I
119THCONGRESS
1
STSESSION H. R. 1532
To amend the Federal Food, Drug, and Cosmetic Act to establish a process
for externally led, science-focused drug development meetings, and for
other purposes.
IN THE HOUSE OF REPRESENTATIVES
FEBRUARY24, 2025
Ms. M
ATSUI(for herself and Mr. BILIRAKIS) introduced the following bill;
which was referred to the Committee on Energy and Commerce
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to
establish a process for externally led, science-focused
drug development meetings, and for other purposes.
Be it enacted by the Senate and House of Representa-1
tives of the United States of America in Congress assembled, 2
SECTION 1. SHORT TITLE. 3
This Act may be cited as the ‘‘Scientific External 4
Process for Educated Review of Therapeutics Act of 5
2025’’ or the ‘‘Scientific EXPERT Act of 2025’’. 6
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SEC. 2. SCIENCE-FOCUSED DRUG DEVELOPMENT MEET-1
INGS. 2
The Federal Food, Drug, and Cosmetic Act (21 3
U.S.C. 301 et seq.) is amended by inserting after section 4
770 (21 U.S.C. 379dd) the following: 5
‘‘SEC. 770A. SCIENCE-FOCUSED DRUG DEVELOPMENT 6
MEETINGS. 7
‘‘(a) I
NGENERAL.—The Secretary shall develop and 8
implement a process for externally led, science-focused 9
drug development meetings to provide an opportunity for 10
medical experts, drug sponsors, scientific organizations, 11
and patient organizations to— 12
‘‘(1) discuss science-related challenges impact-13
ing the development of drugs for rare diseases and 14
conditions; 15
‘‘(2) identify scientific approaches and opportu-16
nities to facilitate the development, review, and ap-17
proval of such drugs; and 18
‘‘(3) align on novel approaches for the develop-19
ment of drugs for particular diseases, including ap-20
propriate clinical trial designs and metrics, manufac-21
turing standards, patient populations, clinical 22
endpoints, the use of biomarkers as surrogate 23
endpoints, and natural history as a control, to ad-24
vance treatment options to address unmet medical 25
needs. 26
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‘‘(b) ARRANGEMENT.— 1
‘‘(1) Q
UALIFIED THIRD PARTY CONVENOR .— 2
The Secretary shall enter into an arrangement with 3
the Reagan-Udall Foundation for the Food and 4
Drug Administration (in this section referred to as 5
the ‘Foundation’) under which the Foundation 6
agrees to convene EL–SFDD meetings in accord-7
ance with this section. 8
‘‘(2) M
INIMUM NUMBER OF MEETINGS .—The 9
Foundation shall convene no fewer than four EL– 10
SFDD meetings each year, with each such meeting 11
focused on addressing a different rare disease or 12
condition or a different group of rare diseases and 13
conditions. 14
‘‘(3) S
TEERING COMMITTEE .— 15
‘‘(A) I
N GENERAL.—The Foundation shall 16
establish and maintain a permanent steering 17
committee, to be known as the Science-Focused 18
Drug Development Multistakeholder Steering 19
Committee, to advise the Foundation on imple-20
mentation of this section, including by— 21
‘‘(i) establishing a process by which 22
medical experts, drug sponsors, scientific 23
organizations, patient organizations, and 24
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other entities can provide suggested meet-1
ing topics to the Foundation; 2
‘‘(ii) reviewing such suggested meeting 3
topics for EL–SFDD meetings; and 4
‘‘(iii) based on the criteria under sub-5
paragraph (B), recommending to the 6
Foundation topics for EL–SFDD meet-7
ings. 8
‘‘(B) C
RITERIA FOR MEETINGS .—In for-9
mulating recommendations under subparagraph 10
(A), the Foundation shall consider— 11
‘‘(i) unmet therapeutic needs; 12
‘‘(ii) the size of the patient population 13
of the rare disease or condition; 14
‘‘(iii) whether there were or are mul-15
tiple products in development to prevent or 16
treat the rare disease or condition involved; 17
‘‘(iv) whether there is a need for in-18
creased regulatory flexibility to facilitate 19
the development of products; 20
‘‘(v) whether the disease or condition 21
involved would benefit from clarity and 22
alignment on drug development questions 23
(such as clinical trial design, natural his-24
tory as a control, appropriate clinical 25
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endpoints, biomarkers that may serve as 1
surrogate endpoints, and other approaches) 2
to expedite drug development for such dis-3
ease or condition; and 4
‘‘(vi) whether the discussions about 5
such rare disease or condition may have 6
broader impact on other rare diseases and 7
conditions. 8
‘‘(C) M
EMBERSHIP.—The members of the 9
Steering Committee shall be subject to all rel-10
evant conflict of interest policies of the Founda-11
tion and shall include— 12
‘‘(i) representatives of the Center for 13
Drug Evaluation and Research, the Center 14
for Biologics Evaluation and Research, and 15
the Center for Devices and Radiological 16
Health; 17
‘‘(ii) academic and medical experts; 18
‘‘(iii) patient representatives; and 19
‘‘(iv) industry representatives engaged 20
in the development of drugs for rare dis-21
eases and conditions. 22
‘‘(4) P
LANNING PROCESS.—In planning an EL– 23
SFDD meeting under this section, the Foundation, 24
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in consultation with the stakeholders listed in para-1
graph (5), shall develop— 2
‘‘(A) a list of the specific objectives of the 3
meeting related to key drug development issues 4
for the rare disease or condition, or group of 5
rare diseases and conditions, with a goal of ex-6
pediting drug development; 7
‘‘(B) a proposed agenda for the meeting; 8
and 9
‘‘(C) a list of medical experts, drug spon-10
sors, scientific organizations, patient organiza-11
tions, and other entities to be invited to partici-12
pate in the meeting. 13
‘‘(5) A
GENCY AND STAKEHOLDER ENGAGE -14
MENT.—Throughout the process of planning an EL– 15
SFDD meeting, the Foundation shall consult with— 16
‘‘(A) appropriate staff of the Food and 17
Drug Administration; 18
‘‘(B) the Steering Committee established 19
under this subsection; 20
‘‘(C) industry representatives engaged in 21
the development of products for rare diseases 22
and conditions to be discussed at such EL– 23
SFDD meeting; 24
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‘‘(D) patient representatives of rare dis-1
eases and conditions under discussion in such 2
EL–SFDD meeting; and 3
‘‘(E) other appropriate stakeholders. 4
‘‘(6) P
OST-MEETING REPORTS.— 5
‘‘(A) I
N GENERAL.—Within 180 days after 6
an EL–SFDD meeting, the Foundation shall 7
make publicly available on the website of the 8
Food and Drug Administration— 9
‘‘(i) a transcript and recording of the 10
meeting; and 11
‘‘(ii) in consultation with the stake-12
holders listed in paragraph (5), a summary 13
analysis of the input received during the 14
meeting that is relevant to approval or li-15
censing of drugs for the rare disease or 16
condition involved. 17
‘‘(B) C
ONTENTS.—Each publication under 18
subparagraph (A) shall include a clear identi-19
fication of— 20
‘‘(i) areas of consensus; 21
‘‘(ii) areas where additional clarifica-22
tion or information is needed to reach con-23
sensus; and 24
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‘‘(iii) next steps agreed upon with the 1
Food and Drug Administration. 2
‘‘(c) R
EPRESENTATIVES OF FDA REVIEWDIVI-3
SIONS.—The Secretary shall require appropriate rep-4
resentatives of the review divisions of the Food and Drug 5
Administration to participate in each EL–SFDD meeting 6
under this section. 7
‘‘(d) R
ULES OFCONSTRUCTION.—Nothing in this 8
section shall be construed— 9
‘‘(1) to prevent other third-party organizations 10
from organizing similarly structured EL–SFDD-like 11
meetings to discuss challenges in rare disease drug 12
development; 13
‘‘(2) to require the Food and Drug Administra-14
tion to participate in additional meetings described 15
in paragraph (1); 16
‘‘(3) to alter the protections offered by laws, 17
regulations, or policies governing disclosure of con-18
fidential commercial or trade secret information and 19
any other information exempt from disclosure pursu-20
ant to section 552(b) of title 5, United States Code; 21
‘‘(4) to limit the ability of the Secretary to con-22
sult with individuals and organizations; 23
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‘‘(5) to create a legal right for consultation on 1
any matter or require the Secretary to meet with 2
any particular expert or stakeholder; 3
‘‘(6) to alter agreed-upon goals and procedures 4
identified in the letters described in section 1001(b) 5
of the FDA User Fee Reauthorization Act of 2022; 6
or 7
‘‘(7) to increase the number of review cycles for 8
drugs. 9
‘‘(e) D
EFINITIONS.—In this section: 10
‘‘(1) The term ‘EL–SFDD meeting’ means an 11
externally led, science-focused drug development 12
meeting. 13
‘‘(2) The terms ‘rare diseases and conditions’ 14
and ‘rare disease or condition’ refer to a rare disease 15
or condition as that term is defined in section 526. 16
‘‘(3) The term ‘Steering Committee’ means the 17
Science-Focused Drug Development Multistake-18
holder Steering Committee established under sub-19
section (b)(3). 20
‘‘(f) A
UTHORIZATION OFAPPROPRIATIONS.— 21
‘‘(1) I
N GENERAL.—To carry out this section, 22
there is authorized to be appropriated $1,000,000 23
for each of fiscal years 2026 through 2030. 24
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‘‘(2) RULE OF CONSTRUCTION .—Nothing in 1
this section shall be construed to prohibit the Foun-2
dation from soliciting or accepting funds pursuant to 3
section 770(i) for the purposes of planning or oper-4
ating an EL–SFDD meeting authorized by this sec-5
tion. 6
‘‘SEC. 770B. REQUIRED ACTIONS FOLLOWING EL–SFDD 7
MEETINGS. 8
‘‘(a) I
NCORPORATION OF INPUTINTORISK-BENEFIT 9
A
SSESSMENTS.—In approving or licensing a drug under 10
subsection (c) or (j) of section 505 of this Act or sub-11
section (a) or (k) of section 351 of the Public Health Serv-12
ice Act, the Secretary shall make public a brief state-13
ment— 14
‘‘(1) stating whether any EL–SFDD meeting 15
under section 770A was held that was relevant to 16
such approval or licensure; and 17
‘‘(2) if so, including a description of how the 18
Secretary incorporated input from such meeting in 19
the risk-benefit assessment described in section 20
505(d). 21
‘‘(b) A
NNUALREPORT.—On an annual basis, the 22
Secretary shall submit a report to the Congress summa-23
rizing— 24
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‘‘(1) the number and topics of EL–SFDD 1
meetings held during the reporting period; 2
‘‘(2) the extent of participation in such meet-3
ings from the review divisions of the Food and Drug 4
Administration; 5
‘‘(3) the impact of EL–SFDD meetings on the 6
workload and resources of the Food and Drug Ad-7
ministration; and 8
‘‘(4) an assessment of how the input received 9
during such meetings was used in— 10
‘‘(A) deliberations throughout the drug de-11
velopment lifecycle; 12
‘‘(B) regulatory decisionmaking; and 13
‘‘(C) formulating recommendations for fu-14
ture meetings. 15
‘‘(c) D
EFINITION.—In this section, the term ‘EL– 16
SFDD meeting’ has the meaning given to that term in 17
section 770A. 18
‘‘(d) A
UTHORIZATION OF APPROPRIATIONS.—To 19
carry out this section, there is authorized to be appro-20
priated $1,000,000 for each of fiscal years 2026 through 21
2030.’’. 22
Æ
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