Increasing Transparency in Generic Drug Applications Act

340B Program/Transparency; generics access; Pharmacy Benefit Managers; Prescription Drug Cost; Step Therapy S. 1114, Expanding Access to Low-Cost Generics Act To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period. Sponsor: Sen. Smith, Tina [D-MN] S. 2305 - 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. 150 - Affordable Prescriptions for Patients Act of 2023 To amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] H.R.9070 - Affordable Prescriptions for Patients Act of 2024 To amend title 35, United States Code, to prohibit product hopping, and for other purposes. Sponsor: Rep. Issa, Darrell [R-CA-48] S. 142 - Preserve Access to Affordable Generics and Biosimilars Act 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. 1067, Ensuring Timely Access to Generics Act 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]

Client expense: $265,983 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues: 340B Program/Transparency; generics access; Pharmacy Benefit Managers; Prescription Drug Cost; Step Therapy Bills: S. 1114, Expanding Access to Low-Cost Generics Act To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period. Sponsor: Sen. Smith, Tina [D-MN] S. 2305 - 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. 148 - 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. Amy Klobuchar (D-MN) S.1339 - Pharmacy Benefit Manager Reform Act To provide for increased oversight of entities that provide pharmacy benefit management services on behalf of group health plans and health insurance coverage. Sponsor: Sen. Sanders, Bernard [I-VT] 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. 150 - Affordable Prescriptions for Patients Act of 2023 To amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] H.R.9070 - Affordable Prescriptions for Patients Act of 2024 To amend title 35, United States Code, to prohibit product hopping, and for other purposes. Sponsor: Rep. Issa, Darrell [R-CA-48] S.1542, DRUG Act To improve services provided by pharmacy benefit managers. Sponsor: Sen. Marshall, Roger [R-KS] S. 142 - Preserve Access to Affordable Generics and Biosimilars Act 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. 1067, Ensuring Timely Access to Generics Act 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]

Client expense: $210,000 · 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

Issues: 340B Program/Transparency; generics access; Pharmacy Benefit Managers; Prescription Drug Cost; Step Therapy Bills: S. 1114, Expanding Access to Low-Cost Generics Act To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period. Sponsor: Sen. Smith, Tina [D-MN] S. 2305 - 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. 148 - 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. Amy Klobuchar (D-MN) S.1339 - Pharmacy Benefit Manager Reform Act To provide for increased oversight of entities that provide pharmacy benefit management services on behalf of group health plans and health insurance coverage. Sponsor: Sen. Sanders, Bernard [I-VT] 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. 150 - Affordable Prescriptions for Patients Act of 2023 To amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] H.R.9070 - Affordable Prescriptions for Patients Act of 2024 To amend title 35, United States Code, to prohibit product hopping, and for other purposes. Sponsor: Rep. Issa, Darrell [R-CA-48] S.1542, DRUG Act To improve services provided by pharmacy benefit managers. Sponsor: Sen. Marshall, Roger [R-KS] S. 142 - Preserve Access to Affordable Generics and Biosimilars Act 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. 1067, Ensuring Timely Access to Generics Act 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]

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), SENATE, White House Office

340B Program/Transparency; generics access; Pharmacy Benefit Managers; Prescription Drug Cost; Step Therapy S. 1114, Expanding Access to Low-Cost Generics Act To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period. Sponsor: Sen. Smith, Tina [D-MN] S. 2305 - 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. 148 - 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. Amy Klobuchar (D-MN) S.1339 - Pharmacy Benefit Manager Reform Act To provide for increased oversight of entities that provide pharmacy benefit management services on behalf of group health plans and health insurance coverage. Sponsor: Sen. Sanders, Bernard [I-VT] 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. 150 - Affordable Prescriptions for Patients Act of 2023 To amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] H.R.9070 - Affordable Prescriptions for Patients Act of 2024 To amend title 35, United States Code, to prohibit product hopping, and for other purposes. Sponsor: Rep. Issa, Darrell [R-CA-48] S.1542, DRUG Act To improve services provided by pharmacy benefit managers. Sponsor: Sen. Marshall, Roger [R-KS] S. 142 - Preserve Access to Affordable Generics and Biosimilars Act 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. 1067, Ensuring Timely Access to Generics Act 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]

Client expense: $1,200,000 · 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

Issues: 340B Program/Transparency; generics access; Pharmacy Benefit Managers; Prescription Drug Cost; Step Therapy Bills: S. 1114, Expanding Access to Low-Cost Generics Act To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period. Sponsor: Sen. Smith, Tina [D-MN] S. 2305 - 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. 148 - 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. Amy Klobuchar (D-MN) S.1339 - Pharmacy Benefit Manager Reform Act To provide for increased oversight of entities that provide pharmacy benefit management services on behalf of group health plans and health insurance coverage. Sponsor: Sen. Sanders, Bernard [I-VT] 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. 150 - Affordable Prescriptions for Patients Act of 2023 To amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] H.R.9070 - Affordable Prescriptions for Patients Act of 2024 To amend title 35, United States Code, to prohibit product hopping, and for other purposes. Sponsor: Rep. Issa, Darrell [R-CA-48] S.1542, DRUG Act To improve services provided by pharmacy benefit managers. Sponsor: Sen. Marshall, Roger [R-KS] S. 142 - Preserve Access to Affordable Generics and Biosimilars Act 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. 1067, Ensuring Timely Access to Generics Act 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]

Client expense: $28,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

340B Program/Transparency; generics access; Pharmacy Benefit Managers; Prescription Drug Cost; Step Therapy S. 1114, Expanding Access to Low-Cost Generics Act To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period. Sponsor: Sen. Smith, Tina [D-MN] S. 2305 - 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. 148 - 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. Amy Klobuchar (D-MN) S.1339 - Pharmacy Benefit Manager Reform Act To provide for increased oversight of entities that provide pharmacy benefit management services on behalf of group health plans and health insurance coverage. Sponsor: Sen. Sanders, Bernard [I-VT] 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. 150 - Affordable Prescriptions for Patients Act of 2023 To amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] H.R.9070 - Affordable Prescriptions for Patients Act of 2024 To amend title 35, United States Code, to prohibit product hopping, and for other purposes. Sponsor: Rep. Issa, Darrell [R-CA-48] S.1542, DRUG Act To improve services provided by pharmacy benefit managers. Sponsor: Sen. Marshall, Roger [R-KS] S. 142 - Preserve Access to Affordable Generics and Biosimilars Act 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. 1067, Ensuring Timely Access to Generics Act 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]

Client expense: $10,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

S. 775 - Increasing Transparency in Generic Drug Applications Act. Issues related to pharmaceutical manufacturing domestic supply chain, in H.R. 8070 - National Defense Authorization Act. S.2220 - PREVAIL Act. S.4097 - PERA Act.

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

Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, SENATE

S. 775 - Increasing Transparency in Generic Drug Applications Act. Issues related to pharmaceutical manufacturing domestic supply chain, in H.R. 8070 - National Defense Authorization Act. S.2220 - PREVAIL Act. S.4097 - PERA Act.

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

Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, SENATE

Prescription Drug Costs. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. 180-Day Exclusivity. H.R.3839/S.775: Increasing Transparency in Generic Drug Applications Act. Generic Drug Procurement Language as it Relates to H.R.2670/S.2226 - National Defense Authorization Act for Fiscal Year 2024. S.1961: Pharmaceutical Supply Chain Risk Assessment Act of 2023. H.R.6109: Producing Incentives for Long-term Production of Lifesaving Supply of Medicines (PILLS) Act. Drug Shortages. S.2362 - Drug Shortage Prevention Act. S.2305: Biosimilar Red Tape Elimination Act. FDA Inspections. Drug-Device Combination Products. Third Party Drug Quality Studies. H.R.1503/S.2916: Prescription Information Modernization Act of 2023. H.R.2880: Protecting Patients Against PBM Abuses Act.

Client expense: $530,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), HOUSE OF REPRESENTATIVES, SENATE

Issues related to prescription drug pricing. S. 2305 Biosimilar Red Tape Elimination Act. S. 148 Stop Significant and Time-Wasting Abuse Limiting Legitimate Innovation of New Generics Act. S. 1067 Ensuring Timely Access to Generics Act. S. 775/H.R. 3839 Increasing Transparency in Generic Drug Applications Act. S. 1214 Retaining Access and Restoring Exclusivity (RARE) Act. H.R.10545, the American Relief Act.

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

340B Program/Transparency; generics access; Clinical Trial Diversity S. 1114, Expanding Access to Low-Cost Generics Act To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period. Sponsor: Sen. Smith, Tina [D-MN] S. 127 - Pharmacy Benefit Manager Transparency Act of 2023 To prevent unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs, and for other purposes. Sponsor: Sen. Cantwell, Maria [D-WA] S.1339 - Pharmacy Benefit Manager Reform Act To provide for increased oversight of entities that provide pharmacy benefit management services on behalf of group health plans and health insurance coverage. Sponsor: Sen. Sanders, Bernard [I-VT] 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] H.R. 9070, Affordable Prescriptions for Patients Act of 2024 To amend title 35, United States Code, to prohibit product hopping, and for other purposes. Sponsor: Rep. Issa, Darrell [R-CA-48] S. 150 - Affordable Prescriptions for Patients Act of 2023 To amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1542, DRUG Act To improve services provided by pharmacy benefit managers. Sponsor: Sen. Marshall, Roger [R-KS] S. 142 - Preserve Access to Affordable Generics and Biosimilars Act 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.2666 - EPCS 2.0 Act To amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to provide for requirements for electronic-prescribing for controlled substances under group health plans and group and individual health insurance coverage. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.7312 - EPCS 2.0 Act To provide for requirements for electronic-prescribing for controlled substances under group health plans and group and individual health insurance coverage. Sponsor: Rep. Kuster, Ann M. [D-NH-2] S. 1067, Ensuring Timely Access to Generics Act To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions. Sponsor: Sen. Shaheen, Jeanne [D-NH] H.R.1359 - Modernizing Opioid Treatment Access Act To expand the take-home prescribing of methadone through pharmacies. Sponsor: Rep. Norcross, Donald [D-NJ-1] S.644 - Modernizing Opioid Treatment Access Act To expand the take-home prescribing of methadone through pharmacies. Sponsor: Sen. Markey, Edward J. [D-MA]

Client expense: $269,075 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.652 - Safe Step Act (Murkowski/Hassan), support passage H.R. 830 - HELP Copays Act, support passage S.935- Fair Accountability and Innovative Research Drug Pricing Act of 2023, support passage H.R. 485, Protecting Health Care For All Patients Act, oppose passage as currently written S.127, the Pharmacy Benefit Manager Transparency Act, support passage Urged HELP and House Energy and Commerce Committee to hold roundtables and advance proposals that address workforce issues within the healthcare community. S. 2333 - Pandemic and All-Hazards Preparedness and Response Act, support passage H.R. 824, Telehealth Benefit Expansion for Workers Act of 2023, oppose passage H.R. 4421, Preparing for All Hazards and Pathogens Reauthorization Act, monitor legislation H.R. 4420, Preparedness and Response Reauthorization Act, monitor legislation Committee Draft -The Primary Care and Health Workforce Expansion Act, support passage S. 1339, the Pharmacy Benefit Manager Reform Act, support passage S.127, the PBM Transparency Act of 2023, support passage S.113, The Prescription Pricing for the People Act of 2023, support passage S.2052, Protect Patient Access to Pharmacies Act H.R. 1692, Health Care Affordability Act of 2023 H.R. 3561, the PATIENT Act of 2023, support passage H.R. 3284, Providers and Payers Compete Act, support passage H.R. 4507, Transparency in Coverage Act, support passage H.R. 4508, Hidden Fee Disclosure Act, support passage H.R. 2816, PBM Sunshine and Accountability Act, support passage S.79- Interagency Patent Coordination and Improvement Act of 2023, support passage S. 142- Preserve Access to Affordable Generics and Biosimilars Act, support passage S.148- Stop STALLING Act, support passage S.150- Affordable Prescriptions for Patients Act of 2023, support passage S.775-Increasing Transparency in Generic Drug Applications Act, monitoring S.1067-Ensuring Timely Access to Generics Act of 2023, support passage S. 2780 Medication Affordability and Patent Integrity Ac H.R. 4189, the CONNECT for Health Act, support passage H.R. 1843, the Telehealth Expansion Act, support passage H.R. 8018, the Alleviating Barriers for Caregivers Act, support passage S. 3109, the Alleviating Barriers for Caregivers Act, support passage H.R.6302, the Health Share Transparency Act of 2023 H.R.7623, the Telehealth Modernization Act of 2024

Client expense: $51,247 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

340B Program/Transparency; generics access; Clinical Trial Diversity S. 1114, Expanding Access to Low-Cost Generics Act To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period. Sponsor: Sen. Smith, Tina [D-MN] S. 2305 - 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. 127 - Pharmacy Benefit Manager Transparency Act of 2023 To prevent unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs, and for other purposes. Sponsor: Sen. Cantwell, Maria [D-WA] S. 148 - 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. Amy Klobuchar (D-MN) S.1339 - Pharmacy Benefit Manager Reform Act To provide for increased oversight of entities that provide pharmacy benefit management services on behalf of group health plans and health insurance coverage. Sponsor: Sen. Sanders, Bernard [I-VT] 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] H.R. 9070, Affordable Prescriptions for Patients Act of 2024 To amend title 35, United States Code, to prohibit product hopping, and for other purposes. Sponsor: Rep. Issa, Darrell [R-CA-48] S. 150 - Affordable Prescriptions for Patients Act of 2023 To amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1542, DRUG Act To improve services provided by pharmacy benefit managers. Sponsor: Sen. Marshall, Roger [R-KS] H.R.6094 - Providing Realistic Opportunity To Equal and Comparable Treatment (PROTECT) for Rare Act To amend titles XVIII and XIX of the Social Security Act and title XXVII of the Public Health Service Act to refine the set of information sources for determining coverage of certain drugs and biologicals used in the treatment or management of a rare disease or condition, and for other purposes. Sponsor: Rep. Matsui, Doris O. [D-CA-7] S. 142 - Preserve Access to Affordable Generics and Biosimilars Act 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.2666 - EPCS 2.0 Act To amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to provide for requirements for electronic-prescribing for controlled substances under group health plans and group and individual health insurance coverage. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.7312 - EPCS 2.0 Act To provide for requirements for electronic-prescribing for controlled substances under group health plans and group and individual health insurance coverage. Sponsor: Rep. Kuster, Ann M. [D-NH-2] S.4741 - PLASMA Act To amend title XVIII of the Social Security Act to provide a phase-in for plasma-derived products under the manufacturer discount program. Sponsor: Sen. Tillis, Thomas [R-NC] HR 6465 PLASMA Act To amend title XVIII of the Social Security Act to provide a phase-in for plasma-derived products under the manufacturer discount program. Sponsor: Rep. Hudson, Richard [R-NC-9] S. 1067, Ensuring Timely Access to Generics Act To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions. Sponsor: Sen. Shaheen, Jeanne [D-NH] H.R.1359 - Modernizing Opioid Treatment Access Act To expand the take-home prescribing of methadone through pharmacies. Sponsor: Rep. Norcross, Donald [D-NJ-1] S.644 - Modernizing Opioid Treatment Access Act To expand the take-home prescribing of methadone through pharmacies. Sponsor: Sen. Markey, Edward J. [D-MA]

Client expense: $1,760,000 · 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

340B Drug Discount Program ---H.R.8574: 340B Affording Care for Communities and Ensuring a Strong Safety-net Act ---S.1133: 340B Accountability Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---PROTECT 340B Act ---SUSTAIN 340B Act Accelerated Approval Access to non-human Primates (NHPs) Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3832: Disease X Act of 2023 ---H.R.7085: BIOSECURE Act ---S.4667: Risky Research Review Act ---Bio COMPETES (Draft) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---House GOP RFI on Supply Chain ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---American Pandemic Preparedness Plan (AP3) ---Gain of function (Viral Gain of Function Research Moratorium Act, Risky Research Act) ---MCM PRV Program ---NDAA ---Reasonable Pricing Clauses in BARDA Contracts ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---VICP Loopholes ---White House National Biodefense Strategy ---WHO Pandemic Preparedness Accord Biosimilars ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.2305: Biosimilar Red Tape Elimination Act ---Bio COMPETES (Draft) ---Biosimilar Copay ---House GOP RFI on Supply Chain ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy Climate Change Clinical Trial Data in China Data Privacy ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---H.R.8818: American Privacy Rights Act of 2025 ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---Decentralized Clinical Trials ---Implementation of Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act Drug Evaluation and Review ---S.1906: Promising Pathway Act Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents. ---S.2780: Medication Affordability & Patient Integrity Act ---S.3583/H.R.6986: A bill to address patent thickets ---S.5573: A bill to amend title 35, United States Code, to provide for a safe harbor from infringement of a method of use patent relating to drugs or biological products. ---Affordable Prescriptions for Patients Act ---Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.5547/S.476: Maintaining Investments and New Innovation (MINI) Act ---H.R.6283: DRUG Act ---H.R.7174: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.775: Increasing Transparency in Generic Drug Application ---S.1067: Ensuring Timely Access to Generics ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents. ---S.2305: Biosimilar Red Tape Elimination Act ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---H.R.2408: Access to Innovative Treatments Act ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Negotiation and Competitive Licensing Act ---National Coverage Determination ---Patients Before Monopolies (PBM) Act ---PBM Reform ---Patient Cost-Sharing and Implementation ---Strengthening Innovation in Medicare and Medicaid Act Efforts to expand the Bio Economy & Bio Manufacturing Foreign Drug Data Protection Laws ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---MCM PRV ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2025 Appropriations ---VICP Funding for FDA ---FY 2025 Appropriations ---Creating Hope Reauthorization Act ---Prescription Drug User Fee Act (PDUFA) VII Implementation Funding for Health Resources and Services Administration (HRSA) ---FY 2025 Appropriations Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2025 Appropriations Funding for National Institutes of Health ---FY 2025 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) ---Funding for Womens Health Research Generic Drug Entry ---H.R.6973: Generic Drug Application Review Reforms ---S.148: Stop STALLING Act ---S.4351: Enhanced Access to Affordable Medicines Act Issues Relating to Medical Research and Animal Testing Models ---H.R.7248: FDA Modernization Act 3.0 Medicaid ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4758: Accelerating Kids Access to Care Act ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Alternative Payment Arrangements for Gene Therapies ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Medicaid Drug Rebate Program Rule ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2025 Opioid Crisis ---H.R.4531/S.2933: Support for Patients and Communities Reauthorization Act ---Non-Opioid Analgesics ---Coverage and Reimbursement Orphan Drug Issues ---H.R.3433: Give Kids a Chance Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.6664: Innovation in Pediatric Drugs Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.1214: Retaining Access and Restoring Exclusivity (RARE) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---Implementation of the Prepare for and Respond to Existing Viruses ---Emerging New Threats and (PREVENT) Pandemics Act ---Monoclonal Antibody Coverage and Utilization ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.7384/S4583: Creating Hope Reauthorization Act of 2024 ---Helping Experts Accelerate Rare Treatments (HEART)Act ---Rare Disease Pilot Program ---Speeding Therapy Access Today (STAT) Act Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5378: Lower Costs, More Transparency Act ---H.R.5796/S424: Protect our Seniors Act ---Administration Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---In-Home Administration of Part B Drugs ---Lower Costs, More Cures Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---H.R.5260: Reduced Costs and Continued Cures Act ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence Vaccine Injury Compensation Program ---FY 2025 Appropriations ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---VICP CICP (Discussion Draft)

Client expense: $1,460,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Security Council (NSC), SENATE, State, Dept of (DOS), White House Office

340B Drug Discount Program ---H.R.8574: 340B Affording Care for Communities and Ensuring a Strong Safety-net Act ---S.1133: 340B Accountability Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---PROTECT 340B Act ---SUSTAIN 340B Act Accelerated Approval Access to non-human Primates (NHPs) Artificial Intelligence (AI) Alternative Funding Programs Biosimilars ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.2305: Biosimilar Red Tape Elimination Act ---Biosimilar Copay ---BSUFA Negotiations ---Implementation of BSUFA Agreement ---Interchangeability and Pharmacy Substitution ---Reimbursement Cell & Gene Therapy Climate Change Clinical Trial Data in China Data Privacy ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---H.R.8818: American Privacy Rights Act of 2024 ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Diversity & Inclusion ---Decentralized Clinical Trials ---Implementation of Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act Drug Evaluation and Review ---COVID-19 Lessons Learned ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents. ---S.3583/H.R.6986: A bill to address patent thickets ---Affordable Prescriptions for Patients Act ---Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.1790: Biologics Competition Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.5547: Maintaining Investments and New Innovation (MINI) Act ---H.R.6283: DRUG Act ---H.R.7174: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1067: Ensuring Timely Access to Generics ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Access to Innovative Treatments Act ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Negotiation and Competitive Licensing Act ---National Coverage Determination ---Patients Before Monopolies (PBM) Act ---PBM Reform ---Patient Cost-Sharing and Implementation ---Strengthening Innovation in Medicare and Medicaid Act Foreign Drug Data Protection Laws ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Generic Drug Entry ---S.148: Stop STALLING Act ---S.775: Increasing Transparency in Generic Drug Applications Act ---Enhanced Access to Affordable Medicines Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing Models ---H.R.7248: FDA Modernization Act 3.0 Medicaid ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Encouraging Innovation Benefit Design to Lower Costs for Seniors Act ---Medicaid Drug Rebate Program ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2025 Opioid Crisis ---H.R.4531/S.2933: Support for Patients and Communities Reauthorization Act ---Non-Opioid Analgesics ---Transparency ---Coverage and Reimbursement Orphan Drug Issues ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.6664: Innovation in Pediatric Drugs Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.1214: Retaining Access and Restoring Exclusivity (RARE) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---House GOP RFI on Supply Chain ---Implementation of the Prepare for and Respond to Existing Viruses ---Monoclonal Antibody Coverage and Utilization ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.7384/S.4583: Creating Hope Reauthorization Act of 2024 ---Helping Experts Accelerate Rare Treatments (HEART) Act ---Rare Disease Pilot Program ---Speeding Therapy Access Today (STAT) Act Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5378: Lower Costs, More Transparency Act ---Administration Rebate Rule ---CMMI Authority ---In-Home Administration of Part B Drugs ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---Adult Immunization ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence Vaccine Injury Compensation Program ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---VICP CICP (Discussion Draft)

Client expense: $1,460,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Security Council (NSC), SENATE, State, Dept of (DOS), White House Office

Prescription drug pricing issues. S. 2305 - Biosimilar Red Tape Elimination Act. S. 148 - Stop Significant and Time-Wasting Abuse Limiting Legitimate Innovation of New Generics Act. S. 1067 - Ensuring Timely Access to Generics Act. S. 775/H.R. 3839 - Increasing Transparency in Generic Drug Applications Act. S. 1214 - Retaining Access and Restoring Exclusivity (RARE) Act. H.R. 10545 - American Relief Act

Client expense: Not reported · Firm income: $80,000

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

340B Program/Transparency; generics access S. 1114, Expanding Access to Low-Cost Generics Act To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period. Sponsor: Sen. Smith, Tina [D-MN] S. 2305 - 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. 127 - Pharmacy Benefit Manager Transparency Act of 2023 To prevent unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs, and for other purposes. Sponsor: Sen. Cantwell, Maria [D-WA] S. 148 - 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. Amy Klobuchar (D-MN) S.1339 - Pharmacy Benefit Manager Reform Act To provide for increased oversight of entities that provide pharmacy benefit management services on behalf of group health plans and health insurance coverage. Sponsor: Sen. Sanders, Bernard [I-VT] 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. 9070, Affordable Prescriptions for Patients Act of 2024 To amend title 35, United States Code, to prohibit product hopping, and for other purposes. Sponsor: Rep. Issa, Darrell [R-CA-48] S. 150 - Affordable Prescriptions for Patients Act of 2023 To amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1542, DRUG Act To improve services provided by pharmacy benefit managers. Sponsor: Sen. Marshall, Roger [R-KS] H.R.6094 - Providing Realistic Opportunity To Equal and Comparable Treatment (PROTECT) for Rare Act To amend titles XVIII and XIX of the Social Security Act and title XXVII of the Public Health Service Act to refine the set of information sources for determining coverage of certain drugs and biologicals used in the treatment or management of a rare disease or condition, and for other purposes. Sponsor: Rep. Matsui, Doris O. [D-CA-7] S. 142 - Preserve Access to Affordable Generics and Biosimilars Act 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. 1067, Ensuring Timely Access to Generics Act To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions. Sponsor: Sen. Shaheen, Jeanne [D-NH] H.R.1359 - Modernizing Opioid Treatment Access Act To expand the take-home prescribing of methadone through pharmacies. Sponsor: Rep. Norcross, Donald [D-NJ-1] S.644 - Modernizing Opioid Treatment Access Act To expand the take-home prescribing of methadone through pharmacies. Sponsor: Sen. Markey, Edward J. [D-MA]

Client expense: $5,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to drug pricing; issues related to pharmaceutical supply chain; issues related to modernization of prescribing information for physicians and pharmacists; Improved Access to Affordable Medications Act, S. 1120; Increasing Transparency in Generic Drug Applications, S.775 and HR 3839; Part D Formulary Design and Generic Drug Tiering; Prescription Information Modernization Act, HR 1503.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 775 - Increasing Transparency in Generic Drug Applications Act. Issues related to pharmaceutical manufacturing domestic supply chain, in H.R. 8070 - National Defense Authorization Act. S.2220 - PREVAIL Act. S.4097 - PERA Act.

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

Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, SENATE

Prescription Drug Costs. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. 180-Day Exclusivity. S.1114 - Expanding Access to Low-Cost Generics Act of 2023. H.R.3839/S.775: Increasing Transparency in Generic Drug Applications Act. Generic Drug Procurement Language as it Relates to H.R.2670/S.2226 - National Defense Authorization Act for Fiscal Year 2024. H.R.6109: Producing Incentives for Long-term Production of Lifesaving Supply of Medicines (PILLS) Act. Drug Shortages. H.R.10239/S.5368: End Drug Shortages Act. H.R. 3008/S.2362: Drug Shortage Prevention Act of 2023. S.2305: Biosimilar Red Tape Elimination Act. H.R.2880: Protecting Patients Against PBM Abuses Act. H.R.10545: American Relief Act, 2025 as it relates to Patent Thickets and Q1/Q2.

Client expense: $800,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Prescription Drug Affordability S775 Increasing Transparency in Generic Drug Application to provide for increased transparency in generic drug application Sen Hassan, Margaret Wood (D-NH) HR9070, Affordable Prescriptions for Patients Act of 2024 to amend title 35, United States Code, to prohibit product hopping, and for other purposes Sen. Cornyn, John (R-TX) Insulin Out of Pocket Charges; Finance PBNM Framework Proposals; Covid Vaccines S. 150 - Affordable Prescriptions for Patients Act of 2023 A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. John Cornyn (R-TX) S. 127 - Pharmacy Benefit Manager Transparency Act of 2023 A bill to prevent unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs, and for other purposes. Sponsor: Sen. Maria Cantwell (D-WA) S.1067 - Ensuring Timely Access to Generics Act of 2023 To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions. Sponsor: Sen. Shaheen, Jeanne [D-NH] S.1114 - Expanding Access to Low-Cost Generics Act of 2023 To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period. Sponsor: Sen. Smith, Tina [D-MN] S.1269 - INSULIN Act of 2023 To reduce the price of insulin and provide for patient protections with respect to the cost of insulin. Sponsor: Sen. Shaheen, Jeanne [D-NH] S.1339 - Pharmacy Benefit Manager Reform Act To provide for increased oversight of entities that provide pharmacy benefit management services on behalf of group health plans and health insurance coverage. Sponsor: Sen. Sanders, Bernard [I-VT] S.2305 - 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]

Client expense: $31,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

340B Program/Transparency; generics access; Clinical Trial Diversity S. 1114, Expanding Access to Low-Cost Generics Act To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period. Sponsor: Sen. Smith, Tina [D-MN] S. 2305 - 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. 127 - Pharmacy Benefit Manager Transparency Act of 2023 To prevent unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs, and for other purposes. Sponsor: Sen. Cantwell, Maria [D-WA] S. 148 - 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. Amy Klobuchar (D-MN) S.1339 - Pharmacy Benefit Manager Reform Act To provide for increased oversight of entities that provide pharmacy benefit management services on behalf of group health plans and health insurance coverage. Sponsor: Sen. Sanders, Bernard [I-VT] 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] H.R. 9070, Affordable Prescriptions for Patients Act of 2024 To amend title 35, United States Code, to prohibit product hopping, and for other purposes. Sponsor: Rep. Issa, Darrell [R-CA-48] S. 150 - Affordable Prescriptions for Patients Act of 2023 To amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1542, DRUG Act To improve services provided by pharmacy benefit managers. Sponsor: Sen. Marshall, Roger [R-KS] H.R.6094 - Providing Realistic Opportunity To Equal and Comparable Treatment (PROTECT) for Rare Act To amend titles XVIII and XIX of the Social Security Act and title XXVII of the Public Health Service Act to refine the set of information sources for determining coverage of certain drugs and biologicals used in the treatment or management of a rare disease or condition, and for other purposes. Sponsor: Rep. Matsui, Doris O. [D-CA-7] S. 142 - Preserve Access to Affordable Generics and Biosimilars Act 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.2666 - EPCS 2.0 Act To amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to provide for requirements for electronic-prescribing for controlled substances under group health plans and group and individual health insurance coverage. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.7312 - EPCS 2.0 Act To provide for requirements for electronic-prescribing for controlled substances under group health plans and group and individual health insurance coverage. Sponsor: Rep. Kuster, Ann M. [D-NH-2] S.4741 - PLASMA Act To amend title XVIII of the Social Security Act to provide a phase-in for plasma-derived products under the manufacturer discount program. Sponsor: Sen. Tillis, Thomas [R-NC] HR 6465 PLASMA Act To amend title XVIII of the Social Security Act to provide a phase-in for plasma-derived products under the manufacturer discount program. Sponsor: Rep. Hudson, Richard [R-NC-9] S. 1067, Ensuring Timely Access to Generics Act To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions. Sponsor: Sen. Shaheen, Jeanne [D-NH] H.R.1359 - Modernizing Opioid Treatment Access Act To expand the take-home prescribing of methadone through pharmacies. Sponsor: Rep. Norcross, Donald [D-NJ-1] S.644 - Modernizing Opioid Treatment Access Act To expand the take-home prescribing of methadone through pharmacies. Sponsor: Sen. Markey, Edward J. [D-MA]

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), SENATE, White House Office

340B Program/Transparency; generics access; Clinical Trial Diversity S. 1114, Expanding Access to Low-Cost Generics Act To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period. Sponsor: Sen. Smith, Tina [D-MN] S. 2305 - 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. 127 - Pharmacy Benefit Manager Transparency Act of 2023 To prevent unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs, and for other purposes. Sponsor: Sen. Cantwell, Maria [D-WA] S. 148 - 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. Amy Klobuchar (D-MN) S.1339 - Pharmacy Benefit Manager Reform Act To provide for increased oversight of entities that provide pharmacy benefit management services on behalf of group health plans and health insurance coverage. Sponsor: Sen. Sanders, Bernard [I-VT] 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] H.R. 9070, Affordable Prescriptions for Patients Act of 2024 To amend title 35, United States Code, to prohibit product hopping, and for other purposes. Sponsor: Rep. Issa, Darrell [R-CA-48] S. 150 - Affordable Prescriptions for Patients Act of 2023 To amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1542, DRUG Act To improve services provided by pharmacy benefit managers. Sponsor: Sen. Marshall, Roger [R-KS] H.R.6094 - Providing Realistic Opportunity To Equal and Comparable Treatment (PROTECT) for Rare Act To amend titles XVIII and XIX of the Social Security Act and title XXVII of the Public Health Service Act to refine the set of information sources for determining coverage of certain drugs and biologicals used in the treatment or management of a rare disease or condition, and for other purposes. Sponsor: Rep. Matsui, Doris O. [D-CA-7] S. 142 - Preserve Access to Affordable Generics and Biosimilars Act 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.2666 - EPCS 2.0 Act To amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to provide for requirements for electronic-prescribing for controlled substances under group health plans and group and individual health insurance coverage. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.7312 - EPCS 2.0 Act To provide for requirements for electronic-prescribing for controlled substances under group health plans and group and individual health insurance coverage. Sponsor: Rep. Kuster, Ann M. [D-NH-2] S.4741 - PLASMA Act To amend title XVIII of the Social Security Act to provide a phase-in for plasma-derived products under the manufacturer discount program. Sponsor: Sen. Tillis, Thomas [R-NC] HR 6465 PLASMA Act To amend title XVIII of the Social Security Act to provide a phase-in for plasma-derived products under the manufacturer discount program. Sponsor: Rep. Hudson, Richard [R-NC-9] S. 1067, Ensuring Timely Access to Generics Act To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions. Sponsor: Sen. Shaheen, Jeanne [D-NH] H.R.1359 - Modernizing Opioid Treatment Access Act To expand the take-home prescribing of methadone through pharmacies. Sponsor: Rep. Norcross, Donald [D-NJ-1] S.644 - Modernizing Opioid Treatment Access Act To expand the take-home prescribing of methadone through pharmacies. Sponsor: Sen. Markey, Edward J. [D-MA]

Client expense: $140,000 · 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

Increasing Transparency in Generic Drug Applications Act, (S. 775), Part D Formulary Design; 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

340B Drug Discount Program ---H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act ---S1133: 350B Accountability Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---PROTECT 340B Act ---SUSTAIN 340B Act Accelerated Approval Access to non-human Primates (NHPs) Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3832: Disease X Act of 2023 ---H.R.7085: BIOSECURE Act ---S. 4667 Risky Research Review Act ---Bio COMPETES (Draft) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---House GOP RFI on Supply Chain ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---American Pandemic Preparedness Plan (AP3) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---MCM PRV Program ---NDAA ---Reasonable Pricing Clauses in BARDA Contracts ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---VICP Loopholes ---White House National Biodefense Strategy ---WHO Pandemic Preparedness Accord Biosimilars ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.2305: Biosimilar Red Tape Elimination Act ---Bio COMPETES (Draft) ---Biosimilar Copay ---House GOP RFI on Supply Chain ---Interchangeability and Pharmacy Substitution ---Reimbursement Cell & Gene Therapy Climate Change ---FY 2025 Appropriations Clinical Trial Data in China Data Privacy ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---H.R. 8818: American Privacy Rights Act of 2025 ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---Decentralized Clinical Trials ---Implementation of Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act Drug Evaluation and Review ---S.1906: Promising Pathway Act ---COVID-19 Lessons Learned ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---S. 2780 Medication Affordability & Patient Integrity Act ---S.3583/H.R.6986: A bill to address patent thickets ---Affordable Prescriptions for Patients Act ---Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.1790: Biologics Competition Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.5547/S.476: Maintaining Investments and New Innovation (MINI) Act ---H.R.6283: DRUG Act ---H.R.7174: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.775: Increasing Transparency in Generic Drug Application ---S.1067: Ensuring Timely Access to Generics ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents, ---S.2305: Biosimilar Red Tape Elimination Act ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---H.R.2408: Access to Innovative Treatments Act ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Negotiation and Competitive Licensing Act ---National Coverage Determination ---PBM Reform ---Patient Cost-Sharing and Implementation ---Strengthening Innovation in Medicare and Medicaid Act Efforts to expand the Bio Economy & Bio Manufacturing Foreign Drug Data Protection Laws ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---MCM PRV ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2025 Appropriations ---VICP Funding for FDA ---FY 2025 Appropriations ---Creating Hope Reauthorization Act ---Prescription Drug User Fee Act (PDUFA) VII Implementation Funding for Health Resources and Services Administration (HRSA) ---FY 2025 Appropriations Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2025 Appropriations Funding for National Institutes of Health ---FY 2025 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) ---Funding for Womens Health Research Generic Drug Entry ---S.148: Stop STALLING Act ---S.775: Increasing Transparency in Generic Drug Applications Act ---S.4351: Enhanced Access to Affordable Medicines Act ---H.R 6973: Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing Models ---H.R.7248: FDA Modernization Act 3.0 Medicaid ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Encouraging Innovation Benefit Design to Lower Costs for Seniors Act ---Medicaid Drug Rebate Program Rule ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2025 Opioid Crisis ---H.R.4531/2933: SUPPORT Act ---Non-Opioid Analgesics ---Transparency ---Coverage and Reimbursement Orphan Drug Issues ---H.R.3433 - Give Kids a Chance Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.6664: Innovation in Pediatric Drugs Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.1214: Retaining Access and Restoring Exclusivity (RARE) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---Implementation of the Prepare for and Respond to Existing Viruses ---Emerging New Threats and (PREVENT) Pandemics Act ---Monoclonal Antibody Coverage and Utilization ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.7384/S4583: Creating Hope Reauthorization Act of 2024 ---Helping Experts Accelerate Rare Treatments (HEART)Act ---Rare Disease Pilot Program ---Speeding Therapy Access Today (STAT) Act Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5378: Lower Costs, More Transparency Act ---H.R.5796/S424: Protect our Seniors Act ---Administration Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---In-Home Administration of Part B Drugs ---Lower Costs, More Cures Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---H.R.5260: Reduced Costs and Continued Cures Act ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence Vaccine Injury Compensation Program ---FY 2025 Appropriations ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---VICP CICP (Discussion Draft)

Client expense: $1,680,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office

340B Drug Discount Program ---H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---S1133: 350B Accountability Act ---PROTECT 340B Act ---SUSTAIN 340B Act Accelerated Approval Access to non-human Primates (NHPs) Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3832: Disease X Act of 2023 ---H.R.7085: BIOSECURE Act ---American Pandemic Preparedness Plan (AP3) ---Bio COMPETES (Draft) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---House GOP RFI on Supply Chain ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---MCM PRV Program ---NDAA ---Reasonable Pricing Clauses in BARDA Contracts ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---VICP Loopholes ---White House National Biodefense Strategy ---WHO Pandemic Preparedness Accord Biosimilars ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.2305: Biosimilar Red Tape Elimination Act ---Biosimilar Copay ---BSUFA Negotiations ---Implementation of BSUFA Agreement ---Interchangeability and Pharmacy Substitution ---Reimbursement Cell & Gene Therapy Climate Change ---FY 2025 Appropriations Clinical Trial Data in China Data Privacy ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---HR 8818: American Privacy Rights Act of 2024 ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Diversity & Inclusion ---Decentralized Clinical Trials ---Implementation of Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act Drug Evaluation and Review ---S.1906: Promising Pathway Act ---COVID-19 Lessons Learned ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---S.2780 - Medication Affordability and Patent Integrity Act ---S.3583/H.R.6986: A bill to address patent thickets ---Affordable Prescriptions for Patients Act ---Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---FY2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.1790: Biologics Competition Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.5547: Maintaining Investments and New Innovation (MINI) Act ---H.R.6283: DRUG Act ---H.R.7174: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.775: Increasing Transparency in Generic Drug Application ---S.1067: Ensuring Timely Access to Generics ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents, ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Access to Innovative Treatments Act ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Negotiation and Competitive Licensing Act ---National Coverage Determination ---PBM Reform ---Patient Cost-Sharing and Implementation ---Strengthening Innovation in Medicare and Medicaid Act Foreign Drug Data Protection Laws ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain ---Regulatory Harmonization Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Generic Drug Entry ---S.148: Stop STALLING Act ---S.775: Increasing Transparency in Generic Drug Applications Act ---Enhanced Access to Affordable Medicines Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing Models ---H.R.7248: FDA Modernization Act 3.0 Medicaid ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Encouraging Innovation Benefit Design to Lower Costs for Seniors Act ---Medicaid Drug Rebate Program ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2025 Opioid Crisis ---H.R.4531/S.2933: SUPPORT Act ---Non-Opioid Analgesics ---Transparency ---Coverage and Reimbursement Orphan Drug Issues ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.6664: Innovation in Pediatric Drugs Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.1214: Retaining Access and Restoring Exclusivity (RARE) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---House GOP RFI on Supply Chain ---Implementation of the Prepare for and Respond to Existing Viruses ---Monoclonal Antibody Coverage and Utilization ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.7384/S.4583: Creating Hope Reauthorization Act of 2024 ---Helping Experts Accelerate Rare Treatments (HEART)Act ---Rare Disease Pilot Program ---Speeding Therapy Access Today (STAT) Act Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5378: Lower Costs, More Transparency Act ---Administration Rebate Rule ---CMMI Authority ---In-Home Administration of Part B Drugs ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---Adult Immunization ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence Vaccine Injury Compensation Program ---FY 2025 Appropriations ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---VICP CICP (Discussion Draft)

Client expense: $1,680,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office

Issues related to prescription drug coverage and pharmacy benefits Issues related to the prescription drug marketplace, patents, and competition Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits S.113 - Prescription Pricing for the People Act S.127 - Pharmacy Benefit Manager Transparency Act S.142 - Preserve Access to Affordable Generics and Biosimilars Act S.148 - Stop STALLING Act S.652 - Safe Step Act S.775 - Increasing Transparency in Generic Drug Applications Act S.1067 - Ensuring Timely Access to Generics Act S.1114 - Expanding Access to Low-Cost Generics Act S.1120 - Improved Access to Affordable Medications Act S.1128 - Ensuring Access to Generic Medications Act S.1339 - Pharmacy Benefit Manager Reform Act S.1542/H.R.6283 - Delinking Revenue from Unfair Gouging (DRUG) Act S.2973 - Modernizing and Ensuring PBM Accountability Act S.3430 - Better Mental Health Care, Lower-Cost Drugs, and Extenders Act S.150 - Affordable Prescriptions for Patients Act of 2023 H.R.1352 - Increasing Access to Biosimilars Act H.R.1790 - Biologics Competition Act H.R.2880 - Protecting Patients Against PBM Abuses Act H.R.4881 - To amend title XVIII of the Social Security Act to limit cost sharing for drugs under the Medicare program H.R.5378 - Lower Costs More Transparency Act H.R.5385 - Medicare PBM Accountability Act H.R. 8261- Preserving Telehealth, Hospital, and Ambulance Access Act, Sec. 302 H.R.7623- Telehealth Modernization Act of 2024 H.R.4758- Accelerating Kids Access to Care Act AINS Sec. 3 H.R.9096- Pharmacists Fight Back Act Implementation of the Inflation Reduction Act of 2022, P.L. 169- Provisions on Medicare Part D modernization and drug price negotiation

Client expense: $4,165,073 · 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

Gene therapies; Prescription drug affordability S. 1114, Expanding Access to Low-Cost Generics Act To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period. Sponsor: Sen. Smith, Tina [D-MN] S. 2305 - 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. 127 - Pharmacy Benefit Manager Transparency Act of 2023 To prevent unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs, and for other purposes. Sponsor: Sen. Cantwell, Maria [D-WA] S. 148 - 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. Amy Klobuchar (D-MN) S.1339 - Pharmacy Benefit Manager Reform Act To provide for increased oversight of entities that provide pharmacy benefit management services on behalf of group health plans and health insurance coverage. Sponsor: Sen. Sanders, Bernard [I-VT] S. 775, the Increasing Transparency in Generic Drug Applications To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R. 9070, Affordable Prescriptions for Patients Act of 2024 To amend title 35, United States Code, to prohibit product hopping, and for other purposes. Sponsor: Rep. Issa, Darrell [R-CA-48] S. 150 - Affordable Prescriptions for Patients Act of 2023 To amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] H.R. 6094 - PROTECT Rare Act To amend titles XVIII and XIX of the Social Security Act and title XXVII of the Public Health Service Act to refine the set of information sources for determining coverage of certain drugs and biologicals used in the treatment or management of a rare disease or condition, and for other purposes. Sponsor: Rep. Matsui, Doris O. [D-CA-7] S.1542, DRUG Act To improve services provided by pharmacy benefit managers. Sponsor: Sen. Marshall, Roger [R-KS]

Client expense: $1,910,000 · 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

Gene therapies; Prescription drug affordability S. 775, the Increasing Transparency in Generic Drug Applications To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R. 9070, Affordable Prescriptions for Patients Act of 2024 To amend title 35, United States Code, to prohibit product hopping, and for other purposes. Sponsor: Rep. Issa, Darrell [R-CA-48] S. 150 - Affordable Prescriptions for Patients Act of 2023 To amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Comyn, John [R-TX] H.R. 6094 - PROTECT Rare Act To amend titles XVlll and XIX of the Social Security Act and title XXVll of the Public Health Service Act to refine the set of information sources for determining coverage of certain drugs and biologicals used in the treatment or management of a rare disease or condition, and for other purposes. Sponsor: Rep. Matsui, Doris 0. [D-CA-7] S.1542, DRUG Act To improve services provided by pharmacy benefit managers. Sponsor: Sen. Marshall, Roger [R-KS]

Client expense: $10,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Prescription Drug Affordability S775 Increasing Transparency in Generic Drug Application to provide for increased transparency in generic drug application Sen Hassan, Margaret Wood (D-NH) HR9070, Affordable Prescriptions for Patients Act of 2024 to amend title 35, United States Code, to prohibit product hopping, and for other purposes Sen. Cornyn, John (R-TX) Insulin Out of Pocket Charges; Finance PBNM Framework Proposals; Covid Vaccines S. 150 - Affordable Prescriptions for Patients Act of 2023 A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. John Cornyn (R-TX) S. 127 - Pharmacy Benefit Manager Transparency Act of 2023 A bill to prevent unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs, and for other purposes. Sponsor: Sen. Maria Cantwell (D-WA) S.1067 - Ensuring Timely Access to Generics Act of 2023 To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions. Sponsor: Sen. Shaheen, Jeanne [D-NH] S.1114 - Expanding Access to Low-Cost Generics Act of 2023 To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period. Sponsor: Sen. Smith, Tina [D-MN] S.1269 - INSULIN Act of 2023 To reduce the price of insulin and provide for patient protections with respect to the cost of insulin. Sponsor: Sen. Shaheen, Jeanne [D-NH] S.1339 - Pharmacy Benefit Manager Reform Act To provide for increased oversight of entities that provide pharmacy benefit management services on behalf of group health plans and health insurance coverage. Sponsor: Sen. Sanders, Bernard [I-VT] S.2305 - 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]

Client expense: $31,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Prescription drug pricing issues. S. 2305 - Biosimilar Red Tape Elimination Act. S. 148 - Stop Significant and Time-Wasting Abuse Limiting Legitimate Innovation of New Generics Act. S. 1067 - Ensuring Timely Access to Generics Act. S. 775/H.R. 3839 - Increasing Transparency in Generic Drug Applications Act. S. 1214 - Retaining Access and Restoring Exclusivity (RARE) Act.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

S. 775 - Increasing Transparency in Generic Drug Applications Act. Issues related to pharmaceutical manufacturing domestic supply chain, in H.R. 8070 - National Defense Authorization Act. S.2220 - PREVAIL Act. S.4097 - PERA Act.

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

Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, SENATE

Prescription Drug Costs. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. 180-Day Exclusivity. H.R.3839/S.775: Increasing Transparency in Generic Drug Applications Act. Generic Drug Procurement Language as it Relates to H.R.2670/S.2226 - National Defense Authorization Act for Fiscal Year 2024. S.1961: Pharmaceutical Supply Chain Risk Assessment Act of 2023. H.R.6109: Producing Incentives for Long-term Production of Lifesaving Supply of Medicines (PILLS) Act. Drug Shortages. S.2362 - Drug Shortage Prevention Act. S.2305: Biosimilar Red Tape Elimination Act. FDA Inspections. Drug-Device Combination Products. Third Party Drug Quality Studies. H.R.1503/S.2916: Prescription Information Modernization Act of 2023. H.R.2880: Protecting Patients Against PBM Abuses Act.

Client expense: $530,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), HOUSE OF REPRESENTATIVES, SENATE

Gene Therapies; Prescription Drug Affordability HR 6094, PROTECT Rare Act, by Rep. Doris Matsui (D-CA). To amend titles XVIII and XIX of the Social Security Act and title XXVII of the Public Health Service Act to refine the set of information sources for determining coverage of certain drugs and biologicals used in the treatment or management of a rare disease or condition. HR 9070, Affordable Prescriptions for Patients Act of 2024, by Rep. Darrell Issa (R-CA). To amend title 35, United States Code, to prohibit product hopping. S 150, Affordable Prescriptions for Patients Act of 2023, by Sen. John Cornyn (R-TX). To amend the Federal Trade Commission Act to prohibit product hopping. S 775, Increasing Transparency in Generic Drug Applications Act, by Sen. Margaret Hassan (D-NH). To provide for increased transparency in generic drug applications. S 1542, DRUG Act, by Sen. Roger Marshall (R-KS). To improve services provided by pharmacy benefit managers.

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), SENATE, White House Office

Gene Therapies; Prescription Drug Affordability HR 6094, PROTECT Rare Act, by Rep. Doris Matsui (D-CA). To amend titles XVIII and XIX of the Social Security Act and title XXVII of the Public Health Service Act to refine the set of information sources for determining coverage of certain drugs and biologicals used in the treatment or management of a rare disease or condition. HR 9070, Affordable Prescriptions for Patients Act of 2024, by Rep. Darrell Issa (R-CA). To amend title 35, United States Code, to prohibit product hopping. S 150, Affordable Prescriptions for Patients Act of 2023, by Sen. John Cornyn (R-TX). To amend the Federal Trade Commission Act to prohibit product hopping. S 775, Increasing Transparency in Generic Drug Applications Act, by Sen. Margaret Hassan (D-NH). To provide for increased transparency in generic drug applications. S 1542, DRUG Act, by Sen. Roger Marshall (R-KS). To improve services provided by pharmacy benefit managers.

Client expense: $220,000 · 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

Issues related to prescription drug pricing. S. 2305 Biosimilar Red Tape Elimination Act. S. 148 Stop Significant and Time-Wasting Abuse Limiting Legitimate Innovation of New Generics Act. S. 1067 Ensuring Timely Access to Generics Act. S. 775/H.R. 3839 Increasing Transparency in Generic Drug Applications Act. S. 1214 Retaining Access and Restoring Exclusivity (RARE) Act.

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.652 - Safe Step Act (Murkowski/Hassan), support passage H.R. 830 - HELP Copays Act, support passage S.935- Fair Accountability and Innovative Research Drug Pricing Act of 2023, support passage H.R. 485, Protecting Health Care For All Patients Act, oppose passage as currently written S.127, the Pharmacy Benefit Manager Transparency Act, support passage Urged HELP and House Energy and Commerce Committee to hold roundtables and advance proposals that address workforce issues within the healthcare community. S. 2333 - Pandemic and All-Hazards Preparedness and Response Act, support passage H.R. 824, Telehealth Benefit Expansion for Workers Act of 2023, oppose passage H.R. 4421, Preparing for All Hazards and Pathogens Reauthorization Act, monitor legislation H.R. 4420, Preparedness and Response Reauthorization Act, monitor legislation Committee Draft -The Primary Care and Health Workforce Expansion Act, support passage S. 1339, the Pharmacy Benefit Manager Reform Act, support passage S.127, the PBM Transparency Act of 2023, support passage S.113, The Prescription Pricing for the People Act of 2023, support passage S.2052, Protect Patient Access to Pharmacies Act H.R. 1692, Health Care Affordability Act of 2023 H.R. 3561, the PATIENT Act of 2023, support passage H.R. 3284, Providers and Payers Compete Act, support passage H.R. 4507, Transparency in Coverage Act, support passage H.R. 4508, Hidden Fee Disclosure Act, support passage H.R. 2816, PBM Sunshine and Accountability Act, support passage S.79- Interagency Patent Coordination and Improvement Act of 2023, support passage S. 142- Preserve Access to Affordable Generics and Biosimilars Act, support passage S.148- Stop STALLING Act, support passage S.150- Affordable Prescriptions for Patients Act of 2023, support passage S.775-Increasing Transparency in Generic Drug Applications Act, monitoring S.1067-Ensuring Timely Access to Generics Act of 2023, support passage S. 2780 Medication Affordability and Patent Integrity Ac H.R. 4189, the CONNECT for Health Act, support passage H.R. 1843, the Telehealth Expansion Act, support passage H.R. 8018, the Alleviating Barriers for Caregivers Act, support passage S. 3109, the Alleviating Barriers for Caregivers Act, support passage H.R.6302, the Health Share Transparency Act of 2023 H.R.7623, the Telehealth Modernization Act of 2024

Client expense: $60,810 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Issues related to drug pricing; issues related to pharmaceutical supply chain; issues related to modernization of prescribing information for physicians and pharmacists; Improved Access to Affordable Medications Act, S. 1120; Increasing Transparency in Generic Drug Applications, S.775 and HR 3839; Part D Formulary Design and Generic Drug Tiering; Prescription Information Modernization Act, HR 1503.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Increasing Transparency in Generic Drug Applications Act, (S. 775), Part D Formulary Design; 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: $60,000

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

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

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

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

Issues related to prescription drug coverage and pharmacy benefits Issues related to the prescription drug marketplace, patents, and competition Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits S.113 - Prescription Pricing for the People Act S.127 - Pharmacy Benefit Manager Transparency Act S.142 - Preserve Access to Affordable Generics and Biosimilars Act S.148 - Stop STALLING Act S.652 - Safe Step Act S.775 - Increasing Transparency in Generic Drug Applications Act S.1067 - Ensuring Timely Access to Generics Act S.1114 - Expanding Access to Low-Cost Generics Act S.1120 - Improved Access to Affordable Medications Act S.1128 - Ensuring Access to Generic Medications Act S.1339 - Pharmacy Benefit Manager Reform Act S.1542/H.R.6283 - Delinking Revenue from Unfair Gouging (DRUG) Act S.2973 - Modernizing and Ensuring PBM Accountability Act S.3430 - Better Mental Health Care, Lower-Cost Drugs, and Extenders Act S.150 - Affordable Prescriptions for Patients Act of 2023 H.R.1352 - Increasing Access to Biosimilars Act H.R.1790 - Biologics Competition Act H.R.2880 - Protecting Patients Against PBM Abuses Act H.R.4881 - To amend title XVIII of the Social Security Act to limit cost sharing for drugs under the Medicare program H.R.5378 - Lower Costs More Transparency Act H.R.5385 - Medicare PBM Accountability Act H.R. 8261- Preserving Telehealth, Hospital, and Ambulance Access Act, Sec. 302 H.R.7623- Telehealth Modernization Act of 2024 H.R.4758 - Accelerating Kids Access to Care Act AINS Sec. 3 Implementation of the Inflation Reduction Act of 2022, P.L. 169- Provisions on Medicare Part D modernization and drug price negotiation

Client expense: $3,581,756 · 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), Natl Economic Council (NEC), SENATE

H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 456: Fairness in Orphan Drug Exclusivity Act H.R. 830: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes H.R. 885: TRACK Act of 2023 H.R. 1613: Drug Price Transparency in Medicaid Act of 2023 H.R. 1790: Biologics Competition Act of 2023 - To direct the Secretary of Health and Human Services to evaluate the extent to which the substitution of interchangeable biological products is impacted by differences between the system for determining a biological product to be interchangeable and the system for assigning therapeutic equivalence ratings to drugs, and for other purposes H.R. 2534: PROTECT 340B Act of 2023 - Provisions related to the 340B program H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2707: MADE in America Act H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 3008: Drug Shortage Prevention Act of 2023 H.R. 3093: Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023 H.R. 3290: To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program H.R. 3433: Give Kids a Chance Act of 2023 H.R. 3561: Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or PATIENT Act of 2023 H.R. 3839: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications H.R. 4421: Preparing for All Hazards and Pathogens Reauthorization Act H.R. 4818: Treat and Reduce Obesity Act of 2023 H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 4988: Modern Authentication of Pharmaceuticals Act of 2023 H.R. 5376: Share the Savings with Seniors Act  H.R. 5378: Lower Costs, More Transparency Act H.R. 5391: Protecting Patient Access to Cancer and Complex Therapies Act H.R. 5539: ORPHAN Cures Act H.R. 5547: Maintaining Investments in New Innovation Act H.R. 6283: Delinking Revenue from Unfair Gouging or DRUG Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 H.R. 7174: Ensuring Pathways to Innovative Cures (EPIC) Act: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 7248: FDA Modernization Act 3.0 H.R. 7623: Telehealth Modernization Act of 2024 H.R. 7635: The 340B PATIENTS Act of 2024 H.R. 8574: 340B Affording Care for Communities and Ensuring a Strong Safety-net (ACCESS) Act S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to PBMs S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs S. 148: Stop STALLING Act - Provisions related to citizen petitions S. 775: Increasing Transparency in Generic Drug Applications Act S. 935: Fair Accountability and Innovative Research Drug Pricing Act of 2023 - Provisions related to drug pricing S. 1067: Ensuring Timely Access to Generics Act of 2023 S. 1130: Health Care PRICE Transparency Act S. 1128: Ensuring Access to Generic Medications Act S. 1214: RARE Act - To set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1355: PASTEUR Act of 2023 - Provisions related to antimicrobial resistance policy issues S. 1375: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes S. 1476: Pharmaceutical Research Transparency Act of 2023 S. 1497: Emergency Access to Insulin Act of 2023 S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1589: Safeguarding Patients and Taxpayers Act S. 1906: Promising Pathway Act - Approval pathway policy issues S. 1967: PBM Act S. 2305: Biosimilar Red Tape Elimination Act S. 2333: Pandemic and All-Hazards Preparedness and Response Act S. 2474: Share the Savings with Seniors Act S. 2897: Give Kids a Chance Act of 2023 S. 2973: Modernizing and Ensuring PBM Accountability Act (MEPA) S. 3393: SUPPORT for Patients and Communities Reauthorization Act BioCompete Act (draft) Executive Order of February 28, 2024, Preventing Access to Americans' Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) User fee policy issues Inflation Reduction Act of 2022 (P.L. 117-169) Pharmacy Benefit Manager reform and policy issues Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) Cancer Moonshot Initiative 21st Century Cures 2.0 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Accelerated approval policy issues FDA regulatory approval authority policy issues Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance (AMR) policy issues Supply chain policy issues Mental health policy issues Real world evidence policy issues Clinical trial diversity policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues  Pandemic preparedness policy issues Cybersecurity policy issues Artificial intelligence policy issues

Client expense: $6,960,000 · Firm income: Not reported

Government targets: Congressional Budget Office (CBO), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, SENATE

340B Drug Discount Program ---H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---S1133: 350B Accountability Act ---PROTECT 340B Act ---SUSTAIN 340B Act Accelerated Approval Access to non-human Primates (NHPs) Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3832: Disease X Act of 2023 ---H.R.7085: BIOSECURE Act ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---American Pandemic Preparedness Plan (AP3) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---MCM PRV Program ---NDAA ---Reasonable Pricing Clauses in BARDA Contracts ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---VICP Loopholes ---White House National Biodefense Strategy ---WHO Pandemic Preparedness Accord Biosimilars ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.2305: Biosimilar Red Tape Elimination Act ---Biosimilar Copay ---BSUFA Negotiations ---Interchangeability and Pharmacy Substitution ---Reimbursement Cell & Gene Therapy Climate Change ---FY 2025 Appropriations Clinical Trial Data in China Data Privacy ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---HR 8818: American Privacy Rights Act of 2024 ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---Decentralized Clinical Trials ---Implementation of Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act Drug Evaluation and Review ---S.1906: Promising Pathway Act ---COVID-19 Lessons Learned ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---S.3583/H.R.6986: A bill to address patent thickets ---Affordable Prescriptions for Patients Act ---Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---FY2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.1790: Biologics Competition Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.5547: Maintaining Investments and New Innovation (MINI) Act ---H.R.6283: DRUG Act ---H.R.7174: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.775: Increasing Transparency in Generic Drug Application ---S.1067: Ensuring Timely Access to Generics ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents, ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Access to Innovative Treatments Act ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Negotiation and Competitive Licensing Act ---National Coverage Determination ---PBM Reform ---Patient Cost-Sharing and Implementation ---Strengthening Innovation in Medicare and Medicaid Act Foreign Drug Data Protection Laws ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---Regulatory Harmonization Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Generic Drug Entry ---S.148: Stop STALLING Act ---S.775: Increasing Transparency in Generic Drug Applications Act ---Enhanced Access to Affordable Medicines Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing Models ---H.R.7248: FDA Modernization Act 3.0 Medicaid ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Encouraging Innovation Benefit Design to Lower Costs for Seniors Act ---Medicaid Drug Rebate Program ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2025 Opioid Crisis ---H.R.4531: SUPPORT Act ---Non-Opioid Analgesics ---Transparency ---Coverage and Reimbursement Orphan Drug Issues ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.6664: Innovation in Pediatric Drugs Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.1214: Retaining Access and Restoring Exclusivity (RARE) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---Implementation of the Prepare for and Respond to Existing Viruses ---Monoclonal Antibody Coverage and Utilization ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.7384: Creating Hope Reauthorization Act of 2024 ---Helping Experts Accelerate Rare Treatments (HEART)Act ---Rare Disease Pilot Program ---Speeding Therapy Access Today (STAT) Act Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2630/S.652: SAFE STEP Act ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5378: Lower Costs, More Transparency Act ---Administration Rebate Rule ---CMMI Authority ---In-Home Administration of Part B Drugs ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5378: Lower Costs, More Transparency Act ---H.R.5796/S424: Protect our Seniors Act ---Administration Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---In-Home Administration of Part B Drugs ---Lower Costs, More Cures Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Reduced Costs and Continued Cures Act ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---S.4509: Vaccine and Coverage Certainty (VACC) Act ---Adult Immunization ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence Vaccine Injury Compensation Program ---FY 2025 Appropriations ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---VICP CICP (Discussion Draft)

Client expense: $1,790,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

340B Drug Discount Program ---H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act ---S1133: 350B Accountability Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---PROTECT 340B Act ---SUSTAIN 340B Act Accelerated Approval Access to non-human Primates (NHPs) Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3832: Disease X Act of 2023 ---H.R.7085: BIOSECURE Act ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---American Pandemic Preparedness Plan (AP3) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---MCM PRV Program ---NDAA ---Reasonable Pricing Clauses in BARDA Contracts ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---VICP Loopholes ---White House National Biodefense Strategy ---WHO Pandemic Preparedness Accord Biosimilars ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.2305: Biosimilar Red Tape Elimination Act ---Biosimilar Copay ---BSUFA Negotiations ---Interchangeability and Pharmacy Substitution ---Reimbursement Cell & Gene Therapy Climate Change ---FY 2025 Appropriations Clinical Trial Data in China Data Privacy ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---H.R. 8818: American Privacy Rights Act of 2025 ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---Decentralized Clinical Trials ---Implementation of Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act Drug Evaluation and Review ---S.1906: Promising Pathway Act ---COVID-19 Lessons Learned ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---S.3583/H.R.6986: A bill to address patent thickets ---Affordable Prescriptions for Patients Act ---Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.1790: Biologics Competition Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.5547: Maintaining Investments and New Innovation (MINI) Act ---H.R.6283: DRUG Act ---H.R.7174: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.775: Increasing Transparency in Generic Drug Application ---S.1067: Ensuring Timely Access to Generics ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents, ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Access to Innovative Treatments Act ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Negotiation and Competitive Licensing Act ---National Coverage Determination ---PBM Reform ---Patient Cost-Sharing and Implementation ---Strengthening Innovation in Medicare and Medicaid Act Foreign Drug Data Protection Laws ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---Regulatory Harmonization Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2025 Appropriations ---Funding for 2024-2025 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Funding for FDA ---FY 2025 Appropriations ---Prescription Drug User Fee Act (PDUFA) VII Implementation Funding for Health Resources and Services Administration (HRSA) ---FY 2025 Appropriations Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2025 Appropriations Funding for National Institutes of Health ---FY 2025 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) Act ---Funding for Womens Health Research Generic Drug Entry ---S.148: Stop STALLING Act ---S.775: Increasing Transparency in Generic Drug Applications Act ---Enhanced Access to Affordable Medicines Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing Models ---H.R.7248: FDA Modernization Act 3.0 Medicaid ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Encouraging Innovation Benefit Design to Lower Costs for Seniors Act ---Medicaid Drug Rebate Program Rule ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2025 Opioid Crisis ---H.R.4531: SUPPORT Act ---Non-Opioid Analgesics ---Transparency ---Coverage and Reimbursement Orphan Drug Issues ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.6664: Innovation in Pediatric Drugs Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.1214: Retaining Access and Restoring Exclusivity (RARE) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---Implementation of the Prepare for and Respond to Existing Viruses ---Monoclonal Antibody Coverage and Utilization ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.7384: Creating Hope Reauthorization Act of 2024 ---Helping Experts Accelerate Rare Treatments (HEART)Act ---Rare Disease Pilot Program ---Speeding Therapy Access Today (STAT) Act Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5378: Lower Costs, More Transparency Act ---H.R.5796/S424: Protect our Seniors Act ---Administration Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---In-Home Administration of Part B Drugs ---Lower Costs, More Cures Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Reduced Costs and Continued Cures Act ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---S.4509: Vaccine and Coverage Certainty (VACC) Act ---Adult Immunization ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence Vaccine Injury Compensation Program ---FY 2025 Appropriations ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---VICP CICP (Discussion Draft)

Client expense: $1,790,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Security Council (NSC), SENATE, State, Dept of (DOS), White House Office

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

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