II 

110TH CONGRESS 

1ST SESSION S. 823 

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. 

IN THE SENATE OF THE UNITED STATES 

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 Pensions 

A BILL 

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. 

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’’. 

6 SEC. 2. FINDINGS. 

7 Congress makes the following findings: 


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

2 AIDS, and are increasingly affected by the disease 

3 in every region of the world. As of 2006, nearly half 

4 of the 37,200,000 adults living with HIV and AIDS 

5 worldwide were women. In sub-Saharan Africa, that 

6 proportion was 59 percent. 

7 (2) Because of their social and biological 

8 vulnerabilities, young women are particularly at risk 

9 of HIV infection. In sub-Saharan Africa, the preva10 lence of HIV/AIDS is three times higher among 

11 women ages 15 to 24 than it is among men in that 

12 same age group. 

13 (3) Women infected with HIV can transmit the 

14 infection to their infants during pregnancy, labor, 

15 delivery, or breast-feeding. The most effective way to 

16 interrupt mother-to-child transmission is to ensure 

17 that mothers are not infected in the first place. 

18 (4) Many women who become infected with 

19 HIV have just one sexual partner—their husband. 

20 Marriage is not necessarily effective protection 

21 against HIV, because to protect themselves from 

22 HIV, women have to rely on their male partners to 

23 be faithful or to use condoms. Many women, espe24 cially in the developing world, are unable to insist on 


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1 mutual monogamy or negotiate condom use, particu2 larly 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, tablets or rings, microbicides are 

7 being designed to stop the transmission of the 

8 pathogens that cause AIDS and other sexually 

9 transmitted infections (referred to in this section as 

10 ‘‘STIs’’). Microbicides could allow a woman to pro11 tect herself from disease. 

12 (6) Couples need a method of HIV protection 

13 that will allow them to conceive a child and start a 

14 family. No existing HIV prevention method also al15 lows conception. Some microbicides in development 

16 may allow women to become pregnant while at the 

17 same time protecting them from infection. 

18 (7) According to UNICEF, worldwide, the lack 

19 of HIV/AIDS prevention and treatment has left over 

20 15,000,000 children as orphans. Of these, more than 

21 12,000,000 live in sub-Saharan Africa. The number 

22 of AIDS orphans in sub-Saharan Africa alone is ex23 pected to grow to nearly 16,000,000 by 2010. 

24 (8) HIV prevention tools like microbicides could 

25 also be valuable for women in the United States, 


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1 who account for an increasing proportion of new 

2 HIV and AIDS cases among Americans. Minority 

3 women in the United States are particularly af4 fected. Both African-American and Latina women 

5 account for a disproportionate number of new AIDS 

6 cases, and HIV/AIDS was the leading cause of death 

7 in 2002 for African-American women ages 25 to 34. 

8 (9) With nearly 20,000,000 new cases of sexu9 ally transmitted infections occurring every year, the 

10 United States has the highest STI rates of any in11 dustrialized nation. Like HIV, STIs pose significant 

12 health threats and costs, with young people and 

13 women bearing a disproportionate burden. Nearly 

14 half of new STI cases each year occur in people 

15 under 25 years of age with women both more vulner16 able to infection and more likely to experience seri17 ous and lasting health consequences when they do 

18 become infected. Some microbicides could help pre19 vent STIs. 

20 (10) HIV/AIDS threatens national and global 

21 security. Beyond its burdens on individuals, families, 

22 and communities, the pandemic reduces economic 

23 growth, decimates health budgets, undermines civil 

24 society, and burdens the armed forces of many na25 tions, including the United States military. 


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1 (11) The microbicide field has gained consider2 able scientific momentum. Several first-generation 

3 products are in large-scale human trials to measure 

4 effectiveness, and new products based on recent ad5 vances in HIV treatment are well into safety trials. 

6 (12) Microbicides are a public health good with 

7 potential for large social benefits but limited eco8 nomic incentives for private investment, so that pub9 lic funding is required to fill the gap. As is the case 

10 for vaccines and other public goods, microbicide de11 velopment must depend heavily on government lead12 ership and investment. 

13 (13) The Federal Government needs to make a 

14 strong commitment to microbicide research and de15 velopment. Three agencies, the National Institutes of 

16 Health, Centers for Disease Control and Prevention, 

17 and United States Agency for International Develop18 ment, have played important roles in the progress to 

19 date, and each makes a valuable and unique con20 tribution. As the primary federal agency for con21 ducting and supporting medical research and the 

22 largest single Federal Government contributor to 

23 microbicide research, the National Institutes of 

24 Health supports the Microbicide Trials Network as 

25 well as other important research activities. The 


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1 United States Agency for International Development 

2 sustains strong partnerships with public and private 

3 organizations working on microbicide research, in4 cluding trials in developing countries where its expe5 rience is extensive, and is well positioned to facilitate 

6 introduction of microbicides once available. The Cen7 ters for Disease Control and Prevention has a long 

8 history of conducting field trials in developing coun9 tries, but the extent of its current engagement re10 mains quite limited. 

11 (14) According to the National Institutes of 

12 Health’s strategic plan, microbicides may provide 

13 ‘‘one of the most promising primary preventative 

14 interventions that could be safe, effective, readily 

15 available, affordable, and widely acceptable.’’ In a 

16 recent report to Congress, the United States Agency 

17 for International Development states that ‘‘the US 

18 government is firmly committed to accelerating the 

19 development of safe and effective microbicides to 

20 prevent HIV.’’ In addition, the President’s Emer21 gency Plan for AIDS Relief recognizes the urgency 

22 of developing safe and effective microbicides. 

23 (15) The National Institutes of Health, United 

24 States Agency for International Development, and 

25 the Centers for Disease Control and Prevention have 


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1 expanded their microbicide portfolios, but overall 

2 Federal leadership and coordination is required to 

3 eliminate costly inefficiencies and unproductive du4 plication of effort. 

5 (16) HIV prevention options available as of 

6 2006 are insufficient in general. Most critically, they 

7 fail to recognize women’s particular needs and 

8 vulnerabilities. If women are to have a genuine op9 portunity to protect themselves, their best option is 

10 the rapid development of new HIV-prevention tech11 nologies like microbicides, which women can initiate. 

12 TITLE I—MICROBICIDE RE13 SEARCH AT THE NATIONAL 

14 INSTITUTES OF HEALTH 

15 SEC. 101. OFFICE OF AIDS RESEARCH; PROGRAM REGARD16 ING MICROBICIDES FOR PREVENTING TRANS17 MISSION OF HIV/AIDS AND OTHER DISEASES. 

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

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

20 amended by inserting after section 2351 the following: 

21 ‘‘SEC. 2351A. MICROBICIDES FOR PREVENTING TRANS22 MISSION OF HIV/AIDS AND OTHER DISEASES. 

23 ‘‘(a) FEDERAL STRATEGIC PLAN.— 

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

25 of AIDS Research shall— 


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1 ‘‘(A) expedite the implementation of Fed2 eral strategic plans for the conduct and support 

3 of microbicide research and development; and 

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

5 revise such plan, to prioritize funding and ac6 tivities in terms of their scientific urgency. 

7 ‘‘(2) COORDINATION.—In implementing, review8 ing, and prioritizing elements of the plan described 

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

10 AIDS Research shall coordinate with— 

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

12 Director of the Centers for Disease Control and 

13 Prevention and the Administrator of the United 

14 States Agency for International Development, 

15 involved in microbicide research; 

16 ‘‘(B) the microbicide research and develop17 ment community; and 

18 ‘‘(C) health advocates. 

19 ‘‘(b) EXPANSION AND COORDINATION OF ACTIVI20 TIES.—The Director of the Office of AIDS Research, act21 ing in coordination with relevant institutes and offices, 

22 shall expand, intensify, and coordinate the activities of all 

23 appropriate institutes and components of the National In24 stitutes of Health with respect to research and develop25 ment of microbicides to prevent the transmission of the 


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1 human immunodeficiency virus (‘HIV’) and other sexually 

2 transmitted infections. 

3 ‘‘(c) MICROBICIDE DEVELOPMENT BRANCH.—In car4 rying out subsection (b), the Director of the National In5 stitute of Allergy and Infectious Diseases shall establish 

6 within the Division of AIDS in the Institute, a clearly de7 fined organizational branch charged with carrying out 

8 microbicide research and development. In establishing 

9 such branch, the Director shall ensure that there are a 

10 sufficient number of employees dedicated to carrying out 

11 its mission. 

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

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

14 of Allergy and Infectious Diseases shall assign priority to 

15 ensuring adequate funding and support for the 

16 Microbicide Trials Network and other programs for sup17 porting microbicides clinical trials, with particular empha18 sis on implementation of trials leading to product licen19 sure. 

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 


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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 behavioral science; and 

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

18 progress made, during the preceding year, to19 ward the development of effective microbicides. 

20 ‘‘(3) APPROPRIATE COMMITTEES OF CONGRESS

21 DEFINED.—In this subsection, the term ‘appropriate 

22 committees of Congress’ means the Committee on 

23 Health, Education, Labor, and Pensions and the 

24 Committee on Appropriations of the Senate and the 

25 Committee on Energy and Commerce and the ComVerDate Aug 31 2005 23:13 Mar 10, 2007 Jkt 059196 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S823.IS S823

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1 mittee on Appropriations of the House of Represent2 atives. 

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

4 are authorized to be appropriated such sums as may be 

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

6 TITLE II—MICROBICIDE RE7 SEARCH AT THE CENTERS 

8 FOR DISEASE CONTROL AND 

9 PREVENTION 

10 SEC. 201. MICROBICIDES FOR PREVENTING TRANSMISSION 

11 OF HIV/AIDS AND OTHER DISEASES. 

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

13 (42 U.S.C. 243 et seq.) is amended— 

14 (1) by transferring section 317R so as to ap15 pear after section 317Q; and 

16 (2) by inserting after section 317R (as so trans17 ferred) the following: 

18 ‘‘SEC. 371S. MICROBICIDES FOR PREVENTING TRANS19 MISSION OF HIV/AIDS AND OTHER DISEASES. 

20 ‘‘(a) DEVELOPMENT AND IMPLEMENTATION OF THE

21 CENTERS FOR DISEASE CONTROL AND PREVENTION’S

22 MICROBICIDE AGENDA.—The Director of the Centers for 

23 Disease Control and Prevention shall fully implement such 

24 Centers’ microbicide agenda to support microbicide re25 search and development. Such an agenda shall include— 


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1 ‘‘(1) conducting laboratory research in prepara2 tion for, and support of, clinical microbicide trials; 

3 and 

4 ‘‘(2) conducting behavioral research in prepara5 tion for, and support of, clinical microbicide trials. 

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

7 and Prevention shall ensure that there are sufficient num8 bers of dedicated employees for carrying out the 

9 microbicide agenda under subsection (a). 

10 ‘‘(c) REPORT TO CONGRESS.— 

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

12 the date of enactment of the Microbicide Develop13 ment Act, and annually thereafter, the Director of 

14 the Centers for Disease Control and Prevention shall 

15 submit to the appropriate committees of Congress, a 

16 report on the strategies being implemented by the 

17 Centers for Disease Control and Prevention with re18 spect to microbicide research and development. Such 

19 report shall be submitted alone or as part of the 

20 overall Federal strategic plan on microbicides com21 piled annually by the National Institutes of Health 

22 Office of AIDS Research as required under section 

23 2351A. 

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

25 include— 


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

2 to microbicides conducted or supported by the 

3 Director of the Centers for Disease Control and 

4 Prevention; 

5 ‘‘(B) a summary and analysis of the ex6 penditures made by such Director during the 

7 preceding year, for activities with respect to 

8 microbicide-specific research and development, 

9 including the number of employees of such Cen10 ters involved in such activities; and 

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

12 progress made, during the preceding year, to13 ward the development of effective microbicides. 

14 ‘‘(3) APPROPRIATE COMMITTEES OF CONGRESS

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

16 term ‘appropriate committees of Congress’ means 

17 the Committee on Health, Education, Labor, and 

18 Pensions and the Committee on Appropriations of 

19 the Senate and the Committee on Energy and Com20 merce and the Committee on Appropriations of the 

21 House of Representatives. 

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

23 are authorized to be appropriated such sums as may be 

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


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1 TITLE III—MICROBICIDE RE2 SEARCH AND DEVELOPMENT 

3 AT THE UNITED STATES 

4 AGENCY FOR INTER5 NATIONAL DEVELOPMENT 

6 SEC. 301. MICROBICIDES FOR PREVENTING TRANSMISSION 

7 OF HIV/AIDS AND OTHER DISEASES. 

8 Section 104A of the Foreign Assistance Act of 1961 

9 (22 U.S.C. 2151b–2) is amended by adding at the end 

10 the following new subsection: 

11 ‘‘(h) MICROBICIDES FOR PREVENTING TRANS12 MISSION OF HIV/AIDS AND OTHER DISEASES.— 

13 ‘‘(1) DEVELOPMENT AND IMPLEMENTATION OF

14 THE MICROBICIDE AGENDA.—The head of the Office 

15 of HIV/AIDS of the United States Agency for Inter16 national Development, in conjunction with other of17 fices of such Agency, shall develop and implement a 

18 program to support the development of microbicides 

19 for the prevention of the transmission of HIV/AIDS 

20 and other diseases, and facilitate wide-scale avail21 ability of such products after such development. 

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

23 HIV/AIDS shall ensure that the Agency has a suffi24 cient number of dedicated employees to carry out the 

25 microbicide agenda. 


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1 ‘‘(3) REPORTS TO CONGRESS.— 

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

3 after the date of enactment of the Microbicide 

4 Development Act, and annually thereafter, the 

5 Administrator of the Agency shall submit to the 

6 appropriate committees of Congress a report on 

7 the activities of the Administrator to carry out 

8 the microbicide agenda and on any other activi9 ties carried out by the Administrator related to 

10 microbicide research and development. 

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

12 submitted under subparagraph (A) shall in13 clude— 

14 ‘‘(i) a description of activities with re15 spect to microbicides conducted or sup16 ported by the Administrator; 

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

18 expenditures made by the Administrator 

19 during the preceding year for activities 

20 with respect to microbicide-specific re21 search and development, including the 

22 number of employees of the Agency who 

23 are involved in such activities; and 

24 ‘‘(iii) a description and evaluation of 

25 the progress made during the preceding 


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1 year toward the development of effective 

2 microbicides, including activities in support 

3 of eventual product access. 

4 ‘‘(C) CONSULTATION.—The Administrator 

5 shall consult with the Director of the Office of 

6 AIDS Research of the National Institutes of 

7 Health in preparing a report required by sub8 paragraph (A). 

9 ‘‘(D) APPROPRIATE COMMITTEES OF CON10 GRESS DEFINED.—In this paragraph, the term 

11 ‘appropriate committees of Congress’ means the 

12 Committee on Foreign Relations and the Com13 mittee on Appropriations of the Senate and the 

14 Committee on Foreign Affairs and the Com15 mittee on Appropriations of the House of Rep16 resentatives. 

17 ‘‘(4) AUTHORIZATION OF APPROPRIATIONS.— 

18 There are authorized to be appropriated such sums 

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

20 this subsection.’’. 


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1 TITLE IV—ADVANCE MARKET 

2 COMMITMENTS 

3 SEC. 401. REPORT ON ADVANCE MARKET COMMITMENTS 

4 AS INCENTIVES FOR MICROBICIDE DEVELOP5 MENT. 

6 (a) REPORT.—Not later than 180 days after the date 

7 of the enactment of this Act, the Secretary of State shall 

8 submit to the appropriate committees of Congress a report 

9 on the feasibility and impediments to the Government of 

10 the United States entering into advanced market commit11 ments of microbicides to prevent HIV infection as a means 

12 of creating incentives for the private sector to invest in 

13 research, development, and manufacturing of 

14 microbicides. 

15 (b) APPROPRIATE COMMITTEES OF CONGRESS DE16 FINED.—In this section, the term ‘‘appropriate commit17 tees of Congress’’ means the Committee on Health, Edu18 cation, Labor, and Pensions and the Committee on For19 eign Relations of the Senate, and the Committee on En20 ergy and Commerce and the Committee on Foreign Affairs 

21 of the House of Representatives. 

Æ 


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