II 

109TH CONGRESS 

1ST SESSION S. 550 

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 

IN THE SENATE OF THE UNITED STATES 

MARCH 8, 2005 

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) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

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 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Microbicide Develop5 ment Act’’. 
2 

•S 550 IS

1 SEC. 2. FINDINGS. 

2 Congress makes the following findings: 

3 (1) Women and girls are the new face of HIV/ 

4 AIDS, and are increasingly affected by the disease 

5 in each region of the world. Women account for 

nearly 1 6 ⁄2 of the 37,000,000 adults living with HIV 

7 and AIDS worldwide as of 2005. Approximately 

8 7,000 women are newly infected with HIV each day. 

9 (2) Because of their social and biological 

10 vulnerabilities, young women are particularly at risk. 

11 In Sub-Saharan Africa, 76 percent of the young peo12 ple (between ages 15 and 24) with HIV are girls 

13 under 20. 

14 (3) When women become infected with HIV, 

15 they can pass along the infection to their children 

16 during pregnancy, labor and delivery, or breast-feed17 ing. The most effective way to halt mother-to-child 

18 transmission is to ensure that mothers are not in19 fected in the first place. 

20 (4) An increasing number of women who be21 come infected with HIV have only 1 sexual partner, 

22 their husband. Unfortunately, marriage is not nec23 essarily effective protection against HIV, because to 

24 protect themselves from HIV, women have to rely on 

25 their male partners to be faithful or to use condoms. 

26 Many women in the developing world are unable to 
3 

•S 550 IS

1 insist on mutual monogamy or negotiate condom 

2 use, especially in long-term relationships. 

3 (5) Scientists are working on a promising new 

4 prevention tool that could slow down the spread of 

5 the HIV/AIDS epidemic, microbicides. Formulated 

6 as gels, creams, or rings, microbicides inactivate, 

7 block, or otherwise interfere with the transmission of 

8 the pathogens that cause AIDS and other sexually 

9 transmitted diseases (‘‘STD’’s). Microbicides could 

10 allow a woman to protect herself from disease. 

11 (6) Married couples need a method of HIV pro12 tection that will allow them to conceive a child and 

13 start a family. No existing HIV prevention method 

14 also allows conception. Microbicides are being devel15 oped to allow women to both conceive children and 

16 protect themselves from HIV. 

17 (7) Households in developing countries often 

18 dissolve when a mother dies. In the hardest hit 

19 countries, the number of children who are orphaned 

20 by AIDS is increasing dramatically. 

21 (8) Women in the United States also need HIV 

22 prevention tools like microbicides. AIDS is now the 

23 number 1 cause of death among African-American 

24 women between the ages of 25 and 34. 
4 

•S 550 IS

1 (9) In addition to HIV, other STDs continue to 

2 be a major health threat in the United States. The 

3 United States has the highest rates of sexually 

4 transmitted diseases of any industrialized nation. 

5 Nineteen million STD infections occur every year. It 

is estimated that by age 25, 1 6 ⁄2 of all sexually active 

7 people in the United States can expect to be infected 

8 with an STD. 

9 (10) HIV and AIDS represent a threat to na10 tional security and economic well being, with direct 

11 medical costs of up to $15,500,000,000 per year. 

12 The pandemic undermines armies, foments unrest, 

13 and burdens the United States military. 

14 (11) As the Nation’s largest single provider of 

15 HIV/AIDS care, the Veterans Affairs health care 

16 system spent $359,000,000 to provided care to more 

17 than 20,000 American veterans with HIV/AIDS in 

18 fiscal year 2004. 

19 (12) The microbicide field has achieved an ex20 traordinary amount of scientific momentum, with 

21 several first-generation candidates now in large scale 

22 human trials around the world. At same time, new 

23 products, based upon recent advances in HIV treat24 ment, have advanced into early safety trials. 
5 

•S 550 IS

1 (13) Microbicides are a classic public health 

2 good for which the social benefits are high but the 

3 economic incentive to private investment is low. Like 

4 other public health goods, such as vaccines, public 

5 funding must fill the gap. Microbicide research de6 pends in large part on Government leadership and 

7 investment. 

8 (14) The Federal Government needs to make a 

9 strong commitment to microbicide research and de10 velopment. Three agencies—the National Institutes 

11 of Health (‘‘NIH’’), the Centers for Disease Control 

12 and Prevention (‘‘CDC’’), and the United States 

13 Agency of International Development (‘‘USAID’’)— 

14 have played important roles in the progress to date, 

15 but further strong, well-coordinated, and visible pub16 lic sector leadership will be essential for the promise 

17 of microbicides to be realized. 

18 (15) As of 2005, microbicide research at NIH 

19 is conducted under several institutes with no single 

20 line of administrative accountability, no specific 

21 funding coordination, and highly variable levels of 

22 interest and commitment across institute leadership. 

23 Only a few NIH staff can claim microbicides as their 

24 sole focus. 
6 

•S 550 IS

1 (16) The President’s Emergency Plan for AIDS 

2 Relief (‘‘PEPFAR’’) recognizes the urgency of devel3 oping safe and effective microbicides to prevent 

4 HIV. In addition, NIH documents state that ‘‘the 

5 US government is firmly committed to accelerating 

6 the development of safe and effective microbicides to 

7 prevent HIV,’’ recognizing that microbicides may 

8 provide ‘‘one of the most promising preventative 

9 interventions given that could be inexpensive, readily 

10 available, and widely acceptable’’. But as of 2005, 

11 NIH spends barely 2 percent of its HIV/AIDS re12 search budget on microbicides. As more microbicide 

13 candidates are advanced into later-stage clinical 

14 trials and development costs rise correspondingly, 

15 2005 funding levels are simply inadequate. 

16 (17) USAID and the CDC have expanded their 

17 microbicide portfolios, but without overall Federal 

18 coordination, costly inefficiencies and unproductive 

19 duplication of effort may result. USAID sustains 

20 strong partnerships with public and private organi21 zations working on microbicide research, importantly 

22 including clinical trials in developing countries where 

23 its experience is extensive. USAID is well positioned 

24 to facilitate the introduction of microbicides once 

25 they are available. The CDC also engages in critical 
7 

•S 550 IS

1 microbicide research and clinical testing, and has a 

2 long history of conducting field trials in developing 

3 countries. 

4 (18) HIV prevention options available as of 

5 2005 are not enough. HIV prevention strategies 

6 must recognize women’s needs and vulnerabilities. If 

7 women are to have a genuine opportunity to protect 

8 themselves, their best option is the rapid develop9 ment of new HIV-prevention technologies like 

10 microbicides, which women can initiate and control. 

11 TITLE I—MICROBICIDE RE12 SEARCH AT THE NATIONAL 

13 INSTITUTES OF HEALTH 

14 SEC. 101. OFFICE OF AIDS RESEARCH; PROGRAM REGARD15 ING MICROBICIDES FOR PREVENTING TRANS16 MISSION OF HIV AND OTHER DISEASES. 

17 Subpart I of part D of title XXIII of the Public 

18 Health Service Act (42 U.S.C. 300cc–40 et seq.) is 

19 amended by inserting after section 2351 the following: 

20 ‘‘SEC. 2351A. MICROBICIDES FOR PREVENTING TRANS21 MISSION OF HIV AND OTHER DISEASES. 

22 ‘‘(a) FEDERAL STRATEGIC PLAN.— 

23 ‘‘(1) IN GENERAL.—The Director of the Office 

24 of AIDS Research shall— 
8 

•S 550 IS

1 ‘‘(A) expedite the implementation of a 

2 Federal strategic plan for the conduct and sup3 port of microbicide research and development; 

4 and 

5 ‘‘(B) annually review and, as appropriate, 

6 revise such plan, to prioritize funding and ac7 tivities in terms of their scientific urgency. 

8 ‘‘(2) COORDINATION.—In implementing, review9 ing, and prioritizing elements of the plan described 

10 under paragraph (1), the Director of the Office of 

11 AIDS Research shall coordinate with— 

12 ‘‘(A) other Federal agencies, including the 

13 Director of the Centers for Disease Control and 

14 Prevention and the Administrator of the United 

15 States Agency for International Development, 

16 involved in microbicide research; 

17 ‘‘(B) the microbicide research community; 

18 and 

19 ‘‘(C) health advocates. 

20 ‘‘(b) EXPANSION AND COORDINATION OF ACTIVI21 TIES.—The Director of the Office of AIDS Research, act22 ing in coordination with other relevant institutes and of23 fices, shall expand, intensify, and coordinate the activities 

24 of all appropriate institutes and components of the Na25 tional Institutes of Health with respect to research and 
9 

•S 550 IS

1 development of microbicides to prevent the transmission 

2 of the human immunodeficiency virus (‘HIV’) and other 

3 sexually transmitted diseases. 

4 ‘‘(c) MICROBICIDE DEVELOPMENT UNIT.—In car5 rying out subsection (b), the Director of the National In6 stitute of Allergy and Infectious Diseases shall establish 

7 within the Division of AIDS in the Institute, a clearly de8 fined organizational unit charged with carrying out 

9 microbicide research and development. In establishing 

10 such unit, the Director shall ensure that there are a suffi11 cient number of employees dedicated to carrying out the 

12 mission of the unit. 

13 ‘‘(d) MICROBICIDE CLINICAL TRIALS.—In carrying 

14 out subsection (c), the Director of the National Institute 

15 of Allergy and Infectious Diseases shall assign priority to 

16 ensuring adequate funding and support for the integration 

17 of basic science and clinical research, with particular em18 phasis on implementation of trials leading to product li19 censure. 

20 ‘‘(e) REPORTS TO CONGRESS.— 

21 ‘‘(1) IN GENERAL.—Not later than 6 months 

22 after the date of enactment of the Microbicide De23 velopment Act, and annually thereafter, the Director 

24 of the Office of AIDS Research shall submit to the 

25 appropriate committees of Congress a report that 
10 

•S 550 IS

1 describes the strategies being implemented by the 

2 Federal Government regarding microbicide research 

3 and development. 

4 ‘‘(2) CONTENTS OF REPORTS.—Each report 

5 submitted under paragraph (1) shall include— 

6 ‘‘(A) a description of activities with respect 

7 to microbicide research and development con8 ducted and supported by the Federal Govern9 ment; 

10 ‘‘(B) a summary and analysis of the ex11 penditures made by the Director of the Office 

12 of AIDS Research during the preceding year 

13 for activities with respect to microbicide-specific 

14 research and development, including basic re15 search, preclinical product development, clinical 

16 trials, and process development and production; 

17 ‘‘(C) a description and evaluation of the 

18 progress made, during the preceding year, to19 ward the development of effective and accept20 able microbicides; and 

21 ‘‘(D) a review of scientific and pro22 grammatic obstacles to expediting the commer23 cial availability of microbicide products. 

24 ‘‘(3) APPROPRIATE COMMITTEES OF CONGRESS

25 DEFINED.—In this subsection, the term ‘appropriate 
11 

•S 550 IS

1 committees of Congress’ means the Committee on 

2 Health, Education, Labor, and Pensions and the 

3 Committee on Appropriations of the Senate and the 

4 Committee on Energy and Commerce and the Com5 mittee on Appropriations of the House of Represent6 atives. 

7 ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—There 

8 are authorized to be appropriated such sums as may be 

9 necessary for each fiscal year to carry out this section.’’. 

10 TITLE II—MICROBICIDE RE11 SEARCH AT THE CENTERS 

12 FOR DISEASE CONTROL AND 

13 PREVENTION 

14 SEC. 201. MICROBICIDES FOR PREVENTING TRANSMISSION 

15 OF HIV AND OTHER DISEASES. 

16 Part B of title III of the Public Health Service Act 

17 (42 U.S.C. 243 et seq.) is amended— 

18 (1) by transferring section 317R so as to ap19 pear after section 317Q; and 

20 (2) by inserting after section 317R (as so trans21 ferred) the following: 

22 ‘‘SEC. 371S. MICROBICIDES FOR PREVENTING TRANS23 MISSION OF HIV AND OTHER DISEASES. 

24 ‘‘(a) DEVELOPMENT AND IMPLEMENTATION OF THE

25 MICROBICIDE AGENDA SUPPORTED BY THE CENTERS
12 

•S 550 IS

1 FOR DISEASE CONTROL AND PREVENTION.—The Direc2 tor of the Centers for Disease Control and Prevention 

3 shall fully implement such Centers’ topical microbicide 

4 agenda to support microbicide research and development. 

5 Such an agenda shall include— 

6 ‘‘(1) conducting laboratory research in prepara7 tion for, and support of, clinical microbicide trials; 

8 ‘‘(2) conducting behavioral research in prepara9 tion for, and support of, clinical microbicide trials; 

10 ‘‘(3) developing and characterizing domestic 

11 populations and international cohorts appropriate 

12 for Phases I, II, and III clinical trials of candidate 

13 topical microbicides; 

14 ‘‘(4) conducting Phases I and II clinical trials 

15 to assess the safety and acceptability of candidate 

16 microbicides; 

17 ‘‘(5) conducting Phase III clinical trials to as18 sess the efficacy of candidate microbicides; 

19 ‘‘(6) providing technical assistance to, and con20 sulting with, a wide variety of domestic and inter21 national entities involved in developing and evalu22 ating topical microbicides, including health agencies, 

23 extramural researchers, industry, health advocates, 

24 and nonprofit organizations; and 
13 

•S 550 IS

1 ‘‘(7) developing and evaluating the diffusion 

2 and effects of implementation strategies for use of 

3 effective topical microbicides. 

4 ‘‘(b) PERSONNEL.—The Centers for Disease Control 

5 and Prevention shall ensure that there are sufficient num6 bers of dedicated employees for carrying out the 

7 microbicide agenda under subsection (a). 

8 ‘‘(c) REPORT TO CONGRESS.— 

9 ‘‘(1) IN GENERAL.—Not later than 1 year after 

10 the date of enactment of the Microbicide Develop11 ment Act, and annually thereafter, the Director of 

12 the Centers for Disease Control and Prevention shall 

13 submit to the appropriate committees of Congress, a 

14 report on the strategies being implemented by the 

15 Centers for Disease Control and Prevention with re16 spect to microbicide research and development. Such 

17 report shall be submitted alone or as part of the 

18 overall Federal strategic plan on microbicides com19 piled annually by the National Institutes of Health 

20 Office of AIDS Research as required under section 

21 2351A. 

22 ‘‘(2) CONTENTS OF REPORT.—Such report shall 

23 include— 

24 ‘‘(A) a description of activities with respect 

25 to microbicides conducted or supported by the 
14 

•S 550 IS

1 Director of the Centers for Disease Control and 

2 Prevention; 

3 ‘‘(B) a summary and analysis of the ex4 penditures made by such Director during the 

5 preceding year, for activities with respect to 

6 microbicide-specific research and development, 

7 including the number of employees of such Cen8 ters involved in such activities; 

9 ‘‘(C) a description and evaluation of the 

10 progress made, during the preceding year, to11 ward the development of effective and accept12 able microbicides; and 

13 ‘‘(D) a review of scientific and pro14 grammatic obstacles to expediting the commer15 cial availability of microbicide products. 

16 ‘‘(3) APPROPRIATE COMMITTEES OF CONGRESS

17 DEFINED.—For the purposes of this subsection, the 

18 term ‘appropriate committees of Congress’ means 

19 the Committee on Health, Education, Labor, and 

20 Pensions and the Committee on Appropriations of 

21 the Senate and the Committee on Energy and Com22 merce and the Committee on Appropriations of the 

23 House of Representatives. 
15 

•S 550 IS

1 ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There 

2 are authorized to be appropriated such sums as may be 

3 necessary for each fiscal year to carry out this section.’’. 

4 TITLE III—MICROBICIDE RE5 SEARCH AT THE UNITED 

6 STATES AGENCY FOR INTER7 NATIONAL DEVELOPMENT 

8 SEC. 301. MICROBICIDES FOR PREVENTING TRANSMISSION 

9 OF HIV AND OTHER DISEASES. 

10 Section 104A of the Foreign Assistance Act of 1961 

11 (22 U.S.C. 2151b–2) is amended by adding at the end 

12 the following new subsection: 

13 ‘‘(h) MICROBICIDES FOR PREVENTING TRANS14 MISSION OF HIV AND OTHER DISEASES.— 

15 ‘‘(1) DEVELOPMENT AND IMPLEMENTATION OF

16 THE MICROBICIDE AGENDA.—The head of the Office 

17 of HIV/AIDS of the United States Agency for Inter18 national Development, in conjunction with other of19 fices of such Agency, shall develop and implement a 

20 program to support the development of microbicides 

21 products for the prevention of the transmission of 

22 HIV and other diseases, and facilitate wide-scale 

23 availability of such products after such development. 

24 The program shall be known as the ‘microbicide 

25 agenda’ and shall include— 
16 

•S 550 IS

1 ‘‘(A) support for the discovery, develop2 ment, and preclinical evaluation of topical 

3 microbicides; 

4 ‘‘(B) support for the conduct of clinical 

5 studies of candidate microbicides to assess the 

6 safety, acceptability, and effectiveness of such 

7 microbicides in reducing the transmission of 

8 HIV and other sexually transmitted diseases; 

9 ‘‘(C) support for behavioral and social 

10 science research relevant to microbicide develop11 ment, testing, acceptability, and use; 

12 ‘‘(D) support for preintroductory and in13 troductory studies of safe and effective 

14 microbicides in developing countries; and 

15 ‘‘(E) facilitation of access to microbicides 

16 by women at highest risk of contracting HIV or 

17 other sexually transmitted diseases, at the ear18 liest possible time. 

19 ‘‘(2) STAFFING.—The head of the Office of 

20 HIV/AIDS shall ensure that the Agency has a suffi21 cient number of dedicated employees to carry out the 

22 microbicide agenda. 

23 ‘‘(3) REPORTS TO CONGRESS.— 

24 ‘‘(A) IN GENERAL.—Not later than 1 year 

25 after the date of enactment of the Microbicide 
17 

•S 550 IS

1 Development Act, and annually thereafter, the 

2 Administrator of the Agency shall submit to the 

3 appropriate committees of Congress a report on 

4 the activities of the Administrator to carry out 

5 the microbicide agenda and on any other activi6 ties carried out by the Administrator related to 

7 microbicide research and development. 

8 ‘‘(B) CONTENTS OF REPORT.—Each report 

9 submitted under subparagraph (A) shall in10 clude— 

11 ‘‘(i) a description of activities with re12 spect to microbicides conducted or sup13 ported by the Administrator; 

14 ‘‘(ii) a summary and analysis of the 

15 expenditures made by the Administrator 

16 during the preceding year for activities 

17 with respect to microbicide-specific re18 search and development, including the 

19 number of employees of the Agency who 

20 are involved in such activities; 

21 ‘‘(iii) a description and evaluation of 

22 the progress made during the preceding 

23 year toward the development of effective 

24 and acceptable microbicides; 
18 

•S 550 IS

1 ‘‘(iv) a review of scientific and pro2 grammatic obstacles to expediting the com3 mercial availability of microbicide products; 

4 and 

5 ‘‘(v) a description of the activities car6 ried out to increase the availability of 

7 microbicides approved to prevent the trans8 mission of HIV or other sexually trans9 mitted diseases. 

10 ‘‘(C) CONSULTATION.—The Administrator 

11 shall consult with the Director of the Office of 

12 AIDS Research of the National Institutes of 

13 Health in preparing a report required by sub14 paragraph (A). 

15 ‘‘(D) APPROPRIATE COMMITTEES OF CON16 GRESS DEFINED.—In this paragraph, the term 

17 ‘appropriate committees of Congress’ means the 

18 Committee on Foreign Relations and the Com19 mittee on Appropriations of the Senate and the 

20 Committee on International Relations and the 

21 Committee on Appropriations of the House of 

22 Representatives. 

23 ‘‘(4) AUTHORIZATION OF APPROPRIATIONS.— 

24 There are authorized to be appropriated such sums 
19 

•S 550 IS

1 as may be necessary for each fiscal year to carry out 

2 this subsection.’’. 

Æ