S.Amdt. 2135

1. Adds SEC. 10__. CRITICAL DRUG SUPPLY REINFORCEMENT PROGRAM at the end of title X

   Adds a section

   In S. 3187 · Placed on Calendar Senate

   (e) Guidance Regarding Repackaging.--Not later than 1 year after the date of enactment of this Act, the Secretary shall issue guidance that clarifies the policy of the Food and Drug Administration regarding hospital pharmacies repackaging and safely transferring repackaged drugs among hospitals within a common health system during a drug shortage, as identified by the Secretary.

   Inserted: SEC. 10__. CRITICAL DRUG SUPPLY REINFORCEMENT PROGRAM.

   Inserted: Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by adding at the end the following:

   Inserted: "Subchapter G--Drug Shortages "SEC. 575. DEFINITIONS.

   Inserted: "For purposes of this subchapter--

   Inserted: "(1) the term 'critical reinforcement drug' means a drug that--

   Inserted: "(A) is the subject of a permanent discontinuance or an interruption in the manufacture of the drug that could lead to a meaningful disruption in the supply of that drug in the United States, as defined in section 506C(f)(3); and

   Inserted: "(B) is identified as vulnerable to a drug shortage based on the criteria established under section 575A;

   Inserted: "(2) the term 'drug'--

   Inserted: "(A) means a drug (as defined in section 201(g)) that is intended for human use and is the subject of an approved application under section 505(j); and

   Inserted: "(B) does not include biological products (as defined in section 351 of the Public Health Service Act); and

   Inserted: "(3) the term 'drug shortage' or 'shortage', with respect to a drug, means a period of time when the demand or projected demand for the drug within the United States exceeds the supply of the drug.

   Inserted: "SEC. 575A. CRITICAL DRUG SUPPLY EVALUATION AND REINFORCEMENT.

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   Inserted: "(a) Development of Criteria for Evaluation of Critical Reinforcement Need.--

   Inserted: "(1) Evaluation.--Not later than 180 days after the date of enactment of this section, the Secretary, in consultation with Office of Drug Shortages, shall conduct an evaluation to establish evidence-based criteria for identifying drugs that are vulnerable to a drug shortage.

   Inserted: "(2) Content.--The evaluation under paragraph (1) shall include a comprehensive trend analysis to forecast drug shortages and target drugs that are vulnerable to a shortage. The Secretary is authorized to contract with a third party to conduct or participate in such evaluation. In conducting such evaluation, the Secretary or any authorized third party shall not use any confidential, trade secret, or proprietary information of any other entity without such entity's consent.

   Inserted: "(3) Consultation with stakeholders.--The Secretary, as part of the evaluation under paragraph (1), shall convene a discussion with stakeholders to assess methodology and findings applicable to such evaluation.

   Inserted: "(4) Report to congress.--Not later than 2 years after the date of enactment of this section, the Secretary shall submit a report to Congress that describes the methods and processes used to conduct the evaluation under this subsection.

   Inserted: "(b) Critical Reinforcement.--To carry out this section, the Secretary may award the incentives under subsection (d) to qualified manufacturers to secure an agreement--

   Inserted: "(1) for the rapid production of a critical reinforcement drug;

   Inserted: "(2) that the qualified manufacturer will maintain production of a critical reinforcement drug; or

   Inserted: "(3) that would allow the Secretary to purchase supply of a critical reinforcement drug from the qualified manufacturer under certain market conditions and on terms and conditions mutually agreed upon.

   Inserted: "(c) Qualified Manufacturers.--To be a qualified manufacturer for purposes of this section--

   Inserted: "(1) an entity shall be a drug manufacturer; and

   Inserted: "(2) the Secretary shall ensure that the manufacturer--

   Inserted: "(A) is in compliance with good manufacturing practice regulations of the Food and Drug Administration to produce a critical reinforcement drug or a similar product; and

   Inserted: "(B)(i) currently produces a critical reinforcement drug or a similar product and can increase production immediately to address the shortage with no regulatory approvals required;

   Inserted: "(ii) does not currently produce a critical reinforcement drug but has the capability, capacity and regulatory authority to do so and could commence supply in time to address need; or

   Inserted: "(iii) has capability and capacity to produce a critical reinforcement drug but not the regulatory authority and could commence supply upon regulatory filing and approval.

   Inserted: "(d) Incentives.--

   Inserted: "(1) In general.--If the Secretary ensures a manufacturer is a qualified manufacturer, the Secretary shall negotiate a manufacturing contingency plan with the manufacturer to meet an identified critical reinforcement in subsection (c). The Secretary may--

   Inserted: "(A) expedite the review of any abbreviated new drug application submitted under section 505 by the qualified manufacturer for a drug that is vulnerable to shortage as identified pursuant to the criteria established under subsection (a); and

   Inserted: "(B) waive any application fees related to such an abbreviated new drug application.

   Inserted: "(2) Limitation.--If the qualified manufacturer fails to meet benchmarks specified by the Secretary in the agreement between the Secretary and the manufacturer, or otherwise violates such agreement, the Secretary may retroactively assess the application fees waived under paragraph (1)(B).

   Inserted: "(e) Trademark Protection.--Nothing in this section shall be construed to alter or modify in any way, any applicable patent, copyright, trademark, or other intellectual property rights of any holder of a new drug application, an abbreviated new drug application, or a biologics license application, including any applicable regulatory exclusivity periods or periods during which the Secretary may not accept for filing or approve any new drug application, an abbreviated new drug application, or a biologics license application, and procedures associated therewith, under this Act or the Public Health Service Act.".

   Original wording

   At the end of title X, add the following:

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As printed