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Legislative Progress
Introduced
September 14, 2021
Latest Action
September 14, 2021
Primary Sponsor
Sherrod BrownDemocratic(OH)
Momentum (last 30 days)
0
score
0 actions · 0 new cosponsors · 0 votes
Speed vs cohort
0pct
0d open
vs 5,357 other S bills in the 117th — cohort avg 38d
Promoting Readiness and Ensuring Proper Active pharmaceutical ingredient Reserves of Essential medicines Act of 2021 or the PREPARE Act This bill establishes the Strategic Active Pharmaceutical Ingredient Reserve. The Department of Health and Human Services (HHS) must annually publish a public list of essential generic medicines that are medically necessary to have available at all times. HHS must report and implement a plan to establish the reserve, which must be designed to minimize the impact of an interruption or reduction in imports of (1) key starting materials (including active pharmaceutical ingredients) for essential generic medicines, and (2) finished dosage forms of essential generic medicines for which key starting materials are not imported. The plan must also contain provisions to strengthen domestic capacity for active pharmaceutical ingredient production, storage, and conversion. Within one year of this bill's enactment, the plan must include at least 25 of the essential generic medicines on the required list. The plan must add at least 25 medicines each year until the full list is covered. HHS must prioritize domestically manufactured key starting materials for the reserve to the maximum extent possible. A manufacturer of an essential generic medicine that switches to an active pharmaceutical ingredient sourced through the reserve shall not have to update the approved application for that medicine. The Government Accountability Office must report to Congress on active pharmaceutical ingredient manufacturing, including the time and costs needed to develop domestic manufacturing capabilities.
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 (11)
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
2024 · fourth_quarter · Health Issues
Prepare Act, (previously known as H.R. 5388 and S. 2740) (no specific provisions)
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2024 · third_quarter · Health Issues
Prepare Act, (previously known as H.R. 5388 and S. 2740) (no specific provisions)
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2024 · third_quarter · Health Issues
Prepare Act, (previously known as H.R. 5388 and S. 2740) (no specific provisions)
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2024 · third_quarter · Health Issues
Prepare Act, (previously known as H.R. 5388 and S. 2740) (no specific provisions)
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2024 · second_quarter · Health Issues
Prepare Act, (previously known as H.R. 5388 and S. 2740) (no specific provisions)
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2024 · first_quarter · Health Issues
| Democratic |
| PA |
| Shelley Moore Capito | Republican | WV |
| Tim Kaine | Democratic | VA |
Prepare Act, (previously known as H.R. 5388 and S. 2740) (no specific provisions)
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2024 · first_quarter · Health Issues
Prepare Act, (previously known as H.R. 5388 and S. 2740) (no specific provisions)
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2023 · fourth_quarter · Health Issues
Prepare Act, (previously known as H.R. 5388 and S. 2740) (no specific provisions)
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2023 · fourth_quarter · Health Issues
H.R. 5388/S. 2740 - PREPARE Act of 2021, issues relating to Domestic API production.
Client expense: Not reported · Firm income: $80,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2023 · fourth_quarter · Health Issues
Prepare Act, (previously known as H.R. 5388 and S. 2740) (no specific provisions)
Client expense: Not reported · Firm income: $110,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2023 · third_quarter · Health Issues
H.R. 5388/S. 2740 - PREPARE Act of 2021, issues relating to Domestic API production.
Client expense: Not reported · Firm income: $90,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2023 · third_quarter · Health Issues
Prepare Act, (previously known as H.R. 5388 and S. 2740) (no specific provisions)
Client expense: Not reported · Firm income: $110,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2023 · second_quarter · Health Issues
H.R. 5388/S. 2740 - PREPARE Act of 2021, issues relating to Domestic API production.
Client expense: Not reported · Firm income: $90,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2023 · second_quarter · Health Issues
Prepare Act, (previously known as H.R. 5388 and S. 2740) (no specific provisions)
Client expense: Not reported · Firm income: $85,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2023 · first_quarter · Health Issues
H.R. 5388/S. 2740 - PREPARE Act of 2021, issues relating to Domestic API production.
Client expense: Not reported · Firm income: $90,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2023 · first_quarter · Health Issues
Prepare Act, (previously known as H.R. 5388 and S. 2740) (no specific provisions)
Client expense: Not reported · Firm income: $100,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) Biosimilar approval and reimbursement policy issues BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Co-pay accumulator programs COVID-19 Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues FY 2023 Appropriations H.R.2471, Consolidated Appropriations Act for FY 2022 H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform H.R. 5376 - Inflation Reduction Act H.R. 5801 - HELP Co-pays Act H.R. 7389 - MVP Act H.R. 6584 - DEPICT Act Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA H.R 7667 - Food and Drug Amendments Act of 2022 S.4348 - FDASLA Act of 2022 Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act S. 2837 - 340B Accountability Act 2021 Pharmacy benefit manager policy issues Cancer Moonshot
Client expense: $1,760,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office
2022 · fourth_quarter · Health Issues
PREPARE Act H.R. 5388 and S. 2740 (no specific provisions); Administrations activities related to pharmaceutical supply chain and domestic capacity
Client expense: $190,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · fourth_quarter · Trade (domestic/foreign)
H.R. Res. 1285 - WTO TRIPS Waiver Resolution, Waiver Expansion H.R. 2653: MMEDS Act of 2021 - Provisions related to medical supply chains and domestic manufacturing H.R. 3683: Securing Americas Pharmaceutical Supply Chain Act - Provisions related to medical supply chains H.R. 3788: Protecting American Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3927: MADE in America Act - Provisions related to medical supply chains and domestic manufacturing H.R. 4369: National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2021 - Provisions related to medical supply chains and domestic manufacturing H.R. 4376, USTRx Act, provisions related to establishing a Chief Pharmaceutical Trade NegotiatorS. 1176: Onshoring Essential Antibiotics Act - Provisions related to medical supply chains S. 1203: MMEDS Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 2495: Protecting our Pharmaceutical Supply Chain from China Act of 2021 - Provisions related to medical supply chains S. 2740: PREPARE Act of 2021 - Provisions related to medical supply chains and domestic manufacturing Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver
Client expense: $860,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)
2022 · fourth_quarter · Trade (domestic/foreign)
H.R. 2653: MMEDS Act of 2021 - Provisions related to medical supply chains and domestic manufacturing H.R. 3683: Securing Americas Pharmaceutical Supply Chain Act - Provisions related to medical supply chains H.R. 3788: Protecting American Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3927: MADE in America Act - Provisions related to medical supply chains and domestic manufacturing H.R. 4369: National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 1176: Onshoring Essential Antibiotics Act - Provisions related to medical supply chains S. 1203: MMEDS Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 2495: Protecting our Pharmaceutical Supply Chain from China Act of 2021 - Provisions related to medical supply chains S. 2740: PREPARE Act of 2021 - Provisions related to medical supply chains and domestic manufacturing Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Russia/Ukraine policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver
Client expense: $6,610,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) Biosimilar approval and reimbursement policy issues BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Co-pay accumulator programs COVID-19 Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues FY 2023 Appropriations H.R.2471, Consolidated Appropriations Act for FY 2022 H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform H.R. 5376 - Inflation Reduction Act H.R. 5801 - HELP Co-pays Act H.R. 7389 - MVP Act H.R. 6584 - DEPICT Act Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA H.R 7667 - Food and Drug Amendments Act of 2022 S.4348 - FDASLA Act of 2022 Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act S. 2837 - 340B Accountability Act 2021 Pharmacy benefit manager policy issues Cancer Moonshot
Client expense: $880,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office
2022 · fourth_quarter · Health Issues
S. 2740 - PREPARE Act, issues relating to Domestic API production.
Client expense: Not reported · Firm income: $90,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Science/Technology
H.R. 869 and S. 289: Research Investment to Spark the Economy (RISE) Act of 2021 To authorize appropriations to offset costs resulting from reductions in research productivity in connection with the Coronavirus Disease 2019 (COVID-19), and for other purposes (ALL). H.R. 1160: Intelligence on Nefarious Foreign Leaders Using Education Networks for Corrupt Enrichment (INFLUENCE) Act To amend the Higher Education Act of 1965 to improve protections against foreign influence at institutions of higher education, and for other purposes (ALL). S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act A bill to prepare for, and respond to, existing viruses, emerging new threats, and pandemics (provisions relating to the creation of the Advanced Research Projects Agency-Health, university centers of excellence in advanced and continuous pharmaceutical manufacturing, pandemic preparedness university centers of excellence, and research at regional biocontainment labs). H.R. 5585: Advanced Research Project Agency-Health Act To establish the Advanced Research Projects Agency-Health, and for other purposes (ALL). H.R. 6000: Cures 2.0 Act To continue the acceleration of the discovery, development, and delivery of 21st century cures, and for other purposes (provision relating to the creation of the Advanced Research Projects Agency-Health). H.R. 4369: National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2021 To amend the 21st Century Cures Act to provide for designation of institutions of higher education that provide research, data, and leadership on continuous manufacturing as National Centers of Excellence in Continuous Pharmaceutical Manufacturing, and for other purposes (ALL). S. 2589: Securing Americas Medicine Cabinet Act of 2021 A bill to amend the 21st Century Cures Act to provide for designation of institutions of higher education that provide research, data, and leadership on advanced and continuous manufacturing as National Centers of Excellence in Continuous Pharmaceutical Manufacturing, and for other purposes (ALL). H.R. 3851: Continuous Manufacturing Research Act of 2021 To improve support for research and development of advanced pharmaceutical manufacturing techniques and workforce (ALL). H.R. 5388 and S. 2740: Promoting Readiness and Ensuring Proper Active Pharmaceutical Ingredient Reserves of Essential Medicines (PREPARE) Act To establish a strategic active pharmaceutical ingredient reserve to maintain a domestic supply of active pharmaceutical ingredients and key starting materials needed for the manufacturing of essential generic medicines, and to build a pipeline for domestic active pharmaceutical ingredient production (ALL). H.R. 2617: Consolidated Appropriations Act, 2023 Making consolidated appropriations for the fiscal year ending September 30, 2023, and for providing emergency assistance for the situation in Ukraine, and for other purposes (provisions relating to university centers of excellence in advanced and continuous pharmaceutical manufacturing and the authorization of the Advanced Research Projects Agency-Health). Federal policy changes regarding fetal tissue research, biomedical research involving animals, research security, and facilities and administrative costs associated with research grants. White House and Executive Branch implementation of the CHIPS and Science Act.
Client expense: $70,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
Prepare Act, H.R. 5388 and S. 2740 (no specific provisions) H.R. 8295, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2023 (Provisions Related to Health and Human Services) S. 4659, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2023(Provisions Related to Health and Human Services) H.R.2617, FY2023 Consolidated Appropriations Act (Includes 12 reg. approps bills by division and other matters)
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · third_quarter · Health Issues
PREPARE Act H.R. 5388 and S. 2740 (no specific provisions); Administrations activities related to pharmaceutical supply chain and domestic capacity
Client expense: $190,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), SENATE
2022 · third_quarter · Trade (domestic/foreign)
H.R. 1285: Requesting the President to transmit certain information to the House of Representatives relating to a waiver of intellectual property commitments under the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights H.R. 2653: MMEDS Act of 2021 - Provisions related to medical supply chains and domestic manufacturing H.R. 2731: Endless Frontier Act - Provisions related to medical supply chains and domestic manufacturing H.R. 2870: Essential Medicines Strategic Stockpile Act of 2021 - Provisions related to medical supply chains and strategic stockpiles H.R. 3035: Preventing Foreign Attempts to Erode Healthcare Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3683: Securing Americas Pharmaceutical Supply Chain Act - Provisions related to medical supply chains H.R. 3788: Protecting American Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3927: MADE in America Act - Provisions related to medical supply chains and domestic manufacturing H.R. 4369: National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2021 - Provisions related to medical supply chains and domestic manufacturing H.R. 4376, USTRx Act, provisions related to establishing a Chief Pharmaceutical Trade Negotiator H.R. 4521: United States Innovation and Competition Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 1176: Onshoring Essential Antibiotics Act - Provisions related to medical supply chains S. 1203: MMEDS Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 1260: United States Innovation and Competition Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 1367: United States Pharmaceutical Supply Chain Review Act - Provisions related to medical supply chains and domestic manufacturing S. 1388: Prescription Pricing for the People Act of 2021 - Provisions related to medical supply chains and prescription drug pricing transparency S. 2495: Protecting our Pharmaceutical Supply Chain from China Act of 2021 - Provisions related to medical supply chains S. 2740: PREPARE Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 2925: Strategic Planning for Emergency Medical Manufacturing Act - Provisions related to medical supply chains and domestic manufacturing Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver
Client expense: $1,390,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)
2022 · third_quarter · Science/Technology
H.R. 869 and S. 289: Research Investment to Spark the Economy (RISE) Act of 2021 To authorize appropriations to offset costs resulting from reductions in research productivity in connection with the Coronavirus Disease 2019 (COVID-19), and for other purposes (ALL). H.R. 1160: Intelligence on Nefarious Foreign Leaders Using Education Networks for Corrupt Enrichment (INFLUENCE) Act To amend the Higher Education Act of 1965 to improve protections against foreign influence at institutions of higher education, and for other purposes (ALL). S. 1260: United States Innovation and Competition Act of 2021 A bill to establish a new Directorate for Technology and Innovation in the National Science Foundation, to establish a regional technology hub program, to require a strategy and report on economic security, science, research, innovation, manufacturing, and job creation, to establish a critical supply chain resiliency program, and for other purposes (provisions relating to funding for the National Science Foundation, NASA, and the Departments of Commerce and Energy; provisions on research and development and foreign gift/contract reporting at U.S. institutions of higher education). H.R. 4521: America Creating Opportunities for Manufacturing, Pre-Eminence in Technology, and Economic Strength (COMPETES) Act of 2022 Vehicle for the Houses comprehensive innovation and competitiveness legislation (provisions relating to funding for the National Science Foundation, NASA, and the Departments of Commerce and Energy; provisions on research and development and foreign gift/contract reporting at U.S. institutions of higher education; immigration provisions relating to advanced degree holders from U.S. institutions of higher education; and provision relating to university centers of excellence in advanced and continuous pharmaceutical manufacturing). H.R. 4346: CHIPS and Science Act Vehicle for bipartisan legislation to support domestic semiconductor research and development and reauthorize major science agencies (provisions relating to funding for the National Science Foundation, NASA, and the Departments of Commerce and Energy; provisions on research and development and foreign gift/contract reporting at U.S. institutions of higher education). S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act A bill to prepare for, and respond to, existing viruses, emerging new threats, and pandemics (provisions relating to the creation of the Advanced Research Projects Agency-Health, university centers of excellence in advanced and continuous pharmaceutical manufacturing, pandemic preparedness university centers of excellence, and research at regional biocontainment labs). H.R. 5585: Advanced Research Project Agency-Health Act To establish the Advanced Research Projects Agency-Health, and for other purposes (ALL). H.R. 6000: Cures 2.0 Act To continue the acceleration of the discovery, development, and delivery of 21st century cures, and for other purposes (provision relating to the creation of the Advanced Research Projects Agency-Health). H.R. 2225: National Science Foundation for the Future Act To authorize appropriations for fiscal years 2022, 2023, 2024, 2025, and 2026 for the National Science Foundation, and for other purposes (ALL). H.R. 3593: Department of Energy Science for the Future Act To provide guidance for and investment in the research and development activities of the Department of Energy Office of Science, and for other purposes (ALL). H.R. 4369: National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2021 To amend the 21st Century Cures Act to provide for designation of institutions of higher education that provide research, data, and leadership on continuous manufacturing as National Centers of Excellence in Continuous Pharmaceutical Manufacturing, and for other purposes (ALL). S. 2589: Securing Americas Medicine Cabinet Act of 2021 A bill to amend the 21st Century Cures Act to provide for designation of institutions of higher education that provide research, data, and leadership on advanced and continuous manufacturing as National Centers of Excellence in Continuous Pharmaceutical Manufacturing, and for other purposes (ALL). H.R. 3851: Continuous Manufacturing Research Act of 2021 To improve support for research and development of advanced pharmaceutical manufacturing techniques and workforce (ALL). H.R. 5388 and S. 2740: Promoting Readiness and Ensuring Proper Active Pharmaceutical Ingredient Reserves of Essential Medicines (PREPARE) Act To establish a strategic active pharmaceutical ingredient reserve to maintain a domestic supply of active pharmaceutical ingredients and key starting materials needed for the manufacturing of essential generic medicines, and to build a pipeline for domestic active pharmaceutical ingredient production (ALL). S. 4900 SBIR and STTR Extension Act of 2022 A bill to reauthorize the SBIR and STTR programs and pilot programs, and for other purposes (ALL). Federal policy changes regarding fetal tissue research, biomedical research involving animals, research security, and facilities and administrative costs associated with research grants. Pending federal legislation to enhance university climate research, service, and resiliency.
Client expense: $50,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · third_quarter · Trade (domestic/foreign)
H.R. 2653: MMEDS Act of 2021 - Provisions related to medical supply chains and domestic manufacturing H.R. 2731: Endless Frontier Act - Provisions related to medical supply chains and domestic manufacturing H.R. 2870: Essential Medicines Strategic Stockpile Act of 2021 - Provisions related to medical supply chains and strategic stockpiles H.R. 3035: Preventing Foreign Attempts to Erode Healthcare Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3683: Securing Americas Pharmaceutical Supply Chain Act - Provisions related to medical supply chains H.R. 3788: Protecting American Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3927: MADE in America Act - Provisions related to medical supply chains and domestic manufacturing H.R. 4369: National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2021 - Provisions related to medical supply chains and domestic manufacturing H.R. 4521: United States Innovation and Competition Act of 2021 - Provisions related to medical supply chains and domestic manufacturing H. Res. 1285: Requesting the President to transmit certain information to the House of Representatives relating to a waiver of intellectual property commitments under the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights S. 1176: Onshoring Essential Antibiotics Act - Provisions related to medical supply chains S. 1203: MMEDS Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 1260: United States Innovation and Competition Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 1367: United States Pharmaceutical Supply Chain Review Act - Provisions related to medical supply chains and domestic manufacturing S. 1388: Prescription Pricing for the People Act of 2021 - Provisions related to medical supply chains and prescription drug pricing transparency S. 2495: Protecting our Pharmaceutical Supply Chain from China Act of 2021 - Provisions related to medical supply chains S. 2740: PREPARE Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 2925: Strategic Planning for Emergency Medical Manufacturing Act - Provisions related to medical supply chains and domestic manufacturing Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Russia/Ukraine policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver
Client expense: $7,270,000 · Firm income: Not reported
Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) Biosimilar approval and reimbursement policy issues BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Co-pay accumulator programs COVID-19 Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues FY 2023 Appropriations H.R.2471, Consolidated Appropriations Act for FY 2022 H.R.2815, The BIOSIM Act H.R. 4390 - Protect 340B Act of 2021 H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform H.R. 5376 - Inflation Reduction Act H.R. 5801 - HELP Co-pays Act H.R. 7389 - MVP Act H.R. 6584 - DEPICT Act Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA H.R 7667 - Food and Drug Amendments Act of 2022 S.4348 - FDASLA Act of 2022 Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act S. 2837 - 340B Accountability Act 2021 Pharmacy benefit manager policy issues Cancer Moonshot
Client expense: $850,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office
2022 · third_quarter · Health Issues
S. 2740 - PREPARE Act, issues relating to Domestic API production.
Client expense: Not reported · Firm income: $90,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · third_quarter · Health Issues
Prepare Act, H.R. 5388 and S. 2740 (no specific provisions) H.R. 8295, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2023 (Provisions Related to Health and Human Services) S. 4659, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2023(Provisions Related to Health and Human Services)
Client expense: Not reported · Firm income: $100,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · second_quarter · Trade (domestic/foreign)
H.R. 1829: Pharmacy Benefit Manager Accountability Study Act of 2021 - Provisions related to medical supply chains and prescription drug pricing transparency H.R. 2653: MMEDS Act of 2021 - Provisions related to medical supply chains and domestic manufacturing H.R. 2731: Endless Frontier Act - Provisions related to medical supply chains and domestic manufacturing H.R. 2870: Essential Medicines Strategic Stockpile Act of 2021 - Provisions related to medical supply chains and strategic stockpiles H.R. 3035: Preventing Foreign Attempts to Erode Healthcare Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3683: Securing Americas Pharmaceutical Supply Chain Act - Provisions related to medical supply chains H.R. 3694: To direct the Secretary of Health and Human Services, in consultation with the United States Trade Representative and other heads of Federal agencies, to submit to Congress a report the impact of a waiver of certain obligations of member nations under the Agreement on Trade-Related Aspects of Intellectual Property Rights on global COVID-19 vaccine access, and for other purposes - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3788: Protecting American Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3811: TRIPP Act - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3927: MADE in America Act - Provisions related to medical supply chains and domestic manufacturing H.R. 4369: National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2021 - Provisions related to medical supply chains and domestic manufacturing H.R. 4376, USTRx Act, provisions related to establishing a Chief Pharmaceutical Trade Negotiator H.R. 4521: United States Innovation and Competition Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 298: Pharmacy Benefit Manager Accountability Study Act of 2021 - Provisions related to medical supply chains and prescription drug pricing transparency S. 1176: Onshoring Essential Antibiotics Act - Provisions related to medical supply chains S. 1203: MMEDS Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 1260: United States Innovation and Competition Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 1367: United States Pharmaceutical Supply Chain Review Act - Provisions related to medical supply chains and domestic manufacturing S. 1388: Prescription Pricing for the People Act of 2021 - Provisions related to medical supply chains and prescription drug pricing transparency S. 2495: Protecting our Pharmaceutical Supply Chain from China Act of 2021 - Provisions related to medical supply chains S. 2740: PREPARE Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 2925: Strategic Planning for Emergency Medical Manufacturing Act - Provisions related to medical supply chains and domestic manufacturing Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver
Client expense: $1,110,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)
2022 · second_quarter · Science/Technology
H.R. 869 and S. 289: Research Investment to Spark the Economy (RISE) Act of 2021 To authorize appropriations to offset costs resulting from reductions in research productivity in connection with the Coronavirus Disease 2019 (COVID-19), and for other purposes (ALL). H.R. 1160: Intelligence on Nefarious Foreign Leaders Using Education Networks for Corrupt Enrichment (INFLUENCE) Act To amend the Higher Education Act of 1965 to improve protections against foreign influence at institutions of higher education, and for other purposes (ALL). S. 1260: United States Innovation and Competition Act of 2021 A bill to establish a new Directorate for Technology and Innovation in the National Science Foundation, to establish a regional technology hub program, to require a strategy and report on economic security, science, research, innovation, manufacturing, and job creation, to establish a critical supply chain resiliency program, and for other purposes (provisions relating to funding for the National Science Foundation, NASA, and the Departments of Commerce and Energy; provisions on research and development and foreign gift/contract reporting at U.S. institutions of higher education). H.R. 4521: America Creating Opportunities for Manufacturing, Pre-Eminence in Technology, and Economic Strength (COMPETES) Act of 2022 Vehicle for the Houses comprehensive innovation and competitiveness legislation (provisions relating to funding for the National Science Foundation, NASA, and the Departments of Commerce and Energy; provisions on research and development and foreign gift/contract reporting at U.S. institutions of higher education; immigration provisions relating to advanced degree holders from U.S. institutions of higher education; and provision relating to university centers of excellence in advanced and continuous pharmaceutical manufacturing). S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act A bill to prepare for, and respond to, existing viruses, emerging new threats, and pandemics (provisions relating to the creation of the Advanced Research Projects Agency-Health, university centers of excellence in advanced and continuous pharmaceutical manufacturing, pandemic preparedness university centers of excellence, and research at regional biocontainment labs). H.R. 5585: Advanced Research Project Agency-Health Act To establish the Advanced Research Projects Agency-Health, and for other purposes (ALL). H.R. 6000: Cures 2.0 Act To continue the acceleration of the discovery, development, and delivery of 21st century cures, and for other purposes (provision relating to the creation of the Advanced Research Projects Agency-Health). H.R. 2225: National Science Foundation for the Future Act To authorize appropriations for fiscal years 2022, 2023, 2024, 2025, and 2026 for the National Science Foundation, and for other purposes (ALL). H.R. 3593: Department of Energy Science for the Future Act To provide guidance for and investment in the research and development activities of the Department of Energy Office of Science, and for other purposes (ALL). H.R. 4369: National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2021 To amend the 21st Century Cures Act to provide for designation of institutions of higher education that provide research, data, and leadership on continuous manufacturing as National Centers of Excellence in Continuous Pharmaceutical Manufacturing, and for other purposes (ALL). S. 2589: Securing Americas Medicine Cabinet Act of 2021 A bill to amend the 21st Century Cures Act to provide for designation of institutions of higher education that provide research, data, and leadership on advanced and continuous manufacturing as National Centers of Excellence in Continuous Pharmaceutical Manufacturing, and for other purposes (ALL). H.R. 3851: Continuous Manufacturing Research Act of 2021 To improve support for research and development of advanced pharmaceutical manufacturing techniques and workforce (ALL). H.R. 5388 and S. 2740: Promoting Readiness and Ensuring Proper Active Pharmaceutical Ingredient Reserves of Essential Medicines (PREPARE) Act To establish a strategic active pharmaceutical ingredient reserve to maintain a domestic supply of active pharmaceutical ingredients and key starting materials needed for the manufacturing of essential generic medicines, and to build a pipeline for domestic active pharmaceutical ingredient production (ALL). Federal policy changes regarding fetal tissue research, biomedical research involving animals, research security, and facilities and administrative costs associated with research grants. Pending federal legislation to enhance university climate research, service, and resiliency.
Client expense: $90,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · second_quarter · Trade (domestic/foreign)
H.R. 1829: Pharmacy Benefit Manager Accountability Study Act of 2021 - Provisions related to medical supply chains and prescription drug pricing transparency H.R. 2653: MMEDS Act of 2021 - Provisions related to medical supply chains and domestic manufacturing H.R. 2731: Endless Frontier Act - Provisions related to medical supply chains and domestic manufacturing H.R. 2870: Essential Medicines Strategic Stockpile Act of 2021 - Provisions related to medical supply chains and strategic stockpiles H.R. 3035: Preventing Foreign Attempts to Erode Healthcare Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3683: Securing Americas Pharmaceutical Supply Chain Act - Provisions related to medical supply chains H.R. 3694: To direct the Secretary of Health and Human Services, in consultation with the United States Trade Representative and other heads of Federal agencies, to submit to Congress a report on the impact of a waiver of certain obligations of member nations under the Agreement on Trade-Related Aspects of Intellectual Property Rights on global COVID-19 vaccine access, and for other purposes - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3788: Protecting American Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3811: TRIPP Act - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3927: MADE in America Act - Provisions related to medical supply chains and domestic manufacturing H.R. 4369: National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2021 - Provisions related to medical supply chains and domestic manufacturing H.R. 4521: United States Innovation and Competition Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 298: Pharmacy Benefit Manager Accountability Study Act of 2021 - Provisions related to medical supply chains and prescription drug pricing transparency S. 1176: Onshoring Essential Antibiotics Act - Provisions related to medical supply chains S. 1203: MMEDS Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 1260: United States Innovation and Competition Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 1367: United States Pharmaceutical Supply Chain Review Act - Provisions related to medical supply chains and domestic manufacturing S. 1388: Prescription Pricing for the People Act of 2021 - Provisions related to medical supply chains and prescription drug pricing transparency S. 2495: Protecting our Pharmaceutical Supply Chain from China Act of 2021 - Provisions related to medical supply chains S. 2740: PREPARE Act - Provisions related to medical supply chains and domestic manufacturing S. 2925: Strategic Planning for Emergency Medical Manufacturing Act - Provisions related to medical supply chains and domestic manufacturing Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Russia/Ukraine policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver
Client expense: $6,340,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE
2022 · second_quarter · Health Issues
PREPARE Act H.R. 5388 and S. 2740 (no specific provisions); Administrations activities related to pharmaceutical supply chain and domestic capacity
Client expense: $150,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), SENATE
2022 · second_quarter · Health Issues
S. 2740 - PREPARE Act, issues relating to Domestic API production.
Client expense: Not reported · Firm income: $90,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · second_quarter · Health Issues
Prepare Act, H.R. 5388 and S. 2740 (no specific provisions) Fiscal Year 2023 Labor, Health and Human Services, and Education Appropriations Bill (Provisions Related to Health and Human Services)
Client expense: Not reported · Firm income: $70,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · first_quarter · Trade (domestic/foreign)
H.R. 1829: Pharmacy Benefit Manager Accountability Study Act of 2021 - Provisions related to medical supply chains and prescription drug pricing transparency H.R. 2653: MMEDS Act of 2021 - Provisions related to medical supply chains and domestic manufacturing H.R. 2731: Endless Frontier Act - Provisions related to medical supply chains and domestic manufacturing H.R. 2870: Essential Medicines Strategic Stockpile Act of 2021 - Provisions related to medical supply chains and strategic stockpiles H.R. 3035: Preventing Foreign Attempts to Erode Healthcare Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3683: Securing Americas Pharmaceutical Supply Chain Act - Provisions related to medical supply chains H.R. 3788: Protecting American Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3927: MADE in America Act - Provisions related to medical supply chains and domestic manufacturing H.R. 4376, USTRx Act, provisions related to establishing a Chief Pharmaceutical Trade Negotiator H.R. 4369: National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2021 - Provisions related to medical supply chains and domestic manufacturing H.R. 4521: United States Innovation and Competition Act of 2021 H.R. 5388: PREPARE Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 298: Pharmacy Benefit Manager Accountability Study Act of 2021 - Provisions related to medical supply chains and prescription drug pricing transparency S. 1176: Onshoring Essential Antibiotics Act - Provisions related to medical supply chains S. 1203: MMEDS Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 1260: United States Innovation and Competition Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 1367: United States Pharmaceutical Supply Chain Review Act - Provisions related to medical supply chains and domestic manufacturing S. 1388: Prescription Pricing for the People Act of 2021 - Provisions related to medical supply chains and prescription drug pricing transparency S. 1683: Preventing Foreign Attempts to Erode Healthcare Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property S. 2495: Protecting our Pharmaceutical Supply Chain from China Act of 2021 - Provisions related to medical supply chains S. 2740: PREPARE Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 2925: Strategic Planning for Emergency Medical Manufacturing Act - Provisions related to medical supply chains and domestic manufacturing Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver
Client expense: $1,100,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)
2022 · first_quarter · Health Issues
PREPARE Act H.R. 5388 and S. 2740 (no specific provisions); Administrations activities related to pharmaceutical supply chain and domestic capacity
Client expense: $150,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), SENATE
2022 · first_quarter · Trade (domestic/foreign)
H.R. 1829: Pharmacy Benefit Manager Accountability Study Act of 2021 - Provisions related to medical supply chains and prescription drug pricing transparency H.R. 2653: MMEDS Act of 2021 - Provisions related to medical supply chains and domestic manufacturing H.R. 2731: Endless Frontier Act - Provisions related to medical supply chains and domestic manufacturing H.R. 2870: Essential Medicines Strategic Stockpile Act of 2021 - Provisions related to medical supply chains and strategic stockpiles H.R. 3035: Preventing Foreign Attempts to Erode Healthcare Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3683: Securing Americas Pharmaceutical Supply Chain Act - Provisions related to medical supply chains H.R. 3788: Protecting American Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3927: MADE in America Act - Provisions related to medical supply chains and domestic manufacturing H.R. 4376, USTRx Act, provisions related to establishing a Chief Pharmaceutical Trade Negotiator H.R. 4369: National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2021 - Provisions related to medical supply chains and domestic manufacturing H.R. 4521: United States Innovation and Competition Act of 2021 H.R. 5388: PREPARE Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 298: Pharmacy Benefit Manager Accountability Study Act of 2021 - Provisions related to medical supply chains and prescription drug pricing transparency S. 1176: Onshoring Essential Antibiotics Act - Provisions related to medical supply chains S. 1203: MMEDS Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 1260: United States Innovation and Competition Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 1367: United States Pharmaceutical Supply Chain Review Act - Provisions related to medical supply chains and domestic manufacturing S. 1388: Prescription Pricing for the People Act of 2021 - Provisions related to medical supply chains and prescription drug pricing transparency S. 1683: Preventing Foreign Attempts to Erode Healthcare Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property S. 2495: Protecting our Pharmaceutical Supply Chain from China Act of 2021 - Provisions related to medical supply chains S. 2740: PREPARE Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 2925: Strategic Planning for Emergency Medical Manufacturing Act - Provisions related to medical supply chains and domestic manufacturing Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver
Client expense: $830,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)
2022 · first_quarter · Science/Technology
H.R. 869 and S. 289: Research Investment to Spark the Economy (RISE) Act of 2021 To authorize appropriations to offset costs resulting from reductions in research productivity in connection with the Coronavirus Disease 2019 (COVID-19), and for other purposes (ALL). H.R. 1160: Intelligence on Nefarious Foreign Leaders Using Education Networks for Corrupt Enrichment (INFLUENCE) Act To amend the Higher Education Act of 1965 to improve protections against foreign influence at institutions of higher education, and for other purposes (ALL). S. 1260 and H.R. 2731: United States Innovation and Competition Act of 2021 A bill to establish a new Directorate for Technology and Innovation in the National Science Foundation, to establish a regional technology hub program, to require a strategy and report on economic security, science, research, innovation, manufacturing, and job creation, to establish a critical supply chain resiliency program, and for other purposes (provisions relating to funding for the National Science Foundation, NASA, and the Departments of Commerce and Energy; provisions on research and development and foreign gift/contract reporting at U.S. institutions of higher education). H.R. 4521: America Creating Opportunities for Manufacturing, Pre-Eminence in Technology, and Economic Strength (COMPETES) Act of 2022 Vehicle for the Houses comprehensive innovation and competitiveness legislation (provisions relating to funding for the National Science Foundation, NASA, and the Departments of Commerce and Energy; provisions on research and development and foreign gift/contract reporting at U.S. institutions of higher education; immigration provisions relating to advanced degree holders from U.S. institutions of higher education; and provision relating to advanced and continuous pharmaceutical manufacturing university centers of excellence). S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act A bill to prepare for, and respond to, existing viruses, emerging new threats, and pandemics (provisions relating to the creation of the Advanced Research Projects Agency-Health, advanced and continuous pharmaceutical manufacturing university centers of excellence, pandemic preparedness university centers of excellence, and research at regional biocontainment labs). H.R. 5585: Advanced Research Project Agency-Health Act To establish the Advanced Research Projects Agency-Health, and for other purposes (ALL). H.R. 6000: Cures 2.0 Act To continue the acceleration of the discovery, development, and delivery of 21st century cures, and for other purposes (provision relating to the creation of the Advanced Research Projects Agency-Health). H.R. 2225: National Science Foundation for the Future Act To authorize appropriations for fiscal years 2022, 2023, 2024, 2025, and 2026 for the National Science Foundation, and for other purposes (ALL). H.R. 3593: Department of Energy Science for the Future Act To provide guidance for and investment in the research and development activities of the Department of Energy Office of Science, and for other purposes (ALL). H.R. 4369: National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2021 To amend the 21st Century Cures Act to provide for designation of institutions of higher education that provide research, data, and leadership on continuous manufacturing as National Centers of Excellence in Continuous Pharmaceutical Manufacturing, and for other purposes (ALL). S. 2589: Securing Americas Medicine Cabinet Act of 2021 A bill to amend the 21st Century Cures Act to provide for designation of institutions of higher education that provide research, data, and leadership on advanced and continuous manufacturing as National Centers of Excellence in Continuous Pharmaceutical Manufacturing, and for other purposes (ALL). H.R. 3851: Continuous Manufacturing Research Act of 2021 To improve support for research and development of advanced pharmaceutical manufacturing techniques and workforce (ALL). H.R. 5388 and S. 2740: Promoting Readiness and Ensuring Proper Active Pharmaceutical Ingredient Reserves of Essential Medicines (PREPARE) Act To establish a strategic active pharmaceutical ingredient reserve to maintain a domestic supply of active pharmaceutical ingredients and key starting materials needed for the manufacturing of essential generic medicines, and to build a pipeline for domestic active pharmaceutical ingredient production (ALL). Federal policy changes regarding fetal tissue research and research security.
Client expense: $90,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · first_quarter · Trade (domestic/foreign)
H.R. 1829: Pharmacy Benefit Manager Accountability Study Act of 2021 - Provisions related to medical supply chains and prescription drug pricing transparency H.R. 2653: MMEDS Act of 2021 - Provisions related to medical supply chains and domestic manufacturing H.R. 2731: Endless Frontier Act - Provisions related to medical supply chains and domestic manufacturing H.R. 2870: Essential Medicines Strategic Stockpile Act of 2021 - Provisions related to medical supply chains and strategic stockpiles H.R. 3035: Preventing Foreign Attempts to Erode Healthcare Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3683: Securing Americas Pharmaceutical Supply Chain Act - Provisions related to medical supply chains H.R. 3788: Protecting American Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3927: MADE in America Act - Provisions related to medical supply chains and domestic manufacturing H.R. 4369: National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2021 - Provisions related to medical supply chains and domestic manufacturing H.R. 4521: United States Innovation and Competition Act of 2021 H.R. 5388: PREPARE Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 298: Pharmacy Benefit Manager Accountability Study Act of 2021 - Provisions related to medical supply chains and prescription drug pricing transparency S. 1176: Onshoring Essential Antibiotics Act - Provisions related to medical supply chains S. 1203: MMEDS Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 1260: United States Innovation and Competition Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 1367: United States Pharmaceutical Supply Chain Review Act - Provisions related to medical supply chains and domestic manufacturing S. 1388: Prescription Pricing for the People Act of 2021 - Provisions related to medical supply chains and prescription drug pricing transparency S. 1683: Preventing Foreign Attempts to Erode Healthcare Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property S. 2495: Protecting our Pharmaceutical Supply Chain from China Act of 2021 - Provisions related to medical supply chains S. 2740: PREPARE Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 2925: Strategic Planning for Emergency Medical Manufacturing Act - Provisions related to medical supply chains and domestic manufacturing Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues Supply chain policy issues Russia/Ukraine policy issues WTO TRIPS waiver
Client expense: $8,070,000 · Firm income: Not reported
Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · first_quarter · Health Issues
S.2910 - Expanding Access to Low-Cost Generics Act of 2021; S. 2740-Promoting Readiness and Ensuring Proper Active Pharmaceutical Ingredient Reserves of Essential Medicines (PREPARE) Act.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · first_quarter · Health Issues
S. 2740 - PREPARE Act, issues relating to Domestic API production.
Client expense: Not reported · Firm income: $80,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · first_quarter · Health Issues
Prepare Act, H.R. 5388 and S. 2740 (no specific provisions) Fiscal Year 2023 Labor, Health and Human Services, and Education Appropriations Bill (Provisions Related to Health and Human Services)
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2021 · fourth_quarter · Health Issues
S.2910 - Expanding Access to Low-Cost Generics Act of 2021; S. 2740-Promoting Readiness and Ensuring Proper Active Pharmaceutical Ingredient Reserves of Essential Medicines (PREPARE) Act; H.R. 5376-Build Back Better Act.
Client expense: Not reported · Firm income: $50,000
Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE
2021 · fourth_quarter · Health Issues
PREPARE Act H.R. 5388 and S. 2740 (no specific provisions); Administrations activities related to pharmaceutical supply chain and domestic capacity
Client expense: $140,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), SENATE
2021 · fourth_quarter · Health Issues
HR 5376, the Build Back Better Act, Sections 139001, 139101, 131902 provisions relating to negotiating Medicare prescription drug prices, Medicare Part B pharmaceutical rebates, and Medicare Part D rebates respectively; HR 2853, the BLOCKING Act, provisions relating to amending the Hatch-Waxman Act 180-day exclusivity structure; S2910, Expanding Access to Low Cost Generics Act, provisions relating to amending the Hatch-Waxman Act's 180-day exclusivity structure; S2740, the Promoting Readiness and Ensuring Proper Active pharmaceutical ingredient Reserves of Essential Medicines Act of 2021, provisions relating to establishing a strategic national stockpile of active pharmaceutical ingredients for essential medicines; and HR 2870, the Essential Medicines Strategic Stockpile Act of 2021, provisions relating to creating a pilot program with private entities to test the effectiveness of acquiring, maintaining, managing, and distributing a stockpile of generic drugs at risk of shortage.
Client expense: $510,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) AMP Cap Biosimilar approval and reimbursement policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Comprehensive Immunosuppressant Drug Coverage for Kidney Transplant Patients Act of 2020 Co-pay accumulator programs COVID-19 Defense Production Act Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeit policy issues Drug shortages policy issues FDA modernization policy issues Foreign manufacturing policy issues Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement FY 2022 Labor-HHS Appropriations H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.2815, The BIOSIM Act H.R.2855, Star Rating for Biosimilars Act H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 S.164, Advancing Education on Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act Part D Benefit Re-design H.R. 6000: Cures 2.0 Act H.R.19 - Lower Costs, More Cures Act of 2021
Client expense: $1,460,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Energy, Dept of, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA), White House Office
2021 · fourth_quarter · Health Issues
H.R. 5388, S. 2740, PREPARE Act, Issues pertaining to pharmaceutical manufacturing of generic materials.
Client expense: Not reported · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE