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108th CONGRESS
1st Session
S. 859
To amend the Public Health Service Act with respect to facilitating the
development of microbicides for preventing transmission of HIV and
other diseases.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
Mr. Corzine (for himself, Ms. Snowe, Ms. Cantwell, Mr. Smith, Mr. Dodd,
Mr. Leahy, Mrs. Murray, Mr. Durbin, Mr. Lautenberg, and Mr. Bingaman)
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 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
2003''.
SEC. 2. FINDINGS.
Congress makes the following findings:
(1) During 2002, AIDS caused the deaths of an estimated
3,100,000 people, including 1,200,000 women and 610,000
children under 15 years of age. An estimated 14,000,000
children living today have lost one or both parents due to
AIDS.
(2) Worldwide, heterosexual transmission is accounting for
an increasing share of new HIV infections, with adolescents,
women, and disadvantaged people at particular risk.
(3) In the United States, for example, African American and
Latina women account for 64 percent and 17 percent of all
reported HIV cases, respectively, even though they represent
only 25 percent of the total United States female population.
(4) Half of the 38,600,000 adults living today with HIV/
AIDS are women.
(5) Biological, cultural, economic, and social factors
combine to make women and girls particularly vulnerable to HIV
and other sexually transmitted diseases (referred to in this
section as ``STDs''). In the hardest hit areas of Africa,
almost one-quarter of 15 to 19 year-old girls are already
infected with HIV, compared to 4 percent of their male peers.
(6) In addition to HIV, other STDs can cause serious,
costly, even deadly conditions for women and their children,
including infertility, pregnancy complications, cervical
cancer, infant mortality, and higher risk of contracting HIV.
When women become infected with HIV, they risk passing along
the infection to their infants, either through pregnancy,
childbirth, or breastfeeding.
(7) Regrettably, today's HIV prevention methods do not meet
the needs of the millions of women worldwide who, for cultural,
economic, and social reasons, cannot insist on protective
measures such as abstinence, condom use, or mutual monogamy.
(8) A large majority of women become infected with HIV with
only one partner--their husbands. Women need prevention options
that they can use consistently within ongoing, long-term
relationships.
(9) Microbicides are a promising new technology,
complementary to vaccines, that could put the power of
prevention into women's hands. Formulated as gels, creams, or
films, microbicides inactivate, block, or otherwise interfere
with the pathogens that cause HIV/AIDS and other STDs.
(10) Even a moderately effective microbicide could have a
substantial impact on the HIV epidemic. The London School of
Hygiene and Tropical Medicine estimates that a 60 percent
efficacious microbicide introduced into the 73 poorest
countries could avert 2,500,000 HIV infections in men, women,
and children over 3 years.
(11) Microbicides would also benefit men, because their
protective effect is likely to be bidirectional.
(12) Numerous potential microbicides are poised for
successful development. Thirteen products are in clinical
trials and approximately 50 compounds exist that could be
investigated further. There is a backlog in the research and
development pipeline, however, so that innovative and promising
product concepts are languishing, while infection rates are
growing.
(13) At present, there is insufficient economic incentive
for large pharmaceutical companies to become actively engaged
in microbicide research and development, thus, Federal support
is crucial. Three Federal agencies--the National Institutes of
Health, the Centers for Disease Control and Prevention, and the
United States Agency for International Development--have played
important roles in progress to date, but strong, effective,
well-coordinated, and visible public sector leadership will be
essential for the promise of microbicides to be realized.
(14) A microbicide could be available within 5 to 7 years
if sufficient public sector funding were made available to
accelerate research and support the necessary clinical trials.
(15) Microbicide research and development currently receive
only 2 percent of the AIDS research budget of the National
Institutes of Health, not nearly enough to keep pace with
public health need and scientific opportunity.
(16) The United States Agency for International Development
sustains strong partnerships with public and private
organizations working on microbicide research, importantly
including clinical trials in developing countries where its
experience is extensive. The long experience of such Agency in
logistics management, service delivery, provider training, and
social marketing position it well to prepare for and implement
the introduction of microbicides once they are available.
(17) The Centers for Disease Control and Prevention also
engages in critical microbicide research and clinical testing,
and has a long history of conducting field trials in developing
countries.
(18) For the microbicide pipeline to advance significantly
and the essential clinical trials to be fielded soon, the
current amount of Federal investment needs to increase to $130,000,000
in fiscal year 2004 and to $160,000,000 in fiscal year 2005.
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 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
DISEASES.
``(a) Federal Strategic Plan.--
``(1) In general.--The Director of the Office of AIDS
Research shall expedite the development and implementation of a
Federal strategic plan for the conduct and support of
microbicide research and shall biannually review and as
appropriate revise the plan.
``(2) Coordination.--In developing, implementing, and
reviewing the plan, 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 Activities.--The Director of
the Office of AIDS Research, acting in coordination with other relevant
institutes and offices, shall expand, intensify, and coordinate the
activities of all appropriate institutes and components of the National
Institutes of Health with respect to research on the development of
microbicides to prevent the transmission of HIV and other sexually
transmitted diseases.
``(c) Microbicide Development Branch.--In carrying out subsection
(b), the Director of the National Institute of Allergy and Infectious
Diseases shall establish within the Vaccine and Prevention Research
Program of the Division of AIDS in the Institute, a 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 carry out the mission of the branch.
``(d) Report to Congress.--
``(1) In general.--Not later than 1 year after the date on
which the initial Federal strategic plan is developed under
subsection (a), and biannually thereafter, the Director of the
Office of AIDS Research shall submit to the appropriate
committees of Congress a report that describes the strategies
being implemented by the Federal Government regarding
microbicide research and development. Each such report shall
include--
``(A) a description of activities with respect to
microbicides conducted and supported by the Federal
Government;
``(B) a summary and analysis of expenditures,
during the period for which the report is prepared, for
activities with respect to microbicide-specific
research and development, including the number of
employees involved in these activities within each
agency;
``(C) a description and evaluation of the progress
made, during the period for which such report is
prepared, towards the development of effective,
reliable, and acceptable microbicides;
``(D) a review of the remaining scientific and
programmatic obstacles with respect to microbicides;
and
``(E) an updated Federal Strategic Plan, including
professional judgment funding projections.
``(2) Appropriate congressional committees definition.--For
the purposes of this subsection, the term `appropriate
committees of Congress' means 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.
``(e) HIV Definition.--For purposes of this section, the term `HIV'
means the human immunodeficiency virus. Such term includes acquired
immune deficiency syndrome (AIDS).
``(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 fiscal years 2004 and 2005, and
such sums as may be necessary in subsequent fiscal years to sustain
multiyear funding at a productive level.''.
TITLE II--MICROBICIDE RESEARCH AT THE CENTERS FOR DISEASE CONTROL AND
PREVENTION
SEC. 201. MICROBICIDES FOR PREVENTING TRANSMISSION OF HIV AND OTHER
DISEASES.
Part B of title III of the Public Health Service Act (42 U.S.C. 243
et seq.) is amended--
(1) by transferring section 317R so as to appear after
section 317Q; and
(2) by inserting after section 317R (as so transferred) the
following:
``SEC. 317S. MICROBICIDES FOR PREVENTING TRANSMISSION OF HIV AND OTHER
DISEASES.
``(a) Development and Implementation of the Microbicide Agenda
Supported by the Centers for Disease Control and Prevention.--The
Director of the Centers for Disease Control and Prevention shall fully
implement the Centers' 5-year topical microbicide agenda to support
microbicide research and development. Such an agenda shall include--
``(1) conducting 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 nonprofit organizations; and
``(7) developing and evaluating the diffusion and effects
of implementation strategies for use of effective topical
microbicides.
``(b) Staffing.--In carrying out the microbicide agenda, the
Centers for Disease Control and Prevention shall ensure that there are
sufficient numbers of dedicated employees for carrying out the agenda
under subsection (a).
``(c) Report to Congress.--
``(1) In general.--Not later than 1 year after the date of
enactment of this section, and biannually thereafter, the
Director of the Centers for Disease Control and Prevention
shall submit to the appropriate committees of Congress, a
report on the strategies being implemented by the Centers for
Disease Control and Prevention with respect to microbicide
research and development. Such report shall be submitted alone
or as part of the overall Federal strategic plan on
microbicides compiled annually by the National Institutes of
Health Office of AIDS Research as required under section 2351A.
Such report shall include--
``(A) a description of activities with respect to
microbicides conducted and supported by the Centers for
Disease Control and Prevention;
``(B) a summary and analysis of expenditures,
during the period for which the report is prepared, for
activities with respect to microbicide-specific
research and development, including the number of
employees involved in these activities;
``(C) a description and evaluation of the progress
made, during the period for which such report is
prepared, towards the development of effective,
reliable, and acceptable microbicides; and
``(D) a review of the remaining scientific and
programmatic obstacles with respect to microbicides.
``(2) Appropriate congressional committees definition.--For
the purposes of this subsection, the term `appropriate
committees of Congress' means 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.
``(d) Definition.--For the purposes of this section, the term `HIV'
means the human immunodeficiency virus. Such term includes acquired
immune deficiency syndrome (AIDS).
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