Sec. 342. Preventing blocking of generic drugs
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/bill/118/hr/10409/ih/section-342·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Section 505(j)(5)(B)(iv) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j)(5)(B)(iv) ) is amended— in subclause (I), by striking 180 days after the date and all that follows through by any first applicant and inserting 180 days after the earlier of the dates described in items
(aa)and
(bb)of subclause
(II); by redesignating subclause
(II)as subclause (III); and by inserting after subclause
(I)the following: The date described in this item is the date of the first commercial marketing of the drug (including the commercial marketing of the listed drug) by any first applicant. The date described in this item is the date on which all of the following conditions are first met, provided no application submitted by any first applicant is approved on or before such date: An application for the drug submitted by an applicant other than a first applicant has received tentative approval and could receive approval, if no first applicant were eligible for 180-day exclusivity under this clause, and such applicant has not entered into an agreement that would prevent commercial marketing upon approval and has submitted a notification to the Secretary documenting that it has not entered into an agreement that would prevent commercial marketing. Thirty-three months have passed since the date of submission of an application for the drug by one first applicant, if there is only one first applicant, or, in the case of more than one first applicant, 33 months have passed since the date of submission of all such applications. Approval of an application for the drug submitted by at least one first applicant would not be precluded under clause (iii). . Not later than 60 days after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this subsection as the Secretary ) shall publish, as appropriate and available, information sufficient to allow applicants to assess whether the conditions described in subitems
(AA)through
(CC)of section 505(j)(5)(B)(iv)(II)(bb) of the Federal Food, Drug, and Cosmetic Act (as amended by subsection (a)) have been or will be satisfied for all applications where the exclusivity period under (iv)(I) of section 505(j)(5)(B) of the Federal Food, Drug, and Cosmetic Act (as so amended) has not expired, and shall provide updates to reflect the most recent information available to the Secretary.
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Sec. 342
Preventing blocking of generic drugs
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