Us Congress 2025-2026 Regular Session

Us Congress House Bill HB1532 Compare Versions

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Old	New	Differences
1	1	I
2	2	119THCONGRESS
3	3	1
4	4	STSESSION H. R. 1532
5	5	To amend the Federal Food, Drug, and Cosmetic Act to establish a process
6	6	for externally led, science-focused drug development meetings, and for
7	7	other purposes.
8	8	IN THE HOUSE OF REPRESENTATIVES
9	9	FEBRUARY24, 2025
10	10	Ms. M
11	11	ATSUI(for herself and Mr. BILIRAKIS) introduced the following bill;
12	12	which was referred to the Committee on Energy and Commerce
13	13	A BILL
14	14	To amend the Federal Food, Drug, and Cosmetic Act to
15	15	establish a process for externally led, science-focused
16	16	drug development meetings, and for other purposes.
17	17	Be it enacted by the Senate and House of Representa-1
18	18	tives of the United States of America in Congress assembled, 2
19	19	SECTION 1. SHORT TITLE. 3
20	20	This Act may be cited as the ‘‘Scientific External 4
21	21	Process for Educated Review of Therapeutics Act of 5
22	22	2025’’ or the ‘‘Scientific EXPERT Act of 2025’’. 6
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25	25	•HR 1532 IH
26	26	SEC. 2. SCIENCE-FOCUSED DRUG DEVELOPMENT MEET-1
27	27	INGS. 2
28	28	The Federal Food, Drug, and Cosmetic Act (21 3
29	29	U.S.C. 301 et seq.) is amended by inserting after section 4
30	30	770 (21 U.S.C. 379dd) the following: 5
31	31	‘‘SEC. 770A. SCIENCE-FOCUSED DRUG DEVELOPMENT 6
32	32	MEETINGS. 7
33	33	‘‘(a) I
34	34	NGENERAL.—The Secretary shall develop and 8
35	35	implement a process for externally led, science-focused 9
36	36	drug development meetings to provide an opportunity for 10
37	37	medical experts, drug sponsors, scientific organizations, 11
38	38	and patient organizations to— 12
39	39	‘‘(1) discuss science-related challenges impact-13
40	40	ing the development of drugs for rare diseases and 14
41	41	conditions; 15
42	42	‘‘(2) identify scientific approaches and opportu-16
43	43	nities to facilitate the development, review, and ap-17
44	44	proval of such drugs; and 18
45	45	‘‘(3) align on novel approaches for the develop-19
46	46	ment of drugs for particular diseases, including ap-20
47	47	propriate clinical trial designs and metrics, manufac-21
48	48	turing standards, patient populations, clinical 22
49	49	endpoints, the use of biomarkers as surrogate 23
50	50	endpoints, and natural history as a control, to ad-24
51	51	vance treatment options to address unmet medical 25
52	52	needs. 26
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55	55	•HR 1532 IH
56	56	‘‘(b) ARRANGEMENT.— 1
57	57	‘‘(1) Q
58	58	UALIFIED THIRD PARTY CONVENOR .— 2
59	59	The Secretary shall enter into an arrangement with 3
60	60	the Reagan-Udall Foundation for the Food and 4
61	61	Drug Administration (in this section referred to as 5
62	62	the ‘Foundation’) under which the Foundation 6
63	63	agrees to convene EL–SFDD meetings in accord-7
64	64	ance with this section. 8
65	65	‘‘(2) M
66	66	INIMUM NUMBER OF MEETINGS .—The 9
67	67	Foundation shall convene no fewer than four EL– 10
68	68	SFDD meetings each year, with each such meeting 11
69	69	focused on addressing a different rare disease or 12
70	70	condition or a different group of rare diseases and 13
71	71	conditions. 14
72	72	‘‘(3) S
73	73	TEERING COMMITTEE .— 15
74	74	‘‘(A) I
75	75	N GENERAL.—The Foundation shall 16
76	76	establish and maintain a permanent steering 17
77	77	committee, to be known as the Science-Focused 18
78	78	Drug Development Multistakeholder Steering 19
79	79	Committee, to advise the Foundation on imple-20
80	80	mentation of this section, including by— 21
81	81	‘‘(i) establishing a process by which 22
82	82	medical experts, drug sponsors, scientific 23
83	83	organizations, patient organizations, and 24
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86	86	•HR 1532 IH
87	87	other entities can provide suggested meet-1
88	88	ing topics to the Foundation; 2
89	89	‘‘(ii) reviewing such suggested meeting 3
90	90	topics for EL–SFDD meetings; and 4
91	91	‘‘(iii) based on the criteria under sub-5
92	92	paragraph (B), recommending to the 6
93	93	Foundation topics for EL–SFDD meet-7
94	94	ings. 8
95	95	‘‘(B) C
96	96	RITERIA FOR MEETINGS .—In for-9
97	97	mulating recommendations under subparagraph 10
98	98	(A), the Foundation shall consider— 11
99	99	‘‘(i) unmet therapeutic needs; 12
100	100	‘‘(ii) the size of the patient population 13
101	101	of the rare disease or condition; 14
102	102	‘‘(iii) whether there were or are mul-15
103	103	tiple products in development to prevent or 16
104	104	treat the rare disease or condition involved; 17
105	105	‘‘(iv) whether there is a need for in-18
106	106	creased regulatory flexibility to facilitate 19
107	107	the development of products; 20
108	108	‘‘(v) whether the disease or condition 21
109	109	involved would benefit from clarity and 22
110	110	alignment on drug development questions 23
111	111	(such as clinical trial design, natural his-24
112	112	tory as a control, appropriate clinical 25
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115	115	•HR 1532 IH
116	116	endpoints, biomarkers that may serve as 1
117	117	surrogate endpoints, and other approaches) 2
118	118	to expedite drug development for such dis-3
119	119	ease or condition; and 4
120	120	‘‘(vi) whether the discussions about 5
121	121	such rare disease or condition may have 6
122	122	broader impact on other rare diseases and 7
123	123	conditions. 8
124	124	‘‘(C) M
125	125	EMBERSHIP.—The members of the 9
126	126	Steering Committee shall be subject to all rel-10
127	127	evant conflict of interest policies of the Founda-11
128	128	tion and shall include— 12
129	129	‘‘(i) representatives of the Center for 13
130	130	Drug Evaluation and Research, the Center 14
131	131	for Biologics Evaluation and Research, and 15
132	132	the Center for Devices and Radiological 16
133	133	Health; 17
134	134	‘‘(ii) academic and medical experts; 18
135	135	‘‘(iii) patient representatives; and 19
136	136	‘‘(iv) industry representatives engaged 20
137	137	in the development of drugs for rare dis-21
138	138	eases and conditions. 22
139	139	‘‘(4) P
140	140	LANNING PROCESS.—In planning an EL– 23
141	141	SFDD meeting under this section, the Foundation, 24
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144	144	•HR 1532 IH
145	145	in consultation with the stakeholders listed in para-1
146	146	graph (5), shall develop— 2
147	147	‘‘(A) a list of the specific objectives of the 3
148	148	meeting related to key drug development issues 4
149	149	for the rare disease or condition, or group of 5
150	150	rare diseases and conditions, with a goal of ex-6
151	151	pediting drug development; 7
152	152	‘‘(B) a proposed agenda for the meeting; 8
153	153	and 9
154	154	‘‘(C) a list of medical experts, drug spon-10
155	155	sors, scientific organizations, patient organiza-11
156	156	tions, and other entities to be invited to partici-12
157	157	pate in the meeting. 13
158	158	‘‘(5) A
159	159	GENCY AND STAKEHOLDER ENGAGE -14
160	160	MENT.—Throughout the process of planning an EL– 15
161	161	SFDD meeting, the Foundation shall consult with— 16
162	162	‘‘(A) appropriate staff of the Food and 17
163	163	Drug Administration; 18
164	164	‘‘(B) the Steering Committee established 19
165	165	under this subsection; 20
166	166	‘‘(C) industry representatives engaged in 21
167	167	the development of products for rare diseases 22
168	168	and conditions to be discussed at such EL– 23
169	169	SFDD meeting; 24
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172	172	•HR 1532 IH
173	173	‘‘(D) patient representatives of rare dis-1
174	174	eases and conditions under discussion in such 2
175	175	EL–SFDD meeting; and 3
176	176	‘‘(E) other appropriate stakeholders. 4
177	177	‘‘(6) P
178	178	OST-MEETING REPORTS.— 5
179	179	‘‘(A) I
180	180	N GENERAL.—Within 180 days after 6
181	181	an EL–SFDD meeting, the Foundation shall 7
182	182	make publicly available on the website of the 8
183	183	Food and Drug Administration— 9
184	184	‘‘(i) a transcript and recording of the 10
185	185	meeting; and 11
186	186	‘‘(ii) in consultation with the stake-12
187	187	holders listed in paragraph (5), a summary 13
188	188	analysis of the input received during the 14
189	189	meeting that is relevant to approval or li-15
190	190	censing of drugs for the rare disease or 16
191	191	condition involved. 17
192	192	‘‘(B) C
193	193	ONTENTS.—Each publication under 18
194	194	subparagraph (A) shall include a clear identi-19
195	195	fication of— 20
196	196	‘‘(i) areas of consensus; 21
197	197	‘‘(ii) areas where additional clarifica-22
198	198	tion or information is needed to reach con-23
199	199	sensus; and 24
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202	202	•HR 1532 IH
203	203	‘‘(iii) next steps agreed upon with the 1
204	204	Food and Drug Administration. 2
205	205	‘‘(c) R
206	206	EPRESENTATIVES OF FDA REVIEWDIVI-3
207	207	SIONS.—The Secretary shall require appropriate rep-4
208	208	resentatives of the review divisions of the Food and Drug 5
209	209	Administration to participate in each EL–SFDD meeting 6
210	210	under this section. 7
211	211	‘‘(d) R
212	212	ULES OFCONSTRUCTION.—Nothing in this 8
213	213	section shall be construed— 9
214	214	‘‘(1) to prevent other third-party organizations 10
215	215	from organizing similarly structured EL–SFDD-like 11
216	216	meetings to discuss challenges in rare disease drug 12
217	217	development; 13
218	218	‘‘(2) to require the Food and Drug Administra-14
219	219	tion to participate in additional meetings described 15
220	220	in paragraph (1); 16
221	221	‘‘(3) to alter the protections offered by laws, 17
222	222	regulations, or policies governing disclosure of con-18
223	223	fidential commercial or trade secret information and 19
224	224	any other information exempt from disclosure pursu-20
225	225	ant to section 552(b) of title 5, United States Code; 21
226	226	‘‘(4) to limit the ability of the Secretary to con-22
227	227	sult with individuals and organizations; 23
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230	230	•HR 1532 IH
231	231	‘‘(5) to create a legal right for consultation on 1
232	232	any matter or require the Secretary to meet with 2
233	233	any particular expert or stakeholder; 3
234	234	‘‘(6) to alter agreed-upon goals and procedures 4
235	235	identified in the letters described in section 1001(b) 5
236	236	of the FDA User Fee Reauthorization Act of 2022; 6
237	237	or 7
238	238	‘‘(7) to increase the number of review cycles for 8
239	239	drugs. 9
240	240	‘‘(e) D
241	241	EFINITIONS.—In this section: 10
242	242	‘‘(1) The term ‘EL–SFDD meeting’ means an 11
243	243	externally led, science-focused drug development 12
244	244	meeting. 13
245	245	‘‘(2) The terms ‘rare diseases and conditions’ 14
246	246	and ‘rare disease or condition’ refer to a rare disease 15
247	247	or condition as that term is defined in section 526. 16
248	248	‘‘(3) The term ‘Steering Committee’ means the 17
249	249	Science-Focused Drug Development Multistake-18
250	250	holder Steering Committee established under sub-19
251	251	section (b)(3). 20
252	252	‘‘(f) A
253	253	UTHORIZATION OFAPPROPRIATIONS.— 21
254	254	‘‘(1) I
255	255	N GENERAL.—To carry out this section, 22
256	256	there is authorized to be appropriated $1,000,000 23
257	257	for each of fiscal years 2026 through 2030. 24
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261	261	‘‘(2) RULE OF CONSTRUCTION .—Nothing in 1
262	262	this section shall be construed to prohibit the Foun-2
263	263	dation from soliciting or accepting funds pursuant to 3
264	264	section 770(i) for the purposes of planning or oper-4
265	265	ating an EL–SFDD meeting authorized by this sec-5
266	266	tion. 6
267	267	‘‘SEC. 770B. REQUIRED ACTIONS FOLLOWING EL–SFDD 7
268	268	MEETINGS. 8
269	269	‘‘(a) I
270	270	NCORPORATION OF INPUTINTORISK-BENEFIT 9
271	271	A
272	272	SSESSMENTS.—In approving or licensing a drug under 10
273	273	subsection (c) or (j) of section 505 of this Act or sub-11
274	274	section (a) or (k) of section 351 of the Public Health Serv-12
275	275	ice Act, the Secretary shall make public a brief state-13
276	276	ment— 14
277	277	‘‘(1) stating whether any EL–SFDD meeting 15
278	278	under section 770A was held that was relevant to 16
279	279	such approval or licensure; and 17
280	280	‘‘(2) if so, including a description of how the 18
281	281	Secretary incorporated input from such meeting in 19
282	282	the risk-benefit assessment described in section 20
283	283	505(d). 21
284	284	‘‘(b) A
285	285	NNUALREPORT.—On an annual basis, the 22
286	286	Secretary shall submit a report to the Congress summa-23
287	287	rizing— 24
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290	290	•HR 1532 IH
291	291	‘‘(1) the number and topics of EL–SFDD 1
292	292	meetings held during the reporting period; 2
293	293	‘‘(2) the extent of participation in such meet-3
294	294	ings from the review divisions of the Food and Drug 4
295	295	Administration; 5
296	296	‘‘(3) the impact of EL–SFDD meetings on the 6
297	297	workload and resources of the Food and Drug Ad-7
298	298	ministration; and 8
299	299	‘‘(4) an assessment of how the input received 9
300	300	during such meetings was used in— 10
301	301	‘‘(A) deliberations throughout the drug de-11
302	302	velopment lifecycle; 12
303	303	‘‘(B) regulatory decisionmaking; and 13
304	304	‘‘(C) formulating recommendations for fu-14
305	305	ture meetings. 15
306	306	‘‘(c) D
307	307	EFINITION.—In this section, the term ‘EL– 16
308	308	SFDD meeting’ has the meaning given to that term in 17
309	309	section 770A. 18
310	310	‘‘(d) A
311	311	UTHORIZATION OF APPROPRIATIONS.—To 19
312	312	carry out this section, there is authorized to be appro-20
313	313	priated $1,000,000 for each of fiscal years 2026 through 21
314	314	2030.’’. 22
315	315	Æ
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