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Expedited Access to Biosimilars Act
Legislative Progress
Momentum (last 30 days)
0
score
0 actions · 0 new cosponsors · 0 votes
Speed vs cohort
99pct
473d open
vs 5,674 other S bills in the 119th — cohort avg 32d
Expedited Access to Biosimilars Act This bill modifies statutory requirements for demonstrating that a proposed biological product (e.g., a drug or vaccine) is biosimilar to a reference (brand-name) product. Specifically, the bill eliminates the need for a clinical efficacy study unless the Food and Drug Administration (FDA) determines such a study is necessary. Under current law, applicants seeking FDA approval of a proposed biosimilar must submit certain studies and assessments, including a clinical efficacy study demonstrating the safety, purity, and potency of the proposed biosimilar in relevant conditions of use. However, the FDA has discretion not to require studies and assessments it deems unnecessary. (For example, the FDA released draft guidance in October 2025 indicating that clinical efficacy studies may be unnecessary for a class of proposed biosimilars, known as therapeutic protein products, in some circumstances.) The bill generally eliminates the requirement that a biosimilar applicant submit a clinical efficacy study but authorizes the FDA to require such a study if necessary. If requiring a clinical efficacy study, the FDA must provide a written determination of necessity to the applicant within a specified period. Separately, the bill eliminates a requirement that a biosimilar application be reviewed by the same FDA division responsible for review of the reference application.
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Filing registrants (19)
Placed on Senate Legislative Calendar under General Orders. Calendar No. 520.
Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced in Senate
Bills with similar content found using semantic analysis.
Sources: Congress.gov
2026 · third_quarter · Health Issues
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Centers for Disease Control and Prevention (CDC) ---Centers for Medicare and Medicaid (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---Pediatric Priority Review Voucher ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---H.R.9599: SECURE 340B Act ---S.5244: SUSTAIN 340B Act ---Program Implementation & Oversight ---Rebate Models Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---Implementation of BIOSECURE Act ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2027 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes Biosimilars ---H.R.10628/S.5571: Biosimilars Access and Affordability Act ---S.1414: Expedited Access to Biosimilars Act ---S.1954: Biosimilar Red Tape Elimination Act ---Biosimilars Competition (General) ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments in New Innovation (MINI) Act Clinical Trial Data in China ---Next-Generation U.S. Clinical Development to Accelerate Cures - Legislative Discussion Draft Data Privacy ---H.R.8413: SECURE Data Act ---Clinical Trial Data in China ---Implementation of BIOSECURE Act Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---H.R.3521: Clinical Trial Modernization Act ---Decentralized Clinical Trials Drug Evaluation and Review ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---S.3788: CLEAR Labels Act ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act Drug Pricing ---H.R.1492/S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.5391/S.2764 Protecting Patient Access to Cancer and Complex Therapies Act ---H.R.9418: Access to Innovative Treatments Act of 2026 ---S.526: Pharmacy Benefit Manager Transparency Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.1954: Biosimilar Red Tape Elimination Act ---S.3014: Ensuring Timely Access to Generics ---CMMI Authority ---Ensuring Access to Generic Medications Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of ORPHAN Cures Act ---International Pricing Policies ---Tariffs Efforts to Expand the Bioeconomy & Biomanufacturing ---H.R.8930: Federal Biotechnology Workforce Assessment Act ---H.R.8938: Biotechnology Workforce Alignment Act of 2026 Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Generic Drug Entry ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.1095: Stop STALLING Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---Drug Benefit Design ---Most Favored Nation Drug Pricing Proposals ---Pricing and Rebates National Defense ---Medical Countermeasure Priority Review Voucher Reauthorization ---H.R.8800: National Defense Authorization Act for Fiscal Year 2027 National Security ---H.R.10568: Protecting Biological Data as Critical Infrastructure Act ---H.R.10569: Protecting Biotechnology and Biomanufacturing as Critical Infrastructure Act ---S.3741: Biosecurity Modernization and Innovation Act of 2026 ---Clinical Trial Data in China ---CMMI: GLOBE and GUARD Models ---Implementation of BIOSECURE Act ---International Pricing Policies ---Medical Countermeasure Priority Review Voucher Reauthorization ---NSC/OSTP priorities ---Nucleic acid synthesis security and biotechnology governance Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.1414: Cameron's Law ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Supply Chain Issues Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.10359: Priority for Pediatric Cures Act ---S.822: Scientific EXPERT Act ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---H.R.5509/S.2903:SAFE STEP Act ---S.864/H.R.6423: HELP Copays Act ---Access to Innovative Treatments ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Prior Authorization Reform ---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 ---H.R.5509/S.2903: SAFE STEP Act ---H.R.7352/S.4875: PASTEUR Act of 2026 ---H.R.9418: Access to Innovative Treatments Act of 2026 ---H.R.9672: Vaccine Injury Compensation Modernization Act of 2026 ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---Senate Discussion Draft - Vaccine Injury Protection Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
Client expense: $2,560,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), Office of Management & Budget (OMB), SENATE
2026 · third_quarter · Pharmacy
H.R. 1 - One Big Beautiful Bill Act - Rep. Arrington, Jodey - Medicaid eligibility and state financing, Marketplace coverage and enrollment, Health Savings Account expansion, Pharmacy Benefit Manager financing and regulation H.R. 843 - Prompt Approval of Safe Generic Drugs Act - Rep. Barragan, Nanette Diaz - Generic drugs applications and approvals H.R. 946 - ORPHAN Cures Act - Rep. Joyce, John - Medicare Drug Negotiation Program H.R. 950 - Saving Seniors Money on Prescriptions Act - Rep. Landsman, Greg - PBM reporting requirements for MA/Part D plans. H.R. 1117 - Responsibility in Drug Advertising Act - Rep. DeLauro, Rosa - Direct-to-consumer ads H.R. 1244 - Reducing Drug Prices for Seniors Act - Rep. Davis, Donald - Coinsurance for Part D drugs H.R. 2214 - DRUG Act - Rep. Miller-Meeks, Mariannette - PBM contracts H.R. 2450 - Prescription Drug Transparency and Affordability Act - Rep. McDonald Rivet, Kristen - PBM transparency H.R. 3493 - Global Fairness in Drug Pricing Act - Rep. Khanna, Ro - Prescription drug international reference pricing H.R. 3546 - Prescription Drug Price Relief Act - Rep. Khanna, Ro - Prescription drug patent reform H.R. 3775 - Fair Prescription Drug Prices for Americans Act - Rep. Van Drew, Jefferson - Prescription drug and biological product international reference pricing H.R. 3789 - DTC Act - Rep. Taylor, David - Direct-to-consumer prescription advertising transparency H.R. 4139 - Cutting Copays Act - Rep. McGarvey, Morgan - Medicare cost-sharing for generic drugs H.R. 4231 - Treat and Reduce Obesity Act - Rep. Kelly, Mike - Medicare coverage of obesity drugs H.R. 4317 - PBM Reform Act - Rep. Carter, Earl L. "Buddy" - PBM contracting requirements and transparency H.R. 4605 - End Prescription Drug Ads Now Act - Rep. Nadler, Jerrold - Ban on DTC drug ads H.R. 4623 - Plain Prescription Prices Act - Rep. Williams, Nikema - Transparency requirements for DTC drug ads H.R. 5094 - Protect Patients from Costly Care Act - Rep. Pappas, Chris - Repeal of Medicaid cost sharing requirements for drugs; Orphan drug inclusion in Medicare Drug Price Negotiation Program H.R. 5197 - Protect Beneficiaries from Middlemen Act - Rep. Malliotakis, Nicole - Medicare cost-sharing limit for drugs H.R. 5526 - Biosimilar Red Tape Elimination Act - Rep. Pfluger, Austin - Biosimilars approval procedures H.R. 6255 - Affordable Insulin Now Act - Rep. Craig, Angie - require cost-sharing for certain insulin products H.R. 7837 - Most Favored Patient Act - Rep. Meuser, Daniel - MFN demonstration H.R. 8779 - PBM Act - Rep. Harshbarger, Diana - PBM ownership requirements H.R. 9661 - Expedited Access to Biosimilars Act - Rep. Langworthy, Nicholas - Biosimilar approval requirements H.R. 10227 - INSULIN Act - Rep. DeGette, Diana - Copay caps H.R. 10369 - Net Effective Cost Transparency and Prescription Drug Affordability Act - Rep. Mackenzie, Ryan - Requirements for PBMs S. 229 - DTC Act - Sen. Durbin, Richard - Drug advertising requirements S. 483 - Responsibility in Drug Advertising Act - Sen. King, Angus - Drug advertising requirements S. 526 - Pharmacy Benefit Manager Transparency Act of 2025 - Sen. Grassley, Chuck - PBM reporting requirements S. 529 - Capping Prescription Costs Act - Sen. Warnock, Raphael - Drug copay caps S. 652 - Protecting Patients from Deceptive Drugs Ads Act - Sen. Durbin, Richard - Drug advertising requirements S. 882 - Patients Before Middlemen Act - Sen. Blackburn, Marsha - PBM reforms S. 891 - Bipartisan Health Care Act - Sen. Wyden, Ron - PBM reforms and transparency S. 1040 - Drug Competition Enhanced Act - Sen. Cornyn, John - Drug patent reform S. 1041 - Affordable Prescriptions for Patients Act - Sen. Cornyn, John - Patent issues S. 1095 - Stop STALLING Act - Sen. Klobuchar, Amy - Drug patent reform S. 1096 - Preserve Access to Affordable Generics and Biosimilars Act - Sen. Klobuchar, Amy - Drug patent reform S. 1414 - Expedited Access to Biosimilars Act - Sen. Paul, Rand - Biosimilars assessment and approval S. 1587 - Fair Prescription Drug Prices for Americans Act - Sen. Hawley, Josh - Prescription drug international reference pricing S. 1753 - End Price Gouging for Medications Act - Sen. Merkley, Jeff - Prescription drug international reference pricing S. 1818 - Prescription Drug Price Relief Act - Sen. Sanders, Bernard - Prescription drug patent reform S. 1954 - Biosimilar Red Tape Elimination Act - Sen. Lee, Mike - Biological product assessment and approval S. 1973 - Treat and Reduce Obesity Act - Sen. Cassidy, Bill - Medicare coverage for obesity drugs S. 2345 - Short on Competition Act - Sen. Klobuchar, Amy - Expedited approval for generic drugs S. 2447 - Repealing the Trump Sick Tax Act - Sen. Welch, Peter - Repeal of Medicaid cost sharing requirements for drugs; Orphan drug inclusion in Medicare Drug Price Negotiation Program S. 2620 - REMEDY Act - Sen. Durbin, Richard - Expedited approvals for certain drug approvals S. 2658 - Medication Affordability and Patient Integrity Act - Sen. Hassan, Maggie - FDA and USPTO coordination S. 3014 - Ensuring Timely Access to Generics Act - Sen. Shaheen, Jeanne - Generic drug approval S. 4332 - Medication Competition Act - Sen. Hassan, Maggie - Pharmaceutical exclusivity periods S. 4355 - Drug Deal Disclosure Act - Sen. Wyden, Ron - Federal MFN agreement transparency S. 4509 - PBM Act - Sen. Warren, Elizabeth - PBM ownership requirements S. 5059 - A bill to amend the Public Health Service Act to streamline the review of biosimilar biological products. - Sen. Moody, Ashley - Biosimilar and biological product review process Issues related to the implementation of Inflation Reduction Act - Medicare negotiation; cost-sharing and coverage of weight loss drugs/GLP-1s; high priced drugs; patent reforms; generic approval; 340B; Most Favored Nation; Pharmacy Benefit Managers; PBM-related issues; step therapy; copay caps; insulin costs; and copay coupons.
2026 · third_quarter · Health Issues
S. 355: FDA Modernization Act 3.0 S. 652: Protecting Patients from Deceptive Drug Ads Act S. 832: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 S. 864: HELP Copays Act S. 1387: National Biotechnology Initiative Act of 2025 S. 1414: Expedited Access to Biosimilars Act S. 1954: Biosimilar Red Tape Elimination Act S. 2296: BIOSECURE Act (S.Amdt. 3236 to National Defense Authorization Act for FY 2026) S. 2658: Medication Affordability and Patent Integrity Act S. 3014: Ensuring Timely Access to Generics Act of 2025 S. 3345: PBM Price Transparency and Accountability Act S. 3788: CLEAR LABELS Act S. 3794: SAFE Drugs Act of 2026 S. 4189: INSULIN Act of 2026 S. 5043: Secure Drug Supply Chain Act of 2026 S. 5244: SUSTAIN 340B Act H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 946: ORPHAN Cures Act H.R. 1492: 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. 2214: DRUG Act H.R. 3521: Clinical Trial Modernization Act H.R. 4317: PBM Reform Act of 2025 H.R. 5256: 340B ACCESS Act H.R. 6423: HELP Copays Act H.R. 6509: SAFE Drugs Act of 2025 H.R. 6610: Pharmacists Fight Back [in Federal Employee Health Benefit Plans Act] H.R. 7837: Most Favored Patients Act H.R. 7953: FAIR ACT H.R. 8269: CLEAR LABELS Act H.R. 9599: SECURE 340B Act H.R. 9661: Expedited Access to Biosimilars Act 340B Drug Pricing Integrity and Affordability for Patients Act (draft) SECURE Act of 2026 (draft) Biopharmaceutical innovation policy issues User fee issues Vaccine policy issues Inflation Reduction Act of 2022 (P.L. 117-169) implementation policy issues IRA price negotiation expansion policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Most Favored Nation (MFN) policy issues Drug importation policy issues FDA policy issues Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance policy issues Compounding policy issues Supply chain policy issues Peptides/counterfeiting policy issues Controlled substances policy issues Generics/devices policy issues Clinical trial policy issues 340B drug discount program rebate and policy issues 340B Rebate Model Pilot Program Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Artificial intelligence policy issues Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First
2026 · third_quarter · Health Issues
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program Proposed Rule, 91 Fed. Reg. 36236; Medication Affordability and Patent Integrity (MAPIA) Act (S. 2658); Skinny Labels, Big Savings Act (S. 43/H.R. 6485); Expedited Access to Biosimilars Act (S. 1414/ H.R.9661); Biosimilar Red Tape Elimination Act (S. 1954/H.R. 5526); Clinical trial regulation; Community Health Center Clinical Trial Grant Program discussion draft; Alex and Jacis Law discussion draft; Untitled discussion draft on clinical trial regulation (no bill number); Untitled discussion draft on generic drugs intended for use with a device (no bill number); Food & Drug Administration Fiscal Year 2027 Legislative Proposals (no bill number); Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act, (S.3788 / H.R.8269); draft legislation relating to potential improvements the National Childhood Vaccine Injury Act and the Vaccine Injury Compensation Program; American Biotechnology Act, Senate Amendment 6334 to S. 4784, National Defense Authorization Act (NDAA) for Fiscal Year 2027; CARES Act (P.L. 116-136) reporting issues.
Client expense: Not reported · Firm income: $340,000
2026 · third_quarter · Pharmacy
PBM Reform, transparency S. 1414, Expedited Access to Biosimilars Act - A bill to provide that clinical studies required for licensure of biological products as biosimilar shall not be required to include the assessment of immunogenicity, pharmacodynamics, or comparative clinical efficacy. S.4189 - INSULIN Act of 2026 - A bill to reduce the price of insulin and provide for patient protections with respect to the cost of insulin. H.R.7895 - PBM Kickback Prohibition Act - A bill to prohibit kickbacks to pharmacy benefit managers.
Client expense: $300,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
| Senate |
| Referred To |
| April 10, 2025 |
Client expense: $3,010,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Client expense: $1,530,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
2026 · third_quarter · Health Issues
S. 1414 - Expedited Access to Biosimilars Act Correspondence with United States Senate in opposition to the legislation, which would weaken standards of interchangeability studies by reducing Food and Drug Administration (FDA) discretion regarding interchangeability determinations, thereby reducing competition in the realm of complex biologics and lowering applicable standards for substituting biosimilars relative to generics; research relating thereto. ------------------- H.R. 9599 - SECURE 340B Act Correspondence with United States Senate in support of the legislation to reform the 340B Drug Pricing Program and restore its focus back toward the vulnerable patients whom Congress originally intended it to serve; research relating thereto. ------------------- Correspondence with United States Senate Committee on Finance urging opposition toward artificial government pharmaceutical price controls, in support of ensuring that fairly negotiated savings actually reach patients, in favor of reducing unnecessary barriers to treatments, in support of facilitating legitimate generic and biosimilar competition, in support of biomedical research and retention of scientific talent and protection of strong patent and other intellectual property (IP) rights; research relating thereto.
Client expense: $20,000 · Firm income: Not reported
Government targets: SENATE
2026 · third_quarter · Health Issues
H.R. 5526 - Biosimilar Red Tape Elimination Act; all provisions. S. 1414 - Expedited Access to Biosimilars Act; all provisions. S. 2658 - Medication Affordability and Patent Integrity Act; all provisions.
Client expense: $140,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2026 · third_quarter · Health Issues
Drug pricing legislation. Labor, Health and Human Services issues. Efforts surrounding user fees. S.2256 - Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026. H.R.9661/S.1414 - Expedited Access to Biosimilars Act.
Client expense: Not reported · Firm income: $100,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2026 · third_quarter · Medicare/Medicaid
Medicare reimbursement issues. FDA regulations of biosimilars. Issues related to Drug Pricing Reduction and increasing access to Biosimilars. Inflation Reduction Act implementation. H.R.5526/S.1954 - Biosimilar Red Tape Elimination Act. H.R.9661/S.1414 - Expedited Access to Biosimilars Act.
Client expense: Not reported · Firm income: $100,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2026 · third_quarter · Health Issues
Monitor federal issues and legislation associated with health care policy. Monitor federal and legislative activity related to Medicare reimbursement. Monitor federal and legislative activity related to drug pricing. Dr. Lorna Breen Healthcare Provider Protection Reauthorization Act (HR 929 / S 266) Medicare Patient Access and Practice Stabilization Act (HR 879/ S.1640) Reducing Medically Unnecessary Delays in Care Act (HR 2433) Resident Education Deferred Interest (REDI) Act (HR 2028 / S 942) Help Ensure Lower Patient (HELP) Copays Act (S. 864) Patients Before Middlemen Act (S. 882) PBM Transparency Act (S. 526) Prescription Pricing for the People Act (S. 527) Conrad State 30 and Physician Access Reauthorization Act (HR 1585 / S 709) Resident Physician Shortage Reduction Act (HR.3890/S. 2439) Improving Seniors Timely Access to Care Act (S. 1816/HR. 3514) One Big Beautiful Bill Act (HR. 1) Safe Step Act (HR 5509/S. 668) Patient Access to Autoimmune Treatment, PAAT, Act (HR. 5467) Protecting Patient Access to Cancer and Complex Therapies Act (HR 4299) PBM Reform Act of 2025 (HR 4317) Workforce Mobility Act (S.2031) Specialty Physicians Advancing Rural Care, SPARC, Act (H.R 4681/S. 1380) Connect for Health Act of 2025 (HR 2406/S. 1261) Telehealth Modernization Act (HR 5081/S 2709) House Concurrent Res. 14 establishing congressional budget for FY2025 Department of Labor, HHS, and Education Appropriations Act (S. 2587) Department of Defense Appropriations Act (HR 4016/S. 2572) Seniors Deserve SMARTER Care Act (HR 5940) A bill to require private plans to provide for e-prior auth for drugs (S. 4349) Patient Access to Higher Quality Health Care Act (HR 4002) Biosimilar Red Tape Elimination Act (HR 5526/S. 1954) Medical Foods and Formulas Access Act (HR 5684) Physician Led and Rural Access to Quality Care Act (HR 2191/S. 1390) Claims Data Act, H.R. 4331 Rural Residency Planning and development Act of 2025, H.R. 6468 To exempt H-1B health care workers from the restriction under the Presidential Proclamation entitled "Restriction on Entry of Certain Nonimmigrant Workers", and for other purposes, H.R. 7961 Provider Reimbursement Stability Act, H.R. 8163 PBM Fiduciary Accountability, Integrity, and Reform (FAIR) Act, S.3549 Chronic Care Management Act of 2026ﾠHR 8261 Prior Authorization Reform for Autoimmune & Blood Disorders ActﾠHR 9192 Patient Access to Autoimmune Treatments ActﾠHR 5467 Patients First Act H.R. 9693 Expedited Access to Biosimilars Act H.R. 9661/ S. 1414 Protecting Approved Care Act H.R. 10394 Doctors Not AI Act of 2026 H.R. 10210 Protecting Patients from Automatic Denials Act H.R. 9734
Client expense: $50,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2026 · third_quarter · Medicare/Medicaid
Monitor federal issues and legislation associated with health care policy. Monitor federal and legislative activity related to Medicare reimbursement. Monitor federal and legislative activity related to drug pricing. Dr. Lorna Breen Healthcare Provider Protection Reauthorization Act (HR 929 / S 266) Medicare Patient Access and Practice Stabilization Act (HR 879/ S.1640) Reducing Medically Unnecessary Delays in Care Act (HR 2433) Resident Education Deferred Interest (REDI) Act (HR 2028 / S 942) Help Ensure Lower Patient (HELP) Copays Act (S. 864) Patients Before Middlemen Act (S. 882) PBM Transparency Act (S. 526) Prescription Pricing for the People Act (S. 527) Conrad State 30 and Physician Access Reauthorization Act (HR 1585 / S 709) Resident Physician Shortage Reduction Act (HR.3890/S. 2439) Improving Seniors Timely Access to Care Act (S. 1816/HR. 3514) One Big Beautiful Bill Act (HR. 1) Safe Step Act (HR 5509/S. 668) Patient Access to Autoimmune Treatment, PAAT, Act (HR. 5467) Protecting Patient Access to Cancer and Complex Therapies Act (HR 4299) PBM Reform Act of 2025 (HR 4317) Workforce Mobility Act (S.2031) Specialty Physicians Advancing Rural Care, SPARC, Act (H.R 4681/S. 1380) Connect for Health Act of 2025 (HR 2406/S. 1261) Telehealth Modernization Act (HR 5081/S 2709) House Concurrent Res. 14 establishing congressional budget for FY2025 Department of Labor, HHS, and Education Appropriations Act (S. 2587) Department of Defense Appropriations Act (HR 4016/S. 2572) Seniors Deserve SMARTER Care Act (HR 5940) A bill to require private plans to provide for e-prior auth for drugs (S. 4349) Patient Access to Higher Quality Health Care Act (HR 4002) Biosimilar Red Tape Elimination Act (HR 5526/S. 1954) Medical Foods and Formulas Access Act (HR 5684) Physician Led and Rural Access to Quality Care Act (HR 2191/S. 1390) Claims Data Act, H.R. 4331 Rural Residency Planning and development Act of 2025, H.R. 6468 To exempt H-1B health care workers from the restriction under the Presidential Proclamation entitled "Restriction on Entry of Certain Nonimmigrant Workers", and for other purposes, H.R. 7961 Provider Reimbursement Stability Act, H.R. 8163 PBM Fiduciary Accountability, Integrity, and Reform (FAIR) Act, S.3549 Chronic Care Management Act of 2026ﾠHR 8261 Prior Authorization Reform for Autoimmune & Blood Disorders ActﾠHR 9192 Patient Access to Autoimmune Treatments ActﾠHR 5467 Patients First Act H.R. 9693 Expedited Access to Biosimilars Act H.R. 9661/ S. 1414 Protecting Approved Care Act H.R. 10394 Doctors Not AI Act of 2026 H.R. 10210 Protecting Patients from Automatic Denials Act H.R. 9734
Client expense: $50,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2026 · third_quarter · Budget/Appropriations
Monitor federal issues and legislation associated with health care policy. Monitor federal and legislative activity related to Medicare reimbursement. Monitor federal and legislative activity related to drug pricing. Dr. Lorna Breen Healthcare Provider Protection Reauthorization Act (HR 929 / S 266) Medicare Patient Access and Practice Stabilization Act (HR 879/ S.1640) Reducing Medically Unnecessary Delays in Care Act (HR 2433) Resident Education Deferred Interest (REDI) Act (HR 2028 / S 942) Help Ensure Lower Patient (HELP) Copays Act (S. 864) Patients Before Middlemen Act (S. 882) PBM Transparency Act (S. 526) Prescription Pricing for the People Act (S. 527) Conrad State 30 and Physician Access Reauthorization Act (HR 1585 / S 709) Resident Physician Shortage Reduction Act (HR.3890/S. 2439) Improving Seniors Timely Access to Care Act (S. 1816/HR. 3514) One Big Beautiful Bill Act (HR. 1) Safe Step Act (HR 5509/S. 668) Patient Access to Autoimmune Treatment, PAAT, Act (HR. 5467) Protecting Patient Access to Cancer and Complex Therapies Act (HR 4299) PBM Reform Act of 2025 (HR 4317) Workforce Mobility Act (S.2031) Specialty Physicians Advancing Rural Care, SPARC, Act (H.R 4681/S. 1380) Connect for Health Act of 2025 (HR 2406/S. 1261) Telehealth Modernization Act (HR 5081/S 2709) House Concurrent Res. 14 establishing congressional budget for FY2025 Department of Labor, HHS, and Education Appropriations Act (S. 2587) Department of Defense Appropriations Act (HR 4016/S. 2572) Seniors Deserve SMARTER Care Act (HR 5940) A bill to require private plans to provide for e-prior auth for drugs (S. 4349) Patient Access to Higher Quality Health Care Act (HR 4002) Biosimilar Red Tape Elimination Act (HR 5526/S. 1954) Medical Foods and Formulas Access Act (HR 5684) Physician Led and Rural Access to Quality Care Act (HR 2191/S. 1390) Claims Data Act, H.R. 4331 Rural Residency Planning and development Act of 2025, H.R. 6468 To exempt H-1B health care workers from the restriction under the Presidential Proclamation entitled "Restriction on Entry of Certain Nonimmigrant Workers", and for other purposes, H.R. 7961 Provider Reimbursement Stability Act, H.R. 8163 PBM Fiduciary Accountability, Integrity, and Reform (FAIR) Act, S.3549 Chronic Care Management Act of 2026ﾠHR 8261 Prior Authorization Reform for Autoimmune & Blood Disorders ActﾠHR 9192 Patient Access to Autoimmune Treatments ActﾠHR 5467 Patients First Act H.R. 9693 Expedited Access to Biosimilars Act H.R. 9661/ S. 1414 Protecting Approved Care Act H.R. 10394 Doctors Not AI Act of 2026 H.R. 10210 Protecting Patients from Automatic Denials Act H.R. 9734
Client expense: $50,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2026 · third_quarter · Health Issues
HJRes 197 / SJRes 197, CRA related to the 2027 NBPP; HR 247 / S 46, Health Care Affordability Act; HR 6867 / S 3562, the NIH Clinical Trial Integrity Act; HR 3521 / S 4440, the Clinical Trial Modernization Act; HR 4710 / S 2420, No Surprises Act Enforcement Act; HR 5526 / S 1954, Biosimilar Red Tape Elimination Act; HR 5582 / S 2355, the Patients Deserve Price Tags Act; HR 6248 / S 4027, Healthy Competition for Better Care Act HR 6485 / S 43, Skinny Labels, Big Savings Act; HR 6867 / S 3562, NIH Clinical Trial Integrity Act; HR 7895, the PBM Kickback Prohibition Act; HR 8879 / S 4509, Patients Before Monopolies Act; HR 8908, the STOP GAMES Act; HR 9393, Lower Costs, More Transparency Act; HR 9396, the Prior Authorization Accountability Act; HR 9397, the Premium Transparency Act; HR 9645, the Health Care Price Certainty for All Americans Act; HR 9661 / S 1414, the Expedited Access to Biosimilars Act; HR 10370, the AIM to Cure Kids with Cancer Act; HR 10788, the Lower Premiums, Faster Payments Act; S 976, the Insurance Fraud Accountability Act; S 1041, Affordable Prescriptions for Patients Act; S 1095, Stop STALLING Act; S 1096, Preserve Access to Affordable Generics & Biosimilars Act S 1097, Interagency Patent Coordination & Improvements Act; S 2658, Medication Affordability & Patent Integrity Act; S 3014, Ensuring Timely Access to Generics Act; S 3822, the Break Up Big Medicine Act Policies to address the expiration of the enhanced Advanced Premium Tax Credits; Policies to improve transparency in hospital and insurer costs and finances; Policies to streamline pediatric patient access to subspecialist care via telemedicine; Policies to protect patients and consumers from junk insurance, including short-term limited duration insurance; Policies related to modernization of clinical trials; Policies related to the 2027 FDA user fee agreements; Implementation of the No Surprises Act; Policies related to oversight of insurance agents and brokers; Oversight and patient impact of the 340B program; Policies related to consolidation within the healthcare sector;
Client expense: $120,000 · Firm income: Not reported
Government targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Justice, Dept of (DOJ), SENATE
2026 · third_quarter · Health Issues
S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act H.R. 10369: Net Effective Cost Transparency and Prescription Drug Affordability Act of 2026 S. 2658: Medication Affordability and Patent Integrity Act (MAPIA) S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act (BRTEA) S. 1414: Expedited Access to Biosimilars Act S. 43/H.R. 26485: Skinny Labels, Big Savings Act S. 3549/H.R. 6837: PBM Fiduciary Accountability, Integrity, and Reform (FAIR) Act Toxic-Free Medical Devices Drug Enforcement Administration Quotas Department of Labor Proposed and Final PBM Transparency Rule 340b Contract Pharmacies
Client expense: $630,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Natl Economic Council (NEC), Office of Management & Budget (OMB), SENATE, White House Office
2026 · third_quarter · Health Issues
S.1637/H.R 7871; Medicaid VBPs for Patients Act S. 4323/ H.R. 8143; Ensuring Access to Lower-Cost Medicines for Seniors Act of 2026 S. 2355/H.R. 5582; Patients Deserve Price Tags Act S. 2426/H.R. 3164; Ensuring Community Access to Pharmacist Services Act S.4509/ H.R. 8779; Patients Before Monopolies Act S.2276/ H.R. 3269; Eliminating Thickets to Improve Competition Act S. 526; Pharmacy Benefit Manager Transparency Act S. 882; Patients Before Middlemen Act S. 927; Protecting Pharmacies in Medicaid Act S. 1041; Affordable Prescriptions for Patients Act S. 1095; Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act S. 1096; Preserve Access to Affordable Generics and Biosimilars Act S. 1097; Interagency Patent Coordination and Improvements Act of 2025 S. 1414; Expedited Access to Biosimilars Act S. 2617; Reducing Drug Prices for Seniors Act S. 2800; Pharmacy and Medically Underserved Areas Enhancement Act S. 3345; PBM Price Transparency and Accountability Act S. 3349; PBM Disclosure Act S. 3549; PBM Fiduciary, Accountability, Integrity, and Reform Act S. 3822; Break Up Big Medicine Act S. 4189; INSLUN Act of 2026 S. 5586; Ensuring Accurate Payments to Specialty Pharmacies Act H.R. 1244; Reducing Drug Prices for Seniors Act H.R. 2214; Delinking Revenue from Unfair Gouging Act H.R. 4317; PBM Reform Act H.R. 4409; Fair Pharmacies for Federal Employees Act H.R. 4570; Interagency Patent Coordination and Improvements Act of 2025 H.R. 6609; Pharmacists Fight Back Act in Medicare and Medicaid H.R. 6610; Pharmacists Fight Back Act in the Federal Employees Health Benefits Program H.R. 6837; To amend the Employee Retirement Income Security Act of 1974 to ensure that pharmacy benefit managers are considered fiduciaries, and for other purposes. H.R. 7148; Consolidated Appropriations Act of 2026 oSec. 6233- Any Willing Pharmacy oSec 6224- Medicare Delinking oSec. 6701- Oversight of PBM Services oSec. 6702- Full Rebate Pass Through to Plans H.R. 7895; PBM Kickback Prohibition Act H.R. 8324; Great American Healthcare Plan H.R. 9228; Health Data Access, Transparency, and Affordability Act of 2026 H.R. 9486; Health Data Access, Transparency and Affordability Act H.R. 9117; Clear Healthcare Expense Cost Knowledge Act H.R. 9393; Lower Cost, More Transparency Act of 2026 H.R. 9645; Health Care Price Certainty for All Americans Act H.R. 10369; Net Effective Cost Transparency and Prescription Drug Affordability Act of 2026 Implementation of the Inflation Reduction Act of 2022, P.L. 169- Provisions on Medicare Part D modernization and drug price negotiation, and the implementation of the Consolidated Appropriations Act of 2026 (P.L. 119-75)
Client expense: $3,203,049 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), SENATE, Small Business Administration (SBA)
2026 · third_quarter · Pharmacy
Biosimilars; Generic drugs; Issues around country of origin labeling; Supply Chain; S.2658 - Medication Affordability and Patent Integrity Act; S.3014 - Ensuring Timely Access to Generics Act; S.1414 - Expedited Access to Biosimilars Act; S.1954 - Biosimilar Red Tape Reduction Act; S.3788 - Clear Labels Act; S.43 - Skinny Labels, Big Savings Act; Tariffs; General Business Issues.
Client expense: Not reported · Firm income: $60,000
Government targets: SENATE
2026 · third_quarter · Pharmacy
Prescription drug pricing issues. H.R. 1843/S. 1032 - Increasing Transparency in Generic Drug Applications Act. S. 1954/H.R. 5526 - Biosimilar Red Tape Elimination Act; S. 1095 - Stop Stalling Act S. 2630 - Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act H.R.1262 - Mikaela Naylon Give Kids a Chance Act. S. 3014 - Ensuring Timely Access to Generics Act of 2025 S. 1414 - Expedited Access to Biosimilars Act
Client expense: Not reported · Firm income: $90,000
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2026 · third_quarter · Pharmacy
Issues related to pharmaceutical manufacturing supply chain. S. 1040 - Drug Competition Enhancement Act; H.R. 5526/S. 1954 -Biosimilar Red tape Elimination Act; H.R. 3269 - ETHIC Act; S. 43 - Skinny Labels, Big Savings Act; H.R. 1843/S. 1302- Increasing Transparency in Generic Drug Applications Act; Country of origin labeling. H.R. 9661/S. 1414 - Expediated Access to Biosimilars Act.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2026 · third_quarter · Pharmacy
Prescription Drug Costs. H.R.1843: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. S.1302: Increasing Transparency in Generic Drug Applications Act. Drug Shortages. H.R.4191/S.1784: Mapping Americas Pharmaceutical Supply (MAPS) Act. H.R.4132/S.2027: Prescription Information Modernization Act of 2025. S.1414/H.R.9661: Expedited Access to Biosimilars Act. S.3469: BIOSECURE Act of 2025. Hassan Purple Book Proposal. H.R.8269/S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act. American Made Medicines Act. PBM Bid Transparency. S.4280: Security And Freedom Enhancement Act of 2026 (SAFE) Act.
Client expense: $770,000 · Firm income: Not reported
Government targets: Congressional Budget Office (CBO), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), SENATE, White House Office
2026 · third_quarter · Pharmacy
Legislation and regulation regarding pharmaceutical pricing, coverage and care; retail and inpatient pharmacy operations and the role of pharmacy benefit managers. S.1954, H.R.5526 - Biosimilar Red Tape Elimination Act S.1414 - Expedited Access to Biosimilars Act S.2780, H.R.5429 - Medication Affordability and Patent Integrity Act S. 2620 - Reforming Evergreening and Manipulation that Extends Drug Years Act (REMEDY Act) S.2276, H.R. 3269 - Eliminating Thickets to Increase Competition Act (ETHIC Act) S.3014 - Ensuring Timely Access to Generics Act S.43 - Skinny Labels, Big Savings Act
Client expense: $500,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2026 · third_quarter · Pharmacy
Prescription drug industry issues relating to domestic construction and maintenance, prescription drug pricing and price controls, supply chain issues, pharmacy benefit managers transparency issues, intellectual property, trade, and employment issues, 340B program, generally; S. 1040, Drug Competition Enhancement Act; H.R. 1492, 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. 4317, PBM Reform Act of 2025; H.R. 5256, 340B ACCESS Act"; S. 3345, "PBM Price Transparency and Accountability Act"; S. 2658, Medication Affordability and Patent Integrity Act; S. 1414, Expedited Access to Biosimilars Act.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2026 · second_quarter · Pharmacy
Issues related to prescription drug pricing. H.R. 5526 & S. 1954 Biosimilar Red Tape Elimination Act. S. 1095 Stop Significant and Time-Wasting Abuse Limiting Legitimate Innovation of New Generics Act. S. 3014 Ensuring Timely Access to Generics Act of 2025 S. 1414 Expedited Access to Biosimilars Act S. 1032/H.R. 1843 Increasing Transparency in Generic Drug Applications Act. S. 2630, Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act. H.R.1262 Mikaela Naylon Give Kids a Chance Act
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2026 · second_quarter · Health Issues
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Centers for Disease Control and Prevention (CDC) ---Centers for Medicare and Medicaid (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---HHS Office of Infectious Disease and HIV/AIDS Policy ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Funding for Strategic National Stockpile ---Funding for Women's Health Research ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---Pediatric Priority Review Voucher ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---Program Implementation & Oversight ---Rebate Models ---SECURE 340B Act ---SUSTAIN 340B Act Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---Implementation of BIOSECURE Act ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2027 ---Reasonable Pricing Clauses in BARDA Contracts ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes Biosimilars ---S.1414: Expedited Access to Biosimilars Act ---Biosimilars Competition (General) ---Biosimilar Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act Clinical Trial Data in China ---Next-Generation U.S. Clinical Development to Accelerate Cures - Legislative Discussion Draft Data Privacy ---H.R.8413: SECURE Data Act ---Clinical Trial Data in China ---Implementation of BIOSECURE Act Diversity & Inclusion ---H.R.3521: Clinical Trial Modernization Act ---Decentralized Clinical Trials Drug Evaluation and Review ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---S.3788: CLEAR Labels Act ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---H.R.6485/S.43: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act Drug Pricing ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.5391/S.2764 Protecting Patient Access to Cancer and Complex Therapies Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1302: Increasing Transparency in Generic Drug Application ---Access to Innovative Treatments Act ---Biosimilar Red Tape Elimination Act ---CMMI: GLOBE and GUARD Models ---CMMI Authority ---DRUG Act ---Ensuring Access to Generic Medications Act ---Ensuring Timely Access to Generics ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of ORPHAN Cures Act ---International Pricing Policies ---Medicare Drug Price Negotiation Act ---Modernizing and Ensuring PBM Accountability (MEPA) Act ---National Coverage Determination ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---Senate Finance Committee Minority RFI on Drug Pricing ---Tariffs Efforts to Expand the Bio Economy & Bio Manufacturing Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Generic Drug Entry ---H.R.6485/S.43: Skinny Labels, Big Savings Act ---S.1095: Stop STALLING Act ---Generic Drug Application Review Reforms Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---Alternative Payment Arrangements for Gene Therapies ---CMMI (GENEROUS Model) ---CMMI: GLOBE and GUARD Models ---Drug Benefit Design ---International Pricing Policies ---Medicaid VBPs for Patients (MVP) Act ---Most Favored Nation Drug Pricing Proposals ---Pricing and Rebates National Defense ---Medical Countermeasure Priority Review Voucher Reauthorization ---National Defense Authorization Act of 2027 National Security ---S.3741: Biosecurity Modernization and Innovation Act of 2026 ---Clinical Trial Data in China ---CMMI: GLOBE and GUARD Models ---Implementation of BIOSECURE Act ---International Pricing Policies ---Medical Countermeasure Priority Review Voucher Reauthorization ---NSC/OSTP priorities ---Nucleic acid synthesis security and biotechnology governance ---Most Favored Nation Drug Pricing Proposals Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---S.705: Innovation in Pediatric Drugs Act of 2025 ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit ---Retaining Access and Restoring Exclusivity (RARE) Act Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Supply Chain Issues ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---S.822: Scientific EXPERT Act ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---S.864/H.R.6423: HELP Copays Act ---S.1816: Improving Seniors Timely Access to Care Act of 2025 ---Access to Innovative Treatments ---Administrative Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicaid VBPs for Patients (MVP) Act ---Medicare Drug Price Negotiation Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Prescription Drug Price Relief Act ---Prior Authorization Reform ---SAFE STEP Act ---Step Therapy Vaccines and Infectious Diseases ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---PASTEUR ACT ---SAFE STEP Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Modernization Act ---Vaccine Injury Compensation Program ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
Client expense: $2,360,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, Treasury, Dept of, White House Office
2026 · second_quarter · Health Issues
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Fast-tracking Approval for Innovative Rare disease therapies (FAIR) Act (H.R. 7953); Ensuring Timely Access to Generics Act of 2025 (S. 3014); Stop STALLING Act (S. 1095); Food & Drug Administration Fiscal Year 2027 Legislative Proposals; Agriculture, Rural Development, Food and Drug Administration, and Related Agency Appropriations Act, 2027 (H.R. 8646); Medication Affordability and Patent Integrity Act (S. 2658); Biosimilar Red Tape Elimination Act (S. 1954/H.R. 5526); Expedited Access to Biosimilars Act (S. 1414); Clinical trial regulation; Securing Essential Components for U.S. Readiness in Essential Pharmaceuticals (SECURE Rx) Act of 2026 (discussion draft); Securing Innovation and Research from Adversaries (discussion draft); amendments to the National Childhood Vaccine Injury Act of 1986 and the Vaccine Injury Compensation Program; Destruction of Hazardous Imports Act (H.R. 2715); potential amendments to drug country of origin labeling requirements (discussion draft).
Client expense: Not reported · Firm income: $220,000
2026 · second_quarter · Pharmacy
Draft, the Expedited Access to Biosimilars Act (no bill number) - Rep. Langworthy, Nick - Biosimilar approval requirements H.R. 1 - One Big Beautiful Bill Act - Rep. Arrington, Jodey - Medicaid eligibility and state financing, Marketplace coverage and enrollment, Health Savings Account expansion, Pharmacy Benefit Manager financing and regulation H.R. 843 - Prompt Approval of Safe Generic Drugs Act - Rep. Barragan, Nanette Diaz - Generic drugs applications and approvals H.R. 946 - ORPHAN Cures Act - Rep. Joyce, John - Medicare Drug Negotiation Program H.R. 950 - Saving Seniors Money on Prescriptions Act - Rep. Landsman, Greg - PBM reporting requirements for MA/Part D plans. H.R. 1117 - Responsibility in Drug Advertising Act - Rep. DeLauro, Rosa - Direct-to-consumer ads H.R. 1244 - Reducing Drug Prices for Seniors Act - Rep. Davis, Donald - Coinsurance for Part D drugs H.R. 2214 - DRUG Act - Rep. Miller-Meeks, Mariannette - PBM contracts H.R. 2450 - Prescription Drug Transparency and Affordability Act - Rep. McDonald Rivet, Kristen - PBM transparency H.R. 3493 - Global Fairness in Drug Pricing Act - Rep. Khanna, Ro - Prescription drug international reference pricing H.R. 3546 - Prescription Drug Price Relief Act - Rep. Khanna, Ro - Prescription drug patent reform H.R. 3775 - Fair Prescription Drug Prices for Americans Act - Rep. Van Drew, Jefferson - Prescription drug and biological product international reference pricing H.R. 3789 - DTC Act - Rep. Taylor, David - Direct-to-consumer prescription advertising transparency H.R. 4139 - Cutting Copays Act - Rep. McGarvey, Morgan - Medicare cost-sharing for generic drugs H.R. 4231 - Treat and Reduce Obesity Act - Rep. Kelly, Mike - Medicare coverage of obesity drugs H.R. 4317 - PBM Reform Act - Rep. Carter, Earl L. Buddy - PBM contracting requirements and transparency H.R. 4605 - End Prescription Drug Ads Now Act - Rep. Nadler, Jerrold - Ban on DTC drug ads H.R. 4623 - Plain Prescription Prices Act - Rep. Williams, Nikema - Transparency requirements for DTC drug ads H.R. 5094 - Protect Patients from Costly Care Act - Rep. Pappas, Chris - Repeal of Medicaid cost sharing requirements for drugs; Orphan drug inclusion in Medicare Drug Price Negotiation Program H.R. 5197 - Protect Beneficiaries from Middlemen Act - Rep. Malliotakis, Nicole - Medicare cost-sharing limit for drugs H.R. 5526 - Biosimilar Red Tape Elimination Act - Rep. Pfluger, Austin - Biosimilars approval procedures H.R. 6255 - Affordable Insulin Now Act - Rep. Craig, Angie - require cost-sharing for certain insulin products H.R. 7837 - Most Favored Patient Act - Rep. Meuser, Daniel - MFN demonstration H.R. 8779 - PBM Act - Rep. Harshbarger, Diana - PBM ownership requirements S. 229 - DTC Act - Sen. Durbin, Richard - Drug advertising requirements S. 483 - Responsibility in Drug Advertising Act - Sen. King, Angus - Drug advertising requirements S. 526 - Pharmacy Benefit Manager Transparency Act of 2025 - Sen. Grassley, Chuck - PBM reporting requirements S. 529 - Capping Prescription Costs Act - Sen. Warnock, Raphael - Drug copay caps S. 652 - Protecting Patients from Deceptive Drugs Ads Act - Sen. Durbin, Richard - Drug advertising requirements S. 882 - Patients Before Middlemen Act - Sen. Blackburn, Marsha - PBM reforms S. 891 - Bipartisan Health Care Act - Sen. Wyden, Ron - PBM reforms and transparency S. 1040 - Drug Competition Enhanced Act - Sen. Cornyn, John - Drug patent reform S. 1041 - Affordable Prescriptions for Patients Act - Sen. Cornyn, John - Patent issues S. 1095 - Stop STALLING Act - Sen. Klobuchar, Amy - Drug patent reform S. 1096 - Preserve Access to Affordable Generics and Biosimilars Act - Sen. Klobuchar, Amy - Drug patent reform S. 1414 - Expedited Access to Biosimilars Act - Sen. Paul, Rand - Biosimilars assessment and approval S. 1587 - Fair Prescription Drug Prices for Americans Act - Sen. Hawley, Josh - Prescription drug international reference pricing S. 1753 - End Price Gouging for Medications Act - Sen. Merkley, Jeff - Prescription drug international reference pricing S. 1818 - Prescription Drug Price Relief Act - Sen. Sanders, Bernard - Prescription drug patent reform S. 1954 - Biosimilar Red Tape Elimination Act - Sen. Lee, Mike - Biological product assessment and approval S. 1973 - Treat and Reduce Obesity Act - Sen. Cassidy, Bill - Medicare coverage for obesity drugs S. 2345 - Short on Competition Act - Sen. Klobuchar, Amy - Expedited approval for generic drugs S. 2447 - Repealing the Trump Sick Tax Act - Sen. Welch, Peter - Repeal of Medicaid cost sharing requirements for drugs; Orphan drug inclusion in Medicare Drug Price Negotiation Program S. 2620 - REMEDY Act - Sen. Durbin, Richard - Expedited approvals for certain drug approvals S. 2658 - Medication Affordability and Patient Integrity Act - Sen. Hassan, Margaret - FDA and USPTO coordination S. 3014 - Ensuring Timely Access to Generics Act - Sen. Shaheen, Jeanne - Generic drug approval S. 4332 - Medication Competition Act - Sen. Hassan, Maggie - Pharmaceutical exclusivity periods S. 4355 - Drug Deal Disclosure Act - Sen. Wyden, Ron - Federal MFN agreement transparency S. 4509 - PBM Act - Sen. Warren, Elizabeth - PBM ownership requirements Issues related to the implementation of Inflation Reduction Act - Medicare negotiation; cost-sharing and coverage of weight loss drugs/GLP-1s; high priced drugs; patent reforms; generic approval; Pharmacy Benefit Managers; PBM-related issues; step therapy; copay caps; insulin costs; and copay coupons.
Client expense: $3,010,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2026 · second_quarter · Health Issues
S.1637/H.R 7871; Medicaid VBPs for Patients Act S. 4323/ H.R. 8143; Ensuring Access to Lower-Cost Medicines for Seniors Act of 2026 S. 2355/H.R. 5582; Patients Deserve Price Tags Act S. 2426/H.R. 3164; Ensuring Community Access to Pharmacist Services Act S.4509/ H.R. 8779; Patients Before Monopolies Act S. 526; Pharmacy Benefit Manager Transparency Act S. 882; Patients Before Middlemen Act S. 927; Protecting Pharmacies in Medicaid Act S. 1041; Affordable Prescriptions for Patients Act S. 1095; Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act S. 1096; Preserve Access to Affordable Generics and Biosimilars Act S. 1097; Interagency Patent Coordination and Improvements Act of 2025 S. 1414; Expedited Access to Biosimilars Act S. 2617; Reducing Drug Prices for Seniors Act S. 2800; Pharmacy and Medically Underserved Areas Enhancement Act S. 3345; PBM Price Transparency and Accountability Act S. 3349; PBM Disclosure Act S. 3549; PBM Fiduciary, Accountability, Integrity, and Reform Act S. 3822; Break Up Big Medicine Act S. 4189; INSLUN Act of 2026 H.R. 1244; Reducing Drug Prices for Seniors Act H.R. 2214; Delinking Revenue from Unfair Gouging Act H.R. 4317; PBM Reform Act H.R. 4409; Fair Pharmacies for Federal Employees Act H.R. 4570; Interagency Patent Coordination and Improvements Act of 2025 H.R. 6609; Pharmacists Fight Back Act in Medicare and Medicaid H.R. 6610; Pharmacists Fight Back Act in the Federal Employees Health Benefits Program H.R. 6837; To amend the Employee Retirement Income Security Act of 1974 to ensure that pharmacy benefit managers are considered fiduciaries, and for other purposes. H.R. 7148; Consolidated Appropriations Act of 2026 oSec. 6233- Any Willing Pharmacy oSec 6224- Medicare Delinking oSec. 6701- Oversight of PBM Services oSec. 6702- Full Rebate Pass Through to Plans H.R. 7895; PBM Kickback Prohibition Act H.R. 8324; Great American Healthcare Plan H.R. 9228; Health Data Access, Transparency, and Affordability Act of 2026 H.R. 9486; Health Data Access, Transparency and Affordability Act H.R. 9117; Clear Healthcare Expense Cost Knowledge Act H.R. 9393; Lower Cost, More Transparency Act of 2026 Implementation of the Inflation Reduction Act of 2022, P.L. 169- Provisions on Medicare Part D modernization and drug price negotiation, and the implementation of the Consolidated Appropriations Act of 2026 (P.L. 119-75)
Client expense: $3,282,990 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), SENATE, Small Business Administration (SBA)
2026 · second_quarter · Pharmacy
Prescription Drug Costs. Public Law No. 119-60: National Defense Authorization Act for Fiscal Year 2026. Drug Shortages. H.R.5526/S.1954: Biosimilar Red Tape Elimination Act (BRTEA). To amend the Federal Food, Drug, and Cosmetic Act to allow for the approval of an abbreviated new drug application submitted by a subsequent applicant in the case of a failure by a first applicant to commence commercial marketing within a certain period, and for other purposes (H.R.1051). S.1414/H.R.__: Expedited Access to Biosimilars Act. S.3469: BIOSECURE Act of 2025. Quotas on Controlled Substances. Hassan Purple Book Proposal. H.R.8269/S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act. American Made Medicines Act. PBM Bid Transparency. H.R.7148: Consolidated Appropriations Act, 2026 as it relates to PBM reforms and Q1/Q2. H.R.8339: Drug Origin Transparency Act of 2026.
Client expense: $870,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
2026 · second_quarter · Pharmacy
Legislation and regulation regarding pharmaceutical pricing, coverage and care; retail and inpatient pharmacy operations and the role of pharmacy benefit managers. S.1954, H.R.5526 - Biosimilar Red Tape Elimination Act S.1414 - Expedited Access to Biosimilars Act S.2780, H.R.5429 - Medication Affordability and Patent Integrity Act S. 2620 - Reforming Evergreening and Manipulation that Extends Drug Years Act (REMEDY Act) H. R. 3269 - Eliminating Thickets to Increase Competition Act (ETHIC Act) S.3014 - Ensuring Timely Access to Generics Act S.43 - Skinny Labels, Big Savings Act
Client expense: $530,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2026 · second_quarter · Trade (domestic/foreign)
S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act (BRTEA) S. 1414: Expedited Access to Biosimilars Act Section 301 Investigation re: Germany Issues Section 232 of the Trade Expansion Act: Patents as a Barrier to US Manufacturing of Biosimilars Inflation Reduction Act (IRA) redesigned Medicare Part D: Manufacturer Discount Program and Biosimilars CMS Advance Notice of Proposed Rulemaking (ANPRM) on Domestic Manufacturing of Essential Medicines PTAB Proposed Rule - Discretionary Denials and One and Done Federal Procurement Preferences for Domestic Medicines Drug Shortages and Supply Chain Resilience
Client expense: $580,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office
2026 · second_quarter · Health Issues
S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act S. 2658: Medication Affordability and Patent Integrity Act (MAPIA) S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act (BRTEA) S. 1414: Expedited Access to Biosimilars Act PTAB Proposed Rule - Discretionary Denials and One and Done Domestic Production of Essential Medicines Federal Procurement Preferences for Domestic Medicines Ancillary Product Patent Reform CMS Advance Notice of Proposed Rulemaking (ANPRM) on Domestic Manufacturing of Essential Medicines Use of Industrial Chemicals in Medical Devices Drug Shortages and Supply Chain Resilience Employee Benefits Security Administration (EBSA) Proposed Rule Re: Broker/Consultant Transparency to Employer Plans Section 301 Investigation re: Germany Issues PBM Transparency: Implementation of Consolidated Appropriations Act (CAA) Section 232 of the Trade Expansion Act: Patents as a Barrier to US Manufacturing of Biosimilars Inflation Reduction Act (IRA) redesigned Medicare Part D: Manufacturer Discount Program and Biosimilars Net Elective Cost Policy: PBM Reform Through Bid Transparency
Client expense: $580,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Natl Economic Council (NEC), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office
2026 · second_quarter · Pharmacy
Prescription drug pricing issues. H.R. 1843/S. 1032 - Increasing Transparency in Generic Drug Applications Act. S. 1954/H.R. 5526 - Biosimilar Red Tape Elimination Act; S. 1095 - Stop Stalling Act S. 2630 - Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act H.R.1262 - Mikaela Naylon Give Kids a Chance Act. S. 3014 - Ensuring Timely Access to Generics Act of 2025 S. 1414 - Expedited Access to Biosimilars Act
Client expense: Not reported · Firm income: $90,000
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2026 · second_quarter · Pharmacy
H.R.7410 - American Made Medicine Act; Drug shortages; Generic drugs; Issues around country of origin labeling; S.4327 - Securing America's Drug Supply from Communist China Act; S.2658 - Medication Affordability and Patent Integrity Act; S.3014 - Ensuring Timely Access to Generics Act; S.1414 - Expedited Access to Biosimilars Act; S.1954 - Biosimilar Red Tape Reduction Act; S.3788 - Clear Labels Act; S.4784 - Fiscal Year 2027 National Defense Authorization Act; Supply chain.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2026 · second_quarter · Health Issues
S. 355: FDA Modernization Act 3.0 S. 652: Protecting Patients from Deceptive Drug Ads Act S. 832: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 S. 864: HELP Copays Act S. 1414: Expedited Access to Biosimilars Act S. 1954: Biosimilar Red Tape Elimination Act S. 2296: BIOSECURE Act (S.Amdt. 3236 to National Defense Authorization Act for FY 2026) S. 2658: Medication Affordability and Patent Integrity Act S. 3014: Ensuring Timely Access to Generics Act of 2025 S. 3345: PBM Price Transparency and Accountability Act S. 3788: CLEAR LABELS Act H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 946: ORPHAN Cures Act H.R. 1262: Mikaela Naylon Give Kids a Chance Act H.R. 1492: 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. 2214: DRUG Act H.R. 3521: Clinical Trial Modernization Act H.R. 4317: PBM Reform Act of 2025 H.R. 5256: 340B ACCESS Act HR 5509, Safe Step Act, Provisions related step therapy protocols H.R. 6423: HELP Copays Act H.R. 6610: Pharmacists Fight Back [in Federal Employee Health Benefit Plans Act] H.R. 7837: Most Favored Patients Act H.R. 7391, the Community Health Center Drug Pricing Protection Act H.R. 7953: FAIR ACT H.R. 8269: CLEAR LABELS Act Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) 340B Drug Pricing Integrity and Affordability for Patients Act (draft) SECURE Act of 2026 (draft) Biopharmaceutical innovation policy issues User fee issues Vaccine policy issues Inflation Reduction Act of 2022 (P.L. 117-169) implementation policy issues IRA price negotiation expansion policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Most Favored Nation (MFN) policy issues Drug importation policy issues FDA policy issues Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance policy issues Compounding policy issues Supply chain policy issues Clinical trial policy issues 340B drug discount program rebate and policy issues 340B rebate pilot program Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Artificial intelligence policy issues Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First S. 891, Bipartisan Health Care Act (including section 227 - Modernizing and Ensuring PBM Accountability) S.4784, An original bill to authorize appropriations for fiscal year 2027 for military activities of the Department of Defense, for military construction, and for defense activities of the Department of Energy, to prescribe military personnel strengths for such fiscal year, and for other purposes, Provisions related to the pharmaceutical industry. Smucker's VICP bill Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) Vaccine policy issues
Client expense: $890,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
2026 · first_quarter · Health Issues
S.1637/H.R 7871; Medicaid VBPs for Patients Act S. 2355/H.R. 5582; Patients Deserve Price Tags Act S. 2426/H.R. 3164; Ensuring Community Access to Pharmacist Services Act S. 526; Pharmacy Benefit Manager Transparency Act S. 882; Patients Before Middlemen Act S. 927; Protecting Pharmacies in Medicaid Act S. 1041; Affordable Prescriptions for Patients Act S. 1095; Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act S. 1096; Preserve Access to Affordable Generics and Biosimilars Act S. 1097; Interagency Patent Coordination and Improvements Act of 2025 S. 1414; Expedited Access to Biosimilars Act S. 2617; Reducing Drug Prices for Seniors Act S. 2800; Pharmacy and Medically Underserved Areas Enhancement Act S. 3345; PBM Price Transparency and Accountability Act S. 3349; PBM Disclosure Act S. 3549; PBM Fiduciary, Accountability, Integrity, and Reform Act S. 3822; Break Up Big Medicine Act H.R. 1244; Reducing Drug Prices for Seniors Act H.R. 2214; Delinking Revenue from Unfair Gouging Act H.R. 3164; Ensuring Community Access to Pharmacist Service Act H.R. 4317; PBM Reform Act H.R. 4409; Fair Pharmacies for Federal Employees Act H.R. 4570; Interagency Patent Coordination and Improvements Act of 2025 H.R. 6609; Pharmacists Fight Back Act in Medicare and Medicaid H.R. 6610; Pharmacists Fight Back Act in the Federal Employees Health Benefits Program H.R. 6837; To amend the Employee Retirement Income Security Act of 1974 to ensure that pharmacy benefit managers are considered fiduciaries, and for other purposes. H.R. 7148; Consolidated Appropriations Act of 2026 oSec. 6233- Any Willing Pharmacy oSec 6224- Medicare Delinking oSec. 6701- Oversight of PBM Services oSec. 6702- Full Rebate Pass Through to Plans H.R. 7895; PBM Kickback Prohibition Act H.R. 8143; Ensuring Access to Lower-Cost Medicines for Seniors Act of 2026 Implementation of the Inflation Reduction Act of 2022, P.L. 169- Provisions on Medicare Part D modernization and drug price negotiation, and the implementation of the Consolidated Appropriations Act of 2026 (P.L. 119-75)
Client expense: $2,996,995 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), SENATE, Small Business Administration (SBA)
2026 · first_quarter · Pharmacy
Issues related to prescription drug pricing. H.R. 5526 & S. 1954 Biosimilar Red Tape Elimination Act. S. 1095 Stop Significant and Time-Wasting Abuse Limiting Legitimate Innovation of New Generics Act. S. 3014 Ensuring Timely Access to Generics Act of 2025 S. 1414 Expedited Access to Biosimilars Act S. 1032/H.R. 1843 Increasing Transparency in Generic Drug Applications Act. S. 2630, Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act. H.R.1262 Mikaela Naylon Give Kids a Chance Act
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2026 · first_quarter · Pharmacy
Prescription Drug Costs. H.R.1843: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. S.1302: Increasing Transparency in Generic Drug Applications Act. Generic Drug Reporting Requirement Language in Public Law No. 119-60: National Defense Authorization Act for Fiscal Year 2026. Public Law No. 119-60: National Defense Authorization Act for Fiscal Year 2026. H.R.1396/S.1891: Producing Incentives for Long-term Production of Lifesaving Supply of Medicine (PILLS) Act. Drug Shortages. H.R.5526/S.1954: Biosimilar Red Tape Elimination Act (BRTEA). American Relief Act, 2025 (PL. No: 118-158) as it relates to Patent Thickets and Q1/Q2. H.R.3955/S.2062: RAPID Reserve Act. H.R.4132/S.2027: Prescription Information Modernization Act of 2025. S.1414/H.R.__: Expedited Access to Biosimilars Act. S.3469: BIOSECURE Act of 2025. Quotas on Controlled Substances. Hassan Purple Book Proposal. S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act. PBM Bid Transparency. H.R.7148 - Consolidated Appropriations Act, 2026 as it relates to PBM reforms and Q1/Q2.
Client expense: $840,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2026 · first_quarter · Pharmacy
Draft, Expedited Access to Biosimilars Act (no bill number) - Rep. Langworthy, Nick - Biosimilar approval requirements H.R. 1 - One Big Beautiful Bill Act - Rep. Arrington, Jodey - Medicaid eligibility and state financing, Marketplace coverage and enrollment, Health Savings Account expansion, Pharmacy Benefit Manager financing and regulation H.R. 843 - Prompt Approval of Safe Generic Drugs Act - Rep. Barragan, Nanette Diaz - Generic drugs applications and approvals H.R. 946 - ORPHAN Cures Act - Rep. Joyce, John - Medicare Drug Negotiation Program H.R. 950 - Saving Seniors Money on Prescriptions Act - Rep. Landsman, Greg - PBM reporting requirements for MA/Part D plans. H.R. 1117 - Responsibility in Drug Advertising Act - Rep. DeLauro, Rosa - Direct-to-consumer ads H.R. 1244 - Reducing Drug Prices for Seniors Act - Rep. Davis, Donald - Coinsurance for Part D drugs H.R. 2214 - DRUG Act - Rep. Miller-Meeks, Mariannette - PBM contracts H.R. 2450 - Prescription Drug Transparency and Affordability Act - Rep. McDonald Rivet, Kristen - PBM transparency H.R. 3493 - Global Fairness in Drug Pricing Act - Rep. Khanna, Ro - Prescription drug international reference pricing H.R. 3546 - Prescription Drug Price Relief Act - Rep. Khanna, Ro - Prescription drug patent reform H.R. 3775 - Fair Prescription Drug Prices for Americans Act - Rep. Van Drew, Jefferson - Prescription drug and biological product international reference pricing H.R. 3789 - DTC Act - Rep. Taylor, David - Direct-to-consumer prescription advertising transparency H.R. 4139 - Cutting Copays Act - Rep. McGarvey, Morgan - Medicare cost-sharing for generic drugs H.R. 4231 - Treat and Reduce Obesity Act - Rep. Kelly, Mike - Medicare coverage of obesity drugs H.R. 4317 - PBM Reform Act - Rep. Carter, Earl L. Buddy - PBM contracting requirements and transparency H.R. 4605 - End Prescription Drug Ads Now Act - Rep. Nadler, Jerrold - Ban on DTC drug ads H.R. 4623 - Plain Prescription Prices Act - Rep. Williams, Nikema - Transparency requirements for DTC drug ads H.R. 5094 - Protect Patients from Costly Care Act - Rep. Pappas, Chris - Repeal of Medicaid cost sharing requirements for drugs; Orphan drug inclusion in Medicare Drug Price Negotiation Program H.R. 5197 - Protect Beneficiaries from Middlemen Act - Rep. Malliotakis, Nicole - Medicare cost-sharing limit for drugs H.R. 6255 - Affordable Insulin Now Act - Rep. Craig, Angie - require cost-sharing for certain insulin products H.R. 7837 - Most Favored Patient Act - Rep. Meuser, Daniel - MFN demonstration S. 229 - DTC Act - Sen. Durbin, Richard - Drug advertising requirements S. 483 - Responsibility in Drug Advertising Act - Sen. King, Angus - Drug advertising requirements S. 526 - Pharmacy Benefit Manager Transparency Act of 2025 - Sen. Grassley, Chuck - PBM reporting requirements S. 529 - Capping Prescription Costs Act - Sen. Warnock, Raphael - Drug copay caps S. 652 - Protecting Patients from Deceptive Drugs Ads Act - Sen. Durbin, Richard - Drug advertising requirements S. 882 - Patients Before Middlemen Act - Sen. Blackburn, Marsha - PBM reforms S. 891 - Bipartisan Health Care Act - Sen. Wyden, Ron - PBM reforms and transparency S. 1040 - Drug Competition Enhanced Act - Sen. Cornyn, John - Drug patent reform S. 1041 - Affordable Prescriptions for Patients Act - Sen. Cornyn, John - Patent issues S. 1095 - Stop STALLING Act - Sen. Klobuchar, Amy - Drug patent reform S. 1096 - Preserve Access to Affordable Generics and Biosimilars Act - Sen. Klobuchar, Amy - Drug patent reform S. 1414 - Expedited Access to Biosimilars Act - Sen. Paul, Rand - Biosimilars assessment and approval S. 1587 - Fair Prescription Drug Prices for Americans Act - Sen. Hawley, Josh - Prescription drug international reference pricing S. 1753 - End Price Gouging for Medications Act - Sen. Merkley, Jeff - Prescription drug international reference pricing S. 1818 - Prescription Drug Price Relief Act - Sen. Sanders, Bernard - Prescription drug patent reform S. 1954 - Biosimilar Red Tape Elimination Act - Sen. Lee, Mike - Biological product assessment and approval S. 1973 - Treat and Reduce Obesity Act - Sen. Cassidy, Bill - Medicare coverage for obesity drugs S. 2345 - Short on Competition Act - Sen. Klobuchar, Amy - Expedited approval for generic drugs S. 2447 - Repealing the Trump Sick Tax Act - Sen. Welch, Peter - Repeal of Medicaid cost sharing requirements for drugs; Orphan drug inclusion in Medicare Drug Price Negotiation Program S. 2620 - REMEDY Act - Sen. Durbin, Richard - Expedited approvals for certain drug approvals Issues related to the implementation of Inflation Reduction Act - Medicare negotiation; cost-sharing and coverage of weight loss drugs/GLP-1s; high priced drugs; patent reforms; Pharmacy Benefit Managers; PBM related issues; and copay coupons.
Client expense: $5,320,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2026 · first_quarter · Health Issues
Biosimilars Access and Affordability Act (S. 5459); Skinny Labels, Big Savings Act (S. 43/H.R. 6485); Eliminating Thickets to Increase Competition (ETHIC) Act (S. 2276/H.R. 3269); Expedited Access to Biosimilars Act (S. 1414); Biosimilar Red Tape Elimination Act (S. 1954/H.R. 5526); CLEAR Act (H.R.7140); Artificial Intelligence-Ready Data Act (S.4098); Preserve Access to Affordable Generics and Biosimilars Act (S. 1096); Drug Competition Enhancement Act (S.1040); America's Living Library Project Bill (S. 4023); Securing Essential Components for U.S. Readiness in Essential Pharmaceuticals (SECURE Rx) Act of 2026 (discussion draft); improvements to the National Childhood Vaccine Injury Act of 1986; Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act (S. 3788).
Client expense: Not reported · Firm income: $450,000
Government targets: SENATE
2026 · first_quarter · Health Issues
S.1637/H.R 7871; Medicaid VBPs for Patients Act S. 2355/H.R. 5582; Patients Deserve Price Tags Act S. 2426/H.R. 3164; Ensuring Community Access to Pharmacist Services Act S. 526; Pharmacy Benefit Manager Transparency Act S. 882; Patients Before Middlemen Act S. 927; Protecting Pharmacies in Medicaid Act S. 1041; Affordable Prescriptions for Patients Act S. 1095; Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act S. 1096; Preserve Access to Affordable Generics and Biosimilars Act S. 1097; Interagency Patent Coordination and Improvements Act of 2025 S. 1414; Expedited Access to Biosimilars Act S. 2617; Reducing Drug Prices for Seniors Act S. 2800; Pharmacy and Medically Underserved Areas Enhancement Act S. 3345; PBM Price Transparency and Accountability Act S. 3349; PBM Disclosure Act S. 3549; PBM Fiduciary, Accountability, Integrity, and Reform Act S. 3822; Break Up Big Medicine Act H.R. 1244; Reducing Drug Prices for Seniors Act H.R. 2214; Delinking Revenue from Unfair Gouging Act H.R. 3164; Ensuring Community Access to Pharmacist Service Act H.R. 4317; PBM Reform Act H.R. 4409; Fair Pharmacies for Federal Employees Act H.R. 4570; Interagency Patent Coordination and Improvements Act of 2025 H.R. 6609; Pharmacists Fight Back Act in Medicare and Medicaid H.R. 6610; Pharmacists Fight Back Act in the Federal Employees Health Benefits Program H.R. 6837; To amend the Employee Retirement Income Security Act of 1974 to ensure that pharmacy benefit managers are considered fiduciaries, and for other purposes. H.R. 7148; Consolidated Appropriations Act of 2026 oSec. 6233- Any Willing Pharmacy oSec 6224- Medicare Delinking oSec. 6701- Oversight of PBM Services oSec. 6702- Full Rebate Pass Through to Plans H.R. 7895; PBM Kickback Prohibition Act H.R. 8143; Ensuring Access to Lower-Cost Medicines for Seniors Act of 2026 Implementation of the Inflation Reduction Act of 2022, P.L. 169- Provisions on Medicare Part D modernization and drug price negotiation, and the implementation of the Consolidated Appropriations Act of 2026 (P.L. 119-75)
Client expense: $299,699 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), SENATE, Small Business Administration (SBA)
2026 · first_quarter · Pharmacy
Supply Chain; Drug Shortages; Generic Drugs; S.1414 - Expedited Access to Biosimilars Act; S.1954 - Biosimilar Red Tape Reduction Act; S.3788 - Clear Labels Act;S.3510 - Biosimilar Inspection Modernization Act; API; Issues around Country of Origin labeling.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2026 · first_quarter · Pharmacy
Legislation and regulation regarding pharmaceutical pricing, coverage and care; retail and inpatient pharmacy operations and the role of pharmacy benefit managers. S.1954, H.R.5526 - Biosimilar Red Tape Elimination Act S.1414 - Expedited Access to Biosimilars Act S.2780, H.R.5429 - Medication Affordability and Patent Integrity Act S. 2620 - Reforming Evergreening and Manipulation that Extends Drug Years Act (REMEDY Act) H. R. 3269 - Eliminating Thickets to Increase Competition Act (ETHIC Act)
Client expense: $2,990,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2026 · first_quarter · Pharmacy
Prescription drug pricing issues. H.R. 1843/S. 1032 - Increasing Transparency in Generic Drug Applications Act. S. 1954/H.R. 5526 - Biosimilar Red Tape Elimination Act; S. 1095 - Stop Stalling Act S. 2630 - Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act H.R.1262 - Mikaela Naylon Give Kids a Chance Act. S. 3014 - Ensuring Timely Access to Generics Act of 2025 S. 1414 - Expedited Access to Biosimilars Act S. 1032/H.R. 1843 - Increasing Transparency in Generic Drug Applications Act
Client expense: Not reported · Firm income: $90,000
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2025 · fourth_quarter · Pharmacy
H.R. 1 - One Big Beautiful Bill Act - Rep. Arrington, Jodey - Medicaid eligibility and state financing, Marketplace coverage and enrollment, Health Savings Account expansion, Pharmacy Benefit Manager financing and regulation H.R. 843 - Prompt Approval of Safe Generic Drugs Act - Rep. Barragan, Nanette Diaz - Generic drugs applications and approvals H.R. 946 - ORPHAN Cures Act - Rep. Joyce, John - Medicare Drug Negotiation Program H.R. 950 - Saving Seniors Money on Prescriptions Act - Rep. Landsman, Greg - PBM reporting requirements for MA/Part D plans. H.R. 1117 - Responsibility in Drug Advertising Act - Rep. DeLauro, Rosa - Direct-to-consumer ads H.R. 1244 - Reducing Drug Prices for Seniors Act - Rep. Davis, Donald - Coinsurance for Part D drugs H.R. 2214 - DRUG Act - Rep. Miller-Meeks, Mariannette - PBM contracts H.R. 2450 - Prescription Drug Transparency and Affordability Act - Rep. McDonald Rivet, Kristen - PBM transparency H.R. 3493 - Global Fairness in Drug Pricing Act - Rep. Khanna, Ro - Prescription drug international reference pricing H.R. 3546 - Prescription Drug Price Relief Act - Rep. Khanna, Ro - Prescription drug patent reform H.R. 3775 - Fair Prescription Drug Prices for Americans Act - Rep. Van Drew, Jefferson - Prescription drug and biological product international reference pricing H.R. 3789 - DTC Act - Rep. Taylor, David - Direct-to-consumer prescription advertising transparency H.R. 4139 - Cutting Copays Act - Rep. McGarvey, Morgan - Medicare cost-sharing for generic drugs H.R. 4231 - Treat and Reduce Obesity Act - Rep. Kelly, Mike - Medicare coverage of obesity drugs H.R. 4317 - PBM Reform Act - Rep. Carter, Earl L. Buddy - PBM contracting requirements and transparency H.R. 4605 - End Prescription Drug Ads Now Act - Rep. Nadler, Jerrold - Ban on DTC drug ads H.R. 4623 - Plain Prescription Prices Act - Rep. Williams, Nikema - Transparency requirements for DTC drug ads H.R. 5094 - Protect Patients from Costly Care Act - Rep. Pappas, Chris - Repeal of Medicaid cost sharing requirements for drugs; Orphan drug inclusion in Medicare Drug Price Negotiation Program H.R. 5197 - Protect Beneficiaries from Middlemen Act - Rep. Malliotakis, Nicole - Medicare cost-sharing limit for drugs H.R. 6255 - Affordable Insulin Now Act - Rep. Craig, Angie - require cost-sharing for certain insulin products S. 229 - DTC Act - Sen. Durbin, Richard - Drug advertising requirements S. 483 - Responsibility in Drug Advertising Act - Sen. King, Angus - Drug advertising requirements S. 526 - Pharmacy Benefit Manage Transparency - Sen. Grassley, Chuck - PBM reporting requirements S. 529 - Capping Prescription Costs Act - Sen. Warnock, Raphael - Drug copay caps S. 652 - Protecting Patients from Deceptive Drugs Ads Act - Sen. Durbin, Richard - Drug advertising requirements S. 882 - Patients Before Middlemen Act - Sen. Blackburn, Marsha - PBM reforms S. 891 - Bipartisan Health Care Act - Sen. Wyden, Ron - PBM reforms and transparency S. 1040 - Drug Competition Enhanced Act - Sen. Cornyn, John - Drug patent reform S. 1041 - Affordable Prescriptions for Patients Act - Sen. Cornyn, John - Patent issues S. 1095 - Stop STALLING Act - Sen. Klobuchar, Amy - Drug patent reform S. 1096 - Preserve Access to Affordable Generics and Biosimilars Act - Sen. Klobuchar, Amy - Drug patent reform S. 1414 - Expedited Access to Biosimilars Act - Sen. Paul, Rand - Biosimilars assessment and approval S. 1587 - Fair Prescription Drug Prices for Americans Act - Sen. Hawley, Josh - Prescription drug international reference pricing S. 1753 - End Price Gouging for Medications Act - Sen. Merkley, Jeff - Prescription drug international reference pricing S. 1818 - Prescription Drug Price Relief Act - Sen. Sanders, Bernard - Prescription drug patent reform S. 1954 - Biosimilar Red Tape Elimination Act - Sen. Lee, Mike - Biological product assessment and approval S. 1973 - Treat and Reduce Obesity Act - Sen. Cassidy, Bill - Medicare coverage for obesity drugs S. 2345 - Short on Competition Act - Sen. Klobuchar, Amy - Expedited approval for generic drugs S. 2447 - Repealing the Trump Sick Tax Act - Sen. Welch, Peter - Repeal of Medicaid cost sharing requirements for drugs; Orphan drug inclusion in Medicare Drug Price Negotiation Program S. 2620 - REMEDY Act - Sen. Durbin, Richard - Expedited approvals for certain drug approvals Issues related to the implementation of Inflation Reduction Act - Medicare negotiation; cost-sharing and coverage of weight loss drugs/GLP-1s; high priced drugs; patent reforms; Pharmacy Benefit Managers; PBM related issues; and copay coupons.
Client expense: $4,120,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2025 · fourth_quarter · Health Issues
S. 355: FDA Modernization Act 3.0 S. 652: Protecting Patients from Deceptive Drug Ads Act S. 832: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 S. 864: HELP Copays Act S. 882: Patients Before Middlemen Act, and other legislation related to pharmacy benefit manager (PBM) reform. S. 891: Bipartisan Health Care Act (including section 227 - Modernizing and Ensuring PBM Accountability) S. 932: Give Kids a Chance Act of 2025 S. 1414: Expedited Access to Biosimilars Act S. 1954: Biosimilar Red Tape Elimination Act S. 2296: BIOSECURE Act (S.Amdt. 3236 to National Defense Authorization Act for FY 2026) S. 2658: Medication Affordability and Patent Integrity Act S. 2710: Open Payments Expansion Act S. 3345: PBM Price Transparency and Accountability Act H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 946: ORPHAN Cures Act H.R. 1262: Mikaela Naylon Give Kids a Chance Act H.R. 1492: 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; Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 H.R. 2214: DRUG Act H.R. 3701 Family Vaccine Protection Act H.R. 4132: Prescription Information Modernization Act of 2025 H.R. 4299: Protecting Patient Access to Cancer and Complex Therapies Act H.R. 4317: PBM Reform Act of 2025 H.R. 5256: 340B ACCESS Act H.R. 6423: HELP Copays Act H.R. 6283 Delinking Revenue from Unfair Gouging (DRUG Act) Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) Biopharmaceutical innovation policy issues User fee issues Vaccine policy issues Inflation Reduction Act of 2022 (P.L. 117-169) implementation policy issues IRA price negotiation expansion policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Most Favored Nation (MFN) policy issues Drug importation policy issues FDA policy issues MAHA Commission Report - Make Our Children Healthy Again Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance policy issues Compounding policy issues Supply chain policy issues Clinical trial policy issues 340B drug discount program rebate and policy issues 340B rebate pilot program Patient assistance program policy issues Biosimilar approval and reimbursement policy issues S. 5459: Biosimilars Access and Affordability Act (118th Congress) Drug shortages policy issues Artificial intelligence policy issues Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First Presidential Memoranda: Memorandum for the Secretary of Health and Human Services the Commissioner of Drugs - Addressing Misleading Direct-to-Consumer Prescription Drug Advertisements
Client expense: $810,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
2025 · fourth_quarter · Health Issues
S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act S. 1414/H.R._: Expedited Access to Biosimilars Act S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act US Drug Enforcement Administration Quota FDA/PTO Coordination USPTO Practices Most Favored Nation (MFN) Proposed Rule Biosimilar Tariffs Domestic Manufacturing Tariffs Medical Devices Generic Medicines Industry Net Effective Cost Biosimilar User Fee Act (BsUFA) Drug Shortages Domestic Manufacturing
Client expense: $430,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR), White House Office
2025 · fourth_quarter · Pharmacy
Prescription Drug Costs. H.R.1843: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. S.1302: Increasing Transparency in Generic Drug Applications Act. Generic Drug Reporting Requirement Language in the Senate NDAA, S.2296 - National Defense Authorization Act for Fiscal Year 2026. S.1071 - National Defense Authorization Act for Fiscal Year 2026. Drug Shortages. H.R.5526/S.1954: Biosimilar Red Tape Elimination Act (BRTEA). H.R.1051: To amend the Federal Food, Drug, and Cosmetic Act to allow for the approval of an abbreviated new drug application submitted by a subsequent applicant in the case of a failure by a first applicant to commence commercial marketing within a certain period, and for other purposes. American Relief Act, 2025 (PL. No: 118-158) as it relates to Patent Thickets and Q1/Q2. H.R.4191/S.1784: Mapping Americas Pharmaceutical Supply (MAPS) Act. H.R.4132/S.2027: Prescription Information Modernization Act of 2025. Establishment Inspection Reports. S.1414/H.R.__: Expedited Access to Biosimilars Act. S.3469 - BIOSECURE Act of 2025. Quotas on Controlled Substances.
Client expense: $1,150,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
2025 · fourth_quarter · Health Issues
FDA Modernization Act 3.0 (S. 355 / H.R. 2821); Expedited Access to Biosimilars Act (S. 1414); Orphan-drug exclusivity; draft Pioneering Antimicrobial Subscriptions To End Up surging Resistance (PASTEUR) Act (no bill number); Clinical Trials; Reciprocal approvals; Skinny Labels, Big Savings Act (S. 43/H.R. 6485); Increasing Transparency in Generic Drug Applications Act (S. 1302/H.R. 1843); BIOSECURE Act, Sec. 851 of the Fiscal Year (FY) 2026 National Defense Authorization Act (NDAA)(S. 1071/H.R. 3838); Potential legislation relating to the Vaccine Injury Compensation Program and other issues affecting vaccines.
Client expense: Not reported · Firm income: $170,000
2025 · fourth_quarter · Pharmacy
Supply Chain, Drug Shortages, Tariffs, Patent Thickets, Patent Settlements, Generic Drugs, S.43 - Skinny Labels, Big Savings Act, S.1041 - Affordable Prescriptions for Patients Act, S.1096 - Preserve Access to Affordable Generics and Biosimilars Act, S.1302 - A Bill to Provide for Increased Transparency in Generic Drug Applications, S.1414 - Expedited Access to Biosimilars Act, S.1954 - Biosimilar Red Tape Reduction Act, S.2296 - National Defense Authorization Act for FY 2026, H.R.1262 - Give Kids a Chance Act, H.R.3838 - Streamlining Procurement for Effective Execution and Delivery and National Defense Authorization Act for Fiscal Year 2026
Client expense: Not reported · Firm income: $60,000
Government targets: SENATE
2025 · third_quarter · Health Issues
S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act S. 1414/H.R._: Expedited Access to Biosimilars Act S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act S. 1041: Affordable Prescriptions for Patients Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 43: Skinny Labels, Big Savings Act S. 1097/H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 HR 4317: PBM Reform Act of 2025 HR 2214: DRUG Act S. 1553/H.R. 3160: PREVAIL Act S. 2305: Biosimilar Red Tape Elimination Act S. 2658: Medication Affordability and Patient Integrity Act ERISA Fiduciary Duty PTAB Discretionary Denials IRA Reform Human Factor Studies Interchangeability Biosimilar User Fee Act (BsUFA) Drug Shortages Domestic Manufacturing
Client expense: $340,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE, White House Office
2025 · third_quarter · Health Issues
S. 652: Protecting Patients from Deceptive Drug Ads Act S. 832: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 S. 864, HELP Copays Act - A bill to amend title XXVII of the Public Health Service Act to apply financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes. S. 882, Patients Before Middlemen Act, and other legislation related to pharmacy benefit manager (PBM) reform. Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026, Provisions related to the pharmaceutical industry. S. 891: Bipartisan Health Care Act (including section 227 - Modernizing and Ensuring PBM Accountability) S. 1302: Increasing Transparency in Generic Drug Applications Act S. 1414: Expedited Acccess to Biosimilars Act S. 1784: MAPS Act S. 1954: Biosimilar Red Tape Elimination Act H.R. 1: One Big Beautiful Bill Act H.R. 946: Orphan Cures Act H.R. 1492: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 H.R. 2214: DRUG Act H.R. 4132: Prescription Information Modernization Act of 2025 HR 6283: Delinking Revenue from Unfair Gouging (DRUG) Act - bill aimed at reforming practices of Pharmacy Benefit Managers (PBMs) by delinking their revenue from the list price of prescription drugs Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) Biopharmaceutical innovation policy issues User fee issues Vaccine policy issues Inflation Reduction Act of 2022 (P.L. 117-169) implementation policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues Accelerated approval policy issues FDA policy issues Competition policy issues Orphan Drug Act policy issues Compounding policy issues Supply chain policy issues Clinical trial policy issues 340B drug discount program rebate and policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Artificial intelligence policy issues Executive Order, Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order, Lowering Drug Prices by Once Again Putting Americans First
Client expense: $1,700,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE