II 

118TH CONGRESS 

2D SESSION S. 5637 

To establish the ‘‘Biomedical Innovation Fund’’, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

DECEMBER 19 (legislative day, DECEMBER 16), 2024 

Ms. WARREN (for herself, Ms. BALDWIN, Mr. BLUMENTHAL, Mr. BOOKER, 

Ms. DUCKWORTH, Mr. KAINE, Mr. MARKEY, Mr. PADILLA, and Mr. 

SANDERS) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To establish the ‘‘Biomedical Innovation Fund’’, and for 

other purposes. 

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

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘National Biomedical 

5 Research Act’’. 

6 SEC. 2. DEFINITIONS. 

7 In this Act: 

8 (1) DISCRETIONARY APPROPRIATIONS.—The 

9 term ‘‘discretionary appropriations’’ has the mean10 ing given such term in section 250 of the Balanced 


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1 Budget and Emergency Deficit Control Act of 1985 

2 (2 U.S.C. 900). 

3 (2) FUND.—The term ‘‘Fund’’ means the Bio4 medical Innovation Fund established under section 

5 3(a). 

6 (3) MINIMUM AMOUNT.—The term ‘‘minimum 

7 amount’’, with respect to the applicable entity and 

8 for an applicable fiscal year— 

9 (A) means the amount equal to the great10 est amount of discretionary appropriations ap11 propriated to such entity for a fiscal year dur12 ing the period beginning with fiscal year 2025 

13 and ending with the fiscal year before the appli14 cable fiscal year; and 

15 (B) does not include— 

16 (i) any reduction in an appropriation 

17 under a sequestration order issued under 

18 the Balanced Budget and Emergency Def19 icit Control Act of 1985 (2 U.S.C. 900 et 

20 seq.); 

21 (ii) amounts collected by the Secretary 

22 of Health and Human Services under sub23 chapter C of chapter VII of the Federal 

24 Food, Drug, and Cosmetic Act (21 U.S.C. 

25 379f et seq.); 


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1 (iii) amounts distributed under section 

2 3(c)(2); or 

3 (iv) amounts appropriated under a 

4 supplemental or emergency appropriation 

5 Act. 

6 SEC. 3. BIOMEDICAL INNOVATION FUND. 

7 (a) ESTABLISHMENT.—There is established in the 

8 Treasury of the United States a fund to be known as the 

9 ‘‘Biomedical Innovation Fund’’, to be administered by the 

10 Secretary of the Treasury, consisting of— 

11 (1) the amounts transferred to the Fund under 

12 subsection (b); and 

13 (2) any interest earned on the investment of 

14 such amounts under subsection (d). 

15 (b) COMMITMENT TO BIOMEDICAL INNOVATION.— 

16 Not later than September 1, 2025, and every year there17 after through 2034, the Secretary of the Treasury shall 

18 transfer $10,000,000,000 from the general fund of the 

19 Treasury into the Fund. 

20 (c) DISTRIBUTION OF AMOUNTS.— 

21 (1) CALCULATION OF ANNUAL FUND

22 AMOUNT.—For fiscal year 2025 and each fiscal year 

23 thereafter, not later than 15 days after the latter of 

24 the date of enactment of an appropriation Act mak25 ing full fiscal year appropriations for such fiscal year 


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1 to the entity described in paragraph (2)(A) and the 

2 date of enactment of an appropriation Act making 

3 full fiscal year appropriations for such fiscal year to 

4 the entity described in paragraph (2)(B), the Sec5 retary of the Treasury shall calculate the total 

6 amount in the Fund that is available to be distrib7 uted for such fiscal year in accordance with para8 graph (2). 

9 (2) DISTRIBUTION OF AMOUNTS IN THE

10 FUND.—Subject to the other provisions of this sec11 tion, not later than 30 days after a calculation is 

12 made under paragraph (1) for a fiscal year, the Sec13 retary of the Treasury shall distribute the amount 

14 available to be distributed for such fiscal year to 

15 each of the following entities: 

16 (A) The National Institutes of Health. 

17 (B) The Food and Drug Administration. 

18 (3) RATIO.—The amount that the Secretary of 

19 the Treasury distributes to an entity described in 

20 subparagraph (A) or (B) of paragraph (2) during a 

21 fiscal year shall bear the same relation to the total 

22 amount calculated under paragraph (1) for such fis23 cal year as the amount of discretionary appropria24 tions appropriated to such entity for such fiscal year 

25 bears to the total amount of discretionary appropriaVerDate Sep 11 2014 23:29 Jan 27, 2025 Jkt 059200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S5637.IS S5637

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1 tions appropriated to the entities described in sub2 paragraphs (A) and (B) of paragraph (2) for such 

3 fiscal year. 

4 (4) REQUIREMENTS FOR DISTRIBUTION.— 

5 (A) IN GENERAL.—The Secretary of the 

6 Treasury shall distribute amounts in the Fund 

7 during a fiscal year in accordance with para8 graph (2) only if— 

9 (i) the discretionary appropriations 

10 for the entity described in paragraph 

11 (2)(A) is greater than the applicable min12 imum amount for such entity for such fis13 cal year; and 

14 (ii) the discretionary appropriations 

15 for the entity described in paragraph 

16 (2)(B) is greater than the applicable min17 imum amount for such entity for such fis18 cal year. 

19 (B) SUBSEQUENT LAW IMPACTING DIS20 TRIBUTION.— 

21 (i) BELOW MINIMUM AMOUNT.—If a 

22 law is enacted or becomes effective after 

23 amounts are appropriated to each entity 

24 described in subparagraph (A) or (B) of 

25 paragraph (2) for a fiscal year and such 


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1 law decreases the amount appropriated to 

2 either such entity for such fiscal year from 

3 an amount that is greater than the appli4 cable minimum amount to an amount that 

5 is less than or equal to such minimum 

6 amount, any amounts that were distributed 

7 by the Secretary of the Treasury under 

8 paragraph (2) shall remain so distributed 

9 for such fiscal year. 

10 (ii) ABOVE MINIMUM AMOUNT.—If a 

11 law is enacted or becomes effective after 

12 amounts are appropriated for a fiscal year 

13 to each entity described in subparagraph 

14 (A) or (B) of paragraph (2) and such law 

15 increases the amount appropriated to ei16 ther such entity for such fiscal year from 

17 an amount that is less than or equal to the 

18 minimum amount to an amount that is 

19 greater than such minimum amount, and 

20 all other conditions for distribution under 

21 this paragraph are met for the fiscal year, 

22 the amounts in the Fund shall be distrib23 uted by the Secretary of the Treasury 

24 under paragraph (2) for such fiscal year. 


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1 (C) FAILURE TO MEET REQUIREMENTS.— 

2 If the requirements under subparagraph (A) 

3 are not met during a fiscal year, amounts in the 

4 Fund shall— 

5 (i) not be distributed under paragraph 

6 (2); and 

7 (ii) remain in the Fund, earning inter8 est in accordance with subsection (d), until 

9 such requirements, or the conditions under 

10 subsection (f), are met during a fiscal year. 

11 (5) ALLOCATIONS.— 

12 (A) IN GENERAL.—If amounts are distrib13 uted under paragraph (2) during a fiscal year, 

14 of the amounts so distributed— 

15 (i) 20 percent shall become available 

16 for obligation during the fiscal year during 

17 which the distribution is made; 

18 (ii) 20 percent shall become available 

19 for obligation during the first fiscal year 

20 after the fiscal year during which the dis21 tribution is made; 

22 (iii) 20 percent shall become available 

23 for obligation during the second fiscal year 

24 after the fiscal year during which the dis25 tribution is made; 


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1 (iv) 20 percent shall become available 

2 for obligation during the third fiscal year 

3 after the fiscal year during which the dis4 tribution is made; and 

5 (v) 20 percent shall become available 

6 for obligation during the fourth fiscal year 

7 after the fiscal year during which the dis8 tribution is made. 

9 (B) AVAILABILITY OF AMOUNTS.—Any 

10 amounts distributed under paragraph (2) shall 

11 remain available until expended. 

12 (6) AUTHORIZED USES.—Amounts distributed 

13 under paragraph (2) from the Fund shall be used to 

14 support— 

15 (A) basic research on the underlying basis 

16 for disease to better address disease prevention, 

17 diagnosis, and treatment; 

18 (B) research that fosters disruptive innova19 tion, such as— 

20 (i) research on diseases or conditions 

21 for which treatments exist but are inad22 equate, including chronic and acute pain; 

23 (ii) research on diseases or conditions 

24 for which there are unmet medical needs; 


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1 (iii) research on diseases or conditions 

2 for which treatments exist but the side ef3 fect profiles of such treatments limit thera4 peutic potential; 

5 (iv) research on new approaches to 

6 treatment of diseases using drugs, devices, 

7 or therapies that, at the time of distribu8 tion under paragraph (2), are not used or 

9 are underused; or 

10 (v) research conducted by experienced 

11 investigators with a history of productive 

12 and innovative research, such that funding 

13 provides long-term stability for such re14 search and allows such investigators to 

15 take greater risks, be more adventurous in 

16 their lines of inquiry, or take the time to 

17 develop groundbreaking techniques; 

18 (C) research related to diseases that 

19 disproportionally account for Federal health 

20 care spending, including spending under the 

21 Medicare program under title XVIII of the So22 cial Security Act (42 U.S.C. 1395 et seq.), the 

23 Medicaid program under title XIX of the Social 

24 Security Act (42 U.S.C. 1396 et seq.), the 

25 State Children’s Health Insurance Program 


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1 under title XXI of the Social Security Act (42 

2 U.S.C. 1397aa et seq.), the TRICARE program 

3 under chapter 55 of title 10, United States 

4 Code, and hospital care and medical services 

5 furnished by the Department of Veterans Af6 fairs under chapters 17 and 18 of title 38, 

7 United States Code, such as research relating 

8 to— 

9 (i) diseases that disproportionally im10 pact older individuals; 

11 (ii) degenerative diseases; or 

12 (iii) chronic conditions; 

13 (D) early career scientists, such as 

14 through— 

15 (i) awarding research project grants 

16 that support discrete, specified, and cir17 cumscribed projects to be performed by the 

18 investigator in an area representing the 

19 specific interests and competencies of such 

20 investigator, to investigators— 

21 (I) who are within 10 years of 

22 completing a terminal research de23 gree; or 

24 (II) who are within 10 years of 

25 completing a medical residency; 


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1 (ii) awarding grants that support ca2 reer development experiences that lead to 

3 earlier research independence; and 

4 (iii) awarding grants that support in5 novative training programs that, in addi6 tion to scientific training, provide addi7 tional training to enhance employment op8 portunities, including training in manage9 ment and business, to— 

10 (I) graduate students; 

11 (II) post-doctoral fellows; 

12 (III) individuals within 10 years 

13 of completing a terminal research de14 gree; or 

15 (IV) individuals within 10 years 

16 of completing a medical residency; 

17 (E) research efforts that increase the po18 tential for breakthrough discoveries across a di19 verse set of investigators, research groups, and 

20 institutions, which may include supporting— 

21 (i) investigators that are members of 

22 traditionally underrepresented racial and 

23 ethnic groups; 

24 (ii) research groups that are diverse 

25 in size; or 


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1 (iii) institutions that increase the geo2 graphic diversity of funding provided by 

3 the National Institutes of Health; 

4 (F) the development, review, and post-mar5 ket surveillance of medical products, as deter6 mined by the Secretary of Health and Human 

7 Services; and 

8 (G) research to carry out the goals of the 

9 strategy and implementation plan for advancing 

10 science to promote public health and advance 

11 innovation in regulatory decision making devel12 oped under section 1124 of the Food and Drug 

13 Administration Safety and Innovation Act (21 

14 U.S.C. 393 note), and other such research ac15 tivities to improve the predictability, consist16 ency, and efficiency of science-based decision 

17 making concerning medical products, including 

18 facilitating the timely introduction of new tech19 nologies and methodologies in a safe and effec20 tive manner as determined by the Secretary of 

21 Health and Human Services. 

22 (7) INTERAGENCY TRANSFERS.—Amounts dis23 tributed from the Fund under paragraph (2) shall 

24 be available through interagency transfer to support 

25 research conducted jointly by the National Institutes 


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1 of Health or the Food and Dug Administration and 

2 other Federal agencies. 

3 (d) INVESTMENT OF FUND BALANCES.— 

4 (1) IN GENERAL.—Amounts in the Fund shall 

5 be invested in interest-bearing obligations of the 

6 United States in the form of special-issue securities, 

7 paying interest to the Fund at rates applicable to 

8 such securities, and such amounts shall be redeem9 able by the Secretary of the Treasury, for purposes 

10 of distribution under subsection (c)(2). 

11 (2) DISTRIBUTED AMOUNTS.—Any amounts 

12 that have been distributed during a fiscal year under 

13 subsection (c)(2) shall not be considered amounts in 

14 the Fund for the purpose of this subsection. 

15 (e) PROHIBITION.—Amounts in the Fund may not be 

16 made available for any use other than a use described in 

17 subsection (c)(6). 

18 (f) TRANSFER TO REDUCE THE DEFICIT.— 

19 (1) IN GENERAL.—Subject to paragraph (2), if 

20 amounts in the Fund are not distributed by the Sec21 retary of the Treasury under subsection (c)(2) for 

22 any 3 consecutive fiscal years, the Secretary of the 

23 Treasury shall transfer all amounts in the Fund to 

24 the general fund of the Treasury for purposes of re25 ducing the Federal deficit. 


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1 (2) YEAR OF DISTRIBUTION.—For purposes of 

2 paragraph (1), 3 fiscal years shall not be deemed to 

3 be consecutive if during any of such years the Sec4 retary of the Treasury has transferred all amounts 

5 in the Fund into the general fund of the Treasury 

6 in accordance with such paragraph. 

7 (g) REPORTS.— 

8 (1) SECRETARY REPORTS.— 

9 (A) IN GENERAL.—Not later than Novem10 ber 30, 2026, and every year thereafter through 

11 2035 the Secretary of the Treasury shall sub12 mit to the Committee on Appropriations of the 

13 Senate, the Committee on Appropriations of the 

14 House of Representatives, and the authorizing 

15 committees a report on the operation of the 

16 Fund during the fiscal year. 

17 (B) CONTENTS.—Each report shall in18 clude, for the fiscal year covered by the report, 

19 each of the following: 

20 (i) A statement of the amounts, and 

21 the source of such amounts, transferred to, 

22 credited to, and deposited into the Fund. 

23 (ii) A description of any amounts dis24 tributed under subsection (c)(2) during the 

25 fiscal year. 


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1 (iii) A statement of the balance re2 maining in the Fund at the end of the fis3 cal year. 

4 (iv) A statement of the amounts in5 vested in interest-bearing obligations of the 

6 United States, and the interest earned on 

7 such investments. 

8 (2) AGENCY REPORTS.— 

9 (A) ANNUAL REPORTING.—For each fiscal 

10 year in which amounts are available for obliga11 tion under subsection (c)(5), the Director of the 

12 National Institutes of Health and the Commis13 sioner of Food and Drugs shall report on the 

14 use of such amounts in the annual budget sub15 mission for such fiscal year of the National In16 stitutes of Health and the Food and Drug Ad17 ministration, respectively. 

18 (B) NIH REPORTS.—Section 403(a) of the 

19 Public Health Service Act (42 U.S.C. 283(a)) is 

20 amended by adding at the end the following: 

21 ‘‘(7) A summary of the use of funds distributed 

22 under section 3(c)(2)(A) of the National Biomedical 

23 Research Act to the National Institutes of Health 

24 from the Biomedical Innovation Fund, established 

25 under section 3(a) of such Act, including the 


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1 amounts allocated to each national research institute 

2 and national center, the projects funded by such 

3 amounts, the accomplishments that have resulted 

4 from such amounts, and the goals for future use of 

5 such amounts.’’. 

6 (C) FDA REPORTS.—For each 3-year pe7 riod beginning on the date of enactment of this 

8 Act, if amounts are distributed under sub9 section (c)(2)(B) to the Food and Drug Admin10 istration for any fiscal year during such 3-year 

11 period, the Commissioner of Food and Drugs 

12 shall submit, to the Committee on Health, Edu13 cation, Labor, and Pensions of the Senate and 

14 the Committee on Energy and Commerce of the 

15 House of Representatives, a report that de16 scribes the allocation of such amounts within 

17 the Food and Drug Administration, the projects 

18 funded by such amounts, the accomplishments 

19 that have resulted from such amounts, and the 

20 goals for future use of such amounts. 

21 SEC. 4. BUDGETARY PROVISIONS. 

22 (a) DISCRETIONARY SPENDING LIMITS.—The Office 

23 of Management and Budget shall not include amounts dis24 tributed under section 3(c)(2) during a fiscal year in de25 termining whether there has been a breach of the discreVerDate Sep 11 2014 23:29 Jan 27, 2025 Jkt 059200 PO 00000 Frm 00016 Fmt 6652 Sfmt 6201 E:\BILLS\S5637.IS S5637

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1 tionary spending limits under the Balanced Budget and 

2 Emergency Deficit Control Act of 1985 (2 U.S.C. 900 et 

3 seq.) during the fiscal year. 

4 (b) BUDGET ENFORCEMENT.—If a bill or joint reso5 lution, or amendment thereto or conference report there6 on, if enacted, would cause amounts to be distributed 

7 under section 3(c)(2), the Chairperson of the Committee 

8 on the Budget of the House of Representatives and Chair9 person of the Committee on the Budget of the Senate shall 

10 not include the budgetary effects of such distribution for 

11 purposes of enforcement of budgetary allocations, aggre12 gates, levels, and limits in the House of Representatives 

13 and the Senate. 

14 SEC. 5. OFFSETS. 

15 It is the sense of the Senate that the amounts trans16 ferred under section 3(b) should be offset completely. 

Æ 


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