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Income and expense are whole-filing amounts associated with this lobbyist, not personal compensation or an allocated share.
No topic inference: each bill number appears in source LDA issue text assigned to this lobbyist.
Destruction of Hazardous Imports Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Fast-tracking Approval for Innovative Rare disease therapies (FAIR) Act (H.R. 7953); Ensuring Timely Access to Generics Act of 2025 (S. 3014); Stop STALLING Act (S. 1095); Food & Drug Administration Fiscal Year 2027 Legislative Proposals; Agriculture, Rural Development, Food and Drug Administration, and Related Agency Appropriations Act, 2027 (H.R. 8646); Medication Affordability and Patent Integrity Act (S. 2658); Biosimilar Red Tape Elimination Act (S. 1954/H.R. 5526); Expedited Access to Biosimilars Act (S. 1414); Clinical trial regulation; Securing Essential Components for U.S. Readiness in Essential Pharmaceuticals (SECURE Rx) Act of 2026 (discussion draft); Securing Innovation and Research from Adversaries (discussion draft); amendments to the National Childhood Vaccine Injury Act of 1986 and the Vaccine Injury Compensation Program; Destruction of Hazardous Imports Act (H.R. 2715); potential amendments to drug country of origin labeling requirements (discussion draft).
ETHIC Act
Specific issues are shown only where the LDA source assigned them to this lobbyist. Targets apply to the associated filing.
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2026 · third_quarter · Q3
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program Proposed Rule, 91 Fed. Reg. 36236; Medication Affordability and Patent Integrity (MAPIA) Act (S. 2658); Skinny Labels, Big Savings Act (S. 43/H.R. 6485); Expedited Access to Biosimilars Act (S. 1414/ H.R.9661); Biosimilar Red Tape Elimination Act (S. 1954/H.R. 5526); Clinical trial regulation; Community Health Center Clinical Trial Grant Program discussion draft; Alex and Jacis Law discussion draft; Untitled discussion draft on clinical trial regulation (no bill number); Untitled discussion draft on generic drugs intended for use with a device (no bill number); Food & Drug Administration Fiscal Year 2027 Legislative Proposals (no bill number); Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act, (S.3788 / H.R.8269); draft legislation relating to potential improvements the National Childhood Vaccine Injury Act and the Vaccine Injury Compensation Program; American Biotechnology Act, Senate Amendment 6334 to S. 4784, National Defense Authorization Act (NDAA) for Fiscal Year 2027; CARES Act (P.L. 116-136) reporting issues.
Source: Senate LDA
Biosimilars Access and Affordability Act (S. 5459); Skinny Labels, Big Savings Act (S. 43/H.R. 6485); Eliminating Thickets to Increase Competition (ETHIC) Act (S. 2276/H.R. 3269); Expedited Access to Biosimilars Act (S. 1414); Biosimilar Red Tape Elimination Act (S. 1954/H.R. 5526); CLEAR Act (H.R.7140); Artificial Intelligence-Ready Data Act (S.4098); Preserve Access to Affordable Generics and Biosimilars Act (S. 1096); Drug Competition Enhancement Act (S.1040); America's Living Library Project Bill (S. 4023); Securing Essential Components for U.S. Readiness in Essential Pharmaceuticals (SECURE Rx) Act of 2026 (discussion draft); improvements to the National Childhood Vaccine Injury Act of 1986; Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act (S. 3788).
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.
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).
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.
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); 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.
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).
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
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Fast-tracking Approval for Innovative Rare disease therapies (FAIR) Act (H.R. 7953); Ensuring Timely Access to Generics Act of 2025 (S. 3014); Stop STALLING Act (S. 1095); Food & Drug Administration Fiscal Year 2027 Legislative Proposals; Agriculture, Rural Development, Food and Drug Administration, and Related Agency Appropriations Act, 2027 (H.R. 8646); Medication Affordability and Patent Integrity Act (S. 2658); Biosimilar Red Tape Elimination Act (S. 1954/H.R. 5526); Expedited Access to Biosimilars Act (S. 1414); Clinical trial regulation; Securing Essential Components for U.S. Readiness in Essential Pharmaceuticals (SECURE Rx) Act of 2026 (discussion draft); Securing Innovation and Research from Adversaries (discussion draft); amendments to the National Childhood Vaccine Injury Act of 1986 and the Vaccine Injury Compensation Program; Destruction of Hazardous Imports Act (H.R. 2715); potential amendments to drug country of origin labeling requirements (discussion draft).
Biosimilar Red Tape Elimination Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Biosimilars Access and Affordability Act (S. 5459); Skinny Labels, Big Savings Act (S. 43/H.R. 6485); Eliminating Thickets to Increase Competition (ETHIC) Act (S. 2276/H.R. 3269); Expedited Access to Biosimilars Act (S. 1414); Biosimilar Red Tape Elimination Act (S. 1954/H.R. 5526); CLEAR Act (H.R.7140); Artificial Intelligence-Ready Data Act (S.4098); Preserve Access to Affordable Generics and Biosimilars Act (S. 1096); Drug Competition Enhancement Act (S.1040); America's Living Library Project Bill (S. 4023); Securing Essential Components for U.S. Readiness in Essential Pharmaceuticals (SECURE Rx) Act of 2026 (discussion draft); improvements to the National Childhood Vaccine Injury Act of 1986; Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act (S. 3788).
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
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 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.
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).
FDA Modernization Act of 2021
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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).
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)
Affordable Prescriptions for Patients Through Promoting Competition Act of 2021
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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).
Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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).
United States Innovation and Competition Act of 2021
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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).
United States Innovation and Competition 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)
United States Innovation and Competition Act of 2021
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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).
Inflation Reduction Act of 2022
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)
Inflation Reduction Act of 2022
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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).
Inflation Reduction Act of 2022
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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).
ARPA–H Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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).
ARPA–H Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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).
ARPA–H Act
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)
Cures 2.0 Act
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)
Cures 2.0 Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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).
Data Transparency and Drug Safety Act of 2022
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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).
DEPICT Act
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)
DEPICT Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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).
DEPICT Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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).
Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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).
Accelerated Approval Integrity Act of 2022
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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).
Accelerated Approval Integrity Act of 2022
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)
Give Kids a Chance Act of 2022
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)
Give Kids a Chance Act of 2022
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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).
Accelerating Access for Patients Act of 2022
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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).
Accelerating Access for Patients Act of 2022
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)
Increasing Transparency in Generic Drug Applications Act of 2022
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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).
Increasing Transparency in Generic Drug Applications Act of 2022
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)
Biologics Market Transparency Act of 2022
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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).
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.
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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).
Food and Drug Amendments of 2022
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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).
Food and Drug Amendments of 2022
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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).
Affordable Prescriptions for Patients Act of 2021
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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).
Simplifying the Generic Drug Application Process Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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).
Simplifying the Generic Drug Application Process Act
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)
PREVENT Pandemics Act
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)
PREVENT Pandemics Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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).
Give Kids a Chance Act of 2022
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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).
FDASLA Act of 2022
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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).
FDASLA Act of 2022
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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).
Accelerated Approval Transparency Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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).
Interagency Patent Coordination and Improvement Act of 2022
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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).
Interagency Patent Coordination and Improvement Act of 2022
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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).
Modernizing the Accelerated Approval Pathway Act of 2022
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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).
FDASRA Act of 2022
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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).
Increasing Prescription Drug Competition Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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).
Protecting Consumer Access to Generic Drugs Act of 2021
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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.
Protecting Consumer Access to Generic Drugs Act of 2021
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Regulatory exclusivity; Drug pricing; Medicare Part B international reference pricing; Generic drug competition; Drug patent issues; Affordable Prescriptions for Patients Act of 2019 (S. 1416); Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 (H.R. 5133/H.R. 4398); H.R. 3991 - Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019; Executive Order 13944 (List of Essential Medicines, Medical Countermeasures, and Critical Inputs); Executive Order 14001 on a Sustainable Public Health Supply Chain; Compulsory licensing; Real world evidence; National Defense Authorization Act for Fiscal Year 2021 (S. 4049); S.Res.625 - A resolution encouraging the Government and the people of the United States to "Buy American"; Executive Order 13922; Executive Order 13911; Executive Order 13938; Domestic manufacturing incentives; Potential amendments to PREP Act; Bring Entrepreneurial Advancements To Consumers Here In North America Act (H.R. 6690); Bayh-Dole Act; Learnings from Pandemic; Safe Authorization for Vaccines during Emergencies Act (S.4427); Executive Order 13948 (Lowering Drug Prices by Putting America First); Advancing Americas Interests Act (H.R. 8037); Safeguarding American Innovation Act (S. 3997); Safe to Work Act (S. 4317); 340B drug discounts; Executive Order 13962 (Ensuring Access to United States Government COVID-19 Vaccines); antitrust reform proposals; Competition and Antitrust Law Enforcement Reform Act (S. 225); Pioneering Antimicrobial Subscriptions To End Up surging Resistance Act of 2020 (S. 4760/H.R. 8920); Lower Health Care Costs Act (S. 1895); Protecting Our Pharmaceutical Supply Chain from China Act of 2020 (H.R. 6482); Part D non-interference; Ensuring Innovation Act (S.1636); Return on Investment (ROI) Initiative for Unleashing American Innovation; 85 Fed. Reg. 76180; Suitability petitions; Securing America's Vaccines for Emergencies (SAVE) Act of 2020 (H.R. 6399/S. 3715); Pandemic Emergency Manufacturing Act of 2021 (S. 187); H.R.153 - Protecting Consumer Access to Generic Drugs Act of 2021; Lower Costs, More Cures Act (H.R. 19/ S. 3129); Fairness in Orphan Drug Exclusivity Act (S. 250/ H.R. 4712); S. 415 - A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity; S.164 - Advancing Education on Biosimilars Act of 2021; Preserve Access to Affordable Generics and Biosimilars Act (S. 64/HR 2375); Drug recalls; drug shortages; Elijah E. Cummings Lower Drug Costs Now Act (H.R. 3); Medicare reimbursement of prescription drugs; Unnamed bill regarding FDA demand reporting with respect to drugs.
Lower Costs, More Cures Act of 2021
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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.
Lower Costs, More Cures Act of 2021
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Regulatory exclusivity; Drug pricing; Medicare Part B international reference pricing; Generic drug competition; Drug patent issues; Affordable Prescriptions for Patients Act of 2019 (S. 1416); Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 (H.R. 5133/H.R. 4398); H.R. 3991 - Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019; Executive Order 13944 (List of Essential Medicines, Medical Countermeasures, and Critical Inputs); Executive Order 14001 on a Sustainable Public Health Supply Chain; Compulsory licensing; Real world evidence; National Defense Authorization Act for Fiscal Year 2021 (S. 4049); S.Res.625 - A resolution encouraging the Government and the people of the United States to "Buy American"; Executive Order 13922; Executive Order 13911; Executive Order 13938; Domestic manufacturing incentives; Potential amendments to PREP Act; Bring Entrepreneurial Advancements To Consumers Here In North America Act (H.R. 6690); Bayh-Dole Act; Learnings from Pandemic; Safe Authorization for Vaccines during Emergencies Act (S.4427); Executive Order 13948 (Lowering Drug Prices by Putting America First); Advancing Americas Interests Act (H.R. 8037); Safeguarding American Innovation Act (S. 3997); Safe to Work Act (S. 4317); 340B drug discounts; Executive Order 13962 (Ensuring Access to United States Government COVID-19 Vaccines); antitrust reform proposals; Competition and Antitrust Law Enforcement Reform Act (S. 225); Pioneering Antimicrobial Subscriptions To End Up surging Resistance Act of 2020 (S. 4760/H.R. 8920); Lower Health Care Costs Act (S. 1895); Protecting Our Pharmaceutical Supply Chain from China Act of 2020 (H.R. 6482); Part D non-interference; Ensuring Innovation Act (S.1636); Return on Investment (ROI) Initiative for Unleashing American Innovation; 85 Fed. Reg. 76180; Suitability petitions; Securing America's Vaccines for Emergencies (SAVE) Act of 2020 (H.R. 6399/S. 3715); Pandemic Emergency Manufacturing Act of 2021 (S. 187); H.R.153 - Protecting Consumer Access to Generic Drugs Act of 2021; Lower Costs, More Cures Act (H.R. 19/ S. 3129); Fairness in Orphan Drug Exclusivity Act (S. 250/ H.R. 4712); S. 415 - A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity; S.164 - Advancing Education on Biosimilars Act of 2021; Preserve Access to Affordable Generics and Biosimilars Act (S. 64/HR 2375); Drug recalls; drug shortages; Elijah E. Cummings Lower Drug Costs Now Act (H.R. 3); Medicare reimbursement of prescription drugs; Unnamed bill regarding FDA demand reporting with respect to drugs.
STOP Fentanyl Act of 2021
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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.
FDA Modernization Act of 2021
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Supply chain issues; Preserve Access to Affordable Generics and Biosimilars Act (S. 1428/ H.R. 2891); S. 1435, Affordable Prescriptions for Patients Act of 2021; H.R. 2884, Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act; H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021; H.R. 2883, Stop Stalling Access to Affordable Medications; S. 1425, Stop STALLING Act; Elijah E. Cummings Lower Drug Costs Now Act (H.R. 3); Build Back Better Act (H.R. 5376); Reduced Costs and Continued Cures Act (RCCCA) (H.R. 5260, H.R. 5237); drug pricing policy; Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act (S. 1209)/H.R. 3812); Give Kids a Chance Act (H.R. 5416); FDA Modernization Act of 2021 (H.R. 2565).
Endless Frontier Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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.
Affordable Prescriptions for Patients Through Promoting Competition Act of 2021
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Supply chain issues; Preserve Access to Affordable Generics and Biosimilars Act (S. 1428/ H.R. 2891); S. 1435, Affordable Prescriptions for Patients Act of 2021; H.R. 2884, Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act; H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021; H.R. 2883, Stop Stalling Access to Affordable Medications; S. 1425, Stop STALLING Act; Elijah E. Cummings Lower Drug Costs Now Act (H.R. 3); Build Back Better Act (H.R. 5376); Reduced Costs and Continued Cures Act (RCCCA) (H.R. 5260, H.R. 5237); drug pricing policy; Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act (S. 1209)/H.R. 3812); Give Kids a Chance Act (H.R. 5416); FDA Modernization Act of 2021 (H.R. 2565).
Affordable Prescriptions for Patients Through Promoting Competition Act of 2021
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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)
Affordable Prescriptions for Patients Through Promoting Competition Act of 2021
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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.
Stop Stalling Access to Affordable Medications
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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.
Stop Stalling Access to Affordable Medications
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Supply chain issues; Preserve Access to Affordable Generics and Biosimilars Act (S. 1428/ H.R. 2891); S. 1435, Affordable Prescriptions for Patients Act of 2021; H.R. 2884, Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act; H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021; H.R. 2883, Stop Stalling Access to Affordable Medications; S. 1425, Stop STALLING Act; Elijah E. Cummings Lower Drug Costs Now Act (H.R. 3); Build Back Better Act (H.R. 5376); Reduced Costs and Continued Cures Act (RCCCA) (H.R. 5260, H.R. 5237); drug pricing policy; Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act (S. 1209)/H.R. 3812); Give Kids a Chance Act (H.R. 5416); FDA Modernization Act of 2021 (H.R. 2565).
Stop Stalling Access to Affordable Medications
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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)
Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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.
Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Supply chain issues; Preserve Access to Affordable Generics and Biosimilars Act (S. 1428/ H.R. 2891); S. 1435, Affordable Prescriptions for Patients Act of 2021; H.R. 2884, Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act; H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021; H.R. 2883, Stop Stalling Access to Affordable Medications; S. 1425, Stop STALLING Act; Elijah E. Cummings Lower Drug Costs Now Act (H.R. 3); Build Back Better Act (H.R. 5376); Reduced Costs and Continued Cures Act (RCCCA) (H.R. 5260, H.R. 5237); drug pricing policy; Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act (S. 1209)/H.R. 3812); Give Kids a Chance Act (H.R. 5416); FDA Modernization Act of 2021 (H.R. 2565).
Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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)
Preserve Access to Affordable Generics and Biosimilars Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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)
Preserve Access to Affordable Generics and Biosimilars Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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.
Preserve Access to Affordable Generics and Biosimilars Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Supply chain issues; Preserve Access to Affordable Generics and Biosimilars Act (S. 1428/ H.R. 2891); S. 1435, Affordable Prescriptions for Patients Act of 2021; H.R. 2884, Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act; H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021; H.R. 2883, Stop Stalling Access to Affordable Medications; S. 1425, Stop STALLING Act; Elijah E. Cummings Lower Drug Costs Now Act (H.R. 3); Build Back Better Act (H.R. 5376); Reduced Costs and Continued Cures Act (RCCCA) (H.R. 5260, H.R. 5237); drug pricing policy; Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act (S. 1209)/H.R. 3812); Give Kids a Chance Act (H.R. 5416); FDA Modernization Act of 2021 (H.R. 2565).
Elijah E. Cummings Lower Drug Costs Now Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
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)
Elijah E. Cummings Lower Drug Costs Now Act
Client: PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · Firm: COVINGTON & BURLING LLP
Regulatory exclusivity; Drug pricing; Medicare Part B international reference pricing; Generic drug competition; Drug patent issues; Affordable Prescriptions for Patients Act of 2019 (S. 1416); Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 (H.R. 5133/H.R. 4398); H.R. 3991 - Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019; Executive Order 13944 (List of Essential Medicines, Medical Countermeasures, and Critical Inputs); Executive Order 14001 on a Sustainable Public Health Supply Chain; Compulsory licensing; Real world evidence; National Defense Authorization Act for Fiscal Year 2021 (S. 4049); S.Res.625 - A resolution encouraging the Government and the people of the United States to "Buy American"; Executive Order 13922; Executive Order 13911; Executive Order 13938; Domestic manufacturing incentives; Potential amendments to PREP Act; Bring Entrepreneurial Advancements To Consumers Here In North America Act (H.R. 6690); Bayh-Dole Act; Learnings from Pandemic; Safe Authorization for Vaccines during Emergencies Act (S.4427); Executive Order 13948 (Lowering Drug Prices by Putting America First); Advancing Americas Interests Act (H.R. 8037); Safeguarding American Innovation Act (S. 3997); Safe to Work Act (S. 4317); 340B drug discounts; Executive Order 13962 (Ensuring Access to United States Government COVID-19 Vaccines); antitrust reform proposals; Competition and Antitrust Law Enforcement Reform Act (S. 225); Pioneering Antimicrobial Subscriptions To End Up surging Resistance Act of 2020 (S. 4760/H.R. 8920); Lower Health Care Costs Act (S. 1895); Protecting Our Pharmaceutical Supply Chain from China Act of 2020 (H.R. 6482); Part D non-interference; Ensuring Innovation Act (S.1636); Return on Investment (ROI) Initiative for Unleashing American Innovation; 85 Fed. Reg. 76180; Suitability petitions; Securing America's Vaccines for Emergencies (SAVE) Act of 2020 (H.R. 6399/S. 3715); Pandemic Emergency Manufacturing Act of 2021 (S. 187); H.R.153 - Protecting Consumer Access to Generic Drugs Act of 2021; Lower Costs, More Cures Act (H.R. 19/ S. 3129); Fairness in Orphan Drug Exclusivity Act (S. 250/ H.R. 4712); S. 415 - A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity; S.164 - Advancing Education on Biosimilars Act of 2021; Preserve Access to Affordable Generics and Biosimilars Act (S. 64/HR 2375); Drug recalls; drug shortages; Elijah E. Cummings Lower Drug Costs Now Act (H.R. 3); Medicare reimbursement of prescription drugs; Unnamed bill regarding FDA demand reporting with respect to drugs.
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
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 · fourth_quarter · Q4
Supply chain issues; Preserve Access to Affordable Generics and Biosimilars Act (S. 1428/ H.R. 2891); S. 1435, Affordable Prescriptions for Patients Act of 2021; H.R. 2884, Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act; H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021; H.R. 2883, Stop Stalling Access to Affordable Medications; S. 1425, Stop STALLING Act; Elijah E. Cummings Lower Drug Costs Now Act (H.R. 3); Build Back Better Act (H.R. 5376); Reduced Costs and Continued Cures Act (RCCCA) (H.R. 5260, H.R. 5237); drug pricing policy; Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act (S. 1209)/H.R. 3812); Give Kids a Chance Act (H.R. 5416); FDA Modernization Act of 2021 (H.R. 2565).
Filing targets: HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), 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
2021 · first_quarter · Q1
Regulatory exclusivity; Drug pricing; Medicare Part B international reference pricing; Generic drug competition; Drug patent issues; Affordable Prescriptions for Patients Act of 2019 (S. 1416); Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 (H.R. 5133/H.R. 4398); H.R. 3991 - Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019; Executive Order 13944 (List of Essential Medicines, Medical Countermeasures, and Critical Inputs); Executive Order 14001 on a Sustainable Public Health Supply Chain; Compulsory licensing; Real world evidence; National Defense Authorization Act for Fiscal Year 2021 (S. 4049); S.Res.625 - A resolution encouraging the Government and the people of the United States to "Buy American"; Executive Order 13922; Executive Order 13911; Executive Order 13938; Domestic manufacturing incentives; Potential amendments to PREP Act; Bring Entrepreneurial Advancements To Consumers Here In North America Act (H.R. 6690); Bayh-Dole Act; Learnings from Pandemic; Safe Authorization for Vaccines during Emergencies Act (S.4427); Executive Order 13948 (Lowering Drug Prices by Putting America First); Advancing Americas Interests Act (H.R. 8037); Safeguarding American Innovation Act (S. 3997); Safe to Work Act (S. 4317); 340B drug discounts; Executive Order 13962 (Ensuring Access to United States Government COVID-19 Vaccines); antitrust reform proposals; Competition and Antitrust Law Enforcement Reform Act (S. 225); Pioneering Antimicrobial Subscriptions To End Up surging Resistance Act of 2020 (S. 4760/H.R. 8920); Lower Health Care Costs Act (S. 1895); Protecting Our Pharmaceutical Supply Chain from China Act of 2020 (H.R. 6482); Part D non-interference; Ensuring Innovation Act (S.1636); Return on Investment (ROI) Initiative for Unleashing American Innovation; 85 Fed. Reg. 76180; Suitability petitions; Securing America's Vaccines for Emergencies (SAVE) Act of 2020 (H.R. 6399/S. 3715); Pandemic Emergency Manufacturing Act of 2021 (S. 187); H.R.153 - Protecting Consumer Access to Generic Drugs Act of 2021; Lower Costs, More Cures Act (H.R. 19/ S. 3129); Fairness in Orphan Drug Exclusivity Act (S. 250/ H.R. 4712); S. 415 - A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity; S.164 - Advancing Education on Biosimilars Act of 2021; Preserve Access to Affordable Generics and Biosimilars Act (S. 64/HR 2375); Drug recalls; drug shortages; Elijah E. Cummings Lower Drug Costs Now Act (H.R. 3); Medicare reimbursement of prescription drugs; Unnamed bill regarding FDA demand reporting with respect to drugs.
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2020 · fourth_quarter · Q4
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); Compulsory licensing; Real world evidence; National Defense Authorization Act for Fiscal Year 2021 (S. 4049); S.Res.625 - A resolution encouraging the Government and the people of the United States to "Buy American"; Executive Order 13922; Executive Order 13911; Executive Order 13938; Domestic manufacturing incentives; Potential amendments to PREP Act; Bring Entrepreneurial Advancements To Consumers Here In North America Act (H.R. 6690); Bayh-Dole Act; Prescription Drug User Fee Act reauthorization; Learnings from Pandemic; Safe Authorization for Vaccines during Emergencies Act (S.4427); Executive Order 13948 (Lowering Drug Prices by Putting America First); Advancing Americas Interests Act (H.R. 8037); Safeguarding American Innovation Act (S. 3997); Safe to Work Act (S. 4317); 340B drug discounts; Executive Order 13962 (Ensuring Access to United States Government COVID-19 Vaccines); antitrust reform proposals; Pioneering Antimicrobial Subscriptions To End Up surging Resistance Act of 2020 (S. 4760/H.R. 8920); Lower Health Care Costs Act (S. 1895); Orange Book Transparency Act of 2020 (H.R. 1503); Purple Book Continuity Act of 2020 (H.R. 1520); Consolidated Appropriations Act, 2021 (H.R. 133); Protecting Our Pharmaceutical Supply Chain from China Act of 2020 (H.R. 6482); Part D non-interference; Ensuring Innovation Act (S.1636); Return on Investment (ROI) Initiative for Unleashing American Innovation; 85 Fed. Reg. 76180.
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.
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2020 · second_quarter · Q2
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; 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); Protecting Access to Biosimilars Act of 2019 (H.R.2011/S. 1140); Drug importation; State-Based, Market-Oriented, Prescription Drug Negotiations Act of 2019 (H.R. 2038); Transparent Drug Pricing Act of 2019 (S.977); Medicare Negotiation and Competitive Licensing Act of 2019 (H.R. 1046); 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); National Defense Authorization Act for Fiscal Year 2020 (S.1790); 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); 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); 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); Medical Supply Chain Security Act (S. 3343); Strengthening America's Supply Chain and National Security Act (S. 3538 / H.R.6393) Families First Coronavirus Response Act (H.R. 6201), Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 (H.R. 6074), Drug recalls, registration and listing, 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); Biosimilars user fee legislation; Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020 (HR 6260/S.3545); Make Medications Affordable by Preventing Pandemic Pricegouging Act of 2020 (H.R.7296); Strategic National Stockpile; Data Sharing; National Defense Authorization Act for Fiscal Year 2021 (HR 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 (HR 6399/S. 3715); Executive Order 13922; Executive Order 13911; Executive Order 13922; Domestic manufacturing incentives; Potential amendments to PREP Act; Bring Entrepreneurial Advancements To Consumers Here In North America Act (H.R. 6690); Protecting Americans with Preexisting Conditions Act of 2019 (H.R. 986); Bayh-Dole Act; TM Act of 2020 (S.3449 / HR 6196); Pharmaceutical Accountability, Responsibility, and Transparency Act (S.3781); Protecting Our Pharmaceutical Supply Chain from China Act of 2020 (S.3537)
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.
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2019 · fourth_quarter · Q4
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); CREATES Act of 2019 (HR 965/S. 340); 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); Protecting Access to Biosimilars Act of 2019 (H.R.2011/S. 1140); 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); Affordable Insulin Approvals Now Act (S. 2103); 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); National Defense Authorization Act for Fiscal Year 2020 (S.1790); Further Consolidated Appropriations Act, 2020 (H.R.1865); Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 (HR 5133); Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 (HR 4398); STOP GAMES Act of 2019 (HR 2387); H.R. 5198 - Patients' Right to Know Their Medication Act of 2019; 30-month stays; 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.
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2019 · 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); BLOCKING Act of 2019 (H.R. 938); Orange Book Transparency Act of 2019 (H.R. 1503); Purple Book Continuity Act of 2019 (H.R. 1520); CREATES Act of 2019 (HR 965/S. 340); Biologic Patent Transparency Act (S. 659); 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); A bill to establish a process for updating the labeling of certain drugs with outdated labeling (S.1897); Protecting Access to Biosimilars Act of 2019 (H.R.2011/S. 1140); TERM Act. (H.R. 3199); 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); Preserving Access to Cost Effective Drugs Act (S. 440); Affordable Insulin Approvals Now Act (S. 2103); 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); National Defense Authorization Act for Fiscal Year 2020 (S.1790); Patient drug labeling.
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2019 · second_quarter · 2A
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); BLOCKING Act of 2019 (H.R. 938); Orange Book Transparency Act of 2019 (H.R. 1503); Purple Book Continuity Act of 2019 (H.R. 1520); CREATES Act of 2019 (HR 965/S. 340); Biologic Patent Transparency Act (S. 659); 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); Reforming Evergreening and Manipulation that Extends Drug Years Act (S. 1209); Preserve Access to Affordable Generics and Biosimilars Act (H.R.2375); A bill to establish a process for updating the labeling of certain drugs with outdated labeling (S.1897); Protecting Access to Biosimilars Act of 2019 (H.R.2011/S. 1140); Second Look at Drug Patents Act of 2019 (S.1617); TERM Act. (H.R. 3199); 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 2017 (S. 2022); Medicare Negotiation and Competitive Licensing Act of 2019 (H.R. 1046).
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2019 · second_quarter · Q2
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); BLOCKING Act of 2019 (H.R. 938); Orange Book Transparency Act of 2019 (H.R. 1503); Purple Book Continuity Act of 2019 (H.R. 1520); CREATES Act of 2019 (HR 965/S. 340); Biologic Patent Transparency Act (S. 659); 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); Reforming Evergreening and Manipulation that Extends Drug Years Act (S. 1209); Preserve Access to Affordable Generics and Biosimilars Act (H.R.2375); A bill to establish a process for updating the labeling of certain drugs with outdated labeling (S.1897); Protecting Access to Biosimilars Act of 2019 (H.R.2011/S. 1140); Second Look at Drug Patents Act of 2019 (S.1617); TERM Act. (H.R. 3199); 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 2017 (S. 2022); Medicare Negotiation and Competitive Licensing Act of 2019 (H.R. 1046).
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2019 · first_quarter · Q1
Preserve Access to Affordable Generics Act (S. 64); Regulatory exclusivity; Drug pricing; citizen petitions; Medicare Part B international reference pricing; Protecting Consumer Access to Generic Drugs Act of 2019 (H.R. 1499); BLOCKING Act of 2019 (H.R. 938);Orange Book Transparency Act of 2019 (H.R. 1503); Purple Book Continuity Act of 2019 (H.R. 1520); CREATES Act of 2019 (HR 965/S. 340); Biologic Patent Transparency Act (S. 659); Generic drug competition; Drug patent issues; Competitive DRUGS Act of 2019 (HR 1344); FAIR Generics Act (HR 1506); Proposed rule on rebate safe harbor (84 Fed. Reg. 2340); PHAIR Pricing Act of 2019 (HR 1034); Accelerated Drug Approval for Prescription Therapies Act (ADAPT Act) (S.658).
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC via COVINGTON & BURLING LLP
2018 · fourth_quarter · Q4
Preserve Access to Affordable Generics Act (S. 124); Regulatory exclusivity; Improving Access To Affordable Prescription Drugs Act (S. 771/H.R. 1776); Drug pricing; 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); 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; Medicare Part B international reference pricing; Hatch-Waxman Integrity Act of 2018 (S. 3738/H.R. 7251); Affordable Drug Manufacturing Act of 2018 (H.R. 7348/S. 3775); Preserve Access to Affordable Generics and Biosimilars Act (S. 3792); Direct-to-consumer pharmaceutical advertising.
Filing targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)
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
Filing targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)
Filing targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
Filing targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)
Filing targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
Filing targets: HOUSE OF REPRESENTATIVES, SENATE