1.This Act may be cited as
the Lower Prices Reduced with Increased Competition and Efficient
Development of Drugs Act
or the Lower PRICED Drugs Act
.
2.Generic drug use
certification
(a)Section 505(j)(2)(A)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(2)(A)) is
amended—
(1)in clause (vii),
by striking ; and
and inserting a semicolon;
(2)in clause (viii),
by striking the period and inserting ; and
;
(3)by inserting
after clause (viii) the following:
(ix)if with respect to a listed drug
product referred to in clause (i) that contains an antibiotic drug and the
antibiotic drug was the subject of any application for marketing received by
the Secretary under section 507 (as in effect before the date of enactment of
the Food and Drug Administration Modernization Act of 1997) before November 20,
1997, the approved labeling includes a method of use which, in the opinion of
the applicant, is claimed by any patent, a statement that—
(I)identifies the relevant patent and
the approved use covered by the patent; and
(II)the applicant is not seeking
approval of such use under this
subsection.
;
and
(4)in the last
sentence, by striking clauses (i) through (viii)
and inserting
clauses (i) through (ix)
.
(b)The amendments made by this section shall apply to any
abbreviated new drug application under section 505(j) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(j)) that is submitted on, before, or
after the date of enactment of this Act.
3.Preventing abuse
of the thirty-month stay-of-effectiveness period
(a)Section
505(j)(5)(B)(iii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(5)(B)(iii)) is amended—
(1)in the second sentence by striking
may order
and inserting shall order
; and
(2)by adding at the
end the following: In determining whether to shorten the thirty-month
period under this clause, the court shall consider the totality of the
circumstances, including whether the plaintiff sought to extend the discovery
schedule, delayed producing discovery, or otherwise acted in a dilatory manner,
and the public interest.
.
(b)The amendments made by this section shall apply to any stay
of effectiveness period under section 505(j)(5)(B)(iii) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)(B)(iii)) pending or filed on or
after the date of enactment of this Act.
4.Ensuring proper
use of pediatric exclusivity
(a)Section 505A of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355a) is amended by striking drug
each place it
appears and inserting drug product
.
(b)Market
exclusivity for new drugsSection 505A(b) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355a(b)) is amended—
(1)in the matter
preceding paragraph (1), by—
(A)striking
health
and inserting therapeutically
meaningful
;
(B)striking
and
after (which shall include a timeframe for completing
such studies),
; and
(C)inserting
, and based on the results of such studies the Secretary approves
labeling for the new drug product that provides specific, therapeutically
meaningful information about the use of the drug product in pediatric
patients
after in accordance with subsection
(d)(3)
;
(2)in paragraph
(1)(A)—
(A)in clause (i),
by—
(i)striking
the period
and inserting any period
; and
(ii)inserting
that is applicable to the drug product at the time of initial
approval
after in subsection (j)(5)(F)(ii) of such
section
; and
(B)in clause (ii),
by—
(i)striking
the period
and inserting any period
; and
(ii)inserting
that is applicable to the drug product at the time of initial
approval
after of subsection (j)(5)(F) of such section
;
and
(3)in paragraph
(2)—
(A)in subparagraph
(A)—
(i)in
clause (i), by striking a listed patent
and inserting a
patent that was either listed when the pediatric study was submitted to the
Food and Drug Administration or listed as a result of the approval by the Food
and Drug Administration of new pediatric labeling that is claimed by the
patent, and
; and
(ii)in
clause (ii) by striking a listed patent
and inserting a
patent that was either listed when the pediatric study was submitted to the
Food and Drug Administration or listed as a result of the approval by the Food
and Drug Administration of new pediatric labeling that is claimed by the
patent, and
; and
(B)in subparagraph
(B), by striking a listed patent
and inserting a patent
that was either listed when the pediatric study was submitted to the Food and
Drug Administration or listed as a result of the approval by the Food and Drug
Administration of new pediatric labeling that is claimed by the patent,
and
.
(c)Market
exclusivity for already-Marketed drugsSection 505A(c) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a(c)) is amended—
(1)in the matter
preceding paragraph (1), by—
(A)striking
health
and inserting therapeutically
meaningful
;
(B)striking
and
after the studies are completed within any such
timeframe,
; and
(C)inserting
, and based on the results of such studies the Secretary approves
labeling for the approved drug product that provides specific, therapeutically
meaningful information about the use of the drug product in pediatric
patients
after in accordance with subsection
(d)(3)
;
(2)in paragraph
(1)(A)—
(A)in clause
(i)—
(i)by
striking the period
and inserting any period
;
and
(ii)by
inserting that is applicable to the drug product at the time of initial
approval
after in subsection (j)(5)(F)(ii) of such
section
; and
(B)in clause
(ii)—
(i)by
striking the period
and inserting any period
;
and
(ii)by
inserting that is applicable to the drug product at the time of initial
approval
after of subsection (j)(5)(F) of such section
;
and
(3)in paragraph
(2)—
(A)in subparagraph
(A)—
(i)in
clause (i), by striking a listed patent
and inserting a
patent that was either listed when the pediatric study was submitted to the
Food and Drug Administration or listed as a result of the approval by the Food
and Drug Administration of new pediatric labeling that is claimed by the
patent, and
; and
(ii)in
clause (ii), by striking a listed patent
and inserting a
patent that was either listed when the pediatric study was submitted to the
Food and Drug Administration or listed as a result of the approval by the Food
and Drug Administration of new pediatric labeling that is claimed by the
patent, and
; and
(B)in subparagraph
(B), by striking a listed patent
and by inserting a
patent that was either listed when the pediatric study was submitted to the
Food and Drug Administration or listed as a result of the approval by the Food
and Drug Administration of new pediatric labeling that is claimed by the
patent, and
.
(d)Section 505A of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355a) is amended by—
(1)by striking
six months
each place it appears and inserting three
months
;
(2)by striking
six-month
each place it appears and inserting
three-month
;
(3)by striking
6-month
each place it appears and inserting
three-month
;
(4)in subsection
(b)(1)(A)(i), by striking four and one-half years, fifty-four months,
and eight years, respectively
and inserting four years and three
months, fifty-one months, and seven years and nine months,
respectively
; and
(5)in subsection
(c)(1)(A)(i), by striking four and one-half years, fifty-four months,
and eight years, respectively
and inserting four years and three
months, fifty-one months, and seven years and nine months,
respectively
.
(e)Section
505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) is amended by
adding at the end the following:
(o)
(1)For purposes of this section, the term drug
product has the same meaning given such term in section 314.3(b) of
title 21, Code of Federal Regulations (or any successor regulation).
(2)For purposes of this section, each dosage form of a drug
product shall constitute a different drug
product.
.
(f)Section 505A of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355a) is amended—
(1)by striking
subsection (c)(3)(D)
each place it appears and inserting
subsection (c)(3)(E)
; and
(2)in subsection
(n), by striking under subsection (a) or (c)
and inserting
under subsection (b) or (c)
.
(g)The amendments made by
this section shall apply to requests by the Secretary of Health and Human
Services for pediatric studies under section 505A of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355a) after the date of enactment of this
Act.
5.Citizen
petitions and petitions for stay of agency actionSection 505 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355) is amended by adding at the end the
following:
(o)Citizens
petitions and petitions for stay of agency actionWith respect to
any petition that seeks to have the Secretary take, or refrain from taking, any
form of action relating to the approval of an application submitted under
subsection (b)(2) or (j), the following shall apply:
(1)The Secretary shall not delay approval of an application
submitted under subsection (b)(2) or (j) while a petition is reviewed and
considered. Consideration of a petition shall be separate and apart from the
review and approval of an application submitted under either such
subsection.
(2)Timing of final
agency actionThe Secretary shall take final agency action with
respect to a petition within six months of receipt of that petition. The
Secretary shall not extend such six-month review period, even with consent of
the petitioner, for any reason, including based upon the submission of comments
relating to a petition or supplemental information supplied by the petitioner.
If the Secretary has not taken final agency action on a petition by the date
that is six months after the date of receipt of the petition, such petition
shall be deemed to have been denied on such date.
(3)The
Secretary shall not accept for review a petition unless it is signed and
contains the following verification: I certify that, to my best
knowledge and belief: (a) this petition includes all information and views upon
which the petition relies; (b) this petition includes representative data
and/or information known to the petitioner which are unfavorable to the
petition; and (c) I have taken reasonable steps to ensure that any
representative data and/or information which are unfavorable to the petition
were disclosed to me. I further certify that the information upon which I have
based the action requested herein first became known to the party on whose
behalf this petition is filed on or about __________. I verify under penalty of
perjury that the foregoing is true and correct.
, with the date of the
filing of such petition inserted in the blank space.
(4)The thirty-month period referred to in subsection
(j)(5)(D)(i)(IV) shall automatically be extended by the amount of time that
lapses from the date that the Secretary receives a petition and the date of
final agency action on that petition, without regard to whether the Secretary
grants, in whole or in part, or denies, in whole or in part, that
petition.
.