Sec. 301. Actions for delays of generic drugs and biosimilar biological products

1,688 words·~8 min read·/bill/116/hr/1332/ih/section-301·

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

In this section— the term covered product — means— any drug approved under subsection

(b)or

(j)of section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) or biological product licensed under subsection

(a)or

(k)of section 351 of the Public Health Service Act ( 42 U.S.C. 262 ); any combination of a drug or biological product described in clause (i); or when reasonably necessary to demonstrate sameness, biosimilarity, or interchangeability for purposes of 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 ), as applicable, any product, including any device, that is marketed or intended for use with such drug or biological product; and does not include any drug or biological product that the Secretary has determined to be currently in shortage and that appears on the drug shortage list in effect under section 506E of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356e ), unless the shortage will not be promptly resolved— as demonstrated by the fact that the drug or biological product has been in shortage for more than 6 months; or as otherwise determined by the Secretary; the term device has the meaning given the term in section 201 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321 ); the term eligible product developer means a person that seeks to develop a product for approval pursuant to an application for approval under subsection (b)(2) or

(j)of section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) or for licensing pursuant to an application under section 351(k) of the Public Health Service Act ( 42 U.S.C. 262(k) ); the term license holder means the holder of an application approved under subsection

(c)or

(j)of section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) or the holder of a license under subsection

(a)or

(k)of section 351 of the Public Health Service Act ( 42 U.S.C. 262 ) for a covered product; the term REMS means a risk evaluation and mitigation strategy under section 505–1 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355–1 ); the term REMS with ETASU means a REMS that contains elements to assure safe use under section 505–1 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355–1 ); the term Secretary means the Secretary of Health and Human Services; the term single, shared system of elements to assure safe use means a single, shared system of elements to assure safe use under section 505–1 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355–1 ); and the term sufficient quantities means an amount of a covered product that allows the eligible product developer to— conduct testing to support an application— for approval under subsection (b)(2) or

(j)of section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ); or for licensing under section 351(k) of the Public Health Service Act ( 42 U.S.C. 262(k) ); and fulfill any regulatory requirements relating to such an application for approval or licensing. An eligible product developer may bring a civil action against the license holder for a covered product seeking relief under this subsection in an appropriate district court of the United States alleging that the license holder has declined to provide sufficient quantities of the covered product to the eligible product developer on commercially reasonable, market-based terms. To prevail in a civil action brought under paragraph (1), an eligible product developer shall prove, by a preponderance of the evidence— that— the covered product is not subject to a REMS with ETASU; or if the covered product is subject to a REMS with ETASU— the eligible product developer has obtained a covered product authorization from the Secretary in accordance with subparagraph (B); and the eligible product developer has provided a copy of the covered product authorization to the license holder; that, as of the date on which the civil action is filed, the product developer has not obtained sufficient quantities of the covered product on commercially reasonable, market-based terms; that the eligible product developer has requested to purchase sufficient quantities of the covered product from the license holder; and that the license holder has not delivered to the eligible product developer sufficient quantities of the covered product on commercially reasonable, market-based terms— for a covered product that is not subject to a REMS with ETASU, by the date that is 31 days after the date on which the license holder received the request for the covered product; and for a covered product that is subject to a REMS with ETASU, by 31 days after the later of— the date on which the license holder received the request for the covered product; or the date on which the license holder received a copy of the covered product authorization issued by the Secretary in accordance with subparagraph (B). An eligible product developer may submit to the Secretary a written request for the eligible product developer to be authorized to obtain sufficient quantities of an individual covered product subject to a REMS with ETASU. Not later than 90 days after the date on which a request under clause

(i)is received, the Secretary shall, by written notice, authorize the eligible product developer to obtain sufficient quantities of an individual covered product subject to a REMS with ETASU for purposes of— development and testing that does not involve human clinical trials, if the eligible product developer has agreed to comply with any conditions the Secretary determines necessary; or development and testing that involves human clinical trials, if the eligible product developer has— submitted protocols, informed consent documents, and informational materials for testing that include protections that provide safety protections comparable to those provided by the REMS for the covered product; or otherwise satisfied the Secretary that such protections will be provided; and met any other requirements the Secretary may establish. A covered product authorization issued under this subparagraph shall state that the provision of the covered product by the license holder under the terms of the authorization will not be a violation of the REMS for the covered product. In a civil action brought under paragraph (1), it shall be an affirmative defense, on which the defendant has the burden of persuasion by a preponderance of the evidence— that, on the date on which the eligible product developer requested to purchase sufficient quantities of the covered product from the license holder— neither the license holder nor any of its agents, wholesalers, or distributors was engaged in the manufacturing or commercial marketing of the covered product; and neither the license holder nor any of its agents, wholesalers, or distributors otherwise had access to inventory of the covered product to supply to the eligible product developer on commercially reasonable, market-based terms; or that— the license holder sells the covered product through agents, distributors, or wholesalers; the license holder has placed no restrictions, explicit or implicit, on its agents, distributors, or wholesalers to sell covered products to eligible product developers; and the covered product can be purchased by the eligible product developer in sufficient quantities on commercially reasonable, market-based terms from the agents, distributors, or wholesalers of the license holder. If an eligible product developer prevails in a civil action brought under paragraph (1), the court shall— order the license holder to provide to the eligible product developer without delay sufficient quantities of the covered product on commercially reasonable, market-based terms; award to the eligible product developer reasonable attorney fees and costs of the civil action; and award to the eligible product developer a monetary amount sufficient to deter the license holder from failing to provide other eligible product developers with sufficient quantities of a covered product on commercially reasonable, market-based terms, if the court finds, by a preponderance of the evidence— that the license holder delayed providing sufficient quantities of the covered product to the eligible product developer without a legitimate business justification; or that the license holder failed to comply with an order issued under clause (i). A monetary amount awarded under subparagraph (A)(iii) shall not be greater than the revenue that the license holder earned on the covered product during the period— beginning on— for a covered product that is not subject to a REMS with ETASU, the date that is 31 days after the date on which the license holder received the request; or for a covered product that is subject to a REMS with ETASU, the date that is 31 days after the later of— the date on which the license holder received the request; or the date on which the license holder received a copy of the covered product authorization issued by the Secretary in accordance with paragraph (2)(B); and ending on the date on which the eligible product developer received sufficient quantities of the covered product. The court may issue an order under subparagraph (A)(i) before conducting further proceedings that may be necessary to determine whether the eligible product developer is entitled to an award under clause

(ii)or

(iii)of subparagraph (A), or the amount of any such award. A license holder for a covered product shall not be liable for any claim arising out of the failure of an eligible product developer to follow adequate safeguards to assure safe use of the covered product during development or testing activities described in this section, including transportation, handling, use, or disposal of the covered product by the eligible product developer. In this subsection, the term antitrust laws — has the meaning given the term in subsection

(a)of the first section of the Clayton Act ( 15 U.S.C. 12 ); and includes section 5 of the Federal Trade Commission Act ( 15 U.S.C. 45 ) to the extent that such section applies to unfair methods of competition. Nothing in this section shall be construed to limit the operation of any provision of the antitrust laws.

Connectionstraces to 6

Traces to 6 documents

U.S. Code