[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6963 Introduced in House (IH)]
<DOC>
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.
Be it enacted by the Senate and House of Representatives 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''.
SEC. 2. ESTABLISHMENT OF ESSENTIAL PEDIATRIC CANCER DRUG MARKETPLACE
STABILITY PILOT PROGRAM.
(a) In General.--The Secretary shall carry out a pilot program
under which the Secretary enters into agreements 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 manufacturers.--To the greatest
extent practicable, the Secretary 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 marketplace for
drugs included on the essential pediatric cancer drug
list established under section 3;
(B) increases domestic manufacturing capacity;
(C) encourages competition in the marketplace;
(D) assures that any covered pediatric cancer drugs
that the Secretary distributes or orders 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 covered
pediatric cancer drug that the manufacturer agrees to
hold in reserve supply.
(B) A requirement that such quantities shall be in
addition to the average levels of inventory for the
relevant covered pediatric cancer drug held by the
manufacturer during the previous 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 described in subparagraph (C).
(E) A requirement that the covered pediatric cancer
drugs in reserve supply may only be held at a location
in the United States.
(F) In the case of a covered pediatric cancer drug
manufactured at an eligible source facility 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 establishment
located in the United States that is--
(I) registered under section 510 of
the Federal Food, Drug, and Cosmetic
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 pediatric cancer
drug held in reserve supply be manufactured and held in
accordance with--
(i) good manufacturing practice
requirements;
(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 agreement or
applicable law.
(I) A requirement that the manufacturer certify to
the Secretary on an annual basis compliance with the
terms of the agreement.
(4) Optional terms for acquisition, construction,
alteration, or renovation of establishment.--An agreement under
this section between the Secretary and a manufacturer of a
covered pediatric cancer drug may include a provision to allow
the manufacturer to acquire, construct, alter, or renovate a
non-federally owned establishment for the purpose of
manufacturing covered pediatric 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 response 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
covered pediatric cancer drugs that will be held in reserve
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--
(i) the quantity of each covered pediatric
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 supply adequacy.--
(A) In general.--Except as provided in subparagraph
(B), each agreement with a manufacturer 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 cancer drug
to be held in reserve supply under the agreement.
(B) Exceptions for advance payment.--An agreement
under this section may provide that, if the Secretary
determines that an advance payment or partial payment
for significant milestones is necessary to ensure
success of the terms of the agreement, the Secretary
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 accordance 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 Director of the National Cancer
Institute, shall--
(1) not later than 150 days after the date of enactment of
this Act, develop a list of chemotherapeutic drugs that are
essential for treating 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 Federal 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
(D) the PDQ Cancer Information Summaries for Health
Professionals of the National Cancer Institute; and
(4) meets price, quality, manufacturing concentration,
manufacturing complexity, and other appropriate metrics as
determined by the Secretary.
SEC. 4. DISTRIBUTIONS FROM ESSENTIAL PEDIATRIC CANCER DRUG RESERVE
SUPPLIES.
(a) In General.--If a covered pediatric cancer drug is in shortage
(as defined in section 506C(h) of the Federal 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 distributed under subsection
(a) to pay the Secretary for such drug. The amount of such
payment shall not exceed the price for which the Secretary
purchased such drug pursuant to an agreement under section 2.
(2) Limitation.--The Secretary may use payments received
pursuant to paragraph (1) only to replenish the reserve supply
of the drugs distributed under subsection (a).
(c) Inability To Distribute or Manage Reserve Supply.--
(1) Inability to distribute.--If a manufacturer is not able
or willing to distribute drugs in accordance with an order of
the Secretary under subsection (a), the Secretary may take
possession of and distribute such drugs.
(2) Inability to manage reserve supply.--If a manufacturer
can no longer hold or manage a reserve supply of covered
pediatric cancer drugs in accordance with an agreement under
section 2, the Secretary may take possession of the reserve
supply.
SEC. 5. REPORTS TO CONGRESS.
(a) In General.--For each year 1 or more drugs are held by a
manufacturer in reserve supply pursuant to an agreement under section
2, the Secretary shall submit to Congress a report on the progress of
the pilot program under such section.
(b) Contents.--The reports referred to in subsection (a) shall each
include--
(1) the essential pediatric cancer drug list in effect
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 pediatric
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
(C) whose final dosage form is manufactured 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 Cosmetic Act (21 U.S.C.
321(g))); and
(B) includes a biological product (as defined 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 pediatric
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).
(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 appropriated
$500,000,000 for fiscal year 2024, to remain available until expended.
<all>