I 

110TH CONGRESS 

1ST SESSION H. R. 1420 

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 HOUSE OF REPRESENTATIVES 

MARCH 8, 2007 

Ms. SCHAKOWSKY (for herself, Mr. SHAYS, Mrs. CAPPS, Ms. BEAN, Mr. BERMAN, Mr. DAVIS of Illinois, Mr. EMANUEL, Mr. GRIJALVA, Mr. KIRK, Ms. 

LEE, Ms. MATSUI, Mr. MCDERMOTT, Mr. MCNULTY, and Ms. 

SCHWARTZ) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on 

Foreign Affairs, 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 

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’’. 

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

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

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

8 proportion was 59 percent. 

9 (2) Because of their social and biological 

10 vulnerabilities, young women are particularly at risk 

11 of HIV infection. In sub-Saharan Africa, the preva12 lence of HIV/AIDS is three times higher among 

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

14 same age group. 

15 (3) Women infected with HIV can transmit the 

16 infection to their infants during pregnancy, labor, 

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

18 interrupt mother-to-child transmission is to ensure 

19 that mothers are not infected in the first place. 

20 (4) Many women who become infected with 

21 HIV have just one sexual partner—their husband. 

22 Marriage is not necessarily effective protection 

23 against HIV, because to protect themselves from 

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

25 be faithful or to use condoms. Many women, espe26 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 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 and develop18 ment community; 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 relevant institutes and offices, 

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

24 appropriate institutes and components of the National In25 stitutes of Health with respect to research and developmstockstill on PROD1PC66 with BILLS

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1 ment of microbicides to prevent the transmission of the 

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

3 transmitted infections. 

4 ‘‘(c) MICROBICIDE DEVELOPMENT BRANCH.—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 branch charged with carrying out 

9 microbicide research and development. In establishing 

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

11 sufficient number of employees dedicated to carrying out 

12 its mission. 

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 

17 Microbicide Trials Network and other programs for sup18 porting microbicides clinical trials, with particular empha19 sis on implementation of trials leading to product licen20 sure. 

21 ‘‘(e) REPORTS TO CONGRESS.— 

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

23 after the date of enactment of the Microbicide De24 velopment Act, and annually thereafter, the Director 

25 of the Office of AIDS Research shall submit to the 

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1 appropriate committees of Congress a report that 

2 describes the strategies being implemented by the 

3 Federal Government regarding microbicide research 

4 and development. 

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

6 submitted under paragraph (1) shall include— 

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

8 to microbicide research and development con9 ducted and supported by the Federal Govern10 ment; 

11 ‘‘(B) a summary and analysis of the ex12 penditures made by the Director of the Office 

13 of AIDS Research during the preceding year 

14 for activities with respect to microbicide-specific 

15 research and development, including basic re16 search, preclinical product development, clinical 

17 trials, and behavioral science; and 

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

19 progress made, during the preceding year, to20 ward the development of effective microbicides. 

21 ‘‘(3) APPROPRIATE COMMITTEES OF CONGRESS

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

23 committees of Congress’ means the Committee on 

24 Health, Education, Labor, and Pensions and the 

25 Committee on Appropriations of the Senate and the 

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1 Committee on Energy and Commerce and the Com2 mittee on Appropriations of the House of Represent3 atives. 

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

5 are authorized to be appropriated such sums as may be 

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

7 TITLE II—MICROBICIDE RE8 SEARCH AT THE CENTERS 

9 FOR DISEASE CONTROL AND 

10 PREVENTION 

11 SEC. 201. MICROBICIDES FOR PREVENTING TRANSMISSION 

12 OF HIV/AIDS AND OTHER DISEASES. 

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

14 (42 U.S.C. 243 et seq.) is amended by inserting after sec15 tion 317S the following: 

16 ‘‘SEC. 317T. MICROBICIDES FOR PREVENTING TRANS17 MISSION OF HIV/AIDS AND OTHER DISEASES. 

18 ‘‘(a) DEVELOPMENT AND IMPLEMENTATION OF THE

19 CENTERS FOR DISEASE CONTROL AND PREVENTION’S

20 MICROBICIDE AGENDA.—The Director of the Centers for 

21 Disease Control and Prevention shall fully implement such 

22 Centers’ microbicide agenda to support microbicide re23 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 President shall di15 rect the head of the Office of HIV/AIDS of the 

16 United States Agency for International Develop17 ment, in conjunction with other offices of such Agen18 cy, to develop and implement a program to support 

19 the development of microbicides for the prevention of 

20 the transmission of HIV/AIDS and other diseases, 

21 and facilitate wide-scale availability of such products 

22 after such development. 

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

24 HIV/AIDS shall ensure that the Agency has a suffimstockstill on PROD1PC66 with BILLS

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1 cient number of dedicated employees to carry out the 

2 microbicide agenda. 

3 ‘‘(3) REPORTS TO CONGRESS.— 

4 ‘‘(A) IN GENERAL.—Not later than one 

5 year after the date of enactment of the 

6 Microbicide Development Act, and annually 

7 thereafter, the President shall submit to the ap8 propriate congressional committees a report on 

9 the activities of the Agency to carry out the 

10 microbicide agenda and on any other activities 

11 carried out by the Agency related to microbicide 

12 research and development. 

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

14 submitted under subparagraph (A) shall in15 clude— 

16 ‘‘(i) a description of activities with re17 spect to microbicides conducted or sup18 ported by the Agency; 

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

20 expenditures made by the Agency during 

21 the preceding year for activities with re22 spect to microbicide-specific research and 

23 development, including the number of em24 ployees of the Agency who are involved in 

25 such activities; and 

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1 ‘‘(iii) a description and evaluation of 

2 the progress made during the preceding 

3 year toward the development of effective 

4 microbicides, including activities in support 

5 of eventual product access. 

6 ‘‘(C) CONSULTATION.—The President shall 

7 consult with the Director of the Office of AIDS 

8 Research of the National Institutes of Health in 

9 preparing the report required under subpara10 graph (A). 

11 ‘‘(D) APPROPRIATE CONGRESSIONAL COM12 MITTEES DEFINED.—In this paragraph, the 

13 term ‘appropriate congressional committees’ 

14 means the Committee on Foreign Affairs and 

15 the Committee on Appropriations of the House 

16 of Representatives and the Committee on For17 eign Relations and the Committee on Appro18 priations of the Senate. 

19 ‘‘(4) AUTHORIZATION OF APPROPRIATIONS.— 

20 There are authorized to be appropriated to the 

21 Agency such sums as may be necessary for each fis22 cal year to carry out this subsection.’’. 

Æ 

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