I 
118TH CONGRESS 
2D SESSION 
H. R. 9979 
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 
OCTOBER 11, 2024 
Ms. MATSUI (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-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Scientific External 
Process for Educated Review of Therapeutics Act of 
2024’’ or the ‘‘Scientific EXPERT Act of 2024’’. 
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SEC. 2. SCIENCE-FOCUSED DRUG DEVELOPMENT MEET-
INGS. 
The Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 301 et seq.) is amended by inserting after section 
770 (21 U.S.C. 379dd) the following: 
‘‘SEC. 
770A. 
SCIENCE-FOCUSED 
DRUG 
DEVELOPMENT 
MEETINGS. 
‘‘(a) IN GENERAL.—The Secretary shall develop and 
implement a process for externally led, science-focused 
drug development meetings to provide an opportunity for 
medical experts, drug sponsors, scientific organizations, 
and patient organizations to— 
‘‘(1) discuss science-related challenges impact-
ing the development of drugs for rare diseases and 
conditions; 
‘‘(2) identify scientific approaches and opportu-
nities to facilitate the development, review, and ap-
proval of such drugs; and 
‘‘(3) align on novel approaches for the develop-
ment of drugs for particular diseases, including ap-
propriate clinical trial designs and metrics, manufac-
turing 
standards, 
patient 
populations, 
clinical 
endpoints, the use of biomarkers as surrogate 
endpoints, and natural history as a control, to ad-
vance treatment options to address unmet medical 
needs. 
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‘‘(b) ARRANGEMENT.— 
‘‘(1) QUALIFIED
THIRD
PARTY
CONVENOR.— 
The Secretary shall enter into an arrangement with 
the Reagan-Udall Foundation for the Food and 
Drug Administration (in this section referred to as 
the ‘Foundation’) under which the Foundation 
agrees to convene EL–SFDD meetings in accord-
ance with this section. 
‘‘(2) MINIMUM
NUMBER
OF
MEETINGS.—The 
Foundation shall convene no fewer than four EL– 
SFDD meetings each year, with each such meeting 
focused on addressing a different rare disease or 
condition or a different group of rare diseases and 
conditions. 
‘‘(3) STEERING COMMITTEE.— 
‘‘(A) IN GENERAL.—The Foundation shall 
establish and maintain a permanent steering 
committee, to be known as the Science-Focused 
Drug Development Multistakeholder Steering 
Committee, to advise the Foundation on imple-
mentation of this section, including by— 
‘‘(i) establishing a process by which 
medical experts, drug sponsors, scientific 
organizations, patient organizations, and 
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other entities can provide suggested meet-
ing topics to the Foundation; 
‘‘(ii) reviewing such suggested meeting 
topics for EL–SFDD meetings; and 
‘‘(iii) based on the criteria under sub-
paragraph (B), recommending to the 
Foundation topics for EL–SFDD meet-
ings. 
‘‘(B) CRITERIA
FOR
MEETINGS.—In for-
mulating recommendations under subparagraph 
(A), the Foundation shall consider— 
‘‘(i) unmet therapeutic needs; 
‘‘(ii) the size of the patient population 
of the rare disease or condition; 
‘‘(iii) whether there are multiple prod-
ucts in development to prevent or treat the 
rare disease or condition involved; 
‘‘(iv) whether there is a need for in-
creased regulatory flexibility to facilitate 
the development of products; 
‘‘(v) whether the disease or condition 
involved would benefit from clarity and 
alignment on drug development questions 
(such as clinical trial design, natural his-
tory as a control, appropriate clinical 
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endpoints, biomarkers that may serve as 
surrogate endpoints, and other approaches) 
to expedite drug development for such dis-
ease or condition; and 
‘‘(vi) whether the discussions about 
such rare disease or condition may have 
broader impact on other rare diseases and 
conditions. 
‘‘(C) MEMBERSHIP.—The members of the 
Steering Committee shall include— 
‘‘(i) representatives of the Center for 
Drug Evaluation and Research, the Center 
for Biologics Evaluation and Research, and 
the Center for Devices and Radiological 
Health; 
‘‘(ii) academic and medical experts; 
‘‘(iii) patient representatives; 
‘‘(iv) industry experts engaged in the 
development of drugs for rare diseases and 
conditions. 
‘‘(4) PLANNING PROCESS.—In planning an EL– 
SFDD meeting under this section, the Foundation, 
in consultation with the stakeholders listed in para-
graph (5), shall develop— 
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‘‘(A) a list of the specific objectives of the 
meeting related to key drug development issues 
for the rare disease or condition, or group of 
rare diseases and conditions, with a goal of ex-
pediting drug development; 
‘‘(B) a proposed agenda for the meeting; 
and 
‘‘(C) a list of medical experts, drug spon-
sors, scientific organizations, patient organiza-
tions, and other entities to be invited to partici-
pate in the meeting. 
‘‘(5) AGENCY
AND
STAKEHOLDER
ENGAGE-
MENT.—Throughout the process of planning an EL– 
SFDD meeting, the Foundation shall consult with— 
‘‘(A) appropriate staff of the Food and 
Drug Administration; 
‘‘(B) the Steering Committee established 
under this subsection; 
‘‘(C) industry representatives engaged in 
the development of products for rare diseases 
and conditions to be discussed at such EL– 
SFDD meeting; 
‘‘(D) patient representatives of rare dis-
eases and conditions under discussion in such 
EL–SFDD meeting; and 
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‘‘(E) other appropriate stakeholders. 
‘‘(6) POST-MEETING REPORTS.— 
‘‘(A) IN GENERAL.—Within 180 days after 
an EL–SFDD meeting, the Foundation, in con-
sultation with the stakeholders listed in para-
graph (5), shall make publicly available on the 
website of the Food and Drug Administration— 
‘‘(i) a transcript and recording of the 
meeting; and 
‘‘(ii) a summary analysis of the input 
received during the meeting that is rel-
evant to approval or licensing of drugs for 
the rare disease or condition involved. 
‘‘(B) CONTENTS.—Each publication under 
subparagraph (A) shall include a clear identi-
fication of— 
‘‘(i) areas of consensus; 
‘‘(ii) areas where additional clarifica-
tion or information is needed to reach con-
sensus; and 
‘‘(iii) next steps agreed upon with the 
Food and Drug Administration. 
‘‘(c) REPRESENTATIVES
OF FDA REVIEW DIVI-
SIONS.—The Secretary shall require appropriate rep-
resentatives of the review divisions of the Food and Drug 
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Administration to participate in each EL–SFDD meeting 
under this section. 
‘‘(d) RULES OF CONSTRUCTION.—Nothing in this 
section shall be construed— 
‘‘(1) to prevent other third-party organizations 
from organizing similarly structured EL–SFDD-like 
meetings to discuss challenges in rare disease drug 
development; 
‘‘(2) to require the Food and Drug Administra-
tion to participate in additional meetings described 
in paragraph (1); 
‘‘(3) to alter the protections offered by laws, 
regulations, or policies governing disclosure of con-
fidential commercial or trade secret information and 
any other information exempt from disclosure pursu-
ant to section 552(b) of title 5, United States Code; 
‘‘(4) to limit the ability of the Secretary to con-
sult with individuals and organizations; 
‘‘(5) to create a legal right for consultation on 
any matter or require the Secretary to meet with 
any particular expert or stakeholder; 
‘‘(6) to alter agreed-upon goals and procedures 
identified in the letters described in section 1001(b) 
of the FDA User Fee Reauthorization Act of 2022; 
or 
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‘‘(7) to increase the number of review cycles for 
drugs. 
‘‘(e) DEFINITIONS.—In this section: 
‘‘(1) The term ‘EL–SFDD meeting’ means an 
externally led, science-focused drug development 
meeting. 
‘‘(2) The terms ‘rare diseases and conditions’ 
and ‘rare disease or condition’ refer to a rare disease 
or condition as that term is defined in section 526. 
‘‘(3) The term ‘Steering Committee’ means the 
Science-Focused Drug Development Multistake-
holder Steering Committee established under sub-
section (b)(3). 
‘‘(f) AUTHORIZATION OF APPROPRIATIONS.— 
‘‘(1) IN GENERAL.—To carry out this section, 
there is authorized to be appropriated $1,000,000 
for each of fiscal years 2025 through 2029. 
‘‘(2) RULE
OF
CONSTRUCTION.—Nothing in 
this section shall be construed to prohibit the Foun-
dation from soliciting or accepting funds pursuant to 
section 770(i) for the purposes of planning or oper-
ating an EL–SFDD meeting authorized by this sec-
tion. 
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‘‘SEC. 770B. REQUIRED ACTIONS FOLLOWING EL–SFDD 
MEETINGS. 
‘‘(a) INCORPORATION OF INPUT INTO RISK-BENEFIT 
ASSESSMENTS.—In approving or licensing a drug under 
subsection (c) or (j) of section 505 of this Act or sub-
section (a) or (k) of section 351 of the Public Health Serv-
ice Act, the Secretary shall make public a brief state-
ment— 
‘‘(1) stating whether any EL–SFDD meeting 
under section 770A was held that was relevant to 
such approval or licensure; and 
‘‘(2) if so, including a description of how the 
Secretary incorporated input from such meeting in 
the risk-benefit assessment described in section 
505(d). 
‘‘(b) ANNUAL REPORT.—On an annual basis, the 
Secretary shall submit a report to the Congress summa-
rizing— 
‘‘(1) the number and topics of EL–SFDD 
meetings held during the reporting period; 
‘‘(2) the extent of participation in such meet-
ings from the review divisions of the Food and Drug 
Administration; 
‘‘(3) the impact of EL–SFDD meetings on the 
workload and resources of the Food and Drug Ad-
ministration; and 
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