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Legislative Progress
Momentum (last 30 days)
0
score
0 actions · 0 new cosponsors · 0 votes
Speed vs cohort
78pct
28d open
vs 9,062 other HR bills in the 116th — cohort avg 39d
Competitive Deals Resulting in Unleashed Generics and Savings Act of 2019 or the Competitive DRUGS Act of 2019 This bill authorizes the Federal Trade Commission to initiate a proceeding against parties to an agreement resolving or settling a patent infringement claim in connection with the sale of a drug.Such an agreement is generally presumed to be an unfair method of competition and is a violation of this bill if the filer of the generic drug application receives something of value and agrees to limit or forgo research, development, manufacturing, marketing, or sales of the generic drug. However, an agreement is exempted if the only consideration granted to the generic manufacturer is (1) the right to market the generic drug prior to the expiration of any statutory exclusivity, (2) a payment for reasonable litigation expenses, or (3) a covenant not to sue on a claim that the generic drug infringes a patent. An agreement if also exempt if the agreement's pro-competitive benefits outweigh its anticompetitive effects. The bill establishes penalties for violations of the bill.
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Filing registrants (12)
Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.
Referred to the Subcommittee on Health.
Referred to the Committee on Ways and Means, and in addition to the Committees on Energy and Commerce, and the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Subcommittee on Health.
Introduced in House
Congress.gov source codes: 1000, Intro-H
Bills with similar content found using semantic analysis.
Sources: Congress.gov
2020 · third_quarter · Copyright/Patent/Trademark
H.R. 1499, Protecting Consumer Access to Generic Drugs Act, regarding all bio-pharmaceutical related provisions H.R. 965, Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 1344, Competitive DRUGS Act, regarding all bio-pharmaceutical related provisions. H.R. 2279/S. 2546, Safe Step Act of 2019, regarding all bio-pharmaceutical related provisions S. 64, Preserve Access to Affordable Generics and Biosimilars Act,regarding all bio-pharmaceutical related provisions. H.R.2375, Preserve Access to Affordable Generics and Biosimilars Act, regarding all bio-pharmaceutical related provisions H.R. 2387, STOP GAMES Act, regarding all bio-pharmaceutical related provisions H.R. 3199, TERM Act, regarding all bio-pharmaceutical related provisions S. 440, PACED Act, regarding all bio-pharmaceutical related provisions S. 1224/H.R.2374, Stop STALLING Act, regarding all bio-pharmaceutical related provisions S.1416, Affordable Prescriptions for Patients Act, regarding all bio-pharmaceutical related provisions S. 1617, Second Look at Drug Patents Act, regarding all bio-pharmaceutical related provisions
Client expense: $1,600,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)
2020 · second_quarter · Copyright/Patent/Trademark
H.R. 1499, Protecting Consumer Access to Generic Drugs Act, regarding all bio-pharmaceutical related provisions H.R. 965, Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 1344, Competitive DRUGS Act, regarding all bio-pharmaceutical related provisions. H.R. 2279/S. 2546, Safe Step Act of 2019, regarding all bio-pharmaceutical related provisions S. 64, Preserve Access to Affordable Generics and Biosimilars Act,regarding all bio-pharmaceutical related provisions. H.R.2375, Preserve Access to Affordable Generics and Biosimilars Act, regarding all bio-pharmaceutical related provisions H.R. 2387, STOP GAMES Act, regarding all bio-pharmaceutical related provisions H.R. 3199, TERM Act, regarding all bio-pharmaceutical related provisions S. 440, PACED Act, regarding all bio-pharmaceutical related provisions S. 1224/H.R.2374, Stop STALLING Act, regarding all bio-pharmaceutical related provisions S.1416, Affordable Prescriptions for Patients Act, regarding all bio-pharmaceutical related provisions S. 1617, Second Look at Drug Patents Act, regarding all bio-pharmaceutical related provisions
Client expense: $2,160,000 · Firm income: Not reported
2020 · fourth_quarter · Copyright/Patent/Trademark
H.R. 1499, Protecting Consumer Access to Generic Drugs Act, regarding all bio-pharmaceutical related provisions H.R. 965, Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 1344, Competitive DRUGS Act, regarding all bio-pharmaceutical related provisions. H.R. 2279/S. 2546, Safe Step Act of 2019, regarding all bio-pharmaceutical related provisions S. 64, Preserve Access to Affordable Generics and Biosimilars Act,regarding all bio-pharmaceutical related provisions. H.R.2375, Preserve Access to Affordable Generics and Biosimilars Act, regarding all bio-pharmaceutical related provisions H.R. 2387, STOP GAMES Act, regarding all bio-pharmaceutical related provisions H.R. 3199, TERM Act, regarding all bio-pharmaceutical related provisions S. 440, PACED Act, regarding all bio-pharmaceutical related provisions S. 1224/H.R.2374, Stop STALLING Act, regarding all bio-pharmaceutical related provisions S.1416, Affordable Prescriptions for Patients Act, regarding all bio-pharmaceutical related provisions S. 1617, Second Look at Drug Patents Act, regarding all bio-pharmaceutical related provisions H.R. 133, the Consolidated Appropriations Act of 2021, regarding all bio-pharmaceutical related provisions
Client expense: $1,090,000 · Firm income: Not reported
2020 · fourth_quarter · Health Issues
Monitor legislative and administrative action related to health care policy. Monitor legislative and administrative action related to drug importation, drug shortages, authorized genetics, and prescription drug advertising. Monitor legislative and administrative action related to womens health issues. Monitor legislative and administrative action related to over-the-counter consumer care products. Monitor legislative and administrative action related to dietary supplements. Monitor legislative and administrative action related to servicing of medical device equipment. Monitor legislative and administrative action related to FDA monograph reform and user fees. Monitor legislative and administrative action related to the switch of prescription medications to over-the-counter medications. Monitor legislative and administrative action related to drug pricing, including rulemakings at HHS. Monitor legislative and administrative action related to cosmetics reform legislation. Monitor legislative and administrative action related to drug take back and pseudoephedrine regulation. Monitor legislative and administrative action related to COVID-19, including drug supply chain issues. Monitor legislative and administrative action related to the Supplemental Nutrition Assistance Program (SNAP). Monitor legislative and administrative action related to the Rare Pediatric Disease Priority Review Voucher Program. Monitor legislative and administrative action related to implementation of P.L. 116-136, Coronavirus Aid, Relief, and Economic Security Act (CARES Act), including monograph reform and HSA/FSA provisions. H.R. 3, Lower Drug Costs Now Act of 2019. H.R. 863, DXM Abuse Prevention Act of 2019. H.R. 965, CREATES Act of 2019. H.R. 985, FAST Generics Act of 2019. H.R. 1344, Competitive DRUGS Act of 2019. H.R. 1503, Orange Book Transparency Act of 2019. H.R. 1520, Purple Book Continuity Act of 2019. S. 340, CREATES Act of 2019. S. 2543, Prescription Drug Pricing Reduction Act of 2019.
2020 · fourth_quarter · Health Issues
Legislation and proposals related to the COVID-19 crisis; HR 3199-Terminating the Extension of Rights Misappropriated Act of 2019; S.64-Preserve Access to Affordable Generic & Biosimilars Act; HR 1499-Protecting Consumer Access to Generic Drugs Act; HR 1344-Competitive Drugs Act of 2019; HR 938-Bringing Low Cost Options & Competition While Keeping Incentives for New Generics Act ("BLOCKING Act"); HR 1506-Fair & Immediate Release of Generic Drugs Act; HR 1520-Purple Book Continuity Act; HR 1503-Orange Book Transparency Act; S.344/HR 990-Hatch-Waxman Integrity Act; Stronger Patents Act; S.1895-Lower Health Care Costs Act; S. 2543-Prescription Drug Pricing Reduction Act; HR 3-Elijah E Cummings Lower Drug Costs Now Act; Administration review of drug pricing policies; Proposals to improve pharmaceutical supply-chain vlunterabilities; HR 4597-Acting to Cancel Copays & Ensure Substantial Savings for Biosimilars (ACCESS) Act; HR 4455-Bolstering Innovative Options to Save Immediately on Medicines (BIOSIMS) Act; HR 6179-Lowering Costs for Taxpayers & Medicare Seniors with Biosimilars; HR 4629-Star Ratings for Biosimilars Act.
Client expense: $610,000 · Firm income: Not reported
| Democratic |
| DC |
| Elijah E. Cummings | Democratic | MD |
| Grace F. Napolitano | Democratic | CA |
| Gwen Moore | Democratic | WI |
| James R. Langevin | Democratic | RI |
| John Garamendi | Democratic | CA |
| Judy Chu | Democratic | CA |
| Katie Hill | Democratic | CA |
| Katie Porter | Democratic | CA |
| Marcy Kaptur | Democratic | OH |
| Mark DeSaulnier | Democratic | CA |
| Mark Pocan | Democratic | WI |
| Matt Cartwright | Democratic | PA |
| Maxine Waters | Democratic | CA |
| Peter Welch | Democratic | VT |
| Raúl M. Grijalva | Democratic | AZ |
| Ro Khanna | Democratic | CA |
| Rosa L. DeLauro | Democratic | CT |
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)
Client expense: $1,370,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Bureau of Land Management (BLM), Commerce, Dept of (DOC), Council on Environmental Quality (CEQ), Environmental Protection Agency (EPA), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), Interior, Dept of (DOI), Natl Economic Council (NEC), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
Government targets: Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), SENATE, White House Office
2020 · fourth_quarter · Health Issues
Biosimilars, no specific bill Prescription drug value issues, no specific bill FDA issues, no specific bill S. 657 Drug Price Transparency Act S. 658 Accelerated Drug Approval for Prescription Therapies Act S. 660 Efficiency and Transparency in Petitions Act S. 1895, Lower Health Care Costs Act, a comprehensive bill designed to improve healthcare transparency and reduce healthcare costs, including prescription drugs H.R. 1499, Protecting Consumer Access Generic Drugs Act H.R. 1344, Competitive Deals Resulting in Unleashed Generics and Savings (DRUGS) Act S. 1169, Ensuring Timely Access to Generics Act S. 1617, Second Look at Drug Patents Act H.R. 1520, Purple Book Continuity Act S. 977, Transparent Drug Pricing Act S. 102, Prescription Drug Price Relief Act S. 659, Biologic Patent Transparency Act H.R. 1503, Orange Book Transparency Act H.R. 2296, Fair Accountability and Innovative Research (FAIR) Drug Pricing Act S. 1664, Prescription Drug Price Reporting Act S.659 - the Biologics Patent Transparency Act Supply Chain Issues, no specific bill
Client expense: $2,560,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, Treasury, Dept of
2020 · fourth_quarter · Copyright/Patent/Trademark
H.R. 1499, Protecting Consumer Access to Generic Drugs Act, regarding all bio-pharmaceutical related provisions H.R. 965, Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 1344, Competitive DRUGS Act, regarding all bio-pharmaceutical related provisions. H.R. 2279/S. 2546, Safe Step Act of 2019, regarding all bio-pharmaceutical related provisions S. 64, Preserve Access to Affordable Generics and Biosimilars Act,regarding all bio-pharmaceutical related provisions. H.R.2375, Preserve Access to Affordable Generics and Biosimilars Act, regarding all bio-pharmaceutical related provisions H.R. 2387, STOP GAMES Act, regarding all bio-pharmaceutical related provisions H.R. 3199, TERM Act, regarding all bio-pharmaceutical related provisions S. 440, PACED Act, regarding all bio-pharmaceutical related provisions S. 1224/H.R.2374, Stop STALLING Act, regarding all bio-pharmaceutical related provisions S.1416, Affordable Prescriptions for Patients Act, regarding all bio-pharmaceutical related provisions S. 1617, Second Look at Drug Patents Act, regarding all bio-pharmaceutical related provisions H.R. 133, the Consolidated Appropriations Act of 2021, regarding all bio-pharmaceutical related provisions
Client expense: $1,090,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)
2020 · third_quarter · Health Issues
Biosimilars, no specific bill Prescription drug value issues, no specific bill FDA issues, no specific bill Issues related to International Pricing Index (IPI), no specific bill S. 657 Drug Price Transparency Act S. 658 Accelerated Drug Approval for Prescription Therapies Act S. 660 Efficiency and Transparency in Petitions Act S. 1895, Lower Health Care Costs Act, a comprehensive bill designed to improve healthcare transparency and reduce healthcare costs, including prescription drugs H.R. 1499, Protecting Consumer Access Generic Drugs Act H.R. 1344, Competitive Deals Resulting in Unleashed Generics and Savings (DRUGS) Act S. 1169, Ensuring Timely Access to Generics Act S. 1617, Second Look at Drug Patents Act H.R. 1520, Purple Book Continuity Act S. 977, Transparent Drug Pricing Act S. 102, Prescription Drug Price Relief Act S. 659, Biologic Patent Transparency Act H.R. 1503, Orange Book Transparency Act H.R. 2296, Fair Accountability and Innovative Research (FAIR) Drug Pricing Act S. 1664, Prescription Drug Price Reporting Act S.659 - the Biologics Patent Transparency Act Supply Chain Issues, no specific bill
Client expense: $2,920,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), SENATE
2020 · third_quarter · Health Issues
Monitor legislative and administrative action related to health care policy. Monitor legislative and administrative action related to drug importation, drug shortages, authorized genetics, and prescription drug advertising. Monitor legislative and administrative action related to womens health issues. Monitor legislative and administrative action related to over-the-counter consumer care products. Monitor legislative and administrative action related to dietary supplements. Monitor legislative and administrative action related to servicing of medical device equipment. Monitor legislative and administrative action related to FDA monograph reform and user fees. Monitor legislative and administrative action related to the switch of prescription medications to over-the-counter medications. Monitor legislative and administrative action related to drug pricing, including rulemakings at HHS. Monitor legislative and administrative action related to cosmetics reform legislation. Monitor legislative and administrative action related to drug take back and pseudoephedrine regulation. Monitor legislative and administrative action related to COVID-19, including drug supply chain issues. Monitor legislative and administrative action related to the Supplemental Nutrition Assistance Program (SNAP). Monitor legislative and administrative action related to the Rare Pediatric Disease Priority Review Voucher Program. Monitor legislative and administrative action related to implementation of P.L. 116-136, Coronavirus Aid, Relief, and Economic Security Act (CARES Act), including monograph reform and HSA/FSA provisions. H.R. 3, Lower Drug Costs Now Act of 2019. H.R. 863, DXM Abuse Prevention Act of 2019. H.R. 965, CREATES Act of 2019. H.R. 985, FAST Generics Act of 2019. H.R. 1344, Competitive DRUGS Act of 2019. H.R. 1503, Orange Book Transparency Act of 2019. H.R. 1520, Purple Book Continuity Act of 2019. S. 340, CREATES Act of 2019. S. 2543, Prescription Drug Pricing Reduction Act of 2019.
Client expense: $1,430,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Bureau of Land Management (BLM), Commerce, Dept of (DOC), Council on Environmental Quality (CEQ), Environmental Protection Agency (EPA), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), Interior, Dept of (DOI), Natl Economic Council (NEC), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
2020 · third_quarter · Copyright/Patent/Trademark
H.R. 1499, Protecting Consumer Access to Generic Drugs Act, regarding all bio-pharmaceutical related provisions H.R. 965, Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 1344, Competitive DRUGS Act, regarding all bio-pharmaceutical related provisions. H.R. 2279/S. 2546, Safe Step Act of 2019, regarding all bio-pharmaceutical related provisions S. 64, Preserve Access to Affordable Generics and Biosimilars Act,regarding all bio-pharmaceutical related provisions. H.R.2375, Preserve Access to Affordable Generics and Biosimilars Act, regarding all bio-pharmaceutical related provisions H.R. 2387, STOP GAMES Act, regarding all bio-pharmaceutical related provisions H.R. 3199, TERM Act, regarding all bio-pharmaceutical related provisions S. 440, PACED Act, regarding all bio-pharmaceutical related provisions S. 1224/H.R.2374, Stop STALLING Act, regarding all bio-pharmaceutical related provisions S.1416, Affordable Prescriptions for Patients Act, regarding all bio-pharmaceutical related provisions S. 1617, Second Look at Drug Patents Act, regarding all bio-pharmaceutical related provisions
Client expense: $1,600,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)
2020 · third_quarter · Health Issues
Legislation and proposals related to the COVID-19 crisis; HR 3199-Terminating the Extension of Rights Misappropriated Act of 2019; S.64-Preserve Access to Affordable Generic & Biosimilars Act; HR 1499-Protecting Consumer Access to Generic Drugs Act; HR 1344-Competitive Drugs Act of 2019; HR 938-Bringing Low Cost Options & Competition While Keeping Incentives for New Generics Act ("BLOCKING Act"); HR 1506-Fair & Immediate Release of Generic Drugs Act; HR 1520-Purple Book Continuity Act; HR 1503-Orange Book Transparency Act; S.344/HR 990-Hatch-Waxman Integrity Act; Stronger Patents Act; S.1895-Lower Health Care Costs Act; S. 2543-Prescription Drug Pricing Reduction Act; HR 3-Elijah E Cummings Lower Drug Costs Now Act; Administration review of drug pricing policies; Proposals to improve pharmaceutical supply-chain vlunterabilities; HR 4597-Acting to Cancel Copays & Ensure Substantial Savings for Biosimilars (ACCESS) Act; HR 4455-Bolstering Innovative Options to Save Immediately on Medicines (BIOSIMS) Act; HR 6179-Lowering Costs for Taxpayers & Medicare Seniors with Biosimilars; HR 4629-Star Ratings for Biosimilars Act.
Client expense: $500,000 · Firm income: Not reported
Government targets: Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), SENATE, White House Office
2020 · second_quarter · Health Issues
Biosimilars, no specific bill Prescription drug value issues, no specific bill FDA issues, no specific bill Issues related to International Pricing Index (IPI), no specific bill S. 657 Drug Price Transparency Act S. 658 Accelerated Drug Approval for Prescription Therapies Act S. 660 Efficiency and Transparency in Petitions Act S. 1895, Lower Health Care Costs Act, a comprehensive bill designed to improve healthcare transparency and reduce healthcare costs, including prescription drugs H.R. 1499, Protecting Consumer Access Generic Drugs Act H.R. 1344, Competitive Deals Resulting in Unleashed Generics and Savings (DRUGS) Act S. 1169, Ensuring Timely Access to Generics Act S. 1617, Second Look at Drug Patents Act H.R. 1520, Purple Book Continuity Act S. 977, Transparent Drug Pricing Act S. 102, Prescription Drug Price Relief Act S. 659, Biologic Patent Transparency Act H.R. 1503, Orange Book Transparency Act H.R. 2296, Fair Accountability and Innovative Research (FAIR) Drug Pricing Act S. 1664, Prescription Drug Price Reporting Act S.659 - the Biologics Patent Transparency Act Supply Chain Issues, no specific bill
Client expense: $2,970,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), SENATE
2020 · second_quarter · Health Issues
Monitor legislative and administrative action related to health care policy. Monitor legislative and administrative action related to drug importation, drug shortages, authorized genetics, and prescription drug advertising. Monitor legislative and administrative action related to womens health issues. Monitor legislative and administrative action related to over-the-counter consumer care products. Monitor legislative and administrative action related to dietary supplements. Monitor legislative and administrative action related to servicing of medical device equipment. Monitor legislative and administrative action related to FDA monograph reform and user fees. Monitor legislative and administrative action related to the switch of prescription medications to over-the-counter medications. Monitor legislative and administrative action related to drug pricing, including rulemakings at HHS. Monitor legislative and administrative action related to cosmetics reform legislation. Monitor legislative and administrative action related to drug take back and pseudoephedrine regulation. Monitor legislative and administrative action related to COVID-19, including drug supply chain issues. Monitor legislative and administrative action related to the Supplemental Nutrition Assistance Program (SNAP). Monitor legislative and administrative action related to implementation of P.L. 116-136, Coronavirus Aid, Relief, and Economic Security Act (CARES Act), including monograph reform and HASA/FSA provisions. H.R. 3, Lower Drug Costs Now Act of 2019. H.R. 863, DXM Abuse Prevention Act of 2019. H.R. 965, CREATES Act of 2019. H.R. 985, FAST Generics Act of 2019. H.R. 1344, Competitive DRUGS Act of 2019. H.R. 1503, Orange Book Transparency Act of 2019. H.R. 1520, Purple Book Continuity Act of 2019. S. 340, CREATES Act of 2019. S. 2543, Prescription Drug Pricing Reduction Act of 2019.
Client expense: $1,750,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Bureau of Land Management (BLM), Commerce, Dept of (DOC), Council on Environmental Quality (CEQ), Environmental Protection Agency (EPA), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), Interior, Dept of (DOI), Natl Economic Council (NEC), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
2020 · second_quarter · Copyright/Patent/Trademark
H.R. 1499, Protecting Consumer Access to Generic Drugs Act, regarding all bio-pharmaceutical related provisions H.R. 965, Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 1344, Competitive DRUGS Act, regarding all bio-pharmaceutical related provisions. H.R. 2279/S. 2546, Safe Step Act of 2019, regarding all bio-pharmaceutical related provisions S. 64, Preserve Access to Affordable Generics and Biosimilars Act,regarding all bio-pharmaceutical related provisions. H.R.2375, Preserve Access to Affordable Generics and Biosimilars Act, regarding all bio-pharmaceutical related provisions H.R. 2387, STOP GAMES Act, regarding all bio-pharmaceutical related provisions H.R. 3199, TERM Act, regarding all bio-pharmaceutical related provisions S. 440, PACED Act, regarding all bio-pharmaceutical related provisions S. 1224/H.R.2374, Stop STALLING Act, regarding all bio-pharmaceutical related provisions S.1416, Affordable Prescriptions for Patients Act, regarding all bio-pharmaceutical related provisions S. 1617, Second Look at Drug Patents Act, regarding all bio-pharmaceutical related provisions
Client expense: $2,160,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)
2020 · second_quarter · Health Issues
Legislation and proposals related to the COVID-19 crisis; HR 3199-Terminating the Extension of Rights Misappropriated Act of 2019; S.64-Preserve Access to Affordable Generic & Biosimilars Act; HR 1499-Protecting Consumer Access to Generic Drugs Act; HR 1344-Competitive Drugs Act of 2019; HR 938-Bringing Low Cost Options & Competition While Keeping Incentives for New Generics Act ("BLOCKING Act"); HR 1506-Fair & Immediate Release of Generic Drugs Act; HR 1520-Purple Book Continuity Act; HR 1503-Orange Book Transparency Act; S.344/HR 990-Hatch-Waxman Integrity Act; Stronger Patents Act; S.1895-Lower Health Care Costs Act; S. 2543-Prescription Drug Pricing Reduction Act; HR 3-Elijah E Cummings Lower Drug Costs Now Act; Administration review of drug pricing policies; Proposals to improve pharmaceutical supply-chain vlunterabilities; HR 4597-Acting to Cancel Copays & Ensure Substantial Savings for Biosimilars (ACCESS) Act; HR 4455-Bolstering Innovative Options to Save Immediately on Medicines (BIOSIMS) Act; HR 6179-Lowering Costs for Taxpayers & Medicare Seniors with Biosimilars; HR 4629-Star Ratings for Biosimilars Act.
Client expense: $580,000 · Firm income: Not reported
Government targets: Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), SENATE, State, Dept of (DOS), White House Office
2020 · first_quarter · Copyright/Patent/Trademark
H.R. 938: BLOCKING Act of 2019 - Provisions related to 180 day generic prescription drug exclusivity H.R. 987: Strengthening Health Care and Lowering Prescription Drug Costs Act - Provisions related to prescription drug pricing, patent settlements, and other issues H.R. 1344: Competitive Deals Resulting in Unleashed Generics and Savings Act of 2019 - Provisions related to patent settlements H.R. 1499: Protecting Consumer Access to Generic Drugs Act of 2019 - Provisions related to patent settlements H.R. 1503: Orange Book Transparency Act - Provisions related to prescription drug and device patent listings H.R. 1520: Purple Book Continuity Act of 2019 - Provisions related to prescription drug patent listings H.R. 2374: Stop STALLING Act - Provisions related to citizen petitions H.R. 2375: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements H.R. 2387: STOP GAMES Act of 2019 - Provisions related to citizen petitions H.R. 2455: Ensuring Timely Access to Generics Act of 2019 - Provisions related to citizen petitions H.R. 2700: Lowering Prescription Drug Costs and Extending Community Health Centers and Other Public Health Priorities Act - Provisions related to patent settlements, generic exclusivity, Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 3666: STRONGER Patents Act of 2019 - Provisions related to prescription drug patents H.R. 4712: Fairness in Orphan Drug Exclusivity Act - Provisions related to prescription drug exclusivity periods H.R. 4850: Biologic Patent Transparency Act - Provisions related to prescription drug patent disclosures H.R. 5133: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 - Provisions related to prescription drug exclusivity periods and manufacturer behavior H.R. 6196: Trademark Modernization Act of 2020 - Provisions related to trademarks S. 64: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 102: Prescription Drug Price Relief Act of 2019 - Provisions related to foreign reference pricing, patents and march-in rights S. 1209: Reforming Evergreening and Manipulation that Extends Drug Years Act - Provisions related to prescription drug patents S. 1224: Stop STALLING Act - Provisions related to citizen petitions S. 1416: Affordable Prescriptions for Patients Act of 2019 - Provisions related to prescription drug patents S. 1617: Second Look at Drug Patents Act of 2019 - Provisions related to prescription drug patents S. 3449: Trademark Modernization Act of 2020 - Provisions related to trademarks Biopharmaceutical innovation and patent policy issues Trademark legislative proposals Bayh-Dole march-in rights policy issues
Client expense: $940,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
2020 · first_quarter · Health Issues
Monitor legislative and administrative action related to health care policy. Monitor legislative and administrative action related to drug importation, drug shortages, authorized genetics, and prescription drug advertising. Monitor legislative and administrative action related to womens health issues. Monitor legislative and administrative action related to over-the-counter consumer care products. Monitor legislative and administrative action related to dietary supplements. Monitor legislative and administrative action related to servicing of medical device equipment. Monitor legislative and administrative action related to FDA monograph reform and user fees. Monitor legislative and administrative action related to the switch of prescription medications to over-the-counter medications. Monitor legislative and administrative action related to drug pricing, including rulemakings at HHS. Monitor legislative and administrative action related to cosmetics reform legislation. Monitor legislative and administrative action related to drug take back and pseudoephedrine regulation. Monitor legislative and administrative action related to COVID-19, including drug supply chain issues. H.R. 3, Lower Drug Costs Now Act of 2019. H.R. 748, Coronavirus Aid, Relief, and Economic Security Act (CARES Act), including monograph reform and HAS/FSA provisions. H.R. 863, DXM Abuse Prevention Act of 2019. H.R. 965, CREATES Act of 2019. H.R. 985, FAST Generics Act of 2019. H.R. 1344, Competitive DRUGS Act of 2019. H.R. 1503, Orange Book Transparency Act of 2019. H.R. 1520, Purple Book Continuity Act of 2019. S. 340, CREATES Act of 2019. S. 2543, Prescription Drug Pricing Reduction Act of 2019.
Client expense: $1,960,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Bureau of Land Management (BLM), Commerce, Dept of (DOC), Council on Environmental Quality (CEQ), Environmental Protection Agency (EPA), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Interior, Dept of (DOI), Natl Economic Council (NEC), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, Small Business Administration (SBA), State, Dept of (DOS), Treasury, Dept of, U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)
2020 · first_quarter · Health Issues
Biosimilars, no specific bill Prescription drug value issues, no specific bill FDA issues, no specific bill Issues related to International Pricing Index (IPI), no specific bill S. 657 Drug Price Transparency Act S. 658 Accelerated Drug Approval for Prescription Therapies Act S. 660 Efficiency and Transparency in Petitions Act S. 1895, Lower Health Care Costs Act, a comprehensive bill designed to improve healthcare transparency and reduce healthcare costs, including prescription drugs H.R. 1499, Protecting Consumer Access Generic Drugs Act H.R. 1344, Competitive Deals Resulting in Unleashed Generics and Savings (DRUGS) Act S. 1169, Ensuring Timely Access to Generics Act S. 1617, Second Look at Drug Patents Act H.R. 1520, Purple Book Continuity Act S. 977, Transparent Drug Pricing Act S. 102, Prescription Drug Price Relief Act S. 659, Biologic Patent Transparency Act H.R. 1503, Orange Book Transparency Act H.R. 2296, Fair Accountability and Innovative Research (FAIR) Drug Pricing Act S. 1664, Prescription Drug Price Reporting Act S.659 - the Biologics Patent Transparency Act Supply Chain Issues, no specific bill
Client expense: $2,700,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), SENATE
2020 · first_quarter · Copyright/Patent/Trademark
H.R. 938: BLOCKING Act of 2019 - Provisions related to 180 day generic prescription drug exclusivity H.R. 987: Strengthening Health Care and Lowering Prescription Drug Costs Act - Provisions related to prescription drug pricing, patent settlements, and other issues H.R. 1344: Competitive Deals Resulting in Unleashed Generics and Savings Act of 2019 - Provisions related to patent settlements H.R. 1499: Protecting Consumer Access to Generic Drugs Act of 2019 - Provisions related to patent settlements H.R. 1503: Orange Book Transparency Act - Provisions related to prescription drug and device patent listings H.R. 1520: Purple Book Continuity Act of 2019 - Provisions related to prescription drug patent listings H.R. 2374: Stop STALLING Act - Provisions related to citizen petitions H.R. 2375: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements H.R. 2387: STOP GAMES Act of 2019 - Provisions related to citizen petitions H.R. 2455: Ensuring Timely Access to Generics Act of 2019 - Provisions related to citizen petitions H.R. 2700: Lowering Prescription Drug Costs and Extending Community Health Centers and Other Public Health Priorities Act - Provisions related to patent settlements, generic exclusivity, Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 3666: STRONGER Patents Act of 2019 - Provisions related to prescription drug patents H.R. 4712: Fairness in Orphan Drug Exclusivity Act - Provisions related to prescription drug exclusivity periods H.R. 4850: Biologic Patent Transparency Act - Provisions related to prescription drug patent disclosures H.R. 5133: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 - Provisions related to prescription drug exclusivity periods and manufacturer behavior H.R. 6196: Trademark Modernization Act of 2020 - Provisions related to trademarks S. 64: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 102: Prescription Drug Price Relief Act of 2019 - Provisions related to foreign reference pricing, patents and march-in rights S. 1209: Reforming Evergreening and Manipulation that Extends Drug Years Act - Provisions related to prescription drug patents S. 1224: Stop STALLING Act - Provisions related to citizen petitions S. 1416: Affordable Prescriptions for Patients Act of 2019 - Provisions related to prescription drug patents S. 1617: Second Look at Drug Patents Act of 2019 - Provisions related to prescription drug patents S. 3449: Trademark Modernization Act of 2020 - Provisions related to trademarks Biopharmaceutical innovation and patent policy issues Trademark legislative proposals Bayh-Dole march-in rights policy issues
Client expense: $9,020,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)
2020 · first_quarter · Health Issues
Monitor legislative and administrative action related to health care policy. Monitor legislative and administrative action related to drug importation, drug shortages, authorized genetics, and prescription drug advertising. Monitor legislative and administrative action related to womens health issues. Monitor legislative and administrative action related to over-the-counter consumer care products. Monitor legislative and administrative action related to dietary supplements. Monitor legislative and administrative action related to servicing of medical device equipment. Monitor legislative and administrative action related to FDA monograph reform and user fees. Monitor legislative and administrative action related to the switch of prescription medications to over-the-counter medications. Monitor legislative and administrative action related to drug pricing, including rulemakings at HHS. Monitor legislative and administrative action related to cosmetics reform legislation. Monitor legislative and administrative action related to drug take back and pseudoephedrine regulation. Monitor legislative and administrative action related to COVID-19, including drug supply chain issues. H.R. 3, Lower Drug Costs Now Act of 2019. H.R. 748, Coronavirus Aid, Relief, and Economic Security Act (CARES Act), including monograph reform and HAS/FSA provisions. H.R. 863, DXM Abuse Prevention Act of 2019. H.R. 965, CREATES Act of 2019. H.R. 985, FAST Generics Act of 2019. H.R. 1344, Competitive DRUGS Act of 2019. H.R. 1503, Orange Book Transparency Act of 2019. H.R. 1520, Purple Book Continuity Act of 2019. S. 340, CREATES Act of 2019. S. 2543, Prescription Drug Pricing Reduction Act of 2019.
Client expense: $1,890,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Bureau of Land Management (BLM), Commerce, Dept of (DOC), Council on Environmental Quality (CEQ), Environmental Protection Agency (EPA), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Interior, Dept of (DOI), Natl Economic Council (NEC), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, Small Business Administration (SBA), State, Dept of (DOS), Treasury, Dept of, U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)
2020 · first_quarter · Health Issues
Coronavirus Aid, Relief & Economic Stability Act (CARES Act) and other legislative proposals related to the COVID-19 crisis; HR 3199-Terminating the Extension of Rights Misappropriated Act of 2019; S.64-Preserve Access to Affordable Generic & Biosimilars Act; HR 1499-Protecting Consumer Access to Generic Drugs Act; HR 1344-Competitive Drugs Act of 2019; HR 938-Bringing Low Cost Options & Competition While Keeping Incentives for New Generics Act ("BLOCKING Act"); HR 1506-Fair & Immediate Release of Generic Drugs Act; HR 1520-Purple Book Continuity Act; HR 1503-Orange Book Transparency Act; S.344/HR 990-Hatch-Waxman Integrity Act; Stronger Patents Act; S.1895-Lower Health Care Costs Act; S. 2543-Prescription Drug Pricing Reduction Act; HR 3-Elijah E Cummings Lower Drug Costs Now Act; and Administration review of drug pricing policies.
Client expense: $430,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, State, Dept of (DOS), White House Office
2020 · first_quarter · Copyright/Patent/Trademark
H.R. 1499, Protecting Consumer Access to Generic Drugs Act, regarding all bio-pharmaceutical related provisions H.R. 965, Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 1344, Competitive DRUGS Act, regarding all bio-pharmaceutical related provisions. H.R. 2279/S. 2546, Safe Step Act of 2019, regarding all bio-pharmaceutical related provisions S. 64, Preserve Access to Affordable Generics and Biosimilars Act,regarding all bio-pharmaceutical related provisions. H.R.2375, Preserve Access to Affordable Generics and Biosimilars Act, regarding all bio-pharmaceutical related provisions H.R. 2387, STOP GAMES Act, regarding all bio-pharmaceutical related provisions H.R. 3199, TERM Act, regarding all bio-pharmaceutical related provisions S. 440, PACED Act, regarding all bio-pharmaceutical related provisions S. 1224/H.R.2374, Stop STALLING Act, regarding all bio-pharmaceutical related provisions S.1416, Affordable Prescriptions for Patients Act, regarding all bio-pharmaceutical related provisions S. 1617, Second Look at Drug Patents Act, regarding all bio-pharmaceutical related provisions
Client expense: $540,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)
2019 · second_quarter · Health Issues
Biosimilars, no specific bill Prescription drug value issues, no specific bill S. 469 Affordable and Safe Prescription Drug Importation Act H.R. 1245 Affordable and Safe Prescription Drug Importation Act 340B Protecting Access for the Underserved and Safety-Net Entities (340B PAUSE Act). FDA issues, no specific bill S.3158 Labor, Health and Human Services Appropriations Act (Senate Report 115-289) Issues related to International Pricing Index (IPI), no specific bill S. 551 Recovering Excessive Funds for Unused and Needless Drugs Act S. 657 Drug Price Transparency Act S. 658 Accelerated Drug Approval for Prescription Therapies Act S. 660 Efficiency and Transparency in Petitions Act S. 1895, Lower Health Care Costs Act (S. 1895), a comprehensive bill designed to improve healthcare transparency and reduce healthcare costs, including prescription drugs S. 1391, Fair Accountability and Innovative Research (FAIR) Drug Pricing Act (S. 1391) H.R. 1499, Protecting Consumer Access Generic Drugs Act H.R. 1344, Competitive Deals Resulting in Unleashed Generics and Savings (DRUGS) Act S. 1169, Ensuring Timely Access to Generics Act S. 1617, Second Look at Drug Patents Act H.R. 1520, Purple Book Continuity Act S. 1209, Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act S. 977, Transparent Drug Pricing Act S. 102, Prescription Drug Price Relief Act S. 637, Combatting Unreasonable Rises and Excessively (CURE) High Drug Prices Act S. 659, Biologic Patent Transparency Act H.R. 1503, Orange Book Transparency Act H.R. 2296, Fair Accountability and Innovative Research (FAIR) Drug Pricing Act S. 1664, Prescription Drug Price Reporting Act
Client expense: $2,200,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
2019 · fourth_quarter · Health Issues
Biosimilars, no specific bill Prescription drug value issues, no specific bill FDA issues, no specific bill Issues related to International Pricing Index (IPI), no specific bill S. 551 Recovering Excessive Funds for Unused and Needless Drugs Act S. 657 Drug Price Transparency Act S. 658 Accelerated Drug Approval for Prescription Therapies Act S. 660 Efficiency and Transparency in Petitions Act S. 1895, Lower Health Care Costs Act, a comprehensive bill designed to improve healthcare transparency and reduce healthcare costs, including prescription drugs S. 1391, Fair Accountability and Innovative Research (FAIR) Drug Pricing Act H.R. 1499, Protecting Consumer Access Generic Drugs Act H.R. 1344, Competitive Deals Resulting in Unleashed Generics and Savings (DRUGS) Act S. 1169, Ensuring Timely Access to Generics Act S. 1617, Second Look at Drug Patents Act H.R. 1520, Purple Book Continuity Act S. 1209, Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act S. 977, Transparent Drug Pricing Act S. 102, Prescription Drug Price Relief Act S. 659, Biologic Patent Transparency Act H.R. 1503, Orange Book Transparency Act H.R. 2296, Fair Accountability and Innovative Research (FAIR) Drug Pricing Act S. 1664, Prescription Drug Price Reporting Act S.659 - the Biologics Patent Transparency Act
Client expense: $2,400,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), SENATE
2019 · fourth_quarter · Copyright/Patent/Trademark
H.R. 465: Prescription Drug Price Relief Act of 2019 - Provisions related to foreign reference pricing, patents and march-in rights H.R. 938: BLOCKING Act of 2019 - Provisions related to 180 day generic prescription drug exclusivity H.R. 990: Hatch-Waxman Integrity Act of 2019 - Provisions related to PTAB proceedings and other patent system reforms H.R. 1188: FLAT Prices Act - Provisions related to prescription drug patents, exclusivity periods and pricing H.R. 1344: Competitive Deals Resulting in Unleased Generics and Savings Act of 2019 - Provisions related to patent settlements H.R. 1499: Protecting Consumer Access to Generic Drugs Act of 2019 - Provisions related to patent settlements H.R. 1503: Orange Book Transparency Act - Provisions related to prescription drug and device patent listings H.R. 1520: Purple Book Continuity Act of 2019 - Provisions related to prescription drug patent listings H.R. 2374: Stop STALLING Act - Provisions related to citizen petitions H.R. 2375: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements H.R. 2387: STOP GAMES Act of 2019 - Provisions related to citizen petitions H.R. 2455: Ensuring Timely Access to Generics Act of 2019 - Provisions related to citizen petitions H.R. 2700: Lowering Prescription Drug Costs and Extending Community Health Centers and Other Public Health Priorities Act - Provisions related to patent settlements, generic exclusivity, Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 3666: STRONGER Patents Act of 2019 - Provisions related to prescription drug patents H.R. 3991: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 - Provisions related to patent litigation H.R. 4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 - Provisions related to prescription drug patents H.R. 4712: Fairness in Orphan Drug Exclusivity Act - Provisions related to prescription drug exclusivity periods H.R. 4850: Biologic Patent Transparency Act - Provisions related to prescription drug patent disclosures H.R. 4955: Protecting Access to Safe and Effective Medicines Act of 2019 - Provisions related to new chemical exclusivity H.R. 5133: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 - Provisions related to prescription drug exclusivity periods and manufacturer behavior H.R. 5444: To amend the Biologics Price Competition and Innovation Act of 2009 to streamline the transition of certain products from approval as a drug to licensure as a biological product, and for other purposes. - Provisions related to BPCIA and biological products S. 64: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 102: Prescription Drug Price Relief Act of 2019 - Provisions related to foreign reference pricing, patents and march-in rights S. 344: Hatch-Waxman Integrity Act of 2019 - Provisions related to PTAB proceedings and other patent system reforms S. 366: FLAT Prices Act - Provisions related to prescription drug patents, exclusivity periods and pricing S. 440: PACED Act - Provisions related to use of sovereign immunity in patent disputes S. 659: Biologic Patent Transparency Act - Provisions related to prescription drug patent disclosures S. 1169: Ensuring Timely Access to Generics Act of 2019 - Provisions related to citizen petitions S. 1209: Reforming Evergreening and Manipulation that Extends Drug Years Act - Provisions related to prescription drug patents S. 1224: Stop STALLING Act - Provisions related to citizen petitions S. 1416: Affordable Prescriptions for Patients Act of 2019 - Provisions related to prescription drug patents S. 1617: Second Look at Drug Patents Act of 2019 - Provisions related to prescription drug patents S. 1636: Ensuring Innovation Act - Provisions related to new chemical exclusivity S. 2082: STRONGER Patents Act of 2019 - Provisions related to prescription drug patents Biopharmaceutical innovation and patent policy issues Patent litigation reform issues and issues related to post-grant proceeding at the PTO Trademark legislative proposals Bayh-Dole march-in rights policy issues
Client expense: $700,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
2019 · fourth_quarter · Pharmacy
S. 61, Safe and Affordable Drugs from Canada Act (Grassley) - drug importation S. 64, Preserve Access to Affordable Generics and Biosimilars Act (Grassley-Klobuchar) - prohibiting pay-for-delay settlements S. 73, End Taxpayer Subsidies for Drug Ads Act (Shaheen) - prohibiting tax deduction for DTC advertising expenses S. 102, Prescription Drug Price Relief Act (Sanders) - reforms linked to international pricing S. 340, CREATES Act (Leahy) - removing barriers to generic drugs S. 344, Hatch-Waxman Integrity Act (Tillis) - inter partes review process S. 366, FLAT Prices Act (Durbin) - reforms for drugs with sudden price spikes S. 378, Stop Price Gouging Act (Durbin) - excise tax for drugs that have price spikes S. 440, Preserving Access to Cost-Effective Drugs Act (Cotton) - sovereign immunity and Inter Partes Review process S. 474, SPIKE Act (Wyden) - justification for drug price increases S. 476, Creating Transparency to Have Drug Rebates Unlocked Act (Wyden) - drug price transparency S. 637, CURE High Drug Prices Act (Blumenthal) - remedies for price gouging S. 657, Point of Sale Rebates (Braun) S. 659, Biologic Patent Transparency Act (Collins) - patent disclosure requirements S. 660, Efficiency and Transparency in Petitions Act (Braun) - FDA citizen petition process S. 844, Short on Competition Act (Klobuchar) - remedies for marginally competitive drug markets S. 977, Transparency Drug Pricing Act (Scott) - transparency and drug pricing reforms S. 1209, Reforming Evergreening and Manipulation that Extends Drug Years Act (Cassidy) - preventing evergreening of patent protections S. 1224, Stop STALLING Act (Klobuchar) - citizen petition process S. 1227, Prescription Pricing for the People Act (Grassley) - FTC report on role of PBMs and allegations of anticompetitive conduct by manufacturers of sole-source drugs S. 1384, Prescription Drug Rebate Reform Act (Romney-Braun) - prescription drug cost sharing S. 1416, Affordable Prescriptions for Patients Act (Cornyn) - product hopping, patent thickets S. 1664, Prescription Drug Price Reporting Act (Scott) - prescription drug price reporting S. 2247, Phair Relief Act of 2019 (Kennedy)-transparency around price concessions for drugs S. 2387, We Protect American Investment in Drugs Act (Van Hollen)-drug pricing S. 2543, Prescription Drug Pricing Reduction Act of 2019 (Grassley)-Drug pricing S. 2740, Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 (Isakson) - regulations re nonprescription drugs that are marketed without an approved new drug application S. 3052, United States-Mexico-Canada Agreement Implementation Act (Grassley) - drug pricing S. 3067, Non-Opioids Prevent Addiction In the Nation Act (Capito) - non-opioid treatments S. 3092, Expanding Access to Low-Cost Generics Act of 2019 (Smith) - exclusivity period H.R. 3, Lower Drug Costs Now Act of 2019 (Pallone)-drug pricing H.R. 465, Prescription Drug Price Relief Act (Khanna) - reforms linked to international pricing H.R. 478, Safe and Affordable Drugs from Canada Act (Pingree) - drug importation H.R. 938, BLOCKING Act (Schrader) - changes to 180-day period of market exclusivity for first generic applicant H.R. 965, CREATES Act (Cicilline) - removing barriers to generic drugs H.R. 985, FAST Generics Act (Welch) - removing barriers to generic drugs H.R. 990, Hatch-Waxman Integrity Act (Flores) - inter partes review process H.R. 1093, Stop Price Gouging Act (Pocan) - excise tax for drugs that have price spikes H.R. 1188, FLAT Prices Act (Golden) - reforms for drugs with sudden price spikes H.R. 1344, Competitive DRUGS Act (Doggett) - prohibiting pay-for-delay agreements H.R. 1419, Public Option Deficit Reduction Act (DeFazio) - public option H.R. 1499, Protecting Consumer Access to Generic Drugs Act (Rush) - prohibiting pay-for-delay agreements H.R. 1503, Orange Book Transparency Act (Kelly) - removal of invalidated patents from Orange Book H.R. 1506, FAIR Generics Act (Barragan) - changes to 180-day period of market exclusivity for first generic applicant H.R. 1520, Purple Book Continuity Act (Eshoo) - access to updated information on biologics and biosimilars H.R. 2038, State-Based, Market-Oriented Prescription Drug Negotiations Act (Meadows) - drug price negotiations H.R. 2064, Sunshine for Samples Act (Chu) - reporting requirements on drug samples H.R. 2069, SPIKE Act (Horsford) -justification for drug price increases H.R. 2087, Drug Price Transparency Act (Doggett) - reporting of drug pricing data under Medicare Part B H.R. 2113, Prescription Drug Sunshine, Transparency, Accountability and Reporting Act (Neal) - transparency in drug pricing H.R. 2115, Public Disclosure of Drug Discounts Act (Spanberger) - disclosure of negotiated Rx discounts H.R. 2279, Safe Step Act (Ruiz) - exceptions process for medication step therapy H.R. 2296, FAIR Drug Pricing Act (Schakowsky) - transparency requirements and justification for high list prices and drug price increases H.R. 2374, Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act (Jeffries) - citizen petition process H.R. 2375, Preserve Access to Affordable Generics and Biosimilars Act (Nadler) - prohibiting pay-for-delay agreements H.R. 2376, Prescription Pricing for the People Act (Collins) - FTC study on role of PBMs and competition and transparency in pharmaceutical supply chain H.R. 3379, Price Relief, Innovation, and Competition for Essential Drugs Act (Schakowsky) - exclusivity period for biological products H.R. 3805, Prescription Drug Rebate Reform Act of 2019 (Gallagher)- drug rebates H.R. 3927, PDMPs Help Patients Act of 2019 (McKinley)-integrating SUDs and behavioral health into PDMPs H.R. 3947, Competition Prescription Act of 2019 (Meadows)- drug pricing H.R. 4010, Emergency Access to Insulin Act of 2019 (Craig)- drug pricing H.R. 4106, Responsibility in Drug Advertising Act of 2019 (DeLauro)-transparency in drug pricing H.R. 4244, MAGIC Act (Kelly)-pathways for insulin approval H.R. 4398, Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 (Cicilline)-drug pricing H.R. 4455, BIOSIM Act (Schrader)-access to biosimilars H.R. 4460, Turn the Tide Act (Kuster)-Opioids H.R. 4538, Closing Loopholes for Orphan Drugs Act (Welch)-Access to drugs H.R. 4640, Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2019 (DeFazio) - direct negotiation H.R. 4712, Fairness in Orphan Drug Exclusivity Act (Dean) - limitations on exclusive approval of orphan drugs H.R. 4810, Opioid Prescription Verification Act of 2019 (David) - dispensing of controlled substances H.R. 4906, Insulin Price Reduction Act (Diana DeGette) - insulin costs H.R. 5304, PBM Transparency in Prescription Drug Costs Act (Schrader) - PBMs H.R. 5364, End Price Gouging for Insulin Act (Beatty) - annual reference price for insulin products H.R. 5430, United States-Mexico-Canada Agreement Implementation Act (Hoyer) - drug pricing H.R. 5442, Lowest Price for Patients Act (Porter) - pharmacies to disclose any differential between the cost of a prescription drug H.R. 5444, Lower Insulin Costs Now Act (Underwood) - lowering insulin costs H.Con.Res. 55, Expressing the sense of Congress on the need to inform American consumers with more balanced purchasing information for prescription drugs through the disclosure of price information in direct-to-consumer (DTC) advertisements. (Burgess)-drug pricing Regulatory Issues: Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to price of drugs and biologics and proposals to limit high prices; issues related to drug patents and market exclusivity; issues related to pharmacy benefit managers; issues related to biosimilars; issues related to approval of drugs and biologics; issues relating to opioids; issues relating to prescription drug rebates; issues relating to prescription drug price blueprint; direct-to-consumer advertising for prescription drugs; issues related to proposed changes to removal of safe harbor protection for rebates (proposed rule); issues relating to access for investigational drugs; and other issues relating to health care reform implementation.
Client expense: $2,340,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, Treasury, Dept of, White House Office
2019 · fourth_quarter · Copyright/Patent/Trademark
H.R. 465: Prescription Drug Price Relief Act of 2019 - Provisions related to foreign reference pricing, patents and march-in rights H.R. 938: BLOCKING Act of 2019 - Provisions related to 180 day generic prescription drug exclusivity H.R. 990: Hatch-Waxman Integrity Act of 2019 - Provisions related to PTAB proceedings and other patent system reforms H.R. 1188: FLAT Prices Act - Provisions related to prescription drug patents, exclusivity periods and pricing H.R. 1344: Competitive Deals Resulting in Unleased Generics and Savings Act of 2019 - Provisions related to patent settlements H.R. 1499: Protecting Consumer Access to Generic Drugs Act of 2019 - Provisions related to patent settlements H.R. 1503: Orange Book Transparency Act - Provisions related to prescription drug and device patent listings H.R. 1520: Purple Book Continuity Act of 2019 - Provisions related to prescription drug patent listings H.R. 2374: Stop STALLING Act - Provisions related to citizen petitions H.R. 2375: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements H.R. 2387: STOP GAMES Act of 2019 - Provisions related to citizen petitions H.R. 2455: Ensuring Timely Access to Generics Act of 2019 - Provisions related to citizen petitions H.R. 2700: Lowering Prescription Drug Costs and Extending Community Health Centers and Other Public Health Priorities Act - Provisions related to patent settlements, generic exclusivity, Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 3666: STRONGER Patents Act of 2019 - Provisions related to prescription drug patents H.R. 3991: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 - Provisions related to patent litigation H.R. 4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 - Provisions related to prescription drug patents H.R. 4712: Fairness in Orphan Drug Exclusivity Act - Provisions related to prescription drug exclusivity periods H.R. 4850: Biologic Patent Transparency Act - Provisions related to prescription drug patent disclosures H.R. 4955: Protecting Access to Safe and Effective Medicines Act of 2019 - Provisions related to new chemical exclusivity H.R. 5133: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 - Provisions related to prescription drug exclusivity periods and manufacturer behavior H.R. 5444: To amend the Biologics Price Competition and Innovation Act of 2009 to streamline the transition of certain products from approval as a drug to licensure as a biological product, and for other purposes. - Provisions related to BPCIA and biological products S. 64: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 102: Prescription Drug Price Relief Act of 2019 - Provisions related to foreign reference pricing, patents and march-in rights S. 344: Hatch-Waxman Integrity Act of 2019 - Provisions related to PTAB proceedings and other patent system reforms S. 366: FLAT Prices Act - Provisions related to prescription drug patents, exclusivity periods and pricing S. 440: PACED Act - Provisions related to use of sovereign immunity in patent disputes S. 659: Biologic Patent Transparency Act - Provisions related to prescription drug patent disclosures S. 1169: Ensuring Timely Access to Generics Act of 2019 - Provisions related to citizen petitions S. 1209: Reforming Evergreening and Manipulation that Extends Drug Years Act - Provisions related to prescription drug patents S. 1224: Stop STALLING Act - Provisions related to citizen petitions S. 1416: Affordable Prescriptions for Patients Act of 2019 - Provisions related to prescription drug patents S. 1617: Second Look at Drug Patents Act of 2019 - Provisions related to prescription drug patents S. 1636: Ensuring Innovation Act - Provisions related to new chemical exclusivity S. 2082: STRONGER Patents Act of 2019 - Provisions related to prescription drug patents Biopharmaceutical innovation and patent policy issues Patent litigation reform issues and issues related to post-grant proceeding at the PTO Trademark legislative proposals Bayh-Dole march-in rights policy issues
Client expense: $6,450,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
S.659 - Biologic Patent Transparency Act Data Exclusivity Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection issues Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO BPCIA Patents Inter Partes Review at PTO Biosimilars S 1416 - Affordable Prescriptions for Patients Act of 2019 H.R.465 - Prescription Drug Price Relief Act of 2019 H.R.938 - BLOCKING Act of 2019 H.R.987 - Strengthening Health Care and Lowering Prescription Drug Costs Act H.R.990 - Hatch-Waxman Integrity Act of 2019 H.R.1046 - Medicare Negotiation and Competitive Licensing Act of 2019 H.R.2375 - Preserve Access to Affordable Generics and Biosimilars Act H.R.2700 - Lowering Prescription Drug Costs and Extending Community Health Centers and Other Public Health Priorities Act S.64 - Preserve Access to Affordable Generics and Biosimilars Act S.102 - Prescription Drug Price Relief Act of 2019 Bayh-Dole march-in rights policy issues S.440 - Preserving Access to Cost Effective Drugs Act (PACED Act)(Sovereign immunity issues before the PTAB) Section 101 H.R.1344 - Competitive DRUGS Act of 2019 H.R.1499 - Protecting Consumer Access to Generic Drugs Act of 2019 H.R.1503 - Orange Book Transparency Act of 2019 H.R.1520 - Purple Book Continuity Act of 2019 H.R.2374 - Stop STALLING Act H.R.3666 - STRONGER Patents Act of 2019 H.R.3991 - Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 H.R.4398 - Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 H.R.4712 - Born-Alive Abortion Survivors Protection Act H.R.4850 - Biologic Patent Transparency Act H.R.5133 - Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 H.R.5444 - Taxpayer First Act S.344 - Hatch-Waxman Integrity Act of 2019 S.1416 - Affordable Prescriptions for Patients Act of 2019 S.1617 - Second Look at Drug Patents Act of 2019 S.2082 - Support Technology and Research for Our Nation's Growth and Economic Resilience Patents Act of 2019
Client expense: $620,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
2019 · fourth_quarter · Health Issues
HR 3199-Terminating the Extension of Rights Misappropriated Act of 2019; S.340/HR 965-Creating & Restoring Equal Access to Equivalent Samples Act ("Creates Act"); HR 985-Fast Generics Act; S.64-Preserve Access to Affordable Generic & Biosimilars Act; HR 1499-Protecting Consumer Access to Generic Drugs Act; HR 1344-Competitive Drugs Act of 2019; HR 938-Bringing Low Cost Options & Competition While Keeping Incentives for New Generics Act ("BLOCKING Act"); HR 1506-Fair & Immediate Release of Generic Drugs Act; HR 1520-Purple Book Continuity Act; HR 1503-Orange Book Transparency Act; S.344/HR 990-Hatch-Waxman Integrity Act; Stronger Patents Act; S.1895-Lower Health Care Costs Act; S. 2543-Prescription Drug Pricing Reduction Act; and Administration review of drug pricing policies.
Client expense: $410,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR)
2019 · fourth_quarter · Health Issues
Monitor legislative and administrative action related to health care policy. Monitor legislative and administrative action related to drug importation, drug shortages, authorized genetics, and prescription drug advertising. Monitor legislative and administrative action related to womens health issues. Monitor legislative and administrative action related to over-the-counter consumer care products. Monitor legislative and administrative action related to dietary supplements. Monitor legislative and administrative action related to servicing of medical device equipment. Monitor legislative and administrative action related to FDA monograph reform and user fees. Monitor legislative and administrative action related to the switch of prescription medications to over-the-counter medications. Monitor legislative and administrative action related to drug pricing, including rulemakings at HHS. Monitor legislative and administrative action related to repealing the medical device tax. Monitor legislative and administrative action related to sunscreen issues. Monitor legislative and administrative action related to P.L. 113-195, The Sunscreen Innovation Act. Monitor legislative and administrative action related to cosmetics reform legislation. Monitor legislative and administrative action related to drug take back and pseudoephedrine regulation. H.R. 3, Lower Drug Costs Now Act of 2019. H.R. 269, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019. H.R. 863, DXM Abuse Prevention Act of 2019. H.R. 965, CREATES Act of 2019. H.R. 985, FAST Generics Act of 2019. H.R. 1344, Competitive DRUGS Act of 2019. H.R. 1503, Orange Book Transparency Act of 2019. H.R. 1520, Purple Book Continuity Act of 2019. S. 340, CREATES Act of 2019. S. 2543, Prescription Drug Pricing Reduction Act of 2019.
Client expense: $1,910,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Council on Environmental Quality (CEQ), Environmental Protection Agency (EPA), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Interior, Dept of (DOI), Natl Economic Council (NEC), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, Small Business Administration (SBA), State, Dept of (DOS), Treasury, Dept of, U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)
2019 · fourth_quarter · Copyright/Patent/Trademark
H.R. 1499, Protecting Consumer Access to Generic Drugs Act, regarding all bio-pharmaceutical related provisions H.R. 965, Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 1344, Competitive DRUGS Act, regarding all bio-pharmaceutical related provisions. H.R. 2279/S. 2546, Safe Step Act of 2019, regarding all bio-pharmaceutical related provisions S. 64, Preserve Access to Affordable Generics and Biosimilars Act,regarding all bio-pharmaceutical related provisions. S. 340, Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019, regarding all bio-pharmaceutical related provisions. H.R.2375, Preserve Access to Affordable Generics and Biosimilars Act, regarding all bio-pharmaceutical related provisions H.R. 2387, STOP GAMES Act, regarding all bio-pharmaceutical related provisions H.R. 3199, TERM Act, regarding all bio-pharmaceutical related provisions S. 440, PACED Act, regarding all bio-pharmaceutical related provisions S. 1224/H.R.2374, Stop STALLING Act, regarding all bio-pharmaceutical related provisions S.1416, Affordable Prescriptions for Patients Act, regarding all bio-pharmaceutical related provisions S. 1617, Second Look at Drug Patents Act, regarding all bio-pharmaceutical related provisions
Client expense: $690,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)
2019 · third_quarter · Health Issues
Monitor legislative and administrative action related to health care policy. Monitor legislative and administrative action related to drug importation, drug shortages, authorized genetics, and prescription drug advertising. Monitor legislative and administrative action related to womens health issues. Monitor legislative and administrative action related to over-the-counter consumer care products. Monitor legislative and administrative action related to dietary supplements. Monitor legislative and administrative action related to servicing of medical device equipment. Monitor legislative and administrative action related to FDA monograph reform and user fees. Monitor legislative and administrative action related to the switch of prescription medications to over-the-counter medications. Monitor legislative and administrative action related to drug pricing, including rulemakings at HHS. Monitor legislative and administrative action related to repealing the medical device tax. Monitor legislative and administrative action related to sunscreen issues. Monitor legislative and administrative action related to P.L. 113-195, The Sunscreen Innovation Act. Monitor legislative and administrative action related to cosmetics reform legislation. Monitor legislative and administrative action related to drug take back and pseudoephedrine regulation. H.R. 3, Lower Drug Costs Now Act of 2019. H.R. 269, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019. H.R. 863, DXM Abuse Prevention Act of 2019. H.R. 965, CREATES Act of 2019. H.R. 985, FAST Generics Act of 2019. H.R. 1344, Competitive DRUGS Act of 2019. H.R. 1503, Orange Book Transparency Act of 2019. H.R. 1520, Purple Book Continuity Act of 2019. S. 340, CREATES Act of 2019. S. 2543, Prescription Drug Pricing Reduction Act of 2019.
Client expense: $2,110,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Council on Environmental Quality (CEQ), Environmental Protection Agency (EPA), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Interior, Dept of (DOI), Natl Economic Council (NEC), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, Small Business Administration (SBA), State, Dept of (DOS), Treasury, Dept of, U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)
2019 · third_quarter · Pharmacy
S. 61, Safe and Affordable Drugs from Canada Act (Grassley) - drug importation S. 64, Preserve Access to Affordable Generics and Biosimilars Act (Grassley-Klobuchar) - prohibiting pay-for-delay settlements S. 73, End Taxpayer Subsidies for Drug Ads Act (Shaheen) - prohibiting tax deduction for DTC advertising expenses S. 102, Prescription Drug Price Relief Act (Sanders) - reforms linked to international pricing S. 340, CREATES Act (Leahy) - removing barriers to generic drugs S. 344, Hatch-Waxman Integrity Act (Tillis) - inter partes review process S. 366, FLAT Prices Act (Durbin) - reforms for drugs with sudden price spikes S. 378, Stop Price Gouging Act (Durbin) - excise tax for drugs that have price spikes S. 440, Preserving Access to Cost-Effective Drugs Act (Cotton) - sovereign immunity and Inter Partes Review process S. 474, SPIKE Act (Wyden) - justification for drug price increases S. 476, Creating Transparency to Have Drug Rebates Unlocked Act (Wyden) - drug price transparency S. 637, CURE High Drug Prices Act (Blumenthal) - remedies for price gouging S. 657, Point of Sale Rebates (Braun) S. 659, Biologic Patent Transparency Act (Collins) - patent disclosure requirements S. 660, Efficiency and Transparency in Petitions Act (Braun) - FDA citizen petition process S. 844, Short on Competition Act (Klobuchar) - remedies for marginally competitive drug markets S. 977, Transparency Drug Pricing Act (Scott) - transparency and drug pricing reforms S. 1209, Reforming Evergreening and Manipulation that Extends Drug Years Act (Cassidy) - preventing evergreening of patent protections S. 1224, Stop STALLING Act (Klobuchar) - citizen petition process S. 1227, Prescription Pricing for the People Act (Grassley) - FTC report on role of PBMs and allegations of anticompetitive conduct by manufacturers of sole-source drugs S. 1384, Prescription Drug Rebate Reform Act (Romney-Braun) - prescription drug cost sharing S. 1416, Affordable Prescriptions for Patients Act (Cornyn) - product hopping, patent thickets S. 1664, Prescription Drug Price Reporting Act (Scott) - prescription drug price reporting S. 2247, Phair Relief Act of 2019 (Kennedy)-transparency around price concessions for drugs S. 2387, We Protect American Investment in Drugs Act (Van Hollen)-drug pricing S. 2543, Prescription Drug Pricing Reduction Act of 2019 (Grassley)-Drug pricing H.R. 3, Lower Drug Costs Now Act of 2019 (Pallone)-drug pricing H.R. 465, Prescription Drug Price Relief Act (Khanna) - reforms linked to international pricing H.R. 478, Safe and Affordable Drugs from Canada Act (Pingree) - drug importation H.R. 938, BLOCKING Act (Schrader) - changes to 180-day period of market exclusivity for first generic applicant H.R. 965, CREATES Act (Cicilline) - removing barriers to generic drugs H.R. 985, FAST Generics Act (Welch) - removing barriers to generic drugs H.R. 990, Hatch-Waxman Integrity Act (Flores) - inter partes review process H.R. 1093, Stop Price Gouging Act (Pocan) - excise tax for drugs that have price spikes H.R. 1188, FLAT Prices Act (Golden) - reforms for drugs with sudden price spikes H.R. 1344, Competitive DRUGS Act (Doggett) - prohibiting pay-for-delay agreements H.R. 1419, Public Option Deficit Reduction Act (DeFazio) - public option H.R. 1499, Protecting Consumer Access to Generic Drugs Act (Rush) - prohibiting pay-for-delay agreements H.R. 1503, Orange Book Transparency Act (Kelly) - removal of invalidated patents from Orange Book H.R. 1506, FAIR Generics Act (Barragan) - changes to 180-day period of market exclusivity for first generic applicant H.R. 1520, Purple Book Continuity Act (Eshoo) - access to updated information on biologics and biosimilars H.R. 2038, State-Based, Market-Oriented Prescription Drug Negotiations Act (Meadows) - drug price negotiations H.R. 2064, Sunshine for Samples Act (Chu) - reporting requirements on drug samples H.R. 2069, SPIKE Act (Horsford) -justification for drug price increases H.R. 2087, Drug Price Transparency Act (Doggett) - reporting of drug pricing data under Medicare Part B H.R. 2113, Prescription Drug Sunshine, Transparency, Accountability and Reporting Act (Neal) - transparency in drug pricing H.R. 2115, Public Disclosure of Drug Discounts Act (Spanberger) - disclosure of negotiated Rx discounts H.R. 2279, Safe Step Act (Ruiz) - exceptions process for medication step therapy H.R. 2296, FAIR Drug Pricing Act (Schakowsky) - transparency requirements and justification for high list prices and drug price increases H.R. 2374, Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act (Jeffries) - citizen petition process H.R. 2375, Preserve Access to Affordable Generics and Biosimilars Act (Nadler) - prohibiting pay-for-delay agreements H.R. 2376, Prescription Pricing for the People Act (Collins) - FTC study on role of PBMs and competition and transparency in pharmaceutical supply chain H.R. 3379, Price Relief, Innovation, and Competition for Essential Drugs Act (Schakowsky) - exclusivity period for biological products H.R. 3805, Prescription Drug Rebate Reform Act of 2019 (Gallagher)- drug rebates H.R. 3927, PDMPs Help Patients Act of 2019 (McKinley)-integrating SUDs and behavioral health into PDMPs H.R. 3947, Competition Prescription Act of 2019 (Meadows)- drug pricing H.R. 4010, Emergency Access to Insulin Act of 2019 (Craig)- drug pricing H.R. 4106, Responsibility in Drug Advertising Act of 2019 (DeLauro)-transparency in drug pricing H.R. 4244, MAGIC Act (Kelly)-pathways for insulin approval H.R. 4398, Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 (Cicilline)-drug pricing H.R. 4455, BIOSIM Act (Schrader)-access to biosimilars H.R. 4460, Turn the Tide Act (Kuster)-Opioids H.R. 4538, Closing Loopholes for Orphan Drugs Act (Welch)-Access to drugs H.Con.Res. 55, Expressing the sense of Congress on the need to inform American consumers with more balanced purchasing information for prescription drugs through the disclosure of price information in direct-to-consumer (DTC) advertisements. (Burgess)-drug pricing Regulatory Issues: Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to price of drugs and biologics and proposals to limit high prices; issues related to drug patents and market exclusivity; issues related to pharmacy benefit managers; issues related to biosimilars; issues related to approval of drugs and biologics; issues relating to opioids; issues relating to prescription drug rebates; issues relating to prescription drug price blueprint; direct-to-consumer advertising for prescription drugs; issues related to proposed changes to removal of safe harbor protection for rebates (proposed rule); issues relating to access for investigational drugs; and other issues relating to health care reform implementation.
Client expense: $2,110,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), Treasury, Dept of, White House Office
2019 · third_quarter · Health Issues
Biosimilars, no specific bill Prescription drug value issues, no specific bill S. 469 Affordable and Safe Prescription Drug Importation Act H.R. 1245 Affordable and Safe Prescription Drug Importation Act 340B Protecting Access for the Underserved and Safety-Net Entities (340B PAUSE Act). FDA issues, no specific bill S.3158 Labor, Health and Human Services Appropriations Act (Senate Report 115-289) Issues related to International Pricing Index (IPI), no specific bill S. 551 Recovering Excessive Funds for Unused and Needless Drugs Act S. 657 Drug Price Transparency Act S. 658 Accelerated Drug Approval for Prescription Therapies Act S. 660 Efficiency and Transparency in Petitions Act S. 1895, Lower Health Care Costs Act (S. 1895), a comprehensive bill designed to improve healthcare transparency and reduce healthcare costs, including prescription drugs S. 1391, Fair Accountability and Innovative Research (FAIR) Drug Pricing Act (S. 1391) H.R. 1499, Protecting Consumer Access Generic Drugs Act H.R. 1344, Competitive Deals Resulting in Unleashed Generics and Savings (DRUGS) Act S. 1169, Ensuring Timely Access to Generics Act S. 1617, Second Look at Drug Patents Act H.R. 1520, Purple Book Continuity Act S. 1209, Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act S. 977, Transparent Drug Pricing Act S. 102, Prescription Drug Price Relief Act S. 637, Combatting Unreasonable Rises and Excessively (CURE) High Drug Prices Act S. 659, Biologic Patent Transparency Act H.R. 1503, Orange Book Transparency Act H.R. 2296, Fair Accountability and Innovative Research (FAIR) Drug Pricing Act S. 1664, Prescription Drug Price Reporting Act S.659 - the Biologics Patent Transparency Act
Client expense: $3,090,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), SENATE, Treasury, Dept of
2019 · second_quarter · Health Issues
S.340/HR 965-Creating & Restoring Equal Access to Equivalent Samples Act ("Creates Act"); HR 985-Fast Generics Act; S.64-Preserve Access to Affordable Generic & Biosimilars Act; HR 1499-Protecting Consumer Access to Generic Drugs Act; HR 1344-Competitive Drugs Act of 2019; HR 938-Bringing Low Cost Options & Competition While Keeping Incentives for New Generics Act ("BLOCKING Act"); HR 1506-Fair & Immediate Release of Generic Drugs Act; HR 1520-Purple Book Continuity Act; HR 1503-Orange Book Transparency Act; S.344/HR 990-Hatch-Waxman Integrity Act; Stronger Patents Act; S.1895, Lower Health Care Costs Act; and Administration review of drug pricing policies.
Client expense: $780,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR)
2019 · third_quarter · Health Issues
S.340/HR 965-Creating & Restoring Equal Access to Equivalent Samples Act ("Creates Act"); HR 985-Fast Generics Act; S.64-Preserve Access to Affordable Generic & Biosimilars Act; HR 1499-Protecting Consumer Access to Generic Drugs Act; HR 1344-Competitive Drugs Act of 2019; HR 938-Bringing Low Cost Options & Competition While Keeping Incentives for New Generics Act ("BLOCKING Act"); HR 1506-Fair & Immediate Release of Generic Drugs Act; HR 1520-Purple Book Continuity Act; HR 1503-Orange Book Transparency Act; S.344/HR 990-Hatch-Waxman Integrity Act; Stronger Patents Act; S.1895-Lower Health Care Costs Act; S. 2543-Prescription Drug Pricing Reduction Act;and Administration review of drug pricing policies.
Client expense: $480,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR)
2019 · third_quarter · Copyright/Patent/Trademark
H.R. 1499, Protecting Consumer Access to Generic Drugs Act, regarding all bio-pharmaceutical related provisions H.R. 965, Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 1344, Competitive DRUGS Act, regarding all bio-pharmaceutical related provisions. H.R. 2279/S. 2546, Safe Step Act of 2019, regarding all bio-pharmaceutical related provisions S. 64, Preserve Access to Affordable Generics and Biosimilars Act,regarding all bio-pharmaceutical related provisions. S. 340, Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019, regarding all bio-pharmaceutical related provisions. H.R.2375, Preserve Access to Affordable Generics and Biosimilars Act, regarding all bio-pharmaceutical related provisions H.R. 2387, STOP GAMES Act, regarding all bio-pharmaceutical related provisions H.R. 3199, TERM Act, regarding all bio-pharmaceutical related provisions S. 440, PACED Act, regarding all bio-pharmaceutical related provisions S. 1224/H.R.2374, Stop STALLING Act, regarding all bio-pharmaceutical related provisions S.1416, Affordable Prescriptions for Patients Act, regarding all bio-pharmaceutical related provisions S. 1617, Second Look at Drug Patents Act, regarding all bio-pharmaceutical related provisions
Client expense: $1,240,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)
2019 · second_quarter · Copyright/Patent/Trademark
H.R. 465: Prescription Drug Price Relief Act of 2019 - Provisions related to foreign reference pricing, patents and march-in rights H.R. 938: BLOCKING Act of 2019 - Provisions related to 180 day generic prescription drug exclusivity H.R. 987: Strengthening Health Care and Lowering Prescription Drug Costs Act - Provisions related to prescription drug patent issues H.R. 990: Hatch-Waxman Integrity Act of 2019 - Provisions related to PTAB proceedings and other patent system reforms H.R. 1046: Medicare Negotiation and Competitive Licensing Act of 2019 - Provisions related to Part D, drug pricing negotiation and compulsory licensing H.R. 1188: FLAT Prices Act - Provisions related to prescription drug patents, exclusivity periods and pricing H.R. 1344: Competitive Deals Resulting in Unleased Generics and Savings Act of 2019 - Provisions related to patent settlements H.R. 1499: Protecting Consumer Access to Generic Drugs Act of 2019 - Provisions related to patent settlements H.R. 1503: Orange Book Transparency Act - Provisions related to prescription drug patent listings H.R. 1520: Purple Book Continuity Act of 2019 - Provisions related to biologic patent listings H.R. 2374: Stop STALLING Act - Provisions related to citizen petitions H.R. 2375: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements H.R. 2387: STOP GAMES Act of 2019 - Provisions related to citizen petitions H.R. 2455: Ensuring Timely Access to Generics Act of 2019 - Provisions related to citizen petitions H.R. 2700: Lowering Prescription Drug Costs and Extending Community Health Centers and Other Public Health Priorities Act - Provisions related to patent settlements, generic exclusivity, Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 3199: Terminating the Extension of Rights Misappropriated Act of 2019 - Provisions related to prescription drug patents S. 64: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 102: Prescription Drug Price Relief Act of 2019 - Provisions related to foreign reference pricing, patents and march-in rights S. 344: Hatch-Waxman Integrity Act of 2019 - Provisions related to PTAB proceedings and other patent system reforms S. 366: FLAT Prices Act - Provisions related to prescription drug patents, exclusivity periods and pricing S. 377: Medicare Negotiation and Competitive Licensing Act of 2019 - Provisions related to Part D, drug pricing negotiation and compulsory licensing S. 659: Biologic Patent Transparency Act - Provisions related to prescription drug patent disclosures S. 1169: Ensuring Timely Access to Generics Act of 2019 - Provisions related to citizen petitions S. 1209: Reforming Evergreening and Manipulation that Extends Drug Years Act - Provisions related to prescription drug patents S. 1224: Stop STALLING Act - Provisions related to citizen petitions S. 1416: Affordable Prescriptions for Patients Act of 2019 - Provisions related to prescription drug patents S. 1617: Second Look at Drug Patents Act of 2019 - Provisions related to prescription drug patents S. 1636: Ensuring Innovation Act - Provisions related to new chemical exclusivity Biopharmaceutical innovation and patent policy issues Patent litigation reform issues and issues related to post-grant proceedings at the PTO Bayh-Dole march-in rights policy issues
Client expense: $6,310,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
2019 · second_quarter · Pharmacy
HR. 1344 Competitive DRUGS Act of 2019 Drug importation from Canada
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2019 · second_quarter · Health Issues
Monitor legislative and administrative action related to health care policy. Monitor legislative and administrative action related to drug importation, drug shortages, authorized genetics, and prescription drug advertising. Monitor legislative and administrative action related to womens health issues. Monitor legislative and administrative action related to over-the-counter consumer care products. Monitor legislative and administrative action related to dietary supplements. Monitor legislative and administrative action related to servicing of medical device equipment. Monitor legislative and administrative action related to FDA monograph reform and user fees. Monitor legislative and administrative action related to the switch of prescription medications to over-the-counter medications. Monitor legislative and administrative action related to drug pricing, including rulemakings at HHS. Monitor legislative and administrative action related to repealing the medical device tax. Monitor legislative and administrative action related to sunscreen issues. Monitor legislative and administrative action related to P.L. 113-195, The Sunscreen Innovation Act. Monitor legislative and administrative action related to cosmetics reform legislation. Monitor legislative and administrative action related to drug take back and pseudoephedrine regulation. H.R. 269, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019. H.R. 863, DXM Abuse Prevention Act of 2019. H.R. 965, CREATES Act of 2019. H.R. 985, FAST Generics Act of 2019. H.R. 1344, Competitive DRUGS Act of 2019. H.R. 1503, Orange Book Transparency Act of 2019. H.R. 1520, Purple Book Continuity Act of 2019. S. 340, CREATES Act of 2019.
Client expense: $2,610,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Interior, Dept of (DOI), Natl Economic Council (NEC), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR)
2019 · second_quarter · Health Issues
Biosimilars, no specific bill Prescription drug value issues, no specific bill S. 469 Affordable and Safe Prescription Drug Importation Act H.R. 1245 Affordable and Safe Prescription Drug Importation Act 340B Protecting Access for the Underserved and Safety-Net Entities (340B PAUSE Act). FDA issues, no specific bill S.3158 Labor, Health and Human Services Appropriations Act (Senate Report 115-289) Issues related to International Pricing Index (IPI), no specific bill S. 551 Recovering Excessive Funds for Unused and Needless Drugs Act S. 657 Drug Price Transparency Act S. 658 Accelerated Drug Approval for Prescription Therapies Act S. 660 Efficiency and Transparency in Petitions Act S. 1895, Lower Health Care Costs Act (S. 1895), a comprehensive bill designed to improve healthcare transparency and reduce healthcare costs, including prescription drugs S. 1391, Fair Accountability and Innovative Research (FAIR) Drug Pricing Act (S. 1391) H.R. 1499, Protecting Consumer Access Generic Drugs Act H.R. 1344, Competitive Deals Resulting in Unleashed Generics and Savings (DRUGS) Act S. 1169, Ensuring Timely Access to Generics Act S. 1617, Second Look at Drug Patents Act H.R. 1520, Purple Book Continuity Act S. 1209, Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act S. 977, Transparent Drug Pricing Act S. 102, Prescription Drug Price Relief Act S. 637, Combatting Unreasonable Rises and Excessively (CURE) High Drug Prices Act S. 659, Biologic Patent Transparency Act H.R. 1503, Orange Book Transparency Act H.R. 2296, Fair Accountability and Innovative Research (FAIR) Drug Pricing Act S. 1664, Prescription Drug Price Reporting Act
Client expense: $2,200,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), SENATE, Treasury, Dept of
2019 · second_quarter · Health Issues
S.340/HR 965-Creating & Restoring Equal Access to Equivalent Samples Act ("Creates Act"); HR 985-Fast Generics Act; S.64-Preserve Access to Affordable Generic & Biosimilars Act; HR 1499-Protecting Consumer Access to Generic Drugs Act; HR 1344-Competitive Drugs Act of 2019; HR 938-Bringing Low Cost Options & Competition While Keeping Incentives for New Generics Act ("BLOCKING Act"); HR 1506-Fair & Immediate Release of Generic Drugs Act; HR 1520-Purple Book Continuity Act; HR 1503-Orange Book Transparency Act; S.344/HR 990-Hatch-Waxman Integrity Act; Stronger Patents Act; S.1895, Lower Health Care Costs Act; and Administration review of drug pricing policies.
Client expense: $340,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR)
2019 · second_quarter · Pharmacy
S. 61, Safe and Affordable Drugs from Canada Act (Grassley) - drug importation S. 64, Preserve Access to Affordable Generics and Biosimilars Act (Grassley-Klobuchar) - prohibiting pay-for-delay settlements S. 73, End Taxpayer Subsidies for Drug Ads Act (Shaheen) - prohibiting tax deduction for DTC advertising expenses S. 102, Prescription Drug Price Relief Act (Sanders) - reforms linked to international pricing S. 340, CREATES Act (Leahy) - removing barriers to generic drugs S. 344, Hatch-Waxman Integrity Act (Tillis) - inter partes review process S. 366, FLAT Prices Act (Durbin) - reforms for drugs with sudden price spikes S. 378, Stop Price Gouging Act (Durbin) - excise tax for drugs that have price spikes S. 440, Preserving Access to Cost-Effective Drugs Act (Cotton) - sovereign immunity and Inter Partes Review process S. 474, SPIKE Act (Wyden) - justification for drug price increases S. 476, Creating Transparency to Have Drug Rebates Unlocked Act (Wyden) - drug price transparency S. 637, CURE High Drug Prices Act (Blumenthal) - remedies for price gouging S. 657, Point of Sale Rebates (Braun) S. 659, Biologic Patent Transparency Act (Collins) - patent disclosure requirements S. 660, Efficiency and Transparency in Petitions Act (Braun) - FDA citizen petition process S. 844, Short on Competition Act (Klobuchar) - remedies for marginally competitive drug markets S. 977, Transparency Drug Pricing Act (Scott) - transparency and drug pricing reforms S. 1209, Reforming Evergreening and Manipulation that Extends Drug Years Act (Cassidy) - preventing evergreening of patent protections S. 1224, Stop STALLING Act (Klobuchar) - citizen petition process S. 1227, Prescription Pricing for the People Act (Grassley) - FTC report on role of PBMs and allegations of anticompetitive conduct by manufacturers of sole-source drugs S. 1384, Prescription Drug Rebate Reform Act (Romney-Braun) - prescription drug cost sharing S. 1416, Affordable Prescriptions for Patients Act (Cornyn) - product hopping, patent thickets S. 1664, Prescription Drug Price Reporting Act (Scott) - prescription drug price reporting H.R. 465, Prescription Drug Price Relief Act (Khanna) - reforms linked to international pricing H.R. 478, Safe and Affordable Drugs from Canada Act (Pingree) - drug importation H.R. 938, BLOCKING Act (Schrader) - changes to 180-day period of market exclusivity for first generic applicant H.R. 965, CREATES Act (Cicilline) - removing barriers to generic drugs H.R. 985, FAST Generics Act (Welch) - removing barriers to generic drugs H.R. 990, Hatch-Waxman Integrity Act (Flores) - inter partes review process H.R. 1093, Stop Price Gouging Act (Pocan) - excise tax for drugs that have price spikes H.R. 1188, FLAT Prices Act (Golden) - reforms for drugs with sudden price spikes H.R. 1344, Competitive DRUGS Act (Doggett) - prohibiting pay-for-delay agreements H.R. 1419, Public Option Deficit Reduction Act (DeFazio) - public option H.R. 1499, Protecting Consumer Access to Generic Drugs Act (Rush) - prohibiting pay-for-delay agreements H.R. 1503, Orange Book Transparency Act (Kelly) - removal of invalidated patents from Orange Book H.R. 1506, FAIR Generics Act (Barragan) - changes to 180-day period of market exclusivity for first generic applicant H.R. 1520, Purple Book Continuity Act (Eshoo) - access to updated information on biologics and biosimilars H.R. 2038, State-Based, Market-Oriented Prescription Drug Negotiations Act (Meadows) - drug price negotiations H.R. 2064, Sunshine for Samples Act (Chu) - reporting requirements on drug samples H.R. 2069, SPIKE Act (Horsford) -justification for drug price increases H.R. 2087, Drug Price Transparency Act (Doggett) - reporting of drug pricing data under Medicare Part B H.R. 2113, Prescription Drug Sunshine, Transparency, Accountability and Reporting Act (Neal) - transparency in drug pricing H.R. 2115, Public Disclosure of Drug Discounts Act (Spanberger) - disclosure of negotiated Rx discounts H.R. 2279, Safe Step Act (Ruiz) - exceptions process for medication step therapy H.R. 2296, FAIR Drug Pricing Act (Schakowsky) - transparency requirements and justification for high list prices and drug price increases H.R. 2374, Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act (Jeffries) - citizen petition process H.R. 2375, Preserve Access to Affordable Generics and Biosimilars Act (Nadler) - prohibiting pay-for-delay agreements H.R. 2376, Prescription Pricing for the People Act (Collins) - FTC study on role of PBMs and competition and transparency in pharmaceutical supply chain H.R. 3379, Price Relief, Innovation, and Competition for Essential Drugs Act (Schakowsky) - exclusivity period for biological products Regulatory Issues: Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to price of drugs and biologics and proposals to limit high prices; issues related to drug patents and market exclusivity; issues related to pharmacy benefit managers; issues related to biosimilars; issues related to approval of drugs and biologics; issues relating to opioids; issues relating to prescription drug rebates; issues relating to prescription drug price blueprint; direct-to-consumer advertising for prescription drugs; issues related to proposed changes to removal of safe harbor protection for rebates (proposed rule); issues relating to access for investigational drugs; and other issues relating to health care reform implementation.
Client expense: $2,210,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, Treasury, Dept of, White House Office
2019 · second_quarter · Copyright/Patent/Trademark
H.R. 465: Prescription Drug Price Relief Act of 2019 - Provisions related to foreign reference pricing, patents and march-in rights H.R. 938: BLOCKING Act of 2019 - Provisions related to 180 day generic prescription drug exclusivity H.R. 987: Strengthening Health Care and Lowering Prescription Drug Costs Act - Provisions related to prescription drug patent issues H.R. 990: Hatch-Waxman Integrity Act of 2019 - Provisions related to PTAB proceedings and other patent system reforms H.R. 1046: Medicare Negotiation and Competitive Licensing Act of 2019 - Provisions related to Part D, drug pricing negotiation and compulsory licensing H.R. 1188: FLAT Prices Act - Provisions related to prescription drug patents, exclusivity periods and pricing H.R. 1344: Competitive Deals Resulting in Unleased Generics and Savings Act of 2019 - Provisions related to patent settlements H.R. 1499: Protecting Consumer Access to Generic Drugs Act of 2019 - Provisions related to patent settlements H.R. 1503: Orange Book Transparency Act - Provisions related to prescription drug patent listings H.R. 1520: Purple Book Continuity Act of 2019 - Provisions related to biologic patent listings H.R. 2374: Stop STALLING Act - Provisions related to citizen petitions H.R. 2375: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements H.R. 2387: STOP GAMES Act of 2019 - Provisions related to citizen petitions H.R. 2455: Ensuring Timely Access to Generics Act of 2019 - Provisions related to citizen petitions H.R. 2700: Lowering Prescription Drug Costs and Extending Community Health Centers and Other Public Health Priorities Act - Provisions related to patent settlements, generic exclusivity, Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 3199: Terminating the Extension of Rights Misappropriated Act of 2019 - Provisions related to prescription drug patents S. 64: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 102: Prescription Drug Price Relief Act of 2019 - Provisions related to foreign reference pricing, patents and march-in rights S. 344: Hatch-Waxman Integrity Act of 2019 - Provisions related to PTAB proceedings and other patent system reforms S. 366: FLAT Prices Act - Provisions related to prescription drug patents, exclusivity periods and pricing S. 377: Medicare Negotiation and Competitive Licensing Act of 2019 - Provisions related to Part D, drug pricing negotiation and compulsory licensing S. 659: Biologic Patent Transparency Act - Provisions related to prescription drug patent disclosures S. 1169: Ensuring Timely Access to Generics Act of 2019 - Provisions related to citizen petitions S. 1209: Reforming Evergreening and Manipulation that Extends Drug Years Act - Provisions related to prescription drug patents S. 1224: Stop STALLING Act - Provisions related to citizen petitions S. 1416: Affordable Prescriptions for Patients Act of 2019 - Provisions related to prescription drug patents S. 1617: Second Look at Drug Patents Act of 2019 - Provisions related to prescription drug patents S. 1636: Ensuring Innovation Act - Provisions related to new chemical exclusivity Biopharmaceutical innovation and patent policy issues Patent litigation reform issues and issues related to post-grant proceedings at the PTO Bayh-Dole march-in rights policy issues
Client expense: $870,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
2019 · second_quarter · Copyright/Patent/Trademark
H.R. 465: Prescription Drug Price Relief Act of 2019 - Provisions related to foreign reference pricing, patents and march-in rights H.R. 938: BLOCKING Act of 2019 - Provisions related to 180 day generic prescription drug exclusivity H.R. 987: Strengthening Health Care and Lowering Prescription Drug Costs Act - Provisions related to prescription drug patent issues H.R. 990: Hatch-Waxman Integrity Act of 2019 - Provisions related to PTAB proceedings and other patent system reforms H.R. 1046: Medicare Negotiation and Competitive Licensing Act of 2019 - Provisions related to Part D, drug pricing negotiation and compulsory licensing H.R. 1188: FLAT Prices Act - Provisions related to prescription drug patents, exclusivity periods and pricing H.R. 1344: Competitive Deals Resulting in Unleased Generics and Savings Act of 2019 - Provisions related to patent settlements H.R. 1499: Protecting Consumer Access to Generic Drugs Act of 2019 - Provisions related to patent settlements H.R. 1503: Orange Book Transparency Act - Provisions related to prescription drug patent listings H.R. 1520: Purple Book Continuity Act of 2019 - Provisions related to biologic patent listings H.R. 2374: Stop STALLING Act - Provisions related to citizen petitions H.R. 2375: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements H.R. 2387: STOP GAMES Act of 2019 - Provisions related to citizen petitions H.R. 2455: Ensuring Timely Access to Generics Act of 2019 - Provisions related to citizen petitions H.R. 2700: Lowering Prescription Drug Costs and Extending Community Health Centers and Other Public Health Priorities Act - Provisions related to patent settlements, generic exclusivity, Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 3199: Terminating the Extension of Rights Misappropriated Act of 2019 - Provisions related to prescription drug patents S. 64: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 102: Prescription Drug Price Relief Act of 2019 - Provisions related to foreign reference pricing, patents and march-in rights S. 344: Hatch-Waxman Integrity Act of 2019 - Provisions related to PTAB proceedings and other patent system reforms S. 366: FLAT Prices Act - Provisions related to prescription drug patents, exclusivity periods and pricing S. 377: Medicare Negotiation and Competitive Licensing Act of 2019 - Provisions related to Part D, drug pricing negotiation and compulsory licensing S. 659: Biologic Patent Transparency Act - Provisions related to prescription drug patent disclosures S. 1169: Ensuring Timely Access to Generics Act of 2019 - Provisions related to citizen petitions S. 1209: Reforming Evergreening and Manipulation that Extends Drug Years Act - Provisions related to prescription drug patents S. 1224: Stop STALLING Act - Provisions related to citizen petitions S. 1416: Affordable Prescriptions for Patients Act of 2019 - Provisions related to prescription drug patents S. 1617: Second Look at Drug Patents Act of 2019 - Provisions related to prescription drug patents S. 1636: Ensuring Innovation Act - Provisions related to new chemical exclusivity Biopharmaceutical innovation and patent policy issues Patent litigation reform issues and issues related to post-grant proceedings at the PTO Bayh-Dole march-in rights policy issues
Client expense: $6,220,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
2019 · second_quarter · Copyright/Patent/Trademark
H.R. 1499, Protecting Consumer Access to Generic Drugs Act, regarding all bio-pharmaceutical related provisions H.R. 965, Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 1344, Competitive DRUGS Act, regarding all bio-pharmaceutical related provisions. S. 64, Preserve Access to Affordable Generics and Biosimilars Act,regarding all bio-pharmaceutical related provisions. S. 340, Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019, regarding all bio-pharmaceutical related provisions. H.R.2375, Preserve Access to Affordable Generics and Biosimilars Act, regarding all bio-pharmaceutical related provisions H.R. 2387, STOP GAMES Act, regarding all bio-pharmaceutical related provisions H.R. 3199, TERM Act, regarding all bio-pharmaceutical related provisions S. 440, PACED Act, regarding all bio-pharmaceutical related provisions S. 1224/H.R.2374, Stop STALLING Act, regarding all bio-pharmaceutical related provisions S.1416, Affordable Prescriptions for Patients Act, regarding all bio-pharmaceutical related provisions S. 1617, Second Look at Drug Patents Act, regarding all bio-pharmaceutical related provisions
Client expense: $970,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)
2019 · second_quarter · Pharmacy
HR 1046/S 377-Medicare negotiation and competitive licensing act, HR 938-BLOCKING ACT, hr 965/s340- (creates ACT), HR 1503-Orange book transparency act, HR 1520-Purple book continuity act, HR 1499-Protecting consumer access to generic drugs act, S 64-preserve access to affordable generics and biosimilars act, drug pricing, HR 2113-Prescription drug STAR act, HR 1093/S 378 (Stop price gouging act, HR 1344-Competitive drugs act, HR 465/S 102-Prescription drug price relief act, HR-3379- PRICED act, affordable drug manufacturing act, S 1416-Affordable prescriptions to patients act, HR 2374/S 1224 (stop STALLING act) HR 2917 Opioid Crisis accountability act, S 1209-REMEDY ACT, hr 6505 Medicare Negotiation and competitive Licensing act, SEC 101-Patent reform legislation
Client expense: $110,000 · Firm income: Not reported
Government targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, SENATE, Securities & Exchange Commission (SEC), U.S. Trade Representative (USTR)
2019 · first_quarter · Health Issues
S.340/HR 965-Creating & Restoring Equal Access to Equivalent Samples Act ("Creates Act"); HR 985-Fast Generics Act; S.64-Preserve Access to Affordable Generic & Biosimilars Act; HR 1499-Protecting Consumer Access to Generic Drugs Act; HR 1344-Competitive Drugs Act of 2019; HR 938-Bringing Low Cost Options & Competition While Keeping Incentives for New Generics Act ("BLOCKING Act"); HR 1506-Fair & Immediate Release of Generic Drugs Act; HR 1520-Purple Book Continuity Act; HR 1503-Orange Book Transparency Act; S.344/HR 990-Hatch-Waxman Integrity Act; Stronger Patents Act; and Administration rveview of drug pricing policies.
Client expense: $740,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR)
2019 · first_quarter · Copyright/Patent/Trademark
H.R. 465: Prescription Drug Price Relief Act of 2019 - Provisions related to foreign reference pricing and patents H.R. 938: BLOCKING Act of 2019 - Provisions related to 180 day generic prescription drug exclusivity H.R. 990: Hatch-Waxman Integrity Act of 2019 - Provisions related to PTAB proceedings and other patent system reforms H.R. 1188: FLAT Prices Act - Provisions related to prescription drug exclusivity periods and pricing H.R. 1344: Competitive Deals Resulting in Unleashed Generics and Savings Act of 2019 - Provisions related to patent settlements H.R. 1499: Protecting Consumer Access to Generic Drugs Act of 2019 - Provisions related to patent settlements H.R. 1503: Orange Book Transparency Act of 2019 - Provisions related to patent listings H.R. 1506: Fair and Immediate Release of (FAIR) Generic Drugs Act - Provisions related to 180 day exclusivity and patent litigation H.R. 1520: Purple Book Continuity Act of 2019 - Provisions related to biologics patent listings H.R. 2011: To amend the Public Health Service Act with respect to the treatment under section 351(k)(7) of such Act (relating to exclusivity for reference products) of certain products deemed to have a biologics license pursuant to section 7002 of the Biologics Price Competition and Innovation Act of 2009 S. 64: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 102: Prescription Drug Price Relief Act of 2019 - Provisions related to foreign reference pricing and patents S. 344: Hatch-Waxman Integrity Act of 2019 - Provisions related to PTAB proceedings and other patent system reforms S. 366: FLAT Prices Act - Provisions related to prescription drug exclusivity periods and pricing S. 659: Biologic Patent Transparency Act - Provisions related to biologic patent disclosures Biopharmaceutical innovation and patent policy issues Patent litigation reform issues and issues related to post-grant proceeding at the PTO Bayh-Dole march-in rights policy issues
Client expense: $1,490,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
2019 · first_quarter · Health Issues
S.340/HR 965-Creating & Restoring Equal Access to Equivalent Samples Act ("Creates Act"); HR 985-Fast Generics Act; S.64-Preserve Access to Affordable Generic & Biosimilars Act; HR 1499-Protecting Consumer Access to Generic Drugs Act; HR 1344-Competitive Drugs Act of 2019; HR 938-Bringing Low Cost Options & Competition While Keeping Incentives for New Generics Act ("BLOCKING Act"); HR 1506-Fair & Immediate Release of Generic Drugs Act; HR 1520-Purple Book Continuity Act; HR 1503-Orange Book Transparency Act; S.344/HR 990-Hatch-Waxman Integrity Act; Stronger Patents Act; and Administration rveview of drug pricing policies.
Client expense: $720,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR)