Us Congress 2025-2026 Regular Session

Us Congress Senate Bill SB1302 Compare Versions

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

Old	New	Differences
1	1	II
2	2	119THCONGRESS
3	3	1
4	4	STSESSION S. 1302
5	5	To provide for increased transparency in generic drug applications.
6	6	IN THE SENATE OF THE UNITED STATES
7	7	APRIL3, 2025
8	8	Ms. H
9	9	ASSAN(for herself, Mr. PAUL, Mr. HICKENLOOPER, and Mr. LEE) in-
10	10	troduced the following bill; which was read twice and referred to the Com-
11	11	mittee on Health, Education, Labor, and Pensions
12	12	A BILL
13	13	To provide for increased transparency in generic drug
14	14	applications.
15	15	Be it enacted by the Senate and House of Representa-1
16	16	tives of the United States of America in Congress assembled, 2
17	17	SECTION 1. SHORT TITLE. 3
18	18	This Act may be cited as the ‘‘Increasing Trans-4
19	19	parency in Generic Drug Applications Act’’. 5
20	20	SEC. 2. INCREASING TRANSPARENCY IN GENERIC DRUG 6
21	21	APPLICATIONS. 7
22	22	(a) I
23	23	NGENERAL.—Section 505(j)(3) of the Federal 8
24	24	Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(3)) is 9
25	25	amended by adding at the end the following: 10
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28	28	•S 1302 IS
29	29	‘‘(H)(i) Upon request (in controlled correspondence 1
30	30	or an analogous process) by a person that has submitted 2
31	31	or intends to submit an abbreviated application under this 3
32	32	subsection for a drug that is required by regulation to con-4
33	33	tain one or more of the same inactive ingredients in the 5
34	34	same concentrations as the listed drug referred to, or for 6
35	35	which the Secretary determines there is a scientific jus-7
36	36	tification for an approach that is in vitro, in whole or in 8
37	37	part, to be used to demonstrate bioequivalence for a drug 9
38	38	if such a drug contains one or more of the same inactive 10
39	39	ingredients in the same concentrations as the listed drug 11
40	40	referred to, the Secretary shall inform the person whether 12
41	41	such drug is qualitatively and quantitatively the same as 13
42	42	the listed drug. The Secretary may also provide such infor-14
43	43	mation to such a person on the Secretary’s own initiative 15
44	44	during the review of an abbreviated application under this 16
45	45	subsection for such drug. 17
46	46	‘‘(ii) Notwithstanding section 301(j), if the Secretary 18
47	47	determines that such drug is not qualitatively or quan-19
48	48	titatively the same as the listed drug, the Secretary shall 20
49	49	identify and disclose to the person— 21
50	50	‘‘(I) the ingredient or ingredients that cause 22
51	51	such drug not to be qualitatively or quantitatively 23
52	52	the same as the listed drug; and 24
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55	55	•S 1302 IS
56	56	‘‘(II) for any ingredient for which there is an 1
57	57	identified quantitative deviation, the amount of such 2
58	58	deviation. 3
59	59	‘‘(iii) If the Secretary determines that such drug is 4
60	60	qualitatively and quantitatively the same as the listed 5
61	61	drug, the Secretary shall not change or rescind such deter-6
62	62	mination after the submission of an abbreviated applica-7
63	63	tion for such drug under this subsection unless— 8
64	64	‘‘(I) the formulation of the listed drug has been 9
65	65	changed and the Secretary has determined that the 10
66	66	prior listed drug formulation was withdrawn for rea-11
67	67	sons of safety or effectiveness; or 12
68	68	‘‘(II) the Secretary makes a written determina-13
69	69	tion that the prior determination must be changed 14
70	70	because an error has been identified. 15
71	71	‘‘(iv) If the Secretary makes a written determination 16
72	72	described in clause (iii)(II), the Secretary shall provide no-17
73	73	tice and a copy of the written determination to the person 18
74	74	making the request under clause (i). 19
75	75	‘‘(v) The disclosures authorized under clauses (i) and 20
76	76	(ii) are disclosures authorized by law, including for pur-21
77	77	poses of section 1905 of title 18, United States Code. This 22
78	78	subparagraph shall not otherwise be construed to author-23
79	79	ize the disclosure of nonpublic qualitative or quantitative 24
80	80	information about the ingredients in a listed drug, or to 25
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83	83	•S 1302 IS
84	84	affect the status, if any, of such information as trade se-1
85	85	cret or confidential commercial information for purposes 2
86	86	of section 301(j) of this Act, section 552 of title 5, United 3
87	87	States Code, or section 1905 of title 18, United States 4
88	88	Code.’’. 5
89	89	(b) G
90	90	UIDANCE.— 6
91	91	(1) I
92	92	N GENERAL.—Not later than one year 7
93	93	after the date of enactment of this Act, the Sec-8
94	94	retary of Health and Human Services shall issue 9
95	95	draft guidance, or update guidance, describing how 10
96	96	the Secretary will determine whether a drug is quali-11
97	97	tatively and quantitatively the same as the listed 12
98	98	drug (as such terms are used in section 13
99	99	505(j)(3)(H) of the Federal Food, Drug, and Cos-14
100	100	metic Act, as added by subsection (a)), including 15
101	101	with respect to assessing pH adjusters. 16
102	102	(2) P
103	103	ROCESS.—In issuing guidance under this 17
104	104	subsection, the Secretary of Health and Human 18
105	105	Services shall— 19
106	106	(A) publish draft guidance; 20
107	107	(B) provide a period of at least 60 days for 21
108	108	comment on the draft guidance; and 22
109	109	(C) after considering any comments re-23
110	110	ceived and not later than one year after the 24
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113	113	•S 1302 IS
114	114	close of the comment period on the draft guid-1
115	115	ance, publish final guidance. 2
116	116	(c) A
117	117	PPLICABILITY.—Section 505(j)(3)(H) of the 3
118	118	Federal Food, Drug, and Cosmetic Act, as added by sub-4
119	119	section (a), applies beginning on the date of enactment 5
120	120	of this Act, irrespective of the date on which the guidance 6
121	121	required by subsection (b) is finalized. 7
122	122	Æ
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