I 

118TH CONGRESS 

2D SESSION H. R. 6963 

To direct the Secretary of Health and Human Services to enter into agreements with drug manufacturers to establish reserve supplies of covered 

pediatric cancer drugs, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

JANUARY 11, 2024 

Ms. ESHOO (for herself, Ms. DEGETTE, and Ms. SCHRIER) introduced the 

following bill; which was referred to the Committee on Energy and Commerce 

A BILL 

To direct the Secretary of Health and Human Services to 

enter into agreements with drug manufacturers to establish reserve supplies of covered pediatric cancer drugs, 

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 ‘‘Pediatric Cancer Drug 

5 Supply Act of 2024’’. 


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1 SEC. 2. ESTABLISHMENT OF ESSENTIAL PEDIATRIC CAN2 CER DRUG MARKETPLACE STABILITY PILOT 

3 PROGRAM. 

4 (a) IN GENERAL.—The Secretary shall carry out a 

5 pilot program under which the Secretary enters into agree6 ments with manufacturers to purchase and maintain not 

7 less than a 6-month reserve supply, to be held by such 

8 manufacturers, of each covered pediatric cancer drug. 

9 (b) PILOT PROGRAM.— 

10 (1) PREFERENCE FOR MULTIPLE MANUFACTUR11 ERS.—To the greatest extent practicable, the Sec12 retary shall seek to enter into agreements described 

13 in subsection (a) with more than 1 manufacturer for 

14 each covered pediatric cancer drug. 

15 (2) IMPLEMENTATION GOALS.—To the greatest 

16 extent practicable, the Secretary shall implement the 

17 pilot program under this section in a manner that— 

18 (A) minimizes the impact on the market19 place for drugs included on the essential pedi20 atric cancer drug list established under section 

21 3; 

22 (B) increases domestic manufacturing ca23 pacity; 

24 (C) encourages competition in the market25 place; 


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1 (D) assures that any covered pediatric can2 cer drugs that the Secretary distributes or or3 ders to be distributed under section 4 are used 

4 to treat pediatric cancer patients; and 

5 (E) rewards manufacturing quality. 

6 (3) REQUIRED AGREEMENT TERMS.—Each 

7 agreement under this section between the Secretary 

8 and a manufacturer of a covered pediatric cancer 

9 drug shall include the following: 

10 (A) The identity and quantity of each cov11 ered pediatric cancer drug that the manufac12 turer agrees to hold in reserve supply. 

13 (B) A requirement that such quantities 

14 shall be in addition to the average levels of in15 ventory for the relevant covered pediatric cancer 

16 drug held by the manufacturer during the pre17 vious year. 

18 (C) A provision to ensure that each drug 

19 held in reserve supply has an expiration date at 

20 least 1 year beyond the current date. 

21 (D) A provision to allow the manufacturer 

22 to sell and replace, through normal commercial 

23 channels, any drug in reserve supply in order to 

24 remain in compliance with the provision de25 scribed in subparagraph (C). 


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1 (E) A requirement that the covered pedi2 atric cancer drugs in reserve supply may only 

3 be held at a location in the United States. 

4 (F) In the case of a covered pediatric can5 cer drug manufactured at an eligible source fa6 cility that is not located in the United States, 

7 the manufacturer of such drug may comply 

8 with subparagraph (E)— 

9 (i) by storing the drug at an establish10 ment located in the United States that 

11 is— 

12 (I) registered under section 510 

13 of the Federal Food, Drug, and Cos14 metic Act (21 U.S.C. 360); and 

15 (II) under common ownership 

16 and control with the manufacturer; or 

17 (ii) by contracting with an authorized 

18 third-party logistics provider (as defined in 

19 section 581 of the Federal Food Drug, and 

20 Cosmetic Act (21 U.S.C. 360eee)) located 

21 in the United States to store the drug in 

22 the United States. 

23 (G) A requirement that any covered pedi24 atric cancer drug held in reserve supply be 

25 manufactured and held in accordance with— 


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1 (i) good manufacturing practice re2 quirements; 

3 (ii) the approved application for such 

4 drug under section 505 of the Federal 

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

6 355) or section 351 of the Public Health 

7 Service Act (42 U.S.C. 262); and 

8 (iii) applicable law. 

9 (H) A provision that allows the Secretary, 

10 or a third party designated by the Secretary, to 

11 audit the manufacturer and the eligible source 

12 facility for compliance with the terms of the 

13 agreement and applicable law— 

14 (i) on an annual basis; or 

15 (ii) more frequently, if the Secretary 

16 has a reasonable basis to believe that the 

17 manufacturer or eligible source facility is 

18 not complying with the terms of the agree19 ment or applicable law. 

20 (I) A requirement that the manufacturer 

21 certify to the Secretary on an annual basis com22 pliance with the terms of the agreement. 

23 (4) OPTIONAL TERMS FOR ACQUISITION, CON24 STRUCTION, ALTERATION, OR RENOVATION OF ES25 TABLISHMENT.—An agreement under this section 


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1 between the Secretary and a manufacturer of a cov2 ered pediatric cancer drug may include a provision 

3 to allow the manufacturer to acquire, construct, 

4 alter, or renovate a non-federally owned establish5 ment for the purpose of manufacturing covered pedi6 atric cancer drugs— 

7 (A) as the Secretary determines necessary 

8 to ensure sufficient amounts of such drugs; or 

9 (B) as the Secretary determines necessary 

10 to carry out or improve preparedness and re11 sponse capability at the State and local levels. 

12 (5) REASONABLE TIME FOR MANUFACTURE.— 

13 The Secretary shall allow each manufacturer with 

14 whom the Secretary has entered into an agreement 

15 under this section a reasonable amount of time after 

16 entering into the agreement to manufacture the cov17 ered pediatric cancer drugs that will be held in re18 serve supply pursuant to the agreement. 

19 (c) PAYMENT TERMS.— 

20 (1) PAYMENT AMOUNTS.— 

21 (A) IN GENERAL.—The amount paid to 

22 each manufacturer pursuant to an agreement 

23 with the Secretary under this section shall be 

24 based on— 


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1 (i) the quantity of each covered pedi2 atric cancer drug the manufacturer agrees 

3 to hold in reserve supply; and 

4 (ii) the wholesale acquisition cost of 

5 each such drug. 

6 (B) ADMINISTRATIVE FEE.—The Secretary 

7 may pay a manufacturer an administrative fee 

8 pursuant to an agreement under this section, 

9 provided that the payment of the administrative 

10 fee does not cause the Secretary to exhaust the 

11 amounts appropriated for the pilot program 

12 under this section prior to securing adequate 

13 reserves for each covered pediatric cancer drug. 

14 (2) PAYMENT CONDITIONED ON RESERVE SUP15 PLY ADEQUACY.— 

16 (A) IN GENERAL.—Except as provided in 

17 subparagraph (B), each agreement with a man18 ufacturer under this section shall provide that 

19 no payment under the agreement may be made 

20 until the manufacturer demonstrates to the 

21 Secretary that the manufacturer has set aside 

22 a portion, as determined by the Secretary, of 

23 the total quantity of the covered pediatric can24 cer drug to be held in reserve supply under the 

25 agreement. 


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1 (B) EXCEPTIONS FOR ADVANCE PAY2 MENT.—An agreement under this section may 

3 provide that, if the Secretary determines that 

4 an advance payment or partial payment for sig5 nificant milestones is necessary to ensure suc6 cess of the terms of the agreement, the Sec7 retary shall pay, in advance, an amount not to 

8 exceed 10 percent of the total amount to be 

9 paid to the manufacturer by the Secretary 

10 under the agreement. 

11 (d) FORFEITURE.—If a manufacturer is unable or 

12 fails to distribute a covered pediatric cancer drug in ac13 cordance with the terms of an agreement entered into 

14 under this section, the manufacturer shall— 

15 (1) forfeit any payments it has received under 

16 the agreement; and 

17 (2) not later than 30 days after the date of 

18 such inability or failure, refund such payments. 

19 SEC. 3. ESSENTIAL PEDIATRIC CANCER DRUG LIST. 

20 (a) IN GENERAL.—The Secretary, in consultation 

21 with the Commissioner of Food and Drugs and the Direc22 tor of the National Cancer Institute, shall— 

23 (1) not later than 150 days after the date of 

24 enactment of this Act, develop a list of 


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1 chemotherapeutic drugs that are essential for treat2 ing pediatric cancer; and 

3 (2) update such list on a schedule determined 

4 by the Secretary. 

5 (b) CRITERIA.—Under subsection (a), a 

6 chemotherapeutic drug shall be considered essential for 

7 treating pediatric cancer only if the drug— 

8 (1) is approved under section 505 of the Fed9 eral Food, Drug, and Cosmetic Act (21 U.S.C. 355) 

10 or licensed under section 351 of the Public Health 

11 Service Act (42 U.S.C. 262) for use in the treatment 

12 of cancer; 

13 (2) has the potential alone or in combination 

14 with other drugs to treat a pediatric cancer; 

15 (3) is supported by 1 or more citations to treat 

16 a pediatric cancer included or approved for inclusion 

17 in— 

18 (A) the National Comprehensive Cancer 

19 Network Compendia; 

20 (B) American Hospital Formulary Service 

21 Drug Information; 

22 (C) the DRUGDEX Information System; 

23 or 


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1 (D) the PDQ Cancer Information Sum2 maries for Health Professionals of the National 

3 Cancer Institute; and 

4 (4) meets price, quality, manufacturing con5 centration, manufacturing complexity, and other ap6 propriate metrics as determined by the Secretary. 

7 SEC. 4. DISTRIBUTIONS FROM ESSENTIAL PEDIATRIC CAN8 CER DRUG RESERVE SUPPLIES. 

9 (a) IN GENERAL.—If a covered pediatric cancer drug 

10 is in shortage (as defined in section 506C(h) of the Fed11 eral Food, Drug, and Cosmetic Act (21 U.S.C. 356c(h))), 

12 or the Secretary has reason to believe that such a drug 

13 may be at risk of such a shortage, the Secretary may order 

14 a manufacturer with whom the Secretary has entered into 

15 an agreement under section 2 to distribute such drug from 

16 the reserve supply in accordance with such agreement in 

17 an effort to alleviate or prevent the shortage. 

18 (b) PAYMENTS FOR DISTRIBUTION.— 

19 (1) IN GENERAL.—The Secretary shall require 

20 a recipient of a covered pediatric cancer drug dis21 tributed under subsection (a) to pay the Secretary 

22 for such drug. The amount of such payment shall 

23 not exceed the price for which the Secretary pur24 chased such drug pursuant to an agreement under 

25 section 2. 


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1 (2) LIMITATION.—The Secretary may use pay2 ments received pursuant to paragraph (1) only to re3 plenish the reserve supply of the drugs distributed 

4 under subsection (a). 

5 (c) INABILITY TO DISTRIBUTE OR MANAGE RESERVE

6 SUPPLY.— 

7 (1) INABILITY TO DISTRIBUTE.—If a manufac8 turer is not able or willing to distribute drugs in ac9 cordance with an order of the Secretary under sub10 section (a), the Secretary may take possession of 

11 and distribute such drugs. 

12 (2) INABILITY TO MANAGE RESERVE SUPPLY.— 

13 If a manufacturer can no longer hold or manage a 

14 reserve supply of covered pediatric cancer drugs in 

15 accordance with an agreement under section 2, the 

16 Secretary may take possession of the reserve supply. 

17 SEC. 5. REPORTS TO CONGRESS. 

18 (a) IN GENERAL.—For each year 1 or more drugs 

19 are held by a manufacturer in reserve supply pursuant to 

20 an agreement under section 2, the Secretary shall submit 

21 to Congress a report on the progress of the pilot program 

22 under such section. 

23 (b) CONTENTS.—The reports referred to in sub24 section (a) shall each include— 


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1 (1) the essential pediatric cancer drug list in ef2 fect during the year covered by the report (including 

3 any changes made to the list throughout the year); 

4 (2) the total number of agreements entered into 

5 under section 2 during such year; 

6 (3) the total amount of each covered pediatric 

7 cancer drug purchased by the Secretary pursuant to 

8 such agreements during such year; 

9 (4) the total amount of each covered pediatric 

10 cancer drug distributed from the reserve supplies 

11 under section 4 during such year; and 

12 (5) any other information that the Secretary 

13 determines relevant. 

14 SEC. 6. DEFINITIONS. 

15 In this Act: 

16 (1) COVERED PEDIATRIC CANCER DRUG.—The 

17 term ‘‘covered pediatric cancer drug’’ means a 

18 drug— 

19 (A) that is included on the essential pedi20 atric cancer drug list established under section 

21 3; 

22 (B) that may be at risk of a meaningful 

23 disruption (as defined in section 506J(j) of the 

24 Federal Food, Drug, and Cosmetic Act (21 

25 U.S.C. 356j(j))) in the supply of the drug; and 


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1 (C) whose final dosage form is manufac2 tured at an eligible source facility. 

3 (2) DRUG.—The term ‘‘drug’’— 

4 (A) means a drug (as defined in section 

5 201(g) of the Federal Food, Drug, and Cos6 metic Act (21 U.S.C. 321(g))); and 

7 (B) includes a biological product (as de8 fined in section 351(i) of the Public Health 

9 Service Act (42 U.S.C. 262(i))). 

10 (3) ELIGIBLE SOURCE FACILITY.—The term 

11 ‘‘eligible source facility’’ means a facility— 

12 (A) registered under section 510 of the 

13 Federal Food, Drug, and Cosmetic Act (21 

14 U.S.C. 360); 

15 (B) lawfully manufacturing a covered pedi16 atric cancer drug; and 

17 (C) located in— 

18 (i) the United States; or 

19 (ii) a country that is a member of the 

20 Organisation for Economic Co-operation 

21 and Development. 

22 (4) ESSENTIAL PEDIATRIC CANCER DRUG

23 LIST.—The term ‘‘essential pediatric cancer drug 

24 list’’ means the list under section 3(a). 


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1 (5) SECRETARY.—The term ‘‘Secretary’’ means 

2 the Secretary of Health and Human Services. 

3 (6) UNITED STATES.—The term ‘‘United 

4 States’’ means each of the several States and the 

5 territories and possessions of the United States. 

6 SEC. 7. AUTHORIZATION OF APPROPRIATIONS. 

7 To carry out this Act, there are authorized to be ap8 propriated $500,000,000 for fiscal year 2024, to remain 

9 available until expended. 

Æ 


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