Us Congress 2025-2026 Regular Session

Us Congress House Bill HB1051 Compare Versions

Only one version of the bill is available at this time.

Old	New	Differences
1	1	I
2	2	119THCONGRESS
3	3	1
4	4	STSESSION H. R. 1051
5	5	To amend the Federal Food, Drug, and Cosmetic Act to allow for the
6	6	approval of an abbreviated new drug application submitted by a subse-
7	7	quent applicant in the case of a failure by a first applicant to commence
8	8	commercial marketing within a certain period, and for other purposes.
9	9	IN THE HOUSE OF REPRESENTATIVES
10	10	FEBRUARY6, 2025
11	11	Ms. B
12	12	UDZINSKIintroduced the following bill; which was referred to the
13	13	Committee on Energy and Commerce
14	14	A BILL
15	15	To amend the Federal Food, Drug, and Cosmetic Act to
16	16	allow for the approval of an abbreviated new drug appli-
17	17	cation submitted by a subsequent applicant in the case
18	18	of a failure by a first applicant to commence commercial
19	19	marketing within a certain period, and for other pur-
20	20	poses.
21	21	Be it enacted by the Senate and House of Representa-1
22	22	tives of the United States of America in Congress assembled, 2
23	23	SECTION 1. 180-DAY EXCLUSIVITY PERIOD. 3
24	24	(a) I
25	25	NGENERAL.—Section 505(j)(5)(B)(iv) of the 4
26	26	Federal Food, Drug, and Cosmetic Act (21 U.S.C. 5
27	27	355(j)(5)(B)(iv)) is amended— 6
28	28	VerDate Sep 11 2014 01:13 Mar 05, 2025 Jkt 059200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H1051.IH H1051
29	29	ssavage on LAPJG3WLY3PROD with BILLS 2
30	30	•HR 1051 IH
31	31	(1) in subclause (I)— 1
32	32	(A) by inserting ‘‘and subclause (III)’’ 2
33	33	after ‘‘subparagraph (D)’’; and 3
34	34	(B) by inserting before the period at the 4
35	35	end the following: ‘‘or an applicant whose appli-5
36	36	cation was approved pursuant to subclause 6
37	37	(III). If an applicant described in subclause 7
38	38	(III) is eligible for effective approval on the 8
39	39	same day a tentatively approved first applicant 9
40	40	who has requested final approval is determined 10
41	41	by the Secretary to be eligible for effective ap-11
42	42	proval by meeting all the approval requirements 12
43	43	of this subsection, such applicant may not re-13
44	44	ceive effective approval until 180 days after the 14
45	45	first applicant begins commercial marketing of 15
46	46	the drug’’; and 16
47	47	(2) by adding at the end the following new sub-17
48	48	clause: 18
49	49	‘‘(III) A
50	50	PPLICANT APPROVAL .—The Sec-19
51	51	retary may approve an application containing a 20
52	52	certification described in paragraph 21
53	53	(2)(A)(vii)(IV) that is for a drug for which a 22
54	54	first applicant has submitted an application 23
55	55	containing such a certification, notwithstanding 24
56	56	the eligibility of a first applicant for the 180- 25
57	57	VerDate Sep 11 2014 01:13 Mar 05, 2025 Jkt 059200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H1051.IH H1051
58	58	ssavage on LAPJG3WLY3PROD with BILLS 3
59	59	•HR 1051 IH
60	60	day exclusivity period described in subclause 1
61	61	(II)(aa), if each of the following conditions is 2
62	62	met: 3
63	63	‘‘(aa) The approval of such applica-4
64	64	tion could be made effective, but for the 5
65	65	eligibility of a first applicant for 180-day 6
66	66	exclusivity under this clause. 7
67	67	‘‘(bb) The applicant of such applica-8
68	68	tion has submitted a certification to the 9
69	69	abbreviated new drug application that 10
70	70	there are no conditions that would prevent 11
71	71	the applicant from commercial marketing 12
72	72	within 75 days after the date of approval 13
73	73	and that the applicant intends to so mar-14
74	74	ket the drug. 15
75	75	‘‘(cc) At least 33 months have passed 16
76	76	since the date of submission of an applica-17
77	77	tion for the drug by at least one first ap-18
78	78	plicant. 19
79	79	‘‘(dd) Approval of an application for 20
80	80	the drug submitted by at least one first ap-21
81	81	plicant is not precluded under clause (iii). 22
82	82	‘‘(ee) No application for the drug sub-23
83	83	mitted by any first applicant is effectively 24
84	84	approved on the date that the conditions 25
85	85	VerDate Sep 11 2014 01:13 Mar 05, 2025 Jkt 059200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H1051.IH H1051
86	86	ssavage on LAPJG3WLY3PROD with BILLS 4
87	87	•HR 1051 IH
88	88	under items (aa), (bb), (cc), and (dd) are 1
89	89	all met and maintained.’’. 2
90	90	(b) S
91	91	PECIALFORFEITURERULE FORCERTAINSUB-3
92	92	SEQUENTAPPLICANTS.—Section 505(j)(5)(D) of the Fed-4
93	93	eral Food, Drug, and Cosmetic Act (21 U.S.C. 355 5
94	94	(j)(5)(D)) is amended by adding at the end the following: 6
95	95	‘‘(v) S
96	96	PECIAL FORFEITURE RULE FOR 7
97	97	CERTAIN SUBSEQUENT APPLICANTS .— 8
98	98	‘‘(I) I
99	99	N GENERAL.—Except as 9
100	100	specified in subclause (II), an applica-10
101	101	tion that is approved pursuant to sub-11
102	102	clause (III) of subparagraph (B)(iv) is 12
103	103	deemed to be tentatively approved and 13
104	104	to no longer have an effective ap-14
105	105	proval pursuant to such subclause 15
106	106	(III) beginning on the day after the 16
107	107	end of the 75-day period specified in 17
108	108	item (bb) of such subclause (III) if 18
109	109	the applicant fails to commence com-19
110	110	mercial marketing as required under 20
111	111	such item. 21
112	112	‘‘(II) O
113	113	PPORTUNITY TO CURE.— 22
114	114	‘‘(aa) I
115	115	N GENERAL.—If the 23
116	116	applicant of an application ap-24
117	117	proved pursuant to subclause 25
118	118	VerDate Sep 11 2014 01:13 Mar 05, 2025 Jkt 059200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H1051.IH H1051
119	119	ssavage on LAPJG3WLY3PROD with BILLS 5
120	120	•HR 1051 IH
121	121	(III) of subparagraph (B)(iv) 1
122	122	submits, pursuant to item (bb) of 2
123	123	such subclause, a notification 3
124	124	that it can no longer commence 4
125	125	commercial marketing within the 5
126	126	75-day period specified in such 6
127	127	item, such application is deemed 7
128	128	to be tentatively approved and to 8
129	129	no longer be effectively approved 9
130	130	beginning on the date that such 10
131	131	a notification is received. 11
132	132	‘‘(bb) I
133	133	NELIGIBILITY FOR 12
134	134	SUBSEQUENT EFFECTIVE AP -13
135	135	PROVAL.—If an applicant de-14
136	136	scribed in item (aa) does not 15
137	137	commence commercial marketing 16
138	138	within such 75-day period, the 17
139	139	applicant shall not be eligible for 18
140	140	a subsequent effective approval 19
141	141	for the application involved under 20
142	142	subclause (III) of subparagraph 21
143	143	(B)(iv) unless, in addition to 22
144	144	meeting each of the conditions in 23
145	145	such subclause (III), the appli-24
146	146	cant submits a certification to its 25
147	147	VerDate Sep 11 2014 01:13 Mar 05, 2025 Jkt 059200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H1051.IH H1051
148	148	ssavage on LAPJG3WLY3PROD with BILLS 6
149	149	•HR 1051 IH
150	150	abbreviated new drug application 1
151	151	that— 2
152	152	‘‘(AA) an event that 3
153	153	could not have been reason-4
154	154	ably foreseen by the appli-5
155	155	cant prevented it from com-6
156	156	mencing commercial mar-7
157	157	keting; and 8
158	158	‘‘(BB) it has fully re-9
159	159	solved any issues preventing 10
160	160	such commercial marketing 11
161	161	from commencing as a result 12
162	162	of such event. 13
163	163	‘‘(cc) T
164	164	IMING FOR SUBMIS-14
165	165	SION.—An applicant described in 15
166	166	item (aa) shall, not later than 16
167	167	one business day after com-17
168	168	mencing marketing of the drug 18
169	169	that is the subject of the applica-19
170	170	tion described in such item, sub-20
171	171	mit a notification to the abbre-21
172	172	viated new drug application con-22
173	173	firming that such applicant has 23
174	174	commenced commercial mar-24
175	175	keting of the drug.’’. 25
176	176	VerDate Sep 11 2014 01:13 Mar 05, 2025 Jkt 059200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H1051.IH H1051
177	177	ssavage on LAPJG3WLY3PROD with BILLS 7
178	178	•HR 1051 IH
179	179	(c) APPLICABILITY.—The amendments made by sub-1
180	180	sections (a) and (b) shall apply only with respect to an 2
181	181	application filed under section 505(j) of the Federal Food, 3
182	182	Drug, and Cosmetic Act (21 U.S.C. 355(j)) after the date 4
183	183	of enactment of this Act that identifies a listed drug for 5
184	184	which no certification under paragraph (2)(A)(vii)(IV) of 6
185	185	such section was made before such date of enactment. 7
186	186	Æ
187	187	VerDate Sep 11 2014 01:13 Mar 05, 2025 Jkt 059200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6301 E:\BILLS\H1051.IH H1051
188	188	ssavage on LAPJG3WLY3PROD with BILLS