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Income and expense are whole-filing amounts associated with this lobbyist, not personal compensation or an allocated share.
No topic inference: each bill number appears in source LDA issue text assigned to this lobbyist.
Destruction of Hazardous Imports Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Fast-tracking Approval for Innovative Rare disease therapies (FAIR) Act (H.R. 7953); Ensuring Timely Access to Generics Act of 2025 (S. 3014); Stop STALLING Act (S. 1095); Food & Drug Administration Fiscal Year 2027 Legislative Proposals; Agriculture, Rural Development, Food and Drug Administration, and Related Agency Appropriations Act, 2027 (H.R. 8646); Medication Affordability and Patent Integrity Act (S. 2658); Biosimilar Red Tape Elimination Act (S. 1954/H.R. 5526); Expedited Access to Biosimilars Act (S. 1414); Clinical trial regulation; Securing Essential Components for U.S. Readiness in Essential Pharmaceuticals (SECURE Rx) Act of 2026 (discussion draft); Securing Innovation and Research from Adversaries (discussion draft); amendments to the National Childhood Vaccine Injury Act of 1986 and the Vaccine Injury Compensation Program; Destruction of Hazardous Imports Act (H.R. 2715); potential amendments to drug country of origin labeling requirements (discussion draft).
ETHIC Act
Specific issues are shown only where the LDA source assigned them to this lobbyist. Targets apply to the associated filing.
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2026 · third_quarter · Q3
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program Proposed Rule, 91 Fed. Reg. 36236; Medication Affordability and Patent Integrity (MAPIA) Act (S. 2658); Skinny Labels, Big Savings Act (S. 43/H.R. 6485); Expedited Access to Biosimilars Act (S. 1414/ H.R.9661); Biosimilar Red Tape Elimination Act (S. 1954/H.R. 5526); Clinical trial regulation; Community Health Center Clinical Trial Grant Program discussion draft; Alex and Jacis Law discussion draft; Untitled discussion draft on clinical trial regulation (no bill number); Untitled discussion draft on generic drugs intended for use with a device (no bill number); Food & Drug Administration Fiscal Year 2027 Legislative Proposals (no bill number); Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act, (S.3788 / H.R.8269); draft legislation relating to potential improvements the National Childhood Vaccine Injury Act and the Vaccine Injury Compensation Program; American Biotechnology Act, Senate Amendment 6334 to S. 4784, National Defense Authorization Act (NDAA) for Fiscal Year 2027; CARES Act (P.L. 116-136) reporting issues.
Source: Senate LDA
Biosimilars Access and Affordability Act (S. 5459); Skinny Labels, Big Savings Act (S. 43/H.R. 6485); Eliminating Thickets to Increase Competition (ETHIC) Act (S. 2276/H.R. 3269); Expedited Access to Biosimilars Act (S. 1414); Biosimilar Red Tape Elimination Act (S. 1954/H.R. 5526); CLEAR Act (H.R.7140); Artificial Intelligence-Ready Data Act (S.4098); Preserve Access to Affordable Generics and Biosimilars Act (S. 1096); Drug Competition Enhancement Act (S.1040); America's Living Library Project Bill (S. 4023); Securing Essential Components for U.S. Readiness in Essential Pharmaceuticals (SECURE Rx) Act of 2026 (discussion draft); improvements to the National Childhood Vaccine Injury Act of 1986; Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act (S. 3788).
ETHIC Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Skinny Labels, Big Savings Act (S. 43/H.R. 6485); Eliminating Thickets to Increase Competition (ETHIC) Act (S. 2276/H.R. 3269).
Biosimilar Red Tape Elimination Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Fast-tracking Approval for Innovative Rare disease therapies (FAIR) Act (H.R. 7953); Ensuring Timely Access to Generics Act of 2025 (S. 3014); Stop STALLING Act (S. 1095); Food & Drug Administration Fiscal Year 2027 Legislative Proposals; Agriculture, Rural Development, Food and Drug Administration, and Related Agency Appropriations Act, 2027 (H.R. 8646); Medication Affordability and Patent Integrity Act (S. 2658); Biosimilar Red Tape Elimination Act (S. 1954/H.R. 5526); Expedited Access to Biosimilars Act (S. 1414); Clinical trial regulation; Securing Essential Components for U.S. Readiness in Essential Pharmaceuticals (SECURE Rx) Act of 2026 (discussion draft); Securing Innovation and Research from Adversaries (discussion draft); amendments to the National Childhood Vaccine Injury Act of 1986 and the Vaccine Injury Compensation Program; Destruction of Hazardous Imports Act (H.R. 2715); potential amendments to drug country of origin labeling requirements (discussion draft).
Biosimilar Red Tape Elimination Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Biosimilars Access and Affordability Act (S. 5459); Skinny Labels, Big Savings Act (S. 43/H.R. 6485); Eliminating Thickets to Increase Competition (ETHIC) Act (S. 2276/H.R. 3269); Expedited Access to Biosimilars Act (S. 1414); Biosimilar Red Tape Elimination Act (S. 1954/H.R. 5526); CLEAR Act (H.R.7140); Artificial Intelligence-Ready Data Act (S.4098); Preserve Access to Affordable Generics and Biosimilars Act (S. 1096); Drug Competition Enhancement Act (S.1040); America's Living Library Project Bill (S. 4023); Securing Essential Components for U.S. Readiness in Essential Pharmaceuticals (SECURE Rx) Act of 2026 (discussion draft); improvements to the National Childhood Vaccine Injury Act of 1986; Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act (S. 3788).
Biosimilar Red Tape Elimination Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program Proposed Rule, 91 Fed. Reg. 36236; Medication Affordability and Patent Integrity (MAPIA) Act (S. 2658); Skinny Labels, Big Savings Act (S. 43/H.R. 6485); Expedited Access to Biosimilars Act (S. 1414/ H.R.9661); Biosimilar Red Tape Elimination Act (S. 1954/H.R. 5526); Clinical trial regulation; Community Health Center Clinical Trial Grant Program discussion draft; Alex and Jacis Law discussion draft; Untitled discussion draft on clinical trial regulation (no bill number); Untitled discussion draft on generic drugs intended for use with a device (no bill number); Food & Drug Administration Fiscal Year 2027 Legislative Proposals (no bill number); Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act, (S.3788 / H.R.8269); draft legislation relating to potential improvements the National Childhood Vaccine Injury Act and the Vaccine Injury Compensation Program; American Biotechnology Act, Senate Amendment 6334 to S. 4784, National Defense Authorization Act (NDAA) for Fiscal Year 2027; CARES Act (P.L. 116-136) reporting issues.
Skinny Labels, Big Savings Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program Proposed Rule, 91 Fed. Reg. 36236; Medication Affordability and Patent Integrity (MAPIA) Act (S. 2658); Skinny Labels, Big Savings Act (S. 43/H.R. 6485); Expedited Access to Biosimilars Act (S. 1414/ H.R.9661); Biosimilar Red Tape Elimination Act (S. 1954/H.R. 5526); Clinical trial regulation; Community Health Center Clinical Trial Grant Program discussion draft; Alex and Jacis Law discussion draft; Untitled discussion draft on clinical trial regulation (no bill number); Untitled discussion draft on generic drugs intended for use with a device (no bill number); Food & Drug Administration Fiscal Year 2027 Legislative Proposals (no bill number); Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act, (S.3788 / H.R.8269); draft legislation relating to potential improvements the National Childhood Vaccine Injury Act and the Vaccine Injury Compensation Program; American Biotechnology Act, Senate Amendment 6334 to S. 4784, National Defense Authorization Act (NDAA) for Fiscal Year 2027; CARES Act (P.L. 116-136) reporting issues.
Skinny Labels, Big Savings Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Biosimilars Access and Affordability Act (S. 5459); Skinny Labels, Big Savings Act (S. 43/H.R. 6485); Eliminating Thickets to Increase Competition (ETHIC) Act (S. 2276/H.R. 3269); Expedited Access to Biosimilars Act (S. 1414); Biosimilar Red Tape Elimination Act (S. 1954/H.R. 5526); CLEAR Act (H.R.7140); Artificial Intelligence-Ready Data Act (S.4098); Preserve Access to Affordable Generics and Biosimilars Act (S. 1096); Drug Competition Enhancement Act (S.1040); America's Living Library Project Bill (S. 4023); Securing Essential Components for U.S. Readiness in Essential Pharmaceuticals (SECURE Rx) Act of 2026 (discussion draft); improvements to the National Childhood Vaccine Injury Act of 1986; Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act (S. 3788).
Skinny Labels, Big Savings Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Medication Affordability and Patent Integrity Act (S. 2658); Biopharmaceutical policy issues; Skinny Labels, Big Savings Act (S. 43/H.R. 6485).
Skinny Labels, Big Savings Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Skinny Labels, Big Savings Act (S. 43/H.R. 6485); Eliminating Thickets to Increase Competition (ETHIC) Act (S. 2276/H.R. 3269).
CLEAR Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Biosimilars Access and Affordability Act (S. 5459); Skinny Labels, Big Savings Act (S. 43/H.R. 6485); Eliminating Thickets to Increase Competition (ETHIC) Act (S. 2276/H.R. 3269); Expedited Access to Biosimilars Act (S. 1414); Biosimilar Red Tape Elimination Act (S. 1954/H.R. 5526); CLEAR Act (H.R.7140); Artificial Intelligence-Ready Data Act (S.4098); Preserve Access to Affordable Generics and Biosimilars Act (S. 1096); Drug Competition Enhancement Act (S.1040); America's Living Library Project Bill (S. 4023); Securing Essential Components for U.S. Readiness in Essential Pharmaceuticals (SECURE Rx) Act of 2026 (discussion draft); improvements to the National Childhood Vaccine Injury Act of 1986; Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act (S. 3788).
FAIR ACT
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Fast-tracking Approval for Innovative Rare disease therapies (FAIR) Act (H.R. 7953); Ensuring Timely Access to Generics Act of 2025 (S. 3014); Stop STALLING Act (S. 1095); Food & Drug Administration Fiscal Year 2027 Legislative Proposals; Agriculture, Rural Development, Food and Drug Administration, and Related Agency Appropriations Act, 2027 (H.R. 8646); Medication Affordability and Patent Integrity Act (S. 2658); Biosimilar Red Tape Elimination Act (S. 1954/H.R. 5526); Expedited Access to Biosimilars Act (S. 1414); Clinical trial regulation; Securing Essential Components for U.S. Readiness in Essential Pharmaceuticals (SECURE Rx) Act of 2026 (discussion draft); Securing Innovation and Research from Adversaries (discussion draft); amendments to the National Childhood Vaccine Injury Act of 1986 and the Vaccine Injury Compensation Program; Destruction of Hazardous Imports Act (H.R. 2715); potential amendments to drug country of origin labeling requirements (discussion draft).
CLEAR LABELS Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program Proposed Rule, 91 Fed. Reg. 36236; Medication Affordability and Patent Integrity (MAPIA) Act (S. 2658); Skinny Labels, Big Savings Act (S. 43/H.R. 6485); Expedited Access to Biosimilars Act (S. 1414/ H.R.9661); Biosimilar Red Tape Elimination Act (S. 1954/H.R. 5526); Clinical trial regulation; Community Health Center Clinical Trial Grant Program discussion draft; Alex and Jacis Law discussion draft; Untitled discussion draft on clinical trial regulation (no bill number); Untitled discussion draft on generic drugs intended for use with a device (no bill number); Food & Drug Administration Fiscal Year 2027 Legislative Proposals (no bill number); Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act, (S.3788 / H.R.8269); draft legislation relating to potential improvements the National Childhood Vaccine Injury Act and the Vaccine Injury Compensation Program; American Biotechnology Act, Senate Amendment 6334 to S. 4784, National Defense Authorization Act (NDAA) for Fiscal Year 2027; CARES Act (P.L. 116-136) reporting issues.
Agriculture, Rural Development, Food and Drug Administration, and Related Agency Appropriations Act, 2027
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Fast-tracking Approval for Innovative Rare disease therapies (FAIR) Act (H.R. 7953); Ensuring Timely Access to Generics Act of 2025 (S. 3014); Stop STALLING Act (S. 1095); Food & Drug Administration Fiscal Year 2027 Legislative Proposals; Agriculture, Rural Development, Food and Drug Administration, and Related Agency Appropriations Act, 2027 (H.R. 8646); Medication Affordability and Patent Integrity Act (S. 2658); Biosimilar Red Tape Elimination Act (S. 1954/H.R. 5526); Expedited Access to Biosimilars Act (S. 1414); Clinical trial regulation; Securing Essential Components for U.S. Readiness in Essential Pharmaceuticals (SECURE Rx) Act of 2026 (discussion draft); Securing Innovation and Research from Adversaries (discussion draft); amendments to the National Childhood Vaccine Injury Act of 1986 and the Vaccine Injury Compensation Program; Destruction of Hazardous Imports Act (H.R. 2715); potential amendments to drug country of origin labeling requirements (discussion draft).
Expedited Access to Biosimilars Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program Proposed Rule, 91 Fed. Reg. 36236; Medication Affordability and Patent Integrity (MAPIA) Act (S. 2658); Skinny Labels, Big Savings Act (S. 43/H.R. 6485); Expedited Access to Biosimilars Act (S. 1414/ H.R.9661); Biosimilar Red Tape Elimination Act (S. 1954/H.R. 5526); Clinical trial regulation; Community Health Center Clinical Trial Grant Program discussion draft; Alex and Jacis Law discussion draft; Untitled discussion draft on clinical trial regulation (no bill number); Untitled discussion draft on generic drugs intended for use with a device (no bill number); Food & Drug Administration Fiscal Year 2027 Legislative Proposals (no bill number); Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act, (S.3788 / H.R.8269); draft legislation relating to potential improvements the National Childhood Vaccine Injury Act and the Vaccine Injury Compensation Program; American Biotechnology Act, Senate Amendment 6334 to S. 4784, National Defense Authorization Act (NDAA) for Fiscal Year 2027; CARES Act (P.L. 116-136) reporting issues.
Drug Competition Enhancement Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Biosimilars Access and Affordability Act (S. 5459); Skinny Labels, Big Savings Act (S. 43/H.R. 6485); Eliminating Thickets to Increase Competition (ETHIC) Act (S. 2276/H.R. 3269); Expedited Access to Biosimilars Act (S. 1414); Biosimilar Red Tape Elimination Act (S. 1954/H.R. 5526); CLEAR Act (H.R.7140); Artificial Intelligence-Ready Data Act (S.4098); Preserve Access to Affordable Generics and Biosimilars Act (S. 1096); Drug Competition Enhancement Act (S.1040); America's Living Library Project Bill (S. 4023); Securing Essential Components for U.S. Readiness in Essential Pharmaceuticals (SECURE Rx) Act of 2026 (discussion draft); improvements to the National Childhood Vaccine Injury Act of 1986; Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act (S. 3788).
Stop STALLING Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Fast-tracking Approval for Innovative Rare disease therapies (FAIR) Act (H.R. 7953); Ensuring Timely Access to Generics Act of 2025 (S. 3014); Stop STALLING Act (S. 1095); Food & Drug Administration Fiscal Year 2027 Legislative Proposals; Agriculture, Rural Development, Food and Drug Administration, and Related Agency Appropriations Act, 2027 (H.R. 8646); Medication Affordability and Patent Integrity Act (S. 2658); Biosimilar Red Tape Elimination Act (S. 1954/H.R. 5526); Expedited Access to Biosimilars Act (S. 1414); Clinical trial regulation; Securing Essential Components for U.S. Readiness in Essential Pharmaceuticals (SECURE Rx) Act of 2026 (discussion draft); Securing Innovation and Research from Adversaries (discussion draft); amendments to the National Childhood Vaccine Injury Act of 1986 and the Vaccine Injury Compensation Program; Destruction of Hazardous Imports Act (H.R. 2715); potential amendments to drug country of origin labeling requirements (discussion draft).
Preserve Access to Affordable Generics and Biosimilars Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Biosimilars Access and Affordability Act (S. 5459); Skinny Labels, Big Savings Act (S. 43/H.R. 6485); Eliminating Thickets to Increase Competition (ETHIC) Act (S. 2276/H.R. 3269); Expedited Access to Biosimilars Act (S. 1414); Biosimilar Red Tape Elimination Act (S. 1954/H.R. 5526); CLEAR Act (H.R.7140); Artificial Intelligence-Ready Data Act (S.4098); Preserve Access to Affordable Generics and Biosimilars Act (S. 1096); Drug Competition Enhancement Act (S.1040); America's Living Library Project Bill (S. 4023); Securing Essential Components for U.S. Readiness in Essential Pharmaceuticals (SECURE Rx) Act of 2026 (discussion draft); improvements to the National Childhood Vaccine Injury Act of 1986; Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act (S. 3788).
Interagency Patent Coordination and Improvement Act of 2025
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Interagency Patent Coordination and Improvement Act of 2025 (S. 1097); Medication Affordability and Patent Integrity Act (S. 2658); Biopharmaceutical policy issues.
Expedited Access to Biosimilars Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Biosimilars Access and Affordability Act (S. 5459); Skinny Labels, Big Savings Act (S. 43/H.R. 6485); Eliminating Thickets to Increase Competition (ETHIC) Act (S. 2276/H.R. 3269); Expedited Access to Biosimilars Act (S. 1414); Biosimilar Red Tape Elimination Act (S. 1954/H.R. 5526); CLEAR Act (H.R.7140); Artificial Intelligence-Ready Data Act (S.4098); Preserve Access to Affordable Generics and Biosimilars Act (S. 1096); Drug Competition Enhancement Act (S.1040); America's Living Library Project Bill (S. 4023); Securing Essential Components for U.S. Readiness in Essential Pharmaceuticals (SECURE Rx) Act of 2026 (discussion draft); improvements to the National Childhood Vaccine Injury Act of 1986; Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act (S. 3788).
Expedited Access to Biosimilars Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Fast-tracking Approval for Innovative Rare disease therapies (FAIR) Act (H.R. 7953); Ensuring Timely Access to Generics Act of 2025 (S. 3014); Stop STALLING Act (S. 1095); Food & Drug Administration Fiscal Year 2027 Legislative Proposals; Agriculture, Rural Development, Food and Drug Administration, and Related Agency Appropriations Act, 2027 (H.R. 8646); Medication Affordability and Patent Integrity Act (S. 2658); Biosimilar Red Tape Elimination Act (S. 1954/H.R. 5526); Expedited Access to Biosimilars Act (S. 1414); Clinical trial regulation; Securing Essential Components for U.S. Readiness in Essential Pharmaceuticals (SECURE Rx) Act of 2026 (discussion draft); Securing Innovation and Research from Adversaries (discussion draft); amendments to the National Childhood Vaccine Injury Act of 1986 and the Vaccine Injury Compensation Program; Destruction of Hazardous Imports Act (H.R. 2715); potential amendments to drug country of origin labeling requirements (discussion draft).
Expedited Access to Biosimilars Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program Proposed Rule, 91 Fed. Reg. 36236; Medication Affordability and Patent Integrity (MAPIA) Act (S. 2658); Skinny Labels, Big Savings Act (S. 43/H.R. 6485); Expedited Access to Biosimilars Act (S. 1414/ H.R.9661); Biosimilar Red Tape Elimination Act (S. 1954/H.R. 5526); Clinical trial regulation; Community Health Center Clinical Trial Grant Program discussion draft; Alex and Jacis Law discussion draft; Untitled discussion draft on clinical trial regulation (no bill number); Untitled discussion draft on generic drugs intended for use with a device (no bill number); Food & Drug Administration Fiscal Year 2027 Legislative Proposals (no bill number); Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act, (S.3788 / H.R.8269); draft legislation relating to potential improvements the National Childhood Vaccine Injury Act and the Vaccine Injury Compensation Program; American Biotechnology Act, Senate Amendment 6334 to S. 4784, National Defense Authorization Act (NDAA) for Fiscal Year 2027; CARES Act (P.L. 116-136) reporting issues.
Biosimilar Red Tape Elimination Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Fast-tracking Approval for Innovative Rare disease therapies (FAIR) Act (H.R. 7953); Ensuring Timely Access to Generics Act of 2025 (S. 3014); Stop STALLING Act (S. 1095); Food & Drug Administration Fiscal Year 2027 Legislative Proposals; Agriculture, Rural Development, Food and Drug Administration, and Related Agency Appropriations Act, 2027 (H.R. 8646); Medication Affordability and Patent Integrity Act (S. 2658); Biosimilar Red Tape Elimination Act (S. 1954/H.R. 5526); Expedited Access to Biosimilars Act (S. 1414); Clinical trial regulation; Securing Essential Components for U.S. Readiness in Essential Pharmaceuticals (SECURE Rx) Act of 2026 (discussion draft); Securing Innovation and Research from Adversaries (discussion draft); amendments to the National Childhood Vaccine Injury Act of 1986 and the Vaccine Injury Compensation Program; Destruction of Hazardous Imports Act (H.R. 2715); potential amendments to drug country of origin labeling requirements (discussion draft).
Biosimilar Red Tape Elimination Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Biosimilars Access and Affordability Act (S. 5459); Skinny Labels, Big Savings Act (S. 43/H.R. 6485); Eliminating Thickets to Increase Competition (ETHIC) Act (S. 2276/H.R. 3269); Expedited Access to Biosimilars Act (S. 1414); Biosimilar Red Tape Elimination Act (S. 1954/H.R. 5526); CLEAR Act (H.R.7140); Artificial Intelligence-Ready Data Act (S.4098); Preserve Access to Affordable Generics and Biosimilars Act (S. 1096); Drug Competition Enhancement Act (S.1040); America's Living Library Project Bill (S. 4023); Securing Essential Components for U.S. Readiness in Essential Pharmaceuticals (SECURE Rx) Act of 2026 (discussion draft); improvements to the National Childhood Vaccine Injury Act of 1986; Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act (S. 3788).
Biosimilar Red Tape Elimination Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program Proposed Rule, 91 Fed. Reg. 36236; Medication Affordability and Patent Integrity (MAPIA) Act (S. 2658); Skinny Labels, Big Savings Act (S. 43/H.R. 6485); Expedited Access to Biosimilars Act (S. 1414/ H.R.9661); Biosimilar Red Tape Elimination Act (S. 1954/H.R. 5526); Clinical trial regulation; Community Health Center Clinical Trial Grant Program discussion draft; Alex and Jacis Law discussion draft; Untitled discussion draft on clinical trial regulation (no bill number); Untitled discussion draft on generic drugs intended for use with a device (no bill number); Food & Drug Administration Fiscal Year 2027 Legislative Proposals (no bill number); Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act, (S.3788 / H.R.8269); draft legislation relating to potential improvements the National Childhood Vaccine Injury Act and the Vaccine Injury Compensation Program; American Biotechnology Act, Senate Amendment 6334 to S. 4784, National Defense Authorization Act (NDAA) for Fiscal Year 2027; CARES Act (P.L. 116-136) reporting issues.
ETHIC Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Biosimilars Access and Affordability Act (S. 5459); Skinny Labels, Big Savings Act (S. 43/H.R. 6485); Eliminating Thickets to Increase Competition (ETHIC) Act (S. 2276/H.R. 3269); Expedited Access to Biosimilars Act (S. 1414); Biosimilar Red Tape Elimination Act (S. 1954/H.R. 5526); CLEAR Act (H.R.7140); Artificial Intelligence-Ready Data Act (S.4098); Preserve Access to Affordable Generics and Biosimilars Act (S. 1096); Drug Competition Enhancement Act (S.1040); America's Living Library Project Bill (S. 4023); Securing Essential Components for U.S. Readiness in Essential Pharmaceuticals (SECURE Rx) Act of 2026 (discussion draft); improvements to the National Childhood Vaccine Injury Act of 1986; Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act (S. 3788).
ETHIC Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Skinny Labels, Big Savings Act (S. 43/H.R. 6485); Eliminating Thickets to Increase Competition (ETHIC) Act (S. 2276/H.R. 3269).
Medication Affordability and Patent Integrity Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program Proposed Rule, 91 Fed. Reg. 36236; Medication Affordability and Patent Integrity (MAPIA) Act (S. 2658); Skinny Labels, Big Savings Act (S. 43/H.R. 6485); Expedited Access to Biosimilars Act (S. 1414/ H.R.9661); Biosimilar Red Tape Elimination Act (S. 1954/H.R. 5526); Clinical trial regulation; Community Health Center Clinical Trial Grant Program discussion draft; Alex and Jacis Law discussion draft; Untitled discussion draft on clinical trial regulation (no bill number); Untitled discussion draft on generic drugs intended for use with a device (no bill number); Food & Drug Administration Fiscal Year 2027 Legislative Proposals (no bill number); Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act, (S.3788 / H.R.8269); draft legislation relating to potential improvements the National Childhood Vaccine Injury Act and the Vaccine Injury Compensation Program; American Biotechnology Act, Senate Amendment 6334 to S. 4784, National Defense Authorization Act (NDAA) for Fiscal Year 2027; CARES Act (P.L. 116-136) reporting issues.
Medication Affordability and Patent Integrity Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Interagency Patent Coordination and Improvement Act of 2025 (S. 1097); Medication Affordability and Patent Integrity Act (S. 2658); Biopharmaceutical policy issues.
Medication Affordability and Patent Integrity Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Medication Affordability and Patent Integrity Act (S. 2658); Biopharmaceutical policy issues; Skinny Labels, Big Savings Act (S. 43/H.R. 6485).
Medication Affordability and Patent Integrity Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Fast-tracking Approval for Innovative Rare disease therapies (FAIR) Act (H.R. 7953); Ensuring Timely Access to Generics Act of 2025 (S. 3014); Stop STALLING Act (S. 1095); Food & Drug Administration Fiscal Year 2027 Legislative Proposals; Agriculture, Rural Development, Food and Drug Administration, and Related Agency Appropriations Act, 2027 (H.R. 8646); Medication Affordability and Patent Integrity Act (S. 2658); Biosimilar Red Tape Elimination Act (S. 1954/H.R. 5526); Expedited Access to Biosimilars Act (S. 1414); Clinical trial regulation; Securing Essential Components for U.S. Readiness in Essential Pharmaceuticals (SECURE Rx) Act of 2026 (discussion draft); Securing Innovation and Research from Adversaries (discussion draft); amendments to the National Childhood Vaccine Injury Act of 1986 and the Vaccine Injury Compensation Program; Destruction of Hazardous Imports Act (H.R. 2715); potential amendments to drug country of origin labeling requirements (discussion draft).
Ensuring Timely Access to Generics Act of 2025
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Fast-tracking Approval for Innovative Rare disease therapies (FAIR) Act (H.R. 7953); Ensuring Timely Access to Generics Act of 2025 (S. 3014); Stop STALLING Act (S. 1095); Food & Drug Administration Fiscal Year 2027 Legislative Proposals; Agriculture, Rural Development, Food and Drug Administration, and Related Agency Appropriations Act, 2027 (H.R. 8646); Medication Affordability and Patent Integrity Act (S. 2658); Biosimilar Red Tape Elimination Act (S. 1954/H.R. 5526); Expedited Access to Biosimilars Act (S. 1414); Clinical trial regulation; Securing Essential Components for U.S. Readiness in Essential Pharmaceuticals (SECURE Rx) Act of 2026 (discussion draft); Securing Innovation and Research from Adversaries (discussion draft); amendments to the National Childhood Vaccine Injury Act of 1986 and the Vaccine Injury Compensation Program; Destruction of Hazardous Imports Act (H.R. 2715); potential amendments to drug country of origin labeling requirements (discussion draft).
CLEAR LABELS Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program Proposed Rule, 91 Fed. Reg. 36236; Medication Affordability and Patent Integrity (MAPIA) Act (S. 2658); Skinny Labels, Big Savings Act (S. 43/H.R. 6485); Expedited Access to Biosimilars Act (S. 1414/ H.R.9661); Biosimilar Red Tape Elimination Act (S. 1954/H.R. 5526); Clinical trial regulation; Community Health Center Clinical Trial Grant Program discussion draft; Alex and Jacis Law discussion draft; Untitled discussion draft on clinical trial regulation (no bill number); Untitled discussion draft on generic drugs intended for use with a device (no bill number); Food & Drug Administration Fiscal Year 2027 Legislative Proposals (no bill number); Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act, (S.3788 / H.R.8269); draft legislation relating to potential improvements the National Childhood Vaccine Injury Act and the Vaccine Injury Compensation Program; American Biotechnology Act, Senate Amendment 6334 to S. 4784, National Defense Authorization Act (NDAA) for Fiscal Year 2027; CARES Act (P.L. 116-136) reporting issues.
CLEAR LABELS Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Biosimilars Access and Affordability Act (S. 5459); Skinny Labels, Big Savings Act (S. 43/H.R. 6485); Eliminating Thickets to Increase Competition (ETHIC) Act (S. 2276/H.R. 3269); Expedited Access to Biosimilars Act (S. 1414); Biosimilar Red Tape Elimination Act (S. 1954/H.R. 5526); CLEAR Act (H.R.7140); Artificial Intelligence-Ready Data Act (S.4098); Preserve Access to Affordable Generics and Biosimilars Act (S. 1096); Drug Competition Enhancement Act (S.1040); America's Living Library Project Bill (S. 4023); Securing Essential Components for U.S. Readiness in Essential Pharmaceuticals (SECURE Rx) Act of 2026 (discussion draft); improvements to the National Childhood Vaccine Injury Act of 1986; Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act (S. 3788).
America’s Living Library Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Biosimilars Access and Affordability Act (S. 5459); Skinny Labels, Big Savings Act (S. 43/H.R. 6485); Eliminating Thickets to Increase Competition (ETHIC) Act (S. 2276/H.R. 3269); Expedited Access to Biosimilars Act (S. 1414); Biosimilar Red Tape Elimination Act (S. 1954/H.R. 5526); CLEAR Act (H.R.7140); Artificial Intelligence-Ready Data Act (S.4098); Preserve Access to Affordable Generics and Biosimilars Act (S. 1096); Drug Competition Enhancement Act (S.1040); America's Living Library Project Bill (S. 4023); Securing Essential Components for U.S. Readiness in Essential Pharmaceuticals (SECURE Rx) Act of 2026 (discussion draft); improvements to the National Childhood Vaccine Injury Act of 1986; Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act (S. 3788).
Artificial Intelligence-Ready Data Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Biosimilars Access and Affordability Act (S. 5459); Skinny Labels, Big Savings Act (S. 43/H.R. 6485); Eliminating Thickets to Increase Competition (ETHIC) Act (S. 2276/H.R. 3269); Expedited Access to Biosimilars Act (S. 1414); Biosimilar Red Tape Elimination Act (S. 1954/H.R. 5526); CLEAR Act (H.R.7140); Artificial Intelligence-Ready Data Act (S.4098); Preserve Access to Affordable Generics and Biosimilars Act (S. 1096); Drug Competition Enhancement Act (S.1040); America's Living Library Project Bill (S. 4023); Securing Essential Components for U.S. Readiness in Essential Pharmaceuticals (SECURE Rx) Act of 2026 (discussion draft); improvements to the National Childhood Vaccine Injury Act of 1986; Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act (S. 3788).
Skinny Labels, Big Savings Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Medication Affordability and Patent Integrity Act (S. 2658); Biopharmaceutical policy issues; Skinny Labels, Big Savings Act (S. 43/H.R. 6485).
Skinny Labels, Big Savings Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Biosimilars Access and Affordability Act (S. 5459); Skinny Labels, Big Savings Act (S. 43/H.R. 6485); Eliminating Thickets to Increase Competition (ETHIC) Act (S. 2276/H.R. 3269); Expedited Access to Biosimilars Act (S. 1414); Biosimilar Red Tape Elimination Act (S. 1954/H.R. 5526); CLEAR Act (H.R.7140); Artificial Intelligence-Ready Data Act (S.4098); Preserve Access to Affordable Generics and Biosimilars Act (S. 1096); Drug Competition Enhancement Act (S.1040); America's Living Library Project Bill (S. 4023); Securing Essential Components for U.S. Readiness in Essential Pharmaceuticals (SECURE Rx) Act of 2026 (discussion draft); improvements to the National Childhood Vaccine Injury Act of 1986; Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act (S. 3788).
Skinny Labels, Big Savings Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Skinny Labels, Big Savings Act (S. 43/H.R. 6485); Eliminating Thickets to Increase Competition (ETHIC) Act (S. 2276/H.R. 3269).
Skinny Labels, Big Savings Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program Proposed Rule, 91 Fed. Reg. 36236; Medication Affordability and Patent Integrity (MAPIA) Act (S. 2658); Skinny Labels, Big Savings Act (S. 43/H.R. 6485); Expedited Access to Biosimilars Act (S. 1414/ H.R.9661); Biosimilar Red Tape Elimination Act (S. 1954/H.R. 5526); Clinical trial regulation; Community Health Center Clinical Trial Grant Program discussion draft; Alex and Jacis Law discussion draft; Untitled discussion draft on clinical trial regulation (no bill number); Untitled discussion draft on generic drugs intended for use with a device (no bill number); Food & Drug Administration Fiscal Year 2027 Legislative Proposals (no bill number); Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act, (S.3788 / H.R.8269); draft legislation relating to potential improvements the National Childhood Vaccine Injury Act and the Vaccine Injury Compensation Program; American Biotechnology Act, Senate Amendment 6334 to S. 4784, National Defense Authorization Act (NDAA) for Fiscal Year 2027; CARES Act (P.L. 116-136) reporting issues.
National Defense Authorization Act for Fiscal Year 2027
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program Proposed Rule, 91 Fed. Reg. 36236; Medication Affordability and Patent Integrity (MAPIA) Act (S. 2658); Skinny Labels, Big Savings Act (S. 43/H.R. 6485); Expedited Access to Biosimilars Act (S. 1414/ H.R.9661); Biosimilar Red Tape Elimination Act (S. 1954/H.R. 5526); Clinical trial regulation; Community Health Center Clinical Trial Grant Program discussion draft; Alex and Jacis Law discussion draft; Untitled discussion draft on clinical trial regulation (no bill number); Untitled discussion draft on generic drugs intended for use with a device (no bill number); Food & Drug Administration Fiscal Year 2027 Legislative Proposals (no bill number); Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act, (S.3788 / H.R.8269); draft legislation relating to potential improvements the National Childhood Vaccine Injury Act and the Vaccine Injury Compensation Program; American Biotechnology Act, Senate Amendment 6334 to S. 4784, National Defense Authorization Act (NDAA) for Fiscal Year 2027; CARES Act (P.L. 116-136) reporting issues.
Biosimilars Access and Affordability Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Biosimilars Access and Affordability Act (S. 5459); Skinny Labels, Big Savings Act (S. 43/H.R. 6485); Eliminating Thickets to Increase Competition (ETHIC) Act (S. 2276/H.R. 3269); Expedited Access to Biosimilars Act (S. 1414); Biosimilar Red Tape Elimination Act (S. 1954/H.R. 5526); CLEAR Act (H.R.7140); Artificial Intelligence-Ready Data Act (S.4098); Preserve Access to Affordable Generics and Biosimilars Act (S. 1096); Drug Competition Enhancement Act (S.1040); America's Living Library Project Bill (S. 4023); Securing Essential Components for U.S. Readiness in Essential Pharmaceuticals (SECURE Rx) Act of 2026 (discussion draft); improvements to the National Childhood Vaccine Injury Act of 1986; Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act (S. 3788).
An act to provide for reconciliation pursuant to title II of H. Con. Res. 14.
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Biosimilars Access and Affordability Act (S. 5459); Preserve Access to Affordable Generics and Biosimilars Act (S. 1096); EPIC Act of 2025 (S. 832); H.R.1492 - To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program; Increasing Transparency in Generic Drug Applications Act (S.1302); Stop STALLING Act (S. 1095); S. 1040, A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes; Interagency Patent Coordination and Improvement Act of 2025 (S. 1097); approval pathways; Expedited Access to Biosimilars Act (S. 1414); Biosimilar Red Tape Elimination Act (S. 1954); USFDA-PTO collaboration; FDA reductions in force and FDA reforms; drug supply chain; right to try; ORPHAN Cures Act (H.R. 946); H.R.1 - One Big Beautiful Bill Act; priority review vouchers; Family Vaccine Protection Act (H.R. 3701).
Mikaela Naylon Give Kids a Chance Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Give Kids a Chance Act of 2025 (H.R. 1262/S. 932); Stop STALLING Act (S. 1095); approval pathways; S. 1040, A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes; biosimilar testing; S. 1041, A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes; Interagency Patent Coordination and Improvement Act of 2025 (S. 1097); Preserve Access to Affordable Generics and Biosimilars Act (S. 1096); EPIC Act of 2025 (S. 832); H.R.1492 - To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program; Innovation in Pediatric Drugs Act of 2025 (S. 705); biosimilar policy issues; Skinny Labels, Big Savings Act (S. 43).
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.
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Give Kids a Chance Act of 2025 (H.R. 1262/S. 932); Stop STALLING Act (S. 1095); approval pathways; S. 1040, A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes; biosimilar testing; S. 1041, A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes; Interagency Patent Coordination and Improvement Act of 2025 (S. 1097); Preserve Access to Affordable Generics and Biosimilars Act (S. 1096); EPIC Act of 2025 (S. 832); H.R.1492 - To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program; Innovation in Pediatric Drugs Act of 2025 (S. 705); biosimilar policy issues; Skinny Labels, Big Savings Act (S. 43).
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.
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Biosimilars Access and Affordability Act (S. 5459); Preserve Access to Affordable Generics and Biosimilars Act (S. 1096); EPIC Act of 2025 (S. 832); H.R.1492 - To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program; Increasing Transparency in Generic Drug Applications Act (S.1302); Stop STALLING Act (S. 1095); S. 1040, A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes; Interagency Patent Coordination and Improvement Act of 2025 (S. 1097); approval pathways; Expedited Access to Biosimilars Act (S. 1414); Biosimilar Red Tape Elimination Act (S. 1954); USFDA-PTO collaboration; FDA reductions in force and FDA reforms; drug supply chain; right to try; ORPHAN Cures Act (H.R. 946); H.R.1 - One Big Beautiful Bill Act; priority review vouchers; Family Vaccine Protection Act (H.R. 3701).
FDA Modernization Act 3.0
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Biosimilars Access and Affordability Act (no bill number); REMEDY Act (S. 2620); FDA Modernization Act 3.0 (S. 355 / H.R. 2821); issues related to reauthorization of the Prescription Drug User Fee Act (no bill); proposed amendment to the National Defense Authorization Act for Fiscal Year 2026 (S.Amdt.3236 to S.2296); issues related to vaccine access (no bill); Interagency Patent Coordination and Improvement Act of 2025 (S. 1097); Medication Affordability and Patent Integrity Act (S. 2658 / no House bill); Expedited Access to Biosimilars Act (S. 1414); Biosimilar Red Tape Elimination Act (S. 1954, HR 5526); Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 (S.2256); conditional approval; orphan-drug exclusivity; FDA reform.
Family Vaccine Protection Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Biosimilars Access and Affordability Act (S. 5459); Preserve Access to Affordable Generics and Biosimilars Act (S. 1096); EPIC Act of 2025 (S. 832); H.R.1492 - To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program; Increasing Transparency in Generic Drug Applications Act (S.1302); Stop STALLING Act (S. 1095); S. 1040, A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes; Interagency Patent Coordination and Improvement Act of 2025 (S. 1097); approval pathways; Expedited Access to Biosimilars Act (S. 1414); Biosimilar Red Tape Elimination Act (S. 1954); USFDA-PTO collaboration; FDA reductions in force and FDA reforms; drug supply chain; right to try; ORPHAN Cures Act (H.R. 946); H.R.1 - One Big Beautiful Bill Act; priority review vouchers; Family Vaccine Protection Act (H.R. 3701).
Biosimilar Red Tape Elimination Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Biosimilars Access and Affordability Act (no bill number); REMEDY Act (S. 2620); FDA Modernization Act 3.0 (S. 355 / H.R. 2821); issues related to reauthorization of the Prescription Drug User Fee Act (no bill); proposed amendment to the National Defense Authorization Act for Fiscal Year 2026 (S.Amdt.3236 to S.2296); issues related to vaccine access (no bill); Interagency Patent Coordination and Improvement Act of 2025 (S. 1097); Medication Affordability and Patent Integrity Act (S. 2658 / no House bill); Expedited Access to Biosimilars Act (S. 1414); Biosimilar Red Tape Elimination Act (S. 1954, HR 5526); Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 (S.2256); conditional approval; orphan-drug exclusivity; FDA reform.
ORPHAN Cures Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Biosimilars Access and Affordability Act (S. 5459); Preserve Access to Affordable Generics and Biosimilars Act (S. 1096); EPIC Act of 2025 (S. 832); H.R.1492 - To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program; Increasing Transparency in Generic Drug Applications Act (S.1302); Stop STALLING Act (S. 1095); S. 1040, A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes; Interagency Patent Coordination and Improvement Act of 2025 (S. 1097); approval pathways; Expedited Access to Biosimilars Act (S. 1414); Biosimilar Red Tape Elimination Act (S. 1954); USFDA-PTO collaboration; FDA reductions in force and FDA reforms; drug supply chain; right to try; ORPHAN Cures Act (H.R. 946); H.R.1 - One Big Beautiful Bill Act; priority review vouchers; Family Vaccine Protection Act (H.R. 3701).
Drug Competition Enhancement Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Biosimilars Access and Affordability Act (S. 5459); Preserve Access to Affordable Generics and Biosimilars Act (S. 1096); EPIC Act of 2025 (S. 832); H.R.1492 - To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program; Increasing Transparency in Generic Drug Applications Act (S.1302); Stop STALLING Act (S. 1095); S. 1040, A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes; Interagency Patent Coordination and Improvement Act of 2025 (S. 1097); approval pathways; Expedited Access to Biosimilars Act (S. 1414); Biosimilar Red Tape Elimination Act (S. 1954); USFDA-PTO collaboration; FDA reductions in force and FDA reforms; drug supply chain; right to try; ORPHAN Cures Act (H.R. 946); H.R.1 - One Big Beautiful Bill Act; priority review vouchers; Family Vaccine Protection Act (H.R. 3701).
Drug Competition Enhancement Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Give Kids a Chance Act of 2025 (H.R. 1262/S. 932); Stop STALLING Act (S. 1095); approval pathways; S. 1040, A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes; biosimilar testing; S. 1041, A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes; Interagency Patent Coordination and Improvement Act of 2025 (S. 1097); Preserve Access to Affordable Generics and Biosimilars Act (S. 1096); EPIC Act of 2025 (S. 832); H.R.1492 - To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program; Innovation in Pediatric Drugs Act of 2025 (S. 705); biosimilar policy issues; Skinny Labels, Big Savings Act (S. 43).
Affordable Prescriptions for Patients Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Biopharmaceutical innovation and intellectual property policy issues; patent subject matter; Interagency Patent Coordination and Improvement Act of 2025 (S. 1097); Skinny Labels, Big Savings Act (S. 43); Preserve Access to Affordable Generics and Biosimilars Act (S. 1096); S. 1041, A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes.
Affordable Prescriptions for Patients Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Give Kids a Chance Act of 2025 (H.R. 1262/S. 932); Stop STALLING Act (S. 1095); approval pathways; S. 1040, A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes; biosimilar testing; S. 1041, A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes; Interagency Patent Coordination and Improvement Act of 2025 (S. 1097); Preserve Access to Affordable Generics and Biosimilars Act (S. 1096); EPIC Act of 2025 (S. 832); H.R.1492 - To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program; Innovation in Pediatric Drugs Act of 2025 (S. 705); biosimilar policy issues; Skinny Labels, Big Savings Act (S. 43).
Stop STALLING Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Give Kids a Chance Act of 2025 (H.R. 1262/S. 932); Stop STALLING Act (S. 1095); approval pathways; S. 1040, A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes; biosimilar testing; S. 1041, A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes; Interagency Patent Coordination and Improvement Act of 2025 (S. 1097); Preserve Access to Affordable Generics and Biosimilars Act (S. 1096); EPIC Act of 2025 (S. 832); H.R.1492 - To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program; Innovation in Pediatric Drugs Act of 2025 (S. 705); biosimilar policy issues; Skinny Labels, Big Savings Act (S. 43).
Stop STALLING Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Biosimilars Access and Affordability Act (S. 5459); Preserve Access to Affordable Generics and Biosimilars Act (S. 1096); EPIC Act of 2025 (S. 832); H.R.1492 - To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program; Increasing Transparency in Generic Drug Applications Act (S.1302); Stop STALLING Act (S. 1095); S. 1040, A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes; Interagency Patent Coordination and Improvement Act of 2025 (S. 1097); approval pathways; Expedited Access to Biosimilars Act (S. 1414); Biosimilar Red Tape Elimination Act (S. 1954); USFDA-PTO collaboration; FDA reductions in force and FDA reforms; drug supply chain; right to try; ORPHAN Cures Act (H.R. 946); H.R.1 - One Big Beautiful Bill Act; priority review vouchers; Family Vaccine Protection Act (H.R. 3701).
Preserve Access to Affordable Generics and Biosimilars Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Give Kids a Chance Act of 2025 (H.R. 1262/S. 932); Stop STALLING Act (S. 1095); approval pathways; S. 1040, A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes; biosimilar testing; S. 1041, A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes; Interagency Patent Coordination and Improvement Act of 2025 (S. 1097); Preserve Access to Affordable Generics and Biosimilars Act (S. 1096); EPIC Act of 2025 (S. 832); H.R.1492 - To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program; Innovation in Pediatric Drugs Act of 2025 (S. 705); biosimilar policy issues; Skinny Labels, Big Savings Act (S. 43).
Preserve Access to Affordable Generics and Biosimilars Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Biopharmaceutical innovation and intellectual property policy issues; Preserve Access to Affordable Generics and Biosimilars Act (S. 1096); induced infringement.
Preserve Access to Affordable Generics and Biosimilars Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Biosimilars Access and Affordability Act (S. 5459); Preserve Access to Affordable Generics and Biosimilars Act (S. 1096); EPIC Act of 2025 (S. 832); H.R.1492 - To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program; Increasing Transparency in Generic Drug Applications Act (S.1302); Stop STALLING Act (S. 1095); S. 1040, A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes; Interagency Patent Coordination and Improvement Act of 2025 (S. 1097); approval pathways; Expedited Access to Biosimilars Act (S. 1414); Biosimilar Red Tape Elimination Act (S. 1954); USFDA-PTO collaboration; FDA reductions in force and FDA reforms; drug supply chain; right to try; ORPHAN Cures Act (H.R. 946); H.R.1 - One Big Beautiful Bill Act; priority review vouchers; Family Vaccine Protection Act (H.R. 3701).
Preserve Access to Affordable Generics and Biosimilars Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Biopharmaceutical innovation and intellectual property policy issues; patent subject matter; Interagency Patent Coordination and Improvement Act of 2025 (S. 1097); Skinny Labels, Big Savings Act (S. 43); Preserve Access to Affordable Generics and Biosimilars Act (S. 1096); S. 1041, A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes.
Interagency Patent Coordination and Improvement Act of 2025
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Biosimilars Access and Affordability Act (no bill number); REMEDY Act (S. 2620); FDA Modernization Act 3.0 (S. 355 / H.R. 2821); issues related to reauthorization of the Prescription Drug User Fee Act (no bill); proposed amendment to the National Defense Authorization Act for Fiscal Year 2026 (S.Amdt.3236 to S.2296); issues related to vaccine access (no bill); Interagency Patent Coordination and Improvement Act of 2025 (S. 1097); Medication Affordability and Patent Integrity Act (S. 2658 / no House bill); Expedited Access to Biosimilars Act (S. 1414); Biosimilar Red Tape Elimination Act (S. 1954, HR 5526); Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 (S.2256); conditional approval; orphan-drug exclusivity; FDA reform.
Interagency Patent Coordination and Improvement Act of 2025
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Biopharmaceutical innovation and intellectual property policy issues; patent subject matter; Interagency Patent Coordination and Improvement Act of 2025 (S. 1097); Skinny Labels, Big Savings Act (S. 43); Preserve Access to Affordable Generics and Biosimilars Act (S. 1096); S. 1041, A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes.
Interagency Patent Coordination and Improvement Act of 2025
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Give Kids a Chance Act of 2025 (H.R. 1262/S. 932); Stop STALLING Act (S. 1095); approval pathways; S. 1040, A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes; biosimilar testing; S. 1041, A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes; Interagency Patent Coordination and Improvement Act of 2025 (S. 1097); Preserve Access to Affordable Generics and Biosimilars Act (S. 1096); EPIC Act of 2025 (S. 832); H.R.1492 - To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program; Innovation in Pediatric Drugs Act of 2025 (S. 705); biosimilar policy issues; Skinny Labels, Big Savings Act (S. 43).
Interagency Patent Coordination and Improvement Act of 2025
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Biosimilars Access and Affordability Act (S. 5459); Preserve Access to Affordable Generics and Biosimilars Act (S. 1096); EPIC Act of 2025 (S. 832); H.R.1492 - To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program; Increasing Transparency in Generic Drug Applications Act (S.1302); Stop STALLING Act (S. 1095); S. 1040, A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes; Interagency Patent Coordination and Improvement Act of 2025 (S. 1097); approval pathways; Expedited Access to Biosimilars Act (S. 1414); Biosimilar Red Tape Elimination Act (S. 1954); USFDA-PTO collaboration; FDA reductions in force and FDA reforms; drug supply chain; right to try; ORPHAN Cures Act (H.R. 946); H.R.1 - One Big Beautiful Bill Act; priority review vouchers; Family Vaccine Protection Act (H.R. 3701).
Increasing Transparency in Generic Drug Applications Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Biosimilars Access and Affordability Act (S. 5459); Preserve Access to Affordable Generics and Biosimilars Act (S. 1096); EPIC Act of 2025 (S. 832); H.R.1492 - To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program; Increasing Transparency in Generic Drug Applications Act (S.1302); Stop STALLING Act (S. 1095); S. 1040, A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes; Interagency Patent Coordination and Improvement Act of 2025 (S. 1097); approval pathways; Expedited Access to Biosimilars Act (S. 1414); Biosimilar Red Tape Elimination Act (S. 1954); USFDA-PTO collaboration; FDA reductions in force and FDA reforms; drug supply chain; right to try; ORPHAN Cures Act (H.R. 946); H.R.1 - One Big Beautiful Bill Act; priority review vouchers; Family Vaccine Protection Act (H.R. 3701).
Expedited Access to Biosimilars Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Biosimilars Access and Affordability Act (S. 5459); Preserve Access to Affordable Generics and Biosimilars Act (S. 1096); EPIC Act of 2025 (S. 832); H.R.1492 - To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program; Increasing Transparency in Generic Drug Applications Act (S.1302); Stop STALLING Act (S. 1095); S. 1040, A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes; Interagency Patent Coordination and Improvement Act of 2025 (S. 1097); approval pathways; Expedited Access to Biosimilars Act (S. 1414); Biosimilar Red Tape Elimination Act (S. 1954); USFDA-PTO collaboration; FDA reductions in force and FDA reforms; drug supply chain; right to try; ORPHAN Cures Act (H.R. 946); H.R.1 - One Big Beautiful Bill Act; priority review vouchers; Family Vaccine Protection Act (H.R. 3701).
Expedited Access to Biosimilars Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Biosimilars Access and Affordability Act (no bill number); REMEDY Act (S. 2620); FDA Modernization Act 3.0 (S. 355 / H.R. 2821); issues related to reauthorization of the Prescription Drug User Fee Act (no bill); proposed amendment to the National Defense Authorization Act for Fiscal Year 2026 (S.Amdt.3236 to S.2296); issues related to vaccine access (no bill); Interagency Patent Coordination and Improvement Act of 2025 (S. 1097); Medication Affordability and Patent Integrity Act (S. 2658 / no House bill); Expedited Access to Biosimilars Act (S. 1414); Biosimilar Red Tape Elimination Act (S. 1954, HR 5526); Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 (S.2256); conditional approval; orphan-drug exclusivity; FDA reform.
Biosimilar Red Tape Elimination Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Biosimilars Access and Affordability Act (no bill number); REMEDY Act (S. 2620); FDA Modernization Act 3.0 (S. 355 / H.R. 2821); issues related to reauthorization of the Prescription Drug User Fee Act (no bill); proposed amendment to the National Defense Authorization Act for Fiscal Year 2026 (S.Amdt.3236 to S.2296); issues related to vaccine access (no bill); Interagency Patent Coordination and Improvement Act of 2025 (S. 1097); Medication Affordability and Patent Integrity Act (S. 2658 / no House bill); Expedited Access to Biosimilars Act (S. 1414); Biosimilar Red Tape Elimination Act (S. 1954, HR 5526); Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 (S.2256); conditional approval; orphan-drug exclusivity; FDA reform.
Biosimilar Red Tape Elimination Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Biosimilars Access and Affordability Act (S. 5459); Preserve Access to Affordable Generics and Biosimilars Act (S. 1096); EPIC Act of 2025 (S. 832); H.R.1492 - To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program; Increasing Transparency in Generic Drug Applications Act (S.1302); Stop STALLING Act (S. 1095); S. 1040, A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes; Interagency Patent Coordination and Improvement Act of 2025 (S. 1097); approval pathways; Expedited Access to Biosimilars Act (S. 1414); Biosimilar Red Tape Elimination Act (S. 1954); USFDA-PTO collaboration; FDA reductions in force and FDA reforms; drug supply chain; right to try; ORPHAN Cures Act (H.R. 946); H.R.1 - One Big Beautiful Bill Act; priority review vouchers; Family Vaccine Protection Act (H.R. 3701).
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Biosimilars Access and Affordability Act (no bill number); REMEDY Act (S. 2620); FDA Modernization Act 3.0 (S. 355 / H.R. 2821); issues related to reauthorization of the Prescription Drug User Fee Act (no bill); proposed amendment to the National Defense Authorization Act for Fiscal Year 2026 (S.Amdt.3236 to S.2296); issues related to vaccine access (no bill); Interagency Patent Coordination and Improvement Act of 2025 (S. 1097); Medication Affordability and Patent Integrity Act (S. 2658 / no House bill); Expedited Access to Biosimilars Act (S. 1414); Biosimilar Red Tape Elimination Act (S. 1954, HR 5526); Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 (S.2256); conditional approval; orphan-drug exclusivity; FDA reform.
National Defense Authorization Act for Fiscal Year 2026
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Biosimilars Access and Affordability Act (no bill number); REMEDY Act (S. 2620); FDA Modernization Act 3.0 (S. 355 / H.R. 2821); issues related to reauthorization of the Prescription Drug User Fee Act (no bill); proposed amendment to the National Defense Authorization Act for Fiscal Year 2026 (S.Amdt.3236 to S.2296); issues related to vaccine access (no bill); Interagency Patent Coordination and Improvement Act of 2025 (S. 1097); Medication Affordability and Patent Integrity Act (S. 2658 / no House bill); Expedited Access to Biosimilars Act (S. 1414); Biosimilar Red Tape Elimination Act (S. 1954, HR 5526); Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 (S.2256); conditional approval; orphan-drug exclusivity; FDA reform.
REMEDY Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Biosimilars Access and Affordability Act (no bill number); REMEDY Act (S. 2620); FDA Modernization Act 3.0 (S. 355 / H.R. 2821); issues related to reauthorization of the Prescription Drug User Fee Act (no bill); proposed amendment to the National Defense Authorization Act for Fiscal Year 2026 (S.Amdt.3236 to S.2296); issues related to vaccine access (no bill); Interagency Patent Coordination and Improvement Act of 2025 (S. 1097); Medication Affordability and Patent Integrity Act (S. 2658 / no House bill); Expedited Access to Biosimilars Act (S. 1414); Biosimilar Red Tape Elimination Act (S. 1954, HR 5526); Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 (S.2256); conditional approval; orphan-drug exclusivity; FDA reform.
Medication Affordability and Patent Integrity Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Biosimilars Access and Affordability Act (no bill number); REMEDY Act (S. 2620); FDA Modernization Act 3.0 (S. 355 / H.R. 2821); issues related to reauthorization of the Prescription Drug User Fee Act (no bill); proposed amendment to the National Defense Authorization Act for Fiscal Year 2026 (S.Amdt.3236 to S.2296); issues related to vaccine access (no bill); Interagency Patent Coordination and Improvement Act of 2025 (S. 1097); Medication Affordability and Patent Integrity Act (S. 2658 / no House bill); Expedited Access to Biosimilars Act (S. 1414); Biosimilar Red Tape Elimination Act (S. 1954, HR 5526); Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 (S.2256); conditional approval; orphan-drug exclusivity; FDA reform.
FDA Modernization Act 3.0
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Biosimilars Access and Affordability Act (no bill number); REMEDY Act (S. 2620); FDA Modernization Act 3.0 (S. 355 / H.R. 2821); issues related to reauthorization of the Prescription Drug User Fee Act (no bill); proposed amendment to the National Defense Authorization Act for Fiscal Year 2026 (S.Amdt.3236 to S.2296); issues related to vaccine access (no bill); Interagency Patent Coordination and Improvement Act of 2025 (S. 1097); Medication Affordability and Patent Integrity Act (S. 2658 / no House bill); Expedited Access to Biosimilars Act (S. 1414); Biosimilar Red Tape Elimination Act (S. 1954, HR 5526); Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 (S.2256); conditional approval; orphan-drug exclusivity; FDA reform.
Skinny Labels, Big Savings Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Give Kids a Chance Act of 2025 (H.R. 1262/S. 932); Stop STALLING Act (S. 1095); approval pathways; S. 1040, A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes; biosimilar testing; S. 1041, A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes; Interagency Patent Coordination and Improvement Act of 2025 (S. 1097); Preserve Access to Affordable Generics and Biosimilars Act (S. 1096); EPIC Act of 2025 (S. 832); H.R.1492 - To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program; Innovation in Pediatric Drugs Act of 2025 (S. 705); biosimilar policy issues; Skinny Labels, Big Savings Act (S. 43).
Skinny Labels, Big Savings Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Biopharmaceutical innovation and intellectual property policy issues; patent subject matter; Interagency Patent Coordination and Improvement Act of 2025 (S. 1097); Skinny Labels, Big Savings Act (S. 43); Preserve Access to Affordable Generics and Biosimilars Act (S. 1096); S. 1041, A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes.
Innovation in Pediatric Drugs Act of 2025
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Give Kids a Chance Act of 2025 (H.R. 1262/S. 932); Stop STALLING Act (S. 1095); approval pathways; S. 1040, A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes; biosimilar testing; S. 1041, A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes; Interagency Patent Coordination and Improvement Act of 2025 (S. 1097); Preserve Access to Affordable Generics and Biosimilars Act (S. 1096); EPIC Act of 2025 (S. 832); H.R.1492 - To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program; Innovation in Pediatric Drugs Act of 2025 (S. 705); biosimilar policy issues; Skinny Labels, Big Savings Act (S. 43).
EPIC Act of 2025
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Biosimilars Access and Affordability Act (S. 5459); Preserve Access to Affordable Generics and Biosimilars Act (S. 1096); EPIC Act of 2025 (S. 832); H.R.1492 - To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program; Increasing Transparency in Generic Drug Applications Act (S.1302); Stop STALLING Act (S. 1095); S. 1040, A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes; Interagency Patent Coordination and Improvement Act of 2025 (S. 1097); approval pathways; Expedited Access to Biosimilars Act (S. 1414); Biosimilar Red Tape Elimination Act (S. 1954); USFDA-PTO collaboration; FDA reductions in force and FDA reforms; drug supply chain; right to try; ORPHAN Cures Act (H.R. 946); H.R.1 - One Big Beautiful Bill Act; priority review vouchers; Family Vaccine Protection Act (H.R. 3701).
EPIC Act of 2025
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Give Kids a Chance Act of 2025 (H.R. 1262/S. 932); Stop STALLING Act (S. 1095); approval pathways; S. 1040, A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes; biosimilar testing; S. 1041, A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes; Interagency Patent Coordination and Improvement Act of 2025 (S. 1097); Preserve Access to Affordable Generics and Biosimilars Act (S. 1096); EPIC Act of 2025 (S. 832); H.R.1492 - To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program; Innovation in Pediatric Drugs Act of 2025 (S. 705); biosimilar policy issues; Skinny Labels, Big Savings Act (S. 43).
Genomic Data Protection Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Issues related to biopharmaceutical innovation and intellectual property (no bill); issues related to intellectual property and Bayh-Dole in the Genomic Data Protection Act (S. 863 / no House bill); induced infringement.
Give Kids a Chance Act of 2025
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Give Kids a Chance Act of 2025 (H.R. 1262/S. 932); Stop STALLING Act (S. 1095); approval pathways; S. 1040, A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes; biosimilar testing; S. 1041, A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes; Interagency Patent Coordination and Improvement Act of 2025 (S. 1097); Preserve Access to Affordable Generics and Biosimilars Act (S. 1096); EPIC Act of 2025 (S. 832); H.R.1492 - To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program; Innovation in Pediatric Drugs Act of 2025 (S. 705); biosimilar policy issues; Skinny Labels, Big Savings Act (S. 43).
Biosimilars Access and Affordability Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Biosimilars Access and Affordability Act (S. 5459); Preserve Access to Affordable Generics and Biosimilars Act (S. 1096); EPIC Act of 2025 (S. 832); H.R.1492 - To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program; Increasing Transparency in Generic Drug Applications Act (S.1302); Stop STALLING Act (S. 1095); S. 1040, A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes; Interagency Patent Coordination and Improvement Act of 2025 (S. 1097); approval pathways; Expedited Access to Biosimilars Act (S. 1414); Biosimilar Red Tape Elimination Act (S. 1954); USFDA-PTO collaboration; FDA reductions in force and FDA reforms; drug supply chain; right to try; ORPHAN Cures Act (H.R. 946); H.R.1 - One Big Beautiful Bill Act; priority review vouchers; Family Vaccine Protection Act (H.R. 3701).
Further Continuing Appropriations and Disaster Relief Supplemental Appropriations Act, 2025
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); 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); S.3583/H.R. 6986, A bill to address patent thickets; Medication Affordability and Patent Integrity Act (S.2780); Stop STALLING Act (S. 148); S.5573 - A bill to amend title 35, United States Code, to provide for a safe harbor from infringement of a method of use patent relating to drugs or biological products; H.R.3839 - To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications; Further Continuing Appropriations and Disaster Relief Supplemental Appropriations Act, 2025 (H.R. 10445); FDA Modernization Act 3.0 (H.R. 7248); Promising Pathway Act (H.R. 3761/S. 1644); BIOSECURE Act (H.R. 7085); Section 851 (Prohibition on Contracting with Covered Entities that Contract with Lobbyists for Chinese Military Companies) of the Fiscal Year 2024 National Defense Authorization bill ((H.R. 5009/S. 4638); Biotechnological Innovation and Opportunity for Competitive Economic Transformation Act of 2024 (BioCompete) ; clinical trial diversity; rare diseases; patent listing; rare pediatric disease priority review vouchers.
Give Kids a Chance Act of 2024
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); 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); S.3583/H.R. 6986, A bill to address patent thickets; Medication Affordability and Patent Integrity Act (S.2780); Stop STALLING Act (S. 148); S.5573 - A bill to amend title 35, United States Code, to provide for a safe harbor from infringement of a method of use patent relating to drugs or biological products; H.R.3839 - To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications; Further Continuing Appropriations and Disaster Relief Supplemental Appropriations Act, 2025 (H.R. 10445); FDA Modernization Act 3.0 (H.R. 7248); Promising Pathway Act (H.R. 3761/S. 1644); BIOSECURE Act (H.R. 7085); Section 851 (Prohibition on Contracting with Covered Entities that Contract with Lobbyists for Chinese Military Companies) of the Fiscal Year 2024 National Defense Authorization bill ((H.R. 5009/S. 4638); Biotechnological Innovation and Opportunity for Competitive Economic Transformation Act of 2024 (BioCompete) ; clinical trial diversity; rare diseases; patent listing; rare pediatric disease priority review vouchers.
Give Kids a Chance Act of 2024
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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).
Give Kids a Chance Act of 2024
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Implementation and proposed amendments to the Inflation Reduction Act (P.L. 117-169); Innovation in Pediatric Drugs Act of 2023 (H.R. 6664); Biosimilar Red Tape Elimination Act (S.2305); Give Kids a Chance Act of 2023 (H.R. 3433/S.2897); Affordable Prescriptions for Patients Act of 2023 (S. 150); Induced infringement and generic drug labeling; S.3583/H.R. 6986, A bill to address patent thickets; REMEDY Act (S. 1209); Medication Affordability and Patent Integrity Act (S.2780); rare pediatric disease priority review vouchers; Stop STALLING Act (S. 148); Interagency Patent Coordination and Improvement Act of 2023 (S. 79); Preserve Access to Affordable Generics and Biosimilars Act (S. 142); Bayh-Dole; Biosecure Act (H.R. 7085, H.R. 8333, S. 3385); and The Federal Acquisition Security Council Improvement Act (discussion draft).
Give Kids a Chance Act of 2024
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Implementation and proposed amendments to the Inflation Reduction Act (P.L. 117-169); Innovation in Pediatric Drugs Act of 2023 (H.R. 6664); S.2305 - Biosimilar Red Tape Elimination Act; Promising Pathway Act (S. 1906/H.R.4408); 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 - A bill to address patent thickets; REMEDY Act (S. 1209); Biosecure Act (S. 3558); proposed changes to Vaccine Injury Compensation Program.
To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications.
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); 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); S.3583/H.R. 6986, A bill to address patent thickets; Medication Affordability and Patent Integrity Act (S.2780); Stop STALLING Act (S. 148); S.5573 - A bill to amend title 35, United States Code, to provide for a safe harbor from infringement of a method of use patent relating to drugs or biological products; H.R.3839 - To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications; Further Continuing Appropriations and Disaster Relief Supplemental Appropriations Act, 2025 (H.R. 10445); FDA Modernization Act 3.0 (H.R. 7248); Promising Pathway Act (H.R. 3761/S. 1644); BIOSECURE Act (H.R. 7085); Section 851 (Prohibition on Contracting with Covered Entities that Contract with Lobbyists for Chinese Military Companies) of the Fiscal Year 2024 National Defense Authorization bill ((H.R. 5009/S. 4638); Biotechnological Innovation and Opportunity for Competitive Economic Transformation Act of 2024 (BioCompete) ; clinical trial diversity; rare diseases; patent listing; rare pediatric disease priority review vouchers.
Promising Pathway Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Implementation and proposed amendments to the Inflation Reduction Act (P.L. 117-169); Innovation in Pediatric Drugs Act of 2023 (H.R. 6664); S.2305 - Biosimilar Red Tape Elimination Act; Promising Pathway Act (S. 1906/H.R.4408); 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 - A bill to address patent thickets; REMEDY Act (S. 1209); Biosecure Act (S. 3558); proposed changes to Vaccine Injury Compensation Program.
Servicemember Quality of Life Improvement and National Defense Authorization Act for Fiscal Year 2025
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); 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); S.3583/H.R. 6986, A bill to address patent thickets; Medication Affordability and Patent Integrity Act (S.2780); Stop STALLING Act (S. 148); S.5573 - A bill to amend title 35, United States Code, to provide for a safe harbor from infringement of a method of use patent relating to drugs or biological products; H.R.3839 - To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications; Further Continuing Appropriations and Disaster Relief Supplemental Appropriations Act, 2025 (H.R. 10445); FDA Modernization Act 3.0 (H.R. 7248); Promising Pathway Act (H.R. 3761/S. 1644); BIOSECURE Act (H.R. 7085); Section 851 (Prohibition on Contracting with Covered Entities that Contract with Lobbyists for Chinese Military Companies) of the Fiscal Year 2024 National Defense Authorization bill ((H.R. 5009/S. 4638); Biotechnological Innovation and Opportunity for Competitive Economic Transformation Act of 2024 (BioCompete) ; clinical trial diversity; rare diseases; patent listing; rare pediatric disease priority review vouchers.
Innovation in Pediatric Drugs Act of 2023
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Implementation and proposed amendments to the Inflation Reduction Act (P.L. 117-169); Innovation in Pediatric Drugs Act of 2023 (H.R. 6664); Biosimilar Red Tape Elimination Act (S.2305); Give Kids a Chance Act of 2023 (H.R. 3433/S.2897); Affordable Prescriptions for Patients Act of 2023 (S. 150); Induced infringement and generic drug labeling; S.3583/H.R. 6986, A bill to address patent thickets; REMEDY Act (S. 1209); Medication Affordability and Patent Integrity Act (S.2780); rare pediatric disease priority review vouchers; Stop STALLING Act (S. 148); Interagency Patent Coordination and Improvement Act of 2023 (S. 79); Preserve Access to Affordable Generics and Biosimilars Act (S. 142); Bayh-Dole; Biosecure Act (H.R. 7085, H.R. 8333, S. 3385); and The Federal Acquisition Security Council Improvement Act (discussion draft).
Innovation in Pediatric Drugs Act of 2023
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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).
Innovation in Pediatric Drugs Act of 2023
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Implementation and proposed amendments to the Inflation Reduction Act (P.L. 117-169); Innovation in Pediatric Drugs Act of 2023 (H.R. 6664); S.2305 - Biosimilar Red Tape Elimination Act; Promising Pathway Act (S. 1906/H.R.4408); 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 - A bill to address patent thickets; REMEDY Act (S. 1209); Biosecure Act (S. 3558); proposed changes to Vaccine Injury Compensation Program.
To address patent thickets.
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Implementation and proposed amendments to the Inflation Reduction Act (P.L. 117-169); Innovation in Pediatric Drugs Act of 2023 (H.R. 6664); Biosimilar Red Tape Elimination Act (S.2305); Give Kids a Chance Act of 2023 (H.R. 3433/S.2897); Affordable Prescriptions for Patients Act of 2023 (S. 150); Induced infringement and generic drug labeling; S.3583/H.R. 6986, A bill to address patent thickets; REMEDY Act (S. 1209); Medication Affordability and Patent Integrity Act (S.2780); rare pediatric disease priority review vouchers; Stop STALLING Act (S. 148); Interagency Patent Coordination and Improvement Act of 2023 (S. 79); Preserve Access to Affordable Generics and Biosimilars Act (S. 142); Bayh-Dole; Biosecure Act (H.R. 7085, H.R. 8333, S. 3385); and The Federal Acquisition Security Council Improvement Act (discussion draft).
To address patent thickets.
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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).
To address patent thickets.
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); 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); S.3583/H.R. 6986, A bill to address patent thickets; Medication Affordability and Patent Integrity Act (S.2780); Stop STALLING Act (S. 148); S.5573 - A bill to amend title 35, United States Code, to provide for a safe harbor from infringement of a method of use patent relating to drugs or biological products; H.R.3839 - To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications; Further Continuing Appropriations and Disaster Relief Supplemental Appropriations Act, 2025 (H.R. 10445); FDA Modernization Act 3.0 (H.R. 7248); Promising Pathway Act (H.R. 3761/S. 1644); BIOSECURE Act (H.R. 7085); Section 851 (Prohibition on Contracting with Covered Entities that Contract with Lobbyists for Chinese Military Companies) of the Fiscal Year 2024 National Defense Authorization bill ((H.R. 5009/S. 4638); Biotechnological Innovation and Opportunity for Competitive Economic Transformation Act of 2024 (BioCompete) ; clinical trial diversity; rare diseases; patent listing; rare pediatric disease priority review vouchers.
To address patent thickets.
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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; S.3583/H.R. 6986, A bill to address patent thickets; Affordable Prescriptions for Patients Act of 2023 (S. 150); Patent Eligibility Restoration Act (PERA) (S. 2140); Biopharmaceutical innovation and intellectual property policy issues.
To address patent thickets.
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Induced infringement and generic drug labeling; S.3583/H.R. 6986, A bill to address patent thickets; Affordable Prescriptions for Patients Act of 2023 (S. 150); Biopharmaceutical innovation and intellectual property policy issues.
To address patent thickets.
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Induced infringement and generic drug labeling; S.3583/HR 6986, A bill to address patent thickets; Affordable Prescriptions for Patients Act of 2023 (S. 150); Biopharmaceutical innovation and intellectual property policy issues.
BIOSECURE Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); 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); S.3583/H.R. 6986, A bill to address patent thickets; Medication Affordability and Patent Integrity Act (S.2780); Stop STALLING Act (S. 148); S.5573 - A bill to amend title 35, United States Code, to provide for a safe harbor from infringement of a method of use patent relating to drugs or biological products; H.R.3839 - To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications; Further Continuing Appropriations and Disaster Relief Supplemental Appropriations Act, 2025 (H.R. 10445); FDA Modernization Act 3.0 (H.R. 7248); Promising Pathway Act (H.R. 3761/S. 1644); BIOSECURE Act (H.R. 7085); Section 851 (Prohibition on Contracting with Covered Entities that Contract with Lobbyists for Chinese Military Companies) of the Fiscal Year 2024 National Defense Authorization bill ((H.R. 5009/S. 4638); Biotechnological Innovation and Opportunity for Competitive Economic Transformation Act of 2024 (BioCompete) ; clinical trial diversity; rare diseases; patent listing; rare pediatric disease priority review vouchers.
Medication Affordability and Patent Integrity Act (S. 2658); Biopharmaceutical policy issues; Skinny Labels, Big Savings Act (S. 43/H.R. 6485).
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2026 · second_quarter · Q2
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Fast-tracking Approval for Innovative Rare disease therapies (FAIR) Act (H.R. 7953); Ensuring Timely Access to Generics Act of 2025 (S. 3014); Stop STALLING Act (S. 1095); Food & Drug Administration Fiscal Year 2027 Legislative Proposals; Agriculture, Rural Development, Food and Drug Administration, and Related Agency Appropriations Act, 2027 (H.R. 8646); Medication Affordability and Patent Integrity Act (S. 2658); Biosimilar Red Tape Elimination Act (S. 1954/H.R. 5526); Expedited Access to Biosimilars Act (S. 1414); Clinical trial regulation; Securing Essential Components for U.S. Readiness in Essential Pharmaceuticals (SECURE Rx) Act of 2026 (discussion draft); Securing Innovation and Research from Adversaries (discussion draft); amendments to the National Childhood Vaccine Injury Act of 1986 and the Vaccine Injury Compensation Program; Destruction of Hazardous Imports Act (H.R. 2715); potential amendments to drug country of origin labeling requirements (discussion draft).
Interagency Patent Coordination and Improvement Act of 2025 (S. 1097); Medication Affordability and Patent Integrity Act (S. 2658); Biopharmaceutical policy issues.
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2026 · first_quarter · Q1
Skinny Labels, Big Savings Act (S. 43/H.R. 6485); Eliminating Thickets to Increase Competition (ETHIC) Act (S. 2276/H.R. 3269).
Biosimilars Access and Affordability Act (S. 5459); Skinny Labels, Big Savings Act (S. 43/H.R. 6485); Eliminating Thickets to Increase Competition (ETHIC) Act (S. 2276/H.R. 3269); Expedited Access to Biosimilars Act (S. 1414); Biosimilar Red Tape Elimination Act (S. 1954/H.R. 5526); CLEAR Act (H.R.7140); Artificial Intelligence-Ready Data Act (S.4098); Preserve Access to Affordable Generics and Biosimilars Act (S. 1096); Drug Competition Enhancement Act (S.1040); America's Living Library Project Bill (S. 4023); Securing Essential Components for U.S. Readiness in Essential Pharmaceuticals (SECURE Rx) Act of 2026 (discussion draft); improvements to the National Childhood Vaccine Injury Act of 1986; Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act (S. 3788).
Filing targets: SENATE
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2025 · third_quarter · Q3
Issues related to biopharmaceutical innovation and intellectual property (no bill); issues related to intellectual property and Bayh-Dole in the Genomic Data Protection Act (S. 863 / no House bill); induced infringement.
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Biosimilars Access and Affordability Act (no bill number); REMEDY Act (S. 2620); FDA Modernization Act 3.0 (S. 355 / H.R. 2821); issues related to reauthorization of the Prescription Drug User Fee Act (no bill); proposed amendment to the National Defense Authorization Act for Fiscal Year 2026 (S.Amdt.3236 to S.2296); issues related to vaccine access (no bill); Interagency Patent Coordination and Improvement Act of 2025 (S. 1097); Medication Affordability and Patent Integrity Act (S. 2658 / no House bill); Expedited Access to Biosimilars Act (S. 1414); Biosimilar Red Tape Elimination Act (S. 1954, HR 5526); Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 (S.2256); conditional approval; orphan-drug exclusivity; FDA reform.
Filing targets: SENATE
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2025 · second_quarter · Q2
Biopharmaceutical innovation and intellectual property policy issues; Preserve Access to Affordable Generics and Biosimilars Act (S. 1096); induced infringement.
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Biosimilars Access and Affordability Act (S. 5459); Preserve Access to Affordable Generics and Biosimilars Act (S. 1096); EPIC Act of 2025 (S. 832); H.R.1492 - To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program; Increasing Transparency in Generic Drug Applications Act (S.1302); Stop STALLING Act (S. 1095); S. 1040, A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes; Interagency Patent Coordination and Improvement Act of 2025 (S. 1097); approval pathways; Expedited Access to Biosimilars Act (S. 1414); Biosimilar Red Tape Elimination Act (S. 1954); USFDA-PTO collaboration; FDA reductions in force and FDA reforms; drug supply chain; right to try; ORPHAN Cures Act (H.R. 946); H.R.1 - One Big Beautiful Bill Act; priority review vouchers; Family Vaccine Protection Act (H.R. 3701).
Filing targets: SENATE
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2025 · first_quarter · Q1
Biopharmaceutical innovation and intellectual property policy issues; patent subject matter; Interagency Patent Coordination and Improvement Act of 2025 (S. 1097); Skinny Labels, Big Savings Act (S. 43); Preserve Access to Affordable Generics and Biosimilars Act (S. 1096); S. 1041, A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes.
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Give Kids a Chance Act of 2025 (H.R. 1262/S. 932); Stop STALLING Act (S. 1095); approval pathways; S. 1040, A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes; biosimilar testing; S. 1041, A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes; Interagency Patent Coordination and Improvement Act of 2025 (S. 1097); Preserve Access to Affordable Generics and Biosimilars Act (S. 1096); EPIC Act of 2025 (S. 832); H.R.1492 - To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program; Innovation in Pediatric Drugs Act of 2025 (S. 705); biosimilar policy issues; Skinny Labels, Big Savings Act (S. 43).
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2024 · fourth_quarter · Q4
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); 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); S.3583/H.R. 6986, A bill to address patent thickets; Medication Affordability and Patent Integrity Act (S.2780); Stop STALLING Act (S. 148); S.5573 - A bill to amend title 35, United States Code, to provide for a safe harbor from infringement of a method of use patent relating to drugs or biological products; H.R.3839 - To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications; Further Continuing Appropriations and Disaster Relief Supplemental Appropriations Act, 2025 (H.R. 10445); FDA Modernization Act 3.0 (H.R. 7248); Promising Pathway Act (H.R. 3761/S. 1644); BIOSECURE Act (H.R. 7085); Section 851 (Prohibition on Contracting with Covered Entities that Contract with Lobbyists for Chinese Military Companies) of the Fiscal Year 2024 National Defense Authorization bill ((H.R. 5009/S. 4638); Biotechnological Innovation and Opportunity for Competitive Economic Transformation Act of 2024 (BioCompete) ; clinical trial diversity; rare diseases; patent listing; rare pediatric disease priority review vouchers.
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2024 · third_quarter · Q3
Induced infringement and generic drug labeling; S.3583/HR 6986, A bill to address patent thickets; Affordable Prescriptions for Patients Act of 2023 (S. 150); Biopharmaceutical innovation and intellectual property policy issues.
Implementation and proposed amendments to the Inflation Reduction Act (P.L. 117-169); Innovation in Pediatric Drugs Act of 2023 (H.R. 6664); Biosimilar Red Tape Elimination Act (S.2305); Give Kids a Chance Act of 2023 (H.R. 3433/S.2897); Affordable Prescriptions for Patients Act of 2023 (S. 150); Induced infringement and generic drug labeling; S.3583/H.R. 6986, A bill to address patent thickets; REMEDY Act (S. 1209); Medication Affordability and Patent Integrity Act (S.2780); rare pediatric disease priority review vouchers; Stop STALLING Act (S. 148); Interagency Patent Coordination and Improvement Act of 2023 (S. 79); Preserve Access to Affordable Generics and Biosimilars Act (S. 142); Bayh-Dole; Biosecure Act (H.R. 7085, H.R. 8333, S. 3385); and The Federal Acquisition Security Council Improvement Act (discussion draft).
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2024 · second_quarter · Q2
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).
Induced infringement and generic drug labeling; S.3583/H.R. 6986, A bill to address patent thickets; Affordable Prescriptions for Patients Act of 2023 (S. 150); Biopharmaceutical innovation and intellectual property policy issues.
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2024 · first_quarter · Q1
Implementation and proposed amendments to the Inflation Reduction Act (P.L. 117-169); Innovation in Pediatric Drugs Act of 2023 (H.R. 6664); S.2305 - Biosimilar Red Tape Elimination Act; Promising Pathway Act (S. 1906/H.R.4408); 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 - A bill to address patent thickets; REMEDY Act (S. 1209); Biosecure Act (S. 3558); proposed changes to Vaccine Injury Compensation Program.
Induced infringement and generic drug labeling; S.3583 - A bill to address patent thickets; Biopharmaceutical innovation and intellectual property policy issues.
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2023 · fourth_quarter · Q4
Give Kids a Chance Act of 2023 (H.R. 3433); Affordable Prescriptions for Patients Act of 2023 (S. 150); Implementation and proposed amendments to the Inflation Reduction Act (P.L. 117-169); Promising Pathway Act (S. 1906/H.R.4408); Improving Efficiency to Increase Competition Act (H.R. 6684); Use code issues; Opioids regulation; Induced infringement and generic drug labeling; proposed amendments to the National Childhood Vaccine Injury Act and the Public Readiness and Emergency Preparedness (PREP) Act relating to compensation for injuries associated with covered vaccines.
Induced infringement and generic drug labeling; Biopharmaceutical innovation and intellectual property policy issues.
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2023 · third_quarter · Q3
Implementation and proposed amendments to the Inflation Reduction Act (P.L. 117-169); Biosimilar Red Tape Elimination Act (S. 6); Discussion draft of the Primary Care and Health Workforce Act; Biosimilars; Drug compounding; Medication Affordability and Patient Integrity Act (S. 2780/H.R. 5429); Accelerated Approval; Orphan Cures Act (H.R. 5539); Pandemic and All-Hazards Preparedness Act reauthorization bills (S. 2333/H.R. 4220 and 4221).
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2023 · second_quarter · Q2
Biopharmaceutical innovation and intellectual property policy issues.
Maintaining Investments in New Innovation Act (S. 476); Increasing Prescription Drug Competition Act (S. 574); Implementation and proposed amendments to the Inflation Reduction Act (P.L. 117-169); Biologics Competition Act of 2023 (H.R. 1790); Bayh-Dole Act; Affordable Prescriptions for Patients Act of 2023 (S. 150); Stop STALLING Act (S. 148); Increasing Transparency in Generic Drug Applications Act (S. 4338/S. 775); Ensuring Timely Access to Generics Act of 2023 (S. 1067); Taxpayer Research and Contributions Knowledge Act of 2023 (S.315); S.1114 - Expanding Access to Low-Cost Generics Act of 2023; Generic drug labeling and regulation; Method of Use patents and use codes; Potential amendments to S.1339 - Pharmacy Benefit Manager Reform Act; S.6 - Biosimilar Red Tape Elimination Act; H.R.3433 - Give Kids a Chance Act of 2023.
Filing targets: SENATE
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2023 · first_quarter · Q1
Biopharmaceutical innovation and intellectual property policy issues; Interagency Patent Coordination and Improvement Act of 2023 (S. 79/H.R. 1717).
Maintaining Investments in New Innovation Act (S. 476); Interagency Patent Coordination and Improvement Act of 2023 (S. 79/H.R. 1717); Increasing Prescription Drug Competition Act (S. 574); Implementation and proposed amendments to the Inflation Reduction Act (P.L. 117-169); Biologics Competition Act of 2023 (H.R. 1790); Bayh-Dole Act; Affordable Prescriptions for Patients Act of 2023 (S. 150); Preserve Access to Affordable Generics and Biosimilars Act (S. 142); Stop STALLING Act (S. 148); Increasing Transparency in Generic Drug Applications Act (S. 4338); Ensuring Timely Access to Generics Act of 2021 (S. 562); Taxpayer Research and Contributions Knowledge Act of 2023 (S.315).
Filing targets: Health & Human Services, Dept of (HHS), SENATE
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2022 · fourth_quarter · Q4
Biopharmaceutical innovation and intellectual property policy issues; Interagency Patent Coordination and Improvement Act of 2022 (S. 4430); Pride in Patent Ownership Act (S. 2774).
FDA Safety and Landmark Advancements (FDASLA) Act (S. 4348); Food and Drug Amendments of 2022 (H.R. 7667); Diverse and Equitable Participation in Clinical Trials Act (H.R. 6584); Advanced Research Project Agency-Health Act (H.R. 5585); America COMPETES Act of 2022 (H.R. 4521); Interagency Patent Coordination and Improvement Act of 2022 (S. 4430); Increasing Prescription Drug Competition Act (S. 4918); Consolidated Appropriations Act, 2023 (H.R. 2617); PASTEUR Act of 2021 (H.R. 3932/S. 2076); Biologics Competition Act of 2022 (H.R. 8877); Give Kids a Chance Act of 2022 (S. 4125/H.R. 6972); Orange Book listing issues; Bayh-Dole Act.
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2022 · third_quarter · Q3
FDA Safety and Landmark Advancements (FDASLA) Act (S. 4348); Food and Drug Amendments of 2022 (H.R.7667); Build Back Better Act (H.R. 5376); Diverse and Equitable Participation in Clinical Trials Act (H.R. 6584); Advanced Research Project Agency-Health Act (H.R. 5585); America COMPETES Act of 2022 (H.R. 4521); Interagency Patent Coordination and Improvement Act of 2022 (S. 4430); Food and Drug Administration Simple Reauthorization Act (S. 4535); Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023 (H.R. 6833); Inflation Reduction Act (H.R. 5376); Pediatric testing for drugs; Increasing Prescription Drug Competition Act (S. 4918).
Biopharmaceutical innovation and intellectual property policy issues; Interagency Patent Coordination and Improvement Act of 2022 (S. 4430); Patent Eligibility Restoration Act of 2022 (S. 4734); Patent Examination and Quality Improvement Act of 2022 (S. 4704).
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2022 · second_quarter · Q2
Biopharmaceutical innovation and intellectual property policy issues; Interagency Patent Coordination and Improvement Act of 2022 (S. 4430).
FDA Safety and Landmark Advancements (FDASLA) Act (S. 4348); Food and Drug Amendments of 2022 (H.R.7667); Build Back Better Act (H.R. 5376); Increasing Transparency in Generic Drug Applications Act of 2022 (H.R. 7032) ; Abbreviated approval pathway for biologics; 180-day exclusivity; Cures 2.0 Act (H.R. 6000); Accelerated Approval Integrity Act of 2022 (H.R. 6963); Give Kids a Chance Act (S.4215, H.R. 6972); Diverse and Equitable Participation in Clinical Trials Act (H.R. 6584); Accelerating Access for Patients Act of 2022 (H.R. 6996); FDA Modernization Act of 2021 (H.R. 2565) ; PREVENT Pandemics Act (S. 3799) Simplifying the Generic Drug Application Process Act (S. 1462); Advanced Research Project Agency-Health Act (H.R. 5585); America COMPETES Act of 2022 (H.R. 4521); Interagency Patent Coordination and Improvement Act of 2022 (S. 4430); Accelerated Approval Transparency Act (S. 4390); Modernizing the Accelerated Approval Pathway Act of 2022 (S. 4446 ); Biologics Market Transparency Act of 2022 (H.R. 7035); Bill to direct the Secretary of Health and Human Services to open a public docket for the submission of public comments regarding factors that should be taken into consideration when reviewing a proposed modification to an approved risk evaluation and mitigation strategy, and for other purposes (H.R. 7649); Affordable Prescriptions for Patients Act of 2021 (S. 1435); Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act (H.R. 2884); Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 (H.R. 2873); Data Transparency and Drug Safety Act of 2022 (H.R. 6431).
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2022 · first_quarter · Q1
Biopharmaceutical innovation and intellectual property policy issues; Restoring the American Invents Act (S. 2891)
Build Back Better Act (H.R. 5376); Increasing Transparency in Generic Drug Applications Act of 2022 (H.R. 7032); Abbreviated approval pathway for biologics; Orphan-drug exclusivity; Cures 2.0 Act (H.R. 6000); Accelerated Approval Integrity Act of 2022 (H.R. 6963); Give Kids a Chance Act (H.R. 6972); Diverse and Equitable Participation in Clinical Trials Act (H.R. 6584); Accelerating Access for Patients Act of 2022 (H.R. 6996); FDA Modernization Act of 2021 (H.R. 2565); PREVENT Pandemics Act (S. 3799) Simplifying the Generic Drug Application Process Act (S. 1462); Prescription Drug User Fee Act Reauthorization; Amendments to the Pediatric Research Equity Act; Right to try; Patent listing issues; Legislation to overrule Genus case; supply chain issues; Advanced Research Project Agency-Health Act (H.R. 5585); America COMPETES Act of 2022 (H.R. 4521)
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2021 · fourth_quarter · Q4
Supply chain issues; Preserve Access to Affordable Generics and Biosimilars Act (S. 1428/ H.R. 2891); S. 1435, Affordable Prescriptions for Patients Act of 2021; H.R. 2884, Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act; H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021; H.R. 2883, Stop Stalling Access to Affordable Medications; S. 1425, Stop STALLING Act; Elijah E. Cummings Lower Drug Costs Now Act (H.R. 3); Build Back Better Act (H.R. 5376); Reduced Costs and Continued Cures Act (RCCCA) (H.R. 5260, H.R. 5237); drug pricing policy; Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act (S. 1209)/H.R. 3812); Give Kids a Chance Act (H.R. 5416); FDA Modernization Act of 2021 (H.R. 2565).
Biopharmaceutical innovation and intellectual property policy issues; WTO TRIPS agreement; Restoring the American Invents Act (S. 2891); Countering Communist China Act (H.R. 4792); Second Look at Patents Act (S.1617); Conducting Legally Efficient Administration and Resolution of (CLEAR) Patents Act of 2021 (H.R. 5902).
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2021 · third_quarter · Q3
Clinical Trial Diversity; Preserve Access to Affordable Generics and Biosimilars Act (S. 1428/ H.R. 2891); S. 1435, Affordable Prescriptions for Patients Act of 2021; H.R. 2884, Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act; H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021; Pediatric study requirements for drugs; Transparency of EUA Information; Induced Infringement; Biosimilarity; H.R. 2883, Stop Stalling Access to Affordable Medications; S. 1425, Stop STALLING Act; proposed amendments to the National Childhood Vaccine Injury Act; Elijah E. Cummings Lower Drug Costs Now Act (H.R. 3); Build Back Better Act (H.R. 5376); drug pricing policy; drug quality issues; Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act (S. 1209/H.R. 3812)
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2021 · second_quarter · Q2
Biopharmaceutical innovation and patent policy issues; WTO TRIPS agreement.
Communications regarding China's draft patent/regulatory linkage framework.
Regulatory exclusivity; Drug pricing; Medicare Part B international reference pricing; Generic drug competition; Drug patent issues; Affordable Prescriptions for Patients Act of 2019 (S. 1416); Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 (H.R. 5133/H.R. 4398); H.R. 3991 - Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019; Executive Order 13944 (List of Essential Medicines, Medical Countermeasures, and Critical Inputs); Executive Order 14001 on a Sustainable Public Health Supply Chain; Compulsory licensing; S.Res.625 - A resolution encouraging the Government and the people of the United States to "Buy American"; Executive Order 13922; Executive Order 13911; Executive Order 13938; Domestic manufacturing incentives; Potential amendments to PREP Act; Bayh-Dole Act; Learnings from Pandemic; Safe Authorization for Vaccines during Emergencies Act (S. 4427); Executive Order 13948 (Lowering Drug Prices by Putting America First); Advancing Americas Interests Act (H.R. 8037); Safeguarding American Innovation Act (S. 3997); Safe to Work Act (S. 4317); 340B drug discounts; Executive Order 13962 (Ensuring Access to United States Government COVID-19 Vaccines); Competition and Antitrust Law Enforcement Reform Act (S. 225); Pioneering Antimicrobial Subscriptions To End Up surging Resistance Act of 2020 (S. 4760/H.R. 8920);Protecting Our Pharmaceutical Supply Chain from China Act of 2020 (H.R. 6482); Part D noninterference; Return on Investment (ROI) Initiative for Unleashing American Innovation; 85 Fed. Reg. 76180; Suitability petitions; Securing America's Vaccines for Emergencies (SAVE) Act of 2020 (H.R. 6399/S. 3715); Pandemic Emergency Manufacturing Act of 2021 (S. 187); H.R.153 - Protecting Consumer Access to Generic Drugs Act of 2021; Lower Costs, More Cures Act (H.R. 19/ S. 3129); S.164 - Advancing Education on Biosimilars Act of 2021; Drug recalls; drug shortages; Elijah E. Cummings Lower Drug Costs Now Act (H.R. 3); Medicare reimbursement of prescription drugs; S. 1435, Affordable Prescriptions for Patients Act of 2021; H.R. 2884, Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act; H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021; H.R. 2387, STOP GAMES Act of 2019; H.R. 4384, Patient Safety and Drug Labeling Improvement; Transparency of EUA Information and FDA-State Information Sharing; Cures 2.0 Act Discussion Draft; H.R. 2883, Stop Stalling Access to Affordable Medications; S. 1425, Stop STALLING Act; Clinical Trial Diversity; S. 1644, Promising Pathway Act; Preserve Access to Affordable Generics and Biosimilars Act (S. 1428/ H.R. 2891); STOP Fentanyl Act of 2021 (S. 1457/H.R. 2366); S. 1508 - A bill to provide for the use of emergency use authorization data and real world evidence gathered during an emergency to support premarket applications for drugs, biological products, and devices, and for other purposes; S. 1260, United States Innovation and Competition Act of 2021; H.R. 2731, Endless Frontier Act; draft Fiscal Year 2022 Labor, Health and Human Services, Education, and Related Agencies funding bill; draft legislation to amend provisions of the National Childhood Vaccination Injury Act to establish new criteria and procedures for covering vaccines in the Vaccine Injury Compensation Program; Country of origin labeling; Supply chain issues; Quality Systems; National Institute of Standards and Technologys (NIST) January 4, 2021 Notice of Proposed Rulemaking (NPRM) on 37 CFR Parts 401 and 404, the implementing regulations of the Bayh-Dole Act; Health Advanced Research Projects Agency (HARPA) proposal.
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2021 · first_quarter · Q1
Regulatory exclusivity; Drug pricing; Medicare Part B international reference pricing; Generic drug competition; Drug patent issues; Affordable Prescriptions for Patients Act of 2019 (S. 1416); Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 (H.R. 5133/H.R. 4398); H.R. 3991 - Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019; Executive Order 13944 (List of Essential Medicines, Medical Countermeasures, and Critical Inputs); Executive Order 14001 on a Sustainable Public Health Supply Chain; Compulsory licensing; Real world evidence; National Defense Authorization Act for Fiscal Year 2021 (S. 4049); S.Res.625 - A resolution encouraging the Government and the people of the United States to "Buy American"; Executive Order 13922; Executive Order 13911; Executive Order 13938; Domestic manufacturing incentives; Potential amendments to PREP Act; Bring Entrepreneurial Advancements To Consumers Here In North America Act (H.R. 6690); Bayh-Dole Act; Learnings from Pandemic; Safe Authorization for Vaccines during Emergencies Act (S.4427); Executive Order 13948 (Lowering Drug Prices by Putting America First); Advancing Americas Interests Act (H.R. 8037); Safeguarding American Innovation Act (S. 3997); Safe to Work Act (S. 4317); 340B drug discounts; Executive Order 13962 (Ensuring Access to United States Government COVID-19 Vaccines); antitrust reform proposals; Competition and Antitrust Law Enforcement Reform Act (S. 225); Pioneering Antimicrobial Subscriptions To End Up surging Resistance Act of 2020 (S. 4760/H.R. 8920); Lower Health Care Costs Act (S. 1895); Protecting Our Pharmaceutical Supply Chain from China Act of 2020 (H.R. 6482); Part D non-interference; Ensuring Innovation Act (S.1636); Return on Investment (ROI) Initiative for Unleashing American Innovation; 85 Fed. Reg. 76180; Suitability petitions; Securing America's Vaccines for Emergencies (SAVE) Act of 2020 (H.R. 6399/S. 3715); Pandemic Emergency Manufacturing Act of 2021 (S. 187); H.R.153 - Protecting Consumer Access to Generic Drugs Act of 2021; Lower Costs, More Cures Act (H.R. 19/ S. 3129); Fairness in Orphan Drug Exclusivity Act (S. 250/ H.R. 4712); S. 415 - A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity; S.164 - Advancing Education on Biosimilars Act of 2021; Preserve Access to Affordable Generics and Biosimilars Act (S. 64/HR 2375); Drug recalls; drug shortages; Elijah E. Cummings Lower Drug Costs Now Act (H.R. 3); Medicare reimbursement of prescription drugs; Unnamed bill regarding FDA demand reporting with respect to drugs.
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; S.3583/H.R. 6986, A bill to address patent thickets; Affordable Prescriptions for Patients Act of 2023 (S. 150); Patent Eligibility Restoration Act (PERA) (S. 2140); Biopharmaceutical innovation and intellectual property policy issues.
Filing targets: SENATE
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
Filing targets: HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE
Filing targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)
Communications regarding China's draft patent/regulatory linkage framework and the state of patent enforcement generally.
Biopharmaceutical innovation and patent policy issues; WTO TRIPS agreement adherence.
Filing targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)