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Does -- 21 USC 355-2: Actions for delays

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iwishiknew   Friday, 09/11/20 07:35:56 PM
Re: None
Post # of 348175 
Does -- 21 USC 355-2: Actions for delays of generic drugs and biosimilar biological products --affect the generic's access to the API

To find this go to https://uscode.house.gov/advancedSearch.xhtml ....
Search in version: CURRENT +
SEARCH IN TITLE: 21 +
SEARCH FOR: REMS

I suggest you find this section mentioned above.
Some snippets from this follow to give you my concerns re generics having difficulty getting API. I'm not a lawyer (and barely litterate in my reading anything related to US code) so I might be totally wrong re my concerns.

From the above:
commercially reasonable, market-based terms" means- nondiscriminatory price for the sale of the covered product at or below, but not greater than, the most recent wholesale acquisition cost for the drug
"covered product" means- any drug approved under subsection (c) or (j) of section 355 of this title or biological product licensed under subsection (a) or (k) of section 262 of title 42 and does not include any drug or biological product that appears on the drug shortage list in effect under section 356e of this title, unless-
(i) the drug or biological product has been on the drug shortage list in effect under such section 356e of this title continuously for more than 6 months or Secretary determines that inclusion of the drug or biological product as a covered product is likely to contribute to alleviating or preventing a shortage
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 355 of this title or for licensing pursuant to an application under section 262(k) of title 42;

Civil action for failure to provide sufficient quantities of a covered product
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 term
as of the date on which the civil action is filed, the eligible product developer has not obtained sufficient quantities of the covered product on commercially reasonable, market-based terms;
that the license holder has not delivered to the eligible product developer sufficient quantities of the covered product on commercially reasonable, market-based terms-

Affirmative defense
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-

(A) that, on the date on which the eligible product developer requested to purchase sufficient quantities of the covered product from the license holder-
(i) 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
(ii) 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;
(B) that-
(i) the license holder sells the covered product through agents, distributors, or wholesalers;
(ii) 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
(iii) 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
4) Remedies
(A) In general
If an eligible product developer prevails in a civil action brought under paragraph (1), the court shall-
(i) 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;
(ii) award to the eligible product developer reasonable attorney's fees and costs of the civil action; and
(iii) award to the eligible product developer a monetary amount sufficient to deter the license holder from failing to provide 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-
B) Maximum monetary amount
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-

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