I ask unanimous consent that the text of the bill be printed in the Record. There being no objection, the text of the bill was ordered to be printed in the Record, as follows: S. 4878 Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, SECTION 1. SHORT TITLE. This Act may be cited as the ``Reforming Evergreening and Manipulation that Extends Drug Years Act'' or the ``REMEDY Act''. SEC. 2. AMENDMENTS TO ANDA APPROVAL PROVISIONS. Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) is amended-- (1) in subsection (c)(2) by adding at the end the following: ``With respect to a drug approved on or after the date of enactment of the Reforming Evergreening and Manipulation that Extends Drug Years Act, when a holder of an approved application first files information under this paragraph with respect to one or more patents described in subsection (b)(1)(A)(viii), the holder shall select one such patent with respect to which the owner or licensee may receive the 30-month stay under paragraph (3)(C), as applicable; for purposes of paragraphs (3)(C) and (3)(E) and subsections (j)(5)(D)(iii) and (j)(5)(F)(ii), such patent shall be referred to as the `covered patent'.…
On the recordJuly 31, 2024
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