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Speeding Therapy Access Today Act of 2021
Legislative Progress
Momentum (last 30 days)
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0 actions · 0 new cosponsors · 0 votes
Speed vs cohort
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vs 5,357 other S bills in the 117th — cohort avg 38d
Speeding Therapy Access Today Act of 2021 This bill requires and authorizes various actions to accelerate the development of therapies for rare diseases. The Food and Drug Administration (FDA) shall establish the Intercenter Institute on Rare Diseases and Conditions. The institute shall (1) coordinate engagement with relevant stakeholders, (2) build the FDA's expertise in the review of medical products to treat rare diseases, (3) coordinate regulatory science initiatives related to rare diseases, (4) establish and implement a program to make recommendations to address challenges associated with developing medical products to treat rare diseases in an individual or in very small populations, (5) convene a stakeholder meeting to consider potential amendments to labels for medical products to treat rare diseases, and (6) establish and carry out a program to facilitate voluntary communication between the sponsors of such medical products and third-party payers (e.g., insurance companies). The bill also authorizes the FDA to make grants to assist in developing practices related to the development and production of individualized therapies or therapies to treat very small populations. The bill also establishes an advisory committee to advise the FDA on issues related to the development of therapies to treat rare diseases.
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 (15)
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced in Senate
Bills with similar content found using semantic analysis.
Sources: Congress.gov
2023 · first_quarter · Medical/Disease Research/Clinical Labs
H.R.7506, legislation to revolutionize education, diagnoses, and treatment of rare kidney diseases; H.R.1730/S.670, Speeding Therapy Access Today Act; H.R.7667, the Food and Drug Amendments of 2022 - provisions concerning accelerated approval, orphan drugs; S.4348, Food and Drug Administration Safety and Landmark Advancements Act of 2022 - provisions concerning accelerated approval, orphan drugs; H.R.6963, Accelerated Approval Integrity Act, a bill to amend the Federal Food, Drug, and Cosmetic Act to strengthen requirements for post-approval studies for drugs approved using accelerated approval, and for other purposes; H.R.2617, the Consolidated Appropriations Act, 2023.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · fourth_quarter · Medical/Disease Research/Clinical Labs
H.R.7506, legislation to revolutionize education, diagnoses, and treatment of rare kidney diseases; H.R.1730/S.670, Speeding Therapy Access Today Act; H.R.7667, the Food and Drug Amendments of 2022 - provisions concerning accelerated approval, orphan drugs; S.4348, Food and Drug Administration Safety and Landmark Advancements Act of 2022 - provisions concerning accelerated approval, orphan drugs; H.R.6963, Accelerated Approval Integrity Act, a bill to amend the Federal Food, Drug, and Cosmetic Act to strengthen requirements for post-approval studies for drugs approved using accelerated approval, and for other purposes; H.R.2617, the Consolidated Appropriations Act, 2023.
Client expense: Not reported · Firm income: $60,000
2022 · fourth_quarter · Health Issues
H.R. 483/S. 350 - Newborn Screening Saves Lives Act; H.R. 1730/S. 670- Speeding Therapy Access Today Act H.R. 1946, S. 1873. Cancer Moonshot Items related to the Administrations Cancer Moonshot initiative; H.R. 5030/ S. 2706 DIVERSE Trials Act HR 5376, Inflation Reduction Act reconciliation bill; Medicare price negotiation provision and Part D redesign; Preventative healthcare services and screenings; Issues related to preventative services and screenings for underrepresented communities H.R. 6000 Cures 2.0 Act; H.R. 6584 Diverse and Equitable Participation in Clinical Trials Act; H.R. 6963 - Accelerated Approval Integrity Act; H.R. 6996 Accelerating Access for Patients Act; H.R.7667 - Food and Drug Amendments of 2022; S. 1548, H.R. 3085/H.R. 7845. ENACT Act of 2021 S.4348 - FDASLA Act of 2022; General issues related to rare disease and orphan drugs; Reauthorization of the FDA User Fee Act; FDA modernization policy issues; Reauthorization of newborn screening programs; general issues related to health equity in rare disease and clinical trials; general issues related to diagnostics for patients with rare diseases; general issues related to pharmacy benefit managers (PBMs); general issues related to insurance coverage of specialty treatments Issues related to clinical trial diversity COVID-19; COVID-19 vaccine and therapy development Climate, sustainability, and environment; Sustainability & Zero Carbon; Items related to environmental sustainability (including eliminating GHG emissions from pMDIs) and our Ambition Zero Carbon efforts. E-Labeling EVUSHELD Issues related to repeal of the Medicaid AMP Cap. Issues related to drug pricing, IRA Drug Regulation, Approval, Clinical Trial Diversity and FDA User Fees;
Client expense: $1,170,000 · Firm income: Not reported
2022 · fourth_quarter · Medical/Disease Research/Clinical Labs
H.R. 1730, S. 670, Speeding Therapy Access Today Act of 2021; H.R. 3893, Coordination, Accountability, Research, and Equity for All Kidneys Act of 2021. Congressional consideration of the Prescription Drug User Fee Act. H.R. 6963, Accelerated Approval Integrity Act, and H.R. 6996, Accelerated Access for Patient Act, and Senate proposals regarding expedited FDA pathways. H.R. 7506, the New Era of Preventing End-Stage Kidney Disease. H.R.2471, Consolidated Appropriations Act, 2022.
Client expense: $190,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · fourth_quarter · Health Issues
Issues related to the development of therapies for rare diseases and sleep disorders; drug pricing; access to non-controlled medications; PDUFA Reauthorization; H.R.6000, Cures 2.0 Act; FY2022 Budget Reconciliation/Inflation Reduction Act of 2022 (H.R.5376, P.L.117-169); H.R.5585, Advanced Research Project Agency-Health Act; H.R.6963, Accelerated Approval Integrity Act of 2022; H.R.2623, Camerons Law; H.R.7667, Food and Drug Amendments of 2022; S.4348, FDASLA Act of 2022; H.R.6833, Making continuing appropriations for fiscal year 2023, and for other purposes (P.L.117-180); H.R.8641, Orphan Drug COVID-19 Mitigation Act of 2022; H.R. 1730/S. 670, The Speeding Therapy Access Today (STAT) Act of 2021.
Client expense: $250,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
Issues related to the development of therapies for rare diseases and sleep disorders. Drug pricing. Access to non-controlled medications. PDUFA Reauthorization. H.R.6000 - Cures 2.0 Act. FY2022 Budget Reconciliation/Inflation Reduction Act of 2022 (H.R.5376, P.L.117-169). H.R.5585 - Advanced Research Project Agency-Health (ARPA-H) Act. H.R.6963 - Accelerated Approval Integrity Act of 2022. H.R.2623 - Camerons Law. H.R.7667 - Food and Drug Amendments of 2022. S.4348 - FDASLA Act of 2022. H.R.6833 - Making continuing appropriations for fiscal year 2023, and for other purposes (P.L.117-180). H.R.8641 - Orphan Drug COVID-19 Mitigation Act of 2022. H.R.1730/S.670 - Speeding Therapy Access Today (STAT) Act of 2021. Issues related to raising awareness of World Narcolepsy Day.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Taxation/Internal Revenue Code
Issues related to the development of therapies for rare diseases and sleep disorders. Drug pricing. Access to non-controlled medications. PDUFA Reauthorization. H.R.6000 - Cures 2.0 Act. FY2022 Budget Reconciliation/Inflation Reduction Act of 2022 (H.R.5376, P.L.117-169). H.R.5585 - Advanced Research Project Agency-Health (ARPA-H) Act. H.R.6963 - Accelerated Approval Integrity Act of 2022. H.R.2623 - Camerons Law. H.R.7667 - Food and Drug Amendments of 2022. S.4348 - FDASLA Act of 2022. H.R.6833 - Making continuing appropriations for fiscal year 2023, and for other purposes (P.L.117-180). H.R.8641 - Orphan Drug COVID-19 Mitigation Act of 2022. H.R.1730/S.670 - Speeding Therapy Access Today (STAT) Act of 2021.
Client expense: Not reported · Firm income: $50,000
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
H.R. 1730, S. 670 the Speeding Therapy Access Today (STAT) Act and related rare disease policy issues and inclusion of policies in year-end omnibus.
Client expense: Not reported · Firm income: $20,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
Issues related to the development of therapies for rare diseases and sleep disorders; drug pricing; access to non-controlled medications; PDUFA Reauthorization; H.R.6000, Cures 2.0 Act; FY2022 Budget Reconciliation/Inflation Reduction Act of 2022 (H.R.5376, P.L.117-169); H.R.5585, Advanced Research Project Agency-Health Act; H.R.6963, Accelerated Approval Integrity Act of 2022; H.R.2623, Camerons Law; H.R.7667, Food and Drug Amendments of 2022; S.4348, FDASLA Act of 2022; H.R.6833, Making continuing appropriations for fiscal year 2023, and for other purposes (P.L.117-180); H.R.8641, Orphan Drug COVID-19 Mitigation Act of 2022; H.R. 1730/S. 670, The Speeding Therapy Access Today (STAT) Act of 2021.
Client expense: $250,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
Issues related to the development of therapies for rare diseases and sleep disorders; drug pricing; access to non-controlled medications; PDUFA Reauthorization; H.R.6000, Cures 2.0 Act; H.R.5585, Advanced Research Project Agency-Health Act; H.R.6963, Accelerated Approval Integrity Act of 2022; H.R.2623, Camerons Law; H.R.7667, Food and Drug Amendments of 2022; S.4348, FDASLA Act of 2022; H.R.8641, Orphan Drug COVID-19 Mitigation Act of 2022; H.R.1730/S.670, The Speeding Therapy Access Today (STAT) Act of 2021; H.R.2617, Consolidated Appropriations Act, 2023.
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
Issues related to the development of therapies for rare diseases and sleep disorders; drug pricing; access to non-controlled medications; PDUFA Reauthorization; H.R.6000, Cures 2.0 Act; H.R.5585, Advanced Research Project Agency-Health Act; H.R.6963, Accelerated Approval Integrity Act of 2022; H.R.2623, Camerons Law; H.R.7667, Food and Drug Amendments of 2022; S.4348, FDASLA Act of 2022; H.R.6833, Making continuing appropriations for fiscal year 2023, and for other purposes (P.L.117-180); H.R.8641, Orphan Drug COVID-19 Mitigation Act of 2022; H.R. 1730/S. 670, The Speeding Therapy Access Today (STAT) Act of 2021;
Client expense: Not reported · Firm income: $20,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
H.R. 1730, S. 670 - STAT Act; H.R. 482, S. 350 - Newborn Screening Save Lives Reauthorization Act; Cures 2.0; PDUFA; ARPA-H; Telehealth; Covid-relief; Appropriations; S. 373, H.R. 4472 - Better Empowerment Now to Enhance Framework to Improve Treatments (BENEFIT) Act; H.R. 2144, S. 1450 - Access to Genetic Counselor Services Act; H.R. 5989 - Precision Medicine Answers for Kids Today Act (PMAKTA); VALID Act.
Client expense: $20,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · third_quarter · Health Issues
H.R. 1730/S. 670- Speeding Therapy Access Today Act; H.R. 483/S. 350 - Newborn Screening Saves Lives Act; H.R. 6000 Cures 2.0 Act; H.R. 6584 Diverse and Equitable Participation in Clinical Trials Act; S. 2706/H.R. 5030 Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act; H.R. 6963 - Accelerated Approval Integrity Act; H.R. 6996 - Accelerating Access for Patients Act - General issues related to rare disease and orphan drugs; General issues related to drug pricing; Reauthorization of the FDA User Fee Act; FDA modernization policy issues; Reauthorization of newborn screening programs; Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients; General issues related to health equity in rare disease and clinical trials; General issues related to diagnostics for patients with rare diseases Cancer screening, diagnosis & treatment Prescription drug electronic labeling H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 - Lower Costs, More Cures Act; H.R. 5260 - Reduced Costs and Continued Cures Act; H.R. 5376 - Build Back Better Act; H.R. 7667 - Food and Drug Amendments of 2022; S.4348 - FDASLA Act of 2022 H.R. 7845 - NIH Clinical Trial Diversity Act of 2022; H.R 7032 - Increasing Transparency in Generic Drug Applications Act of 2022; H.R. 2883, Stop Stalling Access to Affordable Medications Issues related to COVID-19 vaccines and therapies; Items related to the Administrations Cancer Moonshot Prescription Drug User Fee Act (PDUFA) H.R. 4128/S. 2209, VALID Act S. 4293, the Pharmacy Benefit Manager Transparency Act of 2022 Pharmaceutical Innovation, generally;
Client expense: $930,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Science & Technology Policy (OSTP), SENATE, White House Office
2022 · third_quarter · Health Issues
Issues related to the development of therapies for rare diseases and sleep disorders. Drug pricing. Access to non-controlled medications. PDUFA Reauthorization. H.R.6000 - Cures 2.0 Act. FY2022 Budget Reconciliation/Inflation Reduction Act of 2022 (H.R.5376, P.L.117-169). H.R.5585 - Advanced Research Project Agency-Health (ARPA-H) Act. H.R.6963 - Accelerated Approval Integrity Act of 2022. H.R.2623 - Camerons Law. H.R.7667 - Food and Drug Amendments of 2022. S.4348 - FDASLA Act of 2022. H.R.6833 - Making continuing appropriations for fiscal year 2023, and for other purposes (P.L.117-180). H.R.8641 - Orphan Drug COVID-19 Mitigation Act of 2022. H.R.1730/S.670 - Speeding Therapy Access Today (STAT) Act of 2021. Issues relatred to raising awareness of World Narcolepsy Day.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · third_quarter · Taxation/Internal Revenue Code
Issues related to the development of therapies for rare diseases and sleep disorders. Drug pricing. Access to non-controlled medications. PDUFA Reauthorization. H.R.6000 - Cures 2.0 Act. FY2022 Budget Reconciliation/Inflation Reduction Act of 2022 (H.R.5376, P.L.117-169). H.R.5585 - Advanced Research Project Agency-Health (ARPA-H) Act. H.R.6963 - Accelerated Approval Integrity Act of 2022. H.R.2623 - Camerons Law. H.R.7667 - Food and Drug Amendments of 2022. S.4348 - FDASLA Act of 2022. H.R.6833 - Making continuing appropriations for fiscal year 2023, and for other purposes (P.L.117-180). H.R.8641 - Orphan Drug COVID-19 Mitigation Act of 2022. H.R.1730/S.670 - Speeding Therapy Access Today (STAT) Act of 2021.
Client expense: Not reported · Firm income: $50,000
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
2022 · third_quarter · Health Issues
Issues related to the development of therapies for rare diseases and sleep disorders; drug pricing; access to non-controlled medications; PDUFA Reauthorization; H.R.6000, Cures 2.0 Act; H.R.5585, Advanced Research Project Agency-Health Act; H.R.6963, Accelerated Approval Integrity Act of 2022; H.R.2623, Camerons Law; H.R.7667, Food and Drug Amendments of 2022; S.4348, FDASLA Act of 2022; H.R.6833, Making continuing appropriations for fiscal year 2023, and for other purposes (P.L.117-180); H.R.8641, Orphan Drug COVID-19 Mitigation Act of 2022; H.R. 1730/S. 670, The Speeding Therapy Access Today (STAT) Act of 2021;
Client expense: Not reported · Firm income: $20,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · third_quarter · Medical/Disease Research/Clinical Labs
H.R. 7506, legislation to revolutionize education, diagnoses, and treatment of rare kidney diseases; H.R. 1730/S.670, Speeding Therapy Access Today Act; H.R. 7667, the Food and Drug Amendments of 2022 - provisions concerning accelerated approval, orphan drugs; S. 4348, Food and Drug Administration Safety and Landmark Advancements Act of 2022 - provisions concerning accelerated approval, orphan drugs; H.R. 6963, Accelerated Approval Integrity Act, a bill to amend the Federal Food, Drug, and Cosmetic Act to strengthen requirements for post-approval studies for drugs approved using accelerated approval, and for other purposes.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · third_quarter · Health Issues
H.R. 1730/S. 670- Speeding Therapy Access Today Act; H.R. 483/S. 350 - Newborn Screening Saves Lives Act; H.R. 6000 Cures 2.0 Act; H.R. 6584 Diverse and Equitable Participation in Clinical Trials Act; S. 2706/H.R. 5030 Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act; H.R. 6963 - Accelerated Approval Integrity Act; H.R. 6996 - Accelerating Access for Patients Act - General issues related to rare disease and orphan drugs; General issues related to drug pricing; Reauthorization of the FDA User Fee Act; FDA modernization policy issues; Reauthorization of newborn screening programs; Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients; General issues related to health equity in rare disease and clinical trials; General issues related to diagnostics for patients with rare diseases Cancer screening, diagnosis & treatment Prescription drug electronic labeling H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 - Lower Costs, More Cures Act; H.R. 5260 - Reduced Costs and Continued Cures Act; H.R. 5376 - Build Back Better Act; H.R. 7667 - Food and Drug Amendments of 2022; S.4348 - FDASLA Act of 2022 H.R. 7845 - NIH Clinical Trial Diversity Act of 2022; H.R 7032 - Increasing Transparency in Generic Drug Applications Act of 2022; H.R. 2883, Stop Stalling Access to Affordable Medications Issues related to COVID-19 vaccines and therapies; Items related to the Administrations Cancer Moonshot Prescription Drug User Fee Act (PDUFA) H.R. 4128/S. 2209, VALID Act S. 4293, the Pharmacy Benefit Manager Transparency Act of 2022 Pharmaceutical Innovation, generally;
Client expense: $910,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Science & Technology Policy (OSTP), SENATE, White House Office
2022 · third_quarter · Medical/Disease Research/Clinical Labs
H.R. 1730, S. 670, Speeding Therapy Access Today Act of 2021; H.R. 3893, Coordination, Accountability, Research, and Equity for All Kidneys Act of 2021. Congressional consideration of the Prescription Drug User Fee Act. H.R. 6963, Accelerated Approval Integrity Act, and H.R. 6996, Accelerated Access for Patient Act, and Senate proposals regarding expedited FDA pathways. H.R. 7506, the New Era of Preventing End-Stage Kidney Disease.
Client expense: $120,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · third_quarter · Health Issues
Issues related to the development of therapies for rare diseases and sleep disorders; drug pricing; access to non-controlled medications; PDUFA Reauthorization; H.R.6000, Cures 2.0 Act; FY2022 Budget Reconciliation/Inflation Reduction Act of 2022 (H.R.5376, P.L.117-169); H.R.5585, Advanced Research Project Agency-Health Act; H.R.6963, Accelerated Approval Integrity Act of 2022; H.R.2623, Camerons Law; H.R.7667, Food and Drug Amendments of 2022; S.4348, FDASLA Act of 2022; H.R.6833, Making continuing appropriations for fiscal year 2023, and for other purposes (P.L.117-180); H.R.8641, Orphan Drug COVID-19 Mitigation Act of 2022; H.R.1730/S.670, The Speeding Therapy Access Today (STAT) Act of 2021.
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · third_quarter · Health Issues
Issues related to the development of therapies for rare diseases and sleep disorders; drug pricing; access to non-controlled medications; PDUFA Reauthorization; H.R.6000, Cures 2.0 Act; FY2022 Budget Reconciliation/Inflation Reduction Act of 2022 (H.R.5376, P.L.117-169); H.R.5585, Advanced Research Project Agency-Health Act; H.R.6963, Accelerated Approval Integrity Act of 2022; H.R.2623, Camerons Law; H.R.7667, Food and Drug Amendments of 2022; S.4348, FDASLA Act of 2022; H.R.6833, Making continuing appropriations for fiscal year 2023, and for other purposes (P.L.117-180); H.R.8641, Orphan Drug COVID-19 Mitigation Act of 2022; H.R. 1730/S. 670, The Speeding Therapy Access Today (STAT) Act of 2021.
Client expense: $250,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · third_quarter · Health Issues
H.R. 1730, S. 670 the Speeding Therapy Access Today (STAT) Act and related rare disease policy issues, FDA user fee reauthorization legislation (H.R. 7667 and S. 4348), Accelerated Approval pathway, VALID Act.
Client expense: Not reported · Firm income: $20,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · third_quarter · Health Issues
H.R. 1730, S. 670 - STAT Act; H.R. 482, S. 350 - Newborn Screening Save Lives Reauthorization Act; Cures 2.0; PDUFA; ARPA-H; Telehealth; Covid-relief; Appropriations; S. 373, H.R. 4472 - Better Empowerment Now to Enhance Framework to Improve Treatments (BENEFIT) Act; H.R. 2144, S. 1450 - Access to Genetic Counselor Services Act; H.R. 5989 - Precision Medicine Answers for Kids Today Act (PMAKTA); VALID Act.
Client expense: $20,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · second_quarter · Medical/Disease Research/Clinical Labs
H.R. 7506, legislation to revolutionize education, diagnoses, and treatment of rare kidney diseases; H.R. 1730/S.670, Speeding Therapy Access Today Act; H.R. 7667, the Food and Drug Amendments of 2022 - provisions concerning accelerated approval, orphan drugs; S. 4348, Food and Drug Administration Safety and Landmark Advancements Act of 2022 - provisions concerning accelerated approval, orphan drugs; H.R. 6963, Accelerated Approval Integrity Act, a bill to amend the Federal Food, Drug, and Cosmetic Act to strengthen requirements for post-approval studies for drugs approved using accelerated approval, and for other purposes.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · second_quarter · Health Issues
H.R.1730 - Speeding Therapy Access Today Act of 2021, S.670 - Speeding Therapy Access Today Act of 2021
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · second_quarter · Health Issues
H.R. 1730/S. 670- Speeding Therapy Access Today Act; H.R. 483/S. 350 - Newborn Screening Saves Lives Act; H.R. 6000 Cures 2.0 Act; H.R. 6584 Diverse and Equitable Participation in Clinical Trials Act; S. 2706/H.R. 5030 Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act; H.R. 6963 - Accelerated Approval Integrity Act; H.R. 6996 - Accelerating Access for Patients Act - General issues related to rare disease and orphan drugs; Reauthorization of the FDA User Fee Act; FDA modernization policy issues; Reauthorization of newborn screening programs; Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients; General issues related to health equity in rare disease and clinical trials; General issues related to diagnostics for patients with rare diseases Cancer screening, diagnosis & treatment Prescription drug electronic labeling H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 - Lower Costs, More Cures Act; H.R. 5260 - Reduced Costs and Continued Cures Act; H.R. 5376 - Build Back Better Act H.R. 3085/S. 1548 -ENACT Act of 2021 H.R. 5585 - Advanced Research Project Agency-Health Act H.R. 2883, Stop Stalling Access to Affordable Medications Issues related to COVID-19 vaccines and therapies; Items related to the Administrations Cancer Moonshot Prescription Drug User Fee Act (PDUFA) H.R. 4128/S. 2209, VALID Act S. 4293, the Pharmacy Benefit Manager Transparency Act of 2022 Pharmaceutical Innovation, generally;
Client expense: $1,270,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Science & Technology Policy (OSTP), SENATE, White House Office
2022 · second_quarter · Pharmacy
S. 4348, the FDASLA Act of 2022 H.R. 7667, the Food and Drug Amendments of 2022 S. 4071, the Helping Experts Accelerate Rare Treatments (HEART) Act H.R. 1184, the Helping Experts Accelerate Rare Treatments (HEART) Act S. 670/H.R. 1730, the Speeding Therapy Access Today (STAT) Act H.R. 6000, the Cures 2.0 Act S. 373/H.R. 4472, the Better Empowerment Now to Enhance Framework and Improve Treatments (BENEFIT) Act
Client expense: Not reported · Firm income: $20,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · second_quarter · Health Issues
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 1730, S. 670, The STAT Act - The Speeding Therapy Access Today Act of 2021 - provisions related to establishment of a Rare Disease Center of Excellence within FDA; H.R. 19, Lower Costs, More Cures Act of 2021 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 5376, Build Back Better Act (reconciliation package) - provisions related to prescription drug prices; H.R. 7667, Food and Drug Amendments of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); S. 4348, FDASLA Act of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for post approval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; S. 3700, Affordable Insulin Now Act; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; S. 2164, Lower Costs, More Cures Act of 2021; H.R. 6833, Affordable Insulin Now Act; S. 2199, Insulin Price Reduction Act;
Client expense: $1,210,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2022 · second_quarter · Medical/Disease Research/Clinical Labs
H.R. 1730, S. 670, Speeding Therapy Access Today Act of 2021; H.R. 3893, Coordination, Accountability, Research, and Equity for All Kidneys Act of 2021. Congressional consideration of the Prescription Drug User Fee Act. H.R. 6963, Accelerated Approval Integrity Act, and H.R. 6996, Accelerated Access for Patient Act, and Senate proposals regarding expedited FDA pathways. H.R. 7506, the New Era of Preventing End-Stage Kidney Disease
Client expense: $290,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · second_quarter · Health Issues
H.R. 1730, S. 670 the Speeding Therapy Access Today (STAT) Act and related rare disease policy issues, FDA user fee reauthorization legislation (H.R. 7667 and S. 4348), Accelerated Approval pathway, VALID Act.
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · second_quarter · Health Issues
H.R. 1730, S. 670 - STAT Act; H.R. 482, S. 350 - Newborn Screening Save Lives Reauthorization Act; Cures 2.0; PDUFA; ARPA-H; Telehealth; Covid-relief; Appropriations; S. 373, H.R. 4472 - Better Empowerment Now to Enhance Framework to Improve Treatments (BENEFIT) Act; H.R. 2144, S. 1450 - Access to Genetic Counselor Services Act; H.R. 5989 - Precision Medicine Answers for Kids Today Act (PMAKTA); VALID Act.
Client expense: $20,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · first_quarter · Health Issues
H.R. 349: Coronavirus Vaccine and Therapeutic Development Act of 2021 - Provisions related to manufacturing of COVID-19 treatments and vaccines H.R. 550: Immunization Infrastructure Modernization Act (IIS harmonization) H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2815: BIOSIM Act - Provisions related to biosimilars and prescription drug pricing H.R. 2831: Prompt Approval of Safe Generic Drugs Act- Provisions related to FDA policy and approvals H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 2883: Stop Stalling Access to Affordable Medications - Provisions related to citizen petitions H.R. 3656/S. 3087: Vaccine Access Improvement Act (VICP program changes) H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4127: DISARM Act Provisions related to antimicrobial drug development H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act H.R. 5030: DIVERSE Trials Act - Provisions related to clinical trial diversity H.R. 5416: Give Kids a Chance Act H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6228: Capping Prescription Costs Act of 2021 - Provisions related to prescription drug pricing and cost-sharing H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6888: Helping Experts Accelerate Rare Treatments Act of 2022 H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 6988: Drug Manufacturing Innovation Act of 2022 H.R. 6996: Accelerating Access for Patients Act of 2022 H.R. 7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act H.R. 7008: Pre-Approval Information Exchange Act of 2022 H.R. 7032: Increasing Transparency in Generic Drug Applications Act of 2022 H.R. 7035: Biologics Market Transparency Act of 2022 H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 670: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes. - Provisions related to 340B drug discount program S. 912/H.R. 1978: Protecting Seniors Through Immunization Act S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1463: Modernizing Therapeutic Equivalence Rating Determination Act S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2428: False Claims Amendments Act of 2021 - Provisions related to False Claims Act S. 2429: Administrative False Claims Act of 2021 - Provisions related to False Claims Act S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3291: STAAR Act - Provisions related to health research and antibiotic resistance S. 3449: Registration of Certain Foreign Establishments Act S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act Cancer Moonshot Initiative 21st Century Cures 2.0 RFI for Advanced Research Projects Agency - Health (ARPA-H) Department of Homeland Security cybersecurity policy issues Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Orphan Drug Act (ODA) policy issues Health Advanced Research Projects Agency (HARPA) proposal Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues FDA modernization policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Regulatory efficiencies policy issues COVID-19 policy issues/Emergency supplemental funding Pandemic preparedness policy issues Defense Production Act (DPA) policy issues Final Rule; Importation of Prescription Drugs Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Nomination of Robert Califf to FDA Commissioner HSA/FSA for Dietary Supplements Dietary Supplement Health and Education Act Reform
Client expense: $1,100,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
2022 · first_quarter · Health Issues
H.R. 1730/S. 670- Speeding Therapy Access Today Act; H.R. 483/S. 350 - Newborn Screening Saves Lives Act; H.R. 6000 Cures 2.0 Act; H.R. 6584 Diverse and Equitable Participation in Clinical Trials Act; S. 2706/H.R. 5030 Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act; H.R. 6963 - Accelerated Approval Integrity Act; H.R. 6996 - Accelerating Access for Patients Act - General issues related to rare disease and orphan drugs; Reauthorization of the FDA User Fee Act; FDA modernization policy issues; Reauthorization of newborn screening programs; Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients; General issues related to health equity in rare disease and clinical trials; General issues related to diagnostics for patients with rare diseases Cancer screening, diagnosis & treatment Prescription drug electronic labeling H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 - Lower Costs, More Cures Act; H.R. 5260 - Reduced Costs and Continued Cures Act; H.R. 5376 - Build Back Better Act H.R. 3085/S. 1548 -ENACT Act of 2021 H.R. 5585 - Advanced Research Project Agency-Health Act H.R. 2883, Stop Stalling Access to Affordable Medications Issues related to COVID-19 vaccines and therapies; Items related to the Administrations Cancer Moonshot S. 3799, the PREVENT Pandemics Act S. 3509 Creating Efficiency in Foreign Facility Inspections Act Prescription Drug User Fee Act (PDUFA)
Client expense: $1,480,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Science & Technology Policy (OSTP), SENATE, White House Office
2022 · first_quarter · Health Issues
H.R. 349: Coronavirus Vaccine and Therapeutic Development Act of 2021 - Provisions related to manufacturing of COVID-19 treatments and vaccines H.R. 550: Immunization Infrastructure Modernization Act (IIS harmonization) H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2815: BIOSIM Act - Provisions related to biosimilars and prescription drug pricing H.R. 2831: Prompt Approval of Safe Generic Drugs Act- Provisions related to FDA policy and approvals H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 2883: Stop Stalling Access to Affordable Medications - Provisions related to citizen petitions H.R. 3656/S. 3087: Vaccine Access Improvement Act (VICP program changes) H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4127: DISARM Act Provisions related to antimicrobial drug development H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act H.R. 5030: DIVERSE Trials Act - Provisions related to clinical trial diversity H.R. 5416: Give Kids a Chance Act H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6228: Capping Prescription Costs Act of 2021 - Provisions related to prescription drug pricing and cost-sharing H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6888: Helping Experts Accelerate Rare Treatments Act of 2022 H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 6988: Drug Manufacturing Innovation Act of 2022 H.R. 6996: Accelerating Access for Patients Act of 2022 H.R. 7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act H.R. 7008: Pre-Approval Information Exchange Act of 2022 H.R. 7032: Increasing Transparency in Generic Drug Applications Act of 2022 H.R. 7035: Biologics Market Transparency Act of 2022 H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 670: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes. - Provisions related to 340B drug discount program S. 912/H.R. 1978: Protecting Seniors Through Immunization Act S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1463: Modernizing Therapeutic Equivalence Rating Determination Act S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2428: False Claims Amendments Act of 2021 - Provisions related to False Claims Act S. 2429: Administrative False Claims Act of 2021 - Provisions related to False Claims Act S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3291: STAAR Act - Provisions related to health research and antibiotic resistance S. 3449: Registration of Certain Foreign Establishments Act S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act Cancer Moonshot Initiative 21st Century Cures 2.0 RFI for Advanced Research Projects Agency - Health (ARPA-H) Department of Homeland Security cybersecurity policy issues Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Orphan Drug Act (ODA) policy issues Health Advanced Research Projects Agency (HARPA) proposal Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues FDA modernization policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Regulatory efficiencies policy issues COVID-19 policy issues/Emergency supplemental funding Pandemic preparedness policy issues Defense Production Act (DPA) policy issues Final Rule; Importation of Prescription Drugs Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Nomination of Robert Califf to FDA Commissioner HSA/FSA for Dietary Supplements Dietary Supplement Health and Education Act Reform
Client expense: $830,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
2022 · first_quarter · Medical/Disease Research/Clinical Labs
H.R. 7506, legislation to revolutionize education, diagnoses, and treatment of rare kidney diseases; H.R. 1730/S.670, Speeding Therapy Access Today Act.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · first_quarter · Health Issues
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; 42 USC 1320a-7b, Anti-Kickback Statute; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 1730, S. 670, The STAT Act - The Speeding Therapy Access Today Act of 2021 - provisions related to establishment of a Rare Disease Center of Excellence within FDA; H.R. 5376, Build Back Better Act (reconciliation package) - provisions related to prescription drug prices; H.R. 5260, Reduced Costs and Continued Cares Act - provisions related to prescription drug prices; P.L. 117-58 (H.R.3684), Infrastructure Investment and Jobs Act - provisions related to vial size; Proposals related to the reauthorization of the Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA) (no bills introduced); H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for postapproval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; S. 3339, Capping Prescription Costs Act of 2021; S. 3700, Affordable Insulin Now Act; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives;
Client expense: $1,300,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · first_quarter · Health Issues
H.R. 5: Equality Act H.R. 349: Coronavirus Vaccine and Therapeutic Development Act of 2021 - Provisions related to manufacturing of COVID-19 treatments and vaccines H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2815: BIOSIM Act - Provisions related to biosimilars and prescription drug pricing H.R. 2831: Prompt Approval of Safe Generic Drugs Act- Provisions related to FDA policy and approvals H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 2883: Stop Stalling Access to Affordable Medications - Provisions related to citizen petitions H.R. 3085: ENACT Act of 2021- Sets out activities and requirements to increase the participation of underrepresented populations in research and clinical trials for Alzheimers disease and related dementias H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act H.R. 5030: DIVERSE Trials Act - Provisions related to clinical trial diversity H.R. 5416: Give Kids a Chance Act H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6228: Capping Prescription Costs Act of 2021 - Provisions related to prescription drug pricing and cost-sharing H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6888: Helping Experts Accelerate Rare Treatments Act of 2022 H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 6988: Drug Manufacturing Innovation Act of 2022 H.R. 6996: Accelerating Access for Patients Act of 2022 H.R. 7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act H.R. 7008: Pre-Approval Information Exchange Act of 2022 H.R. 7032: Increasing Transparency in Generic Drug Applications Act of 2022 H.R. 7035: Biologics Market Transparency Act of 2022 H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 670: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes. - Provisions related to 340B drug discount program S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1463: Modernizing Therapeutic Equivalence Rating Determination Act S. 1548: ENACT Act of 2021 - To amend the Public Health Service Act to improve the diversity of participants in research on Alzheimers disease, and for other purposes S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2428: False Claims Amendments Act of 2021 - Provisions related to False Claims Act S. 2429: Administrative False Claims Act of 2021 - Provisions related to False Claims Act S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3291: STAAR Act - Provisions related to health research and antibiotic resistance S. 3449: Registration of Certain Foreign Establishments Act S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act Cancer Moonshot Initiative 21st Century Cures 2.0 RFI for Advanced Research Projects Agency - Health (ARPA-H) Department of Homeland Security cybersecurity policy issues Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Orphan Drug Act (ODA) policy issues Health Advanced Research Projects Agency (HARPA) proposal Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues FDA modernization policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Regulatory efficiencies policy issues COVID-19 policy issues Pandemic preparedness policy issues Defense Production Act (DPA) policy issues Nomination of Robert Califf to FDA Commissioner Final Rule; Importation of Prescription Drugs Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients
Client expense: $8,070,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Science & Technology Policy (OSTP), SENATE, State, Dept of (DOS)
2022 · first_quarter · Health Issues
H.R. 1730, S. 670 - STAT Act; H.R. 482, S. 350 - Newborn Screening Save Lives Reauthorization Act; Cures 2.0; PDUFA; ARPA-H; Telehealth; Covid-relief; Appropriations; S. 373, H.R. 4472 - Better Empowerment Now to Enhance Framework to Improve Treatments (BENEFIT) Act; H.R. 2144, S. 1450 - Access to Genetic Counselor Services Act; H.R. 5989 - Precision Medicine Answers for Kids Today Act (PMAKTA).
Client expense: $20,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · first_quarter · Medical/Disease Research/Clinical Labs
H.R. 1730, S. 670, Speeding Therapy Access Today Act of 2021; legislation regarding diagnosis and treatment of rare kidney diseases and related nephrology issues. H.R. 3893, Coordination, Accountability, Research, and Equity for All Kidneys Act of 2021. Congressional consideration of the Prescription Drug User Fee Act. H.R. 6963, Accelerated Approval Integrity Act, and H.R. 6996, Accelerated Access for Patient Act, and Senate proposals regarding expedited FDA pathways.
Client expense: $210,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · first_quarter · Health Issues
H.R. 1730, S. 670 - the Speeding Therapy Access Today (STAT) Act; Related rare disease policies; Reauthorization of the Prescription Drug User Fee Act; including Accelerated Approval pathway.
Client expense: Not reported · Firm income: $20,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2021 · fourth_quarter · Health Issues
H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act. H.R. 19 / S. 2164, the Lower Costs, More Cures Act. H.R. 3749, To amend title XXVII of the Public Health Services Act to expand the availability of coverage for lung cancer screenings without the imposition of cost sharing. Issues related to Cures 2.0. Issues related to drug pricing. COVID-19 vaccine and therapy development. Issues related to health equity and clinical trials H.R. 5376 Build Back Better Act Issues related to drug regulation & approval pathways S.2911, Seniors Prescription Drug Relief Act Issues related to value-based arrangements Oncology Care Model / Oncology Care First H.R. 1730/S. 670- Speeding Therapy Access Today Act; H.R. 483/S. 350 - Newborn Screening Saves Lives Act Diverse and Equitable Participation in Clinical Trials Act Discussion Draft General issues related to orphan disease drugs; FDA modernization policy issues; Reauthorization of newborn screening programs; Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients; General issues related to diagnostics for patients with rare diseases Cancer screening, diagnostics and treatment H.R 5260 Reduced Costs and Continued Cares Act Cancer screening, diagnostics and treatment Prescription drug electronic labeling
Client expense: $1,370,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Science & Technology Policy (OSTP), SENATE, White House Office
2021 · fourth_quarter · Health Issues
H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act. H.R. 19 / S. 2164, the Lower Costs, More Cures Act. H.R. 3749, To amend title XXVII of the Public Health Services Act to expand the availability of coverage for lung cancer screenings without the imposition of cost sharing. Issues related to Cures 2.0. Issues related to drug pricing. COVID-19 vaccine and therapy development. Issues related to health equity and clinical trials H.R. 5376 Build Back Better Act Issues related to drug regulation & approval pathways S.2911, Seniors Prescription Drug Relief Act Issues related to value-based arrangements Oncology Care Model / Oncology Care First H.R. 1730/S. 670- Speeding Therapy Access Today Act; H.R. 483/S. 350 - Newborn Screening Saves Lives Act Diverse and Equitable Participation in Clinical Trials Act Discussion Draft General issues related to orphan disease drugs; FDA modernization policy issues; Reauthorization of newborn screening programs; Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients; General issues related to diagnostics for patients with rare diseases Cancer screening, diagnostics and treatment H.R 5260 Reduced Costs and Continued Cares Act Cancer screening, diagnostics and treatment Prescription drug electronic labeling
Client expense: $1,400,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Science & Technology Policy (OSTP), SENATE, White House Office
2021 · fourth_quarter · Medical/Disease Research/Clinical Labs
Legislation to revolutionize education, diagnoses, and treatment of rare kidney diseases; H.R. 1730/S.670, Speeding Therapy Access Today Act.
Client expense: Not reported · Firm income: $110,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2021 · fourth_quarter · Pharmacy
Orphan Drug Tax Credit Accelerated Approval Pathway Recommendations S. 670/H.R. 1730, the Speeding Therapy Access Today (STAT) Act
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2021 · fourth_quarter · Medical/Disease Research/Clinical Labs
H.R. 1730, S. 670, Speeding Therapy Access Today Act of 2021; legislation regarding diagnosis and treatment of rare kidney diseases
Client expense: $100,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2021 · fourth_quarter · Health Issues
H.R. 1730, S. 670 - the Speeding Therapy Access Today (STAT) Act; Related rare disease policies; Reauthorization of the Prescription Drug User Fee Act.
Client expense: Not reported · Firm income: $10,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2021 · fourth_quarter · Health Issues
H.R. 1730, S. 670 - STAT Act; H.R. 482, S. 350 - Newborn Screening Save Lives Reauthorization Act; Cures 2.0; PDUFA; ARPA-H; Telehealth; Covid-relief; Appropriations; S. 373, H.R. 4472 - Better Empowerment Now to Enhance Framework to Improve Treatments (BENEFIT) Act; H.R. 2144, S. 1450 - Access to Genetic Counselor Services Act; H.R. 4393 - Advancing Precision Medicine Act; H.R. 3783, S. 2013 - Medical Nutrition Equity Act.
Client expense: $20,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2021 · first_quarter · Health Issues
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; 42 USC 1320a-7b, Anti-Kickback Statute; 42 USC 1395nn, Stark Statute; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; H.R.1319, P.L. 117-2, American Rescue Plan Act of 2021 - provisions related to COVID-19 vaccinations, testing, treatment, Medicaid rebates, and prevention and mental health services; H.R. 2017, S. 883, To amend part D of title XVIII of the Social Security Act to require the Secretary of Health and Human Services to negotiate covered part D drug prices on behalf of Medicare beneficiaries - provisions related to Part D and drug pricing negotiation; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; S. 464, Safe Step Act - provisions related to step therapy policy (House companion bill not yet introduced); H.R. 1730, S. 670, The STAT Act - The Speeding Therapy Access Today Act of 2021 - provisions related to establishment of a Rare Disease Center of Excellence within FDA; S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act (116th Congress) - provisions related to prescription drug vial sizes and rebates; S. 2543, The Prescription Drug Pricing Reduction Act of 2019 (116th Congress) - provisions related to lower prescription drug prices and transparency of pharmaceutical prices and transactions; H.R. 19, Lower Costs, More Cures Act of 2019 (116th Congress) - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; E.O. 13937, Access to Affordable Life-Saving Medications; E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients; E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen; E.O. 13947, 13948, Lowering Drug Prices by Putting America First; E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States;
Client expense: $690,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
2021 · third_quarter · Medical/Disease Research/Clinical Labs
Legislation to revolutionize education, diagnoses, and treatment of rare kidney diseases; H.R. 1730/S.670, Speeding Therapy Access Today Act.
Client expense: Not reported · Firm income: $60,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2021 · third_quarter · Health Issues
H.R. 1730, S. 670 - the Speeding Therapy Access Today (STAT) Act; Related rare disease policies; Reauthorization of the Prescription Drug User Fee Act.
Client expense: Not reported · Firm income: $20,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE