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Legislative Progress
Introduced
February 24, 2025
Latest Action
February 24, 2025
Primary Sponsor
Doris O. MatsuiDemocratic(CA)
Momentum (last 30 days)
6
score
0 actions · 3 new cosponsors · 0 votes
Speed vs cohort
0pct
0d open
vs 10,940 other HR bills in the 119th — cohort avg 30d
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.
These links require the bill number to appear in the filing's source-reported specific issue text. Client expenses and lobbying-firm income are separate disclosure fields.
Filing registrants (6)
2026 · third_quarter · Health Issues
Referred to the House Committee on Energy and Commerce.
Introduced in House
Congress.gov source codes: 1000, Intro-H
Bills with similar content found using semantic analysis.
Sources: Congress.gov
Issues related to access to rare disease therapies Issues related to FDA modernization and rare disease drug development Issues related to the Accelerated Approval Program Issues related to Public Law No. 117-169 -The Inflation Reduction Act of 2022 Issues related to rare disease diagnosis and testing Issues related to alternative funding programs Issues related to the Rare Pediatric Disease Priority Review Voucher program 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
Client expense: $170,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2026 · third_quarter · Pharmacy
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)
Client expense: $510,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2026 · third_quarter · Health Issues
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.R. 7118 - Genomic Answers for Children's Health Act; H.R. 5509, S. 2903 - Safe Step Act; H.R. 1414 - Cameron's Law; H.R. 10359 - Priority for Pediatric Cures Act
Client expense: $60,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2026 · third_quarter · Pharmacy
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 pharmaceutical tariffs H.R. 1414 - Orphan Drug Tax Credit
Client expense: $80,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2026 · second_quarter · Health Issues
H.R. 1262/S. 932 - Mikaela Naylon Give Kids a Chance Act General discussions about ultra-rare diseases General discussions about ultra-rare disease drug development 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 Related Agencies Appropriations Act (H.R. 4121 / S. 2256) H.R.6280/S.3607 - Access to Genetic Counselor Services Act of 2025/Access to Genetic Counselor Services Act of 2026 H.R.4709 - Newborn Screening Saves Lives Reauthorization Act of 2025 General discussions about genetic testing, diagnostics General discussions about accelerated approval pathway (AAP)
Client expense: $120,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2026 · second_quarter · Pharmacy
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
Client expense: $500,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2026 · second_quarter · Health Issues
Issues related to access to rare disease therapies Issues related to FDA modernization and rare disease drug development Issues related to the Accelerated Approval Program Issues related to Public Law No. 117-169 -The Inflation Reduction Act of 2022 Issues related to rare disease diagnosis and testing Issues related to alternative funding programs Issues related to the Rare Pediatric Disease Priority Review Voucher program 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
Client expense: $170,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2026 · second_quarter · Health Issues
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.R. 7118 - Genomic Answers for Children's Health Act; H.R. 5509, S. 2903 - Safe Step Act; H.R. 1414 - Cameron's Law
Client expense: $40,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2026 · first_quarter · Health Issues
H.R. 1262/S. 932 - Mikaela Naylon Give Kids a Chance Act General discussions about ultra-rare diseases General discussions about ultra-rare disease drug development 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 Related Agencies Appropriations Act (H.R. 4121 / S. 2256) H.R.6280/S.3607 - Access to Genetic Counselor Services Act of 2025/Access to Genetic Counselor Services Act of 2026 H.R.4709 - Newborn Screening Saves Lives Reauthorization Act of 2025 General discussions about genetic testing, diagnostics General discussions about accelerated approval pathway (AAP)
Client expense: $120,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2026 · first_quarter · Health Issues
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 - Newborn Screening Saves Lives Reauthorization Act of 2025; FY 2027 Appropriations
Client expense: $70,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2025 · fourth_quarter · Health Issues
H.R. 1262/S. 932 - Mikaela Naylon Give Kids a Chance Act General discussions about ultra-rare diseases General discussions about ultra-rare disease drug development 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 Related Agencies Appropriations Act (H.R. 4121 / S. 2256)
Client expense: $110,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2025 · fourth_quarter · Health Issues
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 - Newborn Screening Saves Lives Reauthorization Act of 2025
Client expense: $20,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2025 · third_quarter · Pharmacy
Give Kids a Chance Act of 2025 - H.R. 1262; S 932 Camerons Law - H.R. 1414 Tax Provisions in H.R. 1 - One Big Beautiful Bill Act - R&D tax credit, bonus depreciation, interest deduction Provisions related to PBM Reform in H.R. 1 - One Big Beautiful 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
Client expense: $270,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2025 · third_quarter · Health Issues
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 Beautiful Bill Act; H.R. 4709 - Newborn Screening Saves Lives Reauthorization Act of 2025
Client expense: $60,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2025 · second_quarter · Pharmacy
Give Kids a Chance Act of 2025 - H.R. 1262; S 932 Camerons Law - H.R. 1414 Tax Provisions in H.R. 1 - One Big Beautiful Bill Act - R&D tax credit, bonus depreciation, interest deduction, Provisions related to PBM Reform 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
Client expense: $320,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2025 · second_quarter · Pharmacy
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
Client expense: Not reported · Firm income: $20,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2025 · second_quarter · Health Issues
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 Beautiful Bill Act
Client expense: $40,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2025 · second_quarter · Pharmacy
FDA modernization H.R.1262 - Give Kids a Chance Act Trump administration impact on staffing at HHS and FDA Newborn screening Inflation Reduction Act (IRA) H.R.946 - ORPHAN Cures Act H.R. 1414 - Cameron's Law H.R.1532 - Scientific External Process for Educated Review of Therapeutics (EXPERT) Act H.R.1492 - Ensuring Pathways to Innovative Cures (EPIC) Act
Client expense: Not reported · Firm income: Not reported
2025 · first_quarter · Science/Technology
HR 1532 - Scientific EXPERT Act of 2025 S 822 - Scientific EXPERT Act of 2025
Client expense: $60,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES
2025 · first_quarter · Health Issues
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
Client expense: $30,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
| Democratic |
| TX |
| Lloyd Smucker | Republican | PA |
| Maggie Goodlander | Democratic | NH |
| Paul Tonko | Democratic | NY |
| Salud O. Carbajal | Democratic | CA |
| Shri Thanedar | Democratic | MI |