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. BER-
MAN, 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 Com-
mittee on Energy and Commerce, and in addition to the Committee on 
Foreign Affairs, for a period to be subsequently determined by the Speak-
er, in each case for consideration of such provisions as fall within the ju-
risdiction of the committee concerned 
A BILL 
To amend the Public Health Service Act with respect to 
facilitating the development of microbicides for pre-
venting transmission of HIV/AIDS and other diseases, 
and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Microbicide Develop-
ment Act’’. 
VerDate Aug 31 2005 
04:57 Mar 10, 2007
Jkt 059200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6201
E:\BILLS\H1420.IH
H1420
mstockstill on PROD1PC66 with BILLS
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 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. 
(2) Because of their social and biological 
vulnerabilities, young women are particularly at risk 
of HIV infection. In sub-Saharan Africa, the preva-
lence of HIV/AIDS is three times higher among 
women ages 15 to 24 than it is among men in that 
same age group. 
(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. 
(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, espe-
cially in the developing world, are unable to insist on 
VerDate Aug 31 2005 
04:57 Mar 10, 2007
Jkt 059200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
E:\BILLS\H1420.IH
H1420
mstockstill on PROD1PC66 with BILLS
mutual monogamy or negotiate condom use, particu-
larly 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, 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 pro-
tect herself from disease. 
(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 al-
lows conception. Some microbicides in development 
may allow women to become pregnant while at the 
same time protecting them from infection. 
(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 ex-
pected to grow to nearly 16,000,000 by 2010. 
(8) HIV prevention tools like microbicides could 
also be valuable for women in the United States, 
VerDate Aug 31 2005 
04:57 Mar 10, 2007
Jkt 059200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6201
E:\BILLS\H1420.IH
H1420
mstockstill on PROD1PC66 with BILLS
who account for an increasing proportion of new 
HIV and AIDS cases among Americans. Minority 
women in the United States are particularly af-
fected. 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. 
(9) With nearly 20,000,000 new cases of sexu-
ally transmitted infections occurring every year, the 
United States has the highest STI rates of any in-
dustrialized 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 vulner-
able to infection and more likely to experience seri-
ous and lasting health consequences when they do 
become infected. Some microbicides could help pre-
vent STIs. 
(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 na-
tions, including the United States military. 
VerDate Aug 31 2005 
04:57 Mar 10, 2007
Jkt 059200
PO 00000
Frm 00004
Fmt 6652
Sfmt 6201
E:\BILLS\H1420.IH
H1420
mstockstill on PROD1PC66 with BILLS
(11) The microbicide field has gained consider-
able scientific momentum. Several first-generation 
products are in large-scale human trials to measure 
effectiveness, and new products based on recent ad-
vances in HIV treatment are well into safety trials. 
(12) Microbicides are a public health good with 
potential for large social benefits but limited eco-
nomic incentives for private investment, so that pub-
lic funding is required to fill the gap. As is the case 
for vaccines and other public goods, microbicide de-
velopment must depend heavily on government lead-
ership and investment. 
(13) The Federal Government needs to make a 
strong commitment to microbicide research and de-
velopment. Three agencies, the National Institutes of 
Health, Centers for Disease Control and Prevention, 
and United States Agency for International Develop-
ment, have played important roles in the progress to 
date, and each makes a valuable and unique con-
tribution. As the primary Federal agency for con-
ducting 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 
VerDate Aug 31 2005 
04:57 Mar 10, 2007
Jkt 059200
PO 00000
Frm 00005
Fmt 6652
Sfmt 6201
E:\BILLS\H1420.IH
H1420
mstockstill on PROD1PC66 with BILLS
United States Agency for International Development 
sustains strong partnerships with public and private 
organizations working on microbicide research, in-
cluding trials in developing countries where its expe-
rience is extensive, and is well positioned to facilitate 
introduction of microbicides once available. The Cen-
ters for Disease Control and Prevention has a long 
history of conducting field trials in developing coun-
tries, but the extent of its current engagement re-
mains quite limited. 
(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 Emer-
gency Plan for AIDS Relief recognizes the urgency 
of developing safe and effective microbicides. 
(15) The National Institutes of Health, United 
States Agency for International Development, and 
the Centers for Disease Control and Prevention have 
VerDate Aug 31 2005 
04:57 Mar 10, 2007
Jkt 059200
PO 00000
Frm 00006
Fmt 6652
Sfmt 6201
E:\BILLS\H1420.IH
H1420
mstockstill on PROD1PC66 with BILLS
expanded their microbicide portfolios, but overall 
Federal leadership and coordination is required to 
eliminate costly inefficiencies and unproductive du-
plication of effort. 
(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 op-
portunity to protect themselves, their best option is 
the rapid development of new HIV-prevention tech-
nologies like microbicides, which women can initiate. 
TITLE 
I—MICROBICIDE 
RE-
SEARCH AT THE NATIONAL 
INSTITUTES OF HEALTH 
SEC. 101. OFFICE OF AIDS RESEARCH; PROGRAM REGARD-
ING MICROBICIDES FOR PREVENTING TRANS-
MISSION 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: 
‘‘SEC. 2351A. MICROBICIDES FOR PREVENTING TRANS-
MISSION OF HIV/AIDS AND OTHER DISEASES. 
‘‘(a) FEDERAL STRATEGIC PLAN.— 
‘‘(1) IN GENERAL.—The Director of the Office 
of AIDS Research shall— 
VerDate Aug 31 2005 
04:57 Mar 10, 2007
Jkt 059200
PO 00000
Frm 00007
Fmt 6652
Sfmt 6201
E:\BILLS\H1420.IH
H1420
mstockstill on PROD1PC66 with BILLS
‘‘(A) expedite the implementation of a 
Federal strategic plan for the conduct and sup-
port of microbicide research and development; 
and 
‘‘(B) annually review and, as appropriate, 
revise such plan, to prioritize funding and ac-
tivities in terms of their scientific urgency. 
‘‘(2) COORDINATION.—In implementing, review-
ing, 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 and develop-
ment community; and 
‘‘(C) health advocates. 
‘‘(b) EXPANSION
AND COORDINATION
OF ACTIVI-
TIES.—The Director of the Office of AIDS Research, act-
ing in coordination with relevant institutes and offices, 
shall expand, intensify, and coordinate the activities of all 
appropriate institutes and components of the National In-
stitutes of Health with respect to research and develop-
VerDate Aug 31 2005 
04:57 Mar 10, 2007
Jkt 059200
PO 00000
Frm 00008
Fmt 6652
Sfmt 6201
E:\BILLS\H1420.IH
H1420
mstockstill on PROD1PC66 with BILLS
ment of microbicides to prevent the transmission of the 
human immunodeficiency virus (‘HIV’) and other sexually 
transmitted infections. 
‘‘(c) MICROBICIDE DEVELOPMENT BRANCH.—In car-
rying out subsection (b), the Director of the National In-
stitute of Allergy and Infectious Diseases shall establish 
within the Division of AIDS in the Institute, a clearly de-
fined 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. 
‘‘(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 sup-
porting microbicides clinical trials, with particular empha-
sis on implementation of trials leading to product licen-
sure. 
‘‘(e) REPORTS TO CONGRESS.— 
‘‘(1) IN GENERAL.—Not later than 6 months 
after the date of enactment of the Microbicide De-
velopment Act, and annually thereafter, the Director 
of the Office of AIDS Research shall submit to the 
VerDate Aug 31 2005 
04:57 Mar 10, 2007
Jkt 059200
PO 00000
Frm 00009
Fmt 6652
Sfmt 6201
E:\BILLS\H1420.IH
H1420
mstockstill on PROD1PC66 with BILLS
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 con-
ducted and supported by the Federal Govern-
ment; 
‘‘(B) a summary and analysis of the ex-
penditures 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 re-
search, preclinical product development, clinical 
trials, and behavioral science; and 
‘‘(C) a description and evaluation of the 
progress made, during the preceding year, to-
ward the development of effective microbicides. 
‘‘(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 
VerDate Aug 31 2005 
04:57 Mar 10, 2007
Jkt 059200
PO 00000
Frm 00010
Fmt 6652
Sfmt 6201
E:\BILLS\H1420.IH
H1420
mstockstill on PROD1PC66 with BILLS