119-s2620

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 2620 Introduced in Senate

    (IS) ]

<DOC>

119th CONGRESS
 1st Session
 S. 2620

 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, 2025

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 be 
 eligible for the thirty-month period under paragraph

    (3)
            (C) or 
 subsection

    (j)

    (5)
        (B)
            (iii) , as applicable; for purposes of 
 paragraphs

    (3)
            (C) and

    (3)
        (E)
            (ii) and subsections

    (j)

    (5)
        (B)
            (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) 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) ) 
 that is the subject of the certification and 
 for which information was submitted to the 
 Secretary under 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 for which the 
 requirements are met for the thirty-month period described in 
 subparagraph
            (C) '' 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
            (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) ) that is the 
 subject of the certification and for which 
 information was submitted to the Secretary 
 under 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 for which the 
 requirements are met for the thirty-month period described in 
 subparagraph
        (B)
            (iii) ,'' after ``action for patent 
 infringement''.
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