II
118THCONGRESS
1
STSESSION S. 1067
To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen
petitions.
IN THE SENATE OF THE UNITED STATES
MARCH29, 2023
Mrs. S
HAHEEN(for herself, Ms. COLLINS, Mr. BENNET, Mr. RUBIO, Ms.
B
ALDWIN, and Mr. BRAUN) 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 citizen petitions.
Be it enacted by the Senate and House of Representa-1
tives of the United States of America in Congress assembled, 2
SECTION 1. SHORT TITLE. 3
This Act may be cited as the ‘‘Ensuring Timely Ac-4
cess to Generics Act of 2023’’. 5
SEC. 2. ENSURING TIMELY ACCESS TO GENERICS. 6
Section 505(q) of the Federal Food, Drug, and Cos-7
metic Act (21 U.S.C. 355(q)) is amended— 8
(1) in paragraph (1)— 9
VerDate Sep 11 2014 00:49 Apr 08, 2023 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S1067.IS S1067
pbinns on DSKJLVW7X2PROD with $$_JOB 2
•S 1067 IS
(A) in subparagraph (A)(i), by inserting ‘‘, 1
10.31,’’ after ‘‘10.30’’; 2
(B) in subparagraph (E)— 3
(i) by striking ‘‘application and’’ and 4
inserting ‘‘application or’’; 5
(ii) by striking ‘‘If the Secretary’’ and 6
inserting the following: 7
‘‘(i) I
N GENERAL.—If the Secretary’’; 8
(iii) by striking the second sentence 9
and inserting the following: 10
‘‘(ii) P
RIMARY PURPOSE OF DELAY -11
ING.— 12
‘‘(I) I
N GENERAL.—In deter-13
mining whether a petition was sub-14
mitted with the primary purpose of 15
delaying an application, the Secretary 16
may consider the following factors: 17
‘‘(aa) Whether the petition 18
was submitted in accordance with 19
paragraph (2)(B), based on when 20
the petitioner knew or reasonably 21
should have known the relevant 22
information relied upon to form 23
the basis of such petition. 24
VerDate Sep 11 2014 00:49 Apr 08, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1067.IS S1067
pbinns on DSKJLVW7X2PROD with $$_JOB 3
•S 1067 IS
‘‘(bb) Whether the petitioner 1
has submitted multiple or serial 2
petitions or supplements to peti-3
tions raising issues that reason-4
ably could have been known to 5
the petitioner at the time of sub-6
mission of the earlier petition or 7
petitions. 8
‘‘(cc) Whether the petition 9
was submitted close in time to a 10
known, first date upon which an 11
application under subsection 12
(b)(2) or (j) of this section or 13
section 351(k) of the Public 14
Health Service Act could be ap-15
proved. 16
‘‘(dd) Whether the petition 17
was submitted without relevant 18
data or information in support of 19
the scientific positions forming 20
the basis of such petition. 21
‘‘(ee) Whether the petition 22
raises the same or substantially 23
similar issues as a prior petition 24
to which the Secretary has re-25
VerDate Sep 11 2014 00:49 Apr 08, 2023 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S1067.IS S1067
pbinns on DSKJLVW7X2PROD with $$_JOB 4
•S 1067 IS
sponded substantively already, in-1
cluding if the subsequent submis-2
sion follows such response from 3
the Secretary closely in time. 4
‘‘(ff) Whether the petition 5
requests changing the applicable 6
standards that other applicants 7
are required to meet, including 8
requesting testing, data, or label-9
ing standards that are more on-10
erous or rigorous than the stand-11
ards the Secretary has deter-12
mined to be applicable to the list-13
ed drug, reference product, or pe-14
titioner’s version of the same 15
drug. 16
‘‘(gg) The petitioner’s record 17
of submitting petitions to the 18
Food and Drug Administration 19
that have been determined by the 20
Secretary to have been submitted 21
with the primary purpose of 22
delay. 23
‘‘(hh) Other relevant and 24
appropriate factors, which the 25
VerDate Sep 11 2014 00:49 Apr 08, 2023 Jkt 039200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S1067.IS S1067
pbinns on DSKJLVW7X2PROD with $$_JOB 5
•S 1067 IS
Secretary shall describe in guid-1
ance. 2
‘‘(II) G
UIDANCE.—The Secretary 3
may issue or update guidance, as ap-4
propriate, to describe factors the Sec-5
retary considers in accordance with 6
subclause (I).’’; and 7
(iv) by adding at the end the fol-8
lowing: 9
‘‘(iii) R
EFERRAL TO THE FEDERAL 10
TRADE COMMISSION.—The Secretary shall 11
establish procedures for referring to the 12
Federal Trade Commission any petition or 13
supplement to a petition that the Secretary 14
determines was submitted with the primary 15
purpose of delaying approval of an applica-16
tion. Such procedures shall include notifi-17
cation to the petitioner by the Secretary.’’; 18
(C) by striking subparagraph (F); 19
(D) by redesignating subparagraphs (G) 20
through (I) as subparagraphs (F) through (H), 21
respectively; and 22
(E) in subparagraph (H), as so redesig-23
nated, by striking ‘‘submission of this petition’’ 24
and inserting ‘‘submission of this document’’; 25
VerDate Sep 11 2014 00:49 Apr 08, 2023 Jkt 039200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S1067.IS S1067
pbinns on DSKJLVW7X2PROD with $$_JOB 6
•S 1067 IS
(2) in paragraph (2)— 1
(A) by redesignating subparagraphs (A) 2
through (C) as subparagraphs (C) through (E), 3
respectively; 4
(B) by inserting before subparagraph (C), 5
as so redesignated, the following: 6
‘‘(A) I
N GENERAL.—A person shall submit 7
a petition to the Secretary under paragraph (1) 8
before filing a civil action in which the person 9
seeks to set aside, delay, rescind, withdraw, or 10
prevent submission, review, or approval of an 11
application submitted under subsection (b)(2) 12
or (j) of this section or section 351(k) of the 13
Public Health Service Act. Such petition and 14
any supplement to such a petition shall describe 15
all information and arguments that form the 16
basis of the relief requested in any civil action 17
described in the previous sentence. 18
‘‘(B) T
IMELY SUBMISSION OF CITIZEN PE -19
TITION.—A petition and any supplement to a 20
petition shall be submitted within 60 days after 21
the person knew, or reasonably should have 22
known, the information that forms the basis of 23
the request made in the petition or supple-24
ment.’’; 25
VerDate Sep 11 2014 00:49 Apr 08, 2023 Jkt 039200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S1067.IS S1067
pbinns on DSKJLVW7X2PROD with $$_JOB 7
•S 1067 IS
(C) in subparagraph (C), as so redesig-1
nated— 2
(i) in the heading, by striking ‘‘
WITH-3
IN 150 DAYS’’; 4
(ii) in clause (i), by striking ‘‘during 5
the 150-day period referred to in para-6
graph (1)(F),’’; and 7
(iii) by amending clause (ii) to read as 8
follows: 9
‘‘(ii) on or after the date that is 151 10
days after the date of submission of the 11
petition, the Secretary approves or has ap-12
proved the application that is the subject 13
of the petition without having made such a 14
final decision.’’; 15
(D) by amending subparagraph (D), as so 16
redesignated, to read as follows: 17
‘‘(D) D
ISMISSAL OF CERTAIN CIVIL AC -18
TIONS.— 19
‘‘(i) P
ETITION.—If a person files a 20
civil action against the Secretary in which 21
a person seeks to set aside, delay, rescind, 22
withdraw, or prevent submission, review, or 23
approval of an application submitted under 24
subsection (b)(2) or (j) of this section or 25
VerDate Sep 11 2014 00:49 Apr 08, 2023 Jkt 039200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S1067.IS S1067
pbinns on DSKJLVW7X2PROD with $$_JOB 8
•S 1067 IS
section 351(k) of the Public Health Service 1
Act without complying with the require-2
ments of subparagraph (A), the court shall 3
dismiss without prejudice the action for 4
failure to exhaust administrative remedies. 5
‘‘(ii) T
IMELINESS.—If a person files a 6
civil action against the Secretary in which 7
a person seeks to set aside, delay, rescind, 8
withdraw, or prevent submission, review, or 9
approval of an application submitted under 10
subsection (b)(2) or (j) of this section or 11
section 351(k) of the Public Health Service 12
Act without complying with the require-13
ments of subparagraph (B), the court shall 14
dismiss with prejudice the action for fail-15
ure to timely file a petition. 16
‘‘(iii) F
INAL RESPONSE.—If a civil ac-17
tion is filed against the Secretary with re-18
spect to any issue raised in a petition time-19
ly filed under paragraph (1) in which the 20
petitioner requests that the Secretary take 21
any form of action that could, if taken, set 22
aside, delay, rescind, withdraw, or prevent 23
submission, review, or approval of an appli-24
cation submitted under subsection (b)(2) 25
VerDate Sep 11 2014 00:49 Apr 08, 2023 Jkt 039200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S1067.IS S1067
pbinns on DSKJLVW7X2PROD with $$_JOB 9
•S 1067 IS
or (j) of this section or section 351(k) of 1
the Public Health Service Act before the 2
Secretary has taken final agency action on 3
the petition within the meaning of sub-4
paragraph (C), the court shall dismiss 5
without prejudice the action for failure to 6
exhaust administrative remedies.’’; and 7
(E) in clause (iii) of subparagraph (E), as 8
so redesignated, by striking ‘‘as defined under 9
subparagraph (2)(A)’’ and inserting ‘‘within the 10
meaning of subparagraph (C)’’; and 11
(3) in paragraph (4)— 12
(A) by striking ‘‘E
XCEPTIONS’’ in the 13
paragraph heading and all that follows through 14
‘‘This subsection does’’ and inserting ‘‘E
XCEP-15
TIONS.—This subsection does’’; 16
(B) by striking subparagraph (B); and 17
(C) by redesignating clauses (i) and (ii) as 18
subparagraphs (A) and (B), respectively, and 19
adjusting the margins accordingly. 20
Æ
VerDate Sep 11 2014 00:49 Apr 08, 2023 Jkt 039200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6301 E:\BILLS\S1067.IS S1067
pbinns on DSKJLVW7X2PROD with $$_JOB