BIOSECURE Act

Issues regarding support for domestic pharmaceutical manufacturing and the BIOSECURE Act (H.R. 8333 - BIOSECURE Act (118th Congress); S.3558 - Prohibiting Foreign Access to American Genetic Information Act of 2024 (118th Congress)).

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 8333 / S 3558 BIOSECURE Act

Client expense: $70,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 8333 / S 3558 BIOSECURE Act

Client expense: $70,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 3334: STOP CCP Act H.R. 4307: Medical Supply Chain Resiliency Act H.R. 8333: BIOSECURE Act S. 1956: Invent Here, Make Here Act of 2024 S. 2115: Medical Supply Chain Resiliency Act Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver policy issues China outbound investment policy issues

Client expense: $920,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)

S. 79/HR 1717 Interagency Patent Coordination and Improvement Act of 2023 S. 113 Prescription Pricing for the People Act of 2023 . S. 1250 Drug-price Transparency for Consumers Act S.127 Pharmacy Benefit Transparency Act S. 150 Affordable Prescriptions for Patients Act of 2023 S. 148 Stop STALLING Act S. 142 Preserve Access to Affordable Generics and Biosimilars Federal Trade Commission related issues, no specific bill Issues related to the Patent Act, no specific bill Issues related to March-In/Bayh Dole, WTO/TRIPS waiver, no specific bill Issues related to patent thickets/product hopping Issues related to obviousness/ double patenting S.2140 Patent Eligibility Restoration Act of 2023 S.2220/HR 4370 Promoting and Respecting Economically Vital American Innovation Leadership Act S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents H.R. 3858/S.1834: A bill to prohibit the President from negotiating or concluding any withdrawal, suspension, waiver, or modification to the Agreement on Trade-Related Aspects of Intellectual Property Rights without explicit authorization from Congress. H.R. 3535 Advancing Americas Interests Act H.R. 5475 Prohibiting Adversarial Patents Act of 2023 S.3385/HR 8333-- BIOSECURE Act BIOCOMPETE (no bill number)- Issues related to prohibiting the export of biotechnology to certain foreign entities Issues related to FDA/PTO coordination S.2780 Medication Affordability and Patent Integrity Act Issues related to skinny labeling S. 3583/HR 6986 To Address Patent Thickets S. 1956 Invent It Here, Make It Here Act S 5573 Skinny Labels, Big Savings Act

Client expense: $2,780,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 8333: BIOSECURE Act; provisions related to genomics issues pertaining to national security

Client expense: $400,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 3334: STOP CCP Act H.R. 4307: Medical Supply Chain Resiliency Act H.R. 8333: BIOSECURE Act S. 1956: Invent Here, Make Here Act of 2024 S. 2115: Medical Supply Chain Resiliency Act Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver policy issues China outbound investment policy issues

Client expense: $7,560,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Government contracting issues. Reauthorization of the Pandemic and All Hazards Preparedness Act. Data privacy proposals. H.R. 9029/S. 4942, Labor/HHS/Education Appropriations, FY2025, support for data-driven products and services. H.R. 8333, BIOSECURE Act.

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Domestic manufacturing, medicare coverage and reimbursement for ultrasound BioSecure Act - H.R.8333/S. 3558 Funding for the Public Health Social Services Emergency Fund (PHSSEF)- Biomedical Advanced Research and Development Authority (BARDA) Reauthorization of Pandemic and All- Hazards Preparedness and Advancing Innovation Act; International trade issues

Client expense: $225,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

H.R. 8631, Decoupling from Foreign Adversarial Battery Dependence Act of 2024, all provisions. H.R. 8333, BIOSECURE Act, all provisions. Issues related to Chinese EV Manufacturing; Chinese-Made Battery Storage Systems; Countering Unmanned Aerial Systems; Development of Internet Access Technologies; Implementation of the U.S. Operations-Technology Working Group; Securing Critical U.S. Infrastructure and Mineral Supply Chains; TikTok Divestment; and U.S. Cybersecurity Capabilities and Strategy (no bill).

Client expense: $140,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to domestic pharmaceutical manufacturing; S.3558 - Prohibiting Foreign Access to American Genetic Information Act of 2024; H.R. 8333 - BIOSECURE Act.

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 5009 / S 4638Servicemember Quality of Life Improvement and National Defense Authorization Act for FY2025 HR 8333 / S 3558 BIOSECURE Act S 4932 DOE Quantum Leadership Act of 2024 Issues related to research security and integrity, including faculty disclosures, foreign gifts and contracts reporting, international graduate students and scholars in STEM fields, data privacy, and research transparency, including open access. Modernization and investment in the federal science agencies, including NSF, DOEs Office of Science, and NIST, workforce development and related issues, and supply chain resilience, major research equipment and facilities, climate and sustainability, and the commercialization of university-based discoveries. Implementation of the CHIPS and Science Act. Potential legislation to establish a regulatory framework for AI.

Client expense: $170,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Support for biopharmaceutical manufacturing in the U.S.; Reauthorization of Pandemic and All-Hazards Preparedness and Advancing Innovation Act; BioSecure Act - H.R.8333/S. 3558

Client expense: Not reported · Firm income: $50,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 2864 "Countering CCP Drones Act," all provisions. HR 8152 "Remote Access Security Act," all provisions. HR 8333 "BIOSECURE Act," all provisions. HR 8361 "Economic Espionage Prevention Act," all provisions.

Client expense: $150,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES

H.R. 8333 - Biosecure Act - entire bill. H.R. 8070 - Defense Authorization Act for Fiscal Year 2025 - issues related to biotechnology.

Client expense: Not reported · Firm income: $170,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 8333, the BIOSECURE Act; S. 3558 Prohibiting Foreign Access to American Genetic Data Information Act of 2024; communications related to company operations and CRDMO industry, including descriptions of corporate structure, business units, and data handling.

Client expense: $70,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Treasury, Dept of

HR 8333, the BIOSECURE Act; S. 3558 Prohibiting Foreign Access to American Genetic Data Information Act of 2024; communications related to company operations and CRDMO industry

Client expense: Not reported · Firm income: $40,000

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

HR 8333, the BIOSECURE Act; S. 3558 Prohibiting Foreign Access to American Genetic Data Information Act of 2024; communications related to company operations and CRDMO industry

Client expense: Not reported · Firm income: $40,000

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Issues related to section 301 tariffs. Issues related to H.R.8333 - BIOSECURE Act.

Client expense: $430,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to section 301 tariffs. Issues related to H.R.8333 - BIOSECURE Act.

Client expense: $430,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 8333: BIOSECURE Act; provisions related to genomics issues pertaining to national security

Client expense: $280,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 8333: BIOSECURE Act; provisions related to genomics issues pertaining to national security

Client expense: $260,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 79/HR 1717 Interagency Patent Coordination and Improvement Act of 2023 S. 113 Prescription Pricing for the People Act of 2023 . S. 1250 Drug-price Transparency for Consumers Act S.127 Pharmacy Benefit Transparency Act S. 150 Affordable Prescriptions for Patients Act of 2023 S. 148 Stop STALLING Act S. 142 Preserve Access to Affordable Generics and Biosimilars Federal Trade Commission related issues, no specific bill Issues related to the Patent Act, no specific bill Issues related to March-In/Bayh Dole, WTO/TRIPS waiver, no specific bill Issues related to patent thickets/product hopping Issues related to obviousness/ double patenting S.2140 Patent Eligibility Restoration Act of 2023 S.2220/HR 4370 Promoting and Respecting Economically Vital American Innovation Leadership Act S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents H.R. 3858/S.1834: A bill to prohibit the President from negotiating or concluding any withdrawal, suspension, waiver, or modification to the Agreement on Trade-Related Aspects of Intellectual Property Rights without explicit authorization from Congress. H.R. 3535 Advancing Americas Interests Act H.R. 5475 Prohibiting Adversarial Patents Act of 2023 S.3385/HR 8333-- BIOSECURE Act BIOCOMPETE (no bill number)- Issues related to prohibiting the export of biotechnology to certain foreign entities Issues related to FDA/PTO coordination S.2780 Medication Affordability and Patent Integrity Act Issues related to skinny labeling S. 3583/HR 6986 To Address Patent Thickets S. 1956 Invent It Here, Make It Here Act

Client expense: $2,770,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 8070 / S 4638National Defense Authorization Act for FY2025 HR 6213 National Quantum Initiative Reauthorization Act S 4207Spectrum and National Security Act of 2024 HR 8333 / S 3558BIOSECURE Act HR 8958 NASA Reauthorization Act of 2024 HR 1516 DHS Restrictions on Confucious Institutes and Chinese Entities of Concern Act S 4932 DOE Quantum Leadership Act of 2024 Issues related to research security and integrity, including faculty disclosures, foreign gifts and contracts reporting, international graduate students and scholars in STEM fields, data privacy, and research transparency, including open access. Modernization and investment in the federal science agencies, including NSF, DOEs Office of Science, and NIST, workforce development and related issues, and supply chain resilience, major research equipment and facilities, climate and sustainability, and the commercialization of university-based discoveries. Implementation of the CHIPS and Science Act. Potential legislation to establish a regulatory framework for AI.

Client expense: $150,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Domestic manufacturing, medicare coverage and reimbursement for ultrasound BioSecure Act - H.R.8333/S. 3558 Funding for the Public Health Social Services Emergency Fund (PHSSEF)- Biomedical Advanced Research and Development Authority (BARDA) Reauthorization of Pandemic and All- Hazards Preparedness and Advancing Innovation Act; International trade issues

Client expense: $260,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

General provisions related to science and engineering research at NSF, DOE, DOD, NASA, NIH, and IES in FY 2025 H.R. 9026 /S. 4795, the FY 2025 Commerce-Justice-Science Appropriations bill - provisions related to funding for NSF and NASA (including Science, Space Technology, STEM Education, and lunar gravitational waves) H.R. 8774 /S. 4921, the FY 2025 Defense Appropriations bill - provisions related to funding for basic and applied research (6.1-6.3) including Defense-Wide basic research initiatives and funding at DARPA; provisions related to research programs within Army Futures Command; provisions related to dependable AI for national security H.R. 8997 /S. 4927, the FY 2025 Energy-Water Appropriations bill - provisions related to funding for the Dept. of Energys Office of Science, ARPA-E, and language related to independent review and applied research for cleanup decision-making H.R. 9029/S. 4942, the FY 2025 Labor-HHS-Education Appropriations Act - provisions related to funding for the National Institutes of Health, and the Institute of Education Sciences (and National Center for Special Education Research); provisions related to F&A cost reimbursements H.R. 8070/S. 4368, the FY 2025 National Defense Authorization Act - provisions related to defense S&T basic and applied research (6.1-6.3); research security; research programs within Army Futures Command; dependable AI for national security; potential amendments related to Sec. 117 foreign gift reporting for universities and Workforce Pell Act S. 4667, the Risky Research Review Act - provisions related to creation of a Life Sciences Research Security Board to oversee certain high risk research S. 2220, the PREVAIL Act - provisions related to reforms to the PTAB H.R. 8958, the NASA Reauthorization Act - provisions related to Science, Space Technology, Aeronautics, and STEM Education H.R. xxxx/S. xxxx, the American Privacy Rights Act - provisions related to inclusion of universities as covered entities; impact on education research H.R. 1157, the Countering the PRC Malign Influence Fund Authorization Act of 2023 - provisions that authorize funding for a Countering the PRC Malign Influence Fund H.R. 7686 - provisions that would amend the Research and Development, Competition, and Innovation Act to clarify the definition of foreign country for purposes of malign foreign talent recruitment restriction H.R. 1398, the Protect Americas Innovation and Economic Security from CCP Act - provisions related to restoring DOJ's "China Initiative" H.R. 1516, the DHS Restrictions on Confucius Institutes and Chinese Entities of Concern Act - provisions related to the definition of "Chinese entities of concern" and DHS funding S. 2714, the CREATE AI Act - provisions related to NSF's AI programs including NAIRR S. 1956, the Invent Here, Make Here Act - provisions related to manufacturing and commercialization of federally funded research; tech transfer S. 2220, the PREVAIL Act - provisions related to reforms to the PTAB framework H.R. 8333, the BIOSECURE Act - provisions related to prohibitions on certain biotech suppliers S. 4394, the NSF AI Education Act - provisions related to scholarship and fellowship programs in AI at NSF H.R. 6213, the National Quantum Initiative Reauthorization Act - provisions relate to quantum science programs at NSF, DOE, and NASA General issues related to the importance of robust funding for NSF, DOD, NASA, and DOE Office of Science General issues related to research partnerships with the Army Futures Command and the Pathfinder program General issues related to the outlook for NASA reauthorization and budget, including provisions related to Science, Space Technology, and STEM Education General issues related to research security and NSPM-33 General issues related to F&A cost reimbursements General issues related to AI legislation related to science and innovation; and proposals impacting NSF and DOE

Client expense: $40,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Support for biopharmaceutical manufacturing in the U.S.; Reauthorization of Pandemic and All- Hazards Preparedness and Advancing Innovation Act; BioSecure Act - H.R.8333/S. 3558

Client expense: Not reported · Firm income: $50,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to section 301 tariffs. Issues related to H.R.8333 - BIOSECURE Act.

Client expense: $440,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 8333, the BIOSECURE Act; S. 3558 Prohibiting Foreign Access to American Genetic Data Information Act of 2024; communications related to company operations and CRDMO industry, including descriptions of corporate structure, business units, and data handling.

Client expense: $100,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Treasury, Dept of

Implementation and proposed amendments to the Inflation Reduction Act (P.L. 117-169); Innovation in Pediatric Drugs Act of 2023 (H.R. 6664); Biosimilar Red Tape Elimination Act (S.2305); Give Kids a Chance Act of 2023 (H.R. 3433/S.2897); Affordable Prescriptions for Patients Act of 2023 (S. 150); Induced infringement and generic drug labeling; S.3583/H.R. 6986, A bill to address patent thickets; REMEDY Act (S. 1209); Medication Affordability and Patent Integrity Act (S.2780); rare pediatric disease priority review vouchers; Stop STALLING Act (S. 148); Interagency Patent Coordination and Improvement Act of 2023 (S. 79); Preserve Access to Affordable Generics and Biosimilars Act (S. 142); Bayh-Dole; Biosecure Act (H.R. 7085, H.R. 8333, S. 3385); and The Federal Acquisition Security Council Improvement Act (discussion draft).

Client expense: Not reported · Firm income: $290,000

H.R. 6992, S. 2364 - Mapping America's Pharmaceutical Supply (MAPS) Act; H.R. 8333 - BIOSECURE Act: Provisions related to pharmaceutical supply chain and drug shortages.

Client expense: $60,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 8333 - Biosecure Act - entire bill.

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1513, FUTURE Networks Act, all provisions. H.R. 4741, Securing Global Telecommunications Act, all provisions. H.R. 5245, Science and Technology Agreement Enhanced Congressional Notification Act, all provisions. H.R. 7589, ROUTERS Act, all provisions. H.R. 7980, End Chinese Dominance of Electric Vehicles in America Act of 2024, all provisions. H.R. 820, Foreign Adversary Communications Transparency Act, all provisions. H.R. 8333, BIOSECURE Act, all provisions. H.R. 8631, Decoupling from Foreign Adversarial Battery Dependence Act of 2024, all provisions. S. 5190, Blocking Bad Batteries Act, all provisions. H.R. 8315, ENFORCE Act, all provisions. Issues related to Chinese EV Manufacturing; Chinese-Made Battery Storage Systems; Countering Social Media Disinformation; Development of Internet Access Technologies; Foreign Adversaries Use of Artificial Intelligence; Maintaining U.S. Technological Advantages; Protecting U.S. Innovation from Foreign Exploitation; Securing Critical U.S. Infrastructure and Mineral Supply Chains; TikTok Divestment; and U.S. Cybersecurity Capabilities and Strategy (no bill).

Client expense: $160,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to domestic pharmaceutical manufacturing; S.2333 - Pandemic and All-Hazards Preparedness and Response Act reauthorization; S.3558 - Prohibiting Foreign Access to American Genetic Information Act of 2024; H.R. 8333 - BIOSECURE Act.

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 8333, the BIOSECURE Act; S. 3558 Prohibiting Foreign Access to American Genetic Data Information Act of 2024; communications related to company operations and CRDMO industry

Client expense: Not reported · Firm income: $40,000

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

HR 8333, the BIOSECURE Act; S. 3558 Prohibiting Foreign Access to American Genetic Data Information Act of 2024; communications related to company operations and CRDMO industry

Client expense: Not reported · Firm income: $40,000

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

HR 1425 "No WHO Pandemic Preparedness Treaty Without Senate Approval Act," all provisions. HR 2864 "Countering CCP Drones Act," all provisions. HR 3334 "Sanctioning Tyrannical and Oppressive People within the Chinese Communist Party (STOP CCP) Act," all provisions. HR 8152 "Remote Access Security Act," all provisions. HR 8333 "BIOSECURE Act," all provisions. HR 9374 "Stand with Israel Act," all provisions.

Client expense: $180,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES

H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 456: Fairness in Orphan Drug Exclusivity Act H.R. 766: Dr. Michael C. Burgess Preventive Health Savings Act H.R. 830: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes H.R. 885: TRACK Act of 2023 H.R. 1613: Drug Price Transparency in Medicaid Act of 2023 H.R. 1770: Equitable Community Access to Pharmacist Services Act H.R. 1790: Biologics Competition Act of 2023 - To direct the Secretary of Health and Human Services to evaluate the extent to which the substitution of interchangeable biological products is impacted by differences between the system for determining a biological product to be interchangeable and the system for assigning therapeutic equivalence ratings to drugs, and for other purposes H.R. 2534: PROTECT 340B Act of 2023 - Provisions related to the 340B program Bayh-Done march in rights policy issues H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2707: MADE in America Act H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 3008: Drug Shortage Prevention Act of 2023 H.R. 3093: Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023 H.R. 3290: To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program H.R. 3433: Give Kids a Chance Act of 2023 H.R. 3561: Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or PATIENT Act of 2023 H.R. 3839: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications H.R. 4421: Preparing for All Hazards and Pathogens Reauthorization Act H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 4988: Modern Authentication of Pharmaceuticals Act of 2023 H.R. 5376: Share the Savings with Seniors Act  H.R. 5378: Lower Costs, More Transparency Act H.R. 5391: Protecting Patient Access to Cancer and Complex Therapies Act H.R. 5539: ORPHAN Cures Act H.R. 5547: Maintaining Investments in New Innovation Act H.R. 6283: Delinking Revenue from Unfair Gouging or DRUG Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 H.R. 7024: Tax Relief for American Families and Workers Act of 2024 H.R. 7174: Ensuring Pathways to Innovative Cures (EPIC) Act: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 7248: FDA Modernization Act 3.0 H.R. 7623: Telehealth Modernization Act of 2024 H.R. 7635: The 340B PATIENTS Act of 2024 H.R. 8574: 340B Affording Care for Communities and Ensuring a Strong Safety-net (ACCESS) Act H.R. 8333 BIOSECURE Act H.R.8818 American Privacy Rights Act of 2024; Provisions related to pharmaceutical industry S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to PBMs S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs S. 148: Stop STALLING Act - Provisions related to citizen petitions S. 775: Increasing Transparency in Generic Drug Applications Act S. 935: Fair Accountability and Innovative Research Drug Pricing Act of 2023 - Provisions related to drug pricing S. 1067: Ensuring Timely Access to Generics Act of 2023 S. 1130: Health Care PRICE Transparency Act S. 1128: Ensuring Access to Generic Medications Act S. 1214: RARE Act - To set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs; Transparency provisions, Medicare Part D Delinking; Commerical Marketplace Delinking S. 1355: PASTEUR Act of 2023 - Provisions related to antimicrobial resistance policy issues S. 1375: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes S. 1476: Pharmaceutical Research Transparency Act of 2023 S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1589: Safeguarding Patients and Taxpayers Act S. 1906: Promising Pathway Act - Approval pathway policy issues S. 1967: PBM Act S. 2305: Biosimilar Red Tape Elimination Act S. 2333: Pandemic and All-Hazards Preparedness and Response Act S. 2474: Share the Savings with Seniors Act S. 2897: Give Kids a Chance Act of 2023 S. 2973: Modernizing and Ensuring PBM Accountability Act (MEPA) S. 3393: SUPPORT for Patients and Communities Reauthorization Act BioCompete Act (draft) Executive Order of February 28, 2024, Preventing Access to Americans' Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) User fee policy issues Inflation Reduction Act of 2022 (P.L. 117-169) Vaccine provisions of the inflation reduction Act Pharmacy Benefit Manager reform and policy issues Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) Cancer Moonshot Initiative 21st Century Cures 2.0 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Accelerated approval policy issues FDA regulatory approval authority policy issues Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance (AMR) policy issues Supply chain policy issues Mental health policy issues Real world evidence policy issues Clinical trial diversity policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues  Pandemic preparedness policy issues Cybersecurity policy issues Artificial intelligence policy issues

Client expense: $1,510,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE

H.R. 8333: BIOSECURE Act; provisions related to technical issues pertaining to genomics regulation

Client expense: $270,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to drug pricing, implementation of the Inflation Reduction Act, and the ORPHAN Cures Act (H.R. 5539); pharmacy benefit managers legislation; the Food & Drug Administration; issues related to FDA Regulatory Framework and Interaction; informational inquiry related to the BIOSECURE Act (H.R. 8333)

Client expense: $160,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 79/HR 1717 Interagency Patent Coordination and Improvement Act of 2023 S. 113 Prescription Pricing for the People Act of 2023 . S. 1250-the Drug-price Transparency for Consumers Act S.127 Pharmacy Benefit Transparency Act S. 150 Affordable Prescriptions for Patients Act of 2023 S. 148 Stop STALLING Act S. 142 Preserve Access to Affordable Generics and Biosimilars Federal Trade Commission related issues, no specific bill Issues related to the Patent Act, no specific bill Issues related to March-In/Bayh Dole, WTO/TRIPS waiver, no specific bill Issues related to patent thickets/product hopping Issues related to obviousness/ double patenting S.2140 Patent Eligibility Restoration Act of 2023 S.2220/HR 4370 Promoting and Respecting Economically Vital American Innovation Leadership Act S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents H.R. 3858/S.1834: A bill to prohibit the President from negotiating or concluding any withdrawal, suspension, waiver, or modification to the Agreement on Trade-Related Aspects of Intellectual Property Rights without explicit authorization from Congress. H.R. 3535 Advancing Americas Interests Act H.R. 5475 Prohibiting Adversarial Patents Act of 2023 S.3385/HR 8333-- BIOSECURE Act BIOCOMPETE (no bill number)- Issues related to prohibiting the export of biotechnology to certain foreign entities

Client expense: $2,740,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 8333, the BIOSECURE Act; S. 3558 Prohibiting Foreign Access to American Genetic Data Information Act of 2024; communications related to company operations and CRDMO industry, including descriptions of corporate structure, business units, and data handling.

Client expense: $125,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Treasury, Dept of

Implementation and proposed amendments to the Inflation Reduction Act (P.L. 117-169); Innovation in Pediatric Drugs Act of 2023 (H.R. 6664); Biosimilar Red Tape Elimination Act (S. 2305); Give Kids a Chance Act of 2023 (H.R. 3433/S.2897); Affordable Prescriptions for Patients Act of 2023 (S. 150); Induced infringement and generic drug labeling; S.3583/H.R. 6986, A bill to address patent thickets; REMEDY Act (S. 1209); FDA Modernization Act 3.0 (H.R. 7248); Increasing Transparency in Generic Drug Applications Act (S. 775); Medication Affordability and Patent Integrity Act (S. 2780); Patent listing; Requirements for generic drug-device combination products; priority review vouchers; 3-year exclusivity; Biosecure Act (H.R. 7085, H.R. 8333, S. 3385); Biotechnological Innovation and Opportunity for Competitive Economic Transformation Act of 2024 (BioCompete); Invent Here, Make Here (S. 1956).

Client expense: Not reported · Firm income: $300,000

HR 4175 / S 2003 "REPO for Ukrainians Act," all provisions. HR 7476 "Countering Communist China Act," all provisions. HR 8282 "Illegitimate Court Counteraction Act," all provisions. HR 8333 "BIOSECURE Act," all provisions. Issues pertaining to additional aid for Ukraine, provisions relating to accountability measures and impact on drawdown authority. Issues pertaining to aid to Israel. Issues pertaining to a Confronting CCP Human Rights Abusers Act (no bill number).

Client expense: $260,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE