Us Congress 2025-2026 Regular Session

Us Congress Senate Bill SB1040 Compare Versions

Version 1 (Old)

Version 2 (New)

Old	New		Differences
1	1		II
2		-	Calendar No. 43
3	2		119THCONGRESS
4	3		1
5	4		STSESSION S. 1040
6	5		To amend the Federal Trade Commission Act to prohibit product hopping,
7	6		and for other purposes.
8	7		IN THE SENATE OF THE UNITED STATES
9	8		MARCH13, 2025
10	9		Mr. C
11	10		ORNYN(for himself, Mr. BLUMENTHAL, Mr. GRASSLEY, and Mr. DUR-
12	11		BIN) introduced the following bill; which was read twice and referred to
13	12		the Committee on the Judiciary
14		-	A
15		-	PRIL10, 2025
16		-	Reported by Mr. G
17		-	RASSLEY, with an amendment
18		-	[Omit the part struck through and insert the part printed in italic]
19	13		A BILL
20	14		To amend the Federal Trade Commission Act to prohibit
21	15		product hopping, and for other purposes.
22	16		Be it enacted by the Senate and House of Representa-1
23	17		tives of the United States of America in Congress assembled, 2
24	18		SECTION 1. SHORT TITLE. 3
25	19		This Act may be cited as the ‘‘Drug Competition En-4
26	20		hancement Act’’. 5
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29		-	•S 1040 RS
30		-	SEC. 2. PRODUCT HOPPING. 1
	21	+	SEC. 2. PRODUCT HOPPING. 6
31	22		(a) I
32		-	NGENERAL.—The Federal Trade Commission 2
33		-	Act (15 U.S.C. 41 et seq.) is amended by inserting after 3
34		-	section 26 (15 U.S.C. 57c–2) the following: 4
35		-	‘‘SEC. 27. PRODUCT HOPPING. 5
	23	+	NGENERAL.—The Federal Trade Commission 7
	24	+	Act (15 U.S.C. 41 et seq.) is amended by inserting after 8
	25	+	section 26 (15 U.S.C. 57c–2) the following: 9
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	29	+	‘‘SEC. 27. PRODUCT HOPPING. 1
36	30		‘‘(a) D
37		-	EFINITIONS.—In this section: 6
	31	+	EFINITIONS.—In this section: 2
38	32		‘‘(1) A
39		-	BBREVIATED NEW DRUG APPLICATION .— 7
40		-	The term ‘abbreviated new drug application’ means 8
41		-	any application under subsection (j) of section 505 9
42		-	of the Federal Food, Drug, and Cosmetic Act (21 10
43		-	U.S.C. 355) or an application under subsection 11
44		-	(b)(2) of such section 505 that seeks a therapeutic 12
45		-	equivalence rating to the reference product. 13
	33	+	BBREVIATED NEW DRUG APPLICATION .— 3
	34	+	The term ‘abbreviated new drug application’ means 4
	35	+	any application under subsection (j) of section 505 5
	36	+	of the Federal Food, Drug, and Cosmetic Act (21 6
	37	+	U.S.C. 355) or an application under subsection 7
	38	+	(b)(2) of such section 505 that seeks a therapeutic 8
	39	+	equivalence rating to the reference product. 9
46	40		‘‘(2) B
47		-	IOSIMILAR BIOLOGICAL PRODUCT .—The 14
48		-	term ‘biosimilar biological product’ means a biologi-15
49		-	cal product licensed under section 351(k) of the 16
50		-	Public Health Service Act (42 U.S.C. 262(k)). 17
	41	+	IOSIMILAR BIOLOGICAL PRODUCT .—The 10
	42	+	term ‘biosimilar biological product’ means a biologi-11
	43	+	cal product licensed under section 351(k) of the 12
	44	+	Public Health Service Act (42 U.S.C. 262(k)). 13
51	45		‘‘(3) B
52		-	IOSIMILAR BIOLOGICAL PRODUCT LI -18
53		-	CENSE APPLICATION.—The term ‘biosimilar biologi-19
54		-	cal product license application’ means an application 20
55		-	submitted under section 351(k) of the Public Health 21
56		-	Service Act (42 U.S.C. 262(k)). 22
	46	+	IOSIMILAR BIOLOGICAL PRODUCT LI -14
	47	+	CENSE APPLICATION.—The term ‘biosimilar biologi-15
	48	+	cal product license application’ means an application 16
	49	+	submitted under section 351(k) of the Public Health 17
	50	+	Service Act (42 U.S.C. 262(k)). 18
57	51		‘‘(4) F
58		-	OLLOW-ON PRODUCT.—The term ‘follow- 23
59		-	on product’— 24
60		-	‘‘(A) means a drug approved through an 25
61		-	application or supplement to an application sub-26
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64		-	~~•S 1040 RS~~
65		-	~~mitted under section 505(b) of the Federal 1~~
66		-	~~Food~~, ~~Drug, and Cosmetic Act (21~~ U.~~S.C. 2~~
67		-	~~355(b)) or a biological product licensed through~~ 3
68		-	~~an application or supplement to an application 4~~
69		-	submitted under section 351(a) of the Public 5
70		-	Health Service Act (42 U.S.C. 262(a)) for a 6
71		-	change or modification to, or reformulation of, 7
72		-	the same manufacturer’s previously approved 8
73		-	drug or biological product that has an indica-9
74		-	tion that is identical or substantively similar to 10
75		-	an indication of the same manufacturer’s pre-11
76		-	viously approved drug or biological product; and 12
77		-	‘‘(B) excludes such an application or sup-13
78		-	plement to an application for a change, modi-14
79		-	fication, or reformulation of a drug or biological 15
80		-	product that is requested by the Secretary or 16
81		-	necessary to comply with law, including sections 17
82		-	505A and 505B of the Federal Food, Drug, 18
83		-	and Cosmetic Act (21 U.S.C. 355a, 355c). 19
	52	+	OLLOW-ON PRODUCT.—The term ‘follow- 19
	53	+	on product’— 20
	54	+	‘‘(A) means a drug approved through an 21
	55	+	application or supplement to an application sub-22
	56	+	mitted under section 505(b) of the Federal 23
	57	+	Food, Drug, and Cosmetic Act (21 U.S.C. 24
	58	+	355(b)) or a biological product licensed through 25
	59	+	an application or supplement to an application 26
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	63	+	submitted under section 351(a) of the Public 1
	64	+	Health Service Act (42 U.S.C. 262(a)) for a 2
	65	+	change or modification to, or reformulation of, 3
	66	+	the same manufacturer’s previously approved 4
	67	+	drug or biological product that has an indica-5
	68	+	tion that is identical or substantively similar to 6
	69	+	an indication of the same manufacturer’s pre-7
	70	+	viously approved drug or biological product; and 8
	71	+	‘‘(B) excludes such an application or sup-9
	72	+	plement to an application for a change, modi-10
	73	+	fication, or reformulation of a drug or biological 11
	74	+	product that is requested by the Secretary or 12
	75	+	necessary to comply with law, including sections 13
	76	+	505A and 505B of the Federal Food, Drug, 14
	77	+	and Cosmetic Act (21 U.S.C. 355a, 355c). 15
84	78		‘‘(5) G
85		-	ENERIC DRUG.—The term ‘generic drug’ 20
86		-	means any drug approved under an
87		-	applicationsub-21
88		-	mittedundersubsection(j)ofsection505ofthe 22
89		-	FederalFood,Drug,andCosmeticAct(21U.S.C. 23
90		-	355)oranapplicationundersubsection(b)(2)of 24
91		-	suchsection505thatseeksatherapeuticequiva-25
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94		-	•S 1040 RS
95		-	lenceratingtothereferenceproductabbreviated new 1
96		-	drug application. 2
	79	+	ENERIC DRUG.—The term ‘generic drug’ 16
	80	+	means any drug approved under an application sub-17
	81	+	mitted under subsection (j) of section 505 of the 18
	82	+	Federal Food, Drug, and Cosmetic Act (21 U.S.C. 19
	83	+	355) or an application under subsection (b)(2) of 20
	84	+	such section 505 that seeks a therapeutic equiva-21
	85	+	lence rating to the reference product. 22
97	86		‘‘(6) L
98		-	ISTED DRUG.—The term ‘listed drug’ 3
99		-	means a drug listed under section 505(j)(7) of the 4
100		-	Federal Food, Drug, and Cosmetic Act (21 U.S.C. 5
101		-	355(j)(7)). 6
	87	+	ISTED DRUG.—The term ‘listed drug’ 23
	88	+	means a drug listed under section 505(j)(7) of the 24
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	92	+	Federal Food, Drug, and Cosmetic Act (21 U.S.C. 1
	93	+	355(j)(7)). 2
102	94		‘‘(7) M
103		-	ANUFACTURER.—The term ‘manufac-7
104		-	turer’ means the holder, licensee, or assignee of— 8
105		-	‘‘(A) an approved application for a drug 9
106		-	under section 505(c) of the Federal Food, 10
107		-	Drug, and Cosmetic Act (21 U.S.C. 355(c)); or 11
108		-	‘‘(B) a biological product license under sec-12
109		-	tion 351(a) of the Public Health Service Act 13
110		-	(42 U.S.C. 262(a)). 14
	95	+	ANUFACTURER.—The term ‘manufac-3
	96	+	turer’ means the holder, licensee, or assignee of— 4
	97	+	‘‘(A) an approved application for a drug 5
	98	+	under section 505(c) of the Federal Food, 6
	99	+	Drug, and Cosmetic Act (21 U.S.C. 355(c)); or 7
	100	+	‘‘(B) a biological product license under sec-8
	101	+	tion 351(a) of the Public Health Service Act 9
	102	+	(42 U.S.C. 262(a)). 10
111	103		‘‘(8) R
112		-	EFERENCE PRODUCT .—The term ‘ref-15
113		-	erence product’ has the meaning given the term in 16
114		-	section 351(i) of the Public Health Service Act (42 17
115		-	U.S.C. 262(i)). 18
	104	+	EFERENCE PRODUCT .—The term ‘ref-11
	105	+	erence product’ has the meaning given the term in 12
	106	+	section 351(i) of the Public Health Service Act (42 13
	107	+	U.S.C. 262(i)). 14
116	108		‘‘(9) U
117		-	LTIMATE PARENT ENTITY .—The term 19
118		-	‘ultimate parent entity’ has the meaning given the 20
119		-	term in section 801.1 of title 16, Code of Federal 21
120		-	Regulations, or any successor regulation. 22
	109	+	LTIMATE PARENT ENTITY .—The term 15
	110	+	‘ultimate parent entity’ has the meaning given the 16
	111	+	term in section 801.1 of title 16, Code of Federal 17
	112	+	Regulations, or any successor regulation. 18
121	113		‘‘(b) P
122		-	ROHIBITION ONPRODUCTHOPPING.— 23
	114	+	ROHIBITION ONPRODUCTHOPPING.— 19
123	115		‘‘(1) P
124		-	RIMA FACIE.—A manufacturer of a ref-24
125		-	erence product or listed drug shall be considered to 25
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128		-	•S 1040 RS
129		-	have engaged in an unfair method of competition in 1
130		-	or affecting commerce in violation of section 5(a) if 2
131		-	complaint counsel or the Commission demonstrates 3
132		-	in an action or proceeding initiated by the Commis-4
133		-	sion under subsection (c) that, during the period be-5
134		-	ginning on the date on which the manufacturer of 6
135		-	the reference product or listed drug first receives no-7
136		-	tice that an applicant has submitted to the Commis-8
137		-	sioner of Food and Drugs an abbreviated new drug 9
138		-	application or biosimilar biological product license 10
139		-	application referencing the reference product or list-11
140		-	ed drug and ending on the date that is the earlier 12
141		-	of 180 days after the date on which the generic drug 13
142		-	or biosimilar biological product that is the subject of 14
143		-	the abbreviated new drug application or biosimilar 15
144		-	biological product license application or another ge-16
145		-	neric drug or biosimilar biological product ref-17
146		-	erencing the listed drug or reference product is first 18
147		-	marketed or 3 years after the date on which the fol-19
148		-	low-on product is first marketed, the manufacturer 20
149		-	engaged in either of the following actions: 21
150		-	‘‘(A) The manufacturer engaged in a hard 22
151		-	switch, which shall be established by dem-23
152		-	onstrating that the manufacturer engaged in ei-24
153		-	ther of the following actions: 25
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157		-	‘‘(i) Upon the request of the manufac-1
158		-	turer of the listed drug or reference prod-2
159		-	uct, the Commissioner of Food and Drugs 3
160		-	withdrew the approval of the application 4
161		-	for the listed drug or reference product or 5
162		-	placed the listed drug or reference product 6
163		-	on the discontinued products list and the 7
164		-	manufacturer marketed or sold a follow-on 8
165		-	product. 9
166		-	‘‘(ii) The manufacturer of the listed 10
167		-	drug or reference product— 11
168		-	‘‘(I)(aa) withdrew, discontinued 12
169		-	the manufacture of, or announced 13
170		-	withdrawal of, discontinuance of the 14
171		-	manufacture of, or intent to withdraw 15
172		-	the application with respect to the 16
173		-	drug or reference product in a manner 17
174		-	that impedes competition from a ge-18
175		-	neric drug or a biosimilar biological 19
176		-	product, which may be established by 20
177		-	objective circumstances, unless such 21
178		-	actions were taken by the manufac-22
179		-	turer pursuant to a request of the 23
180		-	Commissioner of Food and Drugs; or 24
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183		-	•S 1040 RS
184		-	‘‘(bb) destroyed the inventory of 1
185		-	the listed drug or reference product in 2
186		-	a manner that impedes competition 3
187		-	from a generic drug or a biosimilar bi-4
188		-	ological product, which may be estab-5
189		-	lished by objective circumstances; and 6
190		-	‘‘(II) marketed or sold a follow- 7
191		-	on product. 8
192		-	‘‘(B) The manufacturer engaged in a soft 9
193		-	switch, which shall be established by dem-10
194		-	onstrating that the manufacturer engaged in 11
195		-	both of the following actions: 12
196		-	‘‘(i) The manufacturer took actions 13
197		-	with respect to the listed drug or reference 14
198		-	product other than those described in sub-15
199		-	paragraph (A) that unfairly disadvantage 16
200		-	the listed drug or reference product rel-17
201		-	ative to the follow-on product described in 18
202		-	clause (ii) in a manner that impedes com-19
203		-	petition from a generic drug or a bio-20
204		-	similar biological product, which may be 21
205		-	established by objective circumstances. 22
206		-	‘‘(ii) The manufacturer marketed or 23
207		-	sold a follow-on product. 24
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211		-	‘‘(2) EXCLUSIONS.—Nothing in this section 1
212		-	shall prohibit actions that consist solely of— 2
213		-	‘‘(A) truthful, non-misleading promotional 3
214		-	marketing; or 4
215		-	‘‘(B) ceasing promotional marketing for 5
216		-	the listed drug or reference product. 6
	116	+	RIMA FACIE.—A manufacturer of a ref-20
	117	+	erence product or listed drug shall be considered to 21
	118	+	have engaged in an unfair method of competition in 22
	119	+	or affecting commerce in violation of section 5(a) if 23
	120	+	complaint counsel or the Commission demonstrates 24
	121	+	in an action or proceeding initiated by the Commis-25
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	124	+	•S 1040 IS
	125	+	sion under subsection (c) that, during the period be-1
	126	+	ginning on the date on which the manufacturer of 2
	127	+	the reference product or listed drug first receives no-3
	128	+	tice that an applicant has submitted to the Commis-4
	129	+	sioner of Food and Drugs an abbreviated new drug 5
	130	+	application or biosimilar biological product license 6
	131	+	application referencing the reference product or list-7
	132	+	ed drug and ending on the date that is the earlier 8
	133	+	of 180 days after the date on which the generic drug 9
	134	+	or biosimilar biological product that is the subject of 10
	135	+	the abbreviated new drug application or biosimilar 11
	136	+	biological product license application or another ge-12
	137	+	neric drug or biosimilar biological product ref-13
	138	+	erencing the listed drug or reference product is first 14
	139	+	marketed or 3 years after the date on which the fol-15
	140	+	low-on product is first marketed, the manufacturer 16
	141	+	engaged in either of the following actions: 17
	142	+	‘‘(A) The manufacturer engaged in a hard 18
	143	+	switch, which shall be established by dem-19
	144	+	onstrating that the manufacturer engaged in ei-20
	145	+	ther of the following actions: 21
	146	+	‘‘(i) Upon the request of the manufac-22
	147	+	turer of the listed drug or reference prod-23
	148	+	uct, the Commissioner of Food and Drugs 24
	149	+	withdrew the approval of the application 25
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	152	+	•S 1040 IS
	153	+	for the listed drug or reference product or 1
	154	+	placed the listed drug or reference product 2
	155	+	on the discontinued products list and the 3
	156	+	manufacturer marketed or sold a follow-on 4
	157	+	product. 5
	158	+	‘‘(ii) The manufacturer of the listed 6
	159	+	drug or reference product— 7
	160	+	‘‘(I)(aa) withdrew, discontinued 8
	161	+	the manufacture of, or announced 9
	162	+	withdrawal of, discontinuance of the 10
	163	+	manufacture of, or intent to withdraw 11
	164	+	the application with respect to the 12
	165	+	drug or reference product in a manner 13
	166	+	that impedes competition from a ge-14
	167	+	neric drug or a biosimilar biological 15
	168	+	product, which may be established by 16
	169	+	objective circumstances, unless such 17
	170	+	actions were taken by the manufac-18
	171	+	turer pursuant to a request of the 19
	172	+	Commissioner of Food and Drugs; or 20
	173	+	‘‘(bb) destroyed the inventory of 21
	174	+	the listed drug or reference product in 22
	175	+	a manner that impedes competition 23
	176	+	from a generic drug or a biosimilar bi-24
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	179	+	•S 1040 IS
	180	+	ological product, which may be estab-1
	181	+	lished by objective circumstances; and 2
	182	+	‘‘(II) marketed or sold a follow- 3
	183	+	on product. 4
	184	+	‘‘(B) The manufacturer engaged in a soft 5
	185	+	switch, which shall be established by dem-6
	186	+	onstrating that the manufacturer engaged in 7
	187	+	both of the following actions: 8
	188	+	‘‘(i) The manufacturer took actions 9
	189	+	with respect to the listed drug or reference 10
	190	+	product other than those described in sub-11
	191	+	paragraph (A) that unfairly disadvantage 12
	192	+	the listed drug or reference product rel-13
	193	+	ative to the follow-on product described in 14
	194	+	clause (ii) in a manner that impedes com-15
	195	+	petition from a generic drug or a bio-16
	196	+	similar biological product, which may be 17
	197	+	established by objective circumstances. 18
	198	+	‘‘(ii) The manufacturer marketed or 19
	199	+	sold a follow-on product. 20
	200	+	‘‘(2) E
	201	+	XCLUSIONS.—Nothing in this section 21
	202	+	shall prohibit actions that consist solely of— 22
	203	+	‘‘(A) truthful, non-misleading promotional 23
	204	+	marketing; or 24
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	207	+	•S 1040 IS
	208	+	‘‘(B) ceasing promotional marketing for 1
	209	+	the listed drug or reference product. 2
217	210		‘‘(3) J
218		-	USTIFICATION.— 7
	211	+	USTIFICATION.— 3
219	212		‘‘(A) I
220		-	N GENERAL.—Subject to paragraph 8
221		-	(4), the actions described in paragraph (1) by 9
222		-	a manufacturer of a listed drug or reference 10
223		-	product shall not be considered to be an unfair 11
224		-	method of competition in or affecting commerce 12
225		-	if the manufacturer demonstrates to the Com-13
226		-	mission or a district court of the United States, 14
227		-	as applicable, in an action, suit, or proceeding 15
228		-	initiated by the Commission under subsection 16
229		-	(c)(1) that— 17
230		-	‘‘(i) the manufacturer would have 18
231		-	taken the actions regardless of whether a 19
232		-	generic drug that references the listed drug 20
233		-	or biosimilar biological product that ref-21
234		-	erences the reference product had already 22
235		-	entered the market; and 23
236		-	‘‘(ii)(I) with respect to a hard switch 24
237		-	under paragraph (1)(A), the manufacturer 25
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241		-	~~took the action for reasons relating to the 1~~
242		-	~~safety risk to patients of the listed drug or 2~~
243		-	~~reference product;~~ 3
244		-	‘‘(II) with respect to an action de-4
245		-	scribed in paragraph (1)(A)(ii)(I)(aa), 5
246		-	there is a supply disruption that— 6
247		-	‘‘(aa) is outside of the control of 7
248		-	the manufacturer; 8
249		-	‘‘(bb) prevents the production or 9
250		-	distribution of the applicable listed 10
251		-	drug or reference product; and 11
252		-	‘‘(cc) cannot be remedied by rea-12
253		-	sonable efforts; or 13
254		-	‘‘(III) with respect to a soft switch 14
255		-	under paragraph (1)(B), the manufacturer 15
256		-	had legitimate pro-competitive reasons, 16
257		-	apart from the financial effects of reduced 17
258		-	competition, to take the action. 18
	213	+	N GENERAL.—Subject to paragraph 4
	214	+	(4), the actions described in paragraph (1) by 5
	215	+	a manufacturer of a listed drug or reference 6
	216	+	product shall not be considered to be an unfair 7
	217	+	method of competition in or affecting commerce 8
	218	+	if the manufacturer demonstrates to the Com-9
	219	+	mission or a district court of the United States, 10
	220	+	as applicable, in an action, suit or proceeding 11
	221	+	initiated by the Commission under subsection 12
	222	+	(c)(1) that— 13
	223	+	‘‘(i) the manufacturer would have 14
	224	+	taken the actions regardless of whether a 15
	225	+	generic drug that references the listed drug 16
	226	+	or biosimilar biological product that ref-17
	227	+	erences the reference product had already 18
	228	+	entered the market; and 19
	229	+	‘‘(ii)(I) with respect to a hard switch 20
	230	+	under paragraph (1)(A), the manufacturer 21
	231	+	took the action for reasons relating to the 22
	232	+	safety risk to patients of the listed drug or 23
	233	+	reference product; 24
	234	+	VerDate Sep 11 2014 21:08 Apr 02, 2025 Jkt 059200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S1040.IS S1040
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	236	+	•S 1040 IS
	237	+	‘‘(II) with respect to an action de-1
	238	+	scribed in paragraph (1)(A)(ii)(I)(aa), 2
	239	+	there is a supply disruption that— 3
	240	+	‘‘(aa) is outside of the control of 4
	241	+	the manufacturer; 5
	242	+	‘‘(bb) prevents the production or 6
	243	+	distribution of the applicable listed 7
	244	+	drug or reference product; and 8
	245	+	‘‘(cc) cannot be remedied by rea-9
	246	+	sonable efforts; or 10
	247	+	‘‘(III) with respect to a soft switch 11
	248	+	under paragraph (1)(B), the manufacturer 12
	249	+	had legitimate pro-competitive reasons, 13
	250	+	apart from the financial effects of reduced 14
	251	+	competition, to take the action. 15
259	252		‘‘(B) R
260		-	ULE OF CONSTRUCTION .—Nothing 19
261		-	in subparagraph (A) may be construed to limit 20
262		-	the information that the Commission may oth-21
263		-	erwise obtain in any proceeding or action insti-22
264		-	tuted with respect to a violation of this section. 23
265		-	VerDate Sep 11 2014 18:50 Apr 11, 2025 Jkt 059200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S1040.RS S1040
266		-	ssavage on LAPJG3WLY3PROD with BILLS 10
267		-	•S 1040 RS
268		-	‘‘(4) RESPONSE.—With respect to a justifica-1
269		-	tion offered by a manufacturer under paragraph (3), 2
270		-	the Commission may— 3
271		-	‘‘(A) rebut any evidence presented by a 4
272		-	manufacturer during that justification; or 5
273		-	‘‘(B) establish by a preponderance of the 6
274		-	evidence that— 7
275		-	‘‘(i) on balance, the pro-competitive 8
276		-	benefits from the conduct described in sub-9
277		-	paragraph (A) or (B) of paragraph (1), as 10
278		-	applicable, do not outweigh any anti-11
279		-	competitive effects of the conduct, even in 12
280		-	consideration of the justification so offered; 13
	253	+	ULE OF CONSTRUCTION .—Nothing 16
	254	+	in subparagraph (A) may be construed to limit 17
	255	+	the information that the Commission may oth-18
	256	+	erwise obtain in any proceeding or action insti-19
	257	+	tuted with respect to a violation of this section. 20
	258	+	‘‘(4) R
	259	+	ESPONSE.—With respect to a justifica-21
	260	+	tion offered by a manufacturer under paragraph (3), 22
	261	+	the Commission may— 23
	262	+	‘‘(A) rebut any evidence presented by a 24
	263	+	manufacturer during that justification; or 25
	264	+	VerDate Sep 11 2014 21:08 Apr 02, 2025 Jkt 059200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S1040.IS S1040
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	266	+	•S 1040 IS
	267	+	‘‘(B) establish by a preponderance of the 1
	268	+	evidence that— 2
	269	+	‘‘(i) on balance, the pro-competitive 3
	270	+	benefits from the conduct described in sub-4
	271	+	paragraph (A) or (B) of paragraph (1), as 5
	272	+	applicable, do not outweigh any anti-6
	273	+	competitive effects of the conduct, even in 7
	274	+	consideration of the justification so offered; 8
	275	+	or 9
	276	+	‘‘(ii)(I) the conduct described in para-10
	277	+	graph (1) is not reasonably necessary to 11
	278	+	address or achieve the justifications de-12
	279	+	scribed in clause (ii) of paragraph (3)(A); 13
281	280		or 14
282		-	‘‘(ii)(I) the conduct described in para-15
283		-	graph (1) is not reasonably necessary to 16
284		-	address or achieve the justifications de-17
285		-	scribed in clause (ii) of paragraph (3)(A); 18
286		-	or 19
287		-	‘‘(II) the justifications described in 20
288		-	clause (ii) of paragraph (3)(A) could be 21
289		-	reasonably addressed or achieved through 22
290		-	less anticompetitive means. 23
	281	+	‘‘(II) the justifications described in 15
	282	+	clause (ii) of paragraph (3)(A) could be 16
	283	+	reasonably addressed or achieved through 17
	284	+	less anticompetitive means. 18
291	285		‘‘(c) E
292		-	NFORCEMENT.— 24
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295		-	•S 1040 RS
296		-	‘‘(1) IN GENERAL.—If the Commission has rea-1
297		-	son to believe that any manufacturer has violated, is 2
298		-	violating, or is about to violate this section, or a rule 3
299		-	promulgated under this section, the Commission 4
300		-	may take any of the following actions: 5
301		-	‘‘(A) Institute a proceeding under section 6
302		-	5(b). 7
303		-	‘‘(B) In the same manner and to the same 8
304		-	extent as provided in section 13(b), bring suit 9
305		-	in a district court of the United States to tem-10
306		-	porarily enjoin the action of the manufacturer. 11
307		-	‘‘(C) Bring suit in a district court of the 12
308		-	United States, in which the Commission may 13
309		-	seek— 14
310		-	‘‘(i) to permanently enjoin the action 15
311		-	of the manufacturer; 16
312		-	‘‘(ii) any of the remedies described in 17
313		-	paragraph (3); and 18
314		-	‘‘(iii) any other equitable remedy, in-19
315		-	cluding ancillary equitable relief. 20
	286	+	NFORCEMENT.— 19
	287	+	‘‘(1) I
	288	+	N GENERAL.—If the Commission has rea-20
	289	+	son to believe that any manufacturer has violated, is 21
	290	+	violating, or is about to violate this section, or a rule 22
	291	+	promulgated under this section, the Commission 23
	292	+	may take any of the following actions: 24
	293	+	VerDate Sep 11 2014 21:08 Apr 02, 2025 Jkt 059200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S1040.IS S1040
	294	+	kjohnson on DSK7ZCZBW3PROD with $$_JOB 11
	295	+	•S 1040 IS
	296	+	‘‘(A) Institute a proceeding under section 1
	297	+	5(b). 2
	298	+	‘‘(B) In the same manner and to the same 3
	299	+	extent as provided in section 13(b), bring suit 4
	300	+	in a district court of the United States to tem-5
	301	+	porarily enjoin the action of the manufacturer. 6
	302	+	‘‘(C) Bring suit in a district court of the 7
	303	+	United States, in which the Commission may 8
	304	+	seek— 9
	305	+	‘‘(i) to permanently enjoin the action 10
	306	+	of the manufacturer; 11
	307	+	‘‘(ii) any of the remedies described in 12
	308	+	paragraph (3); and 13
	309	+	‘‘(iii) any other equitable remedy, in-14
	310	+	cluding ancillary equitable relief. 15
316	311		‘‘(2) J
317		-	UDICIAL REVIEW.— 21
	312	+	UDICIAL REVIEW.— 16
318	313		‘‘(A) I
319		-	N GENERAL.—Notwithstanding any 22
320		-	provision of section 5, any manufacturer that is 23
321		-	subject to a final cease and desist order issued 24
322		-	in a proceeding to enforce this section, or a rule 25
323		-	~~VerDate Sep 11 2014 18:50 Apr 11~~, ~~2025 Jkt 059200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\S1040.RS S1040~~
324		-	~~ssavage~~ on ~~LAPJG3WLY3PROD with BILLS 12~~
325		-	~~•S 1040 RS~~
326		-	~~promulgated under this section, may, not later 1~~
327		-	~~than 30 days after the date on which the Com-2~~
328		-	~~mission issues the order,~~ ~~petition for review of 3~~
329		-	~~the order in— 4~~
330		-	‘‘(i) the United States Court of Ap-5
331		-	peals for the District of Columbia Circuit; 6
332		-	or 7
333		-	‘‘(ii) the court of appeals of the 8
334		-	United States for the circuit in which the 9
335		-	ultimate parent entity of the manufacturer 10
336		-	is incorporated. 11
	314	+	N GENERAL.—Notwithstanding any 17
	315	+	provision of section 5, any manufacturer that is 18
	316	+	subject to a final cease and desist order issued 19
	317	+	in a proceeding to enforce this section, or a rule 20
	318	+	promulgated under this section, may, not later 21
	319	+	than 30 days after the date on which the Com-22
	320	+	mission issues the order, petition for review of 23
	321	+	the order in— 24
	322	+	VerDate Sep 11 2014 21:08 Apr 02, 2025 Jkt 059200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\S1040.IS S1040
	323	+	kjohnson on DSK7ZCZBW3PROD with $$_JOB 12
	324	+	•S 1040 IS
	325	+	‘‘(i) the United States Court of Ap-1
	326	+	peals for the District of Columbia Circuit; 2
	327	+	or 3
	328	+	‘‘(ii) the court of appeals of the 4
	329	+	United States for the circuit in which the 5
	330	+	ultimate parent entity of the manufacturer 6
	331	+	is incorporated. 7
337	332		‘‘(B) T
338		-	REATMENT OF FINDINGS .—In a re-12
339		-	view of a final cease and desist order conducted 13
340		-	by a court of appeals of the United States 14
341		-	under subparagraph (A), the factual findings of 15
342		-	the Commission shall be conclusive if those 16
343		-	facts are supported by the evidence. 17
	333	+	REATMENT OF FINDINGS .—In a re-8
	334	+	view of a final cease and desist order conducted 9
	335	+	by a court of appeals of the United States 10
	336	+	under subparagraph (A), the factual findings of 11
	337	+	the Commission shall be conclusive if those 12
	338	+	facts are supported by the evidence. 13
344	339		‘‘(3) E
345		-	QUITABLE REMEDIES.— 18
	340	+	QUITABLE REMEDIES.— 14
346	341		‘‘(A) D
347		-	ISGORGEMENT.— 19
348		-	‘‘(i) I
349		-	N GENERAL.—In a suit brought 20
350		-	under paragraph (1)(C), the Commission 21
351		-	may seek, and the court may order, 22
352		-	disgorgement of any unjust enrichment 23
353		-	that a person obtained as a result of the 24
354		-	violation that gives rise to the suit. 25
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357		-	•S 1040 RS
358		-	‘‘(ii) C ALCULATION.—Any 1
359		-	disgorgement that is ordered with respect 2
360		-	to a person under clause (i) shall be offset 3
361		-	by any amount of restitution ordered 4
362		-	under subparagraph (B). 5
363		-	‘‘(iii) L
364		-	IMITATIONS PERIOD .—The 6
365		-	Commission may seek disgorgement under 7
366		-	this subparagraph not later than 5 years 8
367		-	after the latest date on which the person 9
368		-	from which the disgorgement is sought re-10
369		-	ceives any unjust enrichment from the ef-11
370		-	fects of the violation that gives rise to the 12
371		-	suit in which the Commission seeks the 13
372		-	disgorgement. 14
373		-	‘‘(B) R
374		-	ESTITUTION.— 15
	342	+	ISGORGEMENT.— 15
375	343		‘‘(i) I
376	344		N GENERAL.—In a suit brought 16
377	345		under paragraph (1)(C), the Commission 17
378		-	may seek, and the court may order, res-18
379		-	titution with respect to the violation that 19
380		-	gives rise to the suit. 20
	346	+	may seek, and the court may order, 18
	347	+	disgorgement of any unjust enrichment 19
	348	+	that a person obtained as a result of the 20
	349	+	violation that gives rise to the suit. 21
	350	+	‘‘(ii) C
	351	+	ALCULATION.—Any 22
	352	+	disgorgement that is ordered with respect 23
	353	+	to a person under clause (i) shall be offset 24
	354	+	VerDate Sep 11 2014 21:08 Apr 02, 2025 Jkt 059200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\S1040.IS S1040
	355	+	kjohnson on DSK7ZCZBW3PROD with $$_JOB 13
	356	+	•S 1040 IS
	357	+	by any amount of restitution ordered 1
	358	+	under subparagraph (B). 2
	359	+	‘‘(iii) L
	360	+	IMITATIONS PERIOD .—The 3
	361	+	Commission may seek disgorgement under 4
	362	+	this subparagraph not later than 5 years 5
	363	+	after the latest date on which the person 6
	364	+	from which the disgorgement is sought re-7
	365	+	ceives any unjust enrichment from the ef-8
	366	+	fects of the violation that gives rise to the 9
	367	+	suit in which the Commission seeks the 10
	368	+	disgorgement. 11
	369	+	‘‘(B) R
	370	+	ESTITUTION.— 12
	371	+	‘‘(i) I
	372	+	N GENERAL.—In a suit brought 13
	373	+	under paragraph (1)(C), the Commission 14
	374	+	may seek, and the court may order, res-15
	375	+	titution with respect to the violation that 16
	376	+	gives rise to the suit. 17
381	377		‘‘(ii) L
382		-	IMITATIONS PERIOD .—The 21
383		-	Commission may seek restitution under 22
384		-	this subparagraph not later than 5 years 23
385		-	after the latest date on which the person 24
386		-	from which the restitution is sought re-25
387		-	~~VerDate Sep 11 2014 18:50 Apr 11, 2025 Jkt 059200 PO 00000 Frm 00013 Fmt 6652 Sfmt 6201 E:\BILLS\S1040.RS S1040~~
388		-	~~ssavage on LAPJG3WLY3PROD with BILLS 14~~
389		-	~~•S 1040 RS~~
390		-	~~ceives any unjust enrichment from the ef-1~~
391		-	~~fects of the violation that gives rise to the 2~~
392		-	suit in which the Commission seeks the 3
393		-	restitution. 4
	378	+	IMITATIONS PERIOD .—The 18
	379	+	Commission may seek restitution under 19
	380	+	this subparagraph not later than 5 years 20
	381	+	after the latest date on which the person 21
	382	+	from which the restitution is sought re-22
	383	+	ceives any unjust enrichment from the ef-23
	384	+	fects of the violation that gives rise to the 24
	385	+	VerDate Sep 11 2014 21:08 Apr 02, 2025 Jkt 059200 PO 00000 Frm 00013 Fmt 6652 Sfmt 6201 E:\BILLS\S1040.IS S1040
	386	+	kjohnson on DSK7ZCZBW3PROD with $$_JOB 14
	387	+	•S 1040 IS
	388	+	suit in which the Commission seeks the 1
	389	+	restitution. 2
394	390		‘‘(4) R
395		-	ULES OF CONSTRUCTION .—Nothing in 5
396		-	this subsection may be construed as— 6
397		-	‘‘(A) requiring the Commission to bring a 7
398		-	suit seeking a temporary injunction under para-8
399		-	graph (1)(B) before bringing a suit seeking a 9
400		-	permanent injunction under paragraph (1)(C); 10
401		-	or 11
402		-	‘‘(B) affecting the authority of the Federal 12
403		-	Trade Commission under any other provision of 13
404		-	law.’’. 14
	391	+	ULES OF CONSTRUCTION .—Nothing in 3
	392	+	this subsection may be construed as— 4
	393	+	‘‘(A) requiring the Commission to bring a 5
	394	+	suit seeking a temporary injunction under para-6
	395	+	graph (1)(B) before bringing a suit seeking a 7
	396	+	permanent injunction under paragraph (1)(C); 8
	397	+	or 9
	398	+	‘‘(B) affecting the authority of the Federal 10
	399	+	Trade Commission under any other provision of 11
	400	+	law.’’. 12
405	401		(b) A
406		-	PPLICABILITY.—Section 27 of the Federal 15
407		-	Trade Commission Act, as added by subsection (a), shall 16
408		-	apply with respect to any— 17
409		-	(1) conduct that occurs on or after the date of 18
410		-	enactment of this Act; and 19
411		-	(2) action or proceeding that is commenced on 20
412		-	or after the date of enactment of this Act. 21
	402	+	PPLICABILITY.—Section 27 of the Federal 13
	403	+	Trade Commission Act, as added by subsection (a), shall 14
	404	+	apply with respect to any— 15
	405	+	(1) conduct that occurs on or after the date of 16
	406	+	enactment of this Act; and 17
	407	+	(2) action or proceeding that is commenced on 18
	408	+	or after the date of enactment of this Act. 19
413	409		(c) A
414		-	NTITRUSTLAWS.—Except to the extent sub-22
415		-	section (a) establishes an additional basis for liability 23
416		-	under the Federal Trade Commission Act (15 U.S.C. 41 24
417		-	et seq.), nothing in this section, or the amendments made 25
418		-	~~VerDate Sep 11 2014 18:50 Apr 11~~, ~~2025 Jkt 059200 PO 00000 Frm 00014 Fmt 6652 Sfmt 6201 E:\BILLS\S1040.RS S1040~~
419		-	~~ssavage on LAPJG3WLY3PROD with BILLS 15~~
420		-	~~•S 1040 RS~~
421		-	~~by this section,~~ ~~shall modify,~~ ~~impair, limit, or supersede 1~~
422		-	~~the applicability of the antitrust laws, as defined in sub-2~~
423		-	section (a) of the first section of the Clayton Act (15 3
424		-	U.S.C. 12), or of section 5 of the Federal Trade Commis-4
425		-	sion Act (15 U.S.C. 45) to the extent that it applies to 5
426		-	unfair methods of competition. 6
	410	+	NTITRUSTLAWS.—Except to the extent sub-20
	411	+	section (a) establishes an additional basis for liability 21
	412	+	under the Federal Trade Commission Act (15 U.S.C. 41 22
	413	+	et seq.), nothing in this section, or the amendments made 23
	414	+	by this section, shall modify, impair, limit, or supersede 24
	415	+	the applicability of the antitrust laws, as defined in sub-25
	416	+	VerDate Sep 11 2014 21:08 Apr 02, 2025 Jkt 059200 PO 00000 Frm 00014 Fmt 6652 Sfmt 6201 E:\BILLS\S1040.IS S1040
	417	+	kjohnson on DSK7ZCZBW3PROD with $$_JOB 15
	418	+	•S 1040 IS
	419	+	section (a) of the first section of the Clayton Act (15 1
	420	+	U.S.C. 12), or of section 5 of the Federal Trade Commis-2
	421	+	sion Act (15 U.S.C. 45) to the extent that it applies to 3
	422	+	unfair methods of competition. 4
427	423		(d) R
428		-	ULEMAKING.—The Federal Trade Commission 7
429		-	may issue rules under section 553 of title 5, United States 8
430		-	Code, to define any terms used in section 27 of the Fed-9
431		-	eral Trade Commission Act, as added by subsection (a) 10
432		-	(other than terms that are defined in subsection (a) of 11
433		-	such section 27). 12
434		-	VerDate Sep 11 2014 18:50 Apr 11, 2025 Jkt 059200 PO 00000 Frm 00015 Fmt 6652 Sfmt 6201 E:\BILLS\S1040.RS S1040
435		-	ssavage on LAPJG3WLY3PROD with BILLS Calendar No.
436		-	43
437		-	119
438		-	TH
439		-	CONGRESS
440		-	1
441		-	ST
442		-	S
443		-	ESSION
444		-
445		-	S. 1040 A BILL
446		-	To amend the Federal Trade Commission Act to
447		-	prohibit product hopping, and for other purposes.
448		-	A
449		-	PRIL
450		-	10, 2025
451		-	Reported with an amendment
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453		-	ssavage on LAPJG3WLY3PROD with BILLS
	424	+	ULEMAKING.—The Federal Trade Commission 5
	425	+	may issue rules under section 553 of title 5, United States 6
	426	+	Code, to define any terms used in section 27 of the Fed-7
	427	+	eral Trade Commission Act, as added by subsection (a) 8
	428	+	(other than terms that are defined in subsection (a) of 9
	429	+	such section 27). 10
	430	+	Æ
	431	+	VerDate Sep 11 2014 21:08 Apr 02, 2025 Jkt 059200 PO 00000 Frm 00015 Fmt 6652 Sfmt 6301 E:\BILLS\S1040.IS S1040
	432	+	kjohnson on DSK7ZCZBW3PROD with $$_JOB