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[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 4878 Introduced in Senate (IS)]

<DOC>

118th CONGRESS
  2d Session
                                S. 4878

   To amend the Federal Food, Drug, and Cosmetic Act with respect to 
             approval of abbreviated new drug applications.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                             July 31, 2024

Mr. Durbin (for himself and Mr. Cassidy) introduced the following bill; 
     which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL

 
   To amend the Federal Food, Drug, and Cosmetic Act with respect to 
             approval of abbreviated new drug applications.

    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 
                        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''.
                                 <all>
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