Microbicide Development Act - Amends the Public Health Service Act to require the Director of the Office of AIDS Research to: (1) expedite the implementation of the Federal strategic plan for the conduct and support of microbicide research; and (2) expand, intensify, and coordinate all activities with respect to research and development of microbicides to prevent the transmission of HIV and other sexually transmitted diseases.
Requires the Director of the National Institute of Allergy and Infectious Diseases to: (1) establish within the Division of AIDS an organizational unit to carry out microbicide research and development; and (2) assign priority to ensuring adequate funding and support for the integration of basic science and clinical research.
Requires the Director of the Centers for Disease Control and Prevention (CDC) to fully implement the CDC's topical microbicide agenda to support microbicide research and development.
Directs the head of the Office of HIV/AIDS of the U.S. Agency for International Development (USAID) to develop and implement a program to support the development of microbicides products and facilitate wide-scale availability of such products.
[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3854 Introduced in House (IH)]
109th CONGRESS
1st Session
H. R. 3854
To amend the Public Health Service Act with respect to facilitating the
development of microbicides for preventing transmission of HIV and
other diseases, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
September 21, 2005
Mr. Shays (for himself, Ms. Schakowsky, Mr. Davis of Illinois, Mr.
George Miller of California, Mr. Brown of Ohio, Ms. Millender-McDonald,
Mr. Payne, Mr. Leach, Ms. Lee, Mr. Evans, Ms. Schwartz of Pennsylvania,
Mr. Crowley, Mr. Waxman, Mr. Kirk, Mr. Emanuel, Mr. Berman, Mr.
Grijalva, Mr. Jackson of Illinois, Mr. Larson of Connecticut, Ms. Bean,
Mr. McNulty, Mr. Owens, Mr. Wexler, Mr. Rush, Mr. Gutierrez, Mr.
McDermott, Mr. McGovern, Mr. Van Hollen, Mr. Stark, and Mr. Honda)
introduced the following bill; which was referred to the Committee on
Energy and Commerce, and in addition to the Committee on International
Relations, for a period to be subsequently determined by the Speaker,
in each case for consideration of such provisions as fall within the
jurisdiction of the committee concerned
_______________________________________________________________________
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, and for other purposes.
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''.
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 each region of the
world. Women account for nearly \1/2\ of the 37,000,000 adults
living with HIV and AIDS worldwide as of 2005. Approximately
7,000 women are newly infected with HIV each day.
(2) Because of their social and biological vulnerabilities,
young women are particularly at risk. In Sub-Saharan Africa, 76
percent of the young people (between ages 15 and 24) with HIV
are girls under 20.
(3) When women become infected with HIV, they can pass
along the infection to their children during pregnancy, labor
and delivery, or breast-feeding. The most effective way to halt
mother-to-child transmission is to ensure that mothers are not
infected in the first place.
(4) An increasing number of women who become infected with
HIV have only 1 sexual partner, their husband. Unfortunately,
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 in the developing world are unable to insist on mutual
monogamy or negotiate condom use, especially 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, or rings,
microbicides inactivate, block, or otherwise interfere with the
transmission of the pathogens that cause AIDS and other
sexually transmitted diseases (``STD''s). Microbicides could
allow a woman to protect herself from disease.
(6) Married 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 allows conception. Some
microbicides are being developed with the objective that they
will allow conception while protecting from disease.
(7) Households in developing countries often dissolve when
a mother dies. In the hardest hit countries, the number of
children who are orphaned by AIDS is increasing dramatically.
(8) Women in the United States also need HIV prevention
tools like microbicides. AIDS is now the number 1 cause of
death among African-American women between the ages of 25 and
34.
(9) In addition to HIV, other STDs continue to be a major
health threat in the United States. The United States has the
highest rates of sexually transmitted diseases of any
industrialized nation. Nineteen million STD infections occur
every year. It is estimated that by age 25, \1/2\ of all
sexually active people in the United States can expect to be
infected with an STD.
(10) HIV and AIDS represent a threat to national security
and economic well being, with direct medical costs of up to
$15,500,000,000 per year. The pandemic undermines armies,
foments unrest, and burdens the United States military.
(11) As the Nation's largest single provider of HIV/AIDS
care, the Veterans Affairs health care system spent
$359,000,000 to provided care to more than 20,000 American
veterans with HIV/AIDS in fiscal year 2004.
(12) The microbicide field has achieved an extraordinary
amount of scientific momentum, with several first-generation
candidates now in large scale human trials around the world. At
same time, new products, based upon recent advances in HIV
treatment, 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 depends in large part on Government leadership and
investment.
(14) The Federal Government needs to make a strong
commitment to microbicide research and development. 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 public 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. 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 developing 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 research 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 organizations working on microbicide research,
importantly including clinical trials in developing countries
where its experience is extensive. USAID is well positioned 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
development of new HIV-prevention technologies like
microbicides, which women can initiate.
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--
``(A) expedite the implementation of a Federal
strategic plan for the conduct and support of
microbicide research and development; and
``(B) annually review and, as appropriate, revise
such plan, to prioritize funding and activities in
terms of their scientific urgency.
``(2) Coordination.--In implementing, reviewing, 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 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 and development of
microbicides to prevent the transmission of the human immunodeficiency
virus (`HIV') and other sexually transmitted diseases.
``(c) Microbicide Development Unit.--In carrying out subsection
(b), the Director of the National Institute of Allergy and Infectious
Diseases shall establish within the Division of AIDS in the Institute,
a clearly defined organizational unit charged with carrying out
microbicide research and development. In establishing such unit, the
Director shall ensure that there are a sufficient number of employees
dedicated to carrying out the mission of the unit.
``(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 integration of basic science and clinical research, with
particular emphasis on implementation of trials leading to product
licensure.
``(e) Reports to Congress.--
``(1) In general.--Not later than 6 months after the date
of enactment of the Microbicide Development Act, and annually
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.
``(2) Contents of reports.--Each report submitted under
paragraph (1) shall include--
``(A) a description of activities with respect to
microbicide research and development conducted and
supported by the Federal Government;
``(B) a summary and analysis of the expenditures
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 research, preclinical product
development, clinical trials, and process development
and production;
``(C) a description and evaluation of the progress
made, during the preceding year, toward the development
of effective and acceptable microbicides; and
``(D) a review of scientific and programmatic
obstacles to expediting the commercial availability of
microbicide products.
``(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 Committee on
Energy and Commerce and the Committee on Appropriations of the
House of Representatives.
``(f) Authorization of Appropriations.--There are authorized to be
appropriated such sums as may be necessary for each fiscal year to
carry out this section.''.
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 by inserting after section 317S the following:
``SEC. 371T. 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 such Centers' 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 Phases I, II, and III
clinical trials of candidate topical microbicides;
``(4) conducting Phases 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) Personnel.--The Centers for Disease Control and Prevention
shall ensure that there are sufficient numbers of dedicated employees
for carrying out the microbicide agenda under subsection (a).
``(c) Report to Congress.--
``(1) In general.--Not later than 1 year after the date of
enactment of the Microbicide Development Act, and annually
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.
``(2) Contents of report.--Such report shall include--
``(A) a description of activities with respect to
microbicides conducted or supported by the Director of
the Centers for Disease Control and Prevention;
``(B) a summary and analysis of the expenditures
made by such Director during the preceding year, for
activities with respect to microbicide-specific
research and development, including the number of
employees of such Centers involved in such activities;
``(C) a description and evaluation of the progress
made, during the preceding year, toward the development
of effective and acceptable microbicides; and
``(D) a review of scientific and programmatic
obstacles to expediting the commercial availability of
microbicide products.
``(3) Appropriate committees of congress defined.--For the
purposes of 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 Committee on Energy and Commerce and the Committee on
Appropriations of the House of Representatives.
``(d) Authorization of Appropriations.--There are authorized to be
appropriated such sums as may be necessary for each fiscal year to
carry out this section.''.
TITLE III--MICROBICIDE RESEARCH AT THE UNITED STATES AGENCY FOR
INTERNATIONAL DEVELOPMENT
SEC. 301. MICROBICIDES FOR PREVENTING TRANSMISSION OF HIV AND OTHER
DISEASES.
Section 104A of the Foreign Assistance Act of 1961 (22 U.S.C.
2151b-2) is amended--
(1) by redesignating subsection (g) as subsection (h); and
(2) by inserting after subsection (f) the following:
``(g) Microbicides for Preventing Transmission of HIV and Other
Diseases.--
``(1) Development and implementation of the microbicide
agenda.--The head of the Office of HIV/AIDS of the United
States Agency for International Development, in conjunction
with other offices of such Agency, shall develop and implement
a program to support the development of microbicides products
for the prevention of the transmission of HIV and other
diseases, and facilitate wide-scale availability of such
products after such development. The program shall be known as
the `microbicide agenda' and shall include--
``(A) support for the discovery, development, and
preclinical evaluation of topical microbicides;
``(B) support for the conduct of clinical studies
of candidate microbicides to assess the safety,
acceptability, and effectiveness of such microbicides
in reducing the transmission of HIV and other sexually
transmitted diseases;
``(C) support for behavioral and social science
research relevant to microbicide development, testing,
acceptability, and use;
``(D) support for preintroductory and introductory
studies of safe and effective microbicides in
developing countries; and
``(E) facilitation of access to microbicides by
women at highest risk of contracting HIV or other
sexually transmitted diseases, at the earliest possible
time.
``(2) Staffing.--The head of the Office of HIV/AIDS shall
ensure that the Agency has a sufficient number of dedicated
employees to carry out the microbicide agenda.
``(3) Reports to congress.--
``(A) In general.--Not later than 1 year after the
date of enactment of the Microbicide Development Act,
and annually thereafter, the Administrator of the
Agency shall submit to the appropriate committees of
Congress a report on the activities of the
Administrator to carry out the microbicide agenda and
on any other activities carried out by the
Administrator related to microbicide research and
development.
``(B) Contents of report.--Each report submitted
under subparagraph (A) shall include--
``(i) a description of activities with
respect to microbicides conducted or supported
by the Administrator;
``(ii) a summary and analysis of the
expenditures made by the Administrator during
the preceding year for activities with respect
to microbicide-specific research and
development, including the number of employees
of the Agency who are involved in such
activities;
``(iii) a description and evaluation of the
progress made during the preceding year toward
the development of effective and acceptable
microbicides;
``(iv) a review of scientific and
programmatic obstacles to expediting the
commercial availability of microbicide
products; and
``(v) a description of the activities
carried out to increase the availability of
microbicides approved to prevent the
transmission of HIV or other sexually
transmitted diseases.
``(C) Appropriate committees of congress defined.--
In this paragraph, the term `appropriate committees of
Congress' means the Committee on Foreign Relations and
the Committee on Appropriations of the Senate and the
Committee on International Relations and the Committee
on Appropriations of the House of Representatives.
``(4) Authorization of appropriations.--There are
authorized to be appropriated such sums as may be necessary for
each fiscal year to carry out this subsection.''.
<all>
Introduced in House
Introduced in House
Referred to the Committee on Energy and Commerce, and in addition to the Committee on International Relations, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on Energy and Commerce, and in addition to the Committee on International Relations, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on Energy and Commerce, and in addition to the Committee on International Relations, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Subcommittee on Health.
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