I
107TH CONGRESS
1ST SESSION
H. R. 2405
To amend the Public Health Service Act with respect to facilitating the
development of microbicides for preventing transmission of HIV and
other sexually transmitted diseases.
IN THE HOUSE OF REPRESENTATIVES
JUNE 28, 2001
Mrs. MORELLA (for herself, Ms. ESHOO, Ms. PELOSI, Mr. GREENWOOD, Mr.
GANSKE, Mrs. LOWEY, Mr. SAWYER, Ms. DEGETTE, Mr. UPTON, Mrs.
THURMAN, Ms. SLAUGHTER, Mr. JACKSON of Illinois, Mr. WAXMAN, Ms.
MILLENDER-MCDONALD, Mrs. MALONEY of New York, Ms. DELAURO,
and Mr. GEORGE MILLER of California) introduced the following bill;
which was referred to the Committee on Energy and Commerce
A BILL
To amend the Public Health Service Act with respect to
facilitating the development of microbicides for pre-
venting transmission of HIV and other sexually trans-
mitted diseases.
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 of 2001’’.
(7) Microbicides are a promising new tech-
nology for STD and HIV prevention.
(8) Microbicides are user-controlled products
that could kill or inactivate the bacteria and viruses
that cause STDs and HIV.
(9) Microbicides would fill a critical gap in the
array of STD-prevention technologies, first as an
important backup or alternative to the condom, and
second, as a technology that, unlike most vaccines,
could offer protection against various STDs, not just
HIV.
(10) Several potential microbicides are poised
for successful development; more than 20 products
are in clinical trials and nearly 35 promising com-
pounds exist that could be investigated further.
(11) Studies into the market potential for
microbicides indicate that they would have broad ap-
peal. One nationally representative survey indicated
that at least 21,000,000 sexually active women in
the United States would be interested in such prod-
ucts, if they were available.
(12) Federal support for microbicide research
and development is crucial.
(13) At present, there appear to be insufficient
perceived economic incentives for pharmaceutical
companies to become actively engaged in microbicide
research and development.
(14) Numerous small biotechnology companies
and university researchers are actively engaged in
microbicide research, but they are almost totally de-
pendent on public-sector grants to continue their
work and test their products.
(15) Despite public health need and tremendous
scientific opportunity, microbicide research and de-
velopment currently receives less than 1 percent of
the Federal HIV research budget—not nearly
enough to keep pace with the raging STD and HIV
epidemics.
(16) 
Existing 
public 
sector 
grants 
for
microbicides are too small and too short-term to
move product leads forward, and the availability of
clinical trial sites is limited by funding constraints.
(17) There is a backlog in the research and de-
velopment pipeline, so that innovative and promising
product concepts are languishing, while infection
rates are growing.
(18) For significant progress to be made, the
current amount of Federal investment needs to in-
crease to $75,000,000 in fiscal year 2002, to
$100,000,000 
in 
fiscal 
year 
2003, 
with
$100,000,000 yearly in the successive out-years as
required, in order to sustain multiyear funding at a
productive level.
TITLE 
I—MICROBICIDE 
RE-
SEARCH AT THE NATIONAL
INSTITUTES OF HEALTH
SEC. 101. NATIONAL INSTITUTE OF ALLERGY AND INFEC-
TIOUS 
DISEASES; 
PROGRAM 
REGARDING
MICROBICIDES 
FOR 
PREVENTING 
TRANS-
MISSION OF HIV AND OTHER SEXUALLY
TRANSMITTED DISEASES.
Subpart 6 of part C of title IV of the Public Health
Service Act (42 U.S.C. 285f et seq.) is amended by adding
at the end the following section:
‘‘MICROBICIDES FOR PREVENTING TRANSMISSION OF HIV
AND OTHER SEXUALLY TRANSMITTED DISEASES
‘‘SEC. 447C. (a) EXPANSION AND COORDINATION OF
ACTIVITIES.—The Director of the Institute shall expand,
intensify, and coordinate the activities of the Institute
with respect to research on the development of
microbicides to prevent the transmission of HIV and other
sexually transmitted diseases (in this section referred to
as ‘microbicide research’).
‘‘(b) COORDINATION WITH OTHER INSTITUTES.—
The Director of the Institute shall coordinate the activities
under subsection (a) among all appropriate institutes and
components of the National Institutes of Health to the ex-
tent such institutes and components have responsibilities
that are related to the development of microbicides.
‘‘(c) RESEARCH PLAN.—
‘‘(1) IN GENERAL.—The Director of the Insti-
tute, acting in consultation with the Director of the
Office of AIDS Research, shall develop a comprehen-
sive research plan for the conduct and support of re-
search and development of microbicides (in this sec-
tion referred to as the ‘Research Plan’), and shall
annually review and as appropriate revise the plan.
‘‘(2) REQUIREMENTS.—The Research Plan
shall—
‘‘(A) identify current microbicide research
and development activities conducted or sup-
ported by the National Institutes of Health, in-
cluding a description of each current grant and
contract mechanism explicitly designed to facili-
tate microbicide research, including support for
preclinical product development and clinical
trial capacity; and
‘‘(B) describe microbicide research and de-
velopment opportunities for the five year period
beginning six months after the date of the en-
actment of the Microbicide Development Act of
2001, including professional judgment funding
projections, description of objectives with re-
spect to microbicide research, description of the
institutes involved and their role in microbicide
research, plans for enhancing the capacity of
such institutes to carry out the research oppor-
tunities, including staffing and resources nec-
essary for carrying out the activities of this sec-
tion, and discussion of plans for increasing
number of investigators in this area of research.
‘‘(3) CONSULTATION.—In developing the Re-
search Plan, the Director of the Institute shall work
in close consultation with all appropriate institutes
and components at the National Institutes for
Health that have responsibilities that are related to
the 
development 
of 
microbicides, 
with 
the
microbicide research community, and with health ad-
vocates.
‘‘(4) SUBMISSION OF INITIAL PLAN TO PRESI-
DENT AND CONGRESS.—
‘‘(A) IN GENERAL.—The initial Research
Plan shall be developed not later than six
months after the date of the enactment of the
Microbicide Development Act of 2001. The Di-
rector of the Institute shall transmit such Plan
to the Director of NIH, who shall submit the
Plan to the President and the Congress.
‘‘(B) RELATION TO REQUIREMENT OF BI-
ENNIAL NIH REPORT.—Subparagraph (A) shall
be carried out independently of the process of
reporting that is required in section 403.
‘‘(d) PROGRAM FOR MICROBICIDE DEVELOPMENT.—
‘‘(1) IN GENERAL.—In carrying out subsection
(a), the Director of the Institute shall establish a
program to support research to develop microbicides
that can substantially reduce transmission of HIV
and other sexually transmitted diseases. Activities
under such program shall provide for an expansion
and intensification of the conduct and support of—
‘‘(A) basic research on the initial mecha-
nisms of infection by sexually transmitted
pathogens;
‘‘(B) development of appropriate animal
models for evaluating safety and efficacy of
microbicides;
‘‘(C) development of formulation and deliv-
ery approaches;
‘‘(D) research on targeted designs of
microbicides;
‘‘(E) manufacture of candidate products
for testing in animals and humans;
‘‘(F) conduct of HIV incidence and
microbicide feasibility studies;
‘‘(G) evaluation of microbicides in clinical
trials, both domestically and internationally;
and
‘‘(H) behavioral research on use, accept-
ability, and adherence to microbicides.
‘‘(2) RESEARCH BRANCH.—The Director of the
Institute shall establish, within the Vaccine and Pre-
vention Research Program of the Division of AIDS
in the Institute, an organizational unit to be known
as the Microbicide Research Branch. Such Branch
shall carry out the program under this subsection.
‘‘(e) CONSTRUCTION OF FACILITIES.—The Director
of the Institute may make awards of grants and contracts
to public and nonprofit private entities for the construc-
tion of facilities to conduct microbicide research, including
clinical trials.
‘‘(f) CENTERS FOR MICROBICIDE RESEARCH AND
DEVELOPMENT.—
‘‘(1) IN GENERAL.—The Director of the Insti-
tute, after consultation with the advisory council for
the Institute, and in consultation with the Director
of the Office of AIDS Research, shall make awards
of grants or contracts to public and nonprofit pri-
vate entities for the development and operation of
not less than four multidisciplinary research centers
to conduct microbicide research.
‘‘(2) REQUIREMENTS.—Each center assisted
under this subsection shall—
‘‘(A) use the facilities of a single institu-
tion, or be formed from a consortium of cooper-
ating institutions, meeting such requirements as
may be prescribed by the Director of the Insti-
tute; and
‘‘(B) conduct basic research on muscosal
transmission to design novel microbicide strate-
gies for the prevention of HIV and STD infec-
tion, including research into HIV and STD
pathogenesis, reproductive tract biology and
toxicology, concept testing in animal models,
and formulation and delivery design.
‘‘(g) REPORT TO CONGRESS.—Not later than one
year after the date of the initial submission of the Re-
search Plan under subsection (c)(1), and annually there-
after, the Director of the Institute shall submit to the
Committee on Energy and Commerce in the House of
Representatives and the Committee on Health, Education,
Labor and Pensions in the Senate a report that describes
the activities of the Institute regarding microbicide re-
search. Each such report shall include—
‘‘(1) an updated Research Plan, including pro-
fessional judgment funding projections;
‘‘(2) an assessment of the implementation of
such plan;
‘‘(3) a description and evaluation of the
progress made, during the period for which such re-
port is prepared, in the research on microbicides;
‘‘(4) a summary and analysis of expenditures
made, during the period for which the report is
made, for activities with respect to microbicides re-
search conducted and supported by the National In-
stitutes of Health, including the number of full-time
equivalent employees; and
‘‘(5) such comments and recommendations as
the Director of the Institute considers appropriate.
‘‘(h) COORDINATION WITH OTHER FEDERAL AGEN-
CIES.—The Director of the Institute shall consult with the
Director for the Centers for Disease Control and Preven-
tion and the United States Agency for International De-
velopment in developing the Research Plan that takes into
consideration research on HIV and other sexually trans-
mitted diseases and microbicides carried out at the Cen-
ters for Disease Control and Prevention and the United
States Agency for International Development.
‘‘(i) DEFINITION.—For purposes of this section, the
term ‘HIV’ means the human immunodeficiency virus.
Such term includes acquired immune deficiency syndrome.
‘‘(j) AUTHORIZATION OF APPROPRIATIONS.—For the
purposes of carrying out this section, there are authorized
to be appropriated such sums as may be necessary for
each of the fiscal years 2002 through 2004.’’.
TITLE 
II—MICROBICIDE 
RE-
SEARCH 
AT 
THE 
CENTERS
FOR DISEASE CONTROL AND
PREVENTION
SEC. 201. MICROBICIDES FOR PREVENTING TRANSMISSION
OF HIV AND OTHER SEXUALLY TRANSMITTED
DISEASES.
Part B of title III of the Public Health Service Act
(42 U.S.C. 243 et seq.) is amended by inserting after sec-
tion 317P the following section:
‘‘MICROBICIDES FOR PREVENTING TRANSMISSION OF HIV
AND OTHER SEXUALLY TRANSMITTED DISEASES
‘‘SEC. 317Q. (a) EXPANSION AND COORDINATION OF
MICROBICIDE RESEARCH ACTIVITIES.—The Secretary,
acting through the Director of the Centers for Disease
Control and Prevention, shall expand, intensify, and co-
ordinate the activities of such Centers with respect to re-
search on microbicides to prevent the transmission of HIV
and other sexually transmitted diseases.
‘‘(b) 
GRANTS
REGARDING
MICROBICIDE
RE-
SEARCH.—In order to contribute to the rapid evaluation
of safe and effective microbicides for the prevention of
HIV and other sexually transmitted diseases, the Sec-
retary may in carrying out subsection (a) make grants to
public and nonprofit private entities for the purpose of—
‘‘(1) laboratory research in preparation for, and
support of, clinical microbicide trials;
‘‘(2) conducting behavioral research in prepara-
tion for, and support of, clinical microbicide trials;
‘‘(3) developing and characterizing domestic
populations and international cohorts appropriate
for Phase I, II, and III clinical trials of candidate
topical microbicides;
‘‘(4) conducting Phase I and II clinical trials to
assess the safety and acceptability of candidate
microbicides;
‘‘(5) conducting Phase III clinical trials to as-
sess the efficacy of candidate microbicides;
‘‘(6) provide technical assistance to, and con-
sultation with, a wide variety of domestic and inter-
national entities involved in developing and evalu-
ating topical microbicides, including health agencies,
extramural researchers, industry, health advocates,
and non-profit organizations; and
‘‘(7) developing and evaluating the diffusion
and effects of implementation strategies for use of
effective topical microbicides.
‘‘(c) SELECTION OF AGENTS AND TRIAL DESIGNS;
COORDINATION WITH OTHER AGENCIES.—In coordina-
tion and collaboration with the Director of the National
Institutes of Health and the Administrator of the United
States Agency for International Development, the Sec-
retary shall select agents and trial designs, develop clinical
trial capacity as described in subsection (b), share experi-
ence, and avoid duplication of effort.
‘‘(d) ANNUAL REPORTS.—Not later than six months
after the date of the enactment of the Microbicide Devel-
opment Act of 2001, and annually thereafter, the Sec-
retary shall submit to the Energy and Commerce Com-
mittee in the House of Representatives and the Health,
Education, Labor and Pensions Committee in the Senate
a report on the activities carried out under this section
by the Secretary. Each such report shall include—
‘‘(1) description of research with respect to
microbicide research and development;
‘‘(2) description and evaluation of the progress
made, during the period for which such report is
prepared, in the research on microbicides; and
‘‘(3) summary and analysis of expenditures
made, during the period for which the report is
made, for activities with respect to microbicides con-
ducted and supported by the Centers for Disease
Control and Prevention.
‘‘(e) DEFINITION.—For the purposes of this section,
the term ‘HIV’ means the human immunodeficiency virus.
Such term includes acquired immune deficiency syndrome.
‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—For the
purposes of carrying out this section, there are authorized
to be appropriated such sums as may be necessary for
each of the fiscal years 2002 through 2004.’’.
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