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Increasing Transparency in Generic Drug Applications Act
Legislative Progress
Momentum (last 30 days)
0
score
0 actions · 0 new cosponsors · 0 votes
Speed vs cohort
0pct
0d open
vs 5,674 other S bills in the 119th — cohort avg 32d
No CRS summary is available for this bill yet. The source title, actions, sponsors, and text versions below come from Congress.gov.
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Filing registrants (19)
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 · Pharmacy
Issues: Generics access; Prescription Drug Cost; PBM Reform and Prescription Drug Policy Bills: S.1954 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference product. Sponsor: Sen. Lee, Mike [R-UT] S.3014 - Ensuring Timely Access to Generics Act of 2025 To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions. Sponsor: Sen. Shaheen, Jeanne [D-NH] S.1041 - Affordable Prescriptions for Patients Act A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1040 - Drug Competition Enhancement Act A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1096 - Preserve Access to Affordable Generics and Biosimilars Act A bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1095 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1097 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Sen. Durbin, Richard J. [D-IL] H.R.4570 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Rep. Neguse, Joe [D-CO-2] S.2658 - Medication Affordability and Patent Integrity Act To require sponsors of drug applications and holders of approved applications to provide certain submissions and communications to the Food and Drug Administration and the United States Patent and Trademark Office. Sponsor: Sen. Hassan, Margaret Wood [D-NH] S.1302 - Increasing Transparency in Generic Drug Applications Act To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.1843 - Increasing Transparency in Generic Drug Applications Act To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2] S.1040 - Drug Competition Enhancement Act A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1096 - Preserve Access to Affordable Generics and Biosimilars Act A bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1095 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1097 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Sen. Durbin, Richard J. [D-IL] H.R.4570 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Rep. Neguse, Joe [D-CO-2] S.2658 - Medication Affordability and Patent Integrity Act To require sponsors of drug applications and holders of approved applications to provide certain submissions and communications to the Food and Drug Administration and the United States Patent and Trademark Office. Sponsor: Sen. Hassan, Margaret Wood [D-NH] S.1302 - Increasing Transparency in Generic Drug Applications Act To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.1843 - Increasing Transparency in Generic Drug Applications Act To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2]
Client expense: $30,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2026 · third_quarter · Pharmacy
Generics access; Prescription Drug Cost; PBM Reform and Prescription Drug Policy S.1954 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference product. Sponsor: Sen. Lee, Mike [R-UT] S.3014 - Ensuring Timely Access to Generics Act of 2025 To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions. Sponsor: Sen. Shaheen, Jeanne [D-NH] S.1041 - Affordable Prescriptions for Patients Act A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1040 - Drug Competition Enhancement Act A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1096 - Preserve Access to Affordable Generics and Biosimilars Act A bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1095 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1097 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Sen. Durbin, Richard J. [D-IL] H.R.4570 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Rep. Neguse, Joe [D-CO-2] S.1302 - Increasing Transparency in Generic Drug Applications Act To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.1843 - Increasing Transparency in Generic Drug Applications Act To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2] H.R.7895 - PBM Kickback Prohibition Act To amend section 408 of the Employee Retirement Income Security Act of 1974 to prohibit kickbacks to pharmacy benefit managers. Sponsor: Rep. Allen, Rick W. [R-GA-12] S.4189 - INSULIN Act of 2026 To reduce the price of insulin and provide for patient protections with respect to the cost of insulin. Sponsor: Sen. Shaheen, Jeanne [D-NH]
2026 · third_quarter · Pharmacy
Issues: Generics access; Prescription Drug Cost; PBM Reform and Prescription Drug Policy Bills: S.1954 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference product. Sponsor: Sen. Lee, Mike [R-UT] S.3014 - Ensuring Timely Access to Generics Act of 2025 To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions. Sponsor: Sen. Shaheen, Jeanne [D-NH] S.1041 - Affordable Prescriptions for Patients Act A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1040 - Drug Competition Enhancement Act A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1096 - Preserve Access to Affordable Generics and Biosimilars Act A bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1095 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1097 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Sen. Durbin, Richard J. [D-IL] H.R.4570 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Rep. Neguse, Joe [D-CO-2] S.1302 - Increasing Transparency in Generic Drug Applications Act To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.1843 - Increasing Transparency in Generic Drug Applications Act To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2] H.R.7895 - PBM Kickback Prohibition Act To amend section 408 of the Employee Retirement Income Security Act of 1974 to prohibit kickbacks to pharmacy benefit managers. Sponsor: Rep. Allen, Rick W. [R-GA-12] S.4189 - INSULIN Act of 2026 To reduce the price of insulin and provide for patient protections with respect to the cost of insulin. Sponsor: Sen. Shaheen, Jeanne [D-NH]
2026 · third_quarter · Pharmacy
Generics access; Prescription Drug Cost; PBM Reform and Prescription Drug Policy S.1954 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference product. Sponsor: Sen. Lee, Mike [R-UT] S.3014 - Ensuring Timely Access to Generics Act of 2025 To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions. Sponsor: Sen. Shaheen, Jeanne [D-NH] S.1041 - Affordable Prescriptions for Patients Act A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1040 - Drug Competition Enhancement Act A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1096 - Preserve Access to Affordable Generics and Biosimilars Act A bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1095 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1097 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Sen. Durbin, Richard J. [D-IL] H.R.4570 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Rep. Neguse, Joe [D-CO-2] S.1302 - Increasing Transparency in Generic Drug Applications Act To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.1843 - Increasing Transparency in Generic Drug Applications Act To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2] H.R.7895 - PBM Kickback Prohibition Act To amend section 408 of the Employee Retirement Income Security Act of 1974 to prohibit kickbacks to pharmacy benefit managers. Sponsor: Rep. Allen, Rick W. [R-GA-12] S.4189 - INSULIN Act of 2026 To reduce the price of insulin and provide for patient protections with respect to the cost of insulin. Sponsor: Sen. Shaheen, Jeanne [D-NH]
2026 · third_quarter · Pharmacy
Issues: Generics access; Prescription Drug Cost; PBM Reform and Prescription Drug Policy Bills: S.3014 - Ensuring Timely Access to Generics Act of 2025 To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions. Sponsor: Sen. Shaheen, Jeanne [D-NH] S.1096 - Preserve Access to Affordable Generics and Biosimilars Act A bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1095 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1302 - Increasing Transparency in Generic Drug Applications Act To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.1843 - Increasing Transparency in Generic Drug Applications Act To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2]
Client expense: $276,347 · Firm income: Not reported
| Democratic |
| GA |
| Mike Lee | Republican | UT |
| Rand Paul | Republican | KY |
| HR 1768 |
119th |
| Related bill |
Client expense: $10,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Client expense: $100,000 · 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), Office of Management & Budget (OMB), SENATE, White House Office
Client expense: $1,240,000 · 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), SENATE, White House Office
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2026 · third_quarter · Pharmacy
Issues: Generics access; Prescription Drug Cost; PBM Reform and Prescription Drug Policy Bills: S.1954 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference product. Sponsor: Sen. Lee, Mike [R-UT] S.3014 - Ensuring Timely Access to Generics Act of 2025 To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions. Sponsor: Sen. Shaheen, Jeanne [D-NH] S.1041 - Affordable Prescriptions for Patients Act A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1040 - Drug Competition Enhancement Act A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1096 - Preserve Access to Affordable Generics and Biosimilars Act A bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1095 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1097 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Sen. Durbin, Richard J. [D-IL] H.R.4570 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Rep. Neguse, Joe [D-CO-2] S.1302 - Increasing Transparency in Generic Drug Applications Act To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.1843 - Increasing Transparency in Generic Drug Applications Act To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2] H.R.7895 - PBM Kickback Prohibition Act To amend section 408 of the Employee Retirement Income Security Act of 1974 to prohibit kickbacks to pharmacy benefit managers. Sponsor: Rep. Allen, Rick W. [R-GA-12] S.4189 - INSULIN Act of 2026 To reduce the price of insulin and provide for patient protections with respect to the cost of insulin. Sponsor: Sen. Shaheen, Jeanne [D-NH]
Client expense: Not reported · 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), Office of Management & Budget (OMB), SENATE, White House Office
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 · Health Issues
Issues related to drug pricing; pharmaceutical supply chain; modernization of prescribing information for physicians and pharmacists; Increasing Transparency in Generic Drug Applications, S.1302 and H.R. 1843; Part D Formulary Design and Generic Drug Testing
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2026 · third_quarter · Pharmacy
S. 1302 - Increasing Transparency in Generic Drug Applications Act; Supply Chain Issues; E-labeling; Inflation Reduction Act Implementation; Improving Generic Drug Access; Drug Shortages; Medicaid Generics Penalty.
Client expense: Not reported · Firm income: $50,000
Government targets: Centers For Medicare and Medicaid Services (CMS), 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 · Pharmacy
Issues: Generics access; Prescription Drug Cost; PBM Reform and Prescription Drug Policy Bills: S.1954 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference product. Sponsor: Sen. Lee, Mike [R-UT] S.3014 - Ensuring Timely Access to Generics Act of 2025 To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions. Sponsor: Sen. Shaheen, Jeanne [D-NH] S.1041 - Affordable Prescriptions for Patients Act A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1040 - Drug Competition Enhancement Act A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1096 - Preserve Access to Affordable Generics and Biosimilars Act A bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1095 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1097 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Sen. Durbin, Richard J. [D-IL] H.R.4570 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Rep. Neguse, Joe [D-CO-2] S.2658 - Medication Affordability and Patent Integrity Act To require sponsors of drug applications and holders of approved applications to provide certain submissions and communications to the Food and Drug Administration and the United States Patent and Trademark Office. Sponsor: Sen. Hassan, Margaret Wood [D-NH] S.1302 - Increasing Transparency in Generic Drug Applications Act To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.1843 - Increasing Transparency in Generic Drug Applications Act To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2] H.R.7895 - PBM Kickback Prohibition Act To amend section 408 of the Employee Retirement Income Security Act of 1974 to prohibit kickbacks to pharmacy benefit managers. Sponsor: Rep. Allen, Rick W. [R-GA-12] H.R. 6837 - PBM FAIR Act To amend the Employee Retirement Income Security Act of 1974 to ensure that pharmacy benefit managers are considered fiduciaries, and for other purposes. Sponsor: Rep. Auchincloss, Jake [D-MA-4] H.R.3164 - Ensuring Community Access to Pharmacist Services Act To amend title XVIII of the Social Security Act to provide pharmacy payment of certain services. Sponsor: Rep. Smith, Adrian [R-NE-3] S.43 - Skinny Labels, Big Savings Act To amend title 35, United States Code, to provide for a safe harbor from infringement of a method of use patent relating to drugs or biological products. Sponsor: Sen. Hickenlooper, John W. [D-CO] H.R.6485 - Skinny Labels, Big Savings Act To amend title 35, United States Code, to provide for a safe harbor from infringement of a method of use patent relating to drugs or biological products. Sponsor: Rep. Cline, Ben [R-VA-6] S.4189 - INSULIN Act of 2026 To reduce the price of insulin and provide for patient protections with respect to the cost of insulin. Sponsor: Sen. Shaheen, Jeanne [D-NH]
Client expense: $80,000 · 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), Office of Management & Budget (OMB), SENATE, White House Office
2026 · second_quarter · Pharmacy
Generics access; Prescription Drug Cost; PBM Reform and Prescription Drug Policy S.1954 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference product. Sponsor: Sen. Lee, Mike [R-UT] S.3014 - Ensuring Timely Access to Generics Act of 2025 To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions. Sponsor: Sen. Shaheen, Jeanne [D-NH] S.1041 - Affordable Prescriptions for Patients Act A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1040 - Drug Competition Enhancement Act A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1096 - Preserve Access to Affordable Generics and Biosimilars Act A bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1095 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1097 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Sen. Durbin, Richard J. [D-IL] H.R.4570 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Rep. Neguse, Joe [D-CO-2] S.2658 - Medication Affordability and Patent Integrity Act To require sponsors of drug applications and holders of approved applications to provide certain submissions and communications to the Food and Drug Administration and the United States Patent and Trademark Office. Sponsor: Sen. Hassan, Margaret Wood [D-NH] S.1302 - Increasing Transparency in Generic Drug Applications Act To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.1843 - Increasing Transparency in Generic Drug Applications Act To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2] H.R.7895 - PBM Kickback Prohibition Act To amend section 408 of the Employee Retirement Income Security Act of 1974 to prohibit kickbacks to pharmacy benefit managers. Sponsor: Rep. Allen, Rick W. [R-GA-12] H.R. 6837 - PBM FAIR Act To amend the Employee Retirement Income Security Act of 1974 to ensure that pharmacy benefit managers are considered fiduciaries, and for other purposes. Sponsor: Rep. Auchincloss, Jake [D-MA-4] H.R.3164 - Ensuring Community Access to Pharmacist Services Act To amend title XVIII of the Social Security Act to provide pharmacy payment of certain services. Sponsor: Rep. Smith, Adrian [R-NE-3] S.43 - Skinny Labels, Big Savings Act To amend title 35, United States Code, to provide for a safe harbor from infringement of a method of use patent relating to drugs or biological products. Sponsor: Sen. Hickenlooper, John W. [D-CO] H.R.6485 - Skinny Labels, Big Savings Act To amend title 35, United States Code, to provide for a safe harbor from infringement of a method of use patent relating to drugs or biological products. Sponsor: Rep. Cline, Ben [R-VA-6] S.4189 - INSULIN Act of 2026 To reduce the price of insulin and provide for patient protections with respect to the cost of insulin. Sponsor: Sen. Shaheen, Jeanne [D-NH]
Client expense: $990,000 · 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), SENATE, White House Office
2026 · second_quarter · Pharmacy
Issues: Generics access; Prescription Drug Cost; PBM Reform and Prescription Drug Policy Bills: S.1954 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference product. Sponsor: Sen. Lee, Mike [R-UT] S.3014 - Ensuring Timely Access to Generics Act of 2025 To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions. Sponsor: Sen. Shaheen, Jeanne [D-NH] S.1041 - Affordable Prescriptions for Patients Act A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1040 - Drug Competition Enhancement Act A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1096 - Preserve Access to Affordable Generics and Biosimilars Act A bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1095 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1097 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Sen. Durbin, Richard J. [D-IL] H.R.4570 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Rep. Neguse, Joe [D-CO-2] S.2658 - Medication Affordability and Patent Integrity Act To require sponsors of drug applications and holders of approved applications to provide certain submissions and communications to the Food and Drug Administration and the United States Patent and Trademark Office. Sponsor: Sen. Hassan, Margaret Wood [D-NH] S.1302 - Increasing Transparency in Generic Drug Applications Act To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.1843 - Increasing Transparency in Generic Drug Applications Act To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2] H.R.7895 - PBM Kickback Prohibition Act To amend section 408 of the Employee Retirement Income Security Act of 1974 to prohibit kickbacks to pharmacy benefit managers. Sponsor: Rep. Allen, Rick W. [R-GA-12] H.R. 6837 - PBM FAIR Act To amend the Employee Retirement Income Security Act of 1974 to ensure that pharmacy benefit managers are considered fiduciaries, and for other purposes. Sponsor: Rep. Auchincloss, Jake [D-MA-4] H.R.3164 - Ensuring Community Access to Pharmacist Services Act To amend title XVIII of the Social Security Act to provide pharmacy payment of certain services. Sponsor: Rep. Smith, Adrian [R-NE-3] S.43 - Skinny Labels, Big Savings Act To amend title 35, United States Code, to provide for a safe harbor from infringement of a method of use patent relating to drugs or biological products. Sponsor: Sen. Hickenlooper, John W. [D-CO] H.R.6485 - Skinny Labels, Big Savings Act To amend title 35, United States Code, to provide for a safe harbor from infringement of a method of use patent relating to drugs or biological products. Sponsor: Rep. Cline, Ben [R-VA-6] S.4189 - INSULIN Act of 2026 To reduce the price of insulin and provide for patient protections with respect to the cost of insulin. Sponsor: Sen. Shaheen, Jeanne [D-NH]
Client expense: $20,000 · 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), Office of Management & Budget (OMB), SENATE, White House Office
2026 · second_quarter · Pharmacy
Issues: Generics access; Prescription Drug Cost; PBM Reform and Prescription Drug Policy Bills: S.3014 - Ensuring Timely Access to Generics Act of 2025 To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions. Sponsor: Sen. Shaheen, Jeanne [D-NH] S.1041 - Affordable Prescriptions for Patients Act A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1040 - Drug Competition Enhancement Act A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1096 - Preserve Access to Affordable Generics and Biosimilars Act A bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1302 - Increasing Transparency in Generic Drug Applications Act To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.1843 - Increasing Transparency in Generic Drug Applications Act To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2] H.R.7895 - PBM Kickback Prohibition Act To amend section 408 of the Employee Retirement Income Security Act of 1974 to prohibit kickbacks to pharmacy benefit managers. Sponsor: Rep. Allen, Rick W. [R-GA-12] H.R. 6837 - PBM FAIR Act To amend the Employee Retirement Income Security Act of 1974 to ensure that pharmacy benefit managers are considered fiduciaries, and for other purposes. Sponsor: Rep. Auchincloss, Jake [D-MA-4] H.R.3164 - Ensuring Community Access to Pharmacist Services Act To amend title XVIII of the Social Security Act to provide pharmacy payment of certain services. Sponsor: Rep. Smith, Adrian [R-NE-3] S.4189 - INSULIN Act of 2026 To reduce the price of insulin and provide for patient protections with respect to the cost of insulin. Sponsor: Sen. Shaheen, Jeanne [D-NH]
Client expense: $276,347 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2026 · second_quarter · Pharmacy
Issues: Generics access; Prescription Drug Cost; Step Therapy Bills: S.1954 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference product. Sponsor: Sen. Lee, Mike [R-UT] S.3014 - Ensuring Timely Access to Generics Act of 2025 To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions. Sponsor: Sen. Shaheen, Jeanne [D-NH] S.1041 - Affordable Prescriptions for Patients Act A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1040 - Drug Competition Enhancement Act A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1096 - Preserve Access to Affordable Generics and Biosimilars Act A bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1095 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1097 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Sen. Durbin, Richard J. [D-IL] H.R.4570 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Rep. Neguse, Joe [D-CO-2] S.2658 - Medication Affordability and Patent Integrity Act To require sponsors of drug applications and holders of approved applications to provide certain submissions and communications to the Food and Drug Administration and the United States Patent and Trademark Office. Sponsor: Sen. Hassan, Margaret Wood [D-NH] S.1302 - Increasing Transparency in Generic Drug Applications Act To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.1843 - Increasing Transparency in Generic Drug Applications Act To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2] S.1040 - Drug Competition Enhancement Act A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1096 - Preserve Access to Affordable Generics and Biosimilars Act A bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1095 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1097 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Sen. Durbin, Richard J. [D-IL] H.R.4570 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Rep. Neguse, Joe [D-CO-2] S.2658 - Medication Affordability and Patent Integrity Act To require sponsors of drug applications and holders of approved applications to provide certain submissions and communications to the Food and Drug Administration and the United States Patent and Trademark Office. Sponsor: Sen. Hassan, Margaret Wood [D-NH] S.1302 - Increasing Transparency in Generic Drug Applications Act To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.1843 - Increasing Transparency in Generic Drug Applications Act To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2]
Client expense: $28,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2026 · second_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.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2026 · second_quarter · Health Issues
Issues related to drug pricing; pharmaceutical supply chain; modernization of prescribing information for physicians and pharmacists; Increasing Transparency in Generic Drug Applications, S.1302 and H.R. 1843; Part D Formulary Design and Generic Drug Testing
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2026 · second_quarter · Pharmacy
Generics access; Prescription Drug Cost; Step Therapy S.1954 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference product. Sponsor: Sen. Lee, Mike [R-UT] S.3014 - Ensuring Timely Access to Generics Act of 2025 To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions. Sponsor: Sen. Shaheen, Jeanne [D-NH] S.1041 - Affordable Prescriptions for Patients Act A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1040 - Drug Competition Enhancement Act A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1096 - Preserve Access to Affordable Generics and Biosimilars Act A bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1095 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Klobuchar, Amy [D-MN] S.2658 - Medication Affordability and Patent Integrity Act To require sponsors of drug applications and holders of approved applications to provide certain submissions and communications to the Food and Drug Administration and the United States Patent and Trademark Office. Sponsor: Sen. Hassan, Margaret Wood [D-NH] S.1302 - Increasing Transparency in Generic Drug Applications Act To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.1843 - Increasing Transparency in Generic Drug Applications Act To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2]
Client expense: $10,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2026 · second_quarter · Pharmacy
S. 1302 - Increasing Transparency in Generic Drug Applications Act; Supply Chain Issues; E-labeling; Inflation Reduction Act Implementation; Improving Generic Drug Access; PEPFAR; Drug Shortages; Medicaid Generics Penalty.
Client expense: Not reported · Firm income: $50,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2026 · first_quarter · Health Issues
S. 891, the Bipartisan Health Care Act Part D Formulary Design and Generic Drug Tiering H.R. 1843 / S. 1302 - Increasing Transparency in Generic Drug Applications Act HR 4132 / S.2027 - Prescription Information Modernization Act Medicaid Generics Penalty Implementation of the Inflation Reduction Act Drug Shortages S.2658 - The Medication Affordability and Patent Integrity Act
Client expense: $490,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), 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
Issues: Generics access; Prescription Drug Cost; Step Therapy Bills: S.1954 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference product. Sponsor: Sen. Lee, Mike [R-UT] S.3014 - Ensuring Timely Access to Generics Act of 2025 To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions. Sponsor: Sen. Shaheen, Jeanne [D-NH] S.1041 - Affordable Prescriptions for Patients Act A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1040 - Drug Competition Enhancement Act A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1096 - Preserve Access to Affordable Generics and Biosimilars Act A bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1095 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1097 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Sen. Durbin, Richard J. [D-IL] H.R.4570 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Rep. Neguse, Joe [D-CO-2] S.2658 - Medication Affordability and Patent Integrity Act To require sponsors of drug applications and holders of approved applications to provide certain submissions and communications to the Food and Drug Administration and the United States Patent and Trademark Office. Sponsor: Sen. Hassan, Margaret Wood [D-NH] S.1302 - Increasing Transparency in Generic Drug Applications Act To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.1843 - Increasing Transparency in Generic Drug Applications Act To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2]
Client expense: $10,000 · 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), Office of Management & Budget (OMB), SENATE, White House Office
2026 · first_quarter · Pharmacy
Issues: Generics access; Prescription Drug Cost; Step Therapy Bills: S.1954 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference product. Sponsor: Sen. Lee, Mike [R-UT] S.3014 - Ensuring Timely Access to Generics Act of 2025 To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions. Sponsor: Sen. Shaheen, Jeanne [D-NH] S.1041 - Affordable Prescriptions for Patients Act A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1040 - Drug Competition Enhancement Act A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1096 - Preserve Access to Affordable Generics and Biosimilars Act A bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1095 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1097 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Sen. Durbin, Richard J. [D-IL] H.R.4570 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Rep. Neguse, Joe [D-CO-2] S.2658 - Medication Affordability and Patent Integrity Act To require sponsors of drug applications and holders of approved applications to provide certain submissions and communications to the Food and Drug Administration and the United States Patent and Trademark Office. Sponsor: Sen. Hassan, Margaret Wood [D-NH] S.1302 - Increasing Transparency in Generic Drug Applications Act To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.1843 - Increasing Transparency in Generic Drug Applications Act To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2]
Client expense: $130,000 · 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), Office of Management & Budget (OMB), SENATE, White House Office
2026 · first_quarter · Pharmacy
Issues: Generics access; Prescription Drug Cost; Step Therapy Bills: S.1954 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference product. Sponsor: Sen. Lee, Mike [R-UT] S.3014 - Ensuring Timely Access to Generics Act of 2025 To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions. Sponsor: Sen. Shaheen, Jeanne [D-NH] S.1041 - Affordable Prescriptions for Patients Act A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1040 - Drug Competition Enhancement Act A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1096 - Preserve Access to Affordable Generics and Biosimilars Act A bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1095 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1097 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Sen. Durbin, Richard J. [D-IL] H.R.4570 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Rep. Neguse, Joe [D-CO-2] S.2658 - Medication Affordability and Patent Integrity Act To require sponsors of drug applications and holders of approved applications to provide certain submissions and communications to the Food and Drug Administration and the United States Patent and Trademark Office. Sponsor: Sen. Hassan, Margaret Wood [D-NH] S.1302 - Increasing Transparency in Generic Drug Applications Act To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.1843 - Increasing Transparency in Generic Drug Applications Act To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2] S.1040 - Drug Competition Enhancement Act A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1096 - Preserve Access to Affordable Generics and Biosimilars Act A bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1095 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1097 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Sen. Durbin, Richard J. [D-IL] H.R.4570 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Rep. Neguse, Joe [D-CO-2] S.2658 - Medication Affordability and Patent Integrity Act To require sponsors of drug applications and holders of approved applications to provide certain submissions and communications to the Food and Drug Administration and the United States Patent and Trademark Office. Sponsor: Sen. Hassan, Margaret Wood [D-NH] S.1302 - Increasing Transparency in Generic Drug Applications Act To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.1843 - Increasing Transparency in Generic Drug Applications Act To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2]
Client expense: $30,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2026 · first_quarter · Pharmacy
Issues: Generics access; Prescription Drug Cost; Step Therapy Bills: S.1954 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference product. Sponsor: Sen. Lee, Mike [R-UT] S.3014 - Ensuring Timely Access to Generics Act of 2025 To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions. Sponsor: Sen. Shaheen, Jeanne [D-NH] S.1041 - Affordable Prescriptions for Patients Act A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1096 - Preserve Access to Affordable Generics and Biosimilars Act A bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1302 - Increasing Transparency in Generic Drug Applications Act To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.1843 - Increasing Transparency in Generic Drug Applications Act To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2]
Client expense: $276,347 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2026 · first_quarter · Pharmacy
Generics access; Prescription Drug Cost; Step Therapy S.1954 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference product. Sponsor: Sen. Lee, Mike [R-UT] S.3014 - Ensuring Timely Access to Generics Act of 2025 To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions. Sponsor: Sen. Shaheen, Jeanne [D-NH] S.1041 - Affordable Prescriptions for Patients Act A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1040 - Drug Competition Enhancement Act A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1096 - Preserve Access to Affordable Generics and Biosimilars Act A bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1095 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Klobuchar, Amy [D-MN] S.2658 - Medication Affordability and Patent Integrity Act To require sponsors of drug applications and holders of approved applications to provide certain submissions and communications to the Food and Drug Administration and the United States Patent and Trademark Office. Sponsor: Sen. Hassan, Margaret Wood [D-NH] S.1302 - Increasing Transparency in Generic Drug Applications Act To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.1843 - Increasing Transparency in Generic Drug Applications Act To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2]
Client expense: $10,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2026 · first_quarter · Health Issues
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Biomedical Advanced Research and Development Authority (BARDA) ---Centers for Disease Control and Prevention ---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 ---H.R.1262/S.932: Mikaela Naylon Give Kids A Chance Act ---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) ---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 ---340B Rebate Rule ---Program Implementation & Oversight Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---Disease X Act ---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 ---White House National Biodefense Strategy ---WHO Pandemic Preparedness Accord Biosimilars ---Biosimilars Competition (General) ---Biosimilar Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution ---Purple Book Draft Legislation ---Reimbursement Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act Clinical Trial Data in China Data Privacy ---American Privacy Rights Act ---Clinical Trial Data in China ---Consumer Data Privacy and Security Act (Draft) ---Data Privacy Working Group Draft ---Implementation of BIOSECURE Act Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---Decentralized Clinical Trials Drug Evaluation and Review ---FDA Hiring Flexibility ---Promising Pathway Act ---PDUFA VII Implementation ---PDUFA VIII Negotiations Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability ---Contract Manufacturing Ecosystem in the United States 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.1095: Stop STALLING Act ---S.1041: Affordable Prescriptions for Patients 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 ---Ensuring Access to Generic Medications Act Drug Pricing ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.6166: Lowering Drug Costs for American Families 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 ---H.R. 5391/S. 2764 Protecting Patient Access to Cancer and Complex Therapies 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 ---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 ---S.1302: Increasing Transparency in Generic Drug Applications 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 of 2025 ---Average Manufacturer Price Calculations ---CMMI (GENEROUS Model) ---CMMI: GLOBE and GUARD Models ---Drug Benefit Design ---International Pricing Policies ---Medicaid VBPs for Patients (MVP) Act ---Modernizing and Ensuring PBM Accountability (MEPA) Act ---Most Favored Nation Drug Pricing Proposals ---Pricing and Rebates ---Alternative Payment Arrangements for Gene Therapies 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 ---Coverage and Reimbursement ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.1262/S.932: Mikaela Naylon Give Kids a Chance Act ---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 ---Pediatric Priority Review Voucher 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 ---H.R.1262/S.932: Mikaela Naylon Give Kids a Chance Act ---Pediatric Priority Review Voucher ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---H.R.6166: Lowering Drug Costs for American Families Act ---S.864/H.R.6423: HELP Copays Act ---Access to Innovative Treatments ---340B 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 ---SAFE STEP Act ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-Based Contracting and Communications Vaccines and Infectious Diseases ---Adult Immunization ---Let Injured Americans Be Legally Empowered (LIABLE) Act ---Mandating Exclusive Review of Individual Treatments (MERIT) Act ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---National Coverage Determination ---PASTEUR ACT ---SAFE STEP Act ---Vaccine Access Improvement Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Modernization Act ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
Client expense: $1,620,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Energy, Dept of, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office
2026 · first_quarter · Pharmacy
Generics access; Prescription Drug Cost; Step Therapy S.1954 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference product. Sponsor: Sen. Lee, Mike [R-UT] S.3014 - Ensuring Timely Access to Generics Act of 2025 To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions. Sponsor: Sen. Shaheen, Jeanne [D-NH] S.1041 - Affordable Prescriptions for Patients Act A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1040 - Drug Competition Enhancement Act A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1096 - Preserve Access to Affordable Generics and Biosimilars Act A bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1095 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1097 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Sen. Durbin, Richard J. [D-IL] H.R.4570 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Rep. Neguse, Joe [D-CO-2] S.2658 - Medication Affordability and Patent Integrity Act To require sponsors of drug applications and holders of approved applications to provide certain submissions and communications to the Food and Drug Administration and the United States Patent and Trademark Office. Sponsor: Sen. Hassan, Margaret Wood [D-NH] S.1302 - Increasing Transparency in Generic Drug Applications Act To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.1843 - Increasing Transparency in Generic Drug Applications Act To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2]
Client expense: $1,520,000 · 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), SENATE, White House Office
2026 · first_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; H.R. 1262 - Mikayla Naylon Give Kids a Chance Act. Country of Origin labeling.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2026 · first_quarter · Health Issues
Issues related to drug pricing; pharmaceutical supply chain; modernization of prescribing information for physicians and pharmacists; Increasing Transparency in Generic Drug Applications, S.1302 and H.R. 1843; Part D Formulary Design and Generic Drug Testing
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2026 · first_quarter · Pharmacy
S. 1302 - Increasing Transparency in Generic Drug Applications Act; Supply Chain Issues; E-labeling; Inflation Reduction Act Implementation; Improving Generic Drug Access; PEPFAR; Drug Shortages; Medicaid Generics Penalty.
Client expense: Not reported · Firm income: $50,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2025 · fourth_quarter · Copyright/Patent/Trademark
S. 43: Skinny Labels, Big Savings Act S. 708: RESTORE Patent Rights Act of 2025 S. 1040: Drug Competition Enhancement 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 of 2025 S. 1302: Increasing Transparency in Generic Drug Application Act S. 1546: Patent Eligibility Restoration Act of 2025 (PERA) S. 1553: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) S. 1784 MAPS Act S. 2276: Eliminating Thickets to Increase Competition Act (ETHIC Act) S. 2620: REMEDY Act S. 2658: Medication Affordability and Patent Integrity Act H.R. 890: Stopping Pharmas Ripoffs and Drug Savings For All Act H.R. 1574: RESTORE Patent Rights Act of 2025 H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) H.R. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 H.R. 6485: Skinny Labels, Big Savings Act Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues AI patent policy issues Patent eligibility policy issues Post-grant proceeding policy issues Patent submission policy issues Patent fee policy issues
Client expense: $810,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE
2025 · fourth_quarter · Health Issues
S. 891, the Bipartisan Health Care Act Part D Formulary Design and Generic Drug Tiering H.R. 1843 / S. 1302 - Increasing Transparency in Generic Drug Applications Act HR 4132 / S.2027 - Prescription Information Modernization Act Medicaid Generics Penalty Implementation of the Inflation Reduction Act Drug Shortages S.2658 - The Medication Affordability and Patent Integrity Act
Client expense: $490,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2025 · fourth_quarter · Pharmacy
Issues: 340B Program/Transparency; generics access; Pharmacy Benefit Managers; Prescription Drug Cost; Step Therapy Bills: S. 775, Increasing Transparency in Generic Drug Applications To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.3839 - To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2] S. 1067, Ensuring Timely Access to Generics Act (118th) To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions. Sponsor: Sen. Shaheen, Jeanne [D-NH] S.1096 - Preserve Access to Affordable Generics and Biosimilars Act A bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1302 - Increasing Transparency in Generic Drug Applications Act To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.1843 - Increasing Transparency in Generic Drug Applications Act To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2] H.R.1262 - Mikaela Naylon Give Kids a Chance Act To amend the Federal Food, Drug, and Cosmetic Act with respect to molecularly targeted pediatric cancer investigations, and for other purposes. Sponsor: Rep. McCaul, Michael T. [R-TX-10] S.932 - Give Kids a Chance Act of 2025 A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to molecularly targeted pediatric cancer investigations, and for other purposes. Sponsor: Sen. Mullin, Markwayne [R-OK]
Client expense: $265,983 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2025 · fourth_quarter · Health Issues
FY 2026 Appropriations for Agencies ---ASPR ---Centers for Disease Control and Prevention ---FDA ---Health Resources and Services Administration (HRSA) ---HHS Office of Infectious Disease and HIV/AIDS Policy ---National Institutes of Health FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---Creating Hope Reauthorization Act ---Drug Pricing ---Funding for Strategic National Stockpile ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---PPRV ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of 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.6166: Lowering Drug Costs for American Families Act ---340B Accountability Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---PROTECT 340B Act ---SUSTAIN 340B Act Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---BIOSECURE Act ---House GOP RFI on Supply Chain ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2026 ---Reasonable Pricing Clauses in BARDA Contracts ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---State Strategic Stockpile Act ---Synthetic Nucleic Acid Synthesis Screening ---VICP Loopholes ---WHO Pandemic Preparedness Accord Biosimilars ---Biosimilar Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution ---Preserve Access to Affordable Generics and Biosimilars Act ---Reimbursement Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act Clinical Trial Data in China Data Privacy ---BIOSECURE Act ---Clinical Trial Data in China Drug Evaluation and Review ---FDA Hiring Flexibility ---PDUFA VIII Negotiations ---Promising Pathway Act Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounding Pharmacies ---Contract Manufacturing Ecosystem in the United States ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability Drug Patenting ---S.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 ---A bill to address patent thickets ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.6166: Lowering Drug Costs for American Families 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.1097: Interagency Patent Coordination and Improvement Act ---S.1302: Increasing Transparency in Generic Drug Application ---Access to Innovative Treatments Act ---Biologics Competition Act ---Biosimilar Red Tape Elimination Act ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---DRUG Act ---Ensuring Access to Generic Medications Act ---Ensuring Timely Access to Generics ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Mandating Exclusive Review of Individual Treatments (MERIT) Act ---Medicare Drug Price Negotiation Act ---Medicare Negotiation and Competitive Licensing Act ---Modernizing and Ensuring PBM Accountability (MEPA) Act ---Most Favored Nation Drug Pricing Proposals ---National Coverage Determination ---Patient Cost-Sharing and Implementation ---Strengthening Innovation in Medicare and Medicaid Act Efforts to expand the Bio Economy & Bio Manufacturing Foreign Drug Data Protection Laws ---BIOSECURE Act Generic Drug Entry ---Enhanced Access to Affordable Medicines 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 of 2025 ---Alternative Payment Arrangements for Gene Therapies ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Medicaid Drug Rebate Program Rule ---The Medicaid VBPs for Patients (MVP) Act ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2026 National Security ---BIOSECURE Act ---Clinical Trial Data in China ---Most Favored Nation Pricing Opioid Crisis ---SUPPORT Act Orphan Drug Issues ---H.R.946/S.1862: ORPHAN Cures Act ---H.R.1262/S.932: Mikaela Naylon Give Kids a Chance Act ---S.705: Innovation in Pediatric Drugs Act of 2025 ---Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) 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 ---Temporarily Refundable R&D Credit ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.1262/S.932 Mikaela Naylon Give Kids a Chance Act Reimbursement and Coverage of Innovative Products ---H.R.6166: Lowering Drug Costs for American Families Act ---S.864/H.R.6423: HELP Copays Act ---Access to Innovative Treatments ---Administrative Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Lower Costs, More Transparency Act ---Mandating Exclusive Review of Individual Treatments (MERIT) Act ---Medicare Drug Price Negotiation Act ---Medicare Part B Physician-Administered Products ---Patient Cost-Sharing and Smoothing ---Prescription Drug Price Relief Act ---Protected Classes ---SAFE STEP Act ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---Access to Innovative Treatments Act ---Adult Immunization ---Let Injured Americans Be Legally Empowered (LIABLE) Act ---Mandating Exclusive Review of Individual Treatments (MERIT) Act ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---PASTEUR ACT ---SAFE STEP Act ---Vaccine Access Improvement Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Modernization Act ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
Client expense: $1,510,000 · 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), Office of Science & Technology Policy (OSTP), Office of the Vice President of the United States, SENATE, 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 · Copyright/Patent/Trademark
Skinny Labels, Big Savings Act (S. 43/H.R. 6485); Increasing Transparency in Generic Drug Applications Act (S. 1302/H.R. 1843).
Client expense: Not reported · Firm income: $170,000
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
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; H.R. 1262 - Mikayla Naylon Give Kids a Chance Act.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2025 · fourth_quarter · Pharmacy
Issues: 340B Program/Transparency; generics access; Pharmacy Benefit Managers; Prescription Drug Cost; Step Therapy Bills: S.1954 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference product. Sponsor: Sen. Lee, Mike [R-UT] S. 775, Increasing Transparency in Generic Drug Applications To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.3839 - To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2] S. 1067, Ensuring Timely Access to Generics Act (118th) To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions. Sponsor: Sen. Shaheen, Jeanne [D-NH] S.1041 - Affordable Prescriptions for Patients Act A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1040 - Drug Competition Enhancement Act A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1096 - Preserve Access to Affordable Generics and Biosimilars Act A bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1095 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1097 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Sen. Durbin, Richard J. [D-IL] H.R.4570 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Rep. Neguse, Joe [D-CO-2] S.2658 - Medication Affordability and Patent Integrity Act To require sponsors of drug applications and holders of approved applications to provide certain submissions and communications to the Food and Drug Administration and the United States Patent and Trademark Office. Sponsor: Sen. Hassan, Margaret Wood [D-NH] S.1302 - Increasing Transparency in Generic Drug Applications Act To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.1843 - Increasing Transparency in Generic Drug Applications Act To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2] H.R.1262 - Mikaela Naylon Give Kids a Chance Act To amend the Federal Food, Drug, and Cosmetic Act with respect to molecularly targeted pediatric cancer investigations, and for other purposes. Sponsor: Rep. McCaul, Michael T. [R-TX-10] S.932 - Give Kids a Chance Act of 2025 A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to molecularly targeted pediatric cancer investigations, and for other purposes. Sponsor: Sen. Mullin, Markwayne [R-OK] H.R.6609 - Pharmacists Fight Back in Medicare and Medicaid Act To amend titles XI, XVIII, and XIX of the Social Security Act to establish certain requirements under Medicare and Medicaid with respect to prescription drug benefits and pharmacy benefit managers. Sponsor: Rep. Auchincloss, Jake [D-MA-4] H.R.6610 - Pharmacists Fight Back [in Federal Employee Health Benefit Plans Act] To amend chapter 89 of title 5, United States Code, to limit the costs of pharmacy benefit managers with respect to Federal employee health benefit plans, and for other purposes. Sponsor: Rep. Auchincloss, Jake [D-MA-4]
Client expense: $90,000 · 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), Office of Management & Budget (OMB), SENATE, White House Office
2025 · fourth_quarter · Pharmacy
Issues: 340B Program/Transparency; generics access; Pharmacy Benefit Managers; Prescription Drug Cost; Step Therapy Bills: S.1954 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference product. Sponsor: Sen. Lee, Mike [R-UT] S. 775, Increasing Transparency in Generic Drug Applications To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.3839 - To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2] S. 1067, Ensuring Timely Access to Generics Act (118th) To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions. Sponsor: Sen. Shaheen, Jeanne [D-NH] S.1041 - Affordable Prescriptions for Patients Act A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1040 - Drug Competition Enhancement Act A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1096 - Preserve Access to Affordable Generics and Biosimilars Act A bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1095 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1097 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Sen. Durbin, Richard J. [D-IL] H.R.4570 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Rep. Neguse, Joe [D-CO-2] S.2658 - Medication Affordability and Patent Integrity Act To require sponsors of drug applications and holders of approved applications to provide certain submissions and communications to the Food and Drug Administration and the United States Patent and Trademark Office. Sponsor: Sen. Hassan, Margaret Wood [D-NH] S.1302 - Increasing Transparency in Generic Drug Applications Act To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.1843 - Increasing Transparency in Generic Drug Applications Act To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2] H.R.1262 - Mikaela Naylon Give Kids a Chance Act To amend the Federal Food, Drug, and Cosmetic Act with respect to molecularly targeted pediatric cancer investigations, and for other purposes. Sponsor: Rep. McCaul, Michael T. [R-TX-10] S.932 - Give Kids a Chance Act of 2025 A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to molecularly targeted pediatric cancer investigations, and for other purposes. Sponsor: Sen. Mullin, Markwayne [R-OK] H.R.6609 - Pharmacists Fight Back in Medicare and Medicaid Act To amend titles XI, XVIII, and XIX of the Social Security Act to establish certain requirements under Medicare and Medicaid with respect to prescription drug benefits and pharmacy benefit managers. Sponsor: Rep. Auchincloss, Jake [D-MA-4] H.R.6610 - Pharmacists Fight Back [in Federal Employee Health Benefit Plans Act] To amend chapter 89 of title 5, United States Code, to limit the costs of pharmacy benefit managers with respect to Federal employee health benefit plans, and for other purposes. Sponsor: Rep. Auchincloss, Jake [D-MA-4]
Client expense: Not reported · 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), Office of Management & Budget (OMB), SENATE, White House Office
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 · fourth_quarter · Pharmacy
340B Program/Transparency; generics access; Pharmacy Benefit Managers; Prescription Drug Cost; Step Therapy S.1954 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference product. Sponsor: Sen. Lee, Mike [R-UT] S. 775, Increasing Transparency in Generic Drug Applications To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.3839 - To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2] S. 1067, Ensuring Timely Access to Generics Act (118th) To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions. Sponsor: Sen. Shaheen, Jeanne [D-NH] S.1041 - Affordable Prescriptions for Patients Act A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1040 - Drug Competition Enhancement Act A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1096 - Preserve Access to Affordable Generics and Biosimilars Act A bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1095 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1097 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Sen. Durbin, Richard J. [D-IL] H.R.4570 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Rep. Neguse, Joe [D-CO-2] S.2658 - Medication Affordability and Patent Integrity Act To require sponsors of drug applications and holders of approved applications to provide certain submissions and communications to the Food and Drug Administration and the United States Patent and Trademark Office. Sponsor: Sen. Hassan, Margaret Wood [D-NH] S.1302 - Increasing Transparency in Generic Drug Applications Act To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.1843 - Increasing Transparency in Generic Drug Applications Act To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2] H.R.1262 - Mikaela Naylon Give Kids a Chance Act To amend the Federal Food, Drug, and Cosmetic Act with respect to molecularly targeted pediatric cancer investigations, and for other purposes. Sponsor: Rep. McCaul, Michael T. [R-TX-10] S.932 - Give Kids a Chance Act of 2025 A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to molecularly targeted pediatric cancer investigations, and for other purposes. Sponsor: Sen. Mullin, Markwayne [R-OK] H.R.6609 - Pharmacists Fight Back in Medicare and Medicaid Act To amend titles XI, XVIII, and XIX of the Social Security Act to establish certain requirements under Medicare and Medicaid with respect to prescription drug benefits and pharmacy benefit managers. Sponsor: Rep. Auchincloss, Jake [D-MA-4] H.R.6610 - Pharmacists Fight Back [in Federal Employee Health Benefit Plans Act] To amend chapter 89 of title 5, United States Code, to limit the costs of pharmacy benefit managers with respect to Federal employee health benefit plans, and for other purposes. Sponsor: Rep. Auchincloss, Jake [D-MA-4]
Client expense: $1,440,000 · 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), SENATE, White House Office
2025 · fourth_quarter · Health Issues
Issues related to drug pricing; pharmaceutical supply chain; modernization of prescribing information for physicians and pharmacists; Increasing Transparency in Generic Drug Applications, S.1302 and H.R. 1843; Part D Formulary Design and Generic Drug Testing
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2025 · fourth_quarter · Pharmacy
Issues: 340B Program/Transparency; generics access; Pharmacy Benefit Managers; Prescription Drug Cost; Step Therapy Bills: S.1954 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference product. Sponsor: Sen. Lee, Mike [R-UT] S. 775, Increasing Transparency in Generic Drug Applications To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.3839 - To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2] S. 1067, Ensuring Timely Access to Generics Act (118th) To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions. Sponsor: Sen. Shaheen, Jeanne [D-NH] S.1041 - Affordable Prescriptions for Patients Act A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1040 - Drug Competition Enhancement Act A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1096 - Preserve Access to Affordable Generics and Biosimilars Act A bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1095 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1097 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Sen. Durbin, Richard J. [D-IL] H.R.4570 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Rep. Neguse, Joe [D-CO-2] S.2658 - Medication Affordability and Patent Integrity Act To require sponsors of drug applications and holders of approved applications to provide certain submissions and communications to the Food and Drug Administration and the United States Patent and Trademark Office. Sponsor: Sen. Hassan, Margaret Wood [D-NH] S.1302 - Increasing Transparency in Generic Drug Applications Act To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.1843 - Increasing Transparency in Generic Drug Applications Act To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2]
Client expense: $28,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2025 · fourth_quarter · Health Issues
Federal policy relating to addressing drug shortages and strengthening pharmaceutical supply chains through partnerships with North American and other allied countries; Federal policy relating to providing preferential federal direct and indirect purchasing treatment for domestic and North American manufactured pharmaceuticals; S. 43, Skinny Labels Big Savings Act, provisions relating to providing a safe harbor from infringement for a method of use patent relating to drugs or biological products; and HR 1483/S. 1302, The Increasing Transparency in Generic Drug Applications Act, provisions relating to the Food and Drug Administrations authority to share information about ingredients and deviations in inactive ingredient concentration with generic pharmaceutical product applicants.
Client expense: $260,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2025 · fourth_quarter · Pharmacy
S. 1302 - Increasing Transparency in Generic Drug Applications Act; Supply Chain Issues; E-labeling; Inflation Reduction Act Implementation; Improving Generic Drug Access; PEPFAR; Drug Shortages; Medicaid Generics Penalty.
Client expense: Not reported · Firm income: $50,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2025 · fourth_quarter · Health Issues
Issues related to drug pricing; pharmaceutical supply chain; modernization of prescribing information for physicians and pharmacists; Increasing Transparency in Generic Drug Applications, S.1302 and H.R. 1843; Part D Formulary Design and Generic Drug Testing
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
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