowledge of the partner. Microbicides are 
likely to be cheaper than condoms and, in the future, microbicides 
could be used to prevent mother-to-child transmission of HIV.
  Microbicides have been under development for more than a decade. Yet, 
it is unlikely that they will be available before 2007, which leads to 
the general perception that there has been insufficient progress in 
this area. Three versions are currently in the final stages of clinical 
trials to determine whether they are safe and effective. Many factors 
contribute to this slow progress. The National Institutes of Health, 
NIH, reports that microbicide research requires huge and complex 
efficacy and effectiveness studies that must be conducted in areas with 
high HIV incidence rates. Such rates occur predominantly in developing 
countries where the research infrastructure is underdeveloped. Given 
this dependency on poorer, developing nations, it is not surprising 
that no large pharmaceutical company is interested in funding 
microbicide development. A second obstacle lies in the ethical 
obligation to provide counseling and make condoms available to the 
study subjects, which adds to the complexity and

[[Page S5186]]

size of the trials. As a result, NIH explains, few Phase III efficacy 
trials have been completed. Of those completed, few have yielded 
promising results.
  Reflecting on the reality of the global epidemic, United Nations 
Secretary General Kofi Annan stated that the face of the HIV epidemic 
is that of a woman. ``If you want to save Africa,'' Annan says, ``you 
must save the African woman first. It is they who care for the young, 
the old, the sick and the dying. It is they who nurture social networks 
that help societies share burdens.''
  Lack of access to treatment and care means that for the majority of 
HIV-positive women throughout the world, HIV infection is a death 
sentence. In Haiti, for example, AIDS is now the leading cause of death 
for women of childbearing age.
  Microbicides will never become a viable option for prevention unless 
a serious amount of money is invested in their development. Senator 
Corzine's legislation will make microbicide research a priority, 
calling for the expansion and coordination of microbicide activities at 
the National Institutes of Health and other agencies working in this 
field. The bill requires the Centers for Disease Control to implement a 
5-year topical research plan and requires the U.S. Agency for 
International Development to develop and implement a microbicide 
agenda.
  I am proud to join Senator Corzine as a cosponsor of this legislation 
and hope that my colleagues will join us as we determine the next steps 
in our battle against AIDS, including the development of prevention 
efforts that may help women take control of their lives and their 
survival.
                                 ______