[Congressional Record Volume 151, Number 26 (Tuesday, March 8, 2005)]
[Senate]
[Pages S2252-S2255]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. CORZINE (for himself, Mr. Obama, Ms. Snowe, Mr. Bingaman, 
        Mrs. Boxer, Ms. Cantwell, Mrs. Clinton, Mr. Dodd, Mr. Durbin, 
        Mrs. Feinstein, Mr. Kennedy, Mr. Lautenberg, Mr. Leahy, Ms. 
        Mikulski, Mrs. Murray, Mr. Schumer, Mr. Smith, and Mr. Kerry):
  S. 550. 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; to the 
Committee on Health, Education, Labor, and Pensions.
  Mr. CORZINE. Mr. President, I rise today to introduce legislation, 
the Microbicides Development Act of 2005. I am very pleased to be 
introducing this bipartisan bill along with my colleagues, Senators 
Snowe, Obama, Bingaman, Cantwell, Clinton, Dodd, Durbin, Feinstein, 
Kennedy, Lautenberg, Leahy, Mikulski, Murray, Schumer, and Smith. 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.
  Today we are celebrating International Women's Day. Not only should 
we celebrate the achievements of women nationally and globally today, 
but we should also promise to redouble our efforts to improve the lives 
of women around the globe. I can't think of an issue more deserving of 
our attention in the United States Senate than that of the toll that 
HIV/AIDS is having on women and their children around the world.
  Today, nearly half of the 37 million adults now living with HIV 
worldwide are women. The U.N.'s new Epidemic Update released in late 
2004 shows that women and girls are increasingly affected by the 
disease in each region of the world and the epidemic continues to 
worsen. Women are the new face of AIDS. Approximately 7,000 women are 
infected with HIV everyday. The biggest rise in HIV/AIDS among women is 
occurring in East Asia, which has seen a 56 percent infection rate 
increase, followed by the region of Eastern Europe and Central Asia.
  Notably, these are areas of the world that are not currently included 
in the President's AIDS initiative (PEPFAR). I would like to note that 
later this week I will be introducing legislation to make India 
eligible for PEPFAR assistance. It is estimated that by 2010, India 
could have 20 million HIV infected individuals up from five million 
currently and women are at the center of the rapid growth of the 
disease.
  I would like to quote from a recent news article in USA Today, which 
discusses the HIV/AIDS vulnerabilities that women confront.

       ``In this male-dominated society, ironclad traditions 
     surrounding marriage leave women little say over their sexual 
     or reproductive lives. So many married men bring HIV home to 
     their wives that married women are one of India's highest-
     risk groups. Nearly half of all new HIV infections occur in 
     women, and studies indicate that 90 percent of women with HIV 
     were virgins when they married and remained faithful to their 
     husbands.''

  This statement describes the plight of women in so many societies and 
countries where women simply do not have the economic or political 
power to insist that their husbands use condoms or abstain from having 
sex outside of marriage. 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

[[Page S2253]]

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 unit 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.
  Microbicides may not be a magic bullet, but they are essential to 
addressing the HIV/AIDS crisis. With leading scientists concluding that 
a vaccine is likely to be at least 10 years away, we need to make a 
strong commitment to developing complementary prevention tools such as 
microbicides.
  Microbicides are a public health good for which the social benefits 
are high but economic incentives to private investment are low. Despite 
the potential market size, neither pharmaceutical nor major biotech 
companies have made large investments in the field because development 
is costly and the likelihood of finding an effective product is 
unknown. Like other public health goods, such as vaccines, public 
funding must fill the gap left by market failure.
  The cost of developing the existing pipeline of microbicide candidate 
products has been estimated at $775 million over five years. This 
investment should generate a number of safe, effective microbicides by 
2010. Currently, however, U.S. Federal funding for microbicides is only 
about $88.8 million annually and is spread across all areas of 
microbicide research, not just product development.
  As for any pharmaceutical or health care product, the key to 
developing safe, effective, affordable and accessible microbicides is 
sufficient investment. If we are to realize the promise of microbicides 
and the lifesaving properties they may provide, then additional public 
funding must be made available for research and development. The 
Microbicide Development Act of 2005 will help us achieve this goal.
  I ask unanimous consent that the text of my legislation be printed in 
the Record.
  There being no objection, the bill was ordered to be printed in the 
Record, as follows:

                                 S. 550

       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. 
     Microbicides are being developed to allow women to both 
     conceive children and protect themselves from HIV.
       (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

[[Page S2254]]

     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 and control.

   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--
       (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. 371S. 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.''.

[[Page S2255]]

    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 by adding at the end the following 
     new subsection:
       ``(h) 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) Consultation.--The Administrator shall consult with 
     the Director of the Office of AIDS Research of the National 
     Institutes of Health in preparing a report required by 
     subparagraph (A).
       ``(D) 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.''.
                                 ______