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Fairness in Orphan Drug Exclusivity Act
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Fairness in Orphan Drug Exclusivity Act This bill limits which orphan drugs may be granted a market exclusivity period by the Food and Drug Administration (FDA). (Generally, an orphan drug is one that is not economically viable because of the rarity of the disease that it treats; the sponsor of an FDA-designated orphan drug may be granted various incentives, such as a seven-year period in which the FDA may not grant market approval to a different sponsor for the same drug to treat the same disease.) Under this bill, if a drug is designated as an orphan drug on the basis that there is no reasonable expectation that the sponsor will recover the costs of developing and distributing the drug from U.S. sales, the drug shall be granted the seven-year exclusivity period only if the sponsor demonstrates that there is no reasonable expectation that it will recover such costs specifically within its first 12 years of U.S. sales of the drug. This requirement shall also apply retroactively to an orphan drug that was granted such an exclusivity period before this bill's enactment. When deciding whether an orphan drug meets this requirement, the FDA shall consider the sales of all drugs from the sponsor that are covered by the same orphan drug designation.
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Filing registrants (11)
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced in Senate
Bills with similar content found using semantic analysis.
Sources: Congress.gov
2024 · first_quarter · Pharmacy
H.R, 1629/S 250: Fairness in Orphan Drug Exclusivity Act
Client expense: Not reported · Firm income: $45,000
Government targets: Food & Drug Administration (FDA)
2023 · first_quarter · Pharmacy
H.R, 1629/S 250: Fairness in Orphan Drug Exclusivity Act
Client expense: Not reported · Firm income: Not reported
Government targets: Food & Drug Administration (FDA)
2023 · fourth_quarter · Pharmacy
H.R, 1629/S 250: Fairness in Orphan Drug Exclusivity Act
Client expense: Not reported · Firm income: $45,000
Government targets: Food & Drug Administration (FDA)
2023 · third_quarter · Pharmacy
H.R, 1629/S 250: Fairness in Orphan Drug Exclusivity Act
Client expense: Not reported · Firm income: $45,000
Government targets: Food & Drug Administration (FDA)
2023 · second_quarter · Pharmacy
H.R, 1629/S 250: Fairness in Orphan Drug Exclusivity Act
Client expense: Not reported · Firm income: $45,000
Government targets: Food & Drug Administration (FDA)
2023 · first_quarter · Pharmacy
H.R, 1629/S 250: Fairness in Orphan Drug Exclusivity Act
Client expense: Not reported · Firm income: $45,000
Government targets: Food & Drug Administration (FDA)
2022 · fourth_quarter · Pharmacy
H.R. 153 - Protecting Consumer Access to Generic Drugs Act of 2021- Rep. Rush, Bobby - patent infringement settlements H.R. 1829 - Pharmacy Benefit Manager Accountability Study Act of 2021 - Rep. Harshbarger, Diana - GAO study of PBMs H.R. 2071 - Medicare Prescription Drug Price Negotiation Act of 2021 - Rep. Welch, Peter - Medicare drug prices H.R. 2139 - Medicare Drug Price Negotiation Act - Rep. Doggett, Lloyd - Drug Prices H.R. 6833 - Affordable Insulin Now Act - Rep. Craig, Angie - Insulin copay caps S. 250 - Fairness in Orphan Drug Exclusivity Act - Sen. Cassidy, Bill - orphan drugs S. 298 - Pharmacy Benefit Manager Accountability Study Act of 2021 - Sen. Blackburn, Marsha - PBMs and pharmaceutical supply chain S. 833 - Empowering Medicare Seniors to Negotiate Drug Prices Act of 2021 - Sen. Klobuchar, Amy -Medicare drug prices S. 908 - Medicare Drug Price Negotiation Act - Sen. Sanders, Bernard - Medicare Drug prices S. 3700 - Affordable Insulin Now Act- Sen. Warnock, Raphael - insulin pricing and cost sharing 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 prescription drug coupons and discount programs; contraceptive coverage; issues relating to vaccines; issues related to health equity; issues related to vaccination; potential Medicare NCD relating to monoclonal antibodies for treatment of Alzheimers disease; issues related to coverage of EUA drugs under Medicare Part D; 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 COVID-19, including testing, vaccines and therapeutics; issues related to health care price transparency; issues relating to prescription drug rebates; 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: $2,470,000 · 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
Legislation regarding the Orphan Drug Act and rare disease diagnosis, treatment, and care. Newborn Screening Saves Lives Act Reauthorization, H.R. 482, S 350. FY 2022 and FY 2023 CDC Appropriations for state newborn screening technical assistance and related Senate appropriations. H.R. 1692, S 250, Fairness in Orphan Drug Exclusivity Act.
Client expense: $190,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
Issues generally related to biopharmaceutical drugs and drug development programs, including, but not limited to: Orphan Drug Act incentives, including H.R. 1629/S.250, the Fairness in Orphan Drug Exclusivity Act; drug pricing proposals, including H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act and H.R. 19/S.2164, Lower Costs, More Cures Act of 2021; access to rare disease and gene therapy drugs; education and awareness of genetic rare bone disorders; FDA approvals of drugs designed to treat rare diseases, including gene therapies; and regulatory reforms generally, including but not limited to S. 3799, the PREVENT Pandemics Act, H.R. 6000, CURES 2.0, H.R. 6963, the Accelerated Approval Integrity Act of 2022, H.R. 6996, the Accelerating Access for Patients Act; H.R. 7667, Food and Drug Amendments of 2022, and S. 4348, Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act. Issues pertaining to newborn screening and gene panel screening, including provisions of H.R. 482/S.350 , the Newborn Screening Saves Lives Reauthorization Act of 2021. Policies contained in and amendments offered to S.Con.Res.5, setting forth the congressional budget for the United States Government for fiscal year 2021 and setting forth the appropriate budgetary levels for fiscal years 2022 through 2030; and policies contained in and amendments offered to P.L. 117-2, the American Rescue Plan Act of 2021; P.L. 117-169, Inflation Reduction Act.
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · fourth_quarter · Pharmacy
H.R, 1629/S 250: Fairness in Orphan Drug Exclusivity Act
Client expense: Not reported · Firm income: $45,000
Government targets: Food & Drug Administration (FDA)
2022 · third_quarter · Pharmacy
H.R. 153 - Protecting Consumer Access to Generic Drugs Act of 2021- Rep. Rush, Bobby - patent infringement settlements H.R. 1829 - Pharmacy Benefit Manager Accountability Study Act of 2021 - Rep. Harshbarger, Diana - GAO study of PBMs H.R. 2071 - Medicare Prescription Drug Price Negotiation Act of 2021 - Rep. Welch, Peter - Medicare drug prices H.R. 2139 - Medicare Drug Price Negotiation Act - Rep. Doggett, Lloyd - Drug Prices H.R. 6833 - Affordable Insulin Now Act - Rep. Craig, Angie - Insulin copay caps S. 250 - Fairness in Orphan Drug Exclusivity Act - Sen. Cassidy, Bill - orphan drugs S. 298 - Pharmacy Benefit Manager Accountability Study Act of 2021 - Sen. Blackburn, Marsha - PBMs and pharmaceutical supply chain S. 833 - Empowering Medicare Seniors to Negotiate Drug Prices Act of 2021 - Sen. Klobuchar, Amy -Medicare drug prices S. 908 - Medicare Drug Price Negotiation Act - Sen. Sanders, Bernard - Medicare Drug prices S. 3700 - Affordable Insulin Now Act- Sen. Warnock, Raphael - insulin pricing and cost sharing 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 prescription drug coupons and discount programs; contraceptive coverage; issues relating to vaccines; issues related to health equity; issues related to vaccination; potential Medicare NCD relating to monoclonal antibodies for treatment of Alzheimers disease; 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 COVID-19, including testing, vaccines and therapeutics; issues related to health care price transparency; issues relating to prescription drug rebates; 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: $3,230,000 · 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, White House Office
2022 · third_quarter · Health Issues
Legislation regarding the Orphan Drug Act and rare disease diagnosis, treatment, and care. Newborn Screening Saves Lives Act Reauthorization, H.R. 482, S 350. FY 2022 and FY 2023 CDC Appropriations for state newborn screening technical assistance and related Senate appropriations. H.R. 1692, S 250, Fairness in Orphan Drug Exclusivity Act.
Client expense: $120,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · third_quarter · Pharmacy
H.R, 1629/S 250: Fairness in Orphan Drug Exclusivity Act
Client expense: Not reported · Firm income: $45,000
Government targets: Food & Drug Administration (FDA)
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
Client expense: $7,270,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE
2022 · third_quarter · Health Issues
Issues generally related to biopharmaceutical drugs and drug development programs, including, but not limited to: Orphan Drug Act incentives, including H.R. 1629/S.250, the Fairness in Orphan Drug Exclusivity Act; drug pricing proposals, including H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act and H.R. 19/S.2164, Lower Costs, More Cures Act of 2021; access to rare disease and gene therapy drugs; education and awareness of genetic rare bone disorders; FDA approvals of drugs designed to treat rare diseases, including gene therapies; and regulatory reforms generally, including but not limited to S. 3799, the PREVENT Pandemics Act, H.R. 6000, CURES 2.0, H.R. 6963, the Accelerated Approval Integrity Act of 2022, H.R. 6996, the Accelerating Access for Patients Act; H.R. 7667, Food and Drug Amendments of 2022, and S. 4348, Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act. Issues pertaining to newborn screening and gene panel screening, including provisions of H.R. 482/S.350 , the Newborn Screening Saves Lives Reauthorization Act of 2021. Policies contained in and amendments offered to S.Con.Res.5, setting forth the congressional budget for the United States Government for fiscal year 2021 and setting forth the appropriate budgetary levels for fiscal years 2022 through 2030; and policies contained in and amendments offered to P.L. 117-2, the American Rescue Plan Act of 2021; P.L. 117-169, Inflation Reduction Act.
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · second_quarter · Pharmacy
H.R, 1629/S 250: Fairness in Orphan Drug Exclusivity Act
Client expense: Not reported · Firm income: $45,000
Government targets: Food & Drug Administration (FDA)
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
Client expense: $1,110,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE
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
Client expense: $6,340,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE
2022 · second_quarter · Pharmacy
H.R. 153 - Protecting Consumer Access to Generic Drugs Act of 2021- Rep. Rush, Bobby - patent infringement settlements H.R. 1829 - Pharmacy Benefit Manager Accountability Study Act of 2021 - Rep. Harshbarger, Diana - GAO study of PBMs H.R. 2071 - Medicare Prescription Drug Price Negotiation Act of 2021 - Rep. Welch, Peter - Medicare drug prices H.R. 2139 - Medicare Drug Price Negotiation Act - Rep. Doggett, Lloyd - Drug Prices H.R. 6833 - Affordable Insulin Now Act - Rep. Craig, Angie - Insulin copay caps S. 250 - Fairness in Orphan Drug Exclusivity Act - Sen. Cassidy, Bill - orphan drugs S. 298 - Pharmacy Benefit Manager Accountability Study Act of 2021 - Sen. Blackburn, Marsha - PBMs and pharmaceutical supply chain S. 833 - Empowering Medicare Seniors to Negotiate Drug Prices Act of 2021 - Sen. Klobuchar, Amy -Medicare drug prices S. 908 - Medicare Drug Price Negotiation Act - Sen. Sanders, Bernard - Medicare Drug prices S. 3700 - Affordable Insulin Now Act- Sen. Warnock, Raphael - insulin pricing and cost sharing 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 prescription drug coupons and discount programs; contraceptive coverage; issues relating to vaccines; issues related to health equity; issues related to vaccination; potential Medicare NCD relating to monoclonal antibodies for treatment of Alzheimers disease; Executive Orders relating to international pricing, Part D rebates, insulin costs, and importation; 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 COVID-19, including testing, vaccines and therapeutics; issues related to health care price transparency; issues relating to prescription drug rebates; 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: $2,890,000 · 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), Labor, Dept of (DOL), SENATE, Treasury, Dept of, White House Office
2022 · second_quarter · Health Issues
Legislation regarding the Orphan Drug Act and rare disease diagnosis, treatment, and care. Newborn Screening Saves Lives Act Reauthorization, H.R. 482, S 350. FY 2022 and FY 2023 CDC Appropriations for state newborn screening technical assistance and related Senate appropriations. H.R. 1692, S 250, Fairness in Orphan Drug Exclusivity Act.
Client expense: $290,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · second_quarter · Health Issues
Issues generally related to biopharmaceutical drugs and drug development programs, including, but not limited to: Orphan Drug Act incentives, including H.R. 1629/S.250, the Fairness in Orphan Drug Exclusivity Act; drug pricing proposals, including H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act and H.R. 19/S.2164, Lower Costs, More Cures Act of 2021; access to rare disease and gene therapy drugs; education and awareness of genetic rare bone disorders; FDA approvals of drugs designed to treat rare diseases, including gene therapies; and regulatory reforms generally, including but not limited to S. 3799, the PREVENT Pandemics Act, H.R. 6000, CURES 2.0, H.R. 6963, the Accelerated Approval Integrity Act of 2022, H.R. 6996, the Accelerating Access for Patients Act; H.R. 7667, Food and Drug Amendments of 2022, and S. 4348, Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act. Issues pertaining to newborn screening and gene panel screening, including provisions of H.R. 482/S.350 , the Newborn Screening Saves Lives Reauthorization Act of 2021. Policies contained in and amendments offered to S.Con.Res.5, setting forth the congressional budget for the United States Government for fiscal year 2021 and setting forth the appropriate budgetary levels for fiscal years 2022 through 2030; and policies contained in and amendments offered to P.L. 117-2, the American Rescue Plan Act of 2021.
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
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
Government targets: HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE
2022 · first_quarter · Pharmacy
H.R. 153 - Protecting Consumer Access to Generic Drugs Act of 2021- Rep. Rush, Bobby - patent infringement settlements H.R. 1829 - Pharmacy Benefit Manager Accountability Study Act of 2021 - Rep. Harshbarger, Diana - GAO study of PBMs H.R. 2071 - Medicare Prescription Drug Price Negotiation Act of 2021 - Rep. Welch, Peter - Medicare drug prices H.R. 2139 - Medicare Drug Price Negotiation Act - Rep. Doggett, Lloyd - Drug Prices H.R. 6833 - Affordable Insulin Now Act - Rep. Craig, Angie - Insulin copay caps S. 250 - Fairness in Orphan Drug Exclusivity Act - Sen. Cassidy, Bill - orphan drugs S. 298 - Pharmacy Benefit Manager Accountability Study Act of 2021 - Sen. Blackburn, Marsha - PBMs and pharmaceutical supply chain S. 833 - Empowering Medicare Seniors to Negotiate Drug Prices Act of 2021 - Sen. Klobuchar, Amy -Medicare drug prices S. 908 - Medicare Drug Price Negotiation Act - Sen. Sanders, Bernard - Medicare Drug prices S. 3700 - Affordable Insulin Now Act- Sen. Warnock, Raphael - insulin pricing and cost sharing 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 prescription drug coupons and discount programs; issues relating to vaccines; issues related to health equity; issues related to vaccination; potential Medicare NCD relating to monoclonal antibodies for treatment of Alzheimers disease; Executive Orders relating to international pricing, Part D rebates, insulin costs, and importation; 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 COVID-19, including testing, vaccines and therapeutics; issues related to health care price transparency; issues relating to prescription drug rebates; 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: $4,680,000 · 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 · 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
Government targets: HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE
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: $8,070,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · first_quarter · Health Issues
HCR - HR 1629 To amend the Federal Food, Drug, and Cosmetic Act with respect to limitations on exclusive approval or licensure of orphan drugs; S. 250 Fairness in Orphan Drug Exclusivity Act; reducing stigma and promoting treatment of opioid use disorder; raising awareness of the benefits of medication assisted therapy (MAT); ensuring patient access to MAT; FDA approval and exclusivity process; patient access to practitioner-administered therapies
Client expense: Not reported · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Office of Natl Drug Control Policy (NDCP), SENATE
2022 · first_quarter · Health Issues
Legislation regarding the Orphan Drug Act and rare disease diagnosis, treatment, and care. Newborn Screening Saves Lives Act Reauthorization, H.R. 482, S 350. FY 2022 and FY 2023 CDC Appropriations for state newborn screening technical assistance and related Senate appropriations. H.R. 1692, S 250, Fairness in Orphan Drug Exclusivity Act.
Client expense: $210,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · first_quarter · Health Issues
Issues generally related to biopharmaceutical drugs and drug development programs, including, but not limited to: Orphan Drug Act incentives, including H.R. 1629/S.250, the Fairness in Orphan Drug Exclusivity Act; drug pricing proposals, including H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act and H.R. 19/S.2164, Lower Costs, More Cures Act of 2021; access to rare disease and gene therapy drugs; FDA approvals of drugs designed to treat rare diseases, including gene therapies; and regulatory reforms generally, including but not limited to S. 3799, the PREVENT Pandemics Act, H.R. 6000, CURES 2.0, H.R. 6963, the Accelerated Approval Integrity Act of 2022, H.R. 6996, the Accelerating Access for Patients Act. Issues pertaining to newborn screening and gene panel screening, including provisions of H.R. 482/S.350 , the Newborn Screening Saves Lives Reauthorization Act of 2021. Policies contained in and amendments offered to S.Con.Res.5, setting forth the congressional budget for the United States Government for fiscal year 2021 and setting forth the appropriate budgetary levels for fiscal years 2022 through 2030; and policies contained in and amendments offered to P.L. 117-2, the American Rescue Plan Act of 2021.
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
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
Client expense: $1,000,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE
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
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)
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
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
Antitrust Legislation Bayh-Dole Act Biopharmaceutical Intellectual Property Biosimilars BPCIA Compulsory licenses Data Exclusivity Intellectual Property Issues in Reponse to coronavirus Inter Partes Review at PTO Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO Patents S.1435, Affordable Prescriptions for Patients Act of 2021 S.225, Competition and Antitrust Law Enforcement Reform Act Section 101 H.R. 2883, the Stop Stalling Access to Affordable Medications H.R. 2891, the Preserve Access to Affordable Generics and Biosimilars Act H.R. 2873, the Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R. 2884, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act HR 1629/S. 250 - Fairness in Orphan Drug Exclusivity Act
Client expense: $1,460,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Energy, Dept of, 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), Veterans Affairs, Dept of (VA), White House Office
2021 · fourth_quarter · Health Issues
HCR - HR 1629 To amend the Federal Food, Drug, and Cosmetic Act with respect to limitations on exclusive approval or licensure of orphan drugs; S. 250 Fairness in Orphan Drug Exclusivity Act; reducing stigma and promoting treatment of opioid use disorder; raising awareness of the benefits of medication assisted therapy (MAT); ensuring patient access to MAT; FDA approval and exclusivity process; patient access to practitioner-administered therapies
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, Office of Natl Drug Control Policy (NDCP), SENATE
2021 · fourth_quarter · Health Issues
Issues generally related to biopharmaceutical drugs and drug development programs, including, but not limited to: Orphan Drug Act incentives, including H.R. 1629/S.250, the Fairness in Orphan Drug Exclusivity Act; drug pricing proposals, including H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act and H.R. 19/S.2164, Lower Costs, More Cures Act of 2021; access to rare disease and gene therapy drugs; and FDA approvals of drugs designed to treat rare diseases, including gene therapies. Issues pertaining to newborn screening and gene panel screening, including provisions of H.R. 482/S.350 , the Newborn Screening Saves Lives Reauthorization Act of 2021. Policies contained in and amendments offered to S.Con.Res.5, setting forth the congressional budget for the United States Government for fiscal year 2021 and setting forth the appropriate budgetary levels for fiscal years 2022 through 2030; and policies contained in and amendments offered to P.L. 117-2, the American Rescue Plan Act of 2021. Policies contained in H.R.3684 - Infrastructure Investment and Jobs Act and H.R. 5376, Build Back Better Act.
Client expense: Not reported · Firm income: $30,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2021 · fourth_quarter · Health Issues
Legislation regarding the Orphan Drug Act and rare disease diagnosis, treatment, and care. Newborn Screening Saves Lives Act Reauthorization, H.R. 482, S 350. FY 2022 CDC Appropriations for state newborn screening technical assistance and related Senate appropriations. H.R. 1692, S 250, Fairness in Orphan Drug Exclusivity Act.
Client expense: $100,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2021 · fourth_quarter · Insurance
HR 1629, S250 Fairness in Orphan Drug Exclusivity Act; Administration of controlled substances by HCPs; Storage of controlled substances HR 5950 - Improving Patient Access to Care and Treatment Act S. 3257 - To amend the Controlled Substances Act to lengthen the period of time during which certain controlled substances must be administered to a patient after being delivered by a pharmacy to the administering practitioner.
Client expense: $90,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office
2021 · fourth_quarter · Alcohol and Drug Abuse
HR 1629, S250 Fairness in Orphan Drug Exclusivity Act; Administration of controlled substances by HCPs; Storage of controlled substances HR 5950 - Improving Patient Access to Care and Treatment Act S. 3257 - To amend the Controlled Substances Act to lengthen the period of time during which certain controlled substances must be administered to a patient after being delivered by a pharmacy to the administering practitioner.
Client expense: $90,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office
2021 · fourth_quarter · Pharmacy
HR 1629, S250 Fairness in Orphan Drug Exclusivity Act; Administration of controlled substances by HCPs; Storage of controlled substances HR 5950 - Improving Patient Access to Care and Treatment Act S. 3257 - To amend the Controlled Substances Act to lengthen the period of time during which certain controlled substances must be administered to a patient after being delivered by a pharmacy to the administering practitioner.
Client expense: $90,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office
2021 · fourth_quarter · Health Issues
HR 1629, S250 Fairness in Orphan Drug Exclusivity Act; Administration of controlled substances by HCPs; Storage of controlled substances HR 5950 - Improving Patient Access to Care and Treatment Act S. 3257 - To amend the Controlled Substances Act to lengthen the period of time during which certain controlled substances must be administered to a patient after being delivered by a pharmacy to the administering practitioner.
Client expense: $90,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office
2021 · fourth_quarter · Medicare/Medicaid
HR 1629, S250 Fairness in Orphan Drug Exclusivity Act; Administration of controlled substances by HCPs; Storage of controlled substances HR 5950 - Improving Patient Access to Care and Treatment Act S. 3257 - To amend the Controlled Substances Act to lengthen the period of time during which certain controlled substances must be administered to a patient after being delivered by a pharmacy to the administering practitioner.
Client expense: $90,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office
2021 · fourth_quarter · Alcohol and Drug Abuse
HR 1629, S250 Fairness in Orphan Drug Exclusivity Act; Administration of controlled substances by HCPs; Storage of controlled substances HR 5950 - Improving Patient Access to Care and Treatment Act S. 3257 - To amend the Controlled Substances Act to lengthen the period of time during which certain controlled substances must be administered to a patient after being delivered by a pharmacy to the administering practitioner.
Client expense: $90,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office
2021 · fourth_quarter · Insurance
HR 1629, S250 Fairness in Orphan Drug Exclusivity Act; Administration of controlled substances by HCPs; Storage of controlled substances HR 5950 - Improving Patient Access to Care and Treatment Act S. 3257 - To amend the Controlled Substances Act to lengthen the period of time during which certain controlled substances must be administered to a patient after being delivered by a pharmacy to the administering practitioner.
Client expense: $90,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office
2021 · fourth_quarter · Medicare/Medicaid
HR 1629, S250 Fairness in Orphan Drug Exclusivity Act; Administration of controlled substances by HCPs; Storage of controlled substances HR 5950 - Improving Patient Access to Care and Treatment Act S. 3257 - To amend the Controlled Substances Act to lengthen the period of time during which certain controlled substances must be administered to a patient after being delivered by a pharmacy to the administering practitioner.
Client expense: $90,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office
2021 · fourth_quarter · Health Issues
HR 1629, S250 Fairness in Orphan Drug Exclusivity Act; Administration of controlled substances by HCPs; Storage of controlled substances HR 5950 - Improving Patient Access to Care and Treatment Act S. 3257 - To amend the Controlled Substances Act to lengthen the period of time during which certain controlled substances must be administered to a patient after being delivered by a pharmacy to the administering practitioner.
Client expense: $90,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office
2021 · fourth_quarter · Pharmacy
HR 1629, S250 Fairness in Orphan Drug Exclusivity Act; Administration of controlled substances by HCPs; Storage of controlled substances HR 5950 - Improving Patient Access to Care and Treatment Act S. 3257 - To amend the Controlled Substances Act to lengthen the period of time during which certain controlled substances must be administered to a patient after being delivered by a pharmacy to the administering practitioner.
Client expense: $90,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office
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
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)
2021 · third_quarter · Pharmacy
Fairness in Orphan Drug Exclusivity Act S. 250 Senate Finance Committee Drug Pricing Principles
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2021 · third_quarter · Health Issues
HCR - HR 1629 To amend the Federal Food, Drug, and Cosmetic Act with respect to limitations on exclusive approval or licensure of orphan drugs; S. 250 Fairness in Orphan Drug Exclusivity Act; reducing stigma and promoting treatment of opioid use disorder; raising awareness of the benefits of medication assisted therapy (MAT); ensuring patient access to MAT; FDA approval and exclusivity process; patient access to practitioner-administered therapies
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, Office of Natl Drug Control Policy (NDCP), SENATE