II 

118TH CONGRESS 

2D SESSION S. 5638 

To secure the supply of drugs in the United States, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

DECEMBER 19 (legislative day, DECEMBER 16), 2024 

Ms. WARREN (for herself and Ms. SMITH) introduced the following bill; which 

was read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

A BILL 

To secure the supply of drugs in the United States, 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 ‘‘Pharmaceutical Supply 

5 Chain Defense and Enhancement Act’’. 

6 SEC. 2. LISTING OF CRITICAL DRUGS. 

7 (a) IN GENERAL.—Not later than 1 year after the 

8 date of enactment of this Act, the Secretary, acting 

9 through the Commissioner of Food and Drugs and in con10 sultation with the Secretary of Defense, shall develop a 


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1 confidential list of drugs such Secretary determines to be 

2 critical to the public health or national security. Such list 

3 shall include the name of each such drug, as well as all 

4 active pharmaceutical ingredients and starting materials 

5 required for the manufacture of the drug. In developing 

6 the list, the Secretary may consider the role of shortages 

7 in impeding access to drugs. 

8 (b) UPDATES.—The Secretary shall update the list 

9 described in subsection (a) not less frequently than once 

10 every 2 years. 

11 (c) SUBMISSION OF LIST.—The Secretary shall sub12 mit the list described in subsection (a), including any up13 dates to such list under subsection (b), as a classified mat14 ter, to the Committee on Health, Education, Labor, and 

15 Pensions, the Committee on Armed Services, the Com16 mittee on Foreign Relations, and the Committee on Bank17 ing, Housing, and Urban Affairs of the Senate, and to 

18 the Committee on Energy and Commerce, the Committee 

19 on Armed Services, the Committee on Foreign Affairs, 

20 and the Committee on Financial Services of the House of 

21 Representatives. 

22 (d) INTERIM LIST.—During the period between the 

23 date of enactment of this Act and the date on which the 

24 Secretary issues the first list under subsection (a), the 

25 Secretary, in consultation with the Commissioner of Food 


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1 and Drugs, the Secretary of Defense, and the Assistant 

2 Secretary for Preparedness and Response, shall establish 

3 an interim list of drugs that will be deemed the list under 

4 subsection (a) until the Secretary develops the first list 

5 under subsection (a). Such interim list shall include not 

6 fewer than 30 drugs, as well as the active pharmaceutical 

7 ingredients and starting materials required for the manu8 facture of such drugs, that are— 

9 (1) included on the most recent list of essential 

10 medicines issued by the World Health Organization; 

11 or 

12 (2) countermeasures and products that could 

13 replenish the strategic national stockpile. 

14 (e) COMMENT PERIOD.—Not later than 60 days prior 

15 to the submission of the list described in subsection (a), 

16 the Secretary shall establish a comment period during 

17 which the public may comment on which drugs should be 

18 included on the list under subsection (a). 

19 SEC. 3. BOOSTING DOMESTIC DRUG AND ACTIVE INGRE20 DIENT MANUFACTURING CAPACITY. 

21 (a) IN GENERAL.—The Secretary, acting through the 

22 Director of the Biomedical Advanced Research and Devel23 opment Authority, shall increase the domestic capacity to 

24 manufacture active pharmaceutical ingredients and start25 ing materials for drugs critical to the public health and 


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1 national security by entering into the contracts described 

2 in subsection (b). 

3 (b) CONTRACTS.— 

4 (1) IN GENERAL.—To carry out subsection (a), 

5 the Secretary shall enter into contracts, not later 

6 than 6 months after the date of enactment of this 

7 Act, as follows: 

8 (A) The Secretary shall enter into con9 tracts with companies and nonprofit entities 

10 headquartered in the United States, under 

11 which such companies use manufacturing estab12 lishments located in the United States to manu13 facture the drugs included on the list under sec14 tion 2, and the requisite active pharmaceutical 

15 ingredients and starting materials of such 

16 drugs, using advanced manufacturing, including 

17 continuous manufacturing where applicable. 

18 (B) As a condition for entering into con19 tracts with the Secretary to manufacture drugs, 

20 companies and nonprofit entities shall— 

21 (i) develop and maintain a redun22 dancy risk management and continuity of 

23 business plan (reviewed and approved by 

24 the Secretary) that identifies and evaluates 

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1 ble, for each establishment in which such 

2 drug, and the requisite active pharma3 ceutical ingredients and starting materials 

4 of such drug, is manufactured; 

5 (ii) commit to implementing, as ap6 propriate, risk management and other 

7 strategies to ensure that, in the case of po8 tential supply chain disruptions, the entity 

9 can continue normal production of the 

10 drug, and the requisite active pharma11 ceutical ingredients and starting materials 

12 of such drug, for 18 months; 

13 (iii) commit to maintaining, to the ex14 tent practicable (as determined by the Sec15 retary) for each drug, and the requisite ac16 tive pharmaceutical ingredients and start17 ing materials of such drug, a 3-month sup18 ply in order to mitigate the impact of sup19 ply chain disruptions and shortages; 

20 (iv) commit to selling drugs, or the 

21 requisite active pharmaceutical ingredients 

22 and starting materials of such drugs, de23 veloped under contract with the Secretary 

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1 mined by the Secretary, taking into consid2 eration— 

3 (I) the impact of price on patient 

4 access to the drug; 

5 (II) the cost of the drug to Fed6 eral or State health programs; 

7 (III) the cost of manufacturing 

8 the drug; and 

9 (IV) the impact of price on mar10 ket competition for the drug; and 

11 (v) commit to making the prices de12 scribed in clause (iv) public. 

13 (C) The contracts described in this para14 graph shall contain continuity of business 

15 agreements demonstrating, in advance of receiv16 ing a contract, the company’s ability to rapidly 

17 begin production. 

18 (D) The Secretary shall enter into con19 tracts only with companies headquartered in the 

20 United States that use manufacturing establish21 ments located in the United States, under 

22 which such companies expand the capabilities of 

23 continuous manufacturing and other advanced 

24 manufacturing for the production of the active 

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1 rials for the drugs included on the list under 

2 section 2. 

3 (E) In issuing contracts under this section, 

4 the Secretary shall prioritize— 

5 (i) contracts designed to enhance the 

6 supply of generic drugs and biosimilar bio7 logical products and the requisite active 

8 pharmaceutical ingredients and starting 

9 materials of such generic drugs and bio10 similar products; and 

11 (ii) contracts designed to enhance the 

12 supply of drugs, and the requisite active 

13 pharmaceutical ingredients and starting 

14 materials of such drugs, that are not cur15 rently manufactured in the United States. 

16 (2) INSPECTOR GENERAL REVIEW.—The In17 spector General of the Department of Health and 

18 Human Services shall conduct a review of not fewer 

19 than 1 of every 3 contracts entered into under this 

20 section, and of the entities entering into such con21 tracts, to ensure that contracts are being issued 

22 under fair and reasonable terms and conditions, in23 cluding facilitating the procurement by the Federal 

24 Government of applicable products under section 2 

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1 ical devices at fair and reasonable prices. The In2 spector General shall make each such review public 

3 and, in cases where such a review identifies unrea4 sonable prices, submit recommendations to Congress 

5 on how the Office should improve its contracting 

6 systems to ensure reasonable pricing. 

7 (3) FUNDING.—To carry out this section, there 

8 are authorized to be appropriated $5,000,000,000 

9 for the period of fiscal years 2025 and 2029. Not 

10 later than April 1, 2029, the Secretary shall report 

11 to the congressional committees listed under section 

12 2(c), and provide a recommendation for renewal of 

13 funding under this paragraph. 

14 (c) FEDERAL PROCUREMENT OF DOMESTICALLY

15 MANUFACTURED DRUGS.— 

16 (1) PROCUREMENT OF DRUGS.— 

17 (A) IN GENERAL.—Beginning in fiscal year 

18 2029 when purchasing any drug included on 

19 the list under section 2, the Secretary of De20 fense, the Secretary of Veterans Affairs, the Di21 rector of the Bureau of Prisons, and, for pur22 poses of maintaining the strategic national 

23 stockpile, the Secretary of Health and Human 

24 Services, shall give priority to supplies of the 

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1 cluding all active pharmaceutical ingredient and 

2 starting materials of the drug) that is of high 

3 quality. 

4 (B) USE OF REMAINING FUNDS.—In the 

5 case that a Federal agency described in this 

6 paragraph that, after purchasing all drugs on 

7 the list under section 2 needed by such agency 

8 for a fiscal year, has funds appropriated under 

9 paragraph (2) for that fiscal year remaining, 

10 such Federal agency may use the remaining 

11 funds to purchase drugs wholly manufactured 

12 in the United States that are not included on 

13 the list under section 2. 

14 (2) FUNDING.— 

15 (A) IN GENERAL.—There are authorized to 

16 be appropriated to each of the Secretary of De17 fense, the Secretary of Veterans Affairs, the 

18 Bureau of Prisons, and the Secretary of Health 

19 and Human Services, $1,000,000,000 for the 

20 period of fiscal years 2029 through 2033 to be 

21 used to purchase drugs manufactured in the 

22 United States, as described in paragraph (1). 

23 (B) REVERSION.—All funds that are ap24 propriated under this paragraph for a fiscal 

25 year, but not expended by the end of the fiscal 


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1 year, shall revert to the General Fund of the 

2 Treasury. 

3 (C) NO DIVERSION OR TRANSFER OF

4 FUNDS.—No funding appropriated under this 

5 section shall be diverted, transferred, or other6 wise made available for purposes beyond what 

7 is described in this Act. 

8 (3) NIH AUTHORIZATION.—There are author9 ized to be appropriated to the Director of the Na10 tional Institutes of Health, for each fiscal year for 

11 which amounts are appropriated under paragraph 

12 (2) but not expended in full, an amount equal to the 

13 amount that reverts to the Treasury for such year, 

14 as described in paragraph (2). Such amounts shall 

15 be used by the Director of the National Institutes of 

16 Health to carry out biomedical research. 

17 SEC. 4. SUPPLY CHAIN TRANSPARENCY. 

18 (a) DOMESTIC SUPPLIERS TO FEDERAL PRO19 GRAMS.—Each domestic manufacturer of a drug that sup20 plies such drug to the Department of Defense, the Depart21 ment of Veterans Affairs, the Department of Health and 

22 Human Services, or the Bureau of Prisons, or a domestic 

23 manufacturer of an active ingredient of a drug so supplied, 

24 shall— 


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1 (1) report annually to the Secretary and the 

2 agency receiving such drug on— 

3 (A) whether any ingredients of such drug 

4 is sourced, either wholly or in part, from a for5 eign country; 

6 (B) in the case of an active pharmaceutical 

7 ingredient or key starting material that the 

8 manufacturer procures from a single source in 

9 a single foreign country, as applicable— 

10 (i) not less than 2 alternative sources 

11 of any active pharmaceutical ingredient or 

12 key starting material; 

13 (ii) 1 such alternative source, if only 

14 1 such alternative source is available; or 

15 (iii) a statement that no such alter16 native sources are available; and 

17 (C) an assessment of the resilience and ca18 pacity of the alternate sources identified under 

19 subparagraph (B); and 

20 (2) develop continuity of business plans to pre21 vent the disruption of any drug listed under section 

22 2, including any active or inactive ingredients of 

23 such drug, which the Secretary may audit. 

24 (b) FOREIGN DRUG SUPPLIERS.— 


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1 (1) ESTABLISHMENTS IN A FOREIGN COUN2 TRY.—Section 510(i)(5) of the Federal Food, Drug, 

3 and Cosmetic Act (21 U.S.C. 360(i)(5)) is amended 

4 by inserting before ‘‘The Secretary’’ the following: 

5 ‘‘The requirements of paragraphs (1) and (2) shall 

6 apply to establishments within a foreign country en7 gaged in the manufacture, preparation, propagation, 

8 compounding, or processing of any drug that is re9 quired to be listed pursuant to subsection (j), or of 

10 any active pharmaceutical ingredient of such a 

11 drug.’’. 

12 (2) LISTING OF DRUGS.—Section 510(j)(1) of 

13 the Federal Food, Drug, and Cosmetic Act (21 

14 U.S.C. 360(j)(1)) is amended— 

15 (A) in subparagraph (D), by striking 

16 ‘‘and’’ at the end; 

17 (B) in subparagraph (E), by striking the 

18 period at the end and inserting ‘‘; and’’; and 

19 (C) by adding at the end the following new 

20 subparagraph: 

21 ‘‘(F) in the case of a drug contained in the ap22 plicable list, a certification that the registrant has— 

23 ‘‘(i) identified every other establishment 

24 where manufacturing is performed for the drug 

25 by the registrant; and 


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1 ‘‘(ii) notified each known foreign establish2 ment engaged in the manufacture, preparation, 

3 propagation, compounding, or processing of the 

4 drug or the active pharmaceutical ingredient of 

5 the drug of the inclusion of the drug in the list 

6 and the obligation to register pursuant to sub7 section (i)(5).’’. 

8 (c) REPORTS TO CONGRESS AND THE PUBLIC.— 

9 (1) CLASSIFIED REPORT TO CONGRESS.—Not 

10 later than 1 year after the date of enactment of this 

11 Act and annually thereafter, the Secretary, in con12 sultation with the Secretary of Defense, shall submit 

13 a classified report to Congress on the Nation’s reli14 ance on importation of active and inactive ingredi15 ents of drugs included on the list under section 2. 

16 (2) PUBLIC REPORTS.—Not later than 1 year 

17 after the date of enactment of this Act and annually 

18 thereafter, the Secretary, in consultation with the 

19 Secretary of Defense, shall prepare an unclassified 

20 summary of the report described in paragraph (1), 

21 and shall make such summary publicly available on 

22 the websites of the Department of Health and 

23 Human Services and the Department of Defense for 

24 purposes of understanding the Nation’s dependency 

25 on foreign manufacturers of drugs. Such summaries 


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1 shall not include the names of any drugs, active 

2 pharmaceutical ingredients, or starting materials. 

3 (3) CONTENT.—The reports under paragraph 

4 (1) shall include— 

5 (A) all brand name and generic drugs, and 

6 the active and inactive ingredients of such 

7 drugs that— 

8 (i) are not wholly produced in the 

9 United States; 

10 (ii) are exclusively produced, or utilize 

11 active or inactive ingredients produced 

12 abroad; 

13 (iii) are critical to the public health 

14 and national security of the people of the 

15 United States, as determined by the Sec16 retary, in consultation with the Secretary 

17 of Defense, and including any drugs in18 cluded in the list under section 2; or 

19 (iv) are procured in any quantity by 

20 the Department of Defense for use by serv21 ice members or veterans or by the Depart22 ment of Health and Human Services for 

23 the strategic national stockpile; 

24 (B) a list of potential, alternative sources 

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1 dient of a drug, that is sourced from a single 

2 manufacturer with establishments in the United 

3 States; and 

4 (C) assess the resiliency and capacity of al5 ternative sources of any drug described in sub6 paragraph (A), and whether any such alter7 native source could be relied on to support do8 mestic demand for such drug. 

9 (d) MANUFACTURER COMPLIANCE.— 

10 (1) FAILURE TO NOTIFY OF A PERMANENT DIS11 CONTINUANCE OR AN INTERRUPTION.—Section 301 

12 of the Federal Food, Drug, and Cosmetic Act (21 

13 U.S.C. 331) is amended by adding at the end the 

14 following: 

15 ‘‘(jjj) The failure of a manufacturer of a drug de16 scribed in section 506C(a), or an active pharmaceutical 

17 ingredient of such a drug, to notify the Secretary of a per18 manent discontinuance or an interruption, and the reasons 

19 for such discontinuance or interruption, as required by 

20 section 506C.’’. 

21 (2) EXEMPTION FROM PENALTY.—Section 

22 303(c) of the Federal Food, Drug, and Cosmetic Act 

23 (21 U.S.C. 333(c)) is amended by inserting before 

24 the period at the end the following: ‘‘or (7) for hav25 ing violated section 301(jjj) if such person made a 


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1 good faith determination that the discontinuance or 

2 interruption was not likely to lead to a meaningful 

3 disruption in the supply of that drug in the United 

4 States’’. 

5 (e) REGISTRY OF ACTIVE INGREDIENTS.—There is 

6 authorized to be appropriated to the Secretary of Health 

7 and Human Services $20,000,000 for fiscal year 2026, for 

8 purposes of establishing, in consultation with the Commis9 sioner of Food and Drugs, an online registry of active 

10 pharmaceutical ingredients and key starting materials 

11 using information reported under subsection (a) and pur12 suant to a registration under section 510(i) of the Federal 

13 Food, Drug, and Cosmetic Act (21 U.S.C. 360(i)). 

14 (f) FOOD AND DRUG ADMINISTRATION INSPEC15 TIONS.—There are authorized to be appropriated such 

16 funds as may be necessary to ensure that the Commis17 sioner of Food and Drugs is able to conduct inspections 

18 and evaluations of new establishments established using 

19 funds made available under this Act. 

20 SEC. 5. OVERSIGHT OF FOREIGN PHARMACEUTICAL IN21 VESTMENT. 

22 (a) IN GENERAL.—Not later than 1 year after the 

23 date of the enactment of this Act, and annually thereafter, 

24 the Federal Trade Commission, in consultation with the 

25 Secretary of the Treasury acting through the Committee 


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1 on Foreign Investment in the United States (referred to 

2 in this section as the ‘‘Committee’’), shall submit to the 

3 appropriate congressional committees, the Secretary of 

4 Health and Human Services, and the Commissioner of 

5 Food and Drugs, a report on foreign investment in the 

6 pharmaceutical industry of the United States. 

7 (b) ELEMENTS.—The report required by subsection 

8 (a) shall include the following: 

9 (1) An assessment of— 

10 (A) the supply chain of the pharmaceutical 

11 industry of the United States and the effect of 

12 concentration and reliance on foreign manufac13 turing within that industry; 

14 (B) the effect of foreign investment in the 

15 pharmaceutical industry of the United States 

16 on domestic capacity to produce drugs and ac17 tive and inactive ingredients of drugs; and 

18 (C) the effect of foreign investment in 

19 technologies or other products for sequencing or 

20 storage of DNA, including genome and exome 

21 analysis, in the United States, including the ef22 fect of such investment on the capacity to se23 quence or store DNA in the United States. 

24 (2) The number of reviews and investigations 

25 conducted by the Committee, in each of the 10 fiscal 


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1 years preceding the year in which the study is con2 ducted, with respect to covered transactions (as de3 fined in section 721(a) of the Defense Production 

4 Act of 1950 (50 U.S.C. 4565(a)))— 

5 (A) in the pharmaceutical industry of the 

6 United States; or 

7 (B) relating to the sequencing or storage 

8 of DNA in the United States. 

9 (3) A short description of each such review or 

10 investigation, including whether the transaction was 

11 approved or prohibited. 

12 (c) AUTHORITY.—The Federal Trade Commission 

13 shall have authority under section 6 of the Federal Trade 

14 Commission Act (15 U.S.C. 46) to conduct the studies re15 quired to prepare the report required by subsection (a). 

16 (d) PUBLICATION.—The Federal Trade Commission 

17 shall publish an unclassified summary of the report re18 quired by subsection (a) on a publicly available internet 

19 website of the Commission. 

20 (e) APPROPRIATE CONGRESSIONAL COMMITTEES DE21 FINED.—In this section, the term ‘‘appropriate congres22 sional committees’’ means— 

23 (1) the Committee on Banking, Housing, and 

24 Urban Affairs, the Committee on Health, Education, 

25 Labor, and Pensions, the Committee on Armed 


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1 Services, the Committee on Foreign Relations, the 

2 Committee on Commerce, Science, and Transpor3 tation, and the Committee on Appropriations of the 

4 Senate; and 

5 (2) the Committee on Financial Services, the 

6 Committee on Energy and Commerce, the Com7 mittee on Armed Services, the Committee on For8 eign Affairs, and the Committee on Appropriations 

9 of the House of Representatives. 

10 SEC. 6. DEFINITIONS. 

11 In this Act— 

12 (1) ‘‘advanced manufacturing’’ means an ap13 proach for the manufacturing of pharmaceuticals 

14 that incorporates novel technology, or uses an estab15 lished technique or technology in a new or innovative 

16 way (such as continuous manufacturing where the 

17 input materials are continuously transformed within 

18 the process by 2 or more unit operations), that en19 hances drug quality or improves the manufacturing 

20 process; 

21 (2) the term ‘‘continuous manufacturing’’— 

22 (A) means a process where the input mate23 rials are continuously fed into and transformed 

24 within the process, and the processed output 


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1 materials are continuously removed from the 

2 system; and 

3 (B) consists of an integrated process that 

4 consists of a series of 2 or more unit oper5 ations; 

6 (3) the term ‘‘drug’’ has the meaning given 

7 such term in section 201(g) of the Federal Food, 

8 Drug, and Cosmetic Act (21 U.S.C. 321(g)); 

9 (4) the term ‘‘Secretary’’, unless otherwise 

10 specified, means the Secretary of Health and 

11 Human Services; 

12 (5) the term ‘‘starting material’’ means a raw 

13 material, intermediate, or a drug substance that is 

14 used in the production of a drug substance and that 

15 is incorporated as a significant structural fragment 

16 into the structure of the drug substance; and 

17 (6) the term ‘‘strategic national stockpile’’ 

18 means the stockpile maintained by the Secretary 

19 under section 319F–2 of the Public Health Service 

20 Act (42 U.S.C. 247d–6b). 

Æ 


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