article: 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 every region of the world. As of 2006, nearly half of the 37,200,000 adults living with HIV and AIDS worldwide were women. In sub-Saharan Africa, that proportion was 59 percent. (2) Because of their social and biological vulnerabilities, young women are particularly at risk of HIV infection. In sub- Saharan Africa, the prevalence of HIV/AIDS is three times higher among women ages 15 to 24 than it is among men in that same age group. (3) Women infected with HIV can transmit the infection to their infants during pregnancy, labor, delivery, or breast- feeding. The most effective way to interrupt mother-to-child transmission is to ensure that mothers are not infected in the first place. (4) Many women who become infected with HIV have just one sexual partner--their husband. 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, especially in the developing world, are unable to insist on mutual monogamy or negotiate condom use, particularly 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, tablets or rings, microbicides are being designed to stop the transmission of the pathogens that cause AIDS and other sexually transmitted infections (referred to in this section as ``STIs''). Microbicides could allow a woman to protect herself from disease. (6) 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 in development may allow women to become pregnant while at the same time protecting them from infection. (7) According to UNICEF, worldwide, the lack of HIV/AIDS prevention and treatment has left over 15,000,000 children as orphans. Of these, more than 12,000,000 live in sub-Saharan Africa. The number of AIDS orphans in sub-Saharan Africa alone is expected to grow to nearly 16,000,000 by 2010. (8) HIV prevention tools like microbicides could also be valuable for women in the United States, who account for an increasing proportion of new HIV and AIDS cases among Americans. Minority women in the United States are particularly affected. Both African-American and Latina women account for a disproportionate number of new AIDS cases, and HIV/AIDS was the leading cause of death in 2002 for African-American women ages 25 to 34. (9) With nearly 20,000,000 new cases of sexually transmitted infections occurring every year, the United States has the highest STI rates of any industrialized nation. Like HIV, STIs pose significant health threats and costs, with young people and women bearing a disproportionate burden. Nearly half of new STI cases each year occur in people under 25 years of age with women both more vulnerable to infection and more likely to experience serious and lasting health consequences when they do become infected. Some microbicides could help prevent STIs. (10) HIV/AIDS threatens national and global security. Beyond its burdens on individuals, families, and communities, the pandemic reduces economic growth, decimates health budgets, undermines civil society, and burdens the armed forces of many nations, including the United States military. (11) The microbicide field has gained considerable scientific momentum. Several first-generation products are in large-scale human trials to measure effectiveness, and new products based on recent advances in HIV treatment are well into safety trials. (12) Microbicides are a public health good with potential for large social benefits but limited economic incentives for private investment, so that public funding is required to fill the gap. As is the case for vaccines and other public goods, microbicide development must depend heavily on government leadership and investment. (13) The Federal Government needs to make a strong commitment to microbicide research and development. Three agencies, the National Institutes of Health, Centers for Disease Control and Prevention, and United States Agency for International Development, have played important roles in the progress to date, and each makes a valuable and unique contribution. As the primary Federal agency for conducting and supporting medical research and the largest single Federal Government contributor to microbicide research, the National Institutes of Health supports the Microbicide Trials Network as well as other important research activities. The United States Agency for International Development sustains strong partnerships with public and private organizations working on microbicide research, including trials in developing countries where its experience is extensive, and is well positioned to facilitate introduction of microbicides once available. The Centers for Disease Control and Prevention has a long history of conducting field trials in developing countries, but the extent of its current engagement remains quite limited. (14) According to the National Institutes of Health's strategic plan, microbicides may provide ``one of the most promising primary preventative interventions that could be safe, effective, readily available, affordable, and widely acceptable''. In a recent report to Congress, the United States Agency for International Development states that ``the US government is firmly committed to accelerating the development of safe and effective microbicides to prevent HIV''. In addition, the President's Emergency Plan for AIDS Relief recognizes the urgency of developing safe and effective microbicides. (15) The National Institutes of Health, United States Agency for International Development, and the Centers for Disease Control and Prevention have expanded their microbicide portfolios, but overall Federal leadership and coordination is required to eliminate costly inefficiencies and unproductive duplication of effort. (16) HIV prevention options available as of 2006 are insufficient in general. Most critically, they fail to recognize women's particular 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/AIDS 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/AIDS 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 and development community; and ``(C) health advocates. ``(b) Expansion and Coordination of Activities.--The Director of the Office of AIDS Research, acting in coordination with 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 infections. ``(c) Microbicide Development Branch.--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 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 carrying out its mission. ``(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 Microbicide Trials Network and other programs for supporting microbicides clinical trials, 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 behavioral science; and ``(C) a description and evaluation of the progress made, during the preceding year, toward the development of effective microbicides. ``(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/AIDS 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. 317T. MICROBICIDES FOR PREVENTING TRANSMISSION OF HIV/AIDS AND OTHER DISEASES. ``(a) Development and Implementation of the Centers for Disease Control and Prevention's Microbicide Agenda.--The Director of the Centers for Disease Control and Prevention shall fully implement such Centers' 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; and ``(2) conducting behavioral research in preparation for, and support of, clinical microbicide trials. ``(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; and ``(C) a description and evaluation of the progress made, during the preceding year, toward the development of effective microbicides. ``(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 AND DEVELOPMENT AT THE UNITED STATES AGENCY FOR INTERNATIONAL DEVELOPMENT SEC. 301. MICROBICIDES FOR PREVENTING TRANSMISSION OF HIV/AIDS 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/AIDS and Other Diseases.-- ``(1) Development and implementation of the microbicide agenda.--The President shall direct the head of the Office of HIV/AIDS of the United States Agency for International Development, in conjunction with other offices of such Agency, to develop and implement a program to support the development of microbicides for the prevention of the transmission of HIV/ AIDS and other diseases, and facilitate wide-scale availability of such products after such development. ``(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 one year after the date of enactment of the Microbicide Development Act, and annually thereafter, the President shall submit to the appropriate congressional committees a report on the activities of the Agency to carry out the microbicide agenda and on any other activities carried out by the Agency 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 Agency; ``(ii) a summary and analysis of the expenditures made by the Agency 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; and ``(iii) a description and evaluation of the progress made during the preceding year toward the development of effective microbicides, including activities in support of eventual product access. ``(C) Consultation.--The President shall consult with the Director of the Office of AIDS Research of the National Institutes of Health in preparing the report required under subparagraph (A). ``(D) Appropriate congressional committees defined.--In this paragraph, the term `appropriate congressional committees' means the Committee on Foreign Affairs and the Committee on Appropriations of the House of Representatives and the Committee on Foreign Relations and the Committee on Appropriations of the Senate. ``(4) Authorization of appropriations.--There are authorized to be appropriated to the Agency such sums as may be necessary for each fiscal year to carry out this subsection.''.
summary: Microbicide Development Act - Amends the Public Health Service Act to require the Director of the Office of AIDS Research to: (1) expedite the implementation of the federal strategic plan for the conduct and support of microbicide research and development; and (2) expand, intensify, and coordinate all activities with respect to research and development of microbicides to prevent the transmission of HIV and other sexually transmitted diseases. Requires the Director of the National Institute of Allergy and Infectious Diseases to: (1) establish within the Division of AIDS an organizational branch to carry out microbicide research and development; and (2) assign priority to ensuring adequate funding and support for the Microbicide Trials Network and other programs for supporting microbicides clinical trials. Requires the Director of the Centers for Disease Control and Prevention (CDC) to fully implement the CDC's microbicide agenda to support microbicide research and development. Requires the President to direct the head of the Office of HIV/AIDS of the U.S. Agency for International Development (USAID) to develop and implement a program to support the development of microbicides products for the prevention of the transmission of HIV/AIDS and other diseases and facilitate wide-scale availability of such products.