Us Congress 2025-2026 Regular Session

Us Congress House Bill HB1632 Compare Versions

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Old	New	Differences
1	1	I
2	2	119THCONGRESS
3	3	1
4	4	STSESSION H. R. 1632
5	5	To amend the Federal Food, Drug, and Cosmetic Act to provide for reciprocal
6	6	marketing approval of certain drugs, biological products, and devices
7	7	that are authorized to be lawfully marketed abroad, and for other pur-
8	8	poses.
9	9	IN THE HOUSE OF REPRESENTATIVES
10	10	FEBRUARY26, 2025
11	11	Mr. R
12	12	OYintroduced the following bill; which was referred to the Committee
13	13	on Energy and Commerce, and in addition to the Committee on Rules,
14	14	for a period to be subsequently determined by the Speaker, in each case
15	15	for consideration of such provisions as fall within the jurisdiction of the
16	16	committee concerned
17	17	A BILL
18	18	To amend the Federal Food, Drug, and Cosmetic Act to
19	19	provide for reciprocal marketing approval of certain
20	20	drugs, biological products, and devices that are author-
21	21	ized to be lawfully marketed abroad, and for other pur-
22	22	poses.
23	23	Be it enacted by the Senate and House of Representa-1
24	24	tives of the United States of America in Congress assembled, 2
25	25	SECTION 1. SHORT TITLE. 3
26	26	This Act may be cited as the ‘‘Reciprocity Ensures 4
27	27	Streamlined Use of Lifesaving Treatments Act of 2025’’. 5
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30	30	•HR 1632 IH
31	31	SEC. 2. RECIPROCAL MARKETING APPROVAL FOR CERTAIN 1
32	32	DRUGS, BIOLOGICAL PRODUCTS, AND DE-2
33	33	VICES. 3
34	34	The Federal Food, Drug, and Cosmetic Act is amend-4
35	35	ed by inserting after section 524B of such Act (21 U.S.C. 5
36	36	360n–2) the following: 6
37	37	‘‘SEC. 524C. RECIPROCAL MARKETING APPROVAL. 7
38	38	‘‘(a) I
39	39	NGENERAL.—A covered product with recip-8
40	40	rocal marketing approval in effect under this section is 9
41	41	deemed to be subject to an application or premarket notifi-10
42	42	cation for which an approval or clearance is in effect under 11
43	43	section 505(c), 510(k), or 515 of this Act or section 12
44	44	351(a) of the Public Health Service Act, as applicable. 13
45	45	‘‘(b) E
46	46	LIGIBILITY.—The Secretary shall, with respect 14
47	47	to a covered product, grant reciprocal marketing approval 15
48	48	if— 16
49	49	‘‘(1) the sponsor of the covered product submits 17
50	50	a request for reciprocal marketing approval; and 18
51	51	‘‘(2) the request demonstrates to the Sec-19
52	52	retary’s satisfaction that— 20
53	53	‘‘(A) the covered product is authorized to 21
54	54	be lawfully marketed in one or more of the 22
55	55	countries included in the list under section 23
56	56	802(b)(1) or in the United Kingdom; 24
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60	60	‘‘(B) absent reciprocal marketing approval, 1
61	61	the covered product is not approved or cleared 2
62	62	for marketing, as described in subsection (a); 3
63	63	‘‘(C) the Secretary has not, because of any 4
64	64	concern relating to the safety or effectiveness of 5
65	65	the covered product, rescinded or withdrawn 6
66	66	any such approval or clearance; 7
67	67	‘‘(D) the authorization to market the cov-8
68	68	ered product in one or more of the countries in-9
69	69	cluded in the list under section 802(b)(1) or in 10
70	70	the United Kingdom has not, because of any 11
71	71	concern relating to the safety or effectiveness of 12
72	72	the covered product, been rescinded or with-13
73	73	drawn; 14
74	74	‘‘(E) the covered product is not a banned 15
75	75	device under section 516; and 16
76	76	‘‘(F) there is a public health or unmet 17
77	77	medical need for the covered product in the 18
78	78	United States. 19
79	79	‘‘(c) S
80	80	AFETY ANDEFFECTIVENESS.— 20
81	81	‘‘(1) I
82	82	N GENERAL.—The Secretary— 21
83	83	‘‘(A) may decline to grant reciprocal mar-22
84	84	keting approval under this section with respect 23
85	85	to a covered product if the Secretary affirma-24
86	86	tively determines that the covered product— 25
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89	89	•HR 1632 IH
90	90	‘‘(i) is a drug that is not safe and ef-1
91	91	fective; or 2
92	92	‘‘(ii) is a device for which there is no 3
93	93	reasonable assurance of safety and effec-4
94	94	tiveness; and 5
95	95	‘‘(B) may condition reciprocal marketing 6
96	96	approval under this section on the conduct of 7
97	97	specified postmarket studies, which may include 8
98	98	such studies pursuant to a risk evaluation and 9
99	99	mitigation strategy under section 505–1. 10
100	100	‘‘(2) R
101	101	EPORT TO CONGRESS .—Upon declining 11
102	102	to grant reciprocal marketing approval under this 12
103	103	section with respect to a covered product, the Sec-13
104	104	retary shall— 14
105	105	‘‘(A) include the denial in a list of such de-15
106	106	nials for each month; and 16
107	107	‘‘(B) not later than the end of the respec-17
108	108	tive month, submit the list to the Committee on 18
109	109	Energy and Commerce of the House of Rep-19
110	110	resentatives and the Committee on Health, 20
111	111	Education, Labor, and Pensions of the Senate. 21
112	112	‘‘(d) R
113	113	EQUEST.—A request for reciprocal marketing 22
114	114	approval shall— 23
115	115	‘‘(1) be in such form, be submitted in such 24
116	116	manner, and contain such information as the Sec-25
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119	119	•HR 1632 IH
120	120	retary deems necessary to determine whether the cri-1
121	121	teria listed in subsection (b)(2) are met; and 2
122	122	‘‘(2) include, with respect to each country in-3
123	123	cluded in the list under section 802(b)(1) where the 4
124	124	covered product is authorized to be lawfully mar-5
125	125	keted, as described in subsection (b)(2)(A), an 6
126	126	English translation of the dossier issued by such 7
127	127	country to authorize such marketing. 8
128	128	‘‘(e) T
129	129	IMING.—The Secretary shall issue an order 9
130	130	granting, or declining to grant, reciprocal marketing ap-10
131	131	proval with respect to a covered product not later than 11
132	132	30 days after the Secretary’s receipt of a request under 12
133	133	subsection (b)(1) for the product. An order issued under 13
134	134	this subsection shall take effect subject to Congressional 14
135	135	disapproval under subsection (g). 15
136	136	‘‘(f) L
137	137	ABELING; DEVICECLASSIFICATION.—During 16
138	138	the 30-day period described in subsection (e)— 17
139	139	‘‘(1) the Secretary and the sponsor of the cov-18
140	140	ered product shall expeditiously negotiate and final-19
141	141	ize the form and content of the labeling for a cov-20
142	142	ered product for which reciprocal marketing ap-21
143	143	proval is to be granted; and 22
144	144	‘‘(2) in the case of a device for which reciprocal 23
145	145	marketing approval is to be granted, the Secretary 24
146	146	shall— 25
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149	149	•HR 1632 IH
150	150	‘‘(A) classify the device pursuant to section 1
151	151	513; and 2
152	152	‘‘(B) determine whether, absent reciprocal 3
153	153	marketing approval, the device would need to be 4
154	154	cleared pursuant to section 510(k) or approved 5
155	155	pursuant to section 515 to be lawfully marketed 6
156	156	under this Act. 7
157	157	‘‘(g) C
158	158	ONGRESSIONAL DISAPPROVAL OF FDA OR-8
159	159	DERS.— 9
160	160	‘‘(1) I
161	161	N GENERAL.—A decision of the Secretary 10
162	162	to decline to grant reciprocal marketing approval 11
163	163	under this section shall not take effect if a joint res-12
164	164	olution of disapproval of the decision is enacted. 13
165	165	‘‘(2) P
166	166	ROCEDURE.— 14
167	167	‘‘(A) I
168	168	N GENERAL.—Subject to subpara-15
169	169	graph (B), the procedures described in sub-16
170	170	sections (b) through (g) of section 802 of title 17
171	171	5, United States Code, shall apply to the con-18
172	172	sideration of a joint resolution under this sub-19
173	173	section. 20
174	174	‘‘(B) T
175	175	ERMS.—For purposes of this sub-21
176	176	section— 22
177	177	‘‘(i) the reference to ‘section 23
178	178	801(a)(1)’ in section 802(b)(2)(A) of title 24
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181	181	•HR 1632 IH
182	182	5, United States Code, shall be considered 1
183	183	to refer to subsection (c)(2); and 2
184	184	‘‘(ii) the reference to ‘section 3
185	185	801(a)(1)(A)’ in section 802(e)(2) of title 4
186	186	5, United States Code, shall be considered 5
187	187	to refer to subsection (c)(2). 6
188	188	‘‘(3) E
189	189	FFECT OF CONGRESSIONAL DIS -7
190	190	APPROVAL.—Reciprocal marketing approval under 8
191	191	this section with respect to the applicable covered 9
192	192	product shall take effect upon enactment of a joint 10
193	193	resolution of disapproval under this subsection. 11
194	194	‘‘(h) A
195	195	PPLICABILITY OFRELEVANTPROVISIONS.— 12
196	196	The provisions of this Act shall apply with respect to a 13
197	197	covered product for which reciprocal marketing approval 14
198	198	is in effect to the same extent and in the same manner 15
199	199	as such provisions apply with respect to a product for 16
200	200	which approval or clearance of an application or pre-17
201	201	market notification under section 505(c), 510(k), or 515 18
202	202	of this Act or section 351(a) of the Public Health Service 19
203	203	Act, as applicable, is in effect. 20
204	204	‘‘(i) F
205	205	EES FORREQUEST.—For purposes of imposing 21
206	206	fees under chapter VII, a request for reciprocal marketing 22
207	207	approval under this section shall be treated as an applica-23
208	208	tion or premarket notification for approval or clearance 24
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211	211	•HR 1632 IH
212	212	under section 505(c), 510(k), or 515 of this Act or section 1
213	213	351(a) of the Public Health Service Act, as applicable. 2
214	214	‘‘(j) O
215	215	UTREACH.—The Secretary shall conduct an 3
216	216	outreach campaign to encourage the sponsors of covered 4
217	217	products that are potentially eligible for reciprocal mar-5
218	218	keting approval to request such approval. 6
219	219	‘‘(k) C
220	220	OVEREDPRODUCTDEFINED.—In this section, 7
221	221	the term ‘covered product’ means a drug, biological prod-8
222	222	uct, or device.’’. 9
223	223	Æ
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