I 
112TH CONGRESS 
2D SESSION 
H. R. 3891 
To amend the Public Health Service Act to speed American innovation in 
research and drug development for the leading causes of death that 
are the most costly chronic conditions for our Nation, to save American 
families and the Federal and State governments money, and to help 
family caregivers. 
IN THE HOUSE OF REPRESENTATIVES 
FEBRUARY 2, 2012 
Mr. MARKEY (for himself and Mr. SMITH of New Jersey) introduced the 
following bill; which was referred to the Committee on Energy and Commerce 
A BILL 
To amend the Public Health Service Act to speed American 
innovation in research and drug development for the 
leading causes of death that are the most costly chronic 
conditions for our Nation, to save American families 
and the Federal and State governments money, and to 
help family caregivers. 
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 ‘‘Spending Reductions 
through Innovations in Therapies Agenda Act of 2012’’ 
or the ‘‘SPRINT Act’’. 
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SEC. 2. FINDINGS. 
Congress finds as follows: 
(1) Half of health care expenses in the United 
States are spent on 5 percent of the population. 
Many of the most expensive health conditions to 
treat are also the leading causes of death. 
(2) Improving a patient’s quality of life by de-
veloping innovative treatments that improve health 
outcomes and lead to a cure will improve produc-
tivity in the United States, reduce government 
spending, and enhance public health. 
(3) More than a quarter of all Americans—and 
2 out of 3 older Americans—have multiple chronic 
conditions, and treatment for these individuals ac-
counts for 66 percent of the health care budget of 
the United States. 
(4) Alzheimer’s disease and related dementias, 
for instance, have a disproportionate health and eco-
nomic impact on patients, particularly those suf-
fering from multiple chronic conditions. In 2004, 
Medicare payments per person for beneficiaries aged 
65 and older with Alzheimer’s disease and other de-
mentias were almost 3 times as high as average 
Medicare payments for other Medicare beneficiaries 
in the same age group. In addition, Alzheimer’s pa-
tients often depend on full-time at home or institu-
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tional care. Medicaid payments per person for Medi-
care beneficiaries aged 65 and older with Alz-
heimer’s disease and other dementias were more 
than 9 times as great as average Medicaid payments 
for other Medicare beneficiaries in the same age 
group. 
(5) The Medicare program under title XVIII of 
the Social Security Act (42 U.S.C. 1395 et seq.) and 
the Medicaid program under title XIX of the Social 
Security Act (42 U.S.C. 1396 et seq.) cover about 
70 percent of the total costs of caring for people 
with Alzheimer’s disease. In 2011, Medicare is ex-
pected to spend approximately $93,000,000,000 for 
the care of individuals with Alzheimer’s disease and 
other dementias, and this amount is projected to in-
crease to $627,000,000,000 in 2050. Medicaid costs 
are expected to increase nearly 400 percent, from 
$34,000,000,000 in 2011 to $178,000,000,000 in 
2050. 
(6) Researchers believe sustained and targeted 
investment in outcomes oriented research for the 
leading causes of death will improve health treat-
ments and make cures more obtainable. 
(7) The United States Government has, in the 
past, successfully addressed major research chal-
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lenges by committing resources in high-risk and 
high-reward basic and applied research. 
SEC. 3. SPRINT PROGRAM. 
Part A of title II of the Public Health Service Act 
(42 U.S.C. 202 et seq.) is amended by adding at the end 
the following: 
‘‘SEC. 230. SPRINT PROGRAM. 
‘‘(a) DEFINITIONS.—In this section: 
‘‘(1) ADVANCED
RESEARCH
AND
DEVELOP-
MENT.—The term ‘advanced research and develop-
ment’ means activities that predominantly are con-
ducted after basic research through early clinical de-
velopment of novel therapies, naturally occurring 
compounds, and repurposed or reformulated drugs, 
biological products, and devices in use to treat 
chronic conditions. 
‘‘(2) BIOLOGICAL
PRODUCT.—The term ‘bio-
logical product’ has the meaning given such term in 
section 351. 
‘‘(3) DEVICE; DRUG.—The terms ‘device’ and 
‘drug’ have the meanings given such terms in section 
201 of the Federal Food, Drug, and Cosmetic Act. 
‘‘(4) 
EARLY-STAGE
COMPANY.—The 
term 
‘early-stage company’ means a business enterprise 
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with a limited operating history, such as a start-up 
enterprise. 
‘‘(5) FEDERAL HEALTH CARE PROGRAM.—The 
term ‘Federal health care program’ has the meaning 
given such term in section 1128B(f) of the Social 
Security Act. 
‘‘(6) GROWTH
COMPANY.—The term ‘growth 
company’ means a business enterprise that grows at 
a greater rate than the United States economy as a 
whole and that usually directs a relatively high pro-
portion of income back into the business. 
‘‘(7) HIGH-COST
CHRONIC
CONDITION.—The 
term ‘high-cost chronic condition’ means a condition 
as determined by the Secretary under subsection 
(c)(1). 
‘‘(8) THERAPY.—The term ‘therapy’ means any 
drug, device, biological product, or diagnostic identi-
fied by the Secretary to treat, prevent, diagnose, 
delay-onset, cure, or aid recovery of a high-cost 
chronic condition. 
‘‘(b) ESTABLISHMENT OF PROGRAM.—The Secretary 
shall establish the Spending Reductions through Innova-
tions in Therapies Program (referred to in this section as 
the ‘SPRINT Program’) to support development of thera-
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pies to reduce spending by Federal health care programs 
for high-cost chronic conditions. 
‘‘(c) HIGH-COST CHRONIC CONDITIONS.— 
‘‘(1) IN GENERAL.—The Secretary shall deter-
mine the high-cost chronic conditions that shall be 
the focus of the SPRINT Program. In making such 
determination, the Secretary shall select chronic con-
ditions, from the top 10 leading causes of death des-
ignated by the Centers for Disease Control and Pre-
vention, that have— 
‘‘(A) the highest current and projected cost 
to Federal health care programs and high long- 
term care costs; 
‘‘(B) a likelihood of reducing the day-to- 
day functioning of an individual and impairing 
the ability of the individual to carry out activi-
ties of daily living, which can result in the indi-
vidual becoming dependent on caregivers; 
‘‘(C) a death rate that has increased and 
is projected to increase significantly in future 
years; and 
‘‘(D) a lack of existing therapies to pre-
vent, control, or cure the condition or delay cog-
nitive decline, if applicable. 
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‘‘(2) 
ALLOCATION.—In 
carrying 
out 
the 
SPRINT Program, the Secretary shall allocate fund-
ing towards the chronic conditions as determined in 
paragraph (1). 
‘‘(d) GOALS.—The SPRINT Program shall be guided 
by national plans and strategies, as appropriate, and 
shall— 
‘‘(1) accelerate advanced research and develop-
ment of therapies for high-cost chronic conditions; 
and 
‘‘(2) encourage innovation in technologies that 
may assist advanced research and development to re-
duce the time and cost of therapy development. 
‘‘(e) DUTIES.—The Secretary shall carry out the fol-
lowing duties under this section: 
‘‘(1) Convene meetings and working groups 
with representatives from relevant industries, aca-
demia, other Federal agencies, States, patients, pa-
tient and consumer advocacy organizations, inter-
national agencies (as appropriate), and other inter-
ested persons as the Secretary deems necessary. 
‘‘(2) Ensure that the activities described in 
paragraph (1) are coordinated among agencies with-
in the Department of Health and Human Services. 
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‘‘(3) Partner with a nonprofit strategic invest-
ment entity or entities that will advise the Depart-
ment of Health and Human Services regarding, and 
may make on behalf of such Department, invest-
ments in public entities, nonprofit entities, early- 
stage companies, or growth companies with expertise 
in advanced research and development of therapies 
for high-cost chronic conditions that can dem-
onstrate a reasonable likelihood of reducing net 
spending under the Medicare program under title 
XVIII of the Social Security Act and the Medicaid 
program under title XIX of such Act within 10 
years after the date of enactment of the Spending 
Reductions through Innovations in Therapies Agen-
da Act of 2012. 
‘‘(4) Award contracts, grants, cooperative 
agreements, or enter into other transactions, such as 
prize payments, to accelerate advanced research and 
development of therapies that have the potential to 
prevent, diagnose, delay-onset, cure, aid recovery, or 
improve health outcomes for high-cost chronic condi-
tions, through the SPRINT Award Program under 
subsection (f). 
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‘‘(5) Reduce the time and cost barriers between 
laboratory discoveries and clinical trials for therapies 
used to treat high-cost chronic conditions. 
‘‘(6) Facilitate innovative and expedited review 
by the Food and Drug Administration of the thera-
pies developed under subsection (f), which may in-
clude— 
‘‘(A) facilitating regular and ongoing com-
munication between the sponsors of such drugs, 
devices, diagnostics, and biological products and 
the Food and Drug Administration regarding 
the status of activities related to such drugs, 
devices, diagnostics, and biological products; 
‘‘(B) ensuring that such activities are co-
ordinated with the approval requirements of the 
Food and Drug Administration, with the goal 
of expediting the development and approval of 
therapies; and 
‘‘(C) developing regulatory science, proc-
esses, and mechanisms to provide clear, effi-
cient pathways for developing and manufac-
turing therapies for high-cost chronic condi-
tions. 
‘‘(f) SPRINT AWARD PROGRAM.— 
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