[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''.
______