S 823 ISCommentsClose CommentsPermalink

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

March 8, 2007

Mr. OBAMA (for himself, Ms. SNOWE, Mr. DURBIN, Mr. DODD, Mrs. CLINTON, Mrs. BOXER, Mr. SCHUMER, and Mr. KERRY) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and PensionsCommentsClose CommentsPermalink

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

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,CommentsClose CommentsPermalink

SECTION 1. SHORT TITLE.

This Act may be cited as the `Microbicide Development Act'.CommentsClose CommentsPermalink

SEC. 2. FINDINGS.

Congress makes the following findings:CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink

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:CommentsClose CommentsPermalink

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

`(a) Federal Strategic Plan-CommentsClose CommentsPermalink





`(1) IN GENERAL- The Director of the Office of AIDS Research shall--CommentsClose CommentsPermalink





`(A) expedite the implementation of Federal strategic plans for the conduct and support of microbicide research and development; andCommentsClose CommentsPermalink





`(B) annually review and, as appropriate, revise such plan, to prioritize funding and activities in terms of their scientific urgency.CommentsClose CommentsPermalink





`(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--CommentsClose CommentsPermalink





`(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;CommentsClose CommentsPermalink





`(B) the microbicide research and development community; andCommentsClose CommentsPermalink





`(C) health advocates.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(e) Reports to Congress-CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(2) CONTENTS OF REPORTS- Each report submitted under paragraph (1) shall include--CommentsClose CommentsPermalink





`(A) a description of activities with respect to microbicide research and development conducted and supported by the Federal Government;CommentsClose CommentsPermalink





`(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; andCommentsClose CommentsPermalink





`(C) a description and evaluation of the progress made, during the preceding year, toward the development of effective microbicides.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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.'.CommentsClose CommentsPermalink

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--CommentsClose CommentsPermalink





(1) by transferring section 317R so as to appear after section 317Q; andCommentsClose CommentsPermalink





(2) by inserting after section 317R (as so transferred) the following:CommentsClose CommentsPermalink

`SEC. 371S. 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--CommentsClose CommentsPermalink





`(1) conducting laboratory research in preparation for, and support of, clinical microbicide trials; andCommentsClose CommentsPermalink





`(2) conducting behavioral research in preparation for, and support of, clinical microbicide trials.CommentsClose CommentsPermalink





`(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).CommentsClose CommentsPermalink





`(c) Report to Congress-CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(2) CONTENTS OF REPORT- Such report shall include--CommentsClose CommentsPermalink





`(A) a description of activities with respect to microbicides conducted or supported by the Director of the Centers for Disease Control and Prevention;CommentsClose CommentsPermalink





`(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; andCommentsClose CommentsPermalink





`(C) a description and evaluation of the progress made, during the preceding year, toward the development of effective microbicides.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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.'.CommentsClose CommentsPermalink

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:CommentsClose CommentsPermalink





`(h) Microbicides for Preventing Transmission of HIV/AIDS and Other Diseases-CommentsClose CommentsPermalink





`(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 for the prevention of the transmission of HIV/AIDS and other diseases, and facilitate wide-scale availability of such products after such development.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(3) REPORTS TO CONGRESS-CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(B) CONTENTS OF REPORT- Each report submitted under subparagraph (A) shall include--CommentsClose CommentsPermalink





`(i) a description of activities with respect to microbicides conducted or supported by the Administrator;CommentsClose CommentsPermalink





`(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; andCommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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).CommentsClose CommentsPermalink





`(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 Foreign Affairs and the Committee on Appropriations of the House of Representatives.CommentsClose CommentsPermalink





`(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.'.CommentsClose CommentsPermalink

TITLE IV--ADVANCE MARKET COMMITMENTS

SEC. 401. REPORT ON ADVANCE MARKET COMMITMENTS AS INCENTIVES FOR MICROBICIDE DEVELOPMENT.

(a) Report- Not later than 180 days after the date of the enactment of this Act, the Secretary of State shall submit to the appropriate committees of Congress a report on the feasibility and impediments to the Government of the United States entering into advanced market commitments of microbicides to prevent HIV infection as a means of creating incentives for the private sector to invest in research, development, and manufacturing of microbicides.CommentsClose CommentsPermalink





(b) Appropriate Committees of Congress Defined- In this section, the term `appropriate committees of Congress' means the Committee on Health, Education, Labor, and Pensions and the Committee on Foreign Relations of the Senate, and the Committee on Energy and Commerce and the Committee on Foreign Affairs of the House of Representatives.CommentsClose CommentsPermalink