119th Congress · introduced in the House · Feb 24, 2025
Scientific EXPERT Act of 2025
Official title from Congress.gov
Latest action (Feb 24, 2025): Referred to the House Committee on Energy and Commerce.
View on Congress.govPolicy area: Health
Congressional Research Service summary, version: Introduced in House (Feb 24, 2025)
Scientific External Process for Educated Review of Therapeutics Act of 2025 or the Scientific EXPERT Act of 2025
This bill requires the Food and Drug Administration (FDA) to facilitate and participate in externally led, science-focused drug development meetings to discuss the development of treatments for rare diseases and conditions.
The FDA must enter into an arrangement with the Reagan-Udall Foundation for the FDA under which the foundation agrees to convene such meetings. Meetings must be held at least four times a year, and each meeting must focus on a different rare disease or condition.
The foundation must establish a permanent steering committee to review and recommend topics for each meeting. In evaluating potential topics, the committee must consider unmet therapeutic needs, patient population sizes for different diseases and conditions, and whether a disease or condition would benefit from clarity and alignment on drug development questions, among other factors.
In planning each meeting, the foundation must develop a list of medical experts, drug sponsors, scientific organizations, patient organizations, and other entities to be invited to participate. Representatives of the FDA’s review divisions must attend each meeting.
After each meeting, the foundation must make available a summary of the meeting noting areas of consensus, areas where additional clarification or information is needed, and next steps agreed upon with the FDA.
The bill also requires the FDA to indicate whether it incorporated any input from these meetings when approving a new drug or biologic.
Show less of the summaryIncludes amendment, cloture, and procedural votes. Each is labeled with its exact question; only a passage question is a vote to pass the bill.
No recorded roll calls on this bill in coverage.
Referred to the House Committee on Energy and Commerce.
Introduced in House
Introduced in House
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LD-2 reports whose issue descriptions explicitly cite this bill (bill type and number validated against Congress.gov records). A citation does not establish the client's position or any contact with a member.
Loading lobbying reportsCoverage: reports for 2025 onward, posted Jan 1, 2025 through Oct 24, 2026.
20 citations.
PTC THERAPEUTICS, INC. · lobbying firm or registrant: PTC THERAPEUTICS, INC.
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Health Issues
$170,000
Spent on own lobbying
…Issues related to Public Law No. 119-21 - The One Big Beautiful Bill Act of 2025 Issues related to international reference pricing Issues related to S. 822 and H.R. 1532 - Scientific External Process for Educated Review of Therapeutics Act of 2025
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
BRIDGEBIO PHARMA, INC. · lobbying firm or registrant: BRIDGEBIO PHARMA, INC.
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Pharmacy
$510,000
Spent on own lobbying
Orphan drug policies General issues and provisions related to PBM Reform General issues and provisions related to tariffs H.R.1532 and S.822 - Scientific EXPERT Act Priority for Pediatric Cures Act (H.R.10359)
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
RARE FOUNDATION (FORMERLY KNOWN AS EVERYLIFE FOUNDATION FOR RARE DISEASES) · lobbying firm or registrant: RARE FOUNDATION (FORMERLY KNOWN AS EVERYLIFE FOUNDATION FOR RARE DISEASES)
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 16, 2026 · issue area: Health Issues
$60,000
Spent on own lobbying
S. 822, H.R. 1532 - Scientific EXPERT Act of 2025; H.R. 4709 - Newborn Screening Saves Lives Reauthorization Act of 2025; FY 2027 Appropriations; FDA user fee reauthorization; H…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
RARE DISEASE COMPANY COALITION · lobbying firm or registrant: RARE DISEASE COMPANY COALITION
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 15, 2026 · issue area: Pharmacy
$80,000
Spent on own lobbying
H.R. 10359 - Priority Review Voucher (PRV) permanence bill H.R. 1532/S. 822 - Scientific EXPERT Act 42 CFR Part 513 - Rare disease exemption from GLOBE mode/final rule 91 FR 18183 - Clarification of orphan exemption from 232 pha…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
STEALTH BIOTHERAPEUTICS INC. · lobbying firm or registrant: STEALTH BIOTHERAPEUTICS INC.
2026 Q2 report (Apr 1, 2026 – Jun 30, 2026) · posted Jul 20, 2026 · issue area: Health Issues
$120,000
Spent on own lobbying
…evelopment General discussions about regulatory reform, including scientific-focused drug development meetings General discussions about mitochondrial diseases H.R. 1532/S. 822, the Scientific EXPERT Act of 2025FDA Rare Disease Innovation Hub Fiscal Year 2026 Agriculture, Rural Development, Food and Drug Administration, and Rel…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
BRIDGEBIO PHARMA, INC. · lobbying firm or registrant: BRIDGEBIO PHARMA, INC.
2026 Q2 report (Apr 1, 2026 – Jun 30, 2026) · posted Jul 20, 2026 · issue area: Pharmacy
$500,000
Spent on own lobbying
Orphan drug policies General issues and provisions related to PBM Reform General issues and provisions related to tariffs H.R.1532 and S.822 - Scientific EXPERT Act
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
PTC THERAPEUTICS, INC. · lobbying firm or registrant: PTC THERAPEUTICS, INC.
2026 Q2 report (Apr 1, 2026 – Jun 30, 2026) · posted Jul 20, 2026 · issue area: Health Issues
$170,000
Spent on own lobbying
…Issues related to Public Law No. 119-21 - The One Big Beautiful Bill Act of 2025 Issues related to international reference pricing Issues related to S. 822 and H.R. 1532 - Scientific External Process for Educated Review of Therapeutics Act of 2025
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
RARE FOUNDATION (FORMERLY KNOWN AS EVERYLIFE FOUNDATION FOR RARE DISEASES) · lobbying firm or registrant: RARE FOUNDATION (FORMERLY KNOWN AS EVERYLIFE FOUNDATION FOR RARE DISEASES)
2026 Q2 report (Apr 1, 2026 – Jun 30, 2026) · posted Jul 17, 2026 · issue area: Health Issues
$40,000
Spent on own lobbying
S. 822, H.R. 1532 - Scientific EXPERT Act of 2025; H.R. 4709 - Newborn Screening Saves Lives Reauthorization Act of 2025; FY 2027 Appropriations; FDA user fee reauthorization; H…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
STEALTH BIOTHERAPEUTICS INC. · lobbying firm or registrant: STEALTH BIOTHERAPEUTICS INC.
2026 Q1 report (Jan 1, 2026 – Mar 31, 2026) · posted Apr 20, 2026 · issue area: Health Issues
$120,000
Spent on own lobbying
…evelopment General discussions about regulatory reform, including scientific-focused drug development meetings General discussions about mitochondrial diseases H.R. 1532/S. 822, the Scientific EXPERT Act of 2025FDA Rare Disease Innovation Hub Fiscal Year 2026 Agriculture, Rural Development, Food and Drug Administration, and Rel…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
RARE FOUNDATION (FORMERLY KNOWN AS EVERYLIFE FOUNDATION FOR RARE DISEASES) · lobbying firm or registrant: RARE FOUNDATION (FORMERLY KNOWN AS EVERYLIFE FOUNDATION FOR RARE DISEASES)
2026 Q1 report (Jan 1, 2026 – Mar 31, 2026) · posted Apr 20, 2026 · issue area: Health Issues
$70,000
Spent on own lobbying
S. 822, H.R. 1532 - Scientific EXPERT Act of 2025; S. 932, H.R. 1262 - Give Kids a Chance Act of 2025; S. 752, H.R. 1509 - Accelerating Kids Access to Care Act; H.R. 4709 - Newb…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
STEALTH BIOTHERAPEUTICS INC. · lobbying firm or registrant: STEALTH BIOTHERAPEUTICS INC.
2025 Q4 report (Oct 1, 2025 – Dec 31, 2025) · posted Jan 20, 2026 · issue area: Health Issues
$110,000
Spent on own lobbying
…evelopment General discussions about regulatory reform, including scientific-focused drug development meetings General discussions about mitochondrial diseases H.R. 1532/S. 822, the Scientific EXPERT Act of 2025FDA Rare Disease Innovation Hub Fiscal Year 2026 Agriculture, Rural Development, Food and Drug Administration, and Rel…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
RARE FOUNDATION (FORMERLY KNOWN AS EVERYLIFE FOUNDATION FOR RARE DISEASES) · lobbying firm or registrant: RARE FOUNDATION (FORMERLY KNOWN AS EVERYLIFE FOUNDATION FOR RARE DISEASES)
2025 Q4 report (Oct 1, 2025 – Dec 31, 2025) · posted Jan 15, 2026 · issue area: Health Issues
$20,000
Spent on own lobbying
S. 822, H.R. 1532 - Scientific EXPERT Act of 2025; S. 932, H.R. 1262 - Give Kids a Chance Act of 2025; S. 752, H.R. 1509 - Accelerating Kids Access to Care Act; H.R. 4709 - Newb…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
BRIDGEBIO PHARMA, INC. · lobbying firm or registrant: BRIDGEBIO PHARMA, INC.
2025 Q3 report (Jul 1, 2025 – Sep 30, 2025) · posted Oct 20, 2025 · issue area: Pharmacy
$270,000
Spent on own lobbying
…ful Bill Act PBM Reform Act - H.R. 4317 ORPHAN Cures Act - included in H.R. 1 - One Big Beautiful Bill Act Orphan drug policies Scientific EXPERT Act of 2025 - H.R. 1532; S. 822
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
RARE FOUNDATION (FORMERLY KNOWN AS EVERYLIFE FOUNDATION FOR RARE DISEASES) · lobbying firm or registrant: RARE FOUNDATION (FORMERLY KNOWN AS EVERYLIFE FOUNDATION FOR RARE DISEASES)
2025 Q3 report (Jul 1, 2025 – Sep 30, 2025) · posted Oct 16, 2025 · issue area: Health Issues
$60,000
Spent on own lobbying
S. 822, H.R. 1532 - Scientific EXPERT Act of 2025; S. 932, H.R. 1262 - Give Kids a Chance Act of 2025; S. 752, H.R. 1509 - Accelerating Kids Access to Care Act; H.R. 1 - One Big…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
BRIDGEBIO PHARMA, INC. · lobbying firm or registrant: BRIDGEBIO PHARMA, INC.
2025 Q2 report (Apr 1, 2025 – Jun 30, 2025) · posted Jul 17, 2025 · issue area: Pharmacy
$320,000
Spent on own lobbying
…in H.R. 1 - One Big Beautiful Bill Act ORPHAN Cures Act - included in H.R. 1 - One Big Beautiful Bill Act Orphan drug policies Scientific EXPERT Act of 2025 - H.R. 1532; S. 822
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
INOZYME PHARMA · lobbying firm or registrant: THE KPM GROUP DC LLC
2025 Q2 report (Apr 1, 2025 – Jun 30, 2025) · posted Jul 17, 2025 · issue area: Pharmacy
$20,000
Paid to lobbying firm
H.R.1262/S.932 - Give Kids a Chance Act H.R.946 - ORPHAN Cures Act H.R. 1414 - Cameron's Law H.R.1532/S.822 - Scientific External Process for Educated Review of Therapeutics (EXPERT) Act H.R.1492 - Ensuring Pathways to Innovative Cures (EPIC) Act
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
RARE FOUNDATION (FORMERLY KNOWN AS EVERYLIFE FOUNDATION FOR RARE DISEASES) · lobbying firm or registrant: RARE FOUNDATION (FORMERLY KNOWN AS EVERYLIFE FOUNDATION FOR RARE DISEASES)
2025 Q2 report (Apr 1, 2025 – Jun 30, 2025) · posted Jul 17, 2025 · issue area: Health Issues
$40,000
Spent on own lobbying
S. 822, H.R. 1532 - Scientific EXPERT Act of 2025; S. 932, H.R. 1262 - Give Kids a Chance Act of 2025; S. 752, H.R. 1509 - Accelerating Kids Access to Care Act; H.R. 1 - One Big…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
RARE DISEASE COMPANY COALITION · lobbying firm or registrant: RARE DISEASE COMPANY COALITION
2025 Q1 report (Jan 1, 2025 – Mar 31, 2025) · amended · posted Apr 21, 2025 · issue area: Science/Technology
$60,000
Spent on own lobbying
HR 1532 - Scientific EXPERT Act of 2025 S 822 - Scientific EXPERT Act of 2025
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
RARE FOUNDATION (FORMERLY KNOWN AS EVERYLIFE FOUNDATION FOR RARE DISEASES) · lobbying firm or registrant: RARE FOUNDATION (FORMERLY KNOWN AS EVERYLIFE FOUNDATION FOR RARE DISEASES)
2025 Q1 report (Jan 1, 2025 – Mar 31, 2025) · posted Apr 21, 2025 · issue area: Health Issues
$30,000
Spent on own lobbying
S. 822, H.R. 1532 - Scientific EXPERT Act of 2025; S. 932, H.R. 1262 - Give Kids a Chance Act of 2025; S. 752, H.R. 1509 - Accelerating Kids Access to Care Act
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
BRIDGEBIO PHARMA, INC. · lobbying firm or registrant: BRIDGEBIO PHARMA, INC.
2025 Q1 report (Jan 1, 2025 – Mar 31, 2025) · posted Apr 18, 2025 · issue area: Pharmacy
$320,000
Spent on own lobbying
Give Kids a Chance Act of 2025 - H.R. 1262; S. 932 Orphan drug policies Scientific EXPERT Act of 2024 - H.R.1532; S. 822 Cameron's Law - H.R. 1414 FY25 Full Year Continuing Appropriations and Extensions Act - H.R. 1968
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing