products, based upon recent advances in HIV treat-
ment, 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 de-
pends in large part on Government leadership and 
investment. 
(14) The Federal Government needs to make a 
strong commitment to microbicide research and de-
velopment. 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 pub-
lic 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. 
VerDate Aug 31 2005 
18:31 Oct 26, 2005
Jkt 049200
PO 00000
Frm 00005
Fmt 6652
Sfmt 6201
E:\BILLS\H3854.IH
H3854
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 devel-
oping 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 re-
search 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 organi-
zations working on microbicide research, importantly 
including clinical trials in developing countries where 
its experience is extensive. USAID is well positioned 
VerDate Aug 31 2005 
18:31 Oct 26, 2005
Jkt 049200
PO 00000
Frm 00006
Fmt 6652
Sfmt 6201
E:\BILLS\H3854.IH
H3854
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 develop-
ment of new HIV-prevention technologies 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 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 AND OTHER DISEASES. 
‘‘(a) FEDERAL STRATEGIC PLAN.— 
VerDate Aug 31 2005 
18:31 Oct 26, 2005
Jkt 049200
PO 00000
Frm 00007
Fmt 6652
Sfmt 6201
E:\BILLS\H3854.IH
H3854
‘‘(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 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 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 other relevant institutes and of-
fices, shall expand, intensify, and coordinate the activities 
VerDate Aug 31 2005 
18:31 Oct 26, 2005
Jkt 049200
PO 00000
Frm 00008
Fmt 6652
Sfmt 6201
E:\BILLS\H3854.IH
H3854