Sec. 2. Fast track review for certain generic drugs
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Section 505(j) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j) ) is amended by adding at the end the following: Notwithstanding any other provision of law, the Secretary shall prioritize the review of a qualifying application under this subsection and shall, within 150 days of the initial receipt of such qualifying application, take final agency action on the application. For purposes of this paragraph, the term qualifying application means an application— that does not contain a certification under subclause
(IV)of paragraph (2)(A)(vii); that may contain a certification under subclause
(III)of paragraph (2)(A)(vii) only if such certification asserts that an existing patent will expire not more than 5 months after the date of such certification; for a drug where the reference drug is a drug for which there is no exclusivity period in effect, including an exclusivity period under paragraph (5)(F), or under section 505A, section 527, or section 505E; and for a drug where the reference drug has not been the reference drug for more than one other drug that— is approved under this subsection; and has been introduced into interstate commerce in the 3-month period preceding the date of the qualifying application. Notwithstanding any other provision of this paragraph and regardless of the date of submission, a qualifying application shall lose status as an application for priority review, and the Secretary’s timeline for taking action on such an application described in subparagraph
(A)shall no longer apply, if the application no longer meets the definition of a qualifying application. .
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Sec. 2
Fast track review for certain generic drugs
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