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.

September 21, 2005

Mr. SHAYS (for himself, Ms. SCHAKOWSKY, Mr. DAVIS of Illinois, Mr. GEORGE MILLER of California, Mr. BROWN of Ohio, Ms. MILLENDER-MCDONALD, Mr. PAYNE, Mr. LEACH, Ms. LEE, Mr. EVANS, Ms. SCHWARTZ of Pennsylvania, Mr. CROWLEY, Mr. WAXMAN, Mr. KIRK, Mr. EMANUEL, Mr. BERMAN, Mr. GRIJALVA, Mr. JACKSON of Illinois, Mr. LARSON of Connecticut, Ms. BEAN, Mr. MCNULTY, Mr. OWENS, Mr. WEXLER, Mr. RUSH, Mr. GUTIERREZ, Mr. MCDERMOTT, Mr. MCGOVERN, Mr. VAN HOLLEN, Mr. STARK, and Mr. HONDA) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on International Relations, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned

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.

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. Some microbicides are being developed with the objective that they will allow conception while protecting from disease.

(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 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.

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 by inserting after section 317S the following:

`SEC. 371T. 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.'.

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--

(1) by redesignating subsection (g) as subsection (h); and

(2) by inserting after subsection (f) the following:

`(g) 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) 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.'.

END