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