Us Congress 2023-2024 Regular Session

Us Congress Senate Bill SB1067 Compare Versions

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Version 2 (New)

Old	New		Differences
1	1		II
2		-	Calendar No. 107
3	2		118THCONGRESS
4	3		1
5	4		STSESSION S. 1067
6	5		To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen
7	6		petitions.
8	7		IN THE SENATE OF THE UNITED STATES
9	8		MARCH29, 2023
10	9		Mrs. S
11	10		HAHEEN(for herself, Ms. COLLINS, Mr. BENNET, Mr. RUBIO, Ms.
12	11		B
13	12		ALDWIN, and Mr. BRAUN) introduced the following bill; which was read
14	13		twice and referred to the Committee on Health, Education, Labor, and
15	14		Pensions
16		-	J
17		-	UNE22, 2023
18		-	Reported by Mr. S
19		-	ANDERS, with an amendment
20		-	[Strike out all after the enacting clause and insert the part printed in italic]
21	15		A BILL
22	16		To amend the Federal Food, Drug, and Cosmetic Act with
23	17		respect to citizen petitions.
24	18		Be it enacted by the Senate and House of Representa-1
25	19		tives of the United States of America in Congress assembled, 2
26	20		SECTION 1. SHORT TITLE. 3
27	21		This Act may be cited as the ‘‘Ensuring Timely Ac-4
28	22		cess to Generics Act of 2023’’. 5
29		-	VerDate Sep 11 2014 00:12 Jun 23, 2023 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6401 E:\BILLS\S1067.RS S1067
	23	+	SEC. 2. ENSURING TIMELY ACCESS TO GENERICS. 6
	24	+	Section 505(q) of the Federal Food, Drug, and Cos-7
	25	+	metic Act (21 U.S.C. 355(q)) is amended— 8
	26	+	(1) in paragraph (1)— 9
	27	+	VerDate Sep 11 2014 00:49 Apr 08, 2023 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S1067.IS S1067
30	28		pbinns on DSKJLVW7X2PROD with $$_JOB 2
31		-	•S 1067 RS
32		-	SEC.2.ENSURING TIMELYACCESSTOGENERICS. 1
33		-	Section505(q)oftheFederalFood,Drug,andCos-2
34		-	meticAct(21U.S.C.355(q))isamended— 3
35		-	(1)inparagraph(1)— 4
36		-	(A)insubparagraph(A)(i),byinserting‘‘, 5
37		-	10.31,’’after‘‘10.30’’; 6
38		-	(B)insubparagraph(E)— 7
39		-	(i)bystriking‘‘applicationand’’and 8
40		-	inserting‘‘applicationor’’; 9
41		-	(ii)bystriking‘‘IftheSecretary’’and 10
42		-	insertingthefollowing: 11
43		-	‘‘(i)INGENERAL.—IftheSecretary’’; 12
44		-	(iii)bystrikingthesecondsentence 13
45		-	andinsertingthefollowing: 14
46		-	‘‘(ii)PRIMARYPURPOSE OFDELAY-15
47		-	ING.— 16
48		-	‘‘(I)INGENERAL.—Indeter-17
49		-	miningwhetherapetitionwassub-18
50		-	mittedwiththeprimarypurposeof 19
51		-	delayinganapplication,theSecretary 20
52		-	mayconsiderthefollowingfactors: 21
53		-	‘‘(aa)Whetherthepetition 22
54		-	wassubmittedinaccordancewith 23
55		-	paragraph(2)(B),basedonwhen 24
56		-	thepetitionerkneworreasonably 25
57		-	shouldhaveknowntherelevant 26
58		-	VerDate Sep 11 2014 00:12 Jun 23, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6401 E:\BILLS\S1067.RS S1067
	29	+	•S 1067 IS
	30	+	(A) in subparagraph (A)(i), by inserting ‘‘, 1
	31	+	10.31,’’ after ‘‘10.30’’; 2
	32	+	(B) in subparagraph (E)— 3
	33	+	(i) by striking ‘‘application and’’ and 4
	34	+	inserting ‘‘application or’’; 5
	35	+	(ii) by striking ‘‘If the Secretary’’ and 6
	36	+	inserting the following: 7
	37	+	‘‘(i) I
	38	+	N GENERAL.—If the Secretary’’; 8
	39	+	(iii) by striking the second sentence 9
	40	+	and inserting the following: 10
	41	+	‘‘(ii) P
	42	+	RIMARY PURPOSE OF DELAY -11
	43	+	ING.— 12
	44	+	‘‘(I) I
	45	+	N GENERAL.—In deter-13
	46	+	mining whether a petition was sub-14
	47	+	mitted with the primary purpose of 15
	48	+	delaying an application, the Secretary 16
	49	+	may consider the following factors: 17
	50	+	‘‘(aa) Whether the petition 18
	51	+	was submitted in accordance with 19
	52	+	paragraph (2)(B), based on when 20
	53	+	the petitioner knew or reasonably 21
	54	+	should have known the relevant 22
	55	+	information relied upon to form 23
	56	+	the basis of such petition. 24
	57	+	VerDate Sep 11 2014 00:49 Apr 08, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1067.IS S1067
59	58		pbinns on DSKJLVW7X2PROD with $$_JOB 3
60		-	•S 1067 RS
61		-	~~informationreliedupontoform~~ 1
62		-	~~thebasisofsuchpetition.~~ 2
63		-	~~‘‘(bb)Whetherthepetitioner~~ 3
64		-	~~hassubmittedmultipleorserial~~ 4
65		-	~~petitionsorsupplementstopeti-~~5
66		-	~~tionsraisingissuesthatreason~~-6
67		-	~~ablycouldhavebeenknownto~~ 7
68		-	~~thepetitioneratthetimeofsub-~~8
69		-	~~missionoftheearlierpetitionor~~ 9
70		-	~~petitions.~~ 10
71		-	~~‘‘(cc)Whetherthepetition~~ 11
72		-	~~wassubmittedcloseintimetoa~~ 12
73		-	~~known,firstdateuponwhichan~~ 13
74		-	~~applicationundersubsection~~ 14
75		-	~~(b)(2)or(j)ofthissectionor~~ 15
76		-	~~section351(k)ofthePublic~~ 16
77		-	~~HealthServiceActcouldbeap-~~17
78		-	~~proved.~~ 18
79		-	~~‘‘(dd)Whetherthepetition~~ 19
80		-	~~wassubmittedwithoutrelevant~~ 20
81		-	~~dataorinformationinsupportof~~ 21
82		-	~~thescientificpositionsforming~~ 22
83		-	~~thebasisofsuchpetition.~~ 23
84		-	~~‘‘(ee)Whetherthepetition~~ 24
85		-	~~raisesthesameorsubstantially~~ 25
86		-	VerDate Sep 11 2014 00:~~12 Jun 23~~, 2023 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt ~~6401~~ E:\BILLS\S1067.RS S1067
	59	+	•S 1067 IS
	60	+	‘‘(bb) Whether the petitioner 1
	61	+	has submitted multiple or serial 2
	62	+	petitions or supplements to peti-3
	63	+	tions raising issues that reason-4
	64	+	ably could have been known to 5
	65	+	the petitioner at the time of sub-6
	66	+	mission of the earlier petition or 7
	67	+	petitions. 8
	68	+	‘‘(cc) Whether the petition 9
	69	+	was submitted close in time to a 10
	70	+	known, first date upon which an 11
	71	+	application under subsection 12
	72	+	(b)(2) or (j) of this section or 13
	73	+	section 351(k) of the Public 14
	74	+	Health Service Act could be ap-15
	75	+	proved. 16
	76	+	‘‘(dd) Whether the petition 17
	77	+	was submitted without relevant 18
	78	+	data or information in support of 19
	79	+	the scientific positions forming 20
	80	+	the basis of such petition. 21
	81	+	‘‘(ee) Whether the petition 22
	82	+	raises the same or substantially 23
	83	+	similar issues as a prior petition 24
	84	+	to which the Secretary has re-25
	85	+	VerDate Sep 11 2014 00:49 Apr 08, 2023 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S1067.IS S1067
87	86		pbinns on DSKJLVW7X2PROD with $$_JOB 4
88		-	•S 1067 RS
89		-	~~similarissuesasapriorpetition~~ 1
90		-	~~towhichtheSecretaryhasre~~-2
91		-	~~spondedsubstantivelyalready,in-~~3
92		-	~~cludingifthesubsequentsubmis-~~4
93		-	~~sionfollowssuchresponsefrom~~ 5
94		-	~~theSecretarycloselyintime.~~ 6
95		-	~~‘‘(ff)Whetherthepetition~~ 7
96		-	~~requestschangingtheapplicable~~ 8
97		-	~~standardsthatotherapplicants~~ 9
98		-	~~arerequiredtomeet,including~~ 10
99		-	~~requestingtesting,data,orlabel~~-11
100		-	~~ingstandardsthataremoreon~~-12
101		-	~~erousorrigorousthanthestand~~-13
102		-	~~ardstheSecretaryhasdeter~~-14
103		-	~~minedtobeapplicabletothelist-~~15
104		-	~~eddrug,referenceproduct,orpe-~~16
105		-	~~titioner~~’~~sversionofthesame~~ 17
106		-	~~drug.~~ 18
107		-	~~‘‘(gg)Thepetitioner’srecord~~ 19
108		-	~~ofsubmittingpetitionstothe~~ 20
109		-	~~FoodandDrugAdministration~~ 21
110		-	~~thathavebeendeterminedbythe~~ 22
111		-	~~Secretarytohavebeensubmitted~~ 23
112		-	~~withtheprimarypurposeof~~ 24
113		-	~~delay.~~ 25
114		-	VerDate Sep 11 2014 00:~~12 Jun 23~~, 2023 Jkt 039200 PO 00000 Frm 00004 Fmt 6652 Sfmt ~~6401~~ E:\BILLS\S1067.RS S1067
	87	+	•S 1067 IS
	88	+	sponded substantively already, in-1
	89	+	cluding if the subsequent submis-2
	90	+	sion follows such response from 3
	91	+	the Secretary closely in time. 4
	92	+	‘‘(ff) Whether the petition 5
	93	+	requests changing the applicable 6
	94	+	standards that other applicants 7
	95	+	are required to meet, including 8
	96	+	requesting testing, data, or label-9
	97	+	ing standards that are more on-10
	98	+	erous or rigorous than the stand-11
	99	+	ards the Secretary has deter-12
	100	+	mined to be applicable to the list-13
	101	+	ed drug, reference product, or pe-14
	102	+	titioner’s version of the same 15
	103	+	drug. 16
	104	+	‘‘(gg) The petitioner’s record 17
	105	+	of submitting petitions to the 18
	106	+	Food and Drug Administration 19
	107	+	that have been determined by the 20
	108	+	Secretary to have been submitted 21
	109	+	with the primary purpose of 22
	110	+	delay. 23
	111	+	‘‘(hh) Other relevant and 24
	112	+	appropriate factors, which the 25
	113	+	VerDate Sep 11 2014 00:49 Apr 08, 2023 Jkt 039200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S1067.IS S1067
115	114		pbinns on DSKJLVW7X2PROD with $$_JOB 5
116		-	•S 1067 RS
117		-	‘‘(hh)Otherrelevantand 1
118		-	appropriatefactors,whichthe 2
119		-	Secretaryshalldescribeinguid-3
120		-	ance. 4
121		-	‘‘(II)GUIDANCE.—TheSecretary 5
122		-	mayissueorupdateguidance,asap-6
123		-	propriate,todescribefactorstheSec-7
124		-	retaryconsidersinaccordancewith 8
125		-	subclause(I).’’;and 9
126		-	(iv)byaddingattheendthefol-10
127		-	lowing: 11
128		-	‘‘(iii)REFERRAL TOTHEFEDERAL 12
129		-	TRADECOMMISSION.—TheSecretaryshall 13
130		-	establishproceduresforreferringtothe 14
131		-	FederalTradeCommissionanypetitionor 15
132		-	supplementtoapetitionthattheSecretary 16
133		-	determineswassubmittedwiththeprimary 17
134		-	purposeofdelayingapprovalofanapplica-18
135		-	tion.Suchproceduresshallincludenotifi-19
136		-	cationtothepetitionerbytheSecretary.’’; 20
137		-	(C)bystrikingsubparagraph(F); 21
138		-	(D)byredesignatingsubparagraphs(G) 22
139		-	through(I)assubparagraphs(F)through(H), 23
140		-	respectively;and 24
141		-	VerDate Sep 11 2014 00:12 Jun 23, 2023 Jkt 039200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6401 E:\BILLS\S1067.RS S1067
	115	+	•S 1067 IS
	116	+	Secretary shall describe in guid-1
	117	+	ance. 2
	118	+	‘‘(II) G
	119	+	UIDANCE.—The Secretary 3
	120	+	may issue or update guidance, as ap-4
	121	+	propriate, to describe factors the Sec-5
	122	+	retary considers in accordance with 6
	123	+	subclause (I).’’; and 7
	124	+	(iv) by adding at the end the fol-8
	125	+	lowing: 9
	126	+	‘‘(iii) R
	127	+	EFERRAL TO THE FEDERAL 10
	128	+	TRADE COMMISSION.—The Secretary shall 11
	129	+	establish procedures for referring to the 12
	130	+	Federal Trade Commission any petition or 13
	131	+	supplement to a petition that the Secretary 14
	132	+	determines was submitted with the primary 15
	133	+	purpose of delaying approval of an applica-16
	134	+	tion. Such procedures shall include notifi-17
	135	+	cation to the petitioner by the Secretary.’’; 18
	136	+	(C) by striking subparagraph (F); 19
	137	+	(D) by redesignating subparagraphs (G) 20
	138	+	through (I) as subparagraphs (F) through (H), 21
	139	+	respectively; and 22
	140	+	(E) in subparagraph (H), as so redesig-23
	141	+	nated, by striking ‘‘submission of this petition’’ 24
	142	+	and inserting ‘‘submission of this document’’; 25
	143	+	VerDate Sep 11 2014 00:49 Apr 08, 2023 Jkt 039200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S1067.IS S1067
142	144		pbinns on DSKJLVW7X2PROD with $$_JOB 6
143		-	•S 1067 RS
144		-	(E)insubparagraph(H),assoredesig-1
145		-	nated,bystriking‘‘submissionofthispetition’’ 2
146		-	andinserting‘‘submissionofthisdocument’’; 3
147		-	(2)inparagraph(2)— 4
148		-	(A)byredesignatingsubparagraphs(A) 5
149		-	through(C)assubparagraphs(C)through(E), 6
150		-	respectively; 7
151		-	(B)byinsertingbeforesubparagraph(C), 8
152		-	assoredesignated,thefollowing: 9
153		-	‘‘(A)INGENERAL.—Apersonshallsubmit 10
154		-	apetitiontotheSecretaryunderparagraph(1) 11
155		-	beforefilingacivilactioninwhichtheperson 12
156		-	seekstosetaside,delay,rescind,withdraw,or 13
157		-	preventsubmission,review,orapprovalofan 14
158		-	applicationsubmittedundersubsection(b)(2) 15
159		-	or(j)ofthissectionorsection351(k)ofthe 16
160		-	PublicHealthServiceAct.Suchpetitionand 17
161		-	anysupplementtosuchapetitionshalldescribe 18
162		-	allinformationandargumentsthatformthe 19
163		-	basisofthereliefrequestedinanycivilaction 20
164		-	describedintheprevioussentence. 21
165		-	‘‘(B)TIMELYSUBMISSIONOFCITIZENPE-22
166		-	TITION.—Apetitionandanysupplementtoa 23
167		-	petitionshallbesubmittedwithin60daysafter 24
168		-	thepersonknew,orreasonablyshouldhave 25
169		-	VerDate Sep 11 2014 00:12 Jun 23, 2023 Jkt 039200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6401 E:\BILLS\S1067.RS S1067
	145	+	•S 1067 IS
	146	+	(2) in paragraph (2)— 1
	147	+	(A) by redesignating subparagraphs (A) 2
	148	+	through (C) as subparagraphs (C) through (E), 3
	149	+	respectively; 4
	150	+	(B) by inserting before subparagraph (C), 5
	151	+	as so redesignated, the following: 6
	152	+	‘‘(A) I
	153	+	N GENERAL.—A person shall submit 7
	154	+	a petition to the Secretary under paragraph (1) 8
	155	+	before filing a civil action in which the person 9
	156	+	seeks to set aside, delay, rescind, withdraw, or 10
	157	+	prevent submission, review, or approval of an 11
	158	+	application submitted under subsection (b)(2) 12
	159	+	or (j) of this section or section 351(k) of the 13
	160	+	Public Health Service Act. Such petition and 14
	161	+	any supplement to such a petition shall describe 15
	162	+	all information and arguments that form the 16
	163	+	basis of the relief requested in any civil action 17
	164	+	described in the previous sentence. 18
	165	+	‘‘(B) T
	166	+	IMELY SUBMISSION OF CITIZEN PE -19
	167	+	TITION.—A petition and any supplement to a 20
	168	+	petition shall be submitted within 60 days after 21
	169	+	the person knew, or reasonably should have 22
	170	+	known, the information that forms the basis of 23
	171	+	the request made in the petition or supple-24
	172	+	ment.’’; 25
	173	+	VerDate Sep 11 2014 00:49 Apr 08, 2023 Jkt 039200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S1067.IS S1067
170	174		pbinns on DSKJLVW7X2PROD with $$_JOB 7
171		-	•S 1067 RS
172		-	known,theinformationthatformsthebasisof 1
173		-	therequestmadeinthepetitionorsupple-2
174		-	ment.’’; 3
175		-	(C)insubparagraph(C),assoredesig-4
176		-	nated— 5
177		-	(i)intheheading,bystriking‘‘WITH-6
178		-	IN150DAYS’’; 7
179		-	(ii)inclause(i),bystriking‘‘during 8
180		-	the150-dayperiodreferredtoinpara-9
181		-	graph(1)(F),’’;and 10
182		-	(iii)byamendingclause(ii)toreadas 11
183		-	follows: 12
184		-	‘‘(ii)onorafterthedatethatis151 13
185		-	daysafterthedateofsubmissionofthe 14
186		-	petition,theSecretaryapprovesorhasap-15
187		-	provedtheapplicationthatisthesubject 16
188		-	ofthepetitionwithouthavingmadesucha 17
189		-	finaldecision.’’; 18
190		-	(D)byamendingsubparagraph(D),asso 19
191		-	redesignated,toreadasfollows: 20
192		-	‘‘(D)DISMISSALOFCERTAINCIVILAC-21
193		-	TIONS.— 22
194		-	‘‘(i)PETITION.—Ifapersonfilesa 23
195		-	civilactionagainsttheSecretaryinwhich 24
196		-	apersonseekstosetaside,delay,rescind, 25
197		-	VerDate Sep 11 2014 00:12 Jun 23, 2023 Jkt 039200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6401 E:\BILLS\S1067.RS S1067
	175	+	•S 1067 IS
	176	+	(C) in subparagraph (C), as so redesig-1
	177	+	nated— 2
	178	+	(i) in the heading, by striking ‘‘
	179	+	WITH-3
	180	+	IN 150 DAYS’’; 4
	181	+	(ii) in clause (i), by striking ‘‘during 5
	182	+	the 150-day period referred to in para-6
	183	+	graph (1)(F),’’; and 7
	184	+	(iii) by amending clause (ii) to read as 8
	185	+	follows: 9
	186	+	‘‘(ii) on or after the date that is 151 10
	187	+	days after the date of submission of the 11
	188	+	petition, the Secretary approves or has ap-12
	189	+	proved the application that is the subject 13
	190	+	of the petition without having made such a 14
	191	+	final decision.’’; 15
	192	+	(D) by amending subparagraph (D), as so 16
	193	+	redesignated, to read as follows: 17
	194	+	‘‘(D) D
	195	+	ISMISSAL OF CERTAIN CIVIL AC -18
	196	+	TIONS.— 19
	197	+	‘‘(i) P
	198	+	ETITION.—If a person files a 20
	199	+	civil action against the Secretary in which 21
	200	+	a person seeks to set aside, delay, rescind, 22
	201	+	withdraw, or prevent submission, review, or 23
	202	+	approval of an application submitted under 24
	203	+	subsection (b)(2) or (j) of this section or 25
	204	+	VerDate Sep 11 2014 00:49 Apr 08, 2023 Jkt 039200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S1067.IS S1067
198	205		pbinns on DSKJLVW7X2PROD with $$_JOB 8
199		-	•S 1067 RS
200		-	withdraw,orpreventsubmission,review,or 1
201		-	approvalofanapplicationsubmittedunder 2
202		-	subsection(b)(2)or(j)ofthissectionor 3
203		-	section351(k)ofthePublicHealthService 4
204		-	Actwithoutcomplyingwiththerequire-5
205		-	mentsofsubparagraph(A),thecourtshall 6
206		-	dismisswithoutprejudicetheactionfor 7
207		-	failuretoexhaustadministrativeremedies. 8
208		-	‘‘(ii)TIMELINESS.—Ifapersonfilesa 9
209		-	civilactionagainsttheSecretaryinwhich 10
210		-	apersonseekstosetaside,delay,rescind, 11
211		-	withdraw,orpreventsubmission,review,or 12
212		-	approvalofanapplicationsubmittedunder 13
213		-	subsection(b)(2)or(j)ofthissectionor 14
214		-	section351(k)ofthePublicHealthService 15
215		-	Actwithoutcomplyingwiththerequire-16
216		-	mentsofsubparagraph(B),thecourtshall 17
217		-	dismisswithprejudicetheactionforfail-18
218		-	uretotimelyfileapetition. 19
219		-	‘‘(iii)FINALRESPONSE.—Ifacivilac-20
220		-	tionisfiledagainsttheSecretarywithre-21
221		-	specttoanyissueraisedinapetitiontime-22
222		-	lyfiledunderparagraph(1)inwhichthe 23
223		-	petitionerrequeststhattheSecretarytake 24
224		-	anyformofactionthatcould,iftaken,set 25
225		-	VerDate Sep 11 2014 00:12 Jun 23, 2023 Jkt 039200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6401 E:\BILLS\S1067.RS S1067
	206	+	•S 1067 IS
	207	+	section 351(k) of the Public Health Service 1
	208	+	Act without complying with the require-2
	209	+	ments of subparagraph (A), the court shall 3
	210	+	dismiss without prejudice the action for 4
	211	+	failure to exhaust administrative remedies. 5
	212	+	‘‘(ii) T
	213	+	IMELINESS.—If a person files a 6
	214	+	civil action against the Secretary in which 7
	215	+	a person seeks to set aside, delay, rescind, 8
	216	+	withdraw, or prevent submission, review, or 9
	217	+	approval of an application submitted under 10
	218	+	subsection (b)(2) or (j) of this section or 11
	219	+	section 351(k) of the Public Health Service 12
	220	+	Act without complying with the require-13
	221	+	ments of subparagraph (B), the court shall 14
	222	+	dismiss with prejudice the action for fail-15
	223	+	ure to timely file a petition. 16
	224	+	‘‘(iii) F
	225	+	INAL RESPONSE.—If a civil ac-17
	226	+	tion is filed against the Secretary with re-18
	227	+	spect to any issue raised in a petition time-19
	228	+	ly filed under paragraph (1) in which the 20
	229	+	petitioner requests that the Secretary take 21
	230	+	any form of action that could, if taken, set 22
	231	+	aside, delay, rescind, withdraw, or prevent 23
	232	+	submission, review, or approval of an appli-24
	233	+	cation submitted under subsection (b)(2) 25
	234	+	VerDate Sep 11 2014 00:49 Apr 08, 2023 Jkt 039200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S1067.IS S1067
226	235		pbinns on DSKJLVW7X2PROD with $$_JOB 9
227		-	•S 1067 RS
228		-	aside,delay,rescind,withdraw,orprevent 1
229		-	submission,review,orapprovalofanappli-2
230		-	cationsubmittedundersubsection(b)(2) 3
231		-	or(j)ofthissectionorsection351(k)of 4
232		-	thePublicHealthServiceActbeforethe 5
233		-	Secretaryhastakenfinalagencyactionon 6
234		-	thepetitionwithinthemeaningofsub-7
235		-	paragraph(C),thecourtshalldismiss 8
236		-	withoutprejudicetheactionforfailureto 9
237		-	exhaustadministrativeremedies.’’;and 10
238		-	(E)inclause(iii)ofsubparagraph(E),as 11
239		-	soredesignated,bystriking‘‘asdefinedunder 12
240		-	subparagraph(2)(A)’’andinserting‘‘withinthe 13
241		-	meaningofsubparagraph(C)’’;and 14
242		-	(3)inparagraph(4)— 15
243		-	(A)bystriking‘‘EXCEPTIONS’’inthe 16
244		-	paragraphheadingandallthatfollowsthrough 17
245		-	‘‘Thissubsectiondoes’’andinserting‘‘EXCEP-18
246		-	TIONS.—Thissubsectiondoes’’; 19
247		-	(B)bystrikingsubparagraph(B);and 20
248		-	(C)byredesignatingclauses(i)and(ii)as 21
249		-	subparagraphs(A)and(B),respectively,and 22
250		-	adjustingthemarginsaccordingly. 23
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253		-	•S 1067 RS
254		-	SECTION 1. SHORT TITLE. 1
255		-	This Act may be cited as the ‘‘Ensuring Timely Access 2
256		-	to Generics Act of 2023’’. 3
257		-	SEC. 2. ENSURING TIMELY ACCESS TO GENERICS. 4
258		-	Section 505(q) of the Federal Food, Drug, and Cos-5
259		-	metic Act (21 U.S.C. 355(q)) is amended— 6
260		-	(1) in paragraph (1)— 7
261		-	(A) in subparagraph (A)(i), by inserting ‘‘, 8
262		-	10.31,’’ after ‘‘10.30’’; 9
263		-	(B) in subparagraph (E)— 10
264		-	(i) by striking ‘‘application and’’ and 11
265		-	inserting ‘‘application or’’; 12
266		-	(ii) by striking ‘‘If the Secretary’’ and 13
267		-	inserting the following: 14
268		-	‘‘(i) I
269		-	N GENERAL.—If the Secretary’’; 15
270		-	and 16
271		-	(iii) by striking the second sentence 17
272		-	and inserting the following: 18
273		-	‘‘(ii) P
274		-	RIMARY PURPOSE OF DELAY -19
275		-	ING.— 20
276		-	‘‘(I) I
277		-	N GENERAL.—In deter-21
278		-	mining whether a petition was sub-22
279		-	mitted with the primary purpose of de-23
280		-	laying an application, the Secretary 24
281		-	may consider the following factors: 25
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284		-	•S 1067 RS
285		-	‘‘(aa) Whether the petition 1
286		-	was submitted in accordance with 2
287		-	paragraph (2)(B), based on when 3
288		-	the petitioner knew the relevant 4
289		-	information relied upon to form 5
290		-	the basis of such petition. 6
291		-	‘‘(bb) When the petition was 7
292		-	submitted in relation to when the 8
293		-	petitioner reasonably should have 9
294		-	known the relevant information 10
295		-	relied upon to form the basis of 11
296		-	such petition. 12
297		-	‘‘(cc) Whether the petitioner 13
298		-	has submitted multiple or serial 14
299		-	petitions or supplements to peti-15
300		-	tions raising issues that reason-16
301		-	ably could have been known to the 17
302		-	petitioner at the time of submis-18
303		-	sion of the earlier petition or peti-19
304		-	tions. 20
305		-	‘‘(dd) Whether the petition 21
306		-	was submitted close in time to a 22
307		-	known, first date upon which an 23
308		-	application under subsection 24
309		-	(b)(2) or (j) of this section or sec-25
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311		-	pbinns on DSKJLVW7X2PROD with $$_JOB 12
312		-	•S 1067 RS
313		-	tion 351(k) of the Public Health 1
314		-	Service Act could be approved. 2
315		-	‘‘(ee) Whether the petition 3
316		-	was submitted without relevant 4
317		-	data or information in support of 5
318		-	the scientific positions forming the 6
319		-	basis of such petition. 7
320		-	‘‘(ff) Whether the petition 8
321		-	raises the same or substantially 9
322		-	similar issues as a prior petition 10
323		-	to which the Secretary has re-11
324		-	sponded substantively already, in-12
325		-	cluding if the subsequent submis-13
326		-	sion follows such response from 14
327		-	the Secretary closely in time. 15
328		-	‘‘(gg) Whether the petition 16
329		-	requests changing the applicable 17
330		-	standards that other applicants 18
331		-	are required to meet, including re-19
332		-	questing testing, data, or labeling 20
333		-	standards that are more onerous 21
334		-	or rigorous than the standards the 22
335		-	Secretary has determined to be 23
336		-	applicable to the listed drug, ref-24
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339		-	•S 1067 RS
340		-	erence product, or petitioner’s 1
341		-	version of the same drug. 2
342		-	‘‘(hh) The petitioner’s record 3
343		-	of submitting petitions to the 4
344		-	Food and Drug Administration 5
345		-	that have been determined by the 6
346		-	Secretary to have been submitted 7
347		-	with the primary purpose of 8
348		-	delay. 9
349		-	‘‘(ii) Other relevant and ap-10
350		-	propriate factors, which the Sec-11
351		-	retary shall describe in guidance. 12
352		-	‘‘(II) G
353		-	UIDANCE.—The Secretary 13
354		-	may issue or update guidance, as ap-14
355		-	propriate, to describe factors the Sec-15
356		-	retary considers in accordance with 16
357		-	subclause (I).’’; 17
358		-	(C) by striking subparagraph (F); 18
359		-	(D) by redesignating subparagraphs (G) 19
360		-	through (I) as subparagraphs (F) through (H), 20
361		-	respectively; and 21
362		-	(E) in subparagraph (H), as so redesig-22
363		-	nated, by striking ‘‘submission of this petition’’ 23
364		-	and inserting ‘‘submission of this document’’; 24
365		-	(2) in paragraph (2)— 25
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368		-	•S 1067 RS
369		-	(A) by redesignating subparagraphs (A) 1
370		-	through (C) as subparagraphs (C) through (E), 2
371		-	respectively; 3
372		-	(B) by inserting before subparagraph (C), 4
373		-	as so redesignated, the following: 5
374		-	‘‘(A) I
375		-	N GENERAL.—A person shall submit a 6
376		-	petition to the Secretary under paragraph (1) 7
377		-	before filing a civil action in which the person 8
378		-	seeks to set aside, delay, rescind, withdraw, or 9
379		-	prevent submission, review, or approval of an 10
380		-	application submitted under subsection (b)(2) or 11
381		-	(j) of this section or section 351(k) of the Public 12
382		-	Health Service Act. Such petition and any sup-13
383		-	plement to such a petition shall describe all in-14
384		-	formation and arguments that form the basis of 15
385		-	the relief requested in any civil action described 16
386		-	in the previous sentence. 17
387		-	‘‘(B) T
388		-	IMELY SUBMISSION OF CITIZEN PETI -18
389		-	TION.—A petition and any supplement to a peti-19
390		-	tion shall be submitted within 180 days after the 20
391		-	person knew the information that forms the basis 21
392		-	of the request made in the petition or supple-22
393		-	ment.’’; 23
394		-	(C) in subparagraph (C), as so redesig-24
395		-	nated— 25
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398		-	•S 1067 RS
399		-	(i) in the heading, by striking ‘‘WITHIN 1
400		-	150 DAYS’’; 2
401		-	(ii) in clause (i), by striking ‘‘during 3
402		-	the 150-day period referred to in paragraph 4
403		-	(1)(F),’’; and 5
404		-	(iii) by amending clause (ii) to read as 6
405		-	follows: 7
406		-	‘‘(ii) on or after the date that is 151 8
407		-	days after the date of submission of the peti-9
408		-	tion, the Secretary approves or has ap-10
409		-	proved the application that is the subject of 11
410		-	the petition without having made such a 12
411		-	final decision.’’; 13
412		-	(D) by amending subparagraph (D), as so 14
413		-	redesignated, to read as follows: 15
414		-	‘‘(D) D
415		-	ISMISSAL OF CERTAIN CIVIL AC -16
416		-	TIONS.— 17
417		-	‘‘(i) P
418		-	ETITION.—If a person files a 18
419		-	civil action against the Secretary in which 19
420		-	a person seeks to set aside, delay, rescind, 20
421		-	withdraw, or prevent submission, review, or 21
422		-	approval of an application submitted under 22
423		-	subsection (b)(2) or (j) of this section or sec-23
424		-	tion 351(k) of the Public Health Service Act 24
425		-	without complying with the requirements of 25
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428		-	•S 1067 RS
429		-	subparagraph (A), the court shall dismiss 1
430		-	without prejudice the action for failure to 2
431		-	exhaust administrative remedies. 3
432		-	‘‘(ii) T
433		-	IMELINESS.—If a person files a 4
434		-	civil action against the Secretary in which 5
435		-	a person seeks to set aside, delay, rescind, 6
436		-	withdraw, or prevent submission, review, or 7
437		-	approval of an application submitted under 8
438		-	subsection (b)(2) or (j) of this section or sec-9
439		-	tion 351(k) of the Public Health Service Act 10
440		-	without complying with the requirements of 11
441		-	subparagraph (B), the court shall dismiss 12
442		-	with prejudice the action for failure to time-13
443		-	ly file a petition. 14
444		-	‘‘(iii) F
445		-	INAL RESPONSE.—If a civil ac-15
446		-	tion is filed against the Secretary with re-16
447		-	spect to any issue raised in a petition time-17
448		-	ly filed under paragraph (1) in which the 18
449		-	petitioner requests that the Secretary take 19
450		-	any form of action that could, if taken, set 20
451		-	aside, delay, rescind, withdraw, or prevent 21
452		-	submission, review, or approval of an appli-22
453		-	cation submitted under subsection (b)(2) or 23
454		-	(j) of this section or section 351(k) of the 24
455		-	Public Health Service Act before the Sec-25
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458		-	•S 1067 RS
459		-	retary has taken final agency action on the 1
460		-	petition within the meaning of subpara-2
461		-	graph (C), the court shall dismiss without 3
462		-	prejudice the action for failure to exhaust 4
463		-	administrative remedies.’’; and 5
464		-	(E) in clause (iii) of subparagraph (E), as 6
465		-	so redesignated, by striking ‘‘as defined under 7
466		-	subparagraph (2)(A)’’ and inserting ‘‘within the 8
467		-	meaning of subparagraph (C)’’; and 9
468		-	(3) in paragraph (4)— 10
	236	+	•S 1067 IS
	237	+	or (j) of this section or section 351(k) of 1
	238	+	the Public Health Service Act before the 2
	239	+	Secretary has taken final agency action on 3
	240	+	the petition within the meaning of sub-4
	241	+	paragraph (C), the court shall dismiss 5
	242	+	without prejudice the action for failure to 6
	243	+	exhaust administrative remedies.’’; and 7
	244	+	(E) in clause (iii) of subparagraph (E), as 8
	245	+	so redesignated, by striking ‘‘as defined under 9
	246	+	subparagraph (2)(A)’’ and inserting ‘‘within the 10
	247	+	meaning of subparagraph (C)’’; and 11
	248	+	(3) in paragraph (4)— 12
469	249		(A) by striking ‘‘E
470		-	XCEPTIONS’’ in the para-11
471		-	graph heading and all that follows through ‘‘This 12
472		-	subsection does’’ and inserting ‘‘E
473		-	XCEPTIONS.— 13
474		-	This subsection does’’; 14
475		-	(B) by striking subparagraph (B); and 15
476		-	(C) by redesignating clauses (i) and (ii) as 16
477		-	subparagraphs (A) and (B), respectively, and 17
478		-	adjusting the margins accordingly. 18
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480		-	pbinns on DSKJLVW7X2PROD with $$_JOB Calendar No.
481		-	107
482		-	118
483		-	TH
484		-	CONGRESS
485		-	1
486		-	ST
487		-	S
488		-	ESSION
489		-
490		-	S. 1067 A BILL
491		-	To amend the Federal Food, Drug, and Cosmetic
492		-	Act with respect to citizen petitions.
493		-	J
494		-	UNE
495		-	22, 2023
496		-	Reported with an amendment
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	250	+	XCEPTIONS’’ in the 13
	251	+	paragraph heading and all that follows through 14
	252	+	‘‘This subsection does’’ and inserting ‘‘E
	253	+	XCEP-15
	254	+	TIONS.—This subsection does’’; 16
	255	+	(B) by striking subparagraph (B); and 17
	256	+	(C) by redesignating clauses (i) and (ii) as 18
	257	+	subparagraphs (A) and (B), respectively, and 19
	258	+	adjusting the margins accordingly. 20
	259	+	Æ
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