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[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.
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