[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 1067 Reported in Senate (RS)]
<DOC>
Calendar No. 107
118th CONGRESS
1st Session
S. 1067
To amend the Federal Food, Drug, and Cosmetic Act with respect to
citizen petitions.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
March 29, 2023
Mrs. Shaheen (for herself, Ms. Collins, Mr. Bennet, Mr. Rubio, Ms.
Baldwin, and Mr. Braun) introduced the following bill; which was read
twice and referred to the Committee on Health, Education, Labor, and
Pensions
June 22, 2023
Reported by Mr. Sanders, with an amendment
[Strike out all after the enacting clause and insert the part printed
in italic]
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act with respect to
citizen petitions.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
<DELETED>SECTION 1. SHORT TITLE.</DELETED>
<DELETED> This Act may be cited as the ``Ensuring Timely Access to
Generics Act of 2023''.</DELETED>
<DELETED>SEC. 2. ENSURING TIMELY ACCESS TO GENERICS.</DELETED>
<DELETED> Section 505(q) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355(q)) is amended--</DELETED>
<DELETED> (1) in paragraph (1)--</DELETED>
<DELETED> (A) in subparagraph (A)(i), by inserting
``, 10.31,'' after ``10.30'';</DELETED>
<DELETED> (B) in subparagraph (E)--</DELETED>
<DELETED> (i) by striking ``application
and'' and inserting ``application
or'';</DELETED>
<DELETED> (ii) by striking ``If the
Secretary'' and inserting the
following:</DELETED>
<DELETED> ``(i) In general.--If the
Secretary'';</DELETED>
<DELETED> (iii) by striking the second
sentence and inserting the following:</DELETED>
<DELETED> ``(ii) Primary purpose of
delaying.--</DELETED>
<DELETED> ``(I) In general.--In
determining whether a petition was
submitted with the primary purpose of
delaying an application, the Secretary
may consider the following
factors:</DELETED>
<DELETED> ``(aa) Whether the
petition was submitted in
accordance with paragraph
(2)(B), based on when the
petitioner knew or reasonably
should have known the relevant
information relied upon to form
the basis of such
petition.</DELETED>
<DELETED> ``(bb) Whether the
petitioner has submitted
multiple or serial petitions or
supplements to petitions
raising issues that reasonably
could have been known to the
petitioner at the time of
submission of the earlier
petition or
petitions.</DELETED>
<DELETED> ``(cc) Whether the
petition was submitted close in
time to a known, first date
upon which an application under
subsection (b)(2) or (j) of
this section or section 351(k)
of the Public Health Service
Act could be
approved.</DELETED>
<DELETED> ``(dd) Whether the
petition was submitted without
relevant data or information in
support of the scientific
positions forming the basis of
such petition.</DELETED>
<DELETED> ``(ee) Whether the
petition raises the same or
substantially similar issues as
a prior petition to which the
Secretary has responded
substantively already,
including if the subsequent
submission follows such
response from the Secretary
closely in time.</DELETED>
<DELETED> ``(ff) Whether the
petition requests changing the
applicable standards that other
applicants are required to
meet, including requesting
testing, data, or labeling
standards that are more onerous
or rigorous than the standards
the Secretary has determined to
be applicable to the listed
drug, reference product, or
petitioner's version of the
same drug.</DELETED>
<DELETED> ``(gg) The
petitioner's record of
submitting petitions to the
Food and Drug Administration
that have been determined by
the Secretary to have been
submitted with the primary
purpose of delay.</DELETED>
<DELETED> ``(hh) Other
relevant and appropriate
factors, which the Secretary
shall describe in
guidance.</DELETED>
<DELETED> ``(II) Guidance.--The
Secretary may issue or update guidance,
as appropriate, to describe factors the
Secretary considers in accordance with
subclause (I).''; and</DELETED>
<DELETED> (iv) by adding at the end the
following:</DELETED>
<DELETED> ``(iii) Referral to the federal
trade commission.--The Secretary shall
establish procedures for referring to the
Federal Trade Commission any petition or
supplement to a petition that the Secretary
determines was submitted with the primary
purpose of delaying approval of an application.
Such procedures shall include notification to
the petitioner by the Secretary.'';</DELETED>
<DELETED> (C) by striking subparagraph
(F);</DELETED>
<DELETED> (D) by redesignating subparagraphs (G)
through (I) as subparagraphs (F) through (H),
respectively; and</DELETED>
<DELETED> (E) in subparagraph (H), as so
redesignated, by striking ``submission of this
petition'' and inserting ``submission of this
document'';</DELETED>
<DELETED> (2) in paragraph (2)--</DELETED>
<DELETED> (A) by redesignating subparagraphs (A)
through (C) as subparagraphs (C) through (E),
respectively;</DELETED>
<DELETED> (B) by inserting before subparagraph (C),
as so redesignated, the following:</DELETED>
<DELETED> ``(A) In general.--A person shall submit a
petition to the Secretary under paragraph (1) before
filing a civil action in which the person seeks to set
aside, delay, rescind, withdraw, or prevent submission,
review, or approval of an application submitted under
subsection (b)(2) or (j) of this section or section
351(k) of the Public Health Service Act. Such petition
and any supplement to such a petition shall describe
all information and arguments that form the basis of
the relief requested in any civil action described in
the previous sentence.</DELETED>
<DELETED> ``(B) Timely submission of citizen
petition.--A petition and any supplement to a petition
shall be submitted within 60 days after the person
knew, or reasonably should have known, the information
that forms the basis of the request made in the
petition or supplement.'';</DELETED>
<DELETED> (C) in subparagraph (C), as so
redesignated--</DELETED>
<DELETED> (i) in the heading, by striking
``within 150 days'';</DELETED>
<DELETED> (ii) in clause (i), by striking
``during the 150-day period referred to in
paragraph (1)(F),''; and</DELETED>
<DELETED> (iii) by amending clause (ii) to
read as follows:</DELETED>
<DELETED> ``(ii) on or after the date that
is 151 days after the date of submission of the
petition, the Secretary approves or has
approved the application that is the subject of
the petition without having made such a final
decision.'';</DELETED>
<DELETED> (D) by amending subparagraph (D), as so
redesignated, to read as follows:</DELETED>
<DELETED> ``(D) Dismissal of certain civil
actions.--</DELETED>
<DELETED> ``(i) Petition.--If a person files
a civil action against the Secretary in which a
person seeks to set aside, delay, rescind,
withdraw, or prevent submission, review, or
approval of an application submitted under
subsection (b)(2) or (j) of this section or
section 351(k) of the Public Health Service Act
without complying with the requirements of
subparagraph (A), the court shall dismiss
without prejudice the action for failure to
exhaust administrative remedies.</DELETED>
<DELETED> ``(ii) Timeliness.--If a person
files a civil action against the Secretary in
which a person seeks to set aside, delay,
rescind, withdraw, or prevent submission,
review, or approval of an application submitted
under subsection (b)(2) or (j) of this section
or section 351(k) of the Public Health Service
Act without complying with the requirements of
subparagraph (B), the court shall dismiss with
prejudice the action for failure to timely file
a petition.</DELETED>
<DELETED> ``(iii) Final response.--If a
civil action is filed against the Secretary
with respect to any issue raised in a petition
timely filed under paragraph (1) in which the
petitioner requests that the Secretary take any
form of action that could, if taken, set aside,
delay, rescind, withdraw, or prevent
submission, review, or approval of an
application submitted under subsection (b)(2)
or (j) of this section or section 351(k) of the
Public Health Service Act before the Secretary
has taken final agency action on the petition
within the meaning of subparagraph (C), the
court shall dismiss without prejudice the
action for failure to exhaust administrative
remedies.''; and</DELETED>
<DELETED> (E) in clause (iii) of subparagraph (E),
as so redesignated, by striking ``as defined under
subparagraph (2)(A)'' and inserting ``within the
meaning of subparagraph (C)''; and</DELETED>
<DELETED> (3) in paragraph (4)--</DELETED>
<DELETED> (A) by striking ``Exceptions'' in the
paragraph heading and all that follows through ``This
subsection does'' and inserting ``Exceptions.--This
subsection does'';</DELETED>
<DELETED> (B) by striking subparagraph (B);
and</DELETED>
<DELETED> (C) by redesignating clauses (i) and (ii)
as subparagraphs (A) and (B), respectively, and
adjusting the margins accordingly.</DELETED>
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Ensuring Timely Access to Generics
Act of 2023''.
SEC. 2. ENSURING TIMELY ACCESS TO GENERICS.
Section 505(q) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(q)) is amended--
(1) in paragraph (1)--
(A) in subparagraph (A)(i), by inserting ``,
10.31,'' after ``10.30'';
(B) in subparagraph (E)--
(i) by striking ``application and'' and
inserting ``application or'';
(ii) by striking ``If the Secretary'' and
inserting the following:
``(i) In general.--If the Secretary''; and
(iii) by striking the second sentence and
inserting the following:
``(ii) Primary purpose of delaying.--
``(I) In general.--In determining
whether a petition was submitted with
the primary purpose of delaying an
application, the Secretary may consider
the following factors:
``(aa) Whether the petition
was submitted in accordance
with paragraph (2)(B), based on
when the petitioner knew the
relevant information relied
upon to form the basis of such
petition.
``(bb) When the petition
was submitted in relation to
when the petitioner reasonably
should have known the relevant
information relied upon to form
the basis of such petition.
``(cc) Whether the
petitioner has submitted
multiple or serial petitions or
supplements to petitions
raising issues that reasonably
could have been known to the
petitioner at the time of
submission of the earlier
petition or petitions.
``(dd) Whether the petition
was submitted close in time to
a known, first date upon which
an application under subsection
(b)(2) or (j) of this section
or section 351(k) of the Public
Health Service Act could be
approved.
``(ee) Whether the petition
was submitted without relevant
data or information in support
of the scientific positions
forming the basis of such
petition.
``(ff) Whether the petition
raises the same or
substantially similar issues as
a prior petition to which the
Secretary has responded
substantively already,
including if the subsequent
submission follows such
response from the Secretary
closely in time.
``(gg) Whether the petition
requests changing the
applicable standards that other
applicants are required to
meet, including requesting
testing, data, or labeling
standards that are more onerous
or rigorous than the standards
the Secretary has determined to
be applicable to the listed
drug, reference product, or
petitioner's version of the
same drug.
``(hh) The petitioner's
record of submitting petitions
to the Food and Drug
Administration that have been
determined by the Secretary to
have been submitted with the
primary purpose of delay.
``(ii) Other relevant and
appropriate factors, which the
Secretary shall describe in
guidance.
``(II) Guidance.--The Secretary may
issue or update guidance, as
appropriate, to describe factors the
Secretary considers in accordance with
subclause (I).'';
(C) by striking subparagraph (F);
(D) by redesignating subparagraphs (G) through (I)
as subparagraphs (F) through (H), respectively; and
(E) in subparagraph (H), as so redesignated, by
striking ``submission of this petition'' and inserting
``submission of this document'';
(2) in paragraph (2)--
(A) by redesignating subparagraphs (A) through (C)
as subparagraphs (C) through (E), respectively;
(B) by inserting before subparagraph (C), as so
redesignated, the following:
``(A) In general.--A person shall submit a petition
to the Secretary under paragraph (1) before filing a
civil action in which the person seeks to set aside,
delay, rescind, withdraw, or prevent submission,
review, or approval of an application submitted under
subsection (b)(2) or (j) of this section or section
351(k) of the Public Health Service Act. Such petition
and any supplement to such a petition shall describe
all information and arguments that form the basis of
the relief requested in any civil action described in
the previous sentence.
``(B) Timely submission of citizen petition.--A
petition and any supplement to a petition shall be
submitted within 180 days after the person knew the
information that forms the basis of the request made in
the petition or supplement.'';
(C) in subparagraph (C), as so redesignated--
(i) in the heading, by striking ``within
150 days'';
(ii) in clause (i), by striking ``during
the 150-day period referred to in paragraph
(1)(F),''; and
(iii) by amending clause (ii) to read as
follows:
``(ii) on or after the date that is 151
days after the date of submission of the
petition, the Secretary approves or has
approved the application that is the subject of
the petition without having made such a final
decision.'';
(D) by amending subparagraph (D), as so
redesignated, to read as follows:
``(D) Dismissal of certain civil actions.--
``(i) Petition.--If a person files a civil
action against the Secretary in which a person
seeks to set aside, delay, rescind, withdraw,
or prevent submission, review, or approval of
an application submitted under subsection
(b)(2) or (j) of this section or section 351(k)
of the Public Health Service Act without
complying with the requirements of subparagraph
(A), the court shall dismiss without prejudice
the action for failure to exhaust
administrative remedies.
``(ii) Timeliness.--If a person files a
civil action against the Secretary in which a
person seeks to set aside, delay, rescind,
withdraw, or prevent submission, review, or
approval of an application submitted under
subsection (b)(2) or (j) of this section or
section 351(k) of the Public Health Service Act
without complying with the requirements of
subparagraph (B), the court shall dismiss with
prejudice the action for failure to timely file
a petition.
``(iii) Final response.--If a civil action
is filed against the Secretary with respect to
any issue raised in a petition timely filed
under paragraph (1) in which the petitioner
requests that the Secretary take any form of
action that could, if taken, set aside, delay,
rescind, withdraw, or prevent submission,
review, or approval of an application submitted
under subsection (b)(2) or (j) of this section
or section 351(k) of the Public Health Service
Act before the Secretary has taken final agency
action on the petition within the meaning of
subparagraph (C), the court shall dismiss
without prejudice the action for failure to
exhaust administrative remedies.''; and
(E) in clause (iii) of subparagraph (E), as so
redesignated, by striking ``as defined under
subparagraph (2)(A)'' and inserting ``within the
meaning of subparagraph (C)''; and
(3) in paragraph (4)--
(A) by striking ``Exceptions'' in the paragraph
heading and all that follows through ``This subsection
does'' and inserting ``Exceptions.--This subsection
does'';
(B) by striking subparagraph (B); and
(C) by redesignating clauses (i) and (ii) as
subparagraphs (A) and (B), respectively, and adjusting
the margins accordingly.
Calendar No. 107
118th CONGRESS
1st Session
S. 1067
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act with respect to
citizen petitions.
_______________________________________________________________________
June 22, 2023
Reported with an amendment