Us Congress 2023-2024 Regular Session

Us Congress Senate Bill SB2737 Compare Versions

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

Old	New	Differences
1	1	II
2	2	118THCONGRESS
3	3	1
4	4	STSESSION S. 2737
5	5	To require the Food and Drug Administration to determine whether to
6	6	permit the use of enriched enrollment randomized withdrawal method-
7	7	ology with respect to clinical trials.
8	8	IN THE SENATE OF THE UNITED STATES
9	9	SEPTEMBER7, 2023
10	10	Mr. M
11	11	ANCHIN(for himself and Mr. BRAUN) introduced the following bill;
12	12	which was read twice and referred to the Committee on Health, Edu-
13	13	cation, Labor, and Pensions
14	14	A BILL
15	15	To require the Food and Drug Administration to determine
16	16	whether to permit the use of enriched enrollment ran-
17	17	domized withdrawal methodology with respect to clinical
18	18	trials.
19	19	Be it enacted by the Senate and House of Representa-1
20	20	tives of the United States of America in Congress assembled, 2
21	21	SECTION 1. SHORT TITLE. 3
22	22	This Act may be cited as the ‘‘FDA Review of Effi-4
23	23	cacy of EERW Double-Blinds of Opioids Act’’ or the 5
24	24	‘‘FREED of Opioids Act’’. 6
25	25	VerDate Sep 11 2014 22:19 Sep 07, 2023 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S2737.IS S2737
26	26	pbinns on DSKJLVW7X2PROD with $$_JOB 2
27	27	•S 2737 IS
28	28	SEC. 2. CONSIDERATION OF ENRICHED ENROLLMENT RAN-1
29	29	DOMIZED WITHDRAWAL METHODOLOGY. 2
30	30	(a) I
31	31	NGENERAL.—Not later than 2 years after the 3
32	32	date of enactment of this Act, the Secretary of Health and 4
33	33	Human Services (referred to in this section as the ‘‘Sec-5
34	34	retary’’), acting through the Commissioner of Food and 6
35	35	Drugs, shall convene a meeting of the Anesthetic and An-7
36	36	algesic Drug Products Advisory Committee and the Drug 8
37	37	Safety and Risk Management Advisory Committee of the 9
38	38	Food and Drug Administration to vote on whether to per-10
39	39	mit the use of the enriched enrollment randomized with-11
40	40	drawal methodology in clinical trials of drugs, including 12
41	41	opioid drugs. In conducting such review, the Secretary 13
42	42	shall consider the report issued by the National Academy 14
43	43	of Sciences under subsection (c). 15
44	44	(b) P
45	45	RESENTATIONS.—If the Secretary allows for 16
46	46	formal presentations in support of the use of the enriched 17
47	47	enrollment randomized withdrawal methodology at the 18
48	48	meeting described in subsection (a), the Secretary shall 19
49	49	also allow for equal time at such meeting for presentations 20
50	50	that are critical of such methodology. 21
51	51	(c) NAS S
52	52	TUDY ANDREPORT.—The Secretary shall 22
53	53	seek to enter into a contract with the National Academy 23
54	54	of Sciences under which the National Academy— 24
55	55	(1) conducts a study on the effectiveness of en-25
56	56	riched enrollment randomized withdrawal method-26
57	57	VerDate Sep 11 2014 22:19 Sep 07, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S2737.IS S2737
58	58	pbinns on DSKJLVW7X2PROD with $$_JOB 3
59	59	•S 2737 IS
60	60	ology in demonstrating the efficacy of opioid drugs 1
61	61	in treating chronic pain; and 2
62	62	(2) not later than 1 year after the date of en-3
63	63	actment of this Act, submits a report on such study 4
64	64	to the Secretary. 5
65	65	(d) P
66	66	OSTMARKETREVIEW.—Not later than 2 years 6
67	67	after the date of enactment of this Act, the Secretary, act-7
68	68	ing through the Commissioner of Food and Drugs, shall 8
69	69	convene 1 or more meetings of the Anesthetic and Analge-9
70	70	sic Drug Products Advisory Committee and the Drug 10
71	71	Safety and Risk Management Advisory Committee of the 11
72	72	Food and Drug Administration to review the approved la-12
73	73	beling on all opioid drugs approved using enriched enroll-13
74	74	ment randomized withdrawal methodology under section 14
75	75	505 of the Federal Food, Drug, and Cosmetic Act (21 15
76	76	U.S.C. 355) as of the date of the first such meeting, for 16
77	77	the purpose of determining whether the indications on 17
78	78	such labeling for such drugs are supported by the enriched 18
79	79	enrollment randomized withdrawal methodology. The find-19
80	80	ings from such meetings shall be made publicly available 20
81	81	on an internet website operated by the Secretary, acting 21
82	82	through the Commissioner of Food and Drugs. 22
83	83	Æ
84	84	VerDate Sep 11 2014 22:19 Sep 07, 2023 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6301 E:\BILLS\S2737.IS S2737
85	85	pbinns on DSKJLVW7X2PROD with $$_JOB