1.This Act may be cited as the
Alzheimer’s Breakthrough Act of
2011
.
2.Congress makes the following
findings:
(1)Alzheimer’s disease is a disorder that
destroys cells in the brain. The disease is the leading cause of dementia, a
condition that involves gradual memory loss, decline in the ability to perform
routine tasks, disorientation, difficulty in learning, loss of language skills,
impairment of judgment, and personality changes. As the disease progresses,
people with Alzheimer's disease become unable to care for themselves. The loss
of brain cells eventually leads to the failure of other systems in the
body.
(2)Alzheimer’s
disease is the sixth leading cause of death in the United States and remains
the only one of the top ten causes of death without an identified way to
prevent, cure, or slow its progression.
(3)An estimated 5.4
million Americans have Alzheimer’s disease. With the aging of the baby boomers,
the number of Americans with Alzheimer’s disease will likely reach 13.5 million
in 2050—and could be as high as 16 million.
(4)An individual will
live with the increasingly devastating, debilitating, and destructive effects
of Alzheimer’s disease for an average of 4 to 8 years after diagnosis, and some
live as long as 20 years.
(5)Alzheimer’s
disease does not just affect those with the disease but takes an emotional,
financial, and physical toll on caregivers. In 2010, nearly 15 million
Americans provided 17 billion hours of unpaid care to family members and
friends with Alzheimer’s disease and other dementias at a total value of over
$202 billion.
(6)In 2011, Medicare
is expected to spend $93 billion for the care of individuals with Alzheimer’s
disease and other dementias and this amount is projected to increase to $627
billion in 2050. Medicaid costs is expected to increase nearly 400 percent,
from $37 billion in 2011 to $178 billion in 2050.
(7)In fiscal year
2010, the Federal Government spent $450 million on Alzheimer’s disease
research. For every $100 the Federal Government spent on Alzheimer’s disease
research in fiscal year 2010, Medicare and Medicaid spent more than $28,000 for
care for people with Alzheimer’s disease.
(8)Research leading
to treatments that delay onset of Alzheimer’s disease by just five years would
cut Federal Government spending on the disease by 45 percent in 2050.
(9)In 2010, Congress
passed the National Alzheimer’s Project Act, which instructs the Department of
Health and Human Services to develop a strategic plan (referred to in this
section as the National Alzheimer’s Project plan) to address the
rapidly escalating Alzheimer’s disease crisis.
(10)The annually
updated National Alzheimer’s Project plan must be transmitted to Congress each
year and is to include outcome-driven objectives, recommendations for priority
actions, and coordination of all federally funded programs in Alzheimer’s
disease research, care, and services.
(11)It is expected
that the National Alzheimer’s Project plan will include research priority
actions to accelerate the development of treatments that would prevent, cure,
or slow the progression of Alzheimer’s disease.
(12)The medical and
research communities have the ideas, the technology, and the will, but need the
Federal Government to commit to an innovative research approach, to find
breakthroughs that will provide significant returns on investment and will save
millions of lives.
3.Requiring a
Federal commitment to Alzheimer's disease research
(a)Part A of title IV of
the Public Health Service Act (42 U.S.C. 281 et seq.) is amended by adding at
the end the following new section:
404I.Requiring a
Federal commitment to Alzheimer's disease research
(a)Definition of
Alzheimer’sIn this section, the term Alzheimer’s
means Alzheimer’s disease and related dementias.
(b)The
purpose of this section is to develop and execute a scientific research plan to
accelerate breakthroughs in treatments that prevent, cure, or slow the
progression of Alzheimer’s disease and reduce the financial burden of
Alzheimer’s on federally funded programs and families.
(c)Federal
commitment to Alzheimer’s disease researchFor the purpose
described in subsection (b), the Director of NIH shall coordinate and focus all
Alzheimer’s research activities of the National Institutes of Health. Such
activities shall include the following:
(1)The establishment
of a strategic Alzheimer’s research plan—
(A)to expedite
therapeutic outcomes for individuals with or at risk for Alzheimer’s, using
scientifically based strategic planning, for the conduct, coordination, and
support of the Alzheimer’s research portfolio within the Office of the Director
of NIH and across all Institutes and Centers of the National Institutes of
Health; and
(B)that, with respect
to such Alzheimer’s research—
(i)identifies research opportunities relating
to emerging science, knowledge gaps, and priorities of the National Institutes
of Health and provides recommendations for conducting such research;
(ii)identifies
opportunities to incorporate Alzheimer’s disease research in all relevant
aging, neuroscience, basic, clinical, and translational science initiatives
carried out by the National Institutes of Health, including initiatives that
are trans-National Institutes of Health, innovative, and nontraditional
initiatives;
(iii)improves
existing Alzheimer’s programs and initiatives at the National Institutes of
Health, including consolidation or expansion of program activities, if such
consolidation or expansion would improve program efficiencies and research
outcomes;
(iv)identifies gaps
in the supporting infrastructure and the coordination of the Alzheimer’s
research portfolio across the Institutes and Centers of the National Institutes
of Health, including the Alzheimer’s Disease Centers and Alzheimer’s Disease
Research Centers and all intramural and extramural Alzheimer’s-related
activities;
(v)identifies
public-private partnership opportunities to expedite the development of
mechanisms for early diagnosis and therapies and assistive technologies for
Alzheimer’s, including such therapies and technologies that demonstrate high
promise of substantially slowing, stopping, or reversing Alzheimer’s and
reducing the amounts that the Federal Government would spend on the future care
provided to individuals who develop Alzheimer’s;
(vi)identifies
opportunities to increase research and improve clinical outcomes for women and
minority populations at high-risk of developing Alzheimer’s; and
(vii)incorporates the
research priority actions identified by the Secretary and Advisory Council on
Alzheimer’s Research, Care, and Services in the report submitted by the
Secretary to Congress under section 2(g) of the National Alzheimer’s Project
Act (42 U.S.C. 11225(g)).
(2)The provision of
budget estimates, without regard to the probability that such amounts so
estimated will be appropriated, including—
(A)budget estimates
of the amounts required for the Institutes and Centers of the National
Institutes of Health to carry out all Alzheimer’s activities identified in the
strategic research plan developed under paragraph (1);
(B)budget estimates
of the amounts required to carry out all identified research priority actions
described in paragraph (1)(B)(vii); and
(C)identification of
funds in the existing budget of the National Institutes of Health to accomplish
Alzheimer’s activities identified by the strategic research plan developed
under paragraph (1).
(d)Public-Private
partnershipsIn providing for Alzheimer’s research activities,
the Director of NIH and the Directors of Institutes and Centers of the National
Institutes of Health conducting Alzheimer’s research, shall make available
contracts, grants, or cooperative agreements to facilitate partnerships between
public and private entities, which may include private or public research
institutions, institutions of higher education, medical centers, biotechnology
companies, pharmaceutical companies, disease advocacy organizations, patient
advocacy organizations, or academic research institutions. Such partnerships
may be established for, but not limited to, any of the following
purposes:
(1)To execute the
Alzheimer’s research plan established under subsection (c)(1).
(2)To support the
development of diagnostic technologies and protocols to encourage early
diagnosis of individuals at risk for Alzheimer’s and to permit the tracking of
the progression of Alzheimer’s in asymptomatic or symptomatic
populations.
(3)To develop and
diffuse data sharing practices that accelerate the advancement of knowledge and
understanding of the pathogenesis, progression, prevention, and treatment of
Alzheimer’s.
(e)
(1)The Director of
NIH shall annually report to the Secretary, the Advisory Council on Alzheimer’s
Research, Care, and Services, and the appropriate committees of jurisdiction in
Congress, on the strategic research plan and budget estimates under subsection
(c).
(2)The Director of
NIH shall, as part of its annual request for appropriations to the Office of
Management and Budget, submit to the Office of Management and Budget and the
Committees on Appropriations of the House of Representatives and the Senate a
report which—
(A)includes budget
estimates developed under subsection (c)(2);
(B)subject to
subparagraph (C), includes requests for amounts to be appropriated for all
Alzheimer’s activities identified in the strategic research plan under
subsection (c)(1);
(C)includes, in the
case a request is not made under subparagraph (C) for an activity identified in
such strategic research plan, a full justification explaining why such request
was not made; and
(D)analyzes the
progress made toward accelerating breakthroughs in treatments that would
prevent, cure, or slow the progression of Alzheimer’s and reducing spending on
Alzheimer’s care under federally funded programs and families and identifies
any remaining hurdles to accelerating such breakthroughs or reducing such
financial
burden.
.
(b)Alzheimer’s
disease centersSection 445(a)(1) of the Public Health Service
Act (42 U.S.C. 285e–2(a)(1)) is amended—
(1)by inserting
, translational
after basic
; and
(2)by inserting
and of outcome measures, and disease management
after
treatment methods
.