Reported covered position: N/A
How to read the money
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
| BIOGEN IDEC |
| 6 |
| 2008–2009 |
| BIOTECHNOLOGY INNOVATION ORGANIZATION (FKA BIOTECHNOLOGY INDUSTRY ORGANIZATION) | 6 | 2008–2009 |
| CHIRON CORP | 5 | 2005–2006 |
| NOVARTIS VACCINES AND DIAGNOSTICS, INC. | 4 | 2006 |
| ABBOTT LABORATORIES | 3 | 2008–2009 |
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.
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); 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).
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).
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).
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
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); 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
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); 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
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).
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).
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.
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
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
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).
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).
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
FDA Modernization Act 3.0 (S. 355 / H.R. 2821); Expedited Access to Biosimilars Act (S. 1414); Orphan-drug exclusivity; draft Pioneering Antimicrobial Subscriptions To End Up surging Resistance (PASTEUR) Act (no bill number); Clinical Trials; Reciprocal approvals; Skinny Labels, Big Savings Act (S. 43/H.R. 6485); Increasing Transparency in Generic Drug Applications Act (S. 1302/H.R. 1843); BIOSECURE Act, Sec. 851 of the Fiscal Year (FY) 2026 National Defense Authorization Act (NDAA)(S. 1071/H.R. 3838); Potential legislation relating to the Vaccine Injury Compensation Program and other issues affecting vaccines.
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.
FDA Modernization Act 3.0
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
FDA Modernization Act 3.0 (S. 355 / H.R. 2821); Expedited Access to Biosimilars Act (S. 1414); Orphan-drug exclusivity; draft Pioneering Antimicrobial Subscriptions To End Up surging Resistance (PASTEUR) Act (no bill number); Clinical Trials; Reciprocal approvals; Skinny Labels, Big Savings Act (S. 43/H.R. 6485); Increasing Transparency in Generic Drug Applications Act (S. 1302/H.R. 1843); BIOSECURE Act, Sec. 851 of the Fiscal Year (FY) 2026 National Defense Authorization Act (NDAA)(S. 1071/H.R. 3838); Potential legislation relating to the Vaccine Injury Compensation Program and other issues affecting vaccines.
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).
Streamlining Procurement for Effective Execution and Delivery and National Defense Authorization Act for Fiscal Year 2026
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
FDA Modernization Act 3.0 (S. 355 / H.R. 2821); Expedited Access to Biosimilars Act (S. 1414); Orphan-drug exclusivity; draft Pioneering Antimicrobial Subscriptions To End Up surging Resistance (PASTEUR) Act (no bill number); Clinical Trials; Reciprocal approvals; Skinny Labels, Big Savings Act (S. 43/H.R. 6485); Increasing Transparency in Generic Drug Applications Act (S. 1302/H.R. 1843); BIOSECURE Act, Sec. 851 of the Fiscal Year (FY) 2026 National Defense Authorization Act (NDAA)(S. 1071/H.R. 3838); Potential legislation relating to the Vaccine Injury Compensation Program and other issues affecting vaccines.
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.
Skinny Labels, Big Savings Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
FDA Modernization Act 3.0 (S. 355 / H.R. 2821); Expedited Access to Biosimilars Act (S. 1414); Orphan-drug exclusivity; draft Pioneering Antimicrobial Subscriptions To End Up surging Resistance (PASTEUR) Act (no bill number); Clinical Trials; Reciprocal approvals; Skinny Labels, Big Savings Act (S. 43/H.R. 6485); Increasing Transparency in Generic Drug Applications Act (S. 1302/H.R. 1843); BIOSECURE Act, Sec. 851 of the Fiscal Year (FY) 2026 National Defense Authorization Act (NDAA)(S. 1071/H.R. 3838); Potential legislation relating to the Vaccine Injury Compensation Program and other issues affecting vaccines.
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).
National Defense Authorization Act for Fiscal Year 2026
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
FDA Modernization Act 3.0 (S. 355 / H.R. 2821); Expedited Access to Biosimilars Act (S. 1414); Orphan-drug exclusivity; draft Pioneering Antimicrobial Subscriptions To End Up surging Resistance (PASTEUR) Act (no bill number); Clinical Trials; Reciprocal approvals; Skinny Labels, Big Savings Act (S. 43/H.R. 6485); Increasing Transparency in Generic Drug Applications Act (S. 1302/H.R. 1843); BIOSECURE Act, Sec. 851 of the Fiscal Year (FY) 2026 National Defense Authorization Act (NDAA)(S. 1071/H.R. 3838); Potential legislation relating to the Vaccine Injury Compensation Program and other issues affecting vaccines.
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); 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).
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).
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.
Increasing Transparency in Generic Drug Applications Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
FDA Modernization Act 3.0 (S. 355 / H.R. 2821); Expedited Access to Biosimilars Act (S. 1414); Orphan-drug exclusivity; draft Pioneering Antimicrobial Subscriptions To End Up surging Resistance (PASTEUR) Act (no bill number); Clinical Trials; Reciprocal approvals; Skinny Labels, Big Savings Act (S. 43/H.R. 6485); Increasing Transparency in Generic Drug Applications Act (S. 1302/H.R. 1843); BIOSECURE Act, Sec. 851 of the Fiscal Year (FY) 2026 National Defense Authorization Act (NDAA)(S. 1071/H.R. 3838); Potential legislation relating to the Vaccine Injury Compensation Program and other issues affecting vaccines.
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
FDA Modernization Act 3.0 (S. 355 / H.R. 2821); Expedited Access to Biosimilars Act (S. 1414); Orphan-drug exclusivity; draft Pioneering Antimicrobial Subscriptions To End Up surging Resistance (PASTEUR) Act (no bill number); Clinical Trials; Reciprocal approvals; Skinny Labels, Big Savings Act (S. 43/H.R. 6485); Increasing Transparency in Generic Drug Applications Act (S. 1302/H.R. 1843); BIOSECURE Act, Sec. 851 of the Fiscal Year (FY) 2026 National Defense Authorization Act (NDAA)(S. 1071/H.R. 3838); Potential legislation relating to the Vaccine Injury Compensation Program and other issues affecting vaccines.
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.
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).
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.
FDA Modernization Act 3.0
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
FDA Modernization Act 3.0 (S. 355 / H.R. 2821); Expedited Access to Biosimilars Act (S. 1414); Orphan-drug exclusivity; draft Pioneering Antimicrobial Subscriptions To End Up surging Resistance (PASTEUR) Act (no bill number); Clinical Trials; Reciprocal approvals; Skinny Labels, Big Savings Act (S. 43/H.R. 6485); Increasing Transparency in Generic Drug Applications Act (S. 1302/H.R. 1843); BIOSECURE Act, Sec. 851 of the Fiscal Year (FY) 2026 National Defense Authorization Act (NDAA)(S. 1071/H.R. 3838); Potential legislation relating to the Vaccine Injury Compensation Program and other issues affecting vaccines.
Skinny Labels, Big Savings Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
FDA Modernization Act 3.0 (S. 355 / H.R. 2821); Expedited Access to Biosimilars Act (S. 1414); Orphan-drug exclusivity; draft Pioneering Antimicrobial Subscriptions To End Up surging Resistance (PASTEUR) Act (no bill number); Clinical Trials; Reciprocal approvals; Skinny Labels, Big Savings Act (S. 43/H.R. 6485); Increasing Transparency in Generic Drug Applications Act (S. 1302/H.R. 1843); BIOSECURE Act, Sec. 851 of the Fiscal Year (FY) 2026 National Defense Authorization Act (NDAA)(S. 1071/H.R. 3838); Potential legislation relating to the Vaccine Injury Compensation Program and other issues affecting vaccines.
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).
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).
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.
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.
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.
Affordable Prescriptions for Patients 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.
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.
Biosimilar Red Tape Elimination 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.
Give Kids a Chance 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.
Prohibiting Foreign Access to American Genetic Information 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.
A bill 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); 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.
REMEDY 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.
Biologics Competition Act of 2023
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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.
Give Kids a Chance Act of 2024
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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.
Give Kids a Chance Act of 2024
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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.
Dental Care for Our Troops 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); 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).
Promising Pathway Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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.
Medication Affordability and Patent Integrity 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); 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).
ORPHAN Cures 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); 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).
Improving Efficiency to Increase Competition Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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.
Ensuring Timely Access to Generics Act of 2023
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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.
Expanding Access to Low-Cost Generics Act of 2023
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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.
Pharmacy Benefit Manager Reform Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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.
Stop STALLING Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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.
Affordable Prescriptions for Patients Act of 2023
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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.
Affordable Prescriptions for Patients Act of 2023
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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.
Promising Pathway Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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.
Pandemic and All-Hazards Preparedness and Response 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); 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).
Medication Affordability and Patent Integrity 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); 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).
TRACK Act of 2023
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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.
Maintaining Investments in New Innovation Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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.
Increasing Prescription Drug Competition Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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.
Increasing Transparency in Generic Drug Applications Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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.
Increasing Transparency in Generic Drug Applications Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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.
Biosimilar Red Tape Elimination 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); 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).
Biosimilar Red Tape Elimination Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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.
FDA Modernization Act of 2021
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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
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).
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2026 · first_quarter · Q1
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 · fourth_quarter · Q4
FDA Modernization Act 3.0 (S. 355 / H.R. 2821); Expedited Access to Biosimilars Act (S. 1414); Orphan-drug exclusivity; draft Pioneering Antimicrobial Subscriptions To End Up surging Resistance (PASTEUR) Act (no bill number); Clinical Trials; Reciprocal approvals; Skinny Labels, Big Savings Act (S. 43/H.R. 6485); Increasing Transparency in Generic Drug Applications Act (S. 1302/H.R. 1843); BIOSECURE Act, Sec. 851 of the Fiscal Year (FY) 2026 National Defense Authorization Act (NDAA)(S. 1071/H.R. 3838); Potential legislation relating to the Vaccine Injury Compensation Program and other issues affecting vaccines.
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2025 · third_quarter · Q3
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
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
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.
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.
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
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
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).
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2022 · second_quarter · Q2
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
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)
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
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
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
2020 · third_quarter · Q3
Preserve Access to Affordable Generics Act (S. 64); Regulatory exclusivity; Drug pricing; Medicare Part B international reference pricing; Protecting Consumer Access to Generic Drugs Act of 2019 (H.R. 1499); Generic drug competition; Drug patent issues; Affordable Prescriptions for Patients Act of 2019 (S. 1416); Preserve Access to Affordable Generics and Biosimilars Act (H.R.2375); Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 (H.R. 5133/H.R. 4398); H.R.3666 - STRONGER Patents Act of 2019, H.R.19 - Lower Costs, More Cures Act of 2019, Pharmaceutical Independence Long-Term Readiness Reform Act (H.R. 4710); H.R. 3991 - Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019; Lowering Prescription Drug Prices for Americas Seniors and Families Act (S. 3384); Second Look at Drug Patents Act of 2019 (S. 1617); Recall Unsafe Drugs Act of 2020 (H.R. 5578); Executive Order 13944; Compulsory licensing; Strengthening Innovation in Medicare and Medicaid Act (H.R. 5741), No Ban Act (H.R. 2214/S. 1123); Benefit and Payment Parameters; Notice Requirement for Non-Federal Governmental Plans (85 Fed. Reg. 7088); Medical Supply Chain Security Act (S. 3343); Strengthening America's Supply Chain and National Security Act (S. 3538 / H.R.6393); Drug recalls, registration and listing, inspections, expiration dating and shortages, and supply chain issues; Real world evidence; Presidential Proclamation 10052 of June 22, 2020; Taxpayer Research and Coronavirus Knowledge Act of 2020 (H.R.7288); Make Medications Affordable by Preventing Pandemic Pricegouging Act of 2020 (H.R.7296); Strategic National Stockpile; National Defense Authorization Act for Fiscal Year 2021 (S. 4049); Endless Frontier Act (H.R.6978 / S. 3832); S.Res.625 - A resolution encouraging the Government and the people of the United States to "Buy American"; Creating Helpful Incentives to Produce Semiconductors (CHIPS) for America Act (S.3933); Securing America From Epidemics Act (H.R.6334); The Heroes Act (H.R.6800); Securing America's Vaccines for Emergencies (H.R. 6399/S. 3715); 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; Pharmaceutical Accountability, Responsibility, and Transparency Act (S.3781); Prescription Drug User Fee Act reauthorization; Learnings from Pandemic; Safe Authorization for Vaccines during Emergencies Act (S.4427); Potential Amendments to the Rules of Practice for Trials Before the Patent Trial and Appeal Board; Executive Order 13948; Advancing Americas Interests Act (H.R. 8037); Safeguarding American Innovation Act (S. 3997); Safe to Work Act (S. 4317); 340B drug discounts.
CONSUMER HEALTHCARE PRODUCTS ASSOCIATION via COVINGTON & BURLING LLP
2020 · third_quarter · Q3
Regulation of Nonprescription Drugs
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
CONSUMER HEALTHCARE PRODUCTS ASSOCIATION via COVINGTON & BURLING LLP
2020 · second_quarter · Q2
Regulation of Nonprescription Drugs
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2020 · first_quarter · Q1
Preserve Access to Affordable Generics Act (S. 64); Regulatory exclusivity; Drug pricing; Medicare Part B international reference pricing; Protecting Consumer Access to Generic Drugs Act of 2019 (H.R. 1499); Generic drug competition; Drug patent issues; Proposed rule on rebate safe Harbor (84 Fed. Reg. 2340); Lower Health Care Costs Act of 2019 (S. 1895); STOP Stalling Act (S. 1224); Affordable Prescriptions for Patients Act of 2019 (S. 1416); Preserve Access to Affordable Generics and Biosimilars Act (H.R.2375); Drug importation; State-Based, Market-Oriented, Prescription Drug Negotiations Act of 2019 (H.R. 2038); Transparent Drug Pricing Act of 2019 (S.977); Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 (S. 2161); Medicare Negotiation and Competitive Licensing Act of 2019 (H.R. 1046); Direct to consumer advertising; Medicare Prescription Drug Price Negotiation Act of 2019 (H.R. 275); Medicare Drug Price Negotiation Act (H.R. 448); Lower Drug Costs Now Act of 2019 (H.R. 3); Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2019 (S.476); Fair Care Act of 2019 (H.R.1332); Prescription Drug Pricing Reduction Act of 2019 (S. 2543); Competition Prescription Act of 2019 (H.R. 3947); Fixing Global Freeloading Act (H.R. 2209); Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 (HR 5133/HR 4398); STOP GAMES Act of 2019 (HR 2387);; H.R.3666 - STRONGER Patents Act of 2019, H.R.19 - Lower Costs, More Cures Act of 2019, Pharmaceutical Independence Long-Term Readiness Reform Act (HR 4710); H.R. 3991 - Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019; Purple Book Continuity Act of 2019 (H.R. 1520); Biologic Patent Transparency Act (S. 659); Conditional Approval Act (S. 3133); Fairness in Orphan Drug Exclusivity Act (H.R. 4712 / S. 3271); Orange Book Transparency Act of 2019 (H.R. 1503); Prescription Drug Affordability and Access Act (S. 3166); Biosimilars user fees legislation; Lowering Prescription Drug Prices for Americas Seniors and Families Act (S. 3384); Anticompetitive Exclusionary Conduct Prevention Act of 2020 (S. 3426); Second Look at Drug Patents Act of 2019 (S. 1617); Priority review vouchers; MODERN Labeling Act of 2020 (HR 5668); CARES Act (HR 748/S. 3548); Recall Unsafe Drugs Act of 2020 (HR 5578); Buy American Executive Order; Compulsory licensing; Strengthening Innovation in Medicare and Medicaid Act (H.R. 5741), No Ban Act (H.R. 2214/S. 1123); Benefit and Payment Parameters; Notice Requirement for Non-Federal Governmental Plans (85 Fed. Reg. 7088); Mitigating Emergency Drug Shortages Act (MEDS Act) (S. 2723); Medical Supply Chain Security Act (S. 3343); Strengthening America's Supply Chain and National Security Act (S. 3538) Families First Coronavirus Response Act (H.R. 6201), Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 (H.R. 6074), Drug recalls, registration and listing, shortages, and supply chain reporting; Strategic National Stockpile.
CONSUMER HEALTHCARE PRODUCTS ASSOCIATION via COVINGTON & BURLING LLP
2020 · first_quarter · Q1
Regulation of Nonprescription Drugs
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
CONSUMER HEALTHCARE PRODUCTS ASSOCIATION via COVINGTON & BURLING LLP
2019 · fourth_quarter · Q4
Regulation of Nonprescription Drugs
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
CONSUMER HEALTHCARE PRODUCTS ASSOCIATION via COVINGTON & BURLING LLP
2019 · third_quarter · Q3
Regulation of Nonprescription Drugs
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
CONSUMER HEALTHCARE PRODUCTS ASSOCIATION via COVINGTON & BURLING LLP
2019 · second_quarter · Q2
Regulation of Nonprescription Drugs
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
CONSUMER HEALTHCARE PRODUCTS ASSOCIATION via COVINGTON & BURLING LLP
2019 · first_quarter · Q1
Regulation of Nonprescription Drugs
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
CONSUMER HEALTHCARE PRODUCTS ASSOCIATION via COVINGTON & BURLING LLP
2018 · fourth_quarter · Q4
Regulation of Nonprescription Drugs
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
CONSUMER HEALTHCARE PRODUCTS ASSOCIATION via COVINGTON & BURLING LLP
2018 · third_quarter · Q3
Regulation of Nonprescription Drugs; S.2315 - Over-the-Counter Drug Safety, Innovation, and Reform Act
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2018 · third_quarter · Q3
Stop the Importation and Trafficking of Synthetic Analogues Act of 2017 (H.R. 2851/S. 1327); The Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now Act (i.e., the "SCREEN Act")(H.R. 5228); Opioid Crisis Response Act of 2018 (S. 2680); Expanding Access to Low Cost Generic Drugs Act (S. 2476); Preserve Access to Affordable Generics Act (S. 124); Regulatory exclusivity; Improving Access To Affordable Prescription Drugs Act (S. 771/H.R. 1776); Comprehensive Addiction Resources Emergency Act (CARE Act)(S. 2700/HR 5545); SOUND Disposal and Packaging Act (HR 5687); Long-Term Opioid Efficacy Act of 2018 (HR 5811); SAFETY Act of 2018 (H.R. 5803); Drug pricing; H.R. 5752, the Stop Illicit Drug Importation Act of 2018; proposed legislation regarding tableting and encapsulating opioid products; Drug Importation; CREATES Act (HR 2212/S. 974; 340B issues; SUPPORT for Patients and Communities Act (H.R. 6), Biosimilars Competition Act of 2018 (H.R. 6478), Patient Right to Know Drug Prices Act (S. 2554/H.R. 6143), Re-Valuing Anti-Microbial Products Act of 2018 (H.R. 6294), Medicare Negotiation and Competitive Licensing Act of 2018 (H.R. 6505), Making Objective Drug Evidence Revisions for New (MODERN) Labeling Act (S. 3519), citizen petitions
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2018 · second_quarter · Q2
Stop the Importation and Trafficking of Synthetic Analogues Act of 2017 (H.R. 2851/S. 1327); The Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now Act (i.e., the "SCREEN Act")(H.R. 5228); Opioid Crisis Response Act of 2018 (S. 2680); Expanding Access to Low Cost Generic Drugs Act (S. 2476); Preserve Access to Affordable Generics Act (S. 124); Regulatory exclusivity; Improving Access To Affordable Prescription Drugs Act (S. 771/H.R. 1776); Legislation on drug labeling; Comprehensive Addiction Resources Emergency Act (CARE Act)(S. 2700/HR 5545); SOUND Disposal and Packaging Act (HR 5687); Biologics patent settlements; Long-Term Opioid Efficacy Act of 2018 (HR 5811); SAFETY Act of 2018 (H.R. 5803); Insulin pricing; H.R. 5752, the Stop Illicit Drug Importation Act of 2018; proposed legislation regarding tableting and encapsulating opioid products; Drug Importation; Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act (HR 5247/S. 204; CREATES Act (HR 2212/S. 974)
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
CONSUMER HEALTHCARE PRODUCTS ASSOCIATION via COVINGTON & BURLING LLP
2018 · second_quarter · Q2
Regulation of Nonprescription Drugs; S.2315 - Over-the-Counter Drug Safety, Innovation, and Reform Act
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2018 · first_quarter · Q1
Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018 (H.R. 5247); Stop the Importation and Trafficking of Synthetic Analogues Act of 2017 (H.R. 2851/S. 1327); Fair Access for Safe and Timely (FAST) Generics Act (H.R. 2051) and CREATES Act (H.R. 2212/S. 974); Synthetic Drug Control Act of 2017 (H.R. 1732); Modernizing Drug Enforcement Act of 2018 (H.R. 5298) The Ensuring Patient Access to Substance Use Disorder Treatments Act of 2018 (H.R. 5202); The Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now Act (i.e., the "SCREEN Act")(H.R. 5228); Opioid Crisis Response Act of 2018; House opioids legislation discussion drafts on FDA Long-term Efficacy, FDA Misuse/Abuse, FDA Packaging and Disposal, FDA Accelerated Approval and Breakthrough Therapy Status, and FDA and International Mail; Drug importation; Expanding Access to Low Cost Generic Drugs Act (S. 2476); Preserve Access to Affordable Generics Act (S. 124); 180-day exclusivity; Over-the-Counter Drug Safety, Innovation, and Reform Act (S. 2315); Improving Access To Affordable Prescription Drugs Act (S. 771/H.R. 1776); Legislation on drug labeling.
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
CONSUMER HEALTHCARE PRODUCTS ASSOCIATION via COVINGTON & BURLING LLP
2018 · first_quarter · Q1
Regulation of Nonprescription Drugs
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2017 · fourth_quarter · Q4
Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 (S. 204); Stop the Importation and Trafficking of Synthetic Analogues Act of 2017 (H.R. 2851/S. 1327); Fair Access for Safe and Timely (FAST) Generics Act (H.R. 2051) and CREATES Act (H.R. 2212/S. 974); Synthetic Drug Control Act of 2017 (H.R. 1732); Pandemic All-Hazards Preparedness Reauthorization Act of 2017; Opioid scheduling not associated with any particular bill.
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
CONSUMER HEALTHCARE PRODUCTS ASSOCIATION via COVINGTON & BURLING LLP
2017 · fourth_quarter · Q4
Regulation of Nonprescription Drugs
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
CONSUMER HEALTHCARE PRODUCTS ASSOCIATION via COVINGTON & BURLING LLP
2017 · third_quarter · Q3
Regulation of Nonprescription Drugs
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2017 · second_quarter · Q2
Identify trade enforcement options; Develop model trade treaty text
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
CONSUMER HEALTHCARE PRODUCTS ASSOCIATION via COVINGTON & BURLING LLP
2017 · second_quarter · Q2
Regulation of Nonprescription Drugs
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2017 · first_quarter · Q1
Identify trade enforcement options; Develop model trade treaty text
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
CONSUMER HEALTHCARE PRODUCTS ASSOCIATION via COVINGTON & BURLING LLP
2017 · first_quarter · Q1
Regulation of Nonprescription Drugs
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2016 · fourth_quarter · Q4
CREATES Act (S.3056)
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
CONSUMER HEALTHCARE PRODUCTS ASSOCIATION via COVINGTON & BURLING LLP
2016 · fourth_quarter · Q4
Drug Legislation
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
CONSUMER HEALTHCARE PRODUCTS ASSOCIATION via COVINGTON & BURLING LLP
2016 · third_quarter · Q3
Drug Legislation
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2016 · second_quarter · Q2
Promoting Biomedical Research and Public Health for Patients Act
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
CONSUMER HEALTHCARE PRODUCTS ASSOCIATION via COVINGTON & BURLING LLP
2016 · second_quarter · Q2
Drug Legislation
Filing targets: HOUSE OF REPRESENTATIVES
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2016 · first_quarter · Q1
REGROW Act (H.R.4762); and Prescription Drug User Fee Act.
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
CONSUMER HEALTHCARE PRODUCTS ASSOCIATION via COVINGTON & BURLING LLP
2016 · first_quarter · Q1
Drug Legislation
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2015 · fourth_quarter · Q4
Drug Legislation Issues.
AMGEN INC via COVINGTON & BURLING LLP
2015 · fourth_quarter · Q4
Drug Legislation
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
CONSUMER HEALTHCARE PRODUCTS ASSOCIATION via COVINGTON & BURLING LLP
2015 · fourth_quarter · Q4
Drug Legislation
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2015 · third_quarter · Q3
Trade Secret Issues.
CONSUMER HEALTHCARE PRODUCTS ASSOCIATION via COVINGTON & BURLING LLP
2015 · fourth_quarter · RA
Drug Legislation
AMGEN INC via COVINGTON & BURLING LLP
2015 · second_quarter · Q2
Follow-On Biologics Drug import safety legislation Drug Legislation
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2015 · first_quarter · Q1
Drug Legislation Issues. Trade Secret Issues.
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2014 · third_quarter · Q3
Drug Legislation Issues Trade Secret Issues
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2014 · second_quarter · Q2
Drug Legislation Issues Trade Secret Issues
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2014 · first_quarter · Q1
Follow-On Biologics Drug Legislation Issues Biosimilars
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2013 · fourth_quarter · Q4
Follow-On Biologics Drug Legislation Issues Biosimilars
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2013 · third_quarter · Q3
Follow-On Biologics Drug Legislation Issues Biosimilars
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2013 · second_quarter · Q2
Follow-On Biologics Drug Legislation Issues
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2013 · first_quarter · Q1
Follow-On Biologics Drug Legislation Issues
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2012 · fourth_quarter · Q4
Follow-On Biologics Drug Legislation Issues
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2012 · third_quarter · Q3
Follow-On Biologics Drug Legislation Issues
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2012 · second_quarter · Q2
Follow-On Biologics Drug Legislation Issues
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2012 · first_quarter · Q1
Follow-On Biologics Drug Legislation Issues
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2011 · fourth_quarter · Q4
Follow-On Biologics Drug Legislation Issues
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
AMGEN INC via COVINGTON & BURLING LLP
2011 · fourth_quarter · Q4
Follow-on biologics
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2011 · third_quarter · Q3
Follow-On Biologics Drug Legislation Issues
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
JOHNSON & JOHNSON SERVICES INC via COVINGTON & BURLING LLP
2011 · third_quarter · Q3
Health Care Reform
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2011 · second_quarter · Q2
Follow-On Biologics Drug Legislation Issues
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2011 · first_quarter · Q1
Follow-On Biologics Drug Legislation Issues
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2010 · fourth_quarter · Q4
Follow-On Biologics Drug Legislation Issues
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
AMGEN INC via COVINGTON & BURLING LLP
2010 · third_quarter · Q3
Federal legislative policy matters; follow-on biologics
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2010 · third_quarter · Q3
Follow-On Biologics Drug Legislation Issues
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2010 · second_quarter · Q2
Follow-On Biologics Drug Legislation Issues
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2010 · first_quarter · Q1
Follow-On Biologics Drug Legislation Issues
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
AMGEN INC via COVINGTON & BURLING LLP
2009 · fourth_quarter · Q4
Follow-on Biologics
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
JOHNSON & JOHNSON SERVICES INC via COVINGTON & BURLING LLP
2009 · fourth_quarter · Q4
Follow-on biologics
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
GENZYME CORPORATION via COVINGTON & BURLING LLP
2009 · fourth_quarter · Q4
Follow-on biologics
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
BIOGEN IDEC via COVINGTON & BURLING LLP
2009 · fourth_quarter · Q4
Follow-on biologics
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
BIOTECHNOLOGY INNOVATION ORGANIZATION (FKA BIOTECHNOLOGY INDUSTRY ORGANIZATION) via COVINGTON & BURLING LLP
2009 · fourth_quarter · Q4
Follow-on Biologics
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
NOVO NORDISK INC via COVINGTON & BURLING LLP
2009 · fourth_quarter · Q4
Follow-on Biologics
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2009 · fourth_quarter · Q4
Follow-On Biologics Drug Legislation Issues
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2009 · third_quarter · Q3
Follow-On Biologics Drug Legislation Issues
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
JOHNSON & JOHNSON SERVICES INC via COVINGTON & BURLING LLP
2009 · third_quarter · Q3
Follow-on biologics
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
GENZYME CORPORATION via COVINGTON & BURLING LLP
2009 · third_quarter · Q3
Follow-on biologics
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
NOVO NORDISK INC via COVINGTON & BURLING LLP
2009 · third_quarter · Q3
Follow-on Biologics
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
BIOTECHNOLOGY INNOVATION ORGANIZATION (FKA BIOTECHNOLOGY INDUSTRY ORGANIZATION) via COVINGTON & BURLING LLP
2009 · third_quarter · Q3
Follow-on Biologics
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
BIOGEN IDEC via COVINGTON & BURLING LLP
2009 · third_quarter · Q3
Follow-on biologics
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
AMGEN INC via COVINGTON & BURLING LLP
2009 · third_quarter · Q3
Follow-on Biologics
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
GENZYME CORPORATION via COVINGTON & BURLING LLP
2009 · second_quarter · Q2
Follow-On Biologics
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
AMGEN INC via COVINGTON & BURLING LLP
2009 · second_quarter · Q2
Follow-On Biologics
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2009 · second_quarter · Q2
Follow-On Biologics Drug Legislation Issues
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
NOVO NORDISK INC via COVINGTON & BURLING LLP
2009 · second_quarter · Q2
Follow-on Biologics
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
JOHNSON & JOHNSON SERVICES INC via COVINGTON & BURLING LLP
2009 · second_quarter · Q2
Follow-On Biologics
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
BIOGEN IDEC via COVINGTON & BURLING LLP
2009 · second_quarter · Q2
Follow-On Biologics
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
BIOTECHNOLOGY INNOVATION ORGANIZATION (FKA BIOTECHNOLOGY INDUSTRY ORGANIZATION) via COVINGTON & BURLING LLP
2009 · second_quarter · Q2
Follow-on Biologics
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
AMGEN INC via COVINGTON & BURLING LLP
2009 · first_quarter · Q1
Follow-on Biologics
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
ABBOTT LABORATORIES via COVINGTON & BURLING LLP
2009 · first_quarter · Q1
Follow-on Biologics
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
BIOTECHNOLOGY INNOVATION ORGANIZATION (FKA BIOTECHNOLOGY INDUSTRY ORGANIZATION) via COVINGTON & BURLING LLP
2009 · first_quarter · Q1
Follow-on Biologics
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
GENZYME CORPORATION via COVINGTON & BURLING LLP
2009 · first_quarter · Q1
Follow-on Biologics
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
BIOGEN IDEC via COVINGTON & BURLING LLP
2009 · first_quarter · Q1
Follow-On Biologics
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
Filing targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
Filing targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)