II
Calendar No. 107
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
J
UNE22, 2023
Reported by Mr. S
ANDERS, 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
SECTION1.SHORTTITLE. 3
ThisActmaybecitedasthe‘‘EnsuringTimelyAc-4
cesstoGenericsActof2023’’. 5
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SEC.2.ENSURING TIMELYACCESSTOGENERICS. 1
Section505(q)oftheFederalFood,Drug,andCos-2
meticAct(21U.S.C.355(q))isamended— 3
(1)inparagraph(1)— 4
(A)insubparagraph(A)(i),byinserting‘‘, 5
10.31,’’after‘‘10.30’’; 6
(B)insubparagraph(E)— 7
(i)bystriking‘‘applicationand’’and 8
inserting‘‘applicationor’’; 9
(ii)bystriking‘‘IftheSecretary’’and 10
insertingthefollowing: 11
‘‘(i)INGENERAL.—IftheSecretary’’; 12
(iii)bystrikingthesecondsentence 13
andinsertingthefollowing: 14
‘‘(ii)PRIMARYPURPOSE OFDELAY-15
ING.— 16
‘‘(I)INGENERAL.—Indeter-17
miningwhetherapetitionwassub-18
mittedwiththeprimarypurposeof 19
delayinganapplication,theSecretary 20
mayconsiderthefollowingfactors: 21
‘‘(aa)Whetherthepetition 22
wassubmittedinaccordancewith 23
paragraph(2)(B),basedonwhen 24
thepetitionerkneworreasonably 25
shouldhaveknowntherelevant 26
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informationreliedupontoform 1
thebasisofsuchpetition. 2
‘‘(bb)Whetherthepetitioner 3
hassubmittedmultipleorserial 4
petitionsorsupplementstopeti-5
tionsraisingissuesthatreason-6
ablycouldhavebeenknownto 7
thepetitioneratthetimeofsub-8
missionoftheearlierpetitionor 9
petitions. 10
‘‘(cc)Whetherthepetition 11
wassubmittedcloseintimetoa 12
known,firstdateuponwhichan 13
applicationundersubsection 14
(b)(2)or(j)ofthissectionor 15
section351(k)ofthePublic 16
HealthServiceActcouldbeap-17
proved. 18
‘‘(dd)Whetherthepetition 19
wassubmittedwithoutrelevant 20
dataorinformationinsupportof 21
thescientificpositionsforming 22
thebasisofsuchpetition. 23
‘‘(ee)Whetherthepetition 24
raisesthesameorsubstantially 25
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similarissuesasapriorpetition 1
towhichtheSecretaryhasre-2
spondedsubstantivelyalready,in-3
cludingifthesubsequentsubmis-4
sionfollowssuchresponsefrom 5
theSecretarycloselyintime. 6
‘‘(ff)Whetherthepetition 7
requestschangingtheapplicable 8
standardsthatotherapplicants 9
arerequiredtomeet,including 10
requestingtesting,data,orlabel-11
ingstandardsthataremoreon-12
erousorrigorousthanthestand-13
ardstheSecretaryhasdeter-14
minedtobeapplicabletothelist-15
eddrug,referenceproduct,orpe-16
titioner’sversionofthesame 17
drug. 18
‘‘(gg)Thepetitioner’srecord 19
ofsubmittingpetitionstothe 20
FoodandDrugAdministration 21
thathavebeendeterminedbythe 22
Secretarytohavebeensubmitted 23
withtheprimarypurposeof 24
delay. 25
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‘‘(hh)Otherrelevantand 1
appropriatefactors,whichthe 2
Secretaryshalldescribeinguid-3
ance. 4
‘‘(II)GUIDANCE.—TheSecretary 5
mayissueorupdateguidance,asap-6
propriate,todescribefactorstheSec-7
retaryconsidersinaccordancewith 8
subclause(I).’’;and 9
(iv)byaddingattheendthefol-10
lowing: 11
‘‘(iii)REFERRAL TOTHEFEDERAL 12
TRADECOMMISSION.—TheSecretaryshall 13
establishproceduresforreferringtothe 14
FederalTradeCommissionanypetitionor 15
supplementtoapetitionthattheSecretary 16
determineswassubmittedwiththeprimary 17
purposeofdelayingapprovalofanapplica-18
tion.Suchproceduresshallincludenotifi-19
cationtothepetitionerbytheSecretary.’’; 20
(C)bystrikingsubparagraph(F); 21
(D)byredesignatingsubparagraphs(G) 22
through(I)assubparagraphs(F)through(H), 23
respectively;and 24
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(E)insubparagraph(H),assoredesig-1
nated,bystriking‘‘submissionofthispetition’’ 2
andinserting‘‘submissionofthisdocument’’; 3
(2)inparagraph(2)— 4
(A)byredesignatingsubparagraphs(A) 5
through(C)assubparagraphs(C)through(E), 6
respectively; 7
(B)byinsertingbeforesubparagraph(C), 8
assoredesignated,thefollowing: 9
‘‘(A)INGENERAL.—Apersonshallsubmit 10
apetitiontotheSecretaryunderparagraph(1) 11
beforefilingacivilactioninwhichtheperson 12
seekstosetaside,delay,rescind,withdraw,or 13
preventsubmission,review,orapprovalofan 14
applicationsubmittedundersubsection(b)(2) 15
or(j)ofthissectionorsection351(k)ofthe 16
PublicHealthServiceAct.Suchpetitionand 17
anysupplementtosuchapetitionshalldescribe 18
allinformationandargumentsthatformthe 19
basisofthereliefrequestedinanycivilaction 20
describedintheprevioussentence. 21
‘‘(B)TIMELYSUBMISSIONOFCITIZENPE-22
TITION.—Apetitionandanysupplementtoa 23
petitionshallbesubmittedwithin60daysafter 24
thepersonknew,orreasonablyshouldhave 25
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known,theinformationthatformsthebasisof 1
therequestmadeinthepetitionorsupple-2
ment.’’; 3
(C)insubparagraph(C),assoredesig-4
nated— 5
(i)intheheading,bystriking‘‘WITH-6
IN150DAYS’’; 7
(ii)inclause(i),bystriking‘‘during 8
the150-dayperiodreferredtoinpara-9
graph(1)(F),’’;and 10
(iii)byamendingclause(ii)toreadas 11
follows: 12
‘‘(ii)onorafterthedatethatis151 13
daysafterthedateofsubmissionofthe 14
petition,theSecretaryapprovesorhasap-15
provedtheapplicationthatisthesubject 16
ofthepetitionwithouthavingmadesucha 17
finaldecision.’’; 18
(D)byamendingsubparagraph(D),asso 19
redesignated,toreadasfollows: 20
‘‘(D)DISMISSALOFCERTAINCIVILAC-21
TIONS.— 22
‘‘(i)PETITION.—Ifapersonfilesa 23
civilactionagainsttheSecretaryinwhich 24
apersonseekstosetaside,delay,rescind, 25
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withdraw,orpreventsubmission,review,or 1
approvalofanapplicationsubmittedunder 2
subsection(b)(2)or(j)ofthissectionor 3
section351(k)ofthePublicHealthService 4
Actwithoutcomplyingwiththerequire-5
mentsofsubparagraph(A),thecourtshall 6
dismisswithoutprejudicetheactionfor 7
failuretoexhaustadministrativeremedies. 8
‘‘(ii)TIMELINESS.—Ifapersonfilesa 9
civilactionagainsttheSecretaryinwhich 10
apersonseekstosetaside,delay,rescind, 11
withdraw,orpreventsubmission,review,or 12
approvalofanapplicationsubmittedunder 13
subsection(b)(2)or(j)ofthissectionor 14
section351(k)ofthePublicHealthService 15
Actwithoutcomplyingwiththerequire-16
mentsofsubparagraph(B),thecourtshall 17
dismisswithprejudicetheactionforfail-18
uretotimelyfileapetition. 19
‘‘(iii)FINALRESPONSE.—Ifacivilac-20
tionisfiledagainsttheSecretarywithre-21
specttoanyissueraisedinapetitiontime-22
lyfiledunderparagraph(1)inwhichthe 23
petitionerrequeststhattheSecretarytake 24
anyformofactionthatcould,iftaken,set 25
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aside,delay,rescind,withdraw,orprevent 1
submission,review,orapprovalofanappli-2
cationsubmittedundersubsection(b)(2) 3
or(j)ofthissectionorsection351(k)of 4
thePublicHealthServiceActbeforethe 5
Secretaryhastakenfinalagencyactionon 6
thepetitionwithinthemeaningofsub-7
paragraph(C),thecourtshalldismiss 8
withoutprejudicetheactionforfailureto 9
exhaustadministrativeremedies.’’;and 10
(E)inclause(iii)ofsubparagraph(E),as 11
soredesignated,bystriking‘‘asdefinedunder 12
subparagraph(2)(A)’’andinserting‘‘withinthe 13
meaningofsubparagraph(C)’’;and 14
(3)inparagraph(4)— 15
(A)bystriking‘‘EXCEPTIONS’’inthe 16
paragraphheadingandallthatfollowsthrough 17
‘‘Thissubsectiondoes’’andinserting‘‘EXCEP-18
TIONS.—Thissubsectiondoes’’; 19
(B)bystrikingsubparagraph(B);and 20
(C)byredesignatingclauses(i)and(ii)as 21
subparagraphs(A)and(B),respectively,and 22
adjustingthemarginsaccordingly. 23
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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) I
N GENERAL.—If the Secretary’’; 15
and 16
(iii) by striking the second sentence 17
and inserting the following: 18
‘‘(ii) P
RIMARY PURPOSE OF DELAY -19
ING.— 20
‘‘(I) I
N 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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‘‘(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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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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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) G
UIDANCE.—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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(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) I
N 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 relief requested in any civil action described 16
in the previous sentence. 17
‘‘(B) T
IMELY SUBMISSION OF CITIZEN PETI -18
TION.—A petition and any supplement to a peti-19
tion shall be submitted within 180 days after the 20
person knew the information that forms the basis 21
of the request made in the petition or supple-22
ment.’’; 23
(C) in subparagraph (C), as so redesig-24
nated— 25
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(i) in the heading, by striking ‘‘WITHIN 1
150 DAYS’’; 2
(ii) in clause (i), by striking ‘‘during 3
the 150-day period referred to in paragraph 4
(1)(F),’’; and 5
(iii) by amending clause (ii) to read as 6
follows: 7
‘‘(ii) on or after the date that is 151 8
days after the date of submission of the peti-9
tion, the Secretary approves or has ap-10
proved the application that is the subject of 11
the petition without having made such a 12
final decision.’’; 13
(D) by amending subparagraph (D), as so 14
redesignated, to read as follows: 15
‘‘(D) D
ISMISSAL OF CERTAIN CIVIL AC -16
TIONS.— 17
‘‘(i) P
ETITION.—If a person files a 18
civil action against the Secretary in which 19
a person seeks to set aside, delay, rescind, 20
withdraw, or prevent submission, review, or 21
approval of an application submitted under 22
subsection (b)(2) or (j) of this section or sec-23
tion 351(k) of the Public Health Service Act 24
without complying with the requirements of 25
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subparagraph (A), the court shall dismiss 1
without prejudice the action for failure to 2
exhaust administrative remedies. 3
‘‘(ii) T
IMELINESS.—If a person files a 4
civil action against the Secretary in which 5
a person seeks to set aside, delay, rescind, 6
withdraw, or prevent submission, review, or 7
approval of an application submitted under 8
subsection (b)(2) or (j) of this section or sec-9
tion 351(k) of the Public Health Service Act 10
without complying with the requirements of 11
subparagraph (B), the court shall dismiss 12
with prejudice the action for failure to time-13
ly file a petition. 14
‘‘(iii) F
INAL RESPONSE.—If a civil ac-15
tion is filed against the Secretary with re-16
spect to any issue raised in a petition time-17
ly filed under paragraph (1) in which the 18
petitioner requests that the Secretary take 19
any form of action that could, if taken, set 20
aside, delay, rescind, withdraw, or prevent 21
submission, review, or approval of an appli-22
cation submitted under subsection (b)(2) or 23
(j) of this section or section 351(k) of the 24
Public Health Service Act before the Sec-25
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retary has taken final agency action on the 1
petition within the meaning of subpara-2
graph (C), the court shall dismiss without 3
prejudice the action for failure to exhaust 4
administrative remedies.’’; and 5
(E) in clause (iii) of subparagraph (E), as 6
so redesignated, by striking ‘‘as defined under 7
subparagraph (2)(A)’’ and inserting ‘‘within the 8
meaning of subparagraph (C)’’; and 9
(3) in paragraph (4)— 10
(A) by striking ‘‘E
XCEPTIONS’’ in the para-11
graph heading and all that follows through ‘‘This 12
subsection does’’ and inserting ‘‘E
XCEPTIONS.— 13
This subsection does’’; 14
(B) by striking subparagraph (B); and 15
(C) by redesignating clauses (i) and (ii) as 16
subparagraphs (A) and (B), respectively, and 17
adjusting the margins accordingly. 18
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107
118
TH
CONGRESS
1
ST
S
ESSION
S. 1067 A BILL
To amend the Federal Food, Drug, and Cosmetic
Act with respect to citizen petitions.
J
UNE
22, 2023
Reported with an amendment
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