Loading…
A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity.
Legislative Progress
Momentum (last 30 days)
0
score
0 actions · 0 new cosponsors · 0 votes
Speed vs cohort
86pct
58d open
vs 5,357 other S bills in the 117th — cohort avg 38d
This bill provides statutory authority for the existing Food and Drug Administration (FDA) practice of defining active ingredient more narrowly as active moiety in certain situations, such as when determining whether a new drug is entitled to a market exclusivity period or providing priority review of drugs for treating rare pediatric diseases. Generally, the FDA defines active moiety as the core molecule or ion in a drug responsible for the relevant physiological or pharmacological action. By contrast, the FDA defines an active ingredient as a component in a drug that is intended to furnish pharmacological activity or other direct effect. The FDA's existing practice of interpreting active ingredient as active moiety in certain situations, as statutorily authorized by this bill, tends to exclude some drugs from market exclusivity. The bill replaces references to active ingredient with active moiety in various statutes authorizing FDA activities.
These links require the bill number to appear in the filing's source-reported specific issue text. Client expenses and lobbying-firm income are separate disclosure fields.
Filing registrants (8)
Became Public Law No: 117-9.
Became Public Law No: 117-9.
Signed by President.
Signed by President.
Presented to President.
Presented to President.
Motion to reconsider laid on the table Agreed to without objection.
On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H1755)
Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote.(text: CR H1755)
DEBATE - The House proceeded with forty minutes of debate on S. 415.
Considered under suspension of the rules. (consideration: CR H1755-1756)
Bills with similar content found using semantic analysis.
Sources: Congress.gov
2022 · third_quarter · Health Issues
H.R. 5376, Inflation Reduction Act (drug pricing provisions). S.3799, "Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act" or the "PREVENT Pandemics Act." Presidents FY23 Budget Request. H.R. 7032, the Increasing Transparency in Generic Drug Applications Act. H.R. 7035, the Biologics Market Transparency Act." H.R. 7047, a bill to amend title III of the Public Health Service Act with respect to the determination by the Secretary regarding certain biosimilar application elements, and for other purposes. H.R. 1730, the Speeding Therapy Access Today Act of 2021. H.R. 2565, the FDA Modernization Act of 2021. H.R. 3085, the Equity in Neuroscience and Alzheimers Clinical Trials Act of 2021 or the ENACT Act of 2021. H.R. 3927, the Manufacturing API, Drugs, and Excipients in America Act or the MADE in America Act. H.R. 6963, the Accelerated Approval Integrity Act of 2022. H.R. 6973, the Enhanced Access to Affordable Medicines Act. H.R. 7006, the Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act." H.R. 7032, the Increasing Transparency in Generic Drug Applications Act. Proposals related to the COVID-19 crisis including proposals to abrogate pharmaceutical patents used in the COVID-19 pandemic. Build Back Better Act provisions relating to drug pricing and H.R. 3, the "Elijah E. Cummings Lower Drug Costs Now Act." H.R. 19, the "Lower Costs, More Cures Act of 2021." HHS drug pricing plan to lower drug costs issued in connection with Executive Order 14,036 (Promote Competition in the American Economy). H.R. 2853, the "Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics Act of 2021" (or the "BLOCKING Act"). H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 (product hopping). Proposals to change pharmaceutical patent laws including H.R. 2891, "Preserve Access to Affordable Generics & Biosimilars Act" (patent settlements) and H.R. 2884, the "Affordable Prescriptions for Patients Through Improvement to Patent Litigation Act" (BPCIA litigation limits). Proposals to improve pharmaceutical supply-chain vulnerabilities. Proposals to retain and attract greater domestic manufacturing of pharmaceuticals including H.R. 2870, The Essential Medicines Strategic Stockpile Act of 2021. Proposals to change Medicare and Medicaid benefit design. Proposals to improve the drug approval process for generic medicines including H.R. 2883, "Stop Stalling Access to Affordable Medications Act" (citizens petitions), H.R. 2831, the "Prompt Approval of Safe Generic Drugs Act," H.R. 2843, "Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2021" (or the "STOP GAMES Act"), and S. 1462, the Simplifying the Generic Drug Application Process Act. S.164, Advancing Education on Biosimilars Act of 2021. S.415, a bill to amend the Federal Food, Drug & Cosmetic Act with respect to the scope of new chemical exclusivity. Implementation of the Food & Drug Reauthorization Act (PL 115-52). H.R. 153, the "Protecting Consumer Access to Generic Drugs Act of 2021." H.R. 2815, the "Bolstering Innovative Options to Save Immediately on Medicines Act" (or the "BIOSIM Act"). H.R. 2846, to amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purpose. S.1463, the Modernizing Therapeutic Equivalence Rating Determination Act.
Client expense: $830,000 · 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), SENATE
2022 · fourth_quarter · Copyright/Patent/Trademark
H.R. 1629: Fairness in Orphan Drug Exclusivity Act - Provisions related to FDA policy and orphan drugs H.R. 2148: Prescription Drug Price Relief Act of 2021 - Provisions related to prescription drug pricing and march-in rights H.R. 2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 - Provisions related to intellectual property and patents H.R. 2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act - Provisions related to patent infringement H.R. 2891: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements H.R. 5635: Intellectual Property Violators Accountability and Transparency Act - Provisions related to intellectual property protections H.R. 5874: Restoring Americas Leadership in Innovation Act of 2021 - Provisions related to intellectual property protections S. 250: Fairness in Orphan Drug Exclusivity Act - Provisions related to FDA policy and orphan drugs S. 415: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity (Public Law 117-9) - Provisions related to FDA policy and exclusivity S. 1428: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 1435: Affordable Prescriptions for Patients Act of 2021 - Provisions related to intellectual property and patents S. 2773: Unleashing American Innovators Act or 2021 - Provisions related to USPTO policy S. 2774: Pride in Patent Ownership Act - Provisions related to patent transparency S. 2891: Restoring the America Invents Act - A bill to amend title 35, United States Code, to address matters relating to the Patent Trial and Appeal Board of the United States Patent and Trademark Office, and for other purposes S. 2910: Expanding Access to Low-Cost Generics Act of 2021 - To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period, and for other purposes S. 4417: Patent Trial and Appeal Board Reform Act of 2022 - To amend title 35, United States Code, to address matter relating to the Patent Trial and Appeal Board of the United States Patent and Trademark Office, and for other purposes S. 4430: Interagency Patent Coordination and Improvement Act of 2022 S. 4704: Patent Examination and Quality Improvement Act of 2022 S. 4918: Increasing Prescription Drug Competition Act - Patent-related policy issues Biopharmaceutical innovation and patent policy issues Bayh-Dole march-in rights policy issues
Client expense: $860,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE
2022 · fourth_quarter · Copyright/Patent/Trademark
H.R. 1629: Fairness in Orphan Drug Exclusivity Act - Provisions related to FDA policy and orphan drugs H.R. 2148: Prescription Drug Price Relief Act of 2021 - Provisions related to prescription drug pricing and march-in rights H.R. 2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 - Provisions related to intellectual property and patents H.R. 2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act - Provisions related to patent infringement H.R. 2891: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements H.R. 5635: Intellectual Property Violators Accountability and Transparency Act - Provisions related to intellectual property protections H.R. 5874: Restoring Americas Leadership in Innovation Act of 2021 - Provisions related to intellectual property protections S. 250: Fairness in Orphan Drug Exclusivity Act - Provisions related to FDA policy and orphan drugs S. 415: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity (Public Law 117-9) - Provisions related to FDA policy and exclusivity S. 1428: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 1435: Affordable Prescriptions for Patients Act of 2021 - Provisions related to intellectual property and patents S. 2773: Unleashing American Innovators Act of 2021 - Provisions related to USPTO policy S. 2774: Pride in Patent Ownership Act - Provisions related to patent transparency S. 2891: Restoring the America Invents Act - A bill to amend title 35, United States Code, to address matters relating to the Patent Trial and Appeal Board of the United States Patent and Trademark Office, and for other purposes S. 2910: Expanding Access to Low-Cost Generics Act of 2021 - To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period, and for other purposes S. 4417: Patent Trial and Appeal Board Reform Act of 2022 - To amend title 35, United States Code, to address matters relating to the Patent Trial and Appeal Board of the United States Patent and Trademark Office, and for other purposes S. 4430: Interagency Patent Coordination and Improvement Act of 2022 S. 4704: Patent Examination and Quality Improvement Act of 2022 S. 4918: Increasing Prescription Drug Competition Act - Patent-related policy issues Biopharmaceutical innovation and patent policy issues Bayh-Dole march-in rights policy issues
Client expense: $6,610,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE
2022 · fourth_quarter · Health Issues
Consolidated Appropriations Act of 2023, H.R. 2617 (provisions related to pharmaceuticals and healthcare). H.R. 5376, Inflation Reduction Act (drug pricing provisions). S.3799, "Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act" or the "PREVENT Pandemics Act." Presidents FY23 Budget Request. H.R. 7032, the Increasing Transparency in Generic Drug Applications Act. H.R. 7035, the Biologics Market Transparency Act." H.R. 7047, a bill to amend title III of the Public Health Service Act with respect to the determination by the Secretary regarding certain biosimilar application elements, and for other purposes. H.R. 1730, the Speeding Therapy Access Today Act of 2021. H.R. 2565, the FDA Modernization Act of 2021. H.R. 3085, the Equity in Neuroscience and Alzheimers Clinical Trials Act of 2021 or the ENACT Act of 2021. H.R. 3927, the Manufacturing API, Drugs, and Excipients in America Act or the MADE in America Act. H.R. 6963, the Accelerated Approval Integrity Act of 2022. H.R. 6973, the Enhanced Access to Affordable Medicines Act. H.R. 7006, the Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act." H.R. 7032, the Increasing Transparency in Generic Drug Applications Act. Proposals related to the COVID-19 crisis including proposals to abrogate pharmaceutical patents used in the COVID-19 pandemic. Build Back Better Act provisions relating to drug pricing and H.R. 3, the "Elijah E. Cummings Lower Drug Costs Now Act." H.R. 19, the "Lower Costs, More Cures Act of 2021." HHS drug pricing plan to lower drug costs issued in connection with Executive Order 14,036 (Promote Competition in the American Economy). H.R. 2853, the "Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics Act of 2021" (or the "BLOCKING Act"). H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 (product hopping). Proposals to change pharmaceutical patent laws including H.R. 2891, "Preserve Access to Affordable Generics & Biosimilars Act" (patent settlements) and H.R. 2884, the "Affordable Prescriptions for Patients Through Improvement to Patent Litigation Act" (BPCIA litigation limits). Proposals to improve pharmaceutical supply-chain vulnerabilities. Proposals to retain and attract greater domestic manufacturing of pharmaceuticals including H.R. 2870, The Essential Medicines Strategic Stockpile Act of 2021. Proposals to change Medicare and Medicaid benefit design. Proposals to improve the drug approval process for generic medicines including H.R. 2883, "Stop Stalling Access to Affordable Medications Act" (citizens petitions), H.R. 2831, the "Prompt Approval of Safe Generic Drugs Act," H.R. 2843, "Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2021" (or the "STOP GAMES Act"), and S. 1462, the Simplifying the Generic Drug Application Process Act. S.164, Advancing Education on Biosimilars Act of 2021. S.415, a bill to amend the Federal Food, Drug & Cosmetic Act with respect to the scope of new chemical exclusivity. Implementation of the Food & Drug Reauthorization Act (PL 115-52). H.R. 153, the "Protecting Consumer Access to Generic Drugs Act of 2021." H.R. 2815, the "Bolstering Innovative Options to Save Immediately on Medicines Act" (or the "BIOSIM Act"). H.R. 2846, to amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purpose. S.1463, the Modernizing Therapeutic Equivalence Rating Determination Act.
Client expense: $480,000 · 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), SENATE
2022 · third_quarter · Copyright/Patent/Trademark
H.R. 2148: Prescription Drug Price Relief Act of 2021 - Provisions related to prescription drug pricing and march-in rights H.R. 2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 - Provisions related to intellectual property and patents H.R. 2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act - Provisions related to patent infringement H.R. 2891: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements H.R. 5635: Intellectual Property Violators Accountability and Transparency Act - Provisions related to intellectual property protections H.R. 5874: Restoring Americas Leadership in Innovation Act of 2021 - Provisions related to intellectual property protections S. 415: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity (Public Law 117-9) - Provisions related to FDA policy and exclusivity S. 1428: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 1435: Affordable Prescriptions for Patients Act of 2021 - Provisions related to intellectual property and patents S. 2773: Unleashing American Innovators Act or 2021 - Provisions related to USPTO policy S. 2774: Pride in Patent Ownership Act - Provisions related to patent transparency S. 2891: Restoring the America Invents Act - A bill to amend title 35, United States Code, to address matters relating to the Patent Trial and Appeal Board of the United States Patent and Trademark Office, and for other purposes S. 2910: Expanding Access to Low-Cost Generics Act of 2021 - To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period, and for other purposes S. 4417: Patent Trial and Appeal Board Reform Act of 2022 - To amend title 35, United States Code, to address matter relating to the Patent Trial and Appeal Board of the United States Patent and Trademark Office, and for other purposes S. 4430: Interagency Patent Coordination and Improvement Act of 2022 S. 4918: Increasing Prescription Drug Competition Act - Patent-related policy issues Biopharmaceutical innovation and patent policy issues Bayh-Dole march-in rights policy issues
Client expense: $1,390,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE
2022 · third_quarter · Copyright/Patent/Trademark
H.R. 1629: Fairness in Orphan Drug Exclusivity Act - Provisions related to FDA policy and orphan drugs H.R. 2148: Prescription Drug Price Relief Act of 2021 - Provisions related to prescription drug pricing and march-in rights H.R. 2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 - Provisions related to intellectual property and patents H.R. 2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act - Provisions related to patent infringement H.R. 2891: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements H.R. 5635: Intellectual Property Violators Accountability and Transparency Act - Provisions related to intellectual property protections H.R. 5874: Restoring Americas Leadership in Innovation Act of 2021 - Provisions related to intellectual property protections S. 250: Fairness in Orphan Drug Exclusivity Act - Provisions related to FDA policy and orphan drugs S. 415: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity (Public Law 117-9) - Provisions related to FDA policy and exclusivity S. 1428: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 1435: Affordable Prescriptions for Patients Act of 2021 - Provisions related to intellectual property and patents S. 2773: Unleashing American Innovators Act of 2021 - Provisions related to USPTO policy S. 2774: Pride in Patent Ownership Act - Provisions related to patent transparency S. 2891: Restoring the America Invents Act - A bill to amend title 35, United States Code, to address matters relating to the Patent Trial and Appeal Board of the United States Patent and Trademark Office, and for other purposes S. 2910: Expanding Access to Low-Cost Generics Act of 2021 - To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period, and for other purposes S. 4417: Patent Trial and Appeal Board Reform Act of 2022 - To amend title 35, United States Code, to address matters relating to the Patent Trial and Appeal Board of the United States Patent and Trademark Office, and for other purposes S. 4430: Interagency Patent Coordination and Improvement Act of 2022 S. 4704: Patent Examination and Quality Improvement Act of 2022 S. 4918: Increasing Prescription Drug Competition Act - Patent-related policy issues Biopharmaceutical innovation and patent policy issues Bayh-Dole march-in rights policy issues
2022 · third_quarter · Health Issues
H.R. 5376, Inflation Reduction Act (drug pricing provisions). S.3799, "Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act" or the "PREVENT Pandemics Act." Presidents FY23 Budget Request. H.R. 7032, the Increasing Transparency in Generic Drug Applications Act. H.R. 7035, the Biologics Market Transparency Act." H.R. 7047, a bill to amend title III of the Public Health Service Act with respect to the determination by the Secretary regarding certain biosimilar application elements, and for other purposes. H.R. 1730, the Speeding Therapy Access Today Act of 2021. H.R. 2565, the FDA Modernization Act of 2021. H.R. 3085, the Equity in Neuroscience and Alzheimers Clinical Trials Act of 2021 or the ENACT Act of 2021. H.R. 3927, the Manufacturing API, Drugs, and Excipients in America Act or the MADE in America Act. H.R. 6963, the Accelerated Approval Integrity Act of 2022. H.R. 6973, the Enhanced Access to Affordable Medicines Act. H.R. 7006, the Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act." H.R. 7032, the Increasing Transparency in Generic Drug Applications Act. Proposals related to the COVID-19 crisis including proposals to abrogate pharmaceutical patents used in the COVID-19 pandemic. Build Back Better Act provisions relating to drug pricing and H.R. 3, the "Elijah E. Cummings Lower Drug Costs Now Act." H.R. 19, the "Lower Costs, More Cures Act of 2021." HHS drug pricing plan to lower drug costs issued in connection with Executive Order 14,036 (Promote Competition in the American Economy). H.R. 2853, the "Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics Act of 2021" (or the "BLOCKING Act"). H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 (product hopping). Proposals to change pharmaceutical patent laws including H.R. 2891, "Preserve Access to Affordable Generics & Biosimilars Act" (patent settlements) and H.R. 2884, the "Affordable Prescriptions for Patients Through Improvement to Patent Litigation Act" (BPCIA litigation limits). Proposals to improve pharmaceutical supply-chain vulnerabilities. Proposals to retain and attract greater domestic manufacturing of pharmaceuticals including H.R. 2870, The Essential Medicines Strategic Stockpile Act of 2021. Proposals to change Medicare and Medicaid benefit design. Proposals to improve the drug approval process for generic medicines including H.R. 2883, "Stop Stalling Access to Affordable Medications Act" (citizens petitions), H.R. 2831, the "Prompt Approval of Safe Generic Drugs Act," H.R. 2843, "Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2021" (or the "STOP GAMES Act"), and S. 1462, the Simplifying the Generic Drug Application Process Act. S.164, Advancing Education on Biosimilars Act of 2021. S.415, a bill to amend the Federal Food, Drug & Cosmetic Act with respect to the scope of new chemical exclusivity. Implementation of the Food & Drug Reauthorization Act (PL 115-52). H.R. 153, the "Protecting Consumer Access to Generic Drugs Act of 2021." H.R. 2815, the "Bolstering Innovative Options to Save Immediately on Medicines Act" (or the "BIOSIM Act"). H.R. 2846, to amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purpose. S.1463, the Modernizing Therapeutic Equivalence Rating Determination Act.
2022 · second_quarter · Copyright/Patent/Trademark
H.R. 1629: Fairness in Orphan Drug Exclusivity Act - Provisions related to FDA policy and orphan drugs H.R. 1857: Protecting Access to Safe and Effective Medicines Act of 2021 - Provisions related to FDA policy and exclusivity H.R. 2148: Prescription Drug Price Relief Act of 2021 - Provisions related to prescription drug pricing and march-in rights H.R. 2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 - Provisions related to intellectual property and patents H.R. 2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act - Provisions related to patent infringement H.R. 2891: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements H.R. 5635: Intellectual Property Violators Accountability and Transparency Act - Provisions related to intellectual property protections H.R. 5874: Restoring Americas Leadership in Innovation Act of 2021 - Provisions related to intellectual property protections S. 250: Fairness in Orphan Drug Exclusivity Act - Provisions related to FDA policy and orphan drugs S. 415: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity (Public Law 117-9) - Provisions related to FDA policy and exclusivity S. 1428: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 1435: Affordable Prescriptions for Patients Act of 2021 - Provisions related to intellectual property and patents S. 2773: Unleashing American Innovators Act or 2021 - Provisions related to USPTO policy S. 2774: Pride in Patent Ownership Act - Provisions related to patent transparency S. 2891: Restoring the America Invents Act - A bill to amend title 35, United States Code, to address matters relating to the Patent Trial and Appeal Board of the United States Patent and Trademark Office, and for other purposes S. 2910: Expanding Access to Low-Cost Generics Act of 2021 - To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period, and for other purposes S. 4417: Patent Trial and Appeal Board Reform Act of 2022 - To amend title 35, United States Code, to address matter relating to the Patent Trial and Appeal Board of the United States Patent and Trademark Office, and for other purposes S. 4430: Interagency Patent Coordination and Improvement Act of 2022 Biopharmaceutical innovation and patent policy issues Bayh-Dole march-in rights policy issues
2022 · second_quarter · Copyright/Patent/Trademark
H.R. 1629: Fairness in Orphan Drug Exclusivity Act - Provisions related to FDA policy and orphan drugs H.R. 1857: Protecting Access to Safe and Effective Medicines Act of 2021 - Provisions related to FDA policy and exclusivity H.R. 2148: Prescription Drug Price Relief Act of 2021 - Provisions related to prescription drug pricing and march-in rights H.R. 2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 - Provisions related to intellectual property and patents H.R. 2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act - Provisions related to patent infringement H.R. 2891: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements H.R. 5635: Intellectual Property Violators Accountability and Transparency Act - Provisions related to intellectual property protections H.R. 5874: Restoring Americas Leadership in Innovation Act of 2021 - Provisions related to intellectual property protections S. 250: Fairness in Orphan Drug Exclusivity Act - Provisions related to FDA policy and orphan drugs S. 415: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity (Public Law 117-9) - Provisions related to FDA policy and exclusivity S. 1428: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 1435: Affordable Prescriptions for Patients Act of 2021 - Provisions related to intellectual property and patents S. 2773: Unleashing American Innovators Act of 2021 - Provisions related to USPTO policy S. 2774: Pride in Patent Ownership Act - Provisions related to patent transparency S. 2891: Restoring the America Invents Act - A bill to amend title 35, United States Code, to address matters relating to the Patent Trial and Appeal Board of the United States Patent and Trademark Office, and for other purposes S. 2910: Expanding Access to Low-Cost Generics Act of 2021 - To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period, and for other purposes S. 4417: Patent Trial and Appeal Board Reform Act of 2022 - To amend title 35, United States Code, to address matters relating to the Patent Trial and Appeal Board of the United States Patent and Trademark Office, and for other purposes S. 4430: Interagency Patent Coordination and Improvement Act of 2022 Biopharmaceutical innovation and patent policy issues Bayh-Dole march-in rights policy issues
2022 · second_quarter · Health Issues
S.3799, "Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act" or the "PREVENT Pandemics Act"; Presidents FY23 Budget Request; H.R. 7032, the Increasing Transparency in Generic Drug Applications Act; H.R. 7035, the Biologics Market Transparency Act"; H.R. 7047, a bill to amend title III of the Public Health Service Act with respect to the determination by the Secretary regarding certain biosimilar application elements, and for other purposes; H.R. 1730, the Speeding Therapy Access Today Act of 2021; H.R. 2565, the FDA Modernization Act of 2021 ; H.R. 3085, the Equity in Neuroscience and Alzheimers Clinical Trials Act of 2021 or the ENACT Act of 2021; H.R. 3927, the Manufacturing API, Drugs, and Excipients in America Act or the MADE in America Act; H.R. 6963, the Accelerated Approval Integrity Act of 2022; H.R. 6973, the Enhanced Access to Affordable Medicines Act; H.R. 7006, the Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act; H.R. 7032, the Increasing Transparency in Generic Drug Applications Act; proposals related to the COVID-19 crisis including proposals to abrogate pharmaceutical patents used in the COVID-19 pandemic. Build Back Better Act provisions relating to drug pricing and HR 3, the "Elijah E. Cummings Lower Drug Costs Now Act," HR 19, the "Lower Costs, More Cures Act of 2021," HHS drug pricing plan to lower drug costs issued in connection with Executive Order 14,036 (Promote Competition in the American Economy), HR 2853, the "Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics Act of 2021" (or the "BLOCKING Act"), and HR 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 (product hopping). Proposals to change pharmaceutical patent laws including HR 2891, "Preserve Access to Affordable Generics & Biosimilars Act" (patent settlements), and HR 2884, the "Affordable Prescriptions for Patients Through Improvement to Patent Litigation Act" (BPCIA litigation limits). Proposals to improve pharmaceutical supply-chain vulnerabilities. Proposals to retain and attract greater domestic manufacturing of pharmaceuticals including H.R. 2870, The Essential Medicines Strategic Stockpile Act of 2021. Proposals to change Medicare and Medicaid benefit design. Proposals to improve the drug approval process for generic medicines including HR 2883, "Stop Stalling Access to Affordable Medications Act" (citizens petitions), HR 2831, the "Prompt Approval of Safe Generic Drugs Act," HR 2843, "Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2021" (or the "STOP GAMES Act"), and S. 1462, the Simplifying the Generic Drug Application Process Act. S.164, Advancing Education on Biosimilars Act of 2021. S.415, a bill to amend the Federal Food, Drug & Cosmetic Act with respect to the scope of new chemical exclusivity. Implementation of the Food & Drug Reauthorization Act (PL 115-52). HR 153, the "Protecting Consumer Access to Generic Drugs Act of 2021." HR 2815, the "Bolstering Innovative Options to Save Immediately on Medicines Act" (or the "BIOSIM Act"). HR 2846, to amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purpose. S.1463, the Modernizing Therapeutic Equivalence Rating Determination Act.
2022 · first_quarter · Copyright/Patent/Trademark
H.R. 153: Protecting Consumer Access to Generic Drugs Act of 2021 - Provisions related to patent settlements H.R. 728: Pandemic Emergency Manufacturing Act of 2021 - Provisions related to intellectual property and march-in rights H.R. 1629: Fairness in Orphan Drug Exclusivity Act - Provisions related to FDA policy and orphan drugs H.R. 2148: Prescription Drug Price Relief Act of 2021 - Provisions related to prescription drug pricing and march-in rights H.R. 2853: BLOCKING Act of 2021 - Provisions related to FDA exclusivity periods H.R. 2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 - Provisions related to intellectual property and patents H.R. 2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act - Provisions related to patent infringement H.R. 2891: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 187: Pandemic Emergency Manufacturing Act of 2021 - Provisions related to intellectual property and march-in rights S. 250: Fairness in Orphan Drug Exclusivity Act - Provisions related to FDA policy and orphan drugs S. 415: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity - Provisions related to FDA policy and exclusivity S. 1428: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 1435: Affordable Prescriptions for Patients Act of 2021 - Provisions related to intellectual property and patents S. 2774: Pride in Patent Ownership Act - Provisions related to patent transparency S. 2891: Restoring the America Invents Act - Provisions related to USPTO policy Biopharmaceutical innovation and patent policy issues Bayh-Dole march-in rights policy issues
Client expense: $1,100,000 · Firm income: Not reported
2022 · first_quarter · Copyright/Patent/Trademark
H.R. 153: Protecting Consumer Access to Generic Drugs Act of 2021 - Provisions related to patent settlements H.R. 728: Pandemic Emergency Manufacturing Act of 2021 - Provisions related to intellectual property and march-in rights H.R. 1629: Fairness in Orphan Drug Exclusivity Act - Provisions related to FDA policy and orphan drugs H.R. 2148: Prescription Drug Price Relief Act of 2021 - Provisions related to prescription drug pricing and march-in rights H.R. 2853: BLOCKING Act of 2021 - Provisions related to FDA exclusivity periods H.R. 2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 - Provisions related to intellectual property and patents H.R. 2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act - Provisions related to patent infringement H.R. 2891: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 187: Pandemic Emergency Manufacturing Act of 2021 - Provisions related to intellectual property and march-in rights S. 250: Fairness in Orphan Drug Exclusivity Act - Provisions related to FDA policy and orphan drugs S. 415: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity - Provisions related to FDA policy and exclusivity S. 1428: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 1435: Affordable Prescriptions for Patients Act of 2021 - Provisions related to intellectual property and patents S. 2774: Pride in Patent Ownership Act - Provisions related to patent transparency S. 2891: Restoring the America Invents Act - Provisions related to USPTO policy Biopharmaceutical innovation and patent policy issues Bayh-Dole march-in rights policy issues
Client expense: $830,000 · Firm income: Not reported
2022 · first_quarter · Health Issues
S.3799, "Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act" or the "PREVENT Pandemics Act"; Presidents FY23 Budget Request; H.R. 7032, the Increasing Transparency in Generic Drug Applications Act; H.R. 7035, the Biologics Market Transparency Act"; H.R. 7047, a bill to amend title III of the Public Health Service Act with respect to the determination by the Secretary regarding certain biosimilar application elements, and for other purposes; H.R. 1730, the Speeding Therapy Access Today Act of 2021; H.R. 2565, the FDA Modernization Act of 2021 ; H.R. 3085, the Equity in Neuroscience and Alzheimers Clinical Trials Act of 2021 or the ENACT Act of 2021; H.R. 3927, the Manufacturing API, Drugs, and Excipients in America Act or the MADE in America Act; H.R. 6963, the Accelerated Approval Integrity Act of 2022; H.R. 6973, the Enhanced Access to Affordable Medicines Act; H.R. 7006, the Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act; H.R. 7032, the Increasing Transparency in Generic Drug Applications Act; proposals related to the COVID-19 crisis including proposals to abrogate pharmaceutical patents used in the COVID-19 pandemic. Build Back Better Act provisions relating to drug pricing and HR 3, the "Elijah E. Cummings Lower Drug Costs Now Act," HR 19, the "Lower Costs, More Cures Act of 2021," HHS drug pricing plan to lower drug costs issued in connection with Executive Order 14,036 (Promote Competition in the American Economy), HR 2853, the "Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics Act of 2021" (or the "BLOCKING Act"), and HR 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 (product hopping). Proposals to change pharmaceutical patent laws including HR 2891, "Preserve Access to Affordable Generics & Biosimilars Act" (patent settlements), and HR 2884, the "Affordable Prescriptions for Patients Through Improvement to Patent Litigation Act" (BPCIA litigation limits). Proposals to improve pharmaceutical supply-chain vulnerabilities. Proposals to retain and attract greater domestic manufacturing of pharmaceuticals including H.R. 2870, The Essential Medicines Strategic Stockpile Act of 2021. Proposals to change Medicare and Medicaid benefit design. Proposals to improve the drug approval process for generic medicines including HR 2883, "Stop Stalling Access to Affordable Medications Act" (citizens petitions), HR 2831, the "Prompt Approval of Safe Generic Drugs Act," HR 2843, "Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2021" (or the "STOP GAMES Act"), and S. 1462, the Simplifying the Generic Drug Application Process Act. S.164, Advancing Education on Biosimilars Act of 2021. S.415, a bill to amend the Federal Food, Drug & Cosmetic Act with respect to the scope of new chemical exclusivity. Implementation of the Food & Drug Reauthorization Act (PL 115-52). HR 153, the "Protecting Consumer Access to Generic Drugs Act of 2021." HR 2815, the "Bolstering Innovative Options to Save Immediately on Medicines Act" (or the "BIOSIM Act"). HR 2846, to amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purpose. S.1463, the Modernizing Therapeutic Equivalence Rating Determination Act.
2022 · first_quarter · Copyright/Patent/Trademark
H.R. 153: Protecting Consumer Access to Generic Drugs Act of 2021 - Provisions related to patent settlements H.R. 728: Pandemic Emergency Manufacturing Act of 2021 - Provisions related to intellectual property and march-in rights H.R. 1629: Fairness in Orphan Drug Exclusivity Act - Provisions related to FDA policy and orphan drugs H.R. 2148: Prescription Drug Price Relief Act of 2021 - Provisions related to prescription drug pricing and march-in rights H.R. 2853: BLOCKING Act of 2021 - Provisions related to FDA exclusivity periods H.R. 2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 - Provisions related to intellectual property and patents H.R. 2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act - Provisions related to patent infringement H.R. 2891: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 187: Pandemic Emergency Manufacturing Act of 2021 - Provisions related to intellectual property and march-in rights S. 250: Fairness in Orphan Drug Exclusivity Act - Provisions related to FDA policy and orphan drugs S. 415: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity - Provisions related to FDA policy and exclusivity S. 1428: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 1435: Affordable Prescriptions for Patients Act of 2021 - Provisions related to intellectual property and patents S. 2774: Pride in Patent Ownership Act - Provisions related to patent transparency S. 2891: Restoring the America Invents Act - Provisions related to USPTO policy Biopharmaceutical innovation and patent policy issues Bayh-Dole march-in rights policy issues
2021 · fourth_quarter · Copyright/Patent/Trademark
H.R. 153: Protecting Consumer Access to Generic Drugs Act of 2021 - Provisions related to patent settlements H.R. 597: Pandemic Treatment Access and Affordability Act of 2021 - Provisions related to intellectual property H.R. 728: Pandemic Emergency Manufacturing Act of 2021 - Provisions related to intellectual property and march-in rights H.R. 1629: Fairness in Orphan Drug Exclusivity Act - Provisions related to FDA policy and orphan drugs H.R. 1857: Protecting Access to Safe and Effective Medicines Act of 2021 - Provisions related to FDA policy and exclusivity H.R. 2148: Prescription Drug Price Relief Act of 2021 - Provisions related to prescription drug pricing and march-in rights H.R. 2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 - Provisions related to intellectual property and patents H.R. 2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act - Provisions related to patent infringement H.R. 2891: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 187: Pandemic Emergency Manufacturing Act of 2021 - Provisions related to intellectual property and march-in rights S. 250: Fairness in Orphan Drug Exclusivity Act - Provisions related to FDA policy and orphan drugs S. 415: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity - Provisions related to FDA policy and exclusivity S. 1428: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 1435: Affordable Prescriptions for Patients Act of 2021 - Provisions related to intellectual property and patents S. 2774: Pride in Patent Ownership Act - Provisions related to patent transparency S. 2891: Restoring the America Invents Act - Provisions related to USPTO policy Biopharmaceutical innovation and patent policy issues Bayh-Dole march-in rights policy issues
2021 · fourth_quarter · Copyright/Patent/Trademark
H.R. 153: Protecting Consumer Access to Generic Drugs Act of 2021 - Provisions related to patent settlements H.R. 597: Pandemic Treatment Access and Affordability Act of 2021 - Provisions related to intellectual property H.R. 728: Pandemic Emergency Manufacturing Act of 2021 - Provisions related to intellectual property and march-in rights H.R. 1629: Fairness in Orphan Drug Exclusivity Act - Provisions related to FDA policy and orphan drugs H.R. 1857: Protecting Access to Safe and Effective Medicines Act of 2021 - Provisions related to FDA policy and exclusivity H.R. 2148: Prescription Drug Price Relief Act of 2021 - Provisions related to prescription drug pricing and march-in rights H.R. 2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 - Provisions related to intellectual property and patents H.R. 2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act - Provisions related to patent infringement H.R. 2891: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 187: Pandemic Emergency Manufacturing Act of 2021 - Provisions related to intellectual property and march-in rights S. 250: Fairness in Orphan Drug Exclusivity Act - Provisions related to FDA policy and orphan drugs S. 415: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity - Provisions related to FDA policy and exclusivity S. 1428: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 1435: Affordable Prescriptions for Patients Act of 2021 - Provisions related to intellectual property and patents S. 2774: Pride in Patent Ownership Act - Provisions related to patent transparency S. 2891: Restoring the America Invents Act - Provisions related to USPTO policy Biopharmaceutical innovation and patent policy issues Bayh-Dole march-in rights policy issues
2021 · fourth_quarter · Copyright/Patent/Trademark
H.R. 153: Protecting Consumer Access to Generic Drugs Act of 2021 - Provisions related to patent settlements H.R. 597: Pandemic Treatment Access and Affordability Act of 2021 - Provisions related to intellectual property H.R. 728: Pandemic Emergency Manufacturing Act of 2021 - Provisions related to intellectual property and march-in rights H.R. 1629: Fairness in Orphan Drug Exclusivity Act - Provisions related to FDA policy and orphan drugs H.R. 1857: Protecting Access to Safe and Effective Medicines Act of 2021 - Provisions related to FDA policy and exclusivity H.R. 2148: Prescription Drug Price Relief Act of 2021 - Provisions related to prescription drug pricing and march-in rights H.R. 2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 - Provisions related to intellectual property and patents H.R. 2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act - Provisions related to patent infringement H.R. 2891: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 187: Pandemic Emergency Manufacturing Act of 2021 - Provisions related to intellectual property and march-in rights S. 250: Fairness in Orphan Drug Exclusivity Act - Provisions related to FDA policy and orphan drugs S. 415: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity - Provisions related to FDA policy and exclusivity S. 1428: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 1435: Affordable Prescriptions for Patients Act of 2021 - Provisions related to intellectual property and patents S. 2774: Pride in Patent Ownership Act - Provisions related to patent transparency S. 2891: Restoring the America Invents Act - Provisions related to USPTO policy Biopharmaceutical innovation and patent policy issues Bayh-Dole march-in rights policy issues
2021 · fourth_quarter · Health Issues
Proposals related to the COVID-19 crisis including proposals to abrogate pharmaceutical patents used in the COVID-19 pandemic. Build Back Better Act provisions relating to drug pricing and HR 3, the "Elijah E. Cummings Lower Drug Costs Now Act," HR 19, the "Lower Costs, More Cures Act of 2021," HHS drug pricing plan to lower drug costs issued in connection with Executive Order 14,036 (Promote Competition in the American Economy), HR 2853, the "Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics Act of 2021" (or the "BLOCKING Act"), and HR 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 (product hopping). Proposals to change pharmaceutical patent laws including HR 2891, "Preserve Access to Affordable Generics & Biosimilars Act" (patent settlements), and HR 2884, the "Affordable Prescriptions for Patients Through Improvement to Patent Litigation Act" (BPCIA litigation limits). Proposals to improve pharmaceutical supply-chain vulnerabilities. Proposals to retain and attract greater domestic manufacturing of pharmaceuticals including H.R. 2870, The Essential Medicines Strategic Stockpile Act of 2021. Proposals to change Medicare and Medicaid benefit design. Proposals to improve the drug approval process for generic medicines including HR 2883, "Stop Stalling Access to Affordable Medications Act" (citizens petitions), HR 2831, the "Prompt Approval of Safe Generic Drugs Act," HR 2843, "Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2021" (or the "STOP GAMES Act"), and S. 1462, the Simplifying the Generic Drug Application Process Act. S.164, Advancing Education on Biosimilars Act of 2021. S.415, a bill to amend the Federal Food, Drug & Cosmetic Act with respect to the scope of new chemical exclusivity. Implementation of the Food & Drug Reauthorization Act (PL 115-52). HR 153, the "Protecting Consumer Access to Generic Drugs Act of 2021." HR 2815, the "Bolstering Innovative Options to Save Immediately on Medicines Act" (or the "BIOSIM Act"). HR 2846, to amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purpose. S.1463, the Modernizing Therapeutic Equivalence Rating Determination Act.
2021 · second_quarter · Health Issues
Legislation and proposals related to the COVID-19 crisis. Drug pricing proposals in Congress and from the Executive Branch. Proposals to change pharmaceutical patent laws. Proposals to restrict settlements of pharmaceutical patent disputes. Proposals to improve pharmaceutical supply-chain vulnerabilities. Proposals to retain and attract greater domestic manufacturing of pharmaceuticals. Proposals to change Medicare and Medicaid benefit design. Proposals to improve the drug approval process for generic medicines. S.164, Advancing Education on Biosimilars Act of 2021. S. 415, a bill to amend the Federal Food, Drug & Cosmetic Act with respect to the scope of new chemical exclusivity. Implementation of the Food & Drug Reauthorization Act (PL 115-52). Proposals to abrogate pharmaceutical patents used in the COVID-19 pandemic. H.R.3, the" Elijah E. Cummings Lower Drug Costs Now Act." H.R.19, the "Lower Costs, More Cures Act of 2021." H.R. 153, the "Protecting Consumer Access to Generic Drugs Act of 2021." H.R. 2815, the "Bolstering Innovative Options to Save Immediately on Medicines Act" (or the "BIOSIM Act"). H.R. 2831, the "Prompt Approval of Safe Generic Drugs Act." H.R. 2843, the "Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2021" (or the "STOP GAMES Act"). H.R. 2846, to amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purpose. H.R. 2853, the "Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2021" (or the "BLOCKING Act"). S. 1462, the Simplifying the Generic Drug Application Process Act, and S.1463, the Modernizing Therapeutic Equivalence Rating Determination Act.
2021 · third_quarter · Health Issues
Proposals related to the COVID-19 crisis including proposals to abrogate pharmaceutical patents used in the COVID-19 pandemic. Drug pricing proposals in Congress and from the Executive Branch including HR 3, the "Elijah E. Cummings Lower Drug Costs Now Act," HR 19, the "Lower Costs, More Cures Act of 2021," HHS drug pricing plan to lower drug costs issued in connection with Executive Order 14,036 (Promote Competition in the American Economy), HR 2853, the "Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics Act of 2021" (or the "BLOCKING Act"), and HR 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 (product hopping). Proposals to change pharmaceutical patent laws including HR 2891, "Preserve Access to Affordable Generics & Biosimilars Act" (patent settlements), and HR 2884, the "Affordable Prescriptions for Patients Through Improvement to Patent Litigation Act" (BPCIA litigation limits). Proposals to improve pharmaceutical supply-chain vulnerabilities. Proposals to retain and attract greater domestic manufacturing of pharmaceuticals including H.R. 8479, The Essential Medicines Strategic Stockpile Act of 2020. Proposals to change Medicare and Medicaid benefit design. Proposals to improve the drug approval process for generic medicines including HR 2883, "Stop Stalling Access to Affordable Medications Act" (citizens petitions), HR 2831, the "Prompt Approval of Safe Generic Drugs Act," HR 2843, "Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2021" (or the "STOP GAMES Act"), and S. 1462, the Simplifying the Generic Drug Application Process Act. S.164, Advancing Education on Biosimilars Act of 2021. S.415, a bill to amend the Federal Food, Drug & Cosmetic Act with respect to the scope of new chemical exclusivity. Implementation of the Food & Drug Reauthorization Act (PL 115-52). HR 153, the "Protecting Consumer Access to Generic Drugs Act of 2021." HR 2815, the "Bolstering Innovative Options to Save Immediately on Medicines Act" (or the "BIOSIM Act"). HR 2846, to amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purpose. S.1463, the Modernizing Therapeutic Equivalence Rating Determination Act.
2021 · third_quarter · Health Issues
Proposals related to the COVID-19 crisis including proposals to abrogate pharmaceutical patents used in the COVID-19 pandemic. Drug pricing proposals in Congress and from the Executive Branch including HR 3, the "Elijah E. Cummings Lower Drug Costs Now Act," HR 19, the "Lower Costs, More Cures Act of 2021," HHS drug pricing plan to lower drug costs issued in connection with Executive Order 14,036 (Promote Competition in the American Economy), HR 2853, the "Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics Act of 2021" (or the "BLOCKING Act"), and HR 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 (product hopping). Proposals to change pharmaceutical patent laws including HR 2891, "Preserve Access to Affordable Generics & Biosimilars Act" (patent settlements), and HR 2884, the "Affordable Prescriptions for Patients Through Improvement to Patent Litigation Act" (BPCIA litigation limits). Proposals to improve pharmaceutical supply-chain vulnerabilities. Proposals to retain and attract greater domestic manufacturing of pharmaceuticals including H.R. 8479, The Essential Medicines Strategic Stockpile Act of 2020. Proposals to change Medicare and Medicaid benefit design. Proposals to improve the drug approval process for generic medicines including HR 2883, "Stop Stalling Access to Affordable Medications Act" (citizens petitions), HR 2831, the "Prompt Approval of Safe Generic Drugs Act," HR 2843, "Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2021" (or the "STOP GAMES Act"), and S. 1462, the Simplifying the Generic Drug Application Process Act. S.164, Advancing Education on Biosimilars Act of 2021. S.415, a bill to amend the Federal Food, Drug & Cosmetic Act with respect to the scope of new chemical exclusivity. Implementation of the Food & Drug Reauthorization Act (PL 115-52). HR 153, the "Protecting Consumer Access to Generic Drugs Act of 2021." HR 2815, the "Bolstering Innovative Options to Save Immediately on Medicines Act" (or the "BIOSIM Act"). HR 2846, to amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purpose. S.1463, the Modernizing Therapeutic Equivalence Rating Determination Act.
2021 · third_quarter · Copyright/Patent/Trademark
H.R. 153: Protecting Consumer Access to Generic Drugs Act of 2021 - Provisions related to patent settlements H.R. 1629: Fairness in Orphan Drug Exclusivity Act - Provisions related to FDA policy and orphan drugs H.R. 2148: Prescription Drug Price Relief Act of 2021 - Provisions related to prescription drug pricing and march-in rights H.R. 2853: BLOCKING Act of 2021 - Provisions related to FDA exclusivity periods H.R. 2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 - Provisions related to intellectual property and patents H.R. 2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act - Provisions related to patent infringement H.R. 2891: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 250: Fairness in Orphan Drug Exclusivity Act - Provisions related to FDA policy and orphan drugs S. 415: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity - Provisions related to FDA policy and exclusivity S. 1428: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 1435: Affordable Prescriptions for Patients Act of 2021 - Provisions related to intellectual property and patents S. 2773: Unleashing American Innovators Act or 2021 - Provisions related to USPTO policy S. 2774: Pride in Patent Ownership Act - Provisions related to patent transparency S. 2891: A bill to amend title 35, United States Code, to address matters relating to the Patent Trial and Appeal Board of the United States Patent and Trademark Office, and for other purposes. - Provisions related to USPTO policy S. 2910: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period, and for other purposes. - Provisions related to FDA exclusivity periods Biopharmaceutical innovation and patent policy issues Bayh-Dole march-in rights policy issues
2021 · third_quarter · Medicare/Medicaid
Communicate with the Center for Medicare and Medicaid Services regarding Innovation Center, direct reimbursement under Medicare Program, annual payment updates, PBM transparency, pharmacy residency audit, and scope of practice. Discussion with House and Senate about increased prescription drug pricing, specifically on the Ensuring Innovation Act (S.415) and the Advancing Education on Biosimilars Act (s. 164). Communication on Direct and Indirect remuneration fees (DIR) under Medicare Part D and Medicare rebate reform. Communication with CMS and Congressional Offices on pharmacy residency programs audits. Communication with CMS, White House Offices, and Congressional Offices on Reimbursement through Medicare Part B. Discussed COVID-19 response recommendations, including pharmacist provision of testing and vaccination, with House and Senate Offices, and HHS. Discussed telehealth reimbursement and virtual supervision flexibilities for pharmacist services with CMS. Discussed continuation of PREP Act allowances with HHS. Discussion with House and Senate Offices about the Pharmacist and Medically Underserved Areas Enhancement Act (H.R. 2759/S. 1362)
Client expense: $530,000 · Firm income: Not reported
2021 · third_quarter · Copyright/Patent/Trademark
H.R. 153: Protecting Consumer Access to Generic Drugs Act of 2021 - Provisions related to patent settlements H.R. 728: Pandemic Emergency Manufacturing Act of 2021 - Provisions related to intellectual property and march-in rights H.R. 1629: Fairness in Orphan Drug Exclusivity Act - Provisions related to FDA policy and orphan drugs H.R. 2148: Prescription Drug Price Relief Act of 2021 - Provisions related to prescription drug pricing and march-in rights H.R. 2853: BLOCKING Act of 2021 - Provisions related to FDA exclusivity periods H.R. 2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 - Provisions related to intellectual property and patents H.R. 2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act - Provisions related to patent infringement H.R. 2891: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 250: Fairness in Orphan Drug Exclusivity Act - Provisions related to FDA policy and orphan drugs S. 415: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity - Provisions related to FDA policy and exclusivity S. 1428: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 1435: Affordable Prescriptions for Patients Act of 2021 - Provisions related to intellectual property and patents S. 2773: Unleashing American Innovators Act of 2021 - Provisions related to USPTO policy S. 2774: Pride in Patent Ownership Act - Provisions related to patent transparency S. 2891: Restoring the America Invents Act - Provisions related to USPTO policy S. 2910: Expanding Access to Low-Cost Generics Act of 2021 - Provisions related to FDA exclusivity periods Biopharmaceutical innovation and patent policy issues Bayh-Dole march-in rights policy issues
2021 · second_quarter · Copyright/Patent/Trademark
H.R. 2148: Prescription Drug Price Relief Act of 2021 - Provisions related to prescription drug pricing and march-in rights H.R. 2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 - Provisions related to intellectual property and patents H.R. 2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act - Provisions related to patent infringement S. 250: Fairness in Orphan Drug Exclusivity Act - Provisions related to FDA policy and orphan drugs S. 415: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity - Provisions related to FDA policy and exclusivity S. 1428: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 1435: Affordable Prescriptions for Patients Act of 2021 - Provisions related to intellectual property and patents Biopharmaceutical innovation and patent policy issues Bayh-Dole march-in rights policy issues
Client expense: $1,300,000 · Firm income: Not reported
2021 · second_quarter · Copyright/Patent/Trademark
H.R. 2148: Prescription Drug Price Relief Act of 2021 - Provisions related to prescription drug pricing and march-in rights H.R. 2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 - Provisions related to intellectual property and patents H.R. 2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act - Provisions related to patent infringement S. 250: Fairness in Orphan Drug Exclusivity Act - Provisions related to FDA policy and orphan drugs S. 415: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity - Provisions related to FDA policy and exclusivity S. 1428: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 1435: Affordable Prescriptions for Patients Act of 2021 - Provisions related to intellectual property and patents Biopharmaceutical innovation and patent policy issues Bayh-Dole march-in rights policy issues
Client expense: $6,430,000 · Firm income: Not reported
2021 · second_quarter · Health Issues
116th Congress S. 1895, The Lower Health Care Costs Act, Sec. 306 Health Plan Oversight of PBMs ; 116th Congress HR 19-Lower Cost, More Cures Act, provisions on drug prices and Part D cost-sharing; 116th Congress HR 3-Elijah E. Cummings Lower Drug Costs Act Now, --Provisions establishing drug pricing and Part D cost sharing; S. 464/H.R. 2163, Safe Step Act,-Amending ERISA to specify exceptions for medication step therapy; Value-based contracting for pharmaceuticals; 116th Congress H.R. 5304, PBM Transparency in Prescription Drug Costs Act,-provisions related to PBM contracting; S. 164/P.S. 117-8 Advancing Education on Biosimilars Act of 2021-provisions related to an FDA campaign for prescriber education on biosimilars; S. 415/P.L. 117-9, A bill to clarify the meaning of a new chemical entity by the FDA; ; potential suspension of pharmacy audits during the public health emergency and reform of the orphan drug act; measures to combat pharma patent thickets
Client expense: $90,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2021 · second_quarter · Pharmacy
S.833 - Empowering Medicare Seniors to Negotiate Drug Prices Act of 2021 - in support. S. 415 - Ensuring Innovation Act - in support. S. 1323. End Price Gouging for Medications Act - in support. H.R. 2829. End Price Gouging for Medications Act - in support. H.R. 3. Lower Drug Costs Now Act - in support. S. 1898. Affordable Medications Act - in support. Lobbied in support of including drug pricing reforms in the reconciliation bill. Lobbied in support of a temporary waiver of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement for the COVID-19 vaccine.
Client expense: Not reported · Firm income: $10,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)
2021 · second_quarter · Medicare/Medicaid
Communicate with the Center for Medicare and Medicaid Services regarding Innovation Center, direct reimbursement under Medicare Program, annual payment updates, PBM transparency, pharmacy residency audit, and scope of practice. Discussion with House and Senate about increased prescription drug pricing, specifically on the Ensuring Innovation Act (S.415) and the Advancing Education on Biosimilars Act (s. 164). Communication on Direct and Indirect remuneration fees (DIR) under Medicare Part D and Medicare rebate reform. Communication with CMS and Congressional Offices on pharmacy residency programs audits. Communication with CMS, White House Offices, and Congressional Offices on Reimbursement through Medicare Part B. Discussed COVID-19 response recommendations, including pharmacist provision of testing and vaccination, with House and Senate Offices, and HHS. Discussed telehealth reimbursement and virtual supervision flexibilities for pharmacist services with CMS. Discussed continuation of PREP Act allowances with HHS. Discussion with House and Senate Offices about the Pharmacist and Medically Underserved Areas Enhancement Act (H.R. 2759/S. 1362)
Client expense: $320,000 · Firm income: Not reported
2021 · second_quarter · Health Issues
Legislation and proposals related to the COVID-19 crisis. Drug pricing proposals in Congress and from the Executive Branch. Proposals to change pharmaceutical patent laws. Proposals to restrict settlements of pharmaceutical patent disputes. Proposals to improve pharmaceutical supply-chain vulnerabilities. Proposals to retain and attract greater domestic manufacturing of pharmaceuticals. Proposals to change Medicare and Medicaid benefit design. Proposals to improve the drug approval process for generic medicines. S.164, Advancing Education on Biosimilars Act of 2021. S. 415, a bill to amend the Federal Food, Drug & Cosmetic Act with respect to the scope of new chemical exclusivity. Implementation of the Food & Drug Reauthorization Act (PL 115-52). Proposals to abrogate pharmaceutical patents used in the COVID-19 pandemic. H.R., the" Elijah E. Cummings Lower Drug Costs Now Act." H.R.19, the "Lower Costs, More Cures Act of 2021." H.R. 153, the "Protecting Consumer Access to Generic Drugs Act of 2021." H.R. 2815, the "Bolstering Innovative Options to Save Immediately on Medicines Act" (or the "BIOSIM Act"). H.R. 2831, the "Prompt Approval of Safe Generic Drugs Act." H.R. 2843, the "Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2021" (or the "STOP GAMES Act"). H.R. 2846, to amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purpose. H.R. 2853, the "Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2021" (or the "BLOCKING Act"). S. 1462, the Simplifying the Generic Drug Application Process Act, and S.1463, the Modernizing Therapeutic Equivalence Rating Determination Act.
2021 · first_quarter · Copyright/Patent/Trademark
H.R. 153: Protecting Consumer Access to Generic Drugs Act of 2021 - Provisions related to patent settlements H.R. 597: Pandemic Treatment Access and Affordability Act of 2021 - Provisions related to intellectual property H.R. 728: Pandemic Emergency Manufacturing Act of 2021 - Provisions related to intellectual property and march-in rights H.R. 1629: To amend the Federal Food, Drug, and Cosmetic Act with respect to limitations on exclusive approval or licensure of orphan drugs, and for other purposes - Provisions related to FDA policy and orphan drugs H.R. 1857: To amend the Federal Food, Drug, and Cosmetic Act to clarify the meaning of a new chemical entity - Provisions related to FDA policy and exclusivity H.R. 2148: To significantly lower prescription drug prices for patients in the United States by ending government-granted monopolies for manufacturers who charge drug prices that are higher than the median prices at which the drugs are available in other countries - Provisions related to prescription drug pricing and march-in rights S. 187: Pandemic Emergency Manufacturing Act of 2021 - Provisions related to intellectual property and march-in rights S. 250: Fairness in Orphan Drug Exclusivity Act - Provisions related to FDA policy and orphan drugs S. 415: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity - Provisions related to FDA policy and exclusivity S. 908: To significantly lower prescription drug prices for patients in the United States by ending government-granted monopolies for manufacturers who charge drug prices that are higher than the median prices at which the drugs are available in other countries - Provisions related to prescription drug pricing and intellectual property S. 917: A bill to allow for expedited approval of generic prescription drugs and temporary importation of prescription drugs in the case of marginally competitive drug markets and drug shortages Biopharmaceutical innovation and patent policy issues Bayh-Dole march-in rights policy issues
2021 · first_quarter · Health Issues
Regulatory exclusivity; Drug pricing; Medicare Part B international reference pricing; Generic drug competition; Drug patent issues; Affordable Prescriptions for Patients Act of 2019 (S. 1416); Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 (H.R. 5133/H.R. 4398); H.R. 3991 - Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019; Executive Order 13944 (List of Essential Medicines, Medical Countermeasures, and Critical Inputs); Executive Order 14001 on a Sustainable Public Health Supply Chain; Compulsory licensing; Real world evidence; National Defense Authorization Act for Fiscal Year 2021 (S. 4049); S.Res.625 - A resolution encouraging the Government and the people of the United States to "Buy American"; Executive Order 13922; Executive Order 13911; Executive Order 13938; Domestic manufacturing incentives; Potential amendments to PREP Act; Bring Entrepreneurial Advancements To Consumers Here In North America Act (H.R. 6690); Bayh-Dole Act; Learnings from Pandemic; Safe Authorization for Vaccines during Emergencies Act (S.4427); Executive Order 13948 (Lowering Drug Prices by Putting America First); Advancing Americas Interests Act (H.R. 8037); Safeguarding American Innovation Act (S. 3997); Safe to Work Act (S. 4317); 340B drug discounts; Executive Order 13962 (Ensuring Access to United States Government COVID-19 Vaccines); antitrust reform proposals; Competition and Antitrust Law Enforcement Reform Act (S. 225); Pioneering Antimicrobial Subscriptions To End Up surging Resistance Act of 2020 (S. 4760/H.R. 8920); Lower Health Care Costs Act (S. 1895); Protecting Our Pharmaceutical Supply Chain from China Act of 2020 (H.R. 6482); Part D non-interference; Ensuring Innovation Act (S.1636); Return on Investment (ROI) Initiative for Unleashing American Innovation; 85 Fed. Reg. 76180; Suitability petitions; Securing America's Vaccines for Emergencies (SAVE) Act of 2020 (H.R. 6399/S. 3715); Pandemic Emergency Manufacturing Act of 2021 (S. 187); H.R.153 - Protecting Consumer Access to Generic Drugs Act of 2021; Lower Costs, More Cures Act (H.R. 19/ S. 3129); Fairness in Orphan Drug Exclusivity Act (S. 250/ H.R. 4712); S. 415 - A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity; S.164 - Advancing Education on Biosimilars Act of 2021; Preserve Access to Affordable Generics and Biosimilars Act (S. 64/HR 2375); Drug recalls; drug shortages; Elijah E. Cummings Lower Drug Costs Now Act (H.R. 3); Medicare reimbursement of prescription drugs; Unnamed bill regarding FDA demand reporting with respect to drugs.
2021 · first_quarter · Health Issues
Legislation and proposals related to the COVID-19 crisis. Drug pricing proposals in Congress and from the Executive Branch. Proposals designed to increase utilization of biosimilar medicines. Proposals to abrogate 180-day exclusivity for certain generic medicines. Proposals to change pharmaceutical patent laws. Proposals to restrict settlements of pharmaceutical patent disputes. Proposals to improve pharmaceutical supply-chain vulnerabilities. Proposals to retain and attract greater domestic manufacturing of pharmaceuticals. Proposals to change Medicare and Medicaid benefit design. Proposals to improve the drug approval process for generic medicines. S.164, Advancing Education on Biosimilars Act of 2021. S. 415, a bill to amend the Federal Food, Drug & Cosmetic Act with respect to the scope of new chemical exclusivity. Implementation of the Food & Drug Reauthorization Act (PL 115-52). Nomination of the HHS Secretary. Proposals to abrogate pharmaceutical patents used in the COVID-19 pandemic.
Client expense: $1,820,000 · Firm income: Not reported
2021 · first_quarter · Copyright/Patent/Trademark
H.R. 153: Protecting Consumer Access to Generic Drugs Act of 2021 - Provisions related to patent settlements H.R. 597: Pandemic Treatment Access and Affordability Act of 2021 - Provisions related to intellectual property H.R. 728: Pandemic Emergency Manufacturing Act of 2021 - Provisions related to intellectual property and march-in rights H.R. 1857: To amend the Federal Food, Drug, and Cosmetic Act to clarify the meaning of a new chemical entity - Provisions related to FDA policy and exclusivity H.R. 2148: To significantly lower prescription drug prices for patients in the United States by ending government-granted monopolies for manufacturers who charge drug prices that are higher than the median prices at which the drugs are available in other countries - Provisions related to prescription drug pricing and march-in rights S. 187: Pandemic Emergency Manufacturing Act of 2021 - Provisions related to intellectual property and march-in rights S. 250: Fairness in Orphan Drug Exclusivity Act - Provisions related to FDA policy and orphan drugs S. 415: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity - Provisions related to FDA policy and exclusivity S. 908: To significantly lower prescription drug prices for patients in the United States by ending government-granted monopolies for manufacturers who charge drug prices that are higher than the median prices at which the drugs are available in other countries - Provisions related to prescription drug pricing and intellectual property S. 917: A bill to allow for expedited approval of generic prescription drugs and temporary importation of prescription drugs in the case of marginally competitive drug markets and drug shortages Biopharmaceutical innovation and patent policy issues Bayh-Dole march-in rights policy issues
2021 · first_quarter · Health Issues
MCM development & procurement process; S. 415, A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity.
Client expense: Not reported · Firm income: $40,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2021 · first_quarter · Medicare/Medicaid
Communicate with the Center for Medicare and Medicaid Services regarding Innovation Center, direct reimbursement under Medicare Program, annual payment updates, PBM transparency, pharmacy residency audit, and scope of practice. Discussion with House and Senate about increased prescription drug pricing, specifically on the Ensuring Innovation Act (S.415) and the Advancing Education on Biosimilars Act (s. 164). Communication on Direct and Indirect remuneration fees (DIR) under Medicare Part D and Medicare rebate reform. Communication with CMS and Congressional Offices on pharmacy residency programs audits. Communication with CMS and Congressional Offices on Reimbursement through Medicare Part B. Discussed COVID-19 response recommendations, including pharmacist provision of testing and vaccination, with House and Senate Offices, and HHS. Discussed telehealth reimbursement and virtual supervision flexibilities for pharmacist services with CMS.
Client expense: $310,000 · Firm income: Not reported
Mr. Pallone moved to suspend the rules and pass the bill.
Held at the desk.
Received in the House.
Message on Senate action sent to the House.
Passed Senate without amendment by Unanimous Consent. (text: CR S1435)
Passed/agreed to in Senate: Passed Senate without amendment by Unanimous Consent.(text: CR S1435)
Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent. (consideration: CR S1435)
Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.(consideration: CR S1435)
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced in Senate
| -- |
Client expense: $7,270,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE
Client expense: $670,000 · 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), SENATE
Client expense: $1,110,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE
Client expense: $6,340,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE
Client expense: $550,000 · 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), SENATE
Government targets: HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE
Government targets: HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE
Client expense: $2,050,000 · 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), SENATE
Client expense: $8,070,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Client expense: $1,000,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE
Client expense: $1,000,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
Client expense: $7,160,000 · Firm income: Not reported
Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE
Client expense: $600,000 · 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), SENATE
Client expense: $700,000 · 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), SENATE
Client expense: $810,000 · 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), SENATE
Client expense: $650,000 · 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), SENATE
Client expense: $1,200,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
Government targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, White House Office
Client expense: $7,440,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
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 Science & Technology Policy (OSTP), SENATE, U.S. Trade Representative (USTR)
Government targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, White House Office
Client expense: $690,000 · 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), SENATE
Client expense: $1,800,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
Client expense: Not reported · Firm income: $380,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)
Government targets: Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
Client expense: $8,540,000 · Firm income: Not reported
Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR)
Government targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE