I 
118TH CONGRESS 
2D SESSION 
H. R. 6963 
To direct the Secretary of Health and Human Services to enter into agree-
ments 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 estab-
lish reserve supplies of covered pediatric cancer drugs, 
and for other purposes. 
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 ‘‘Pediatric Cancer Drug 
Supply Act of 2024’’. 
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SEC. 2. ESTABLISHMENT OF ESSENTIAL PEDIATRIC CAN-
CER DRUG MARKETPLACE STABILITY PILOT 
PROGRAM. 
(a) IN GENERAL.—The Secretary shall carry out a 
pilot program under which the Secretary enters into agree-
ments with manufacturers to purchase and maintain not 
less than a 6-month reserve supply, to be held by such 
manufacturers, of each covered pediatric cancer drug. 
(b) PILOT PROGRAM.— 
(1) PREFERENCE FOR MULTIPLE MANUFACTUR-
ERS.—To the greatest extent practicable, the Sec-
retary shall seek to enter into agreements described 
in subsection (a) with more than 1 manufacturer for 
each covered pediatric cancer drug. 
(2) IMPLEMENTATION GOALS.—To the greatest 
extent practicable, the Secretary shall implement the 
pilot program under this section in a manner that— 
(A) minimizes the impact on the market-
place for drugs included on the essential pedi-
atric cancer drug list established under section 
3; 
(B) increases domestic manufacturing ca-
pacity; 
(C) encourages competition in the market-
place; 
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(D) assures that any covered pediatric can-
cer drugs that the Secretary distributes or or-
ders to be distributed under section 4 are used 
to treat pediatric cancer patients; and 
(E) rewards manufacturing quality. 
(3) REQUIRED
AGREEMENT
TERMS.—Each 
agreement under this section between the Secretary 
and a manufacturer of a covered pediatric cancer 
drug shall include the following: 
(A) The identity and quantity of each cov-
ered pediatric cancer drug that the manufac-
turer agrees to hold in reserve supply. 
(B) A requirement that such quantities 
shall be in addition to the average levels of in-
ventory for the relevant covered pediatric cancer 
drug held by the manufacturer during the pre-
vious year. 
(C) A provision to ensure that each drug 
held in reserve supply has an expiration date at 
least 1 year beyond the current date. 
(D) A provision to allow the manufacturer 
to sell and replace, through normal commercial 
channels, any drug in reserve supply in order to 
remain in compliance with the provision de-
scribed in subparagraph (C). 
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(E) A requirement that the covered pedi-
atric cancer drugs in reserve supply may only 
be held at a location in the United States. 
(F) In the case of a covered pediatric can-
cer drug manufactured at an eligible source fa-
cility that is not located in the United States, 
the manufacturer of such drug may comply 
with subparagraph (E)— 
(i) by storing the drug at an establish-
ment located in the United States that 
is— 
(I) registered under section 510 
of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360); and 
(II) under common ownership 
and control with the manufacturer; or 
(ii) by contracting with an authorized 
third-party logistics provider (as defined in 
section 581 of the Federal Food Drug, and 
Cosmetic Act (21 U.S.C. 360eee)) located 
in the United States to store the drug in 
the United States. 
(G) A requirement that any covered pedi-
atric cancer drug held in reserve supply be 
manufactured and held in accordance with— 
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(i) good manufacturing practice re-
quirements; 
(ii) the approved application for such 
drug under section 505 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 
355) or section 351 of the Public Health 
Service Act (42 U.S.C. 262); and 
(iii) applicable law. 
(H) A provision that allows the Secretary, 
or a third party designated by the Secretary, to 
audit the manufacturer and the eligible source 
facility for compliance with the terms of the 
agreement and applicable law— 
(i) on an annual basis; or 
(ii) more frequently, if the Secretary 
has a reasonable basis to believe that the 
manufacturer or eligible source facility is 
not complying with the terms of the agree-
ment or applicable law. 
(I) A requirement that the manufacturer 
certify to the Secretary on an annual basis com-
pliance with the terms of the agreement. 
(4) OPTIONAL TERMS FOR ACQUISITION, CON-
STRUCTION, ALTERATION, OR RENOVATION OF ES-
TABLISHMENT.—An agreement under this section 
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between the Secretary and a manufacturer of a cov-
ered pediatric cancer drug may include a provision 
to allow the manufacturer to acquire, construct, 
alter, or renovate a non-federally owned establish-
ment for the purpose of manufacturing covered pedi-
atric cancer drugs— 
(A) as the Secretary determines necessary 
to ensure sufficient amounts of such drugs; or 
(B) as the Secretary determines necessary 
to carry out or improve preparedness and re-
sponse capability at the State and local levels. 
(5) REASONABLE TIME FOR MANUFACTURE.— 
The Secretary shall allow each manufacturer with 
whom the Secretary has entered into an agreement 
under this section a reasonable amount of time after 
entering into the agreement to manufacture the cov-
ered pediatric cancer drugs that will be held in re-
serve supply pursuant to the agreement. 
(c) PAYMENT TERMS.— 
(1) PAYMENT AMOUNTS.— 
(A) IN
GENERAL.—The amount paid to 
each manufacturer pursuant to an agreement 
with the Secretary under this section shall be 
based on— 
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(i) the quantity of each covered pedi-
atric cancer drug the manufacturer agrees 
to hold in reserve supply; and 
(ii) the wholesale acquisition cost of 
each such drug. 
(B) ADMINISTRATIVE FEE.—The Secretary 
may pay a manufacturer an administrative fee 
pursuant to an agreement under this section, 
provided that the payment of the administrative 
fee does not cause the Secretary to exhaust the 
amounts appropriated for the pilot program 
under this section prior to securing adequate 
reserves for each covered pediatric cancer drug. 
(2) PAYMENT CONDITIONED ON RESERVE SUP-
PLY ADEQUACY.— 
(A) IN GENERAL.—Except as provided in 
subparagraph (B), each agreement with a man-
ufacturer under this section shall provide that 
no payment under the agreement may be made 
until the manufacturer demonstrates to the 
Secretary that the manufacturer has set aside 
a portion, as determined by the Secretary, of 
the total quantity of the covered pediatric can-
cer drug to be held in reserve supply under the 
agreement. 
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(B) EXCEPTIONS
FOR
ADVANCE
PAY-
MENT.—An agreement under this section may 
provide that, if the Secretary determines that 
an advance payment or partial payment for sig-
nificant milestones is necessary to ensure suc-
cess of the terms of the agreement, the Sec-
retary shall pay, in advance, an amount not to 
exceed 10 percent of the total amount to be 
paid to the manufacturer by the Secretary 
under the agreement. 
(d) FORFEITURE.—If a manufacturer is unable or 
fails to distribute a covered pediatric cancer drug in ac-
cordance with the terms of an agreement entered into 
under this section, the manufacturer shall— 
(1) forfeit any payments it has received under 
the agreement; and 
(2) not later than 30 days after the date of 
such inability or failure, refund such payments. 
SEC. 3. ESSENTIAL PEDIATRIC CANCER DRUG LIST. 
(a) IN GENERAL.—The Secretary, in consultation 
with the Commissioner of Food and Drugs and the Direc-
tor of the National Cancer Institute, shall— 
(1) not later than 150 days after the date of 
enactment 
of 
this 
Act, 
develop 
a 
list 
of 
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chemotherapeutic drugs that are essential for treat-
ing pediatric cancer; and 
(2) update such list on a schedule determined 
by the Secretary. 
(b) 
CRITERIA.—Under 
subsection 
(a), 
a 
chemotherapeutic drug shall be considered essential for 
treating pediatric cancer only if the drug— 
(1) is approved under section 505 of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 355) 
or licensed under section 351 of the Public Health 
Service Act (42 U.S.C. 262) for use in the treatment 
of cancer; 
(2) has the potential alone or in combination 
with other drugs to treat a pediatric cancer; 
(3) is supported by 1 or more citations to treat 
a pediatric cancer included or approved for inclusion 
in— 
(A) the National Comprehensive Cancer 
Network Compendia; 
(B) American Hospital Formulary Service 
Drug Information; 
(C) the DRUGDEX Information System; 
or 
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(D) the PDQ Cancer Information Sum-
maries for Health Professionals of the National 
Cancer Institute; and 
(4) meets price, quality, manufacturing con-
centration, manufacturing complexity, and other ap-
propriate metrics as determined by the Secretary. 
SEC. 4. DISTRIBUTIONS FROM ESSENTIAL PEDIATRIC CAN-
CER DRUG RESERVE SUPPLIES. 
(a) IN GENERAL.—If a covered pediatric cancer drug 
is in shortage (as defined in section 506C(h) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 356c(h))), 
or the Secretary has reason to believe that such a drug 
may be at risk of such a shortage, the Secretary may order 
a manufacturer with whom the Secretary has entered into 
an agreement under section 2 to distribute such drug from 
the reserve supply in accordance with such agreement in 
an effort to alleviate or prevent the shortage. 
(b) PAYMENTS FOR DISTRIBUTION.— 
(1) IN GENERAL.—The Secretary shall require 
a recipient of a covered pediatric cancer drug dis-
tributed under subsection (a) to pay the Secretary 
for such drug. The amount of such payment shall 
not exceed the price for which the Secretary pur-
chased such drug pursuant to an agreement under 
section 2. 
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(1) the essential pediatric cancer drug list in ef-
fect during the year covered by the report (including 
any changes made to the list throughout the year); 
(2) the total number of agreements entered into 
under section 2 during such year; 
(3) the total amount of each covered pediatric 
cancer drug purchased by the Secretary pursuant to 
such agreements during such year; 
(4) the total amount of each covered pediatric 
cancer drug distributed from the reserve supplies 
under section 4 during such year; and 
(5) any other information that the Secretary 
determines relevant. 
SEC. 6. DEFINITIONS. 
In this Act: 
(1) COVERED PEDIATRIC CANCER DRUG.—The 
term ‘‘covered pediatric cancer drug’’ means a 
drug— 
(A) that is included on the essential pedi-
atric cancer drug list established under section 
3; 
(B) that may be at risk of a meaningful 
disruption (as defined in section 506J(j) of the 
Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 356j(j))) in the supply of the drug; and 
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(C) whose final dosage form is manufac-
tured at an eligible source facility. 
(2) DRUG.—The term ‘‘drug’’— 
(A) means a drug (as defined in section 
201(g) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 321(g))); and 
(B) includes a biological product (as de-
fined in section 351(i) of the Public Health 
Service Act (42 U.S.C. 262(i))). 
(3) ELIGIBLE
SOURCE
FACILITY.—The term 
‘‘eligible source facility’’ means a facility— 
(A) registered under section 510 of the 
Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360); 
(B) lawfully manufacturing a covered pedi-
atric cancer drug; and 
(C) located in— 
(i) the United States; or 
(ii) a country that is a member of the 
Organisation for Economic Co-operation 
and Development. 
(4) ESSENTIAL
PEDIATRIC
CANCER
DRUG 
LIST.—The term ‘‘essential pediatric cancer drug 
list’’ means the list under section 3(a). 
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(5) SECRETARY.—The term ‘‘Secretary’’ means 
the Secretary of Health and Human Services. 
(6) 
UNITED
STATES.—The 
term 
‘‘United 
States’’ means each of the several States and the 
territories and possessions of the United States. 
SEC. 7. AUTHORIZATION OF APPROPRIATIONS. 
To carry out this Act, there are authorized to be ap-
propriated $500,000,000 for fiscal year 2024, to remain 
available until expended. 
Æ 
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