II 

112TH CONGRESS 

2D SESSION S. 2069 

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 SENATE OF THE UNITED STATES 

FEBRUARY 2, 2012 

Ms. MIKULSKI (for herself, Mr. KERRY, Ms. COLLINS, Mr. BLUMENTHAL, and 

Mr. WARNER) 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 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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Spending Reductions 

3 through Innovations in Therapies Agenda Act of 2012’’ 

4 or the ‘‘SPRINT Act’’. 

5 SEC. 2. FINDINGS. 

6 Congress finds as follows: 

7 (1) Half of health care expenses in the United 

8 States are spent on 5 percent of the population. 

9 Many of the most expensive health conditions to 

10 treat are also the leading causes of death. 

11 (2) Improving a patient’s quality of life by de12 veloping innovative treatments that improve health 

13 outcomes and lead to a cure will improve produc14 tivity in the United States, reduce government 

15 spending, and enhance public health. 

16 (3) More than a quarter of all Americans—and 

17 2 out of 3 older Americans—have multiple chronic 

18 conditions, and treatment for these individuals ac19 counts for 66 percent of the health care budget of 

20 the United States. 

21 (4) Alzheimer’s disease and related dementias, 

22 for instance, have a disproportionate health and eco23 nomic impact on patients, particularly those suf24 fering from multiple chronic conditions. In 2004, 

25 Medicare payments per person for beneficiaries aged 

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1 mentias were almost 3 times as high as average 

2 Medicare payments for other Medicare beneficiaries 

3 in the same age group. In addition, Alzheimer’s pa4 tients often depend on full-time at home or institu5 tional care. Medicaid payments per person for Medi6 care beneficiaries aged 65 and older with Alz7 heimer’s disease and other dementias were more 

8 than 9 times as great as average Medicaid payments 

9 for other Medicare beneficiaries in the same age 

10 group. 

11 (5) The Medicare program under title XVIII of 

12 the Social Security Act (42 U.S.C. 1395 et seq.) and 

13 the Medicaid program under title XIX of the Social 

14 Security Act (42 U.S.C. 1396 et seq.) cover about 

15 70 percent of the total costs of caring for people 

16 with Alzheimer’s disease. In 2011, Medicare is ex17 pected to spend approximately $93,000,000,000 for 

18 the care of individuals with Alzheimer’s disease and 

19 other dementias, and this amount is projected to in20 crease to $627,000,000,000 in 2050. Medicaid costs 

21 are expected to increase nearly 400 percent, from 

22 $34,000,000,000 in 2011 to $178,000,000,000 in 

23 2050. 

24 (6) Researchers believe sustained and targeted 

25 investment in outcomes oriented research for the 


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1 leading causes of death will improve health treat2 ments and make cures more obtainable. 

3 (7) The United States Government has, in the 

4 past, successfully addressed major research chal5 lenges by committing resources in high-risk and 

6 high-reward basic and applied research. 

7 SEC. 3. SPRINT PROGRAM. 

8 Part A of title II of the Public Health Service Act 

9 (42 U.S.C. 202 et seq.) is amended by adding at the end 

10 the following: 

11 ‘‘SEC. 230. SPRINT PROGRAM. 

12 ‘‘(a) DEFINITIONS.—In this section: 

13 ‘‘(1) ADVANCED RESEARCH AND DEVELOP14 MENT.—The term ‘advanced research and develop15 ment’ means activities that predominantly are con16 ducted after basic research through early clinical de17 velopment of novel therapies, naturally occurring 

18 compounds, and repurposed or reformulated drugs, 

19 biological products, and devices in use to treat 

20 chronic conditions. 

21 ‘‘(2) BIOLOGICAL PRODUCT.—The term ‘bio22 logical product’ has the meaning given such term in 

23 section 351. 


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1 ‘‘(3) DEVICE; DRUG.—The terms ‘device’ and 

2 ‘drug’ have the meanings given such terms in section 

3 201 of the Federal Food, Drug, and Cosmetic Act. 

4 ‘‘(4) EARLY-STAGE COMPANY.—The term 

5 ‘early-stage company’ means a business enterprise 

6 with a limited operating history, such as a start-up 

7 enterprise. 

8 ‘‘(5) FEDERAL HEALTH CARE PROGRAM.—The 

9 term ‘Federal health care program’ has the meaning 

10 given such term in section 1128B(f) of the Social 

11 Security Act. 

12 ‘‘(6) GROWTH COMPANY.—The term ‘growth 

13 company’ means a business enterprise that grows at 

14 a greater rate than the United States economy as a 

15 whole and that usually directs a relatively high pro16 portion of income back into the business. 

17 ‘‘(7) HIGH-COST CHRONIC CONDITION.—The 

18 term ‘high-cost chronic condition’ means a condition 

19 as determined by the Secretary under subsection 

20 (c)(1). 

21 ‘‘(8) THERAPY.—The term ‘therapy’ means any 

22 drug, device, biological product, or diagnostic identi23 fied by the Secretary to treat, prevent, diagnose, 

24 delay-onset, cure, or aid recovery of a high-cost 

25 chronic condition. 


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1 ‘‘(b) ESTABLISHMENT OF PROGRAM.—The Secretary 

2 shall establish the Spending Reductions through Innova3 tions in Therapies Program (referred to in this section as 

4 the ‘SPRINT Program’) to support development of thera5 pies to reduce spending by Federal health care programs 

6 for high-cost chronic conditions. 

7 ‘‘(c) HIGH-COST CHRONIC CONDITIONS.— 

8 ‘‘(1) IN GENERAL.—The Secretary shall deter9 mine the high-cost chronic conditions that shall be 

10 the focus of the SPRINT Program. In making such 

11 determination, the Secretary shall select chronic con12 ditions, from the top 10 leading causes of death des13 ignated by the Centers for Disease Control and Pre14 vention, that have— 

15 ‘‘(A) the highest current and projected cost 

16 to Federal health care programs and high long17 term care costs; 

18 ‘‘(B) a likelihood of reducing the day-to19 day functioning of an individual and impairing 

20 the ability of the individual to carry out activi21 ties of daily living, which can result in the indi22 vidual becoming dependent on caregivers; 

23 ‘‘(C) a death rate that has increased and 

24 is projected to increase significantly in future 

25 years; and 


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1 ‘‘(D) a lack of existing therapies to pre2 vent, control, or cure the condition or delay cog3 nitive decline, if applicable. 

4 ‘‘(2) ALLOCATION.—In carrying out the 

5 SPRINT Program, the Secretary shall allocate fund6 ing towards the chronic conditions as determined in 

7 paragraph (1). 

8 ‘‘(d) GOALS.—The SPRINT Program shall be guided 

9 by national plans and strategies, as appropriate, and 

10 shall— 

11 ‘‘(1) accelerate advanced research and develop12 ment of therapies for high-cost chronic conditions; 

13 and 

14 ‘‘(2) encourage innovation in technologies that 

15 may assist advanced research and development to re16 duce the time and cost of therapy development. 

17 ‘‘(e) DUTIES.—The Secretary shall carry out the fol18 lowing duties under this section: 

19 ‘‘(1) Convene meetings and working groups 

20 with representatives from relevant industries, aca21 demia, other Federal agencies, States, patients, pa22 tient and consumer advocacy organizations, inter23 national agencies (as appropriate), and other inter24 ested persons as the Secretary deems necessary. 


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1 ‘‘(2) Ensure that the activities described in 

2 paragraph (1) are coordinated among agencies with3 in the Department of Health and Human Services. 

4 ‘‘(3) Partner with a nonprofit strategic invest5 ment entity or entities that will advise the Depart6 ment of Health and Human Services regarding, and 

7 may make on behalf of such Department, invest8 ments in public entities, nonprofit entities, early9 stage companies, or growth companies with expertise 

10 in advanced research and development of therapies 

11 for high-cost chronic conditions that can dem12 onstrate a reasonable likelihood of reducing net 

13 spending under the Medicare program under title 

14 XVIII of the Social Security Act and the Medicaid 

15 program under title XIX of such Act within 10 

16 years after the date of enactment of the Spending 

17 Reductions through Innovations in Therapies Agen18 da Act of 2012. 

19 ‘‘(4) Award contracts, grants, cooperative 

20 agreements, or enter into other transactions, such as 

21 prize payments, to accelerate advanced research and 

22 development of therapies that have the potential to 

23 prevent, diagnose, delay-onset, cure, aid recovery, or 

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1 tions, through the SPRINT Award Program under 

2 subsection (f). 

3 ‘‘(5) Reduce the time and cost barriers between 

4 laboratory discoveries and clinical trials for therapies 

5 used to treat high-cost chronic conditions. 

6 ‘‘(6) Facilitate innovative and expedited review 

7 by the Food and Drug Administration of the thera8 pies developed under subsection (f), which may in9 clude— 

10 ‘‘(A) facilitating regular and ongoing com11 munication between the sponsors of such drugs, 

12 devices, diagnostics, and biological products and 

13 the Food and Drug Administration regarding 

14 the status of activities related to such drugs, 

15 devices, diagnostics, and biological products; 

16 ‘‘(B) ensuring that such activities are co17 ordinated with the approval requirements of the 

18 Food and Drug Administration, with the goal 

19 of expediting the development and approval of 

20 therapies; and 

21 ‘‘(C) developing regulatory science, proc22 esses, and mechanisms to provide clear, effi23 cient pathways for developing and manufac24 turing therapies for high-cost chronic condi25 tions. 


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1 ‘‘(f) SPRINT AWARD PROGRAM.— 

2 ‘‘(1) IN GENERAL.—There is established a 

3 SPRINT Award Program, under which the Sec4 retary may, in consultation or partnership with a 

5 nonprofit strategic investment entity, award con6 tracts, grants, cooperative agreements, or enter into 

7 other transactions, such as prize payments, to sup8 port advanced research and the development of 

9 therapies, in order to carry out paragraphs (4) and 

10 (6) of subsection (e). Awards granted through the 

11 SPRINT Award Program shall be funded by the 

12 SPRINT Program. 

13 ‘‘(2) ELIGIBILITY; APPLICATION.— 

14 ‘‘(A) ELIGIBILITY.—To be eligible to re15 ceive an award under this section, an entity 

16 shall be a public, nonprofit, early stage com17 pany, or growth company, which may include a 

18 private or public research institution, an insti19 tution of higher education, a medical center, a 

20 biotechnology company, a pharmaceutical com21 pany, a medical device company, an academic 

22 research institution, or other organization spe23 cializing in advanced research and development, 

24 and shall submit an application to the Secretary 

25 as described in subparagraph (B). 


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1 ‘‘(B) APPLICATION.—An entity desiring an 

2 award under this subsection shall submit to the 

3 Secretary an application at such time, in such 

4 manner, and containing such information as the 

5 Secretary may require, such as— 

6 ‘‘(i) a detailed description of the 

7 project for which the entity seeks an 

8 award; 

9 ‘‘(ii) a timetable for carrying out such 

10 project; 

11 ‘‘(iii) an assurance that the entity will 

12 submit interim reports and a final report 

13 at the conclusion of the award period, as 

14 determined appropriate by the Secretary 

15 under paragraph (3); 

16 ‘‘(iv) a description of how the project 

17 will lead to the development of therapies 

18 aimed at preventing, curing, reversing, or 

19 slowing the progression of an underlying 

20 chronic condition; and 

21 ‘‘(v) a description of how the project 

22 will support efforts to reduce long-term 

23 Federal spending on health care. 

24 ‘‘(3) AWARDEE REPORTING REQUIREMENTS.— 

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1 section shall submit reports to the Secretary which 

2 may include— 

3 ‘‘(A) interim reports describing the 

4 progress in carrying out the project and compli5 ance with all conditions of receipt of such 

6 award; 

7 ‘‘(B) a final report at the conclusion of the 

8 award period describing— 

9 ‘‘(i) the outcomes of the project, in10 cluding whether the entity achieved the 

11 goals set forth in the application; 

12 ‘‘(ii) the protocols the entity followed 

13 to carry out the research and comply with 

14 the research and ethical standards of the 

15 National Institutes of Health, if applicable; 

16 and 

17 ‘‘(iii) the standards and regulatory re18 quirements of the Food and Drug Admin19 istration at all stages of development, man20 ufacturing, review, approval, and safety 

21 surveillance, if applicable; and 

22 ‘‘(C) such additional information required 

23 by the Secretary. 

24 ‘‘(4) TERMINATION OF FUNDING.—The Sec25 retary may modify or terminate a contract, grant, 


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1 cooperative agreement, other transaction, or prize to 

2 an awardee that does not meet milestones that are 

3 conditions of the contract, grant, cooperative agree4 ment, other transaction, or prize. 

5 ‘‘(5) CONSULTATION WITH NONPROFIT STRA6 TEGIC INVESTMENT ENTITY.—In making awards 

7 under this subsection, the Secretary may consult or 

8 partner with a nonprofit strategic investment entity 

9 or entities that— 

10 ‘‘(A) operate independently of the Depart11 ment of Health and Human Services and con12 sist of experts in neurology, biomedical re13 search, drug and medical technology innovation 

14 and discovery, economics, and venture financ15 ing; and 

16 ‘‘(B) have a record of— 

17 ‘‘(i) promoting the development of 

18 therapies; and 

19 ‘‘(ii) supporting novel technologies 

20 that have the potential to improve the de21 velopment of therapies. 

22 ‘‘(6) MATCHING FUNDS.— 

23 ‘‘(A) IN GENERAL.—The Secretary may 

24 not make an award under this section unless 

25 the recipient involved agrees to make available 


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1 non-Federal contributions, in cash or in-kind, 

2 toward the costs of the project in an amount 

3 equal to not less than $2 for each $1 of Federal 

4 funds provided in the award. Such contributions 

5 may be made directly or through donations 

6 from public or private entities. Amounts pro7 vided by the Federal Government, or services 

8 assisted or subsidized to any significant extent 

9 by the Federal Government, may not be in10 cluded in determining the amount of such con11 tributions. 

12 ‘‘(B) EXCEPTION.—The Secretary may 

13 waive or modify the matching requirement 

14 under subparagraph (A) on a case-by-case basis 

15 for each award if the Secretary determines that 

16 the goals and objectives of the SPRINT Award 

17 Program cannot adequately be carried out un18 less such requirement is waived. 

19 ‘‘(g) NON-DUPLICATION OF EFFORTS.—The Sec20 retary shall ensure that the activities under this section 

21 complement and extend other efforts of the Department 

22 of Health and Human Services. 

23 ‘‘(h) GIFTS IN SUPPORT OF THE SPRINT AWARD

24 PROGRAM.—The Secretary may accept on behalf of the 

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1 tionally to the SPRINT Award Program under subsection 

2 (f) for the benefit of the Award Program or any activity 

3 financed through such Award Program. 

4 ‘‘(i) AUTHORIZATION OF APPROPRIATIONS.—To 

5 carry out this section, there are authorized to be appro6 priated $50,000,000 for fiscal year 2013, and such sums 

7 as may be necessary for each of fiscal years 2014 through 

8 2017. Funds appropriated under this section shall be 

9 available until expended.’’. 

10 SEC. 4. EVALUATION AND REPORT. 

11 (a) EVALUATION.—The Secretary of Health and 

12 Human Services shall evaluate the projects funded under 

13 section 230 of the Public Health Service Act (as added 

14 by section 3) as necessary and shall make publicly avail15 able and disseminate the results of such evaluations on 

16 as wide a basis as practicable. 

17 (b) REPORTS.—Not later than 2 years after the date 

18 of enactment of this Act, and annually thereafter, the Sec19 retary of Health and Human Services shall submit to Con20 gress a report that— 

21 (1) describes the specific projects supported 

22 under section 230 of the Public Health Service Act 

23 (as added by section 3) and progress towards meet24 ing science-based metrics; 


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1 (2) provides recommendations for Congress to 

2 improve the effectiveness of the programs under 

3 such section 230; 

4 (3) explains why the Secretary waived or modi5 fied matching funds requirements for an award 

6 under subsection (f) of such section 230, if applica7 ble; and 

8 (4) describes how advanced research and devel9 opment supported through the SPRINT Program 

10 under such section 230 is directed towards reducing 

11 Federal spending on high-cost chronic conditions (as 

12 defined in such section). 

Æ 


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