[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[S. 1752 Introduced in Senate (IS)]
107th CONGRESS
1st Session
S. 1752
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 SENATE OF THE UNITED STATES
November 30, 2001
Mr. Corzine (for himself, Ms. Snowe, Ms. Cantwell, Mr. Dodd, Mr. Leahy,
and Mrs. Murray) 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 and
other sexually transmitted diseases.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Microbicide Development Act of
2001''.
SEC. 2. FINDINGS.
The Congress finds as follows:
(1) Sexually transmitted diseases (``STDs'') and the human
immunodeficiency virus (``HIV'') are producing serious and
costly epidemics of infectious disease in populations
worldwide.
(2) This year, 15,400,000 people in the United States will
acquire a new STD.
(3) Globally, 36,100,000 people are infected with HIV, with
more than 15,000 new infections occurring daily.
(4) Racial and ethnic minorities have been
disproportionately infected with STDs, especially HIV. For
example, although together African American and Latina women
represent roughly 25 percent of the total U.S. female
population, they account for 77 percent of all reported female
HIV cases.
(5) STDs cause serious, costly, even deadly conditions for
women and their children: infertility, pregnancy complications,
cervical cancer, infant mortality, and higher risk of
contracting HIV.
(6) Estimated annual costs of STDs and their complications
in the United States range from $8,400,000,000 in direct
medical costs to nearly $20,000,000,000, including out-of-
pocket costs and lost productivity.
(7) Microbicides are a promising new technology for STD and
HIV prevention.
(8) Microbicides are user-controlled products that could
kill, block, 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 compounds exist that could be
investigated further.
(11) Studies into the market potential for microbicides
indicate that they would have broad appeal. One nationally
representative survey indicated that at least 21,000,000
sexually active women in the United States would be interested
in such products, if they were available.
(12) Federal support for microbicide research and
development is crucial.
(13) At present, there is insufficient economic incentive
for large 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 dependent on public-sector grants to
continue their work and test their products.
(15) Despite public health need and tremendous scientific
opportunity, microbicide research and development 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 development
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 increase 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 RESEARCH AT THE NATIONAL INSTITUTES OF HEALTH
SEC. 101. OFFICE OF AIDS RESEARCH; PROGRAM REGARDING MICROBICIDES FOR
PREVENTING TRANSMISSION OF HIV AND OTHER SEXUALLY
TRANSMITTED 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 TRANSMISSION OF HIV AND OTHER
SEXUALLY TRANSMITTED DISEASES.
``(a) Expansion and Coordination of Activities.--The Director of
the Office of AIDS Research shall expand, intensify, and coordinate the
activities of the Institutes 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 Within the National Institutes of Health.--The
Director of the Office of AIDS Research shall coordinate the activities
under subsection (a) among all appropriate institutes and components of
the National Institutes of Health to the extent such institutes and
components have responsibilities that are related to the development of
microbicides.
``(c) Research Plan.--
``(1) In general.--The Director of the Office of AIDS
Research, acting in consultation with the Director of the
Institute of Allergy and Infectious Diseases, shall expedite
the implementation of the 5-year strategic plan for the conduct
and support of research and development of microbicides (in
this section 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 supported by the
National Institutes of Health, including a description
of each current grant and contract mechanism explicitly
designed to facilitate microbicide research, including
support for preclinical product development and
clinical trial capacity; and
``(B) describe microbicide research and development
opportunities for the five year period beginning three
months after the date of the enactment of the
Microbicide Development Act of 2001, including
professional judgment funding projections, description
of objectives with respect 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
opportunities, including staffing and resources
necessary for carrying out the activities of this
section, and discussion of plans for increasing number
of investigators in this area of research.
``(3) Consultation.--In developing the Research Plan, the
Director of the Office of AIDS Research shall work in close
consultation with the Director of the National Institute of
Allergy and Infectious Diseases, the Director of the National
Institute of Child Health and Human Development, and with all
appropriate institutes and components at the National
Institutes for Health that have responsibilities that are
related to the development of microbicides, with other Federal
agencies involved in microbicide research, with the microbicide
research community, and with health advocates.
``(4) Submission of initial plan to president and
congress.--
``(A) In general.--The initial Research Plan shall
be developed not later than three months after the date
of the enactment of the Microbicide Development Act of
2001. The Director of the Office of AIDS Research 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 biennial 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 National Institute of Allergy and Infectious
Diseases shall establish a program to support research to
develop microbicides that can substantially reduce transmission
of HIV and other sexually transmitted diseases. In accordance
with scientific opportunities, as such opportunities become
evident, activities under such program shall include--
``(A) basic research on the initial mechanisms of
infection by sexually transmitted pathogens;
``(B) development of appropriate animal models for
evaluating safety and efficacy of microbicides;
``(C) development of formulation and delivery
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, acceptability,
and adherence to microbicides.
``(2) Microbicide dedicated unit.--The Director of the
National Institute of Allergy and Infectious Diseases shall
organize, within the Prevention Sciences Branch of the Vaccine
and Prevention Research Program of the Division of AIDS in the
Institute, a dedicated unit charged with carrying out the
program under this subsection. In organizing the unit, the
Director shall designate between three and five additional
full-time employees to the work encompassed by the Research
Plan, while maintaining staffing levels in other areas critical
to advancing microbicide research and development.
``(e) Microbicide Research and Development Teams.--
``(1) In general.--The Director of the National Institutes
of Health shall make awards of grants or contracts to public
and private entities for the development and operation of not
less than four new multidisciplinary teams to conduct research
on innovative microbicide concepts, including combination
microbicides.
``(2) Requirements.--Each team assisted under this
subsection shall--
``(A) use the facilities of a single institution,
or be formed from a consortium of cooperating
institutions, meeting such requirements as may be
prescribed by the Director of the National Institutes
of Health; and
``(B) conduct research on muscosal transmission to
design and develop novel microbicides for the
prevention of HIV and STD infection, including research
into HIV and STD pathogenesis, reproductive tract
biology and toxicology, concept testing in animal
models, and formulation and delivery design.
``(f) Report to Congress.--Not later than one year after the date
of the initial submission of the Research Plan under subsection (c)(1),
and annually thereafter, the Director of the Office of AIDS Research,
in consultation with the Director of the Institute of Allergy and
Infectious Diseases, shall submit to the Committee on Energy and
Commerce and the Committee on Appropriations of the House of
Representatives and the Committee on Health, Education, Labor, and
Pensions and the Committee on Appropriations of the Senate a report
that describes the activities of the National Institutes of Health
regarding microbicide research. Each such report shall include--
``(1) an updated Research Plan, including professional
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 report 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 research conducted and supported by the
National Institutes of Health, including the number of full-
time equivalent employees; and
``(5) such comments and recommendations as the Director of
the Office of AIDS Research considers appropriate.
``(g) Coordination With Other Federal Agencies.--The Director of
the Office of AIDS Research shall consult with the Director for the
Centers for Disease Control and Prevention and the United States Agency
for International Development in developing the Research Plan that
takes into consideration research on HIV and other sexually transmitted
diseases and microbicides carried out at the Centers for Disease
Control and Prevention and the United States Agency for International
Development.
``(h) Definition.--For purposes of this section, the term `HIV'
means the human immunodeficiency virus. Such term includes acquired
immune deficiency syndrome.
``(i) 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 RESEARCH 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 section 317P the following:
``SEC. 317Q. MICROBICIDES FOR PREVENTING TRANSMISSION OF HIV AND OTHER
SEXUALLY TRANSMITTED DISEASES.
``(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
coordinate the activities of such Centers with respect to research on
microbicides to prevent the transmission of HIV and other sexually
transmitted diseases.
``(b) Grants Regarding Microbicide Research.--In order to
contribute to the rapid evaluation of safe and effective microbicides
for the prevention of HIV and other sexually transmitted diseases, the
Secretary 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 preparation 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 assess the
efficacy of candidate microbicides;
``(6) providing technical assistance to, and consulting
with, a wide variety of domestic and international entities
involved in developing and evaluating 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 coordination and collaboration with the Director of
the National Institutes of Health and the Administrator of the United
States Agency for International Development, the Secretary shall select
agents and trial designs, develop clinical trial capacity as described
in subsection (b), share experience, and avoid duplication of effort.
``(d) Annual Reports.--Not later than three months after the date
of the enactment of the Microbicide Development Act of 2001, and
annually thereafter, the Secretary shall submit to the Energy and
Commerce Committee of the House of Representatives and the Health,
Education, Labor, and Pensions Committee of the Senate a report on the
activities carried out under this section by the Secretary. Each such
report shall include--
``(1) a description of research with respect to microbicide
research and development;
``(2) a description and evaluation of the progress made,
during the period for which such report is prepared, in the
research on microbicides; and
``(3) a summary and analysis of expenditures made, during
the period for which the report is made, for activities with
respect to microbicides conducted 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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