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