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Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2021
Legislative Progress
Momentum (last 30 days)
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1d open
vs 9,698 other HR bills in the 117th — cohort avg 63d
Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2021 or the BLOCKING Act of 2021 This bill modifies provisions related to market exclusivity for a generic drug. Currently, the Food and Drug Administration (FDA) awards 180 days of exclusivity on the market to a first applicant to file a qualifying application for market approval of a generic drug. Generally, this exclusivity period begins upon a first applicant's commercial marketing of the drug. The bill authorizes the FDA to approve a subsequent generic drug application prior to a first applicant's first date of commercial marketing if (1) the subsequent application is ready for full approval, (2) a first applicant's application has been pending for at least 30 months, and (3) the approval of a first applicant's application is not precluded by patent infringement claims asserted against that first applicant.
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 (9)
Referred to the Subcommittee on Health.
Referred to the House Committee on Energy and Commerce.
Introduced in House
Congress.gov source codes: 1000, Intro-H
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 · Health Issues
Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 S.464 / H.R.2163: Safe Step Act S.917: Short on Competition Act H.R.2355: Opioid Prescription Verification Act H.R.2410: Medicare and You Handbook Improvement Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2843: STOP GAMES Act H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2853: BLOCKING Act H.R.2855: Star Ratings for Biosimilars Act S.1388: Prescription Pricing for the People Act S.1425 / H.R.2883: Stop STALLING Act S.1427 / H.R.2869: Increasing Access to Biosimilars Act S.1428 / H.R.2891: Preserve Access to Affordable Generics and Biosimilars Act S.1435 / H.R.2873: Affordable Prescriptions for Patients Act of 2021 / Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act S.1462: Simplifying the Generic Drug Application Process Act S.1463: Modernizing Therapeutic Equivalence Rating Determination Act S.1523: The Drug Price Transparency Act S.1524 / H.R.3029: Health Care PRICE Transparency Act H.R.3173: Improving Seniors Timely Access to Care Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act H.R.3682: Improving Transparency to Lower Drug Costs Act S.2164: Lower Costs More Cures Act H.R.4121: To codify a final rule issued by the Secretary of Health and Human Services relating to fraud and abuse and the removal of safe harbor protection for certain drug rebates, and for other purposes H.R.4158: To amend titles XVIII and XIX of the Social Security Act to eliminate cost sharing with respect to coverage of insulin as a covered part D drug under the Medicare program or as a covered outpatient drug under the Medicaid program H.R.4502: Labor, Health and Human Services, Education, Agriculture, Rural Development, Energy and Water Development, Financial Services and General Government, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2022 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R.4813: Matts Act S.2814: Vital Medication Affordability Act S.1132: Ending Pricey Insulin (EPI) Act H.R.3062: A bill making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for fiscal year ending September 30, 2022 H.R.6000: The CURES 2.0 Act, To continue the acceleration of the discovery, development, and delivery of 21st century cures, and for other purposes H.R.3554: To amend title XVIII of the Social Security Act to reform requirements with respect to direct and indirect remuneration under Medicare part D, and for other purposes H.R.6851: To amend the Families First Coronavirus Response Act and the CARES Act to establish new coverage and payment rules for certain COVID-19 diagnostic tests and related items and services, and for other purposes S.3700: A bill to provide for appropriate cost-sharing for insulin products covered under Medicare part D and private health plans H.R.6833: To amend title XXVII of the Public Health Service Act, the Internal Revenue Code of 1986, and the Employee Retirement Income Security Act of 1974 to establish requirements with respect to cost-sharing for certain insulin products, and for other purposes H.R.6757: To amend title XVIII of the Social Security Act to establish under the Medicare prescription drug program a minimum amount of price concessions for insulin to be passed through to beneficiaries at the point-of-sale, and for other purposes H.R.7008: To improve patient access to emerging medication therapies by clarifying the scope of permitted health care economic and scientific information communications between biopharmaceutical manufacturers and population health decision makers, and for other purposes H.R.7047: 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.6833: Affordable Insulin Now Act H.R.6963: Accelerated Approval Integrity Act H.R.7008: Pre-approval Information Exchange Act H.R.7032: Increasing Transparency in Generic Drug Applications Act H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act S.4011: Capping Drug Costs for Seniors Act of 2022 H.R.7666: Restoring Hope for Mental Health and Well-Being Act H.R.7667: Food and Drug Amendments of 2022 H.R.7828: To amend the Public Health Service Act to shorten the exclusivity period for brand name biological products from 12 to 5 years; (PRICED Act) S.4293: Pharmacy Benefit Manager Transparency Act S.4348: A bill to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes; (FDASLA Act) H.R.7995: GOLD CARD Act H.R.5376: The Inflation Reduction Act, Sec. 139301, Prohibiting implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates 42 CFR Part 1001 RIN 0936-AA08: Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees 42 CFR Parts 422 423 RIN 0938-AU30 Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs Proposed Rule (CMS-4192-P)
Client expense: $2,578,869 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
2022 · fourth_quarter · Pharmacy
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADAPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. S.4918: Increasing Prescription Drug Competition Act. Labeling of Generic Drugs and Biosimilars. H.R.9011: Updated Drug Labeling for Patient Safety Act. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize Domestic Manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. S.6: Biosimilar Red Tape Elimination Act. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Energy & Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035/S.4302: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. Implementation of the Inflation Reduction Act.. H.R.6485/S.3495: Inflation Prevention Act. S.3799: PREVENT Pandemics Act. H.R.2617: Consolidated Appropriations Act of 2023.
Client expense: $900,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), SENATE
2022 · fourth_quarter · Health Issues
H.R. 2853, the BLOCKING Act, provisions relating to amending the Hatch-Waxman Act's 180-day exclusivity structure; and S. 4348, the Food and Drug Safety and Landmark Advancements Act, Section 515, 180 Day Exclusivity Period, provisions relating to amending the Hatch-Waxman Act's 180-day exclusivity structure to prevent market blockages.
Client expense: $520,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, 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 · fourth_quarter · Health Issues
H.R. 2853 BLOCKING Act of 2021 (All sections of full text). S. 2910, Expanding Access to Low-Cost Generics Act of 2021 (All sections of full text). Discussions regarding S. 3799, PREVENT Pandemics Act of 2022. Discussions regarding the reauthorization of Generic Drug User Fee Amendments included in P.L.117-95, Extension of Continuing Appropriations Act. Discussions regarding improved education about digital health care. Monitored the implementation of P.L. 117-169, Inflation Reduction Act of 2022. Monitored the implementation of P.L.117-7, To prevent across-the-board direct spending cuts, and for other purposes. Monitored Medicare and prescription drug changes. Monitored discussions related to mental health legislation.
Client expense: Not reported · Firm income: $80,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE, White House Office
2022 · fourth_quarter · Health Issues
21st Century Cures Act 2.0 ---H.R.6000: Cures 2.0 Act 340B Drug Discount Program ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Reauthorization of PAHPA ---White House National Biodefense Strategy Biosimilars ---BSUFA Negotiations ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2022 ---Reimbursement Coronavirus (COVID-19) Pandemic ---H.R.834: Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---H.R.2617: Consolidated Appropriations Act of 2023 ---S.2327: Seniors Prescription Drug Relief Act ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Drug Supply Chain Management ---Healthcare Disparities ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver Climate Change ---H.R.2617: Consolidated Appropriations Act of 2023 ---Implementation of the Inflation Reduction Act (IRA) of 2022 Data Privacy ---H.R.8152: American Data Privacy and Protection Act Diagnostics and Personalized Medicine Regulation and Oversight ---H.R.4128/S.2209: VALID Act Diversity & Inclusion ---H.R.3085: Equity in Neuroscience and Alzheimer's Clinical Trials (ENACT) Act of 2021 ---H.R.5030: Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act ---H.R.6584: Diverse and Equitable Participation in Clinical Trials (DEPICT) Act ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Clinical Trial Diversity Drug Evaluation and Review ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.6963: Accelerated Approval Integrity Act ---H.R.6972/S.4215: Give Kids a Chance Act of 2022 ---H.R.6996: Accelerating Approval for Patients Act ---H.R.7008: The Pre-Approval Information Exchange Act ---S.1644: Promising Pathway Act ---S.1645: Accelerated Drug Approval for Prescription Therapies (ADAPT) Act ---S.4185: Retaining Access and Restoring Exclusivity (RARE) Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---Innovation Incentives ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Reforms to the Accelerated Approval Pathway ---Regulatory Reform & Modernization ---Use of Real-World Evidence Drug Importation ---S.920: A bill to amend the Federal Food, Drug, and Cosmetic Act to allow for the importation of affordable and safe drugs by wholesale distributors, pharmacies, and individuals ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 Drug Manufacturing, Quality & Distribution ---H.R.3927/S.2082: Manufacturing API, Drugs, and Excipients (MADE) in America Act ---H.R.6988: Drug Manufacturing Innovation Act ---H.R.7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and overseeing Needed Supplies (INSPECTIONS) Act ---H.R.7667: The Food and Drug Amendments of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Advanced Manufacturing ---Counterfeiting ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2883/S.1485: Stop Stalling Access to Affordable Medications ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---S.4430: Interagency Patent Coordination and Improvement Act of 2022 ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.7667: The Food and Drug Amendments of 2022 ---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.9358: Access to Innovative Treatments Act of 2022 ---S.1388: Prescription Pricing for the People Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---National Coverage Determination Foreign Drug Data Protection Laws ---Regulatory Harmonization Funding for Antimicrobial Resistance (AMR) Programs ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.7900: National Defense Authorization Act for FY 2023 ---S.4543: James M. Inhofe National Defense Authorization Act for FY 2023 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.2617: Consolidated Appropriations Act of 2023 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of PAHPA Funding for FDA ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.7667: The Food and Drug Amendments of 2022 ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---H.R.2617: Consolidated Appropriations Act of 2023 Funding for National Institutes of Health ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.5585: Advanced Research Projects Agency for Health (ARPA-H) Act Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.2617: Consolidated Appropriations Act of 2023 ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---H.R.2617: Consolidated Appropriations Act of 2023 Generic Drug Entry ---H.R.2853: Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2021 ---H.R.2883: Stop Stalling Access to Affordable Medications Act ---S.4351/H.R. 6973: Enhanced Access to Affordable Medicines Act ---S.4338/H.R. 7032: Increasing Transparency in Generic Drug Applications Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Incentives for Generic Entry Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.7389: Medicaid VBPs for Patients (MVP) Act of 2022 ---S.3013: Encouraging Innovation Benefit Design to Lower Costs for Seniors Act of 2019 ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---Alternative Payment Arrangements for Gene Therapies ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Pricing and Rebates Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.5566: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.4185: Retaining Access and Restoring Exclusivity (RARE) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Rare Pediatric Disease Priority Review ---H.R.6888/S.4071: Helping Experts Accelerate Rare Treatments (HEART) Act ---H.R.6972/S.4215: Give Kids a Chance Act of 2022 Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.9358: Access to Innovative Treatments Act of 2022 ---S.2327: Seniors Prescription Drug Relief Act ---S.2416: New Opportunities for Value that Extend Lives (NOVEL) Act of 2021 ---Administration Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Step Therapy Vaccines and Infectious Diseases ---H.R.951/H.R.959/S.345/S.346: Maternal Vaccinations Act of 2021 ---H.R.1978/S.912: Protecting Seniors through Immunizations Act of 2021 ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347/S.2691: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.9358: Access to Innovative Treatments Act of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---S.4509 Vaccine and Coverage Certainty (VACC) Act ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety Vaccine Injury Compensation Program ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3656: Vaccine Access Improvement Act of 2021 ---S.3087: Vaccine Access Improvement Act of 2021 ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---VICP CICP (Discussion Draft)
2022 · fourth_quarter · Pharmacy
Issues related to generic pharmaceuticals and biosimilars, including reimbursement rate, pricing, and supply chain. Issues related to H.R. 2853, BLOCKING Act of 2021. Issues related to pharmaceutical patents. Issues related to drug pricing. Issues related to FDA provisions in S. 3799, the PREVENT Pandemics Act.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · third_quarter · Health Issues
Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 S.464 / H.R.2163: Safe Step Act S.917: Short on Competition Act H.R.2355: Opioid Prescription Verification Act H.R.2410: Medicare and You Handbook Improvement Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2843: STOP GAMES Act H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2853: BLOCKING Act H.R.2855: Star Ratings for Biosimilars Act S.1388: Prescription Pricing for the People Act S.1425 / H.R.2883: Stop STALLING Act S.1427 / H.R.2869: Increasing Access to Biosimilars Act S.1428 / H.R.2891: Preserve Access to Affordable Generics and Biosimilars Act S.1435 / H.R.2873: Affordable Prescriptions for Patients Act of 2021 / Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act S.1462: Simplifying the Generic Drug Application Process Act S.1463: Modernizing Therapeutic Equivalence Rating Determination Act S.1523: The Drug Price Transparency Act S.1524 / H.R.3029: Health Care PRICE Transparency Act H.R.3173: Improving Seniors Timely Access to Care Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act H.R.3682: Improving Transparency to Lower Drug Costs Act S.2164: Lower Costs More Cures Act H.R.4121: To codify a final rule issued by the Secretary of Health and Human Services relating to fraud and abuse and the removal of safe harbor protection for certain drug rebates, and for other purposes H.R.4158: To amend titles XVIII and XIX of the Social Security Act to eliminate cost sharing with respect to coverage of insulin as a covered part D drug under the Medicare program or as a covered outpatient drug under the Medicaid program H.R.4502: Labor, Health and Human Services, Education, Agriculture, Rural Development, Energy and Water Development, Financial Services and General Government, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2022 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R.4813: Matts Act S.2814: Vital Medication Affordability Act S.1132: Ending Pricey Insulin (EPI) Act H.R.3062: A bill making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for fiscal year ending September 30, 2022 H.R.6000: The CURES 2.0 Act, To continue the acceleration of the discovery, development, and delivery of 21st century cures, and for other purposes H.R.3554: To amend title XVIII of the Social Security Act to reform requirements with respect to direct and indirect remuneration under Medicare part D, and for other purposes H.R.6851: To amend the Families First Coronavirus Response Act and the CARES Act to establish new coverage and payment rules for certain COVID-19 diagnostic tests and related items and services, and for other purposes S.3700: A bill to provide for appropriate cost-sharing for insulin products covered under Medicare part D and private health plans H.R.6833: To amend title XXVII of the Public Health Service Act, the Internal Revenue Code of 1986, and the Employee Retirement Income Security Act of 1974 to establish requirements with respect to cost-sharing for certain insulin products, and for other purposes H.R.6757: To amend title XVIII of the Social Security Act to establish under the Medicare prescription drug program a minimum amount of price concessions for insulin to be passed through to beneficiaries at the point-of-sale, and for other purposes H.R.7008: To improve patient access to emerging medication therapies by clarifying the scope of permitted health care economic and scientific information communications between biopharmaceutical manufacturers and population health decision makers, and for other purposes H.R.7047: 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.6833: Affordable Insulin Now Act H.R.6963: Accelerated Approval Integrity Act H.R.7008: Pre-approval Information Exchange Act H.R.7032: Increasing Transparency in Generic Drug Applications Act H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act S.4011: Capping Drug Costs for Seniors Act of 2022 H.R.7666: Restoring Hope for Mental Health and Well-Being Act H.R.7667: Food and Drug Amendments of 2022 H.R.7828: To amend the Public Health Service Act to shorten the exclusivity period for brand name biological products from 12 to 5 years; (PRICED Act) S.4293: Pharmacy Benefit Manager Transparency Act S.4348: A bill to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes; (FDASLA Act) H.R.7995: GOLD CARD Act H.R.5376: The Inflation Reduction Act, Sec. 139301, Prohibiting implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates 42 CFR Part 1001 RIN 0936-AA08: Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees 42 CFR Parts 422 423 RIN 0938-AU30 Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs Proposed Rule (CMS-4192-P)
2022 · third_quarter · Health Issues
H.R. 2853 BLOCKING Act of 2021 (All sections of full text). P.L. 117-169, Inflation Reduction Act of 2022 (All sections of full text). S. 2910, Expanding Access to Low-Cost Generics Act of 2021 (All sections of full text). Discussions regarding S. 3799, PREVENT Pandemics Act of 2022. Discussions regarding the reauthorization of Generic Drug User Fee Amendments included in P.L.117-95, Extension of Continuing Appropriations Act. Discussions regarding the approval of generic drugs. Discussions regarding improved education about digital health care. Monitored the implementation of P.L.117-7, To prevent across-the-board direct spending cuts, and for other purposes. Monitored Medicare and prescription drug changes. Monitored discussions related to mental health legislation.
Client expense: Not reported · Firm income: $80,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE, White House Office
2022 · third_quarter · Pharmacy
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act of 2022. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize domestic manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Inspections Legislative Proposals. Energy and Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035/S.4302: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.748/S.3548: CARES Act Reporting. H.R.5376: Inflation Reduction Act of 2022. H.R.6485/S.3495: Inflation Prevention Act. S.3799: PREVENT Pandemics Act.
2022 · third_quarter · Pharmacy
Issues related to generic pharmaceuticals and biosimilars, including reimbursement rate, pricing, and supply chain. Issues related to H.R. 2853, BLOCKING Act of 2021. Issues related to pharmaceutical patents. Issues related to drug pricing. Issues related to FDA provisions in S. 3799, the PREVENT Pandemics Act. Issues related to the Generic Drug User Fee Act (GDUFA) and the Biosimilar User Fee Act (BsUFA) in user fees legislation.
Client expense: Not reported · Firm income: $60,000
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 · third_quarter · Pharmacy
Issues related to affordability, essential medicine manufacturing, and pharmaceuticals. General issues related to H.R. 2853, the BLOCKING Act of 2021. Issues related to the Inflation Reduction Act (Public Law 117-169), focusing on pharmaceutical provisions.
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · second_quarter · Health Issues
H.R. 2853 BLOCKING Act of 2021 (All sections of full text). H.R. 5376, Build Back Better Act (All sections of full text). S. 2910, Expanding Access to Low-Cost Generics Act of 2021 (All sections of full text). Discussions regarding S. 3799, PREVENT Pandemics Act of 2022. Discussions regarding the reauthorization of Generic Drug User Fee Amendments. Discussions regarding the approval of generic drugs. Discussions regarding improved education about digital health care. Monitored the implementation of P.L.117-7, To prevent across-the-board direct spending cuts, and for other purposes. Monitored Medicare and prescription drug changes. Monitored discussions related to mental health legislation.
Client expense: Not reported · Firm income: $80,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2022 · second_quarter · Health Issues
HR 7667, the Food and Drug Amendments of 2022, Title III, Fees Relating to Generic Drugs, provisions relating to the reauthorization of the Generic Drug User Fee Act; S 4348, Food and Drug Safety and Landmark Advancement Act, Title III, Fees Relating to Generic Drugs, provisions relating to the reauthorization of the Generic Drug User Fee Act; Senator Tina Smith Amendment #1 to S 4348, provisions relating to amending the Hatch-Waxman 180 exclusivity structure to prevent market blockages; HR 2853, the BLOCKING Act, provisions relating to amending the Hatch-Waxman Act 180-day exclusivity structure; and S2910, Expanding Access to Low Cost Generics Act, provisions relating to amending the Hatch-Waxman Act's 180-day exclusivity structure.
Client expense: $130,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · second_quarter · Health Issues
Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 S.464 / H.R.2163: Safe Step Act S.917: Short on Competition Act H.R.2355: Opioid Prescription Verification Act H.R.2410: Medicare and You Handbook Improvement Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2843: STOP GAMES Act H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2853: BLOCKING Act H.R.2855: Star Ratings for Biosimilars Act S.1388: Prescription Pricing for the People Act S.1425 / H.R.2883: Stop STALLING Act S.1427 / H.R.2869: Increasing Access to Biosimilars Act S.1428 / H.R.2891: Preserve Access to Affordable Generics and Biosimilars Act S.1435 / H.R.2873: Affordable Prescriptions for Patients Act of 2021 / Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act S.1462: Simplifying the Generic Drug Application Process Act S.1463: Modernizing Therapeutic Equivalence Rating Determination Act S.1523: The Drug Price Transparency Act S.1524 / H.R.3029: Health Care PRICE Transparency Act H.R.3173: Improving Seniors Timely Access to Care Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act H.R.3682: Improving Transparency to Lower Drug Costs Act S.2164: Lower Costs More Cures Act H.R.4121: To codify a final rule issued by the Secretary of Health and Human Services relating to fraud and abuse and the removal of safe harbor protection for certain drug rebates, and for other purposes H.R.4158: To amend titles XVIII and XIX of the Social Security Act to eliminate cost sharing with respect to coverage of insulin as a covered part D drug under the Medicare program or as a covered outpatient drug under the Medicaid program H.R.4502: Labor, Health and Human Services, Education, Agriculture, Rural Development, Energy and Water Development, Financial Services and General Government, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2022 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R.4813: Matts Act S.2814: Vital Medication Affordability Act S.1132: Ending Pricey Insulin (EPI) Act H.R.3062: A bill making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for fiscal year ending September 30, 2022 H.R.6000: The CURES 2.0 Act, To continue the acceleration of the discovery, development, and delivery of 21st century cures, and for other purposes H.R.3554: To amend title XVIII of the Social Security Act to reform requirements with respect to direct and indirect remuneration under Medicare part D, and for other purposes H.R.6851: To amend the Families First Coronavirus Response Act and the CARES Act to establish new coverage and payment rules for certain COVID-19 diagnostic tests and related items and services, and for other purposes S.3700: A bill to provide for appropriate cost-sharing for insulin products covered under Medicare part D and private health plans H.R.6833: To amend title XXVII of the Public Health Service Act, the Internal Revenue Code of 1986, and the Employee Retirement Income Security Act of 1974 to establish requirements with respect to cost-sharing for certain insulin products, and for other purposes H.R.6757: To amend title XVIII of the Social Security Act to establish under the Medicare prescription drug program a minimum amount of price concessions for insulin to be passed through to beneficiaries at the point-of-sale, and for other purposes H.R.7008: To improve patient access to emerging medication therapies by clarifying the scope of permitted health care economic and scientific information communications between biopharmaceutical manufacturers and population health decision makers, and for other purposes H.R.7047: 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.6833: Affordable Insulin Now Act H.R.6963: Accelerated Approval Integrity Act H.R.7008: Pre-approval Information Exchange Act H.R.7032: Increasing Transparency in Generic Drug Applications Act H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act S.4011: Capping Drug Costs for Seniors Act of 2022 H.R.7666: Restoring Hope for Mental Health and Well-Being Act H.R.7667: Food and Drug Amendments of 2022 H.R.7828: To amend the Public Health Service Act to shorten the exclusivity period for brand name biological products from 12 to 5 years; (PRICED Act) S.4293: Pharmacy Benefit Manager Transparency Act S.4348: A bill to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes; (FDASLA Act) H.R.7995: GOLD CARD Act 42 CFR Part 1001 RIN 0936-AA08: Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees 42 CFR Parts 422 423 RIN 0938-AU30 Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs Proposed Rule (CMS-4192-P)
2022 · second_quarter · Pharmacy
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act of 2022. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize domestic manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Inspections Legislative Proposals. Energy and Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.748/S.S.3548: CARES Act Reporting. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act.
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 · second_quarter · Health Issues
21st Century Cures Act 2.0 ---H.R.6000: Cures 2.0 Act 340B Drug Discount Program ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Reauthorization of PAHPA ---Tropical Disease Priority Review (PRV) Program ---White House National Biodefense Strategy Biosimilars ---H.R.7035: Biologics Market Transparency Act ---H.R.7047: A bill to Amend title III of PHSA re: determination re: biosimilar application elements ---Biosimilar Copay ---BSUFA Negotiations ---Interchangeability and Pharmacy Substitution ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 ---Reimbursement Coronavirus (COVID-19) Pandemic ---H.R.834: Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---S.2327: Seniors Prescription Drug Relief Act ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of Consolidated Appropriations Act for FY 2021 ---Implementation of Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of Families First Coronavirus Response Act of 2020 ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---R&D Funding for Medical Countermeasures ---Temporarily Refundable R&D Credit ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper ---Small Business Loans ---Supply Chain Issues ---TRIPS IP Waiver Climate Change ---FY 2023 Appropriations Data Privacy ---H.R.8152: American Data Privacy and Protection Act Diagnostics and Personalized Medicine Regulation and Oversight ---H.R.4128/S.2209: VALID Act Diversity & Inclusion ---H.R.729: Strength in Diversity Act of 2021 ---H.R.3085: Equity in Neuroscience and Alzheimer's Clinical Trials (ENACT) Act of 2021 ---H.R.5030: Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act ---H.R.6584: Diverse and Equitable Participation in Clinical Trials (DEPICT) Act ---H.R.7667: The Food and Drug Amendments of 2022 ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Clinical Trial Diversity Drug Evaluation and Review ---H.R.3927/S.2082: Manufacturing API, Drugs, and Excipients (MADE) in America Act ---H.R.4472: Better Empowerment Now To Enhance Framework and Improve Treatments (BENEFIT) Act ---H.R.4511: FDA Advancing Collection of Transformative Science (FACTS) Act ---H.R.6963: Accelerated Approval Integrity Act ---H.R.6972/S.4215: Give Kids a Chance Act of 2022 ---H.R.6996: Accelerating Approval for Patients Act ---H.R.7008: The Pre-Approval Information Exchange Act ---H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act ---H.R.7667: The Food and Drug Amendments of 2022 ---S.1644 Promising Pathway Act ---S.1645: Accelerated Drug Approval for Prescription Therapies ADAPT Act ---S.4185: Retaining Access and Restoring Exclusivity (RARE) Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---S.4351: Enhanced Access to Affordable Medicines Act of 2022 ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---FDA Review of CBD-based Drugs ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Innovation Incentives ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Reforms to the Accelerated Approval Pathway ---Regulatory Reform & Modernization ---Use of Real-World Evidence Drug Importation ---S.920: A bill to amend the Federal Food, Drug, and Cosmetic Act to allow for the importation of affordable and safe drugs by wholesale distributors, pharmacies, and individuals ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 Drug Manufacturing, Quality & Distribution ---H.R.1959: Preserving Patient Access to Compounded Medications Act of 2019 ---H.R.3927/S.2082: Manufacturing API, Drugs, and Excipients (MADE) in America Act ---H.R.6988: Drug Manufacturing Innovation Act ---H.R.7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and overseeing Needed Supplies (INSPECTIONS) Act ---H.R.7767: A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Counterfeiting ---Drug Shortages ---Executive Order on Buy American ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873/S.1435: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2883/S.1485: Stop Stalling Access to Affordable Medications ---H.R.2884/S.1435: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.4418: Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act ---H.R.5376: Build Back Better Act of 2021 ---H.R.7667: The Food and Drug Amendments of 2022 ---S.1388: Prescription Pricing for the People Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---S.2327: Seniors Prescription Drug Relief Act ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Build Back Better Act (Discussion Draft Senate) ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Implementation of Consolidated Appropriations Act for FY 2021 ---National Coverage Determination Foreign Drug Data Protection Laws ---Regulatory Harmonization Funding for Antimicrobial Resistance (AMR) Programs ---FY 2023 Appropriations ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---Implementation of Consolidated Appropriations Act for FY 2021 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2023 Appropriations ---H.R.4521: America COMPETES Act of 2022 ---H.R.5376: Build Back Better Act of 2021 ---S.1260: United States Innovation and Competition Act of 2021 ---Build Back Better Act (Discussion Draft Senate) ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of Consolidated Appropriations Act for FY 2021 ---Implementation of Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Reauthorization of PAHPA Funding for FDA ---FY 2023 Appropriations ---FY 2023 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies funding bill ---H.R.7667: The Food and Drug Amendments of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Implementation of Consolidated Appropriations Act for FY 2021 ---Implementation of Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2023 Appropriations ---Implementation of Consolidated Appropriations Act for FY 2021 Funding for National Institutes of Health ---FY 2023 Appropriations ---H.R.623: Gabriella Miller Kids First Research Act 2.0 ---H.R.5585: Advanced Research Projects Agency for Health (ARPA-H) Act Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2023 Appropriations ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of Consolidated Appropriations Act for FY 2021 ---Implementation of Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2023 Appropriations Generic Drug Entry ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2853: Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2021 ---H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act ---H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act ---H.R.7667: The Food and Drug Amendments of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---S.3013: Encouraging Innovation Benefit Design to Lower Costs for Seniors Act of 2019 ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---Alternative Payment Arrangements for Gene Therapies ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Implementation of Consolidated Appropriations Act for FY 2021 ---Pricing and Rebates Opioid Crisis ---Coverage and Reimbursement ---FDA Reforms ---Implementation of the SUPPORT for Patients and Communities Act of 2018 Orphan Drug Issues ---H.R.1629: Fairness in Orphan Drug Exclusivity Act ---H.R.5376: Build Back Better Act of 2021 ---H.R.5566 Finding Orphan-Disease Remedies With Antifungal Research and Development (FORWARD) Act ---S.4184 Retaining Access and Restoring Exclusivity (RARE) Act ---Build Back Better Act (Discussion Draft Senate) ---Orphan Drug Tax Credit Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.1730: Speeding Therapy Access Today (STAT) Act ---H.R.6888/S.4071: Helping Experts Accelerate Rare Treatments (HEART) Act ---H.R.6972/S.4215: Give Kids a Chance Act of 2022 ---Implementation of Consolidated Appropriations Act for FY 2021 ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.5376: Build Back Better Act of 2021 ---S.2327: Seniors Prescription Drug Relief Act ---S.2416: New Opportunities for Value that Extend Lives (NOVEL) Act of 2021 ---Administration Rebate Rule ---Build Back Better Act (Discussion Draft Senate) ---CMMI Authority ---Implementation of Consolidated Appropriations Act for FY 2021 ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations Vaccines and Infectious Diseases ---FY 2023 Appropriations ---H.R.951/H.R.959/S.345/S.346: Maternal Vaccinations Act of 2021 ---H.R.1978/S.912: Protecting Seniors through Immunizations Act of 2021 ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347/S.2691: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---S.4509: Vaccine and Coverage Certainty (VACC) Act ---Adult Immunization ---Implementation of Consolidated Appropriations Act for FY 2021 ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Recovery of Routine Immunizations ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety Vaccine Injury Compensation Program ---FY 2023 Appropriations ---H.R.3656: Vaccine Access Improvement Act of 2021
2022 · second_quarter · Pharmacy
Issues related to generic pharmaceuticals and biosimilars, including reimbursement rate, pricing, and supply chain. Issues related to H.R. 2853, BLOCKING Act of 2021. Issues related to pharmaceutical patents. Issues related to drug pricing. Issues related to FDA provisions in S. 3799, the PREVENT Pandemics Act. Issues related to the Generic Drug User Fee Act (GDUFA) and the Biosimilar User Fee Act (BsUFA) in H.R. 7667, the Food and Drugs Amendments to 2022, and S. 4348, the Food and Drug Administration Safety and Landmark Advancements Act.
Client expense: Not reported · Firm income: $60,000
2022 · second_quarter · Pharmacy
Issues related to affordability, essential medicine manufacturing and pharmaceuticals. General issues related to the generic drug industry. Issues related to H.R. 2853, the BLOCKING Act of 2021. Issues related to pharmaceutical provisions in H.R. 5376, the Build Back Better Act.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, 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
2022 · first_quarter · Health Issues
Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 S.464 / H.R.2163: Safe Step Act S.917: Short on Competition Act H.R.2355: Opioid Prescription Verification Act H.R.2410: Medicare and You Handbook Improvement Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2843: STOP GAMES Act H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2853: BLOCKING Act H.R.2855: Star Ratings for Biosimilars Act S.1388: Prescription Pricing for the People Act S.1425 / H.R.2883: Stop STALLING Act S.1427 / H.R.2869: Increasing Access to Biosimilars Act S.1428 / H.R.2891: Preserve Access to Affordable Generics and Biosimilars Act S.1435 / H.R.2873: Affordable Prescriptions for Patients Act of 2021 / Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act S.1462: Simplifying the Generic Drug Application Process Act S.1463: Modernizing Therapeutic Equivalence Rating Determination Act S.1523: The Drug Price Transparency Act S.1524 / H.R.3029: Health Care PRICE Transparency Act H.R.3173: Improving Seniors Timely Access to Care Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act H.R.3682: Improving Transparency to Lower Drug Costs Act S.2164: Lower Costs More Cures Act H.R.4121: To codify a final rule issued by the Secretary of Health and Human Services relating to fraud and abuse and the removal of safe harbor protection for certain drug rebates, and for other purposes H.R.4158: To amend titles XVIII and XIX of the Social Security Act to eliminate cost sharing with respect to coverage of insulin as a covered part D drug under the Medicare program or as a covered outpatient drug under the Medicaid program H.R.4502: Labor, Health and Human Services, Education, Agriculture, Rural Development, Energy and Water Development, Financial Services and General Government, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2022 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R.4813: Matts Act S.2814: Vital Medication Affordability Act S.1132: Ending Pricey Insulin (EPI) Act H.R.3062: A bill making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for fiscal year ending September 30, 2022 H.R.6000: The CURES 2.0 Act, To continue the acceleration of the discovery, development, and delivery of 21st century cures, and for other purposes H.R.3554: To amend title XVIII of the Social Security Act to reform requirements with respect to direct and indirect remuneration under Medicare part D, and for other purposes H.R.6851: To amend the Families First Coronavirus Response Act and the CARES Act to establish new coverage and payment rules for certain COVID-19 diagnostic tests and related items and services, and for other purposes S.3700: A bill to provide for appropriate cost-sharing for insulin products covered under Medicare part D and private health plans H.R.6833: To amend title XXVII of the Public Health Service Act, the Internal Revenue Code of 1986, and the Employee Retirement Income Security Act of 1974 to establish requirements with respect to cost-sharing for certain insulin products, and for other purposes H.R.6757: To amend title XVIII of the Social Security Act to establish under the Medicare prescription drug program a minimum amount of price concessions for insulin to be passed through to beneficiaries at the point-of-sale, and for other purposes H.R.7008: To improve patient access to emerging medication therapies by clarifying the scope of permitted health care economic and scientific information communications between biopharmaceutical manufacturers and population health decision makers, and for other purposes H.R.7047: 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 42 CFR Part 1001 RIN 0936-AA08: Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees 42 CFR Parts 422 423 RIN 0938-AU30 Medicare Program; Contract Year 2003 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs Proposed Rule (CMS-4192-P)
2022 · first_quarter · Health Issues
21st Century Cures Act 2.0 ---H.R.6000: Cures 2.0 Act 340B Drug Discount Program ---H.R.5376: Build Back Better Act of 2021 ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---S.3799: PREVENT Pandemics Act ---American Pandemic Preparedness Plan (AP3) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---White House National Biodefense Strategy ---Tropical Disease Priority Review (PRV) Program Biosimilars ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R. 7035: Biologics Market Transparency Act ---H.R.2815: BIO SIM Act ---H.R.5376: Build Back Better Act of 2021 ---Biosimilar Copay ---BSUFA Negotiations ---BSUFA III Discussion Draft ---Interchangeability and Pharmacy Substitution ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R.834: Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---H.R.5237/H.R.5260: Reduced Costs and Continued Cures Act ---H.R.5376: Build Back Better Act of 2021 ---H.R.6119: Further Extending Government Funding Act ---S.2327: Seniors Prescription Drug Relief Act ---S.3799: PREVENT Pandemics Act ---Coronavirus Supplemental Appropriations ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---In-Home Administration of Part B Drugs ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---R&D Funding for Medical Countermeasures ---Temporarily Refundable R&D Credit ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---TRIPS IP Waiver Diagnostics and Personalized Medicine Regulation and Oversight ---VALID Act (Draft Discussion) Diversity & Inclusion ---H.R. 5030: Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act ---H.R. 6584: Diverse and Equitable Participation in Clinical Trials (DEPICT) Act ---H.R.729: Strength in Diversity Act of 2021 ---H.R.3085: Equity in Neuroscience and Alzheimer's Clinical Trials (ENACT) Act of 2021 ---Clinical Trial Diversity Drug Evaluation and Review ---H.R. 4472: Better Empowerment Now To Enhance Framework and Improve Treatments Act ( BENEFIT Act) ---H.R. 4511: FDA Advancing Collection of Transformative Science (FACTS) Act ---H.R. 6963: Accelerated Approval Integrity Act ---H.R. 6996: Accelerating Approval for Patients Act ---H.R. 7008: The Pre-Approval Information Exchange Act ---S.1644 Promising Pathway Act ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Innovation Incentives ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Regulatory Reform & Modernization ---Use of Real-World Evidence ---FDA Hiring Flexibility ---FDA Management and Financial Accountability Drug Importation ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---S.920: A bill to amend the Federal Food, Drug, and Cosmetic Act to allow for the importation of affordable and safe drugs by wholesale distributors, pharmacies, and individuals Drug Manufacturing, Quality & Distribution ---H.R.7767: A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. ---H.R. 3927: Manufacturing API, Drugs, & Excipients in America (MADE in America) Act ---H.R. 7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and overseeing Needed Supplies Act (INSPECTIONS Act) ---Executive Order on Buy American ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873/S.1435: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2883/S.1485: Stop Stalling Access to Affordable Medications ---H.R.2884/S.1435: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---H.R.5376: Build Back Better Act of 2021 ---S.1388: Prescription Pricing for the People Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---H.R.6833/S.3700: Affordable Insulin Now Act ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Senate Finance Committee Drug Pricing Provisions Foreign Drug Data Protection Laws ---Regulatory Harmonization Funding for Antimicrobial Resistance (AMR) Programs ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.5376: Build Back Better Act of 2021 ---H.R.6119: Further Extending Government Funding Act ---S.3799: PREVENT Pandemics Act ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for FDA ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act Funding for National Institutes of Health ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---H.R.5585: Advanced Research Projects Agency for Health (ARPA-H) Act Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---S.3799: PREVENT Pandemics Act ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2023 Appropriations ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act Generic Drug Entry ---H.R. 7032: Increasing Transparency in Generic Drug Applications Act ---H.R.2883: Stop Stalling Access to Affordable Medications Act ---H.R.2853: Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2021 Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.5376: Build Back Better Act of 2021 ---H.R.6833/S.3700: Affordable Insulin Now Act ---Oregon 1115 Medicaid Waiver ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---FDA Reforms Orphan Drug Issues ---H.R.1629: Fairness in Orphan Drug Exclusivity Act ---H.R.5376: Build Back Better Act of 2021 ---H.R. 5566 Finding Orphan-Disease Remedies With Antifungal Research and Development (FORWARD) Act ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R. 6888: Helping Experts Accelerate Rare Treatments (HEART) Act ---H.R. 1730: Speeding Therapy Access Today (STAT) Act ---Orphan Drug Act Reforms ---Tax Credit Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R.2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.5237/H.R.5260: Reduced Costs and Continued Cures Act ---H.R.5376: Build Back Better Act of 2021 ---S.2327: Seniors Prescription Drug Relief Act ---Coronavirus Supplemental Appropriations ---Administration Rebate Rule ---CMMI Authority ---Patient Cost-Sharing and Smoothing ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2023 Appropriations ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---H.R.951/H.R.959/S.345/S.346: Maternal Vaccinations Act of 2021 ---H.R.1978/S.912: Protecting Seniors through Immunizations Act of 2021 ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347/S.2691: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.5376: Build Back Better Act of 2021 ---S.4509: Vaccine and Coverage Certainty (VACC) Act ---S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---S.3799: PREVENT Pandemics Act ---Coronavirus Supplemental Appropriations ---Adult Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program Vaccine Injury Compensation Program ---FY 2023 Appropriations ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---H.R.3656: Vaccine Access Improvement Act of 2021 ---S.3087: Vaccine Access Improvement Act of 2021
2022 · first_quarter · Pharmacy
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. Expanding Access to Low-Cost Generics. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032: Increasing Transparency in Generic Drug Applications Act of 2022. Discounted Drugs for Clinical Trials Act. H.R.5030: DIVERSE Trials Act. H.R.3085: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973: Enhanced Access to Affordable Medicines Act of 2022. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. H.R.6519: Patients Right to Know Their Medication Act of 2022. Generic Formulations. Incentivize domestic manufacturing. Drug Shortages. Stockpile of Generic Drugs. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. Biosims Testing [Legislation not yet introduced]. Biosimilar Animal Data [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Eliminating Phase III Studies for Biosimilars. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. H.R.7006: INSPECTIONS Act. S.3509: Creating Efficiency in Foreign Facility Inspections Act. Inspections Legislative Proposals. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.3576: Accelerated Drug Approval for Prescription Therapies (ADAPT) 2.0 Act. H.R.4472: BENEFIT Act of 2021. H.R.7035: Biologics Market Transparency Act of 2022. H.R.4511: FACTS Act. H.R.6888: Helping Experts Accelerate Rare Treatments Act of 2022. H.R.1730: Speeding Therapy Access Today Act of 2021. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.6972: Give Kids a Chance Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act. H.R.5566: FORWARD Act of 2021. H.R.2910: Veterans Health Care Freedom Act. H.R.5585: Advanced Research Project Agency-Health Act. H.R.2883/S.1425: Stop Stalling Access to Affordable Medications. H.R.4369: National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021.
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 · Health Issues
H.R. 2853 BLOCKING Act of 2021 (All sections of full text). H.R. 5376, Build Back Better Act (All sections of full text). S. 2910, Expanding Access to Low-Cost Generics Act of 2021 (All sections of full text). Discussions regarding S. 3799, PREVENT Pandemics Act of 2022. Discussions regarding the reauthorization of Generic Drug User Fee Amendments. Discussions regarding the approval of generic drugs. Discussions regarding improved education about digital health care. Monitored the implementation of P.L.117-7, To prevent across-the-board direct spending cuts, and for other purposes. Monitored Medicare and prescription drug changes.
Client expense: Not reported · Firm income: $80,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE, Vice President of the U.S.
2022 · first_quarter · Health Issues
HR 2853, the BLOCKING Act, provisions relating to amending the Hatch-Waxman Act 180-day exclusivity structure; S2910, Expanding Access to Low Cost Generics Act, provisions relating to amending the Hatch-Waxman Act's 180-day exclusivity structure; and HR 6431, the Data Transparency and Drug Safety Act of 2022, provisions relating to drug manufacturing data retentions requirements.
Client expense: $120,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, 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
2022 · first_quarter · Pharmacy
Issues related to generic pharmaceuticals and biosimilars, including reimbursement rate, pricing, and supply chain. Issues related to H.R. 2853, BLOCKING Act of 2021. Issues related to pharmaceutical patents. Issues related to drug pricing measures in H.R. 5376, the Build Back Better Act. Issues related to FDA provisions in S. 3799, the PREVENT Pandemics Act. Issues related to the Generic Drug User Fee Act (GDUFA).
Client expense: Not reported · Firm income: $60,000
2022 · first_quarter · Pharmacy
Issues related to affordability, essential medicine manufacturing and pharmaceuticals. General issues related to the generic drug industry. Issues related to H.R. 2853, the BLOCKING Act of 2021. Issues related to pharmaceutical provisions in H.R. 5376, the Build Back Better Act.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2021 · fourth_quarter · Health Issues
HR 5376, the Build Back Better Act, Sections 139001, 139101, 131902 provisions relating to negotiating Medicare prescription drug prices, Medicare Part B pharmaceutical rebates, and Medicare Part D rebates respectively; HR 2853, the BLOCKING Act, provisions relating to amending the Hatch-Waxman Act 180-day exclusivity structure; S2910, Expanding Access to Low Cost Generics Act, provisions relating to amending the Hatch-Waxman Act's 180-day exclusivity structure; S2740, the Promoting Readiness and Ensuring Proper Active pharmaceutical ingredient Reserves of Essential Medicines Act of 2021, provisions relating to establishing a strategic national stockpile of active pharmaceutical ingredients for essential medicines; and HR 2870, the Essential Medicines Strategic Stockpile Act of 2021, provisions relating to creating a pilot program with private entities to test the effectiveness of acquiring, maintaining, managing, and distributing a stockpile of generic drugs at risk of shortage.
Client expense: $510,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2021 · fourth_quarter · Pharmacy
Prescription Drug Costs. Drug Pricing. Biden Executive Order on Drug Pricing. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.2831: The Prompt Approval of Safe Generic Drugs Act. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. Carter Bill on Section 505(j)(10) Labeling. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Legislation to incentivize domestic manufacturing. Drug Shortages. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Pass-through Payments for Biosimilars. Cost Sharing for Biosimilars. Hybrid Biosimilar Applications [Legislation not yet introduced]. Biosims Testing [Legislation not yet introduced]. H.R.2565: FDA Modernization Act of 2021 as it relates to alternative testing methods to animal testing to investigate the safety and effectiveness of a drug, and for other purposes. FDA Inspections. FDA-PTO Collaboration. Buy American Proposals. Issues Related to COVID-19. H.R.2910: Veterans Health Care Freedom Act. H.R.5376: Build Back Better Act.
Client expense: $880,000 · Firm income: Not reported
2021 · fourth_quarter · Pharmacy
Issues related to generic pharmaceuticals and biosimilars, including reimbursement rate, pricing, and supply chain. Issues related to H.R. 2853, BLOCKING Act of 2021, H.R. 2815, the BIOSIM Act, and H.R. 2869, Increasing Access to Biosimilars Act of 2021. Issues related to pharmaceutical patents, including H.R. 153, Protecting Consumer Access to Generic Dugs Act of 2021. Issues related to drug pricing measures in H.R. 5376, the Build Back Better Act.
Client expense: Not reported · Firm income: $60,000
2021 · fourth_quarter · Health Issues
Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 S.464 / H.R.2163: Safe Step Act S.917: Short on Competition Act H.R.2355: Opioid Prescription Verification Act H.R.2410: Medicare and You Handbook Improvement Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2843: STOP GAMES Act H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2853: BLOCKING Act H.R.2855: Star Ratings for Biosimilars Act S.1388: Prescription Pricing for the People Act S.1425 / H.R.2883: Stop STALLING Act S.1427 / H.R.2869: Increasing Access to Biosimilars Act S.1428 / H.R.2891: Preserve Access to Affordable Generics and Biosimilars Act S.1435 / H.R.2873: Affordable Prescriptions for Patients Act of 2021 / Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act S.1462: Simplifying the Generic Drug Application Process Act S.1463: Modernizing Therapeutic Equivalence Rating Determination Act S.1523: The Drug Price Transparency Act S.1524 / H.R.3029: Health Care PRICE Transparency Act H.R.3173: Improving Seniors Timely Access to Care Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act H.R.3682: Improving Transparency to Lower Drug Costs Act S.2164: Lower Costs More Cures Act H.R.4121: To codify a final rule issued by the Secretary of Health and Human Services relating to fraud and abuse and the removal of safe harbor protection for certain drug rebates, and for other purposes H.R.4158: To amend titles XVIII and XIX of the Social Security Act to eliminate cost sharing with respect to coverage of insulin as a covered part D drug under the Medicare program or as a covered outpatient drug under the Medicaid program H.R.4502: Labor, Health and Human Services, Education, Agriculture, Rural Development, Energy and Water Development, Financial Services and General Government, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2022 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R.4813: Matts Act S.2814: Vital Medication Affordability Act S.1132: Ending Pricey Insulin (EPI) Act H.R.3062: A bill making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for fiscal year ending September 30, 2022 H.R.6000: The CURES 2.0 Act, To continue the acceleration of the discovery, development, and delivery of 21st century cures, and for other purposes 42 CFR Part 1001 RIN 0936-AA08: Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees
2021 · fourth_quarter · Health Issues
HR 2853 BLOCKING Act of 2021 (All sections of full text) H.R.5376, Build Back Better Act (All sections of full text) S. 2910, Expanding Access to Low-Cost Generics Act of 2021 (All sections of full text) Discussions regarding the approval of generic drugs Discussions regarding an educational initiative about digital healthcare Monitored the implementation of P.L.117-7, To prevent across-the-board direct spending cuts, and for other purposes Monitored Medicare and prescription drug changes
Client expense: Not reported · Firm income: $80,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE, Vice President of the U.S.
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 · fourth_quarter · Pharmacy
Issues related to affordability, essential medicine manufacturing and pharmaceuticals. General issues related to the generic drug industry. Issues related to H.R. 2853, the BLOCKING Act of 2021. Issues related to pharmaceutical provisions in H.R. 5376, the Build Back Better Act.
Client expense: Not reported · Firm income: $50,000
Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, SENATE
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
Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 S.464 / H.R.2163: Safe Step Act S.917: Short on Competition Act H.R.2355: Opioid Prescription Verification Act H.R.2410: Medicare and You Handbook Improvement Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2843: STOP GAMES Act H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2853: BLOCKING Act H.R.2855: Star Ratings for Biosimilars Act S.1388: Prescription Pricing for the People Act S.1425 / H.R.2883: Stop STALLING Act S.1427 / H.R.2869: Increasing Access to Biosimilars Act S.1428 / H.R.2891: Preserve Access to Affordable Generics and Biosimilars Act S.1435 / H.R.2873: Affordable Prescriptions for Patients Act of 2021 / Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act S.1462: Simplifying the Generic Drug Application Process Act S.1463: Modernizing Therapeutic Equivalence Rating Determination Act S.1523: The Drug Price Transparency Act S.1524 / H.R.3029: Health Care PRICE Transparency Act H.R.3173: Improving Seniors Timely Access to Care Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act H.R.3682: Improving Transparency to Lower Drug Costs Act S.2164: Lower Costs More Cures Act H.R.4121: To codify a final rule issued by the Secretary of Health and Human Services relating to fraud and abuse and the removal of safe harbor protection for certain drug rebates, and for other purposes H.R.4158: To amend titles XVIII and XIX of the Social Security Act to eliminate cost sharing with respect to coverage of insulin as a covered part D drug under the Medicare program or as a covered outpatient drug under the Medicaid program H.R.4502: Labor, Health and Human Services, Education, Agriculture, Rural Development, Energy and Water Development, Financial Services and General Government, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2022 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R.4813: Matts Act S.2814: Vital Medication Affordability Act S.1132: Ending Pricey Insulin (EPI) Act 42 CFR Part 1001 RIN 0936-AA08: Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees
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 · Health Issues
Federal policy relating to the establishment of a strategic national stockpile for active pharmaceutical ingredients; HR 2853, the BLOCKING Act, provisions relating to amending the Hatch-Waxman Act 180-day exclusivity structure; Federal policy relating to amending the Hatch-Waxman Act's 180 day exclusivity framework to prevent market blockages; Federal policy relating to the establishment of an enhanced approval pathway for complex generic drugs; and Federal policy related to suitability petitions and the submission of Abbreviate New Drug Applications (ANDAs).
Client expense: $130,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), SENATE
2021 · third_quarter · Pharmacy
Issues related to generic pharmaceuticals and biosimilars, including H.R. 2853, BLOCKING Act of 2021. Reimbursement rate for biosimilars. Issues related to the implementation of H.R. 133, Consolidated Appropriations Act for Fiscal Year 2021. Issues related to the implementation of H.R. 1319, The American Rescue Plan. Issues related to the pharmaceutical supply chain and domestic manufacturing. Issues related to H.R. 2815, the BIOISM Act and H.R. 2869, Increasing Access to Biosimilars Act of 2021. Issues related to the modernization of prescribing information. Issues related to pharmaceutical patents, including H.R. 153, Protecting Consumer Access to Generic Drugs Act of 2021. Issues related to H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act. Issues related to drug pricing measures in H.R. 5376, the Build Back Better Act.
Client expense: Not reported · Firm income: $60,000
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 · third_quarter · Health Issues
HR 2853 BLOCKING Act of 2021 (All sections of full text) Discussions regarding the approval of generic drugs Monitored H.R.5376, Build Back Better Act Monitored the implementation of P.L.117-7, To prevent across-the-board direct spending cuts, and for other purposes Monitored Medicare and prescription drug changes
Client expense: Not reported · Firm income: $80,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2021 · third_quarter · Pharmacy
Issues related to affordability, essential medicine manufacturing and supply chain, and pricing of pharmaceuticals. General issues related to the generic drug industry. Issues related to H.R. 2853, the BLOCKING Act of 2021.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Client expense: $3,740,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Security Council (NSC), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office
Client expense: $1,908,258 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
Client expense: $720,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE
Government targets: HOUSE OF REPRESENTATIVES, 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: $1,457,755 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
Client expense: $740,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), 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
Client expense: $3,120,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), SENATE, White House Office
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Government targets: HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE
Client expense: $2,715,700 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
Client expense: $3,170,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
Client expense: $830,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), 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
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), SENATE, U.S. Trade Representative (USTR), White House Office
Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, SENATE
Client expense: $1,918,904 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), 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: $1,918,904 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), 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: HOUSE OF REPRESENTATIVES, SENATE
Client expense: $7,440,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE