Sec. 2. Establishment of essential pediatric cancer drug marketplace stability pilot program
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/bill/118/hr/6963/ih/section-2A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
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. 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. To the greatest extent practicable, the Secretary shall implement the pilot program under this section in a manner that— minimizes the impact on the marketplace for drugs included on the essential pediatric cancer drug list established under section 3; increases domestic manufacturing capacity; encourages competition in the marketplace; 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 rewards manufacturing quality. Each agreement under this section between the Secretary and a manufacturer of a covered pediatric cancer drug shall include the following: The identity and quantity of each covered pediatric cancer drug that the manufacturer agrees to hold in reserve supply. 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. A provision to ensure that each drug held in reserve supply has an expiration date at least 1 year beyond the current date. 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). A requirement that the covered pediatric cancer drugs in reserve supply may only be held at a location in the United States. 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)— by storing the drug at an establishment located in the United States that is— registered under section 510 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360 ); and under common ownership and control with the manufacturer; or 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. A requirement that any covered pediatric cancer drug held in reserve supply be manufactured and held in accordance with— good manufacturing practice requirements; 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 applicable law. 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— on an annual basis; or 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. A requirement that the manufacturer certify to the Secretary on an annual basis compliance with the terms of the agreement. 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— as the Secretary determines necessary to ensure sufficient amounts of such drugs; or as the Secretary determines necessary to carry out or improve preparedness and response capability at the State and local levels. 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. The amount paid to each manufacturer pursuant to an agreement with the Secretary under this section shall be based on— the quantity of each covered pediatric cancer drug the manufacturer agrees to hold in reserve supply; and the wholesale acquisition cost of each such drug. 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. 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. 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. 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— forfeit any payments it has received under the agreement; and not later than 30 days after the date of such inability or failure, refund such payments.
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Sec. 2
Establishment of essential pediatric cancer drug marketplace stability pilot program
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