Prohibiting Foreign Access to American Genetic Information Act of 2024
Legislative Progress
Introduced
December 20, 2023
Latest Action
September 23, 2024
Primary Sponsor
Gary C. PetersDemocratic(MI)
Momentum (last 30 days)
0
score
0 actions · 0 new cosponsors · 0 votes
Speed vs cohort
95pct
278d open
vs 5,649 other S bills in the 118th — cohort avg 33d
No CRS summary is available for this bill yet. The source title, actions, sponsors, and text versions below come from Congress.gov.
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 (28)
Placed on Senate Legislative Calendar under General Orders. Calendar No. 521.
Committee on Homeland Security and Governmental Affairs. Reported by Senator Peters with an amendment in the nature of a substitute. With written report No. 118-229.
Committee on Homeland Security and Governmental Affairs. Ordered to be reported with an amendment in the nature of a substitute favorably.
Read twice and referred to the Committee on Homeland Security and Governmental Affairs.
Introduced in Senate
Bills with similar content found using semantic analysis.
Sources: Congress.gov
2025 · first_quarter · Health Issues
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
2024 · fourth_quarter · Science/Technology
HR 8333 / S 3558 BIOSECURE Act
Client expense: $70,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2024 · fourth_quarter · Defense
H.R. 8070; S. 4638; National Defense Authorization Act for Fiscal Year 2025; Issues and provisions related to Title II - O&M; Title III - Procurement; Title IV - RDT&E, Title VI - Defense Health, the Military and National Intelligence programs and environmental restoration and PFAS destruction Technology; Title XXXI DOE National Security Programs. H.R. 8512; S. 4443; Intelligence Authorization Act for FY25; Intelligence Activities including cyber, microelectronics, biotechnology, biopreparedness, biosecurity, research security and intelligence matters relating to China. Draft Bills; Defense Appropriations Bill, 2025; Issues and provisions related to Title II - O&M; Title III - Procurement; Title IV - RDT&E, Title VI - Defense Health, and the Military and National Intelligence programs. S. 3799; PREVENT Pandemics Act; Biosecurity; Biopreparedness; Biotechnology; Congressionally Directed Medical Research Program; Spinal Cord Injury Research Program; Neurotechnology S. 3558; H.R. 7085; A bill to prohibit contracting with certain biotechnology providers, and for other purposes.; All titles and sections. Issues related to NNSA weapons and nonproliferation programs. Issues related to Semiconductor / Microelectronics Manufacturing and Research; implementation of CHIPS and Science Act. Issues related to military health and rehabilitation; veteran rehabilitation; neurotechnology. Issues related to Biosecurity.
Client expense: $210,000 · Firm income: Not reported
2024 · fourth_quarter · Homeland Security
H.R. 8752, Draft Senate Bill; Department of Homeland Security Appropriations Bill, 2025; Issues related to DHS Science and Technology Directorate chem-bio defense mission and laboratory operations, research, and infrastructure; TSA TSL and Procurement, Construction and Improvements; Countering Weapons of Mass Destruction Office issues related to R&D and biodefense; Biowatch and BD21 programs S.1210, H.R. 2791; National Biodefense Analysis and Countermeasures Center Authorization Act of 2023; All titles and sections. S. 3558; H.R. 7085; A bill to prohibit contracting with certain biotechnology providers, and for other purposes.; All titles and sections. Issues related to CWMD; BD21. Issues related to DHS S&T Directorate. Issues related to laboratory facilities and infrastructure.
Client expense: $210,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2024 · fourth_quarter · Health Issues
S. 3799 (117th); Implementation of "PREVENT Pandemics" Act; Issues related to pandemic prevention; testing; surveillance. H.R. 9029; Draft Senate Bill; Labor, HHS Appropriations Bill 2025; Issues related to HHS; pandemic preparedness, vaccines; gene synthesis screening; CDC. Draft Bills; Pandemic All Hazardous Prevent Act (PAHPA); Issues related to MCM PRV; Gene Synthesis Screening. Draft Bills; Securing Gene Synthesis Act; Issues related to gene synthesis products and screening S. 3558; H.R. 7085; A bill to prohibit contracting with certain biotechnology providers, and for other purposes.; All titles and sections. Issues related to COVID-19 testing and vaccine studies; Vaccine durability and efficacy; genomic sequencing; medical countermeasures; autoinjectors; pandemic preparedness and response. Issues related to CDC authorization and appropriations;Consensus Based Entity. Issues related to military health and rehabilitation (neurotechnology).
Client expense: $210,000 · Firm income: Not reported
| Republican |
| MO |
| Katie Boyd Britt | Republican | AL |
| Marco Rubio | Republican | FL |
| Mark R. Warner | Democratic | VA |
| Mitt Romney | Republican | UT |
| Rick Scott | Republican | FL |
| Roger Marshall | Republican | KS |
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2024 · fourth_quarter · Science/Technology
HR 8333 / S 3558 BIOSECURE Act
Client expense: $70,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2024 · fourth_quarter · Health Issues
H.R. 4366, Consolidated Appropriations Act of 2024, including provisions relating to health care H.R. 5027/S. 4469, Chronic Kidney Disease Improvement in Research and Treatment Act of 2023 H.R. 6860, Restore Protections for Dialysis Patients Act H.R. 7085, BIOSECURE Act S. 3558, to prohibit contracting with certain biotechnology providers, and for other purposes Implementation of P.L. 118-14, Continuing Appropriations Act, 2024 and Other Extensions Act, including provisions related to Title III, Health and Human Services. Implications of Supreme Court Decision on Marietta v. DaVita on Medicare Secondary Payer (MSP) statute and commercial group health insurance FY 2025 Appropriations for the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Implementation of P.L. 118-158, the American Relief Act of 2025, including provisions relating to health care
Client expense: $240,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2024 · fourth_quarter · Health Issues
Issues related to drug pricing reform Changes to Public law 117-1769 Inflation Reduction Act Awareness of implications to patients and research and development of Public law 117-1769 Inflation Reduction Act S. 113 Prescription Pricing for the People Act of 2023 S.127 Pharmacy Benefit Manager Transparency Act HR 830/ S 1375 HELP Copays Act HR 485 Protecting Health Care for All Patients Act HR 5378 Lower Costs, More Transparency Act R 2534 PROTECT 340B Act of 2023 HR 3561 the PATIENT Act S. 1542 DRUG Act S. 1967 PBM Act HR 3503 The NIH Clinical Trials Diversity Act Issues related to cardiovascular disease awareness and treatment Issues related to Federal Trade Commission FDA issues Issues related to patient affordability issues, including copay cards, copay accumulators, copay maximizers, National Benefit Payment Parameters Biosimilars reimbursement issues, no specific bill Supply Chain Issues, no specific bill Issues related to 340B Issues related to pharmacy benefit managers Proposed rule: Medicaid Program; Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program HR 4818/ S. 2407 Treat and Reduce Obesity Act S. 2305 Biosimilar Red Tape Elimination Act S. 2129 Ensuring Access to Lower-Cost Medicines for Seniors Act Issues related to PAHPA reauthorization Modernizing and Ensuring PBM Accountability Act (Finance Committee) S. 652/ HR2630 SAFE Step Act S 2474/ HR 5376 Share the Savings with Seniors Act S 2456 Protecting Seniors from High Drug Costs Act HR4881 To amend title XVIII of the Social Security Act to limit cost sharing for drugs under the Medicare program HR 3281 Protecting Patients Against PBM Abuses Act HR 4822 Health Care Price Transparency Act of 2023 S 1339 Pharmacy Benefit Manager Reform Act HR 2679 Pharmacy Benefits Manager Accountability Act HR 4507 Transparency in Coverage Act of 2023 HR 1352 Increasing Access to Biosimilars Act of 2023 HR 2880 Protecting Patients Against PBM Abuses Act Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. HR 5539 Orphan Cures Act HR 5547 Maintaining Investments in New Innovation Act S 3558 BIOSECURE Act HR 7174 Ensuring Pathways to Innovative Cures (EPIC Act) S Res 566 Cholesterol Education Month 2024 HR 7635 340B PATIENTS Act of 2024 H.R. 5391 / S. 2764 The Protecting Patient Access to Cancer and Complex Therapies Act H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act. HR 5376 Share the Savings With Seniors Act S 3430 Mental Health, Lower Cost Drugs and Extenders Package. BIOCOMPETE (no bill number)- Issues related to prohibiting the export of biotechnology to certain foreign entities HR 8412 Clinical Trial Modernization Act S 5573 Skinny Labels, Big Savings Act HR 10515 American Relief Act
Client expense: $2,780,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2024 · fourth_quarter · Homeland Security
Issues related to biosecurity; H.R. 7085/S. 3558, BIOSECURE Act; H.R. 8070, Servicemember Quality of Life Improvement and National Defense Authorization Act for Fiscal Year 2025; S. 4638, National Defense Authorization Act for Fiscal Year 2025; H.R. 10545, American Relief Act, 2025
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2024 · fourth_quarter · Health Issues
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
2024 · fourth_quarter · Health Issues
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
2024 · fourth_quarter · Science/Technology
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
2024 · fourth_quarter · Copyright/Patent/Trademark
Antitrust Legislation ---Oversight Pharmacy Benefit Managers Artificial Intelligence (AI) ---Patent eligibility for inventions created using AI tools Bayh-Dole Act/Tech Transfer ---Bayh-Dole Act ---March-In Rights ---NIST RFI Regarding the Draft Interagency Guidance Framework for Considering the Exercise of March in Rights ---Reasonable Pricing Clause Compulsory Licensing Data Privacy Issues ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---H.R.8818: American Privacy Rights Act of 2024 ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Diversity in Patenting ---S.2566: Inventor Diversity for Economic Advancement (IDEA) Act Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents. ---S.2780: Medication Affordability and Patient Integrity Act ---S.3583/H.R.6986: A bill to address patent thickets ---S.5573: A bill to amend title 35, United States Code, to provide for a safe harbor from infringement of a method of use patent relating to drugs or biological products. ---H.R.5475: Prohibiting Adversarial Patents Act of 2023 (Fitzgerald - WI) ---H.R.6275: Protecting Consumer Access to Generic Drugs Act ---FTC Orange Book Delisting Initiative ---Orange Book Listing ---PTO Proposed Rules on Terminal Disclaimer Practice ---Restrictions on Intellectual Property Rights Foreign Drug Data Protection Law ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Intellectual Property Enforcement ---China ---TRIPS Waiver Patent Reform ---H.R.4575: Prohibiting Adversarial Patents Act (PAPA) ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.2140: Patent Eligibility Restoration Act (PERA) ---S.2220/H.R.4370: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act ---Patent Litigation Reform ---The USPTO Request for Comments: Experimental Use Defense 89 Fed.Reg 53963 Patenting of Biological Inventions ---S.2140: Patent Eligibility Restoration Act (PERA) ---Section 101 Modernization World Health Organization (WHO) ---WHO Pandemic Preparedness Accord World Intellectual Property Office (WIPO) ---Treaty on Intellectual Property, Genetic Resources, and Associated Traditional Knowledge World Trade Organization (WTO) ---TRIPS Waiver
Client expense: $1,460,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office
2024 · fourth_quarter · Health Issues
340B Drug Discount Program ---H.R.8574: 340B Affording Care for Communities and Ensuring a Strong Safety-net Act ---S.1133: 340B Accountability Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---PROTECT 340B Act ---SUSTAIN 340B Act Accelerated Approval Access to non-human Primates (NHPs) Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3832: Disease X Act of 2023 ---H.R.7085: BIOSECURE Act ---S.4667: Risky Research Review Act ---Bio COMPETES (Draft) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---House GOP RFI on Supply Chain ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---American Pandemic Preparedness Plan (AP3) ---Gain of function (Viral Gain of Function Research Moratorium Act, Risky Research Act) ---MCM PRV Program ---NDAA ---Reasonable Pricing Clauses in BARDA Contracts ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---VICP Loopholes ---White House National Biodefense Strategy ---WHO Pandemic Preparedness Accord Biosimilars ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.2305: Biosimilar Red Tape Elimination Act ---Bio COMPETES (Draft) ---Biosimilar Copay ---House GOP RFI on Supply Chain ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy Climate Change Clinical Trial Data in China Data Privacy ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---H.R.8818: American Privacy Rights Act of 2025 ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---Decentralized Clinical Trials ---Implementation of Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act Drug Evaluation and Review ---S.1906: Promising Pathway Act Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents. ---S.2780: Medication Affordability & Patient Integrity Act ---S.3583/H.R.6986: A bill to address patent thickets ---S.5573: A bill to amend title 35, United States Code, to provide for a safe harbor from infringement of a method of use patent relating to drugs or biological products. ---Affordable Prescriptions for Patients Act ---Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.5547/S.476: Maintaining Investments and New Innovation (MINI) Act ---H.R.6283: DRUG Act ---H.R.7174: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.775: Increasing Transparency in Generic Drug Application ---S.1067: Ensuring Timely Access to Generics ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents. ---S.2305: Biosimilar Red Tape Elimination Act ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---H.R.2408: Access to Innovative Treatments Act ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Negotiation and Competitive Licensing Act ---National Coverage Determination ---Patients Before Monopolies (PBM) Act ---PBM Reform ---Patient Cost-Sharing and Implementation ---Strengthening Innovation in Medicare and Medicaid Act Efforts to expand the Bio Economy & Bio Manufacturing Foreign Drug Data Protection Laws ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---MCM PRV ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2025 Appropriations ---VICP Funding for FDA ---FY 2025 Appropriations ---Creating Hope Reauthorization Act ---Prescription Drug User Fee Act (PDUFA) VII Implementation Funding for Health Resources and Services Administration (HRSA) ---FY 2025 Appropriations Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2025 Appropriations Funding for National Institutes of Health ---FY 2025 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) ---Funding for Womens Health Research Generic Drug Entry ---H.R.6973: Generic Drug Application Review Reforms ---S.148: Stop STALLING Act ---S.4351: Enhanced Access to Affordable Medicines Act Issues Relating to Medical Research and Animal Testing Models ---H.R.7248: FDA Modernization Act 3.0 Medicaid ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4758: Accelerating Kids Access to Care Act ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Alternative Payment Arrangements for Gene Therapies ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Medicaid Drug Rebate Program Rule ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2025 Opioid Crisis ---H.R.4531/S.2933: Support for Patients and Communities Reauthorization Act ---Non-Opioid Analgesics ---Coverage and Reimbursement Orphan Drug Issues ---H.R.3433: Give Kids a Chance Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.6664: Innovation in Pediatric Drugs Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.1214: Retaining Access and Restoring Exclusivity (RARE) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---Implementation of the Prepare for and Respond to Existing Viruses ---Emerging New Threats and (PREVENT) Pandemics Act ---Monoclonal Antibody Coverage and Utilization ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.7384/S4583: Creating Hope Reauthorization Act of 2024 ---Helping Experts Accelerate Rare Treatments (HEART)Act ---Rare Disease Pilot Program ---Speeding Therapy Access Today (STAT) Act Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5378: Lower Costs, More Transparency Act ---H.R.5796/S424: Protect our Seniors Act ---Administration Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---In-Home Administration of Part B Drugs ---Lower Costs, More Cures Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---H.R.5260: Reduced Costs and Continued Cures Act ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence Vaccine Injury Compensation Program ---FY 2025 Appropriations ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---VICP CICP (Discussion Draft)
Client expense: $1,460,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Security Council (NSC), SENATE, State, Dept of (DOS), White House Office
2024 · fourth_quarter · Pharmacy
Issues related to prescription drug value, including implementation of the Inflation Reduction Act (PL 117-169). Issues related to vaccine development and distribution. Issues related to insulin pricing. Issues related to FDA regulation of pharmaceuticals. Issues related to prescription drug pricing and pharmacy benefit manager business practices, including S. 127, Pharmacy Benefit Manager Transparency Act, S.1339 - Pharmacy Benefit Manager Reform Act, H.R. 2679, the PBM Accountability Act, H.R.4822 - Health Care Price Transparency Act, H.R. 5378 - Lower Costs, More Transparency Act. Issues related to the 340B program, including H.R. 3290, to ensure transparency and oversight of the 340B drug discount program. Pandemic All-Hazards Preparedness Act (PAHPA) reauthorization, including S.2333 - Pandemic and All-Hazards Preparedness and Response Act. S.3558 - Biosecure. H.R.10545, FY25 Continuing Appropriations.
Client expense: Not reported · Firm income: $40,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2024 · fourth_quarter · Health Issues
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
Discussions regarding drug pricing and supply chain issues, rare diseases, gene therapy and value based arrangements; biosimilar support; Alzheimer's policy, screening and diagnosis and appropriations, PET scan coverage and reimbursement, and dementia care Inflation Reduction Act implementation (P.L.117-1769), including provisions related to corporate taxes, Medicare, research and development, and prescription drug pricing S.1214, RARE Act S.3558, BioSecure Act General issues regarding Priority Review Voucher Reauthorization, no specific bill number
Client expense: $700,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2024 · fourth_quarter · Trade (domestic/foreign)
Issues related to pharmaceutical IP and supply chain; monitoring H.R.7085/S.3558, BIOSECURE Act.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2024 · fourth_quarter · Health Issues
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
2024 · fourth_quarter · Economics/Economic Development
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
2024 · fourth_quarter · Health Issues
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
2024 · third_quarter · Defense
H.R. 8070; S. 4638; National Defense Authorization Act for Fiscal Year 2025; Issues and provisions related to Title II - O&M; Title III - Procurement; Title IV - RDT&E, Title VI - Defense Health, the Military and National Intelligence programs and environmental restoration and PFAS destruction Technology; Title XXXI DOE National Security Programs. H.R. 8512; S. 4443; Intelligence Authorization Act for FY25; Intelligence Activities including cyber, microelectronics, biotechnology, biopreparedness, biosecurity, research security and intelligence matters relating to China. Draft Bills; Defense Appropriations Bill, 2025; Issues and provisions related to Title II - O&M; Title III - Procurement; Title IV - RDT&E, Title VI - Defense Health, and the Military and National Intelligence programs. S. 3799; PREVENT Pandemics Act; Biosecurity; Biopreparedness; Biotechnology; Congressionally Directed Medical Research Program; Spinal Cord Injury Research Program; Neurotechnology S. 3558; H.R. 7085; A bill to prohibit contracting with certain biotechnology providers, and for other purposes.; All titles and sections. Issues related to NNSA weapons and nonproliferation programs. Issues related to Semiconductor / Microelectronics Manufacturing and Research; implementation of CHIPS and Science Act. Issues related to military health and rehabilitation; veteran rehabilitation; neurotechnology. Issues related to Biosecurity.
Client expense: $230,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2024 · third_quarter · Health Issues
S. 3799 (117th); Implementation of "PREVENT Pandemics" Act; Issues related to pandemic prevention; testing; surveillance. H.R. 9029; Draft Senate Bill; Labor, HHS Appropriations Bill 2025; Issues related to HHS; pandemic preparedness, vaccines; gene synthesis screening; CDC. Draft Bills; Pandemic All Hazardous Prevent Act (PAHPA); Issues related to MCM PRV; Gene Synthesis Screening. Draft Bills; Securing Gene Synthesis Act; Issues related to gene synthesis products and screening S. 3558; H.R. 7085; A bill to prohibit contracting with certain biotechnology providers, and for other purposes.; All titles and sections. Issues related to COVID-19 testing and vaccine studies; Vaccine durability and efficacy; genomic sequencing; medical countermeasures; autoinjectors; pandemic preparedness and response. Issues related to CDC authorization and appropriations;Consensus Based Entity. Issues related to military health and rehabilitation (neurotechnology).
Client expense: $230,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2024 · third_quarter · Homeland Security
H.R. 8752, Draft Senate Bill; Department of Homeland Security Appropriations Bill, 2025; Issues related to DHS Science and Technology Directorate chem-bio defense mission and laboratory operations, research, and infrastructure; TSA TSL and Procurement, Construction and Improvements; Countering Weapons of Mass Destruction Office issues related to R&D and biodefense; Biowatch and BD21 programs S.1210, H.R. 2791; National Biodefense Analysis and Countermeasures Center Authorization Act of 2023; All titles and sections. S. 3558; H.R. 7085; A bill to prohibit contracting with certain biotechnology providers, and for other purposes.; All titles and sections. Issues related to CWMD; BD21. Issues related to DHS S&T Directorate. Issues related to laboratory facilities and infrastructure.
Client expense: $230,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2024 · third_quarter · Health Issues
H.R. 4366, Consolidated Appropriations Act of 2024, including provisions relating to health care H.R. 5027/S. 4469, Chronic Kidney Disease Improvement in Research and Treatment Act of 2023 H.R. 6860, Restore Protections for Dialysis Patients Act H.R. 7085, BIOSECURE Act S. 3558, to prohibit contracting with certain biotechnology providers, and for other purposes Implementation of P.L. 118-14, Continuing Appropriations Act, 2024 and Other Extensions Act, including provisions related to Title III, Health and Human Services. Implications of Supreme Court Decision on Marietta v. DaVita on Medicare Secondary Payer (MSP) statute and commercial group health insurance FY 2025 Appropriations for the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Client expense: $280,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2024 · third_quarter · Trade (domestic/foreign)
H.R. 4307: Medical Supply Chain Resiliency Act H.R. 7085: BIOSECURE Act S. 1956: Invent Here, Make Here Act of 2023 S. 2115: Medical Supply Chain Resiliency Act S. 3558: BIOSECURE 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: $1,540,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)
2024 · third_quarter · Health Issues
Issues related to drug pricing reform Changes to Public law 117-1769 Inflation Reduction Act Awareness of implications to patients and research and development of Public law 117-1769 Inflation Reduction Act S. 113 Prescription Pricing for the People Act of 2023 S.127 Pharmacy Benefit Manager Transparency Act HR 830/ S 1375 HELP Copays Act HR 485 Protecting Health Care for All Patients Act HR 5378 Lower Costs, More Transparency Act R 2534 PROTECT 340B Act of 2023 HR 3561 the PATIENT Act S. 1542 DRUG Act S. 1967 PBM Act HR 3503 The NIH Clinical Trials Diversity Act Issues related to cardiovascular disease awareness and treatment Issues related to Federal Trade Commission FDA issues Issues related to patient affordability issues, including copay cards, copay accumulators, copay maximizers, National Benefit Payment Parameters Biosimilars reimbursement issues, no specific bill Supply Chain Issues, no specific bill Issues related to 340B Issues related to pharmacy benefit managers Proposed rule: Medicaid Program; Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program HR 4818/ S. 2407 Treat and Reduce Obesity Act S. 2305 Biosimilar Red Tape Elimination Act S. 2129 Ensuring Access to Lower-Cost Medicines for Seniors Act Issues related to PAHPA reauthorization Modernizing and Ensuring PBM Accountability Act (Finance Committee) S. 652/ HR2630 SAFE Step Act S 2474/ HR 5376 Share the Savings with Seniors Act S 2456 Protecting Seniors from High Drug Costs Act HR4881 To amend title XVIII of the Social Security Act to limit cost sharing for drugs under the Medicare program HR 3281 Protecting Patients Against PBM Abuses Act HR 4822 Health Care Price Transparency Act of 2023 S 1339 Pharmacy Benefit Manager Reform Act HR 2679 Pharmacy Benefits Manager Accountability Act HR 4507 Transparency in Coverage Act of 2023 HR 1352 Increasing Access to Biosimilars Act of 2023 HR 2880 Protecting Patients Against PBM Abuses Act Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. HR 5539 Orphan Cures Act HR 5547 Maintaining Investments in New Innovation Act S 3558 BIOSECURE Act HR 7174 Ensuring Pathways to Innovative Cures (EPIC Act) S Res 566 Cholesterol Education Month 2024 HR 7635 340B PATIENTS Act of 2024 H.R. 5391 / S. 2764 The Protecting Patient Access to Cancer and Complex Therapies Act H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act. HR 5376 Share the Savings With Seniors Act S 3430 Mental Health, Lower Cost Drugs and Extenders Package. BIOCOMPETE (no bill number)- Issues related to prohibiting the export of biotechnology to certain foreign entities HR 8412 Clinical Trial Modernization Act
Client expense: $2,770,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2024 · third_quarter · Medical/Disease Research/Clinical Labs
H.R.7085 - BIOSECURE Act S.3558 - A bill to prohibit contracting with certain biotechnology providers, and for other purposes (Senate BIOSECURE Act) H.R.7024 - Tax Relief for American Families and Workers Act
Client expense: $50,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2024 · third_quarter · Health Issues
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
2024 · third_quarter · Health Issues
340B Drug Discount Program ---H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act ---S1133: 350B Accountability Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---PROTECT 340B Act ---SUSTAIN 340B Act Accelerated Approval Access to non-human Primates (NHPs) Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3832: Disease X Act of 2023 ---H.R.7085: BIOSECURE Act ---S. 4667 Risky Research Review Act ---Bio COMPETES (Draft) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---House GOP RFI on Supply Chain ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---American Pandemic Preparedness Plan (AP3) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---MCM PRV Program ---NDAA ---Reasonable Pricing Clauses in BARDA Contracts ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---VICP Loopholes ---White House National Biodefense Strategy ---WHO Pandemic Preparedness Accord Biosimilars ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.2305: Biosimilar Red Tape Elimination Act ---Bio COMPETES (Draft) ---Biosimilar Copay ---House GOP RFI on Supply Chain ---Interchangeability and Pharmacy Substitution ---Reimbursement Cell & Gene Therapy Climate Change ---FY 2025 Appropriations Clinical Trial Data in China Data Privacy ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---H.R. 8818: American Privacy Rights Act of 2025 ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---Decentralized Clinical Trials ---Implementation of Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act Drug Evaluation and Review ---S.1906: Promising Pathway Act ---COVID-19 Lessons Learned ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---S. 2780 Medication Affordability & Patient Integrity Act ---S.3583/H.R.6986: A bill to address patent thickets ---Affordable Prescriptions for Patients Act ---Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.1790: Biologics Competition Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.5547/S.476: Maintaining Investments and New Innovation (MINI) Act ---H.R.6283: DRUG Act ---H.R.7174: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.775: Increasing Transparency in Generic Drug Application ---S.1067: Ensuring Timely Access to Generics ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents, ---S.2305: Biosimilar Red Tape Elimination Act ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---H.R.2408: Access to Innovative Treatments Act ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Negotiation and Competitive Licensing Act ---National Coverage Determination ---PBM Reform ---Patient Cost-Sharing and Implementation ---Strengthening Innovation in Medicare and Medicaid Act Efforts to expand the Bio Economy & Bio Manufacturing Foreign Drug Data Protection Laws ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---MCM PRV ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2025 Appropriations ---VICP Funding for FDA ---FY 2025 Appropriations ---Creating Hope Reauthorization Act ---Prescription Drug User Fee Act (PDUFA) VII Implementation Funding for Health Resources and Services Administration (HRSA) ---FY 2025 Appropriations Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2025 Appropriations Funding for National Institutes of Health ---FY 2025 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) ---Funding for Womens Health Research Generic Drug Entry ---S.148: Stop STALLING Act ---S.775: Increasing Transparency in Generic Drug Applications Act ---S.4351: Enhanced Access to Affordable Medicines Act ---H.R 6973: Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing Models ---H.R.7248: FDA Modernization Act 3.0 Medicaid ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Encouraging Innovation Benefit Design to Lower Costs for Seniors Act ---Medicaid Drug Rebate Program Rule ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2025 Opioid Crisis ---H.R.4531/2933: SUPPORT Act ---Non-Opioid Analgesics ---Transparency ---Coverage and Reimbursement Orphan Drug Issues ---H.R.3433 - Give Kids a Chance Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.6664: Innovation in Pediatric Drugs Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.1214: Retaining Access and Restoring Exclusivity (RARE) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---Implementation of the Prepare for and Respond to Existing Viruses ---Emerging New Threats and (PREVENT) Pandemics Act ---Monoclonal Antibody Coverage and Utilization ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.7384/S4583: Creating Hope Reauthorization Act of 2024 ---Helping Experts Accelerate Rare Treatments (HEART)Act ---Rare Disease Pilot Program ---Speeding Therapy Access Today (STAT) Act Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5378: Lower Costs, More Transparency Act ---H.R.5796/S424: Protect our Seniors Act ---Administration Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---In-Home Administration of Part B Drugs ---Lower Costs, More Cures Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---H.R.5260: Reduced Costs and Continued Cures Act ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence Vaccine Injury Compensation Program ---FY 2025 Appropriations ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---VICP CICP (Discussion Draft)
Client expense: $1,680,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office
2024 · third_quarter · Medicare/Medicaid
340B Drug Discount Program ---H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---S1133: 350B Accountability Act ---PROTECT 340B Act ---SUSTAIN 340B Act Accelerated Approval Access to non-human Primates (NHPs) Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3832: Disease X Act of 2023 ---H.R.7085: BIOSECURE Act ---American Pandemic Preparedness Plan (AP3) ---Bio COMPETES (Draft) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---House GOP RFI on Supply Chain ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---MCM PRV Program ---NDAA ---Reasonable Pricing Clauses in BARDA Contracts ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---VICP Loopholes ---White House National Biodefense Strategy ---WHO Pandemic Preparedness Accord Biosimilars ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.2305: Biosimilar Red Tape Elimination Act ---Biosimilar Copay ---BSUFA Negotiations ---Implementation of BSUFA Agreement ---Interchangeability and Pharmacy Substitution ---Reimbursement Cell & Gene Therapy Climate Change ---FY 2025 Appropriations Clinical Trial Data in China Data Privacy ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---HR 8818: American Privacy Rights Act of 2024 ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Diversity & Inclusion ---Decentralized Clinical Trials ---Implementation of Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act Drug Evaluation and Review ---S.1906: Promising Pathway Act ---COVID-19 Lessons Learned ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---S.2780 - Medication Affordability and Patent Integrity Act ---S.3583/H.R.6986: A bill to address patent thickets ---Affordable Prescriptions for Patients Act ---Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---FY2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.1790: Biologics Competition Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.5547: Maintaining Investments and New Innovation (MINI) Act ---H.R.6283: DRUG Act ---H.R.7174: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.775: Increasing Transparency in Generic Drug Application ---S.1067: Ensuring Timely Access to Generics ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents, ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Access to Innovative Treatments Act ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Negotiation and Competitive Licensing Act ---National Coverage Determination ---PBM Reform ---Patient Cost-Sharing and Implementation ---Strengthening Innovation in Medicare and Medicaid Act Foreign Drug Data Protection Laws ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain ---Regulatory Harmonization Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Generic Drug Entry ---S.148: Stop STALLING Act ---S.775: Increasing Transparency in Generic Drug Applications Act ---Enhanced Access to Affordable Medicines Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing Models ---H.R.7248: FDA Modernization Act 3.0 Medicaid ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Encouraging Innovation Benefit Design to Lower Costs for Seniors Act ---Medicaid Drug Rebate Program ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2025 Opioid Crisis ---H.R.4531/S.2933: SUPPORT Act ---Non-Opioid Analgesics ---Transparency ---Coverage and Reimbursement Orphan Drug Issues ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.6664: Innovation in Pediatric Drugs Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.1214: Retaining Access and Restoring Exclusivity (RARE) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---House GOP RFI on Supply Chain ---Implementation of the Prepare for and Respond to Existing Viruses ---Monoclonal Antibody Coverage and Utilization ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.7384/S.4583: Creating Hope Reauthorization Act of 2024 ---Helping Experts Accelerate Rare Treatments (HEART)Act ---Rare Disease Pilot Program ---Speeding Therapy Access Today (STAT) Act Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5378: Lower Costs, More Transparency Act ---Administration Rebate Rule ---CMMI Authority ---In-Home Administration of Part B Drugs ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---Adult Immunization ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence Vaccine Injury Compensation Program ---FY 2025 Appropriations ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---VICP CICP (Discussion Draft)
Client expense: $1,680,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office
2024 · third_quarter · Copyright/Patent/Trademark
Antitrust Legislation ---Oversight Pharmacy Benefit Managers Artificial Intelligence (AI) Bayh-Dole Act/Tech Transfer ---S.1956 Invent Here, Make Here Act of 2023 (Baldwin) ---Bayh-Dole Act ---March-In Rights ---NIST RFI Regarding the Draft Interagency Guidance Framework for Considering the Exercise of March in Rights ---Reasonable Pricing Clause Compulsory Licensing Data Privacy Issues ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---H.R. 8818: American Privacy Rights Act of 2024 ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Diversity in Patenting ---S.2566: Inventor Diversity for Economic Advancement (IDEA) Act Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---S. 2780 - Medication Affordability and Patient Integrity Act ---S.3583/H.R.6986: A bill to address patent thickets ---H.R.5475 Prohibiting Adversarial Patents Act of 2023 (Fitzgerald - WI) ---H.R. 6275 Protecting Consumer Access to Generic Drugs Act ---FTC Orange Book Delisting Initiative ---Orange Book Listing ---PTO Proposed Rules on Terminal Disclaimer Practice ---Restrictions on Intellectual Property Rights Foreign Drug Data Protection Law ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Intellectual Property Enforcement ---China ---TRIPS Waiver Patent Reform ---H.R.4575: Prohibiting Adversarial Patents Act (PAPA) ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.2140: Patent Eligibility Restoration Act (PERA) ---S.2220/H.R.4370: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act ---Patent Litigation Reform ---The USPTO Request for Comments: Experimental Use Defense 89 Fed.Reg 53963 Patenting of Biological Inventions ---S.2140: Patent Eligibility Restoration Act (PERA) ---Section 101 Modernization World Health Organization (WHO) ---WHO Pandemic Preparedness Accord World Intellectual Property Office (WIPO) ---Treaty on Intellectual Property, Genetic Resources, and Associated Traditional Knowledge World Trade Organization (WTO) ---TRIPS Waiver
Client expense: $1,680,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office
2024 · third_quarter · Trade (domestic/foreign)
CFIUS and Foreign Investment Drug Importation Drug Pricing ---Reference Pricing in Drug Reimbursement Foreign Agricultural Biotechnology Laws and Regulations ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations ---International Consistency of Regulation for Gene Edited Products ---Korea Biotechnology Regulations ---Mexico Decree Banning Genetically Modified Corn Foreign Drug Data Protection Laws ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Genetically Engineered (GE) Animals ---International Consistency of Regulation for Gene Edited Products Genetically Engineered (GE) Plants ---International Consistency of Regulation for Gene Edited Products Global Supply Chain Resiliency ---B5 Coalition on Supply Chain Resiliency ---Issues Relating to Non-Human Primate Shortages Intellectual Property International Enforcement ---China Synthetic Biotech US-China Trade Agreement ---Ag-Biotech Provisions ---IP Provisions World Health Organization (WHO) ---WHO Pandemic Preparedness Accord World Intellectual Property Office (WIPO) ---Treaty on Intellectual Property, Genetic Resources, and Associated Traditional Knowledge World Trade Organization (WTO) ---TRIPS Waiver
Client expense: $1,680,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office
2024 · third_quarter · Homeland Security
Issues related to biosecurity; H.R. 7085/S. 3558, BIOSECURE Act; H.R. 8070, Servicemember Quality of Life Improvement and National Defense Authorization Act for Fiscal Year 2025; S. 4638, National Defense Authorization Act for Fiscal Year 2025
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2024 · third_quarter · Health Issues
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
2024 · third_quarter · Trade (domestic/foreign)
H.R. 4307: Medical Supply Chain Resiliency Act H.R. 7085: BIOSECURE Act S. 1956: Invent Here, Make Here Act of 2024 S. 2115: Medical Supply Chain Resiliency Act S. 3558: Prohibiting Foreign Access to American Genetic Information Act of 2024 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: $6,880,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2024 · third_quarter · Health Issues
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
2024 · third_quarter · Trade (domestic/foreign)
Issues related to pharmaceutical IP and supply chain; monitoring H.R.7085/S.3558, BIOSECURE Act.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Discussions regarding drug pricing and supply chain issues, rare diseases, gene therapy and value based arrangements; biosimilar support; Alzheimer's policy, screening and diagnosis and appropriations, PET scan coverage and reimbursement, and dementia care Inflation Reduction Act implementation (P.L.117-1769), including provisions related to corporate taxes, Medicare, research and development, and prescription drug pricing S.1214, RARE Act S.3558, BioSecure Act General issues regarding Priority Review Voucher Reauthorization, no specific bill number
Client expense: $710,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2024 · third_quarter · Pharmacy
Issues related to prescription drug value, including implementation of the Inflation Reduction Act (PL 117-169). Issues related to vaccine development and distribution. Issues related to insulin pricing. Issues related to FDA regulation of pharmaceuticals. Issues related to prescription drug pricing and pharmacy benefit manager business practices, including S. 127, Pharmacy Benefit Manager Transparency Act, S.1339 - Pharmacy Benefit Manager Reform Act, H.R. 2679, the PBM Accountability Act, H.R.4822 - Health Care Price Transparency Act, H.R. 5378 - Lower Costs, More Transparency Act. Issues related to the 340B program, including H.R. 3290, to ensure transparency and oversight of the 340B drug discount program. Pandemic All-Hazards Preparedness Act (PAHPA) reauthorization, including S.2333 - Pandemic and All-Hazards Preparedness and Response Act. S.3558 - Biosecure.
Client expense: Not reported · Firm income: $40,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2024 · third_quarter · Defense
H.R. 7085, BIOSECURE ACT S. 3385, A bill to prohibit contracting with certain biotechnology providers S. 3558, A bill to prohibit contracting with certain biotechnology providers
Client expense: $970,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES
2024 · third_quarter · Health Issues
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
2024 · third_quarter · Health Issues
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
2024 · third_quarter · Economics/Economic Development
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
2024 · second_quarter · Trade (domestic/foreign)
H.R. 405: Essential Medicines Strategic Stockpile Act of 2023 H.R. 4307: Medical Supply Chain Resiliency Act H.R. 3858: No Free TRIPS Act H.R. 7085: BIOSECURE Act S. 845: Short on Competition Act S. 1834: No Free TRIPS Act S. 2115: Medical Supply Chain Resiliency Act S. 3558: BIOSECURE 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: $1,510,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)
2024 · second_quarter · Health Issues
S. 3799 (117th); Implementation of "PREVENT Pandemics" Act; Issues related to pandemic prevention; testing; surveillance. H.R. 9029; Draft Senate Bill; Labor, HHS Appropriations Bill 2025; Issues related to HHS; pandemic preparedness, vaccines; gene synthesis screening; CDC. Draft Bills; Pandemic All Hazardous Prevent Act (PAHPA); Issues related to MCM PRV; Gene Synthesis Screening. Draft Bills; Securing Gene Synthesis Act; Issues related to gene synthesis products and screening S. 3558; H.R. 7085; A bill to prohibit contracting with certain biotechnology providers, and for other purposes.; All titles and sections. Issues related to COVID-19 testing and vaccine studies; Vaccine durability and efficacy; genomic sequencing; medical countermeasures; autoinjectors; pandemic preparedness and response. Issues related to CDC authorization and appropriations;Consensus Based Entity. Issues related to military health and rehabilitation (neurotechnology).
Client expense: $260,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2024 · second_quarter · Defense
H.R. 8070; S. 4638; National Defense Authorization Act for Fiscal Year 2025; Issues and provisions related to Title II - O&M; Title III - Procurement; Title IV - RDT&E, Title VI - Defense Health, the Military and National Intelligence programs and environmental restoration and PFAS destruction Technology. Issues related to Senate provision on Price Anderson Act H.R. 8512; S. 4443; Intelligence Authorization Act for FY25; Intelligence Activities including cyber, microelectronics, biotechnology, biopreparedness, biosecurity and intelligence matters relating to China Draft Bills; Defense Appropriations Bill, 2025; Issues and provisions related to Title II - O&M; Title III - Procurement; Title IV - RDT&E, Title VI - Defense Health, and the Military and National Intelligence programs. S. 3799; PREVENT Pandemics Act; Biosecurity; Biopreparedness; Biotechnology; Congressionally Directed Medical Research Program; Spinal Cord Injury Research Program; Neurotechnology S. 3558; H.R. 7085; A bill to prohibit contracting with certain biotechnology providers, and for other purposes.; All titles and sections. Issues related to NNSA weapons and nonproliferation programs. Issues related to Semiconductor / Microelectronics Manufacturing and Research; implementation of CHIPS and Science Act. Issues related to military health and rehabilitation; veteran rehabilitation; neurotechnology. Issues related to Biosecurity.
Client expense: $260,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2024 · second_quarter · Homeland Security
H.R. 8752, Draft Senate Bill; Department of Homeland Security Appropriations Bill, 2025; Issues related to DHS Science and Technology Directorate chem-bio defense mission and laboratory operations, research, and infrastructure; TSA TSL and Procurement, Construction and Improvements; Countering Weapons of Mass Destruction Office issues related to R&D and biodefense; Biowatch and BD21 programs S.1210, H.R. 2791; National Biodefense Analysis and Countermeasures Center Authorization Act of 2023; All titles and sections. S. 3558; H.R. 7085; A bill to prohibit contracting with certain biotechnology providers, and for other purposes.; All titles and sections. Issues related to CWMD; BD21. Issues related to DHS S&T Directorate. Issues related to laboratory facilities and infrastructure.
Client expense: $260,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2024 · second_quarter · Homeland Security
Issues related to biosecurity; H.R. 7085/S. 3558, BIOSECURE Act; General monitoring of the 2025 NDAA
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2024 · second_quarter · Science/Technology
HR 8070 National Defense Authorization Act for FY2025 HR 6213National Quantum Initiative Reauthorization Act S 4207Spectrum and National Security Act of 2024 S 3558/HR 7085BIOSECURE Act 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