What This Bill Does
This bill changes how citizens and groups can file petitions with the Food and Drug Administration (FDA) about generic drug applications. It aims to prevent petitions that are mainly meant to delay approval of generic drugs and other similar medications. The bill sets new deadlines and rules for when petitions must be filed and how courts should handle lawsuits related to these petitions.
Who It Affects
People and companies who file petitions with the FDA about generic drug applications, pharmaceutical companies seeking FDA approval for generic drugs, the FDA, the Federal Trade Commission, and courts hearing cases about drug approval disputes.
Key Provisions
• Anyone filing a petition to stop or delay a generic drug application must file a petition with the FDA first, before they can file a lawsuit in court (Sec. 2, paragraph 2).
• A petition must be submitted within 180 days after the person knew the information that forms the basis of the petition (Sec. 2, paragraph 2(B)).
• The FDA can look at several factors to decide if a petition was mainly submitted to delay approval, including whether the petitioner submitted multiple petitions raising issues they should have known about earlier and whether the petition raises the same issues as a petition already answered by the FDA (Sec. 2, paragraph 1(E)).
• If someone files a lawsuit without first filing a petition with the FDA, the court must dismiss the case without prejudice (meaning they can file again later) (Sec. 2, paragraph 2(D)(i)).
• If someone files a lawsuit late without meeting the deadline, the court must dismiss the case with prejudice (meaning they cannot file again) (Sec. 2, paragraph 2(D)(ii)).
• The FDA must create a process to refer petitions it believes were submitted mainly to delay approval to the Federal Trade Commission (Sec. 2, paragraph 1(E)).
What Changes
Citizens can no longer file lawsuits about generic drug approvals without first submitting a petition to the FDA. Petitions must now be submitted within 180 days of when someone knew the information supporting their petition. Courts will dismiss lawsuits if the person did not follow the new petition rules. The FDA gets new guidelines to identify and refer delay-tactic petitions to the Federal Trade Commission.
Important Definitions
The bill does not explicitly define its key terms.
II
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 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
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SEC. 2. ENSURING TIMELY ACCESS TO GENERICS.
1
Section 505(q) of the Federal Food, Drug, and Cos-
2
metic Act (21 U.S.C. 355(q)) is amended—
3
(1) in paragraph (1)—
4
(A) in subparagraph (A)(i), by inserting ‘‘,
5
10.31,’’ after ‘‘10.30’’;
6
(B) in subparagraph (E)—
7
(i) by striking ‘‘application and’’ and
8
inserting ‘‘application or’’;
9
(ii) by striking ‘‘If the Secretary’’ and
10
inserting the following:
11
‘‘(i) IN GENERAL.—If the Secretary’’;
12
(iii) by striking the second sentence
13
and inserting the following:
14
‘‘(ii) PRIMARY
PURPOSE
OF
DELAY-
15
ING.—
16
‘‘(I)
IN
GENERAL.—In
deter-
17
mining whether a petition was sub-
18
mitted with the primary purpose of
19
delaying an application, the Secretary
20
may consider the following factors:
21
‘‘(aa) Whether the petition
22
was submitted in accordance with
23
paragraph (2)(B), based on when
24
the petitioner knew or reasonably
25
should have known the relevant
26
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•S 1067 RS
information relied upon to form
1
the basis of such petition.
2
‘‘(bb) Whether the petitioner
3
has submitted multiple or serial
4
petitions or supplements to peti-
5
tions raising issues that reason-
6
ably could have been known to
7
the petitioner at the time of sub-
8
mission of the earlier petition or
9
petitions.
10
‘‘(cc) Whether the petition
11
was submitted close in time to a
12
known, first date upon which an
13
application
under
subsection
14
(b)(2) or (j) of this section or
15
section
351(k)
of
the
Public
16
Health Service Act could be ap-
17
proved.
18
‘‘(dd) Whether the petition
19
was submitted without relevant
20
data or information in support of
21
the scientific positions forming
22
the basis of such petition.
23
‘‘(ee) Whether the petition
24
raises the same or substantially
25
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similar issues as a prior petition
1
to which the Secretary has re-
2
sponded substantively already, in-
3
cluding if the subsequent submis-
4
sion follows such response from
5
the Secretary closely in time.
6
‘‘(ff) Whether the petition
7
requests changing the applicable
8
standards that other applicants
9
are required to meet, including
10
requesting testing, data, or label-
11
ing standards that are more on-
12
erous or rigorous than the stand-
13
ards
the
Secretary
has
deter-
14
mined to be applicable to the list-
15
ed drug, reference product, or pe-
16
titioner’s
version
of
the
same
17
drug.
18
‘‘(gg) The petitioner’s record
19
of
submitting
petitions
to
the
20
Food and Drug Administration
21
that have been determined by the
22
Secretary to have been submitted
23
with
the
primary
purpose
of
24
delay.
25
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•S 1067 RS
‘‘(hh)
Other
relevant
and
1
appropriate
factors,
which
the
2
Secretary shall describe in guid-
3
ance.
4
‘‘(II) GUIDANCE.—The Secretary
5
may issue or update guidance, as ap-
6
propriate, to describe factors the Sec-
7
retary considers in accordance with
8
subclause (I).’’; and
9
(iv) by adding at the end the fol-
10
lowing:
11
‘‘(iii) REFERRAL
TO
THE
FEDERAL
12
TRADE COMMISSION.—The Secretary shall
13
establish procedures for referring to the
14
Federal Trade Commission any petition or
15
supplement to a petition that the Secretary
16
determines was submitted with the primary
17
purpose of delaying approval of an applica-
18
tion. Such procedures shall include notifi-
19
cation to the petitioner by the Secretary.’’;
20
(C) by striking subparagraph (F);
21
(D) by redesignating subparagraphs (G)
22
through (I) as subparagraphs (F) through (H),
23
respectively; and
24
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(E) in subparagraph (H), as so redesig-
1
nated, by striking ‘‘submission of this petition’’
2
and inserting ‘‘submission of this document’’;
3
(2) in paragraph (2)—
4
(A) by redesignating subparagraphs (A)
5
through (C) as subparagraphs (C) through (E),
6
respectively;
7
(B) by inserting before subparagraph (C),
8
as so redesignated, the following:
9
‘‘(A) IN GENERAL.—A person shall submit
10
a petition to the Secretary under paragraph (1)
11
before filing a civil action in which the person
12
seeks to set aside, delay, rescind, withdraw, or
13
prevent submission, review, or approval of an
14
application submitted under subsection (b)(2)
15
or (j) of this section or section 351(k) of the
16
Public Health Service Act. Such petition and
17
any supplement to such a petition shall describe
18
all information and arguments that form the
19
basis of the relief requested in any civil action
20
described in the previous sentence.
21
‘‘(B) TIMELY SUBMISSION OF CITIZEN PE-
22
TITION.—A petition and any supplement to a
23
petition shall be submitted within 60 days after
24
the person knew, or reasonably should have
25
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•S 1067 RS
known, the information that forms the basis of
1
the request made in the petition or supple-
2
ment.’’;
3
(C) in subparagraph (C), as so redesig-
4
nated—
5
(i) in the heading, by striking ‘‘WITH-
6
IN 150 DAYS’’;
7
(ii) in clause (i), by striking ‘‘during
8
the 150-day period referred to in para-
9
graph (1)(F),’’; and
10
(iii) by amending clause (ii) to read as
11
follows:
12
‘‘(ii) on or after the date that is 151
13
days after the date of submission of the
14
petition, the Secretary approves or has ap-
15
proved the application that is the subject
16
of the petition without having made such a
17
final decision.’’;
18
(D) by amending subparagraph (D), as so
19
redesignated, to read as follows:
20
‘‘(D) DISMISSAL
OF
CERTAIN
CIVIL
AC-
21
TIONS.—
22
‘‘(i) PETITION.—If a person files a
23
civil action against the Secretary in which
24
a person seeks to set aside, delay, rescind,
25
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•S 1067 RS
withdraw, or prevent submission, review, or
1
approval of an application submitted under
2
subsection (b)(2) or (j) of this section or
3
section 351(k) of the Public Health Service
4
Act without complying with the require-
5
ments of subparagraph (A), the court shall
6
dismiss without prejudice the action for
7
failure to exhaust administrative remedies.
8
‘‘(ii) TIMELINESS.—If a person files a
9
civil action against the Secretary in which
10
a person seeks to set aside, delay, rescind,
11
withdraw, or prevent submission, review, or
12
approval of an application submitted under
13
subsection (b)(2) or (j) of this section or
14
section 351(k) of the Public Health Service
15
Act without complying with the require-
16
ments of subparagraph (B), the court shall
17
dismiss with prejudice the action for fail-
18
ure to timely file a petition.
19
‘‘(iii) FINAL RESPONSE.—If a civil ac-
20
tion is filed against the Secretary with re-
21
spect to any issue raised in a petition time-
22
ly filed under paragraph (1) in which the
23
petitioner requests that the Secretary take
24
any form of action that could, if taken, set
25
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•S 1067 RS
aside, delay, rescind, withdraw, or prevent
1
submission, review, or approval of an appli-
2
cation submitted under subsection (b)(2)
3
or (j) of this section or section 351(k) of
4
the Public Health Service Act before the
5
Secretary has taken final agency action on
6
the petition within the meaning of sub-
7
paragraph (C), the court shall dismiss
8
without prejudice the action for failure to
9
exhaust administrative remedies.’’; and
10
(E) in clause (iii) of subparagraph (E), as
11
so redesignated, by striking ‘‘as defined under
12
subparagraph (2)(A)’’ and inserting ‘‘within the
13
meaning of subparagraph (C)’’; and
14
(3) in paragraph (4)—
15
(A)
by
striking
‘‘EXCEPTIONS’’
in
the
16
paragraph heading and all that follows through
17
‘‘This subsection does’’ and inserting ‘‘EXCEP-
18
TIONS.—This subsection does’’;
19
(B) by striking subparagraph (B); and
20
(C) by redesignating clauses (i) and (ii) as
21
subparagraphs (A) and (B), respectively, and
22
adjusting the margins accordingly.
23
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•S 1067 RS
SECTION 1. SHORT TITLE.
1
This Act may be cited as the ‘‘Ensuring Timely Access
2
to Generics Act of 2023’’.
3
SEC. 2. ENSURING TIMELY ACCESS TO GENERICS.
4
Section 505(q) of the Federal Food, Drug, and Cos-
5
metic Act (21 U.S.C. 355(q)) is amended—
6
(1) in paragraph (1)—
7
(A) in subparagraph (A)(i), by inserting ‘‘,
8
10.31,’’ after ‘‘10.30’’;
9
(B) in subparagraph (E)—
10
(i) by striking ‘‘application and’’ and
11
inserting ‘‘application or’’;
12
(ii) by striking ‘‘If the Secretary’’ and
13
inserting the following:
14
‘‘(i) IN GENERAL.—If the Secretary’’;
15
and
16
(iii) by striking the second sentence
17
and inserting the following:
18
‘‘(ii) PRIMARY
PURPOSE
OF
DELAY-
19
ING.—
20
‘‘(I)
IN
GENERAL.—In
deter-
21
mining whether a petition was sub-
22
mitted with the primary purpose of de-
23
laying an application, the Secretary
24
may consider the following factors:
25
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•S 1067 RS
‘‘(aa) Whether the petition
1
was submitted in accordance with
2
paragraph (2)(B), based on when
3
the petitioner knew the relevant
4
information relied upon to form
5
the basis of such petition.
6
‘‘(bb) When the petition was
7
submitted in relation to when the
8
petitioner reasonably should have
9
known the relevant information
10
relied upon to form the basis of
11
such petition.
12
‘‘(cc) Whether the petitioner
13
has submitted multiple or serial
14
petitions or supplements to peti-
15
tions raising issues that reason-
16
ably could have been known to the
17
petitioner at the time of submis-
18
sion of the earlier petition or peti-
19
tions.
20
‘‘(dd) Whether the petition
21
was submitted close in time to a
22
known, first date upon which an
23
application
under
subsection
24
(b)(2) or (j) of this section or sec-
25
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•S 1067 RS
tion 351(k) of the Public Health
1
Service Act could be approved.
2
‘‘(ee) Whether the petition
3
was submitted without relevant
4
data or information in support of
5
the scientific positions forming the
6
basis of such petition.
7
‘‘(ff) Whether the petition
8
raises the same or substantially
9
similar issues as a prior petition
10
to which the Secretary has re-
11
sponded substantively already, in-
12
cluding if the subsequent submis-
13
sion follows such response from
14
the Secretary closely in time.
15
‘‘(gg) Whether the petition
16
requests changing the applicable
17
standards that other applicants
18
are required to meet, including re-
19
questing testing, data, or labeling
20
standards that are more onerous
21
or rigorous than the standards the
22
Secretary has determined to be
23
applicable to the listed drug, ref-
24
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•S 1067 RS
erence product, or petitioner’s
1
version of the same drug.
2
‘‘(hh) The petitioner’s record
3
of submitting petitions to the
4
Food and Drug Administration
5
that have been determined by the
6
Secretary to have been submitted
7
with the primary purpose of
8
delay.
9
‘‘(ii) Other relevant and ap-
10
propriate factors, which the Sec-
11
retary shall describe in guidance.
12
‘‘(II) GUIDANCE.—The Secretary
13
may issue or update guidance, as ap-
14
propriate, to describe factors the Sec-
15
retary considers in accordance with
16
subclause (I).’’;
17
(C) by striking subparagraph (F);
18
(D) by redesignating subparagraphs (G)
19
through (I) as subparagraphs (F) through (H),
20
respectively; and
21
(E) in subparagraph (H), as so redesig-
22
nated, by striking ‘‘submission of this petition’’
23
and inserting ‘‘submission of this document’’;
24
(2) in paragraph (2)—
25
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•S 1067 RS
(A) by redesignating subparagraphs (A)
1
through (C) as subparagraphs (C) through (E),
2
respectively;
3
(B) by inserting before subparagraph (C),
4
as so redesignated, the following:
5
‘‘(A) IN GENERAL.—A person shall submit a
6
petition to the Secretary under paragraph (1)
7
before filing a civil action in which the person
8
seeks to set aside, delay, rescind, withdraw, or
9
prevent submission, review, or approval of an
10
application submitted under subsection (b)(2) or
11
(j) of this section or section 351(k) of the Public
12
Health Service Act. Such petition and any sup-
13
plement to such a petition shall describe all in-
14
formation and arguments that form the basis of
15
the
[Text truncated for display. Full text available on Congress.gov.]