[Congressional Record Volume 170, Number 125 (Wednesday, July 31, 2024)]
[Senate]
[Pages S5684-S5685]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. DURBIN (for himself and Mr. Cassidy):
  S. 4878. A bill to amend the Federal Food, Drug, and Cosmetic Act 
with respect to approval of abbreviated new drug applications; to the 
Committee on Health, Education, Labor, and Pensions.
  Mr. DURBIN. Madam President, 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'. The selection 
     of such covered patent may not be changed or amended.'';
       (2) in subsection (c)(3)(C)--
       (A) in the matter preceding clause (i)--
       (i) by striking ``an action is brought for infringement'' 
     and all that follows through the period at the end of the 
     first sentence and inserting ``with respect to a drug 
     approved under this subsection before the date of enactment 
     of the Reforming Evergreening and Manipulation that Extends 
     Drug Years Act, an action is brought for infringement of any 
     patent that is the subject of the certification and for which 
     information was submitted to the Secretary under paragraph 
     (2) or subsection (b)(1) before the date on which the 
     application (excluding an amendment or supplement to the 
     application) was submitted, or, with respect to a drug 
     approved under this subsection on or after the date of 
     enactment of the Reforming Evergreening and Manipulation that 
     Extends Drug Years Act, an action is brought for infringement 
     of the covered patent (as described in paragraph (2)), before 
     the date on which the application (excluding an amendment or 
     supplement to the application) was submitted.''; and
       (ii) by striking ``an action is brought before'' and 
     inserting ``an action with respect to a patent or a covered 
     patent, as applicable, is brought before''; and
       (B) in clause (i), by striking ``decides that the patent'' 
     and inserting ``decides that the patent or the covered 
     patent, as applicable'';
       (3) in the second sentence of subsection (c)(3)(E)(ii), by 
     inserting ``with respect to any patent that claims a drug 
     that was approved under this subsection before the date of 
     enactment of the Reforming Evergreening and Manipulation that 
     Extends Drug Years Act, or, with respect to a covered patent 
     (as described in paragraph (2)) that claims a drug approved 
     under this subsection on or after the date of enactment of 
     such Act,'' after ``action for patent infringement'';
       (4) in subsection (j)(5)(B)(iii)--
       (A) in the matter preceding subclause (I)--
       (i) by striking ``an action is brought for infringement'' 
     and all that follows through the period at the end of the 
     first sentence and inserting ``with respect to a drug 
     approved under subsection (c) before the date of enactment of 
     the Reforming Evergreening and Manipulation that Extends Drug 
     Years Act, an action is brought for infringement of any

[[Page S5685]]

     patent that is the subject of the certification and for which 
     information was submitted to the Secretary under subsection 
     (b)(1) or (c)(2) before the date on which the application 
     (excluding an amendment or supplement to the application), 
     which the Secretary later determines to be substantially 
     complete, was submitted, or, with respect to a drug approved 
     under subsection (c) on or after the date of enactment of the 
     Reforming Evergreening and Manipulation that Extends Drug 
     Years Act, an action is brought for infringement of the 
     covered patent (as described in subsection (c)(2)) before the 
     date on which the application (excluding an amendment or 
     supplement to the application), which the Secretary later 
     determines to be substantially complete, was submitted.''; 
     and
       (ii) by striking ``an action is brought before'' and 
     inserting ``an action with respect to a patent or a covered 
     patent, as applicable, is brought before''; and
       (B) in subclause (I), by striking ``decides that the 
     patent'' and inserting ``decides that the patent or covered 
     patent, as applicable,''; and
       (5) in the second sentence of subsection (j)(5)(F)(ii), by 
     inserting ``with respect to any patent that claims a drug 
     that was approved under subsection (c) before the date of 
     enactment of the Reforming Evergreening and Manipulation that 
     Extends Drug Years Act, or, with respect to a covered patent 
     (as described in subsection (c)(2)) that claims a drug 
     approved under subsection (c) on or after the date of 
     enactment of such Act,'' after ``action for patent 
     infringement''.
                                 ______