Us Congress 2025-2026 Regular Session

Us Congress Senate Bill SB1095 Compare Versions

Version 1 (Old)

Version 2 (New)

Old	New		Differences
1	1		II
2		-	Calendar No. 45
3	2		119THCONGRESS
4	3		1
5	4		STSESSION S. 1095
6	5		To enable the Federal Trade Commission to deter filing of sham citizen
7	6		petitions to cover an attempt to interfere with approval of a competing
8	7		generic drug or biosimilar, to foster competition, and facilitate the effi-
9	8		cient review of petitions filed in good faith to raise legitimate public
10	9		health concerns, and for other purposes.
11	10		IN THE SENATE OF THE UNITED STATES
12	11		MARCH24, 2025
13	12		Ms. K
14	13		LOBUCHAR (for herself, Mr. GRASSLEY, Mr. DURBIN, Mr.
15	14		B
16	15		LUMENTHAL, Mr. CRUZ, Mr. WELCH, and Mr. BOOKER) introduced the
17	16		following bill; which was read twice and referred to the Committee on the
18	17		Judiciary
19		-	A
20		-	PRIL10, 2025
21		-	Reported by Mr. G
22		-	RASSLEY, without amendment
23	18		A BILL
24	19		To enable the Federal Trade Commission to deter filing
25	20		of sham citizen petitions to cover an attempt to interfere
26	21		with approval of a competing generic drug or biosimilar,
27	22		to foster competition, and facilitate the efficient review
28	23		of petitions filed in good faith to raise legitimate public
29	24		health concerns, and for other purposes.
30	25		Be it enacted by the Senate and House of Representa-1
31	26		tives of the United States of America in Congress assembled, 2
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35	30		SECTION 1. SHORT TITLE. 1
36	31		This Act may be cited as the ‘‘Stop Significant and 2
37	32		Time-wasting Abuse Limiting Legitimate Innovation of 3
38	33		New Generics Act’’ or the ‘‘Stop STALLING Act’’. 4
39	34		SEC. 2. FEDERAL TRADE COMMISSION ENFORCEMENT 5
40	35		AGAINST SHAM PETITIONS. 6
41	36		(a) D
42	37		EFINITIONS.—In this section: 7
43	38		(1) C
44	39		OMMISSION.—The term ‘‘Commission’’ 8
45	40		means the Federal Trade Commission. 9
46	41		(2) C
47	42		OVERED APPLICATION .—The term ‘‘cov-10
48	43		ered application’’ means an application filed pursu-11
49	44		ant to subsection (b)(2) or (j) of section 505 of the 12
50	45		Federal Food, Drug, and Cosmetic Act (21 U.S.C. 13
51	46		355) or section 351(k) of the Public Health Service 14
52	47		Act (42 U.S.C. 262(k)). 15
53	48		(3) C
54	49		OVERED PETITION.—The term ‘‘covered 16
55	50		petition’’ means a petition, or a supplement to a pe-17
56	51		tition, filed under section 505(q) of the Federal 18
57	52		Food, Drug, and Cosmetic Act (21 U.S.C. 355(q)). 19
58	53		(4) P
59	54		ERSON.—The term ‘‘person’’— 20
60	55		(A) means an individual or entity; and 21
61	56		(B) includes— 22
62	57		(i) a successor or an assign of an enti-23
63	58		ty; 24
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67	62		(ii) a joint venture, subsidiary, part-1
68	63		nership, division, group, or affiliate con-2
69	64		trolled by an entity; and 3
70	65		(iii) a successor or an assign of a joint 4
71	66		venture, subsidiary, partnership, division, 5
72	67		group, or affiliate controlled by an entity. 6
73	68		(5) S
74	69		ERIES OF COVERED PETITIONS .—The 7
75	70		term ‘‘series of covered petitions’’ means any group 8
76	71		of more than 1 covered petition relating to the same 9
77	72		covered application. 10
78	73		(6) S
79	74		HAM.—The term ‘‘sham’’ means— 11
80	75		(A) a covered petition that— 12
81	76		(i) is objectively baseless; and 13
82	77		(ii) attempts to use a governmental 14
83	78		process, as opposed to the outcome of that 15
84	79		process, to interfere with the business of a 16
85	80		competitor; or 17
86	81		(B) a series of covered petitions that at-18
87	82		tempts to use a governmental process, as op-19
88	83		posed to the outcome of that process, to inter-20
89	84		fere with the business of a competitor. 21
90	85		(b) V
91	86		IOLATION.—A person submitting or causing the 22
92	87		submission of a covered petition or a series of covered peti-23
93	88		tions that is a sham shall be liable for engaging in an 24
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97	92		unfair method of competition under section 5(a)(1) of the 1
98	93		Federal Trade Commission Act (15 U.S.C. 45(a)(1)). 2
99	94		(c) C
100	95		IVILACTION.— 3
101	96		(1) I
102	97		N GENERAL.—If the Commission has rea-4
103	98		son to believe that the submission of a covered peti-5
104	99		tion or a series of covered petitions constitutes a vio-6
105	100		lation of section 5(a)(1) of the Federal Trade Com-7
106	101		mission Act (15 U.S.C. 45(a)(1)), the Commission 8
107	102		may commence a civil action to recover a civil pen-9
108	103		alty and seek other appropriate relief in a district 10
109	104		court of the United States against any person that 11
110	105		submitted or caused to be submitted such covered 12
111	106		petition or such series of covered petitions. 13
112	107		(2) P
113	108		RESUMPTION.—In a civil action under 14
114	109		paragraph (1), a covered petition shall be presumed 15
115	110		to be part of a series of covered petitions that is a 16
116	111		sham under subsection (b) of this section if— 17
117	112		(A) the Secretary of Health and Human 18
118	113		Services— 19
119	114		(i) has determined that the covered 20
120	115		petition was submitted with the primary 21
121	116		purpose of delaying the approval of a cov-22
122	117		ered application; and 23
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126	121		(ii) has referred such determination to 1
127	122		the Commission in writing, including a rea-2
128	123		soned basis for the determination; and 3
129	124		(B) the covered petition was part of a se-4
130	125		ries of covered petitions. 5
131	126		(3) E
132	127		XCEPTION.—The presumption in para-6
133	128		graph (2) shall not apply if the defendant estab-7
134	129		lishes, by a preponderance of the evidence, that the 8
135	130		series of covered petitions that includes the covered 9
136	131		petition referred to the Commission by the Secretary 10
137	132		of Health and Human Services is not a sham. 11
138	133		(4) C
139	134		IVIL PENALTY.—In an action under para-12
140	135		graph (1), any person that has been found liable for 13
141	136		a violation of section 5(a)(1) of the Federal Trade 14
142	137		Commission Act (15 U.S.C. 45(a)(1)) shall be sub-15
143	138		ject to a civil penalty for each violation of not more 16
144	139		than the greater of— 17
145	140		(A) any revenue earned from the sale by 18
146	141		such person of any drug product, referenced in 19
147	142		a covered application that was the subject of a 20
148	143		covered petition or a series of covered petitions 21
149	144		that is a sham, during the period during which 22
150	145		the covered petition or series of covered peti-23
151	146		tions was under review by the Secretary of 24
152	147		Health and Human Services; or 25
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156	151		(B) $50,000 for each calendar day that 1
157	152		each covered petition that is a sham or that was 2
158	153		part of a series of covered petitions that is a 3
159	154		sham was under review by the Secretary of 4
160	155		Health and Human Services. 5
161	156		(5) R
162	157		EVIEW OF REFERRAL .—No referral by the 6
163	158		Secretary of Health and Human Services under 7
164	159		paragraph (2)(A) shall be subject to judicial review, 8
165	160		except as a third-party claim asserted by the defend-9
166	161		ant under section 706(2)(A) of title 5, United States 10
167	162		Code, against the Secretary of Health and Human 11
168	163		Services or the Department of Health and Human 12
169	164		Services, as part of a civil action commenced under 13
170	165		paragraph (1). 14
171	166		(6) A
172	167		NTITRUST LAWS.—Nothing in this section 15
173	168		shall modify, impair, limit, or supersede the applica-16
174	169		bility of the antitrust laws, as defined in subsection 17
175	170		(a) of the first section of the Clayton Act (15 U.S.C. 18
176	171		12), and of section 5 of the Federal Trade Commis-19
177	172		sion Act (15 U.S.C. 45) to the extent that it applies 20
178	173		to unfair methods of competition. 21
179	174		(7) R
180	175		ULE OF CONSTRUCTION .—The civil pen-22
181	176		alty provided in this subsection is in addition to, and 23
182	177		not in lieu of, any other remedies provided by Fed-24
183	178		eral law, including under section 16 of the Clayton 25
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187	182		Act (15 U.S.C. 26) or under section 13(b) of the 1
188	183		Federal Trade Commission Act (15 U.S.C. 53(b)). 2
189	184		(d) A
190	185		PPLICABILITY.—This section shall apply to any 3
191	186		covered petition submitted on or after the date of enact-4
192	187		ment of this Act. 5
193	188		(e) R
194	189		ULE OFCONSTRUCTION.—Nothing in this Act 6
195	190		shall be construed to limit any authority of the Commis-7
196	191		sion under any other provision of law. 8
197	192		SEC. 3. SEVERABILITY. 9
198	193		If any provision of this Act or the application of such 10
199	194		provision to any person or circumstance is held to be un-11
200	195		constitutional, the remainder of this Act and the applica-12
201	196		tion of the provisions of such Act to any person or cir-13
202	197		cumstance shall not be affected. 14
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205		-	45
206		-	119
207		-	TH
208		-	CONGRESS
209		-	1
210		-	ST
211		-	S
212		-	ESSION
213		-
214		-	S. 1095 A BILL
215		-	To enable the Federal Trade Commission to deter
216		-	filing of sham citizen petitions to cover an at-
217		-	tempt to interfere with approval of a competing
218		-	generic drug or biosimilar, to foster competition,
219		-	and facilitate the efficient review of petitions
220		-	filed in good faith to raise legitimate public
221		-	health concerns, and for other purposes.
222		-	A
223		-	PRIL
224		-	10, 2025
225		-	Reported without amendment
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