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Preserve Access to Affordable Generics Act
Legislative Progress
Momentum (last 30 days)
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vs 3,805 other S bills in the 115th — cohort avg 41d
Preserve Access to Affordable Generics Act This bill amends the Federal Trade Commission Act to authorize the Federal Trade Commission (FTC) to initiate proceedings against parties to any agreement resolving or settling a patent infringement claim in connection with the sale of a drug. Such an agreement, with specified exceptions, is presumed to have anticompetitive effects and is a violation of this bill if the filer of the abbreviated new drug (generic) application receives anything of value and agrees to limit or forego research, development, manufacturing, marketing, or sales of the generic drug. An agreement is exempted if the only consideration granted to the generic manufacturer is: (1) the right to market the generic drug prior to the expiration of any statutory exclusivity, (2) a payment for reasonable litigation expenses, or (3) a covenant not to sue on any claim that the generic drug infringes a patent. An entity subject to an FTC enforcement order may petition for the order be reviewed in federal court. Civil penalties are imposed for violations of this bill. This bill amends the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 to require a brand name manufacturer and generic manufacturer to submit to the FTC any other agreements the parties enter into within 30 days of entering into an agreement related to the manufacturing, marketing, sale, or exclusivity period of a drug. This bill amends the Federal Food, Drug, and Cosmetic Act to forfeit the 180-day exclusivity period for a generic drug if the FTC or a court decides that an agreement violated this bill. The FTC is granted exclusive authority to litigate matters relating to anticompetitive practices in connection with the sale of generic drugs. The FTC may not commence enforcement actions (other than cease and desist requests) more than six years after the FTC is notified of an agreement.
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Read twice and referred to the Committee on the Judiciary.
Introduced in Senate
Bills with similar content found using semantic analysis.
Sources: Congress.gov
2020 · fourth_quarter · Copyright/Patent/Trademark
S. 124 Preserve Access to Affordable Generics Act Issues related to drug patents and exclusivities (no bill) H.R. 1520, Purple Book Continuity Act of 2019 H.R. 1499, Protecting Consumer Access to Generic Drugs Act of 2019 S. 1224, The Stop STALLING Act S. 1416, The Affordable Prescriptions for Patients Act S.659 - the Biologics Patent Transparency Act H.R. 938 Bringing Low-cost Options and Competition while Keeping Incentives for New Generics H.R. 5133 Affordable Prescriptions for Patients Through Promoting Competition H.R. 3991 Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R. 2374 Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act H.R. 2375 Preserve Access to Affordable Generics and Biosimilars Act Patent eligibility reform, no specific bill
Client expense: $2,560,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, Treasury, Dept of
2020 · third_quarter · Copyright/Patent/Trademark
S. 124 Preserve Access to Affordable Generics Act Issues related to drug patents and exclusivities (no bill) H.R. 1520, Purple Book Continuity Act of 2019 H.R. 1499, Protecting Consumer Access to Generic Drugs Act of 2019 S. 1224, The Stop STALLING Act S. 1416, The Affordable Prescriptions for Patients Act S.659 - the Biologics Patent Transparency Act H.R. 938 Bringing Low-cost Options and Competition while Keeping Incentives for New Generics H.R. 5133 Affordable Prescriptions for Patients Through Promoting Competition H.R. 3991 Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R. 2374 Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act H.R. 2375 Preserve Access to Affordable Generics and Biosimilars Act
Client expense: $2,920,000 · Firm income: Not reported
2020 · second_quarter · Copyright/Patent/Trademark
S. 124 Preserve Access to Affordable Generics Act Issues related to drug patents and exclusivities (no bill) H.R. 1520, Purple Book Continuity Act of 2019 H.R. 1499, Protecting Consumer Access to Generic Drugs Act of 2019 S. 1224, The Stop STALLING Act S. 1416, The Affordable Prescriptions for Patients Act, on product hopping and patent thicketing S.659 - the Biologics Patent Transparency Act H.R. 938 Bringing Low-cost Options and Competition while Keeping Incentives for New Generics H.R. 5133 Affordable Prescriptions for Patients Through Promoting Competition H.R. 3991 Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R. 2374 Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act H.R. 2375 Preserve Access to Affordable Generics and Biosimilars Act
Client expense: $2,970,000 · Firm income: Not reported
2020 · first_quarter · Copyright/Patent/Trademark
S. 124 Preserve Access to Affordable Generics Act Issues related to drug patents and exclusivities (no bill) H.R. 1520, Purple Book Continuity Act of 2019 H.R. 1499, Protecting Consumer Access to Generic Drugs Act of 2019 S. 1224, The Stop STALLING Act S. 1416, The Affordable Prescriptions for Patients Act, on product hopping and patent thicketing S.659 - the Biologics Patent Transparency Act H.R. 938 Bringing Low-cost Options and Competition while Keeping Incentives for New Generics H.R. 5133 Affordable Prescriptions for Patients Through Promoting Competition H.R. 3991 Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R. 2374 Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act H.R. 2375 Preserve Access to Affordable Generics and Biosimilars Act
Client expense: $2,700,000 · Firm income: Not reported
2019 · second_quarter · Copyright/Patent/Trademark
S. 974 CREATES Act of 2017 S. 124 Preserve Access to Affordable Generics Act Issues related to drug patents and exclusivities (no bill) H.R. 1520, Purple Book Continuity Act of 2019 H.R. 1499, Protecting Consumer Access to Generic Drugs Act of 2019 S. 1224, The Stop STALLING Act S. 1416, The Affordable Prescriptions for Patients Act, on product hopping and patent thicketing
Client expense: $2,200,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), SENATE
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), SENATE
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), SENATE
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2019 · fourth_quarter · Copyright/Patent/Trademark
S. 124 Preserve Access to Affordable Generics Act Issues related to drug patents and exclusivities (no bill) H.R. 1520, Purple Book Continuity Act of 2019 H.R. 1499, Protecting Consumer Access to Generic Drugs Act of 2019 S. 1224, The Stop STALLING Act S. 1416, The Affordable Prescriptions for Patients Act, on product hopping and patent thicketing S.659 - the Biologics Patent Transparency Act H.R. 938 Bringing Low-cost Options and Competition while Keeping Incentives for New Generics H.R. 5133 Affordable Prescriptions for Patients Through Promoting Competition H.R. 3991 Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R. 2374 Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act H.R. 2375 Preserve Access to Affordable Generics and Biosimilars Act
Client expense: $2,400,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), SENATE
2019 · third_quarter · Copyright/Patent/Trademark
S. 974 CREATES Act of 2017 S. 124 Preserve Access to Affordable Generics Act Issues related to drug patents and exclusivities (no bill) H.R. 1520, Purple Book Continuity Act of 2019 H.R. 1499, Protecting Consumer Access to Generic Drugs Act of 2019 S. 1224, The Stop STALLING Act S. 1416, The Affordable Prescriptions for Patients Act, on product hopping and patent thicketing S.659 - the Biologics Patent Transparency Act
Client expense: $3,090,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), SENATE, Treasury, Dept of
2019 · second_quarter · Copyright/Patent/Trademark
S. 974 CREATES Act of 2017 S. 124 Preserve Access to Affordable Generics Act Issues related to drug patents and exclusivities (no bill) H.R. 1520, Purple Book Continuity Act of 2019 H.R. 1499, Protecting Consumer Access to Generic Drugs Act of 2019 S. 1224, The Stop STALLING Act S. 1416, The Affordable Prescriptions for Patients Act, on product hopping and patent thicketing
Client expense: $2,200,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), SENATE, Treasury, Dept of
2019 · first_quarter · Copyright/Patent/Trademark
S. 974 CREATES Act of 2017 S. 124 Preserve Access to Affordable Generics Act Issues related to drug patents and exclusivities (no bill) H.R. 6 -- Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act or the SUPPORT for Patients and Communities Act H.R. 1520, Purple Book Continuity Act of 2019 H.R. 1499, Protecting Consumer Access to Generic Drugs Act of 2019
Client expense: $3,250,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, Treasury, Dept of
2018 · fourth_quarter · Health Issues
Issues related to the implementation of the Generic Drug User Fee Agreement; issues related to drug pricing; Risk Evaluation and Mitigation Strategies (REMS), H.R. 2051 - FAST Generics Act of 2017, S.974, H.R. 2212 - CREATES Act of 2017; and S. 124, Preserve Access to Affordable Generics Act.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Copyright/Patent/Trademark
S. 974 CREATES Act of 2017 S. 124 Preserve Access to Affordable Generics Act Issues related to drug patents and exclusivities (no bill) H.R. 6 -- Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act or the SUPPORT for Patients and Communities Act
Client expense: $2,700,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, Treasury, Dept of
2018 · fourth_quarter · Copyright/Patent/Trademark
H.R. 5340: The Support Technology & Research for Our Nations Growth and Economic Resilience (STRONGER) Patents Act of 2018 - Provisions related to reforms of Patent Trial and Appeal Board (PTAB) proceedings and other patent system reforms H.R. 7251: Hatch-Waxman Integrity Act of 2018 - Provisions related to PTAB proceedings S. 124: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 3738: Hatch-Waxman Integrity Act of 2018 - Provisions related to PTAB proceedings Biopharmaceutical innovation and patent policy issues Patent litigation reform issues and issues related to post-grant proceeding at the PTO Bayh-Dole march-in rights policy issues
Client expense: $920,000 · 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), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)
2018 · fourth_quarter · Copyright/Patent/Trademark
H.R. 4117: Competitive Deals Resulting in Unleashed Generics and Savings Act of 2017 or the Competitive DRUGS Act of 2017 - Patent Settlements H.R. 5340: The Support Technology & Research for Our Nations Growth and Economic Resilience (STRONGER) Patents Act of 2018 - Provisions related to reforms of Patent Trial and Appeal Board (PTAB) proceedings and other patent system reforms S. 124: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 1390: STRONGER Patents Act of 2017 - Provisions related to reforms of PTAB proceedings and other patent system reforms Biopharmaceutical innovation and patent policy issues Patent litigation reform issues and issues related to post-grant proceeding at the PTO S. 2554:Patient Right to Know Drug Prices Act - provisions related to notification of agreements to the FTC and DOJ
Client expense: $1,820,000 · Firm income: Not reported
Government targets: Council of Economic Advisers (CEA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Vice President of the U.S.
2018 · fourth_quarter · Copyright/Patent/Trademark
Issues related to barriers to generic drug and biosimilar market entry including pay-for-delay and REMS. S. 124, The Preserve Access to Affordable Generics Act of 2017 S.771/H.R. 1776, The Improving Access to Affordable Prescription Drugs Act of 2017 H.R. 2051, The Fair Access for Safe and Timely Generics Act of 2017 S. 974/H.R. 2212, The Creating and Restoring Equal Access to Equivalent Samples Act of 2017
Client expense: $1,993,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Veterans Affairs, Dept of (VA), White House Office
2018 · fourth_quarter · Health Issues
Preserve Access to Affordable Generics Act (S. 124); Regulatory exclusivity; Improving Access To Affordable Prescription Drugs Act (S. 771/H.R. 1776); Drug pricing; SUPPORT for Patients and Communities Act (H.R. 6); Biosimilars Competition Act of 2018 (H.R. 6478); Patient Right to Know Drug Prices Act (S. 2554/H.R. 6143); Medicare Negotiation and Competitive Licensing Act of 2018 (H.R. 6505); Making Objective Drug Evidence Revisions for New (MODERN) Labeling Act (S. 3519); citizen petitions; Medicare Part B international reference pricing; Hatch-Waxman Integrity Act of 2018 (S. 3738/H.R. 7251); Affordable Drug Manufacturing Act of 2018 (H.R. 7348/S. 3775); Preserve Access to Affordable Generics and Biosimilars Act (S. 3792); Direct-to-consumer pharmaceutical advertising.
Client expense: Not reported · Firm income: $320,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)
2018 · fourth_quarter · Copyright/Patent/Trademark
H.R. 5340: The Support Technology & Research for Our Nations Growth and Economic Resilience (STRONGER) Patents Act of 2018 - Provisions related to reforms of Patent Trial and Appeal Board (PTAB) proceedings and other patent system reforms H.R. 7251: Hatch-Waxman Integrity Act of 2018 - Provisions related to PTAB proceedings S. 124: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 3738: Hatch-Waxman Integrity Act of 2018 - Provisions related to PTAB proceedings Biopharmaceutical innovation and patent policy issues Patent litigation reform issues and issues related to post-grant proceeding at the PTO Bayh-Dole march-in rights policy issues
Client expense: $6,030,000 · 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), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
2018 · fourth_quarter · Pharmacy
Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. S.3519: MODERN Labeling Act. Drug Compounding. Drug Shortages. Biosimilars Naming. Pass Through Payments for Biosimilars. Prescription Drug Costs. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. S.3792: Preserve Access to Affordable Generics and Biosimilars Act. H.R.449: Synthetic Drug Awareness Act of 2018. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Pharmaceutical Exclusivity. H.R.6577: PRICED Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. H.R.7348/S.3775: Affordable Drug Manufacturing Act of 2018. H.R.2212/S.974: CREATES Act of 2017. H.R.5002: Advancing Cutting Edge Research Act. H.R.2439/S.1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. S.3680: Low Drug Prices Act. Public Law 115-52: FDA Reauthorization Act of 2017. H.R.1223/S.1509: Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017. H.R.6: SUPPORT for Patients and Communities Act.
Client expense: $1,570,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR)
H.R. 2212/ S. 974, CREATES Act - Discussed support of bill. H.R. 2439/S.1131, FAIR Drug Pricing Act - Discussed support of bill. S. 124, The Preserve Access to Affordable Generics Act - Discussed support of bill. Part D Deal in Bipartisan Budget Act, met with House and Senate offices to reiterate our support for the deal; sent multiple letters to House and Senate leadership; discussed support for the deal with House and Senate staff. Discussed the Presidents Prescription Drug Blueprint and RFI. S. 2553, Know the Lowest Price Act - supported passage of legislation. S.2554, Patient Right to Know Act - supported passage of legislation. Discussed possible ways to improve Medicare Part D. Discussed Rx Price Watch Reports and the impact of high drug costs. Discussed drug pricing reforms AARP supports, including secretarial negotiation, importation, reducing exclusivity for biologics, and ending pay-for-delay deals. Discussed Rx issues with HHS.
Client expense: $2,140,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Equal Employment Opportunity Commission (EEOC), Federal Highway Administration (FHA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Natl Highway Traffic Safety Administration (NHTSA), SENATE, Securities & Exchange Commission (SEC), Treasury, Dept of, White House Office
2018 · fourth_quarter · Pharmacy
Preserving access to group purchasing organizations (GPOs) and protecting the GPO safe harbor; educating policymakers on hospital drug shortages and significant drug price increases, including raising awareness about saline and local anesthetic shortages. Oppose legislation that would harm the 340B Drug Discount Program for safety net hospitals and support legislation to prevents the implementation of the cuts in CMS Final 2017 OPPS Rule (CMS-2017-0091), the SERV Communities Act (support) (H.R. 6071) and H.R. 4392 (support). Support reforms aimed at creating more competition in the generic drug market, including ending pay for delay (S.124), and support other pro-competition policies, including legislation that would prohibit evergreening and abuse of citizen petitions, and promote the growth of biosimilars. Supported legislation to increase competition in the drug marketplace and prevent REMS abuses, the CREATES Act (S. 974/H.R.2214) (support). Raise awareness about generic injectable opioid shortages, urge engagement by the Food & Drug Administration Office of Drug Shortages and approval by the Drug Enforcement Agency of CII quota requests to increase production of injectable opioid products in short supply. Submitted comments to DEA urging the revision of its quota allocation process to recognize the unique institutional needs for injectable opioids. Submitted comments to DEA opposing proposed aggregate quota reductions for CY 2018 Schedule II controlled substances.
Client expense: $580,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Homeland Security, Dept of (DHS), Office of Management & Budget (OMB), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), White House Office
2018 · fourth_quarter · Health Issues
Group Purchasing - Conducted education and outreach efforts about the value hospital group purchasing organizations deliver the U.S. health care system. 340B Drug Pricing Program - Opposed changes to eligibility and the structure of the 340B Drug Pricing Program. Supported passage of H.R. 4392 and H.R 6071. Opposed H.R. 4710, H.R. 6240, S. 2312 and S.2453. Drug Shortages - Engaged in discussions around how ongoing shortages of prescription drugs are impacting hospitals and possible solutions. Advocated for the Drug Enforcement Agency to modify total annual production quotas to address hospital shortage of injectable opioid solutions. Drug Pricing - Supported the CREATES Act (S. 974), The Fair Access to Safe and Timely Generics Act (H.R. 2051), The Preserving Access to Affordable Generics (S.124), The Increasing Competition in Pharmaceuticals Act (S.297) and The Lower Drug Costs through Competition Act (H.R. 749). Biosimilar Drug adoption - Supported administrative proposals that would expand the adoption of biosimilar medications. Urged the Food and Drug Administration to finalize guidance related biosimilar interchangeability. Opioid Abuse - Supported changes to privacy requirements under 42 CFR Part 2 to better support coordinated care for patients. Supported H.R. 6082. Children's Hospital GME Support Reauthorization Act (H.R.5385, S.2597) - Endorsed passage of legislation to reauthorize the Children's Hospital GME program. Overall Hospital Quality Star Ratings - Urged modifications to the methodology used to calculate Overall Hospital Quality Star Ratings Program. Stark Law Reform - Monitored discussions in the House and Senate seeking reforms to the Stark Law. Voiced support for reforms that ease barriers to value-based care arrangements.
Client expense: $190,000 · 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), SENATE
2018 · fourth_quarter · Health Issues
FAST Genetics Act of 2017 (H.R. 2051) CREATES Act of 2017 (H.R. 2212/S. 974) Preserve Access to Affordable Generics Act (S. 124) 340B PAUSE ACT (H.R. 4710) Legislation to place a moratorium on the 340B drug payment cuts in the CY 2018 Outpatient Prospective Payment System Rule (H.R. 4392) Protecting Jessica Grubbs Legacy Act (S. 1850) Overdose Prevention and Patient Safety Act (H.R. 3545, 5795, 6082) ACA Medicaid disproportionate share hospital (DSH) cuts Childrens Health Insurance Program (CHIP) funding ACO Improvement Act of 2017 (H.R. 4580) Medicare Home Infusion Therapy Access Act of 2017 (S. 1738)/ Section 101 of Medicare Part B Improvement Act of 2017 (H.R. 3178) Prescription Drug Price Transparency Act (MAC bill) (H.R.1316) Improving Transparency and Accuracy in Medicare Part D Spending Act (H.R.1038/S.413) Ensuring Seniors Access to Local Pharmacies Act of 2017 (H.R.1939/S.1044) Pharmacy and Medically Underserved Areas Enhancement Act (H.R.592/S.109) CARA 2.0 Act of 2018 (H.R.5311/S.2456) Biosimilars Competition Act of 2018 (H.R. 6478) Know the Lowest Price Act of 2018 (S.2553) Patient Right to Know Drug Prices Act (S.2554) SUPPORT for Patients and Communities Act (H.R. 6)
Client expense: $400,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Pharmacy
HR 6505-Medicare Negotiation and competitive licensing act, S 1369/HR 2974-Stop price gouging Act, HR 6577-PRICED Act, S 124-Preserve access to affordable generics act, HR 4117-competitive drugs act, S 974/HR 2212-CREATES act, drug pricing, HR 4116-Transparent drug pricing act, HR 1776-Improving access to affordable prescription drugs act, S 3680-Low Drug Prices act, HR 676-Expanded and Improved Medicare for all act, S 3775-Affordable drug manufacturing act,
Client expense: $70,000 · Firm income: Not reported
Government targets: Commodity Futures Trading Commission (CFTC), Federal Deposit Insurance Corporation (FDIC), Federal Reserve System, HOUSE OF REPRESENTATIVES, SENATE, Securities & Exchange Commission (SEC), U.S. Trade Representative (USTR)
2018 · fourth_quarter · Medicare/Medicaid
General Medicare Protection, Prevention of Fraud, Waste, and Abuse: H.R. 2460 and H.R. 4841 and H.R. 4704, Prescription Drug Re-Importation: S. 92 and S. 469 and H.R. 1245, Negotiation of Prescription Drug Prices: H.R. 242 and S. 41, General Prescription Drug Affordability: S. 124 and S. 771 and H.R. 1776 and H.R. 4138 and H.R. 4116 and H.R. 4117 and S. 2011 and S. 974 and H.R. 2212 and S. 2553, Medicare Enrollment Simplification: H.R. 2575 and S. 1909, Expanding Medicare Coverage: H.R. 5083 and H.R. 4957 and S. 2387 and H.R. 807 and H.R. 3098 and H.R. 4701 and H.R. 508 and H.R. 2276 and S. 2575 and H.R. 5083.
Client expense: Not reported · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · third_quarter · Pharmacy
Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. S.3519: MODERN Labeling Act. Drug Compounding. Biosimilars Naming. Pass Through Payments for Biosimilars. Prescription Drug Costs. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.449: Synthetic Drug Awareness Act of 2018. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. H.R.6577: PRICED Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. H.R.2212/S.974: CREATES Act of 2017. H.R.5002: Advancing Cutting Edge Research Act. H.R.2439/S.1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Public Law 115-52: FDA Reauthorization Act of 2017. H.R.1223/S.1509: Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017. Discussion Draft of H.R.__, Packaging and Disposal. H.R.6: SUPPORT for Patients and Communities Act.
Client expense: $870,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)
2018 · second_quarter · Pharmacy
Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Drug Compounding. Biosimilars Naming. Pass Through Payments for Biosimilars. Prescription Drug Costs. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.449: Synthetic Drug Awareness Act of 2018. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. H.R.2212/S.974: CREATES Act of 2017. H.R.5002: Advancing Cutting Edge Research Act. H.R.2439/S.1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Public Law 115-52: FDA Reauthorization Act of 2017. H.R.1223/S.1509: Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017. Discussion Draft of H.R.__, FDA Accelerated Approval and Breakthrough Therapy Status. Discussion Draft of H.R.__, FDA and International Mail. Discussion Draft of H.R.__, Opioid Sparing. Discussion Draft of H.R.__, Packaging and Disposal. Discussion Draft of H.R.__, Long-term Efficiency. Discussion Draft of H.R.__, Misuse/Abuse.
Client expense: $900,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)
2018 · first_quarter · Pharmacy
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Drug Compounding. Biosimilars Naming. Pass Through Payments for Biosimilars. Prescription Drug Costs. Opioid abuse. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. H.R.1892: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. H.R.2212/S.974: CREATES Act of 2017. H.R.2439/S.1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. H.R.2430/S.934: FDA Reauthorization Act of 2017. H.R.1223/S.1509: Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017. Discussion Draft of H.R.__, FDA Accelerated Approval and Breakthrough Therapy Status. Discussion Draft of H.R.__, FDA and International Mail. Discussion Draft of H.R.__, Opioid Sparing. Discussion Draft of H.R.__, Packaging and Disposal. Discussion Draft of H.R.__, Long-term Efficiency. Discussion Draft of H.R.__, Misuse/Abuse.
Client expense: $1,040,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)
2018 · third_quarter · Pharmacy
Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. S.3519: MODERN Labeling Act. Drug Compounding. Biosimilars Naming. Pass Through Payments for Biosimilars. Prescription Drug Costs. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.449: Synthetic Drug Awareness Act of 2018. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. H.R.6577: PRICED Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. H.R.2212/S.974: CREATES Act of 2017. H.R.5002: Advancing Cutting Edge Research Act. H.R.2439/S.1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Public Law 115-52: FDA Reauthorization Act of 2017. H.R.1223/S.1509: Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017. Discussion Draft of H.R.__, Packaging and Disposal. H.R.6: SUPPORT for Patients and Communities Act.
Client expense: $860,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)
2018 · third_quarter · Copyright/Patent/Trademark
Issues related to barriers to generic drug and biosimilar market entry including pay-for-delay and REMS. S. 124, The Preserve Access to Affordable Generics Act of 2017 S.771/H.R. 1776, The Improving Access to Affordable Prescription Drugs Act of 2017 H.R. 2051, The Fair Access for Safe and Timely Generics Act of 2017 S. 974/H.R. 2212, The Creating and Restoring Equal Access to Equivalent Samples Act of 2017
Client expense: $1,442,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Veterans Affairs, Dept of (VA), White House Office
2018 · third_quarter · Copyright/Patent/Trademark
H.R. 4117: Competitive Deals Resulting in Unleashed Generics and Savings Act of 2017 or the Competitive DRUGS Act of 2017 - Patent Settlements H.R. 5340: The Support Technology & Research for Our Nations Growth and Economic Resilience (STRONGER) Patents Act of 2018 - Provisions related to reforms of Patent Trial and Appeal Board (PTAB) proceedings and other patent system reforms S. 124: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 1390: STRONGER Patents Act of 2017 - Provisions related to reforms of PTAB proceedings and other patent system reforms Biopharmaceutical innovation and patent policy issues Patent litigation reform issues and issues related to post-grant proceeding at the PTO Draft legislation related to notification of agreements to the FTC and DOJ
Client expense: $600,000 · Firm income: Not reported
Government targets: Council of Economic Advisers (CEA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Vice President of the U.S.
2018 · third_quarter · Copyright/Patent/Trademark
H.R. 5340: The Support Technology & Research for Our Nations Growth and Economic Resilience (STRONGER) Patents Act of 2018 - Provisions related to reforms of Patent Trial and Appeal Board (PTAB) proceedings and other patent system reforms H.R. 5887: BIG Data for IP Act - Provisions related to fee-setting authority H.R. 6758: SUCCESS Act - Provisions related to fee authority and study S. 124: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 974 Amendment: Hatch-Waxman Integrity Act of 2018 - Provisions related to PTAB proceedings S. 1390: STRONGER Patents Act of 2017 - Provisions related to reforms of PTAB proceedings and other patent system reforms S. 3416: USPTO FEES Act - Provisions related to fee-setting authority Biopharmaceutical innovation and patent policy issues Patent litigation reform issues and issues related to post-grant proceeding at the PTO Bayh-Dole march-in rights policy issues
Client expense: $5,990,000 · 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), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE
2018 · third_quarter · Copyright/Patent/Trademark
S. 974 CREATES Act of 2017 S. 124 Preserve Access to Affordable Generics Act Issues related to drug patents and exclusivities (no bill) H.R. 6 -- Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act or the SUPPORT for Patients and Communities Act
Client expense: $2,660,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, Treasury, Dept of
2018 · third_quarter · Health Issues
FAST Genetics Act of 2017 (H.R. 2051) CREATES Act of 2017 (H.R. 2212/S. 974) Preserve Access to Affordable Generics Act (S. 124) 340B PAUSE ACT (H.R. 4710) Legislation to place a moratorium on the 340B drug payment cuts in the CY 2018 Outpatient Prospective Payment System Rule (H.R. 4392) Protecting Jessica Grubbs Legacy Act (S. 1850) Overdose Prevention and Patient Safety Act (H.R. 3545, 5795, 6082) ACA Medicaid disproportionate share hospital (DSH) cuts Childrens Health Insurance Program (CHIP) funding ACO Improvement Act of 2017 (H.R. 4580) Medicare Home Infusion Therapy Access Act of 2017 (S. 1738)/ Section 101 of Medicare Part B Improvement Act of 2017 (H.R. 3178) Prescription Drug Price Transparency Act (MAC bill) (H.R.1316) Improving Transparency and Accuracy in Medicare Part D Spending Act (H.R.1038/S.413) Ensuring Seniors Access to Local Pharmacies Act of 2017 (H.R.1939/S.1044) Pharmacy and Medically Underserved Areas Enhancement Act (H.R.592/S.109) CARA 2.0 Act of 2018 (H.R.5311/S.2456) Biosimilars Competition Act of 2018 (H.R. 6478) Know the Lowest Price Act of 2018 (S.2553) Patient Right to Know Drug Prices Act (S.2554) SUPPORT for Patients and Communities Act (H.R. 6)
Client expense: $310,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · third_quarter · Health Issues
340B Drug Pricing Program - Opposed changes to eligibility and the structure of the 340B Drug Pricing Program. Supported passage of H.R. 4392, H.R 6071. Opposed H.R. 4710, H.R. 6240, S. 2312 and S.2453. Group Purchasing - Conducted education and outreach efforts about the value hospital group purchasing organizations deliver the U.S. health care system. Drug Shortages - Advocated for Drug Enforcement Agency to modify total production quotas for injectable opioid solutions to address hospital shortages. Drug Pricing - Supported the CREATES Act (S. 974), The Fair Access to Safe and Timely Generics Act (H.R. 2051), The Preserving Access to Affordable Generics (S.124), The Increasing Competition in Pharmaceuticals Act (S.297) and The Lower Drug Costs through Competition Act (H.R. 749). Biosimilar Drug adoption - Supported administrative proposals that would expand the adoption of biosimilar medications. Urged the Food and Drug Administration to finalize guidance related biosimilar interchangeability. Opioid Abuse - Supported passage of H.R. 6 and ongoing efforts to enhance funding and treatment options to address opioid abuse and addiction issues. Supported changes to privacy requirements under 42 CFR Part 2 to better support coordinated care for patients. Overall Hospital Quality Star Ratings - Urged modifications to the methodology used to calculate Overall Hospital Quality Star Ratings Program. Prescription Drug Compounding - Supported ongoing efforts to maintain access to safe and effective drug compounding as the Drug Quality and Safety Act is implemented. Stark Law Reform - Monitored discussions in the House and Senate seeking reforms to the Stark Law. Voiced support for reforms that ease barriers to value-based care arrangements.
Client expense: $155,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2018 · third_quarter · Health Issues
Stop the Importation and Trafficking of Synthetic Analogues Act of 2017 (H.R. 2851/S. 1327); The Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now Act (i.e., the "SCREEN Act")(H.R. 5228); Opioid Crisis Response Act of 2018 (S. 2680); Expanding Access to Low Cost Generic Drugs Act (S. 2476); Preserve Access to Affordable Generics Act (S. 124); Regulatory exclusivity; Improving Access To Affordable Prescription Drugs Act (S. 771/H.R. 1776); Comprehensive Addiction Resources Emergency Act (CARE Act)(S. 2700/HR 5545); SOUND Disposal and Packaging Act (HR 5687); Long-Term Opioid Efficacy Act of 2018 (HR 5811); SAFETY Act of 2018 (H.R. 5803); Drug pricing; H.R. 5752, the Stop Illicit Drug Importation Act of 2018; proposed legislation regarding tableting and encapsulating opioid products; Drug Importation; CREATES Act (HR 2212/S. 974; 340B issues; SUPPORT for Patients and Communities Act (H.R. 6), Biosimilars Competition Act of 2018 (H.R. 6478), Patient Right to Know Drug Prices Act (S. 2554/H.R. 6143), Re-Valuing Anti-Microbial Products Act of 2018 (H.R. 6294), Medicare Negotiation and Competitive Licensing Act of 2018 (H.R. 6505), Making Objective Drug Evidence Revisions for New (MODERN) Labeling Act (S. 3519), citizen petitions
Client expense: Not reported · Firm income: $270,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · third_quarter · Pharmacy
Preserving access to group purchasing organizations (GPOs) and protecting the GPO safe harbor; educating policymakers on hospital drug shortages and significant drug price increases, including raising awareness about saline and local anesthetic shortages. Oppose legislation that would harm the 340B Drug Discount Program for safety net hospitals and support legislation to prevents the implementation of the cuts in CMS Final 2017 OPPS Rule (CMS-2017-0091), the SERV Communities Act (support) (H.R. 6071) and H.R. 4392 (support). Support reforms aimed at creating more competition in the generic drug market, including ending pay for delay (S.124), and support other pro-competition policies, including legislation that would prohibit evergreening and abuse of citizen petitions, and promote the growth of biosimilars. Supported legislation to increase competition in the drug marketplace and prevent REMS abuses, the CREATES Act (S. 974/H.R.2214) (support). Raise awareness about generic injectable opioid shortages, urge engagement by the Food & Drug Administration Office of Drug Shortages and approval by the Drug Enforcement Agency of CII quota requests to increase production of injectable opioid products in short supply. Submitted comments to DEA urging the revision of its quota allocation process to recognize the unique institutional needs for injectable opioids. Submitted comments to DEA opposing proposed aggregate quota reductions for CY 2018 Schedule II controlled substances.
Client expense: $600,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Homeland Security, Dept of (DHS), Office of Management & Budget (OMB), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), White House Office
Discussed efforts to include harmful prescription drug policies in NAFTA with House and Senate staff. H.R. 2212/ S. 974, CREATES Act - Discussed support of bill. H.R. 2439/S.1131, FAIR Drug Pricing Act - Discussed support of bill. S. 124, The Preserve Access to Affordable Generics Act - Discussed support of bill. Part D Deal in Bipartisan Budget Act, Met with House offices to reiterate our support for the deal; sent multiple letters to House and Senate leadership; discussed support for the deal with House and Senate staff. Discussed the Presidents Prescription Drug Blueprint and RFI. S. 1091, the Supporting Grandparents Raising Grandkids Act - Advocated for passage of bill. S. 2553, Know the Lowest Price Act - Endorsed legislation. S.2554, Patient Right to Know Act - Endorsed legislation. Discussed opioid abuse legislation to address opioid abuse and misuse. Discussed possible ways to improve Medicare Part D. Discussed Rx Price Watch Reports and the impact of high drug costs. Discussed drug pricing reforms AARP supports, including secretarial negotiation, importation, reducing exclusivity for biologics, and ending pay-for-delay deals. Discussed family caregiving, opioids, and Supporting Grandparents Raising Grandchildren Act (P.L. 115-196, S. 1091/H.R. 3105).
Client expense: $1,740,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Federal Highway Administration (FHA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Housing & Urban Development, Dept of (HUD), Labor, Dept of (DOL), Natl Highway Traffic Safety Administration (NHTSA), SENATE, Securities & Exchange Commission (SEC), Treasury, Dept of, White House Office
2018 · third_quarter · Medicare/Medicaid
General Medicare Protection, Prevention of Fraud, Waste, and Abuse: H.R. 2460 and H.R. 4841 and H.R. 4704, Prescription Drug Re-Importation: S. 92 and S. 469 and H.R. 1245, Negotiation of Prescription Drug Prices: H.R. 242 and S. 41, General Prescription Drug Affordability: S. 124 and S. 771 and H.R. 1776 and H.R. 4138 and H.R. 4116 and H.R. 4117 and S. 2011 and S. 974 and H.R. 2212 and S. 2553, Medicare Enrollment Simplification: H.R. 2575 and S. 1909, Expanding Medicare Coverage: H.R. 5083 and H.R. 4957 and S. 2387 and H.R. 807 and H.R. 3098 and H.R. 4701 and H.R. 508 and H.R. 2276 and S. 2575 and H.R. 5083.
Client expense: Not reported · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · third_quarter · Health Issues
Issues related to the implementation of the Generic Drug User Fee Agreement; issues related to drug pricing; Risk Evaluation and Mitigation Strategies (REMS), H.R. 2051 - FAST Generics Act of 2017, S.974, H.R. 2212 - CREATES Act of 2017; and S. 124, Preserve Access to Affordable Generics Act.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · second_quarter · Copyright/Patent/Trademark
Issues related to barriers to generic drug and biosimilar market entry including pay-for-delay and REMS. S. 124, The Preserve Access to Affordable Generics Act of 2017 S.771/H.R. 1776, The Improving Access to Affordable Prescription Drugs Act of 2017 H.R. 2051, The Fair Access for Safe and Timely Generics Act of 2017 S. 974/H.R. 2212, The Creating and Restoring Equal Access to Equivalent Samples Act of 2017
Client expense: $1,300,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
2018 · second_quarter · Health Issues
FAST Genetics Act of 2017 (H.R. 2051) CREATES Act of 2017 (H.R. 2212/S. 974) Preserve Access to Affordable Generics Act (S. 124) 340B PAUSE ACT (H.R. 4710) Legislation to place a moratorium on the 340B drug payment cuts in the CY 2018 Outpatient Prospective Payment System Rule (H.R. 4392) Protecting Jessica Grubbs Legacy Act (S. 1850) Overdose Prevention and Patient Safety Act (H.R. 3545, 5795, 6082) ACA Medicaid disproportionate share hospital (DSH) cuts Childrens Health Insurance Program (CHIP) funding ACO Improvement Act of 2017 (H.R. 4580) Medicare Home Infusion Therapy Access Act of 2017 (S. 1738)/ Section 101 of Medicare Part B Improvement Act of 2017 (H.R. 3178) Prescription Drug Price Transparency Act (MAC bill) (H.R.1316) Improving Transparency and Accuracy in Medicare Part D Spending Act (H.R.1038/S.413) Ensuring Seniors Access to Local Pharmacies Act of 2017 (H.R.1939/S.1044) Pharmacy and Medically Underserved Areas Enhancement Act (H.R.592/S.109) CARA 2.0 Act of 2018 (H.R.5311/S.2456).
Client expense: $350,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · second_quarter · Health Issues
Stop the Importation and Trafficking of Synthetic Analogues Act of 2017 (H.R. 2851/S. 1327); The Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now Act (i.e., the "SCREEN Act")(H.R. 5228); Opioid Crisis Response Act of 2018 (S. 2680); Expanding Access to Low Cost Generic Drugs Act (S. 2476); Preserve Access to Affordable Generics Act (S. 124); Regulatory exclusivity; Improving Access To Affordable Prescription Drugs Act (S. 771/H.R. 1776); Legislation on drug labeling; Comprehensive Addiction Resources Emergency Act (CARE Act)(S. 2700/HR 5545); SOUND Disposal and Packaging Act (HR 5687); Biologics patent settlements; Long-Term Opioid Efficacy Act of 2018 (HR 5811); SAFETY Act of 2018 (H.R. 5803); Insulin pricing; H.R. 5752, the Stop Illicit Drug Importation Act of 2018; proposed legislation regarding tableting and encapsulating opioid products; Drug Importation; Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act (HR 5247/S. 204; CREATES Act (HR 2212/S. 974)
Client expense: Not reported · Firm income: $290,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · second_quarter · Copyright/Patent/Trademark
S. 974 CREATES Act of 2017 S. 124 Preserve Access to Affordable Generics Act Issues related to drug patents and exclusivities (no bill)
Client expense: $2,290,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, Treasury, Dept of
2018 · second_quarter · Copyright/Patent/Trademark
H.R. 5340: The Support Technology & Research for Our Nations Growth and Economic Resilience (STRONGER) Patents Act of 2018 - Provisions related to reforms of Patent Trial and Appeal Board (PTAB) proceedings and other patent system reforms S. 124: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 974 Amendment: Hatch-Waxman Integrity Act of 2018 - Provisions related to inter partes review process S. 1390: STRONGER Patents Act of 2017 - Provisions related to reforms of PTAB proceedings and other patent system reforms S. 2601: BIG Data for IP Act - Provisions related to fee-setting authority Biopharmaceutical innovation and patent policy issues Patent litigation reform issues and issues related to post-grant proceeding at the PTO Bayh-Dole march-in rights policy issues
Client expense: $5,540,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institute of Standards & Technology (NIST), Office of Management & Budget (OMB), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
2018 · second_quarter · Copyright/Patent/Trademark
H.R. 4117: Competitive Deals Resulting in Unleashed Generics and Savings Act of 2017 or the Competitive DRUGS Act of 2017 - Patent Settlements H.R. 5340: The Support Technology & Research for Our Nations Growth and Economic Resilience (STRONGER) Patents Act of 2018 - Provisions related to reforms of Patent Trial and Appeal Board (PTAB) proceedings and other patent system reforms S. 124: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 974 Amendment: Hatch-Waxman Integrity Act of 2018 - Provisions related to inter partes review process S. 1390: STRONGER Patents Act of 2017 - Provisions related to reforms of PTAB proceedings and other patent system reforms S. 2601: BIG Data for IP Act - Provisions related to fee-setting authority Biopharmaceutical innovation and patent policy issues Patent litigation reform issues and issues related to post-grant proceeding at the PTO Draft legislation related to notification of agreements to the FTC and DOJ Bayh-Dole march-in rights policy issues
Client expense: $790,000 · Firm income: Not reported
Government targets: Council of Economic Advisers (CEA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Vice President of the U.S.
2018 · second_quarter · Pharmacy
Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Drug Compounding. Biosimilars Naming. Pass Through Payments for Biosimilars. Prescription Drug Costs. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.449: Synthetic Drug Awareness Act of 2018. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. H.R.2212/S.974: CREATES Act of 2017. H.R.5002: Advancing Cutting Edge Research Act. H.R.2439/S.1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Public Law 115-52: FDA Reauthorization Act of 2017. H.R.1223/S.1509: Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017. Discussion Draft of H.R.__, FDA Accelerated Approval and Breakthrough Therapy Status. Discussion Draft of H.R.__, FDA and International Mail. Discussion Draft of H.R.__, Opioid Sparing. Discussion Draft of H.R.__, Packaging and Disposal. Discussion Draft of H.R.__, Long-term Efficiency. Discussion Draft of H.R.__, Misuse/Abuse.
Client expense: $800,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)
Sent a letter to USTR regarding prescription drugs concerns in NAFTA negotiations. Sent letter supporting the inclusion of H.R. 3032, the Mental Health Access Improvement Act, in larger opioids bill, H.R. 5531, the Opioid Emergency Response Act. Participated in stakeholder calls organized by the White House and HHS on the Presidents Prescription Drug Blueprint. H.R. 2212/ S. 974, CREATES Act - Discussed support of bill. H.R. 2439/S.1131, FAIR Drug Pricing Act - Discussed support of bill. S. 124, The Preserve Access to Affordable Generics Act - Discussed support of bill. Part D Deal in Bipartisan Budget Act - Met with House offices to reiterate our support for the deal; sent a letter to House and Senate leadership; discussed support for the deal with Senate staff. Discussed the Presidents Prescription Drug Blueprint and RFI. S. 1091, the Supporting Grandparents Raising Grandkids Act - Advocated for passage of bill. S. 2553, Know the Lowest Price Act - Sent letter of endorsement. S.2554, Patient Right to Know Act - Sent letter of endorsement. Discussed Committee activities on opioid abuse legislation to address opioid abuse and misuse. Discussed possible ways to improve Medicare Part D. Discussed Rx Price Watch Reports and the impact of high drug costs. Discussed drug pricing reforms AARP supporting, including secretarial negotiation, importation, reducing exclusivity for biologics, and ending pay-for-delay deals. Discussed family caregiving, opioids, and Supporting Grandparents Raising Grandchildren Act (P.L. 115-196, S. 1091/H.R. 3105).
Client expense: $2,220,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Consumer Financial Protection Bureau (CFPB), Federal Communications Commission (FCC), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Housing & Urban Development, Dept of (HUD), Natl Highway Traffic Safety Administration (NHTSA), Office of Management & Budget (OMB), SENATE, Securities & Exchange Commission (SEC), Social Security Administration (SSA), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA), White House Office
2018 · second_quarter · Health Issues
340B Drug Pricing Program - Highlighted importance of the 340B Drug Pricing program for safety net hospitals and monitored ongoing discussions around reforming the program. Supported passage of H.R. 4392, H.R 6071. Opposed H.R. 4710, H.R. 6240, S. 2312 and S.2453. Group Purchasing - Conducted education and outreach efforts about the value hospital group purchasing organizations deliver the U.S. health care system. Drug Shortages - Advocated for Drug Enforcement Agency to modify total production quotas for injectable opioid solutions to address hospital shortages. Drug Pricing - Supported the CREATES Act (S. 974), The Fair Access to Safe and Timely Generics Act (H.R. 2051), The Preserving Access to Affordable Generics (S.124), The Increasing Competition in Pharmaceuticals Act (S.297) and The Lower Drug Costs through Competition Act (H.R. 749). Opioid Abuse - Supported House passage of H.R. 6 and ongoing efforts to enhance funding and treatment options to address opioid abuse and addiction issues. Overall Hospital Quality Star Ratings - Urged modifications to the methodology used to calculate Overall Hospital Quality Star Ratings Program. Prescription Drug Compounding - Supported ongoing efforts to maintain access to safe and effective drug compounding as the Drug Quality and Safety Act is implemented. Stark Law Reform - Monitored discussions in the House and Senate seeking reforms to the Stark Law. Voiced support for reforms that ease barriers to value-based care arrangements. Medical Device Cybersecurity - Urged additional steps to promote enhanced cybersecurity for networked medical devices.
Client expense: $175,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
2018 · second_quarter · Pharmacy
Preserving access to group purchasing organizations (GPOs) and protecting the GPO safe harbor; educating policymakers on hospital drug shortages and significant drug price increases, including raising awareness about saline shortages. Oppose legislation that would harm the 340B Drug Discount Program for safety net hospitals and support legislation to prevents the implementation of the cuts in CMS Final 2017 OPPS Rule (CMS-2017-0091), the SERV Communities Act (support) (H.R. 6071) and H.R. 4392 (support) Support reforms aimed at creating more competition in the generic drug market, including ending pay for delay (S.124) and prohibiting REMS abuses (S.944/H.R.2214), and support other pro-competition policies, including legislation that would prohibit evergreening and abuse of citizen petitions, and promote the growth of biosimilars. Raise awareness about injectable opioid shortages, urge engagement by the Food & Drug Administration Office of Drug Shortages and approval by the Drug Enforcement Agency of CII quota requests to increase production of injectable opioid products in short supply. Submitted comments to DEA urging the revision of its quota allocation process to recognize the unique institutional needs for injectable opioids. Supported legislation to increase competition in the drug marketplace, the CREATES Act (S. 974) (support)
Client expense: $610,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Homeland Security, Dept of (DHS), Office of Management & Budget (OMB), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), White House Office
2018 · second_quarter · Health Issues
Issues related to the implementation of the Generic Drug User Fee Agreement; issues related to drug pricing; Risk Evaluation and Mitigation Strategies (REMS), H.R. 2051 - FAST Generics Act of 2017, S.974, H.R. 2212 - CREATES Act of 2017; and S. 124, Preserve Access to Affordable Generics Act.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office
2018 · second_quarter · Pharmacy
S 2011/HR 4138-Medicare Drug Price Negotiation Act, S 974/HR 2212-CREATES Act of 2017, S 124-Preserve Access to Affordable Generics Act, HR 1625-OMNIBUS, opioid addiction data analysis, S 771-Improving access to affordable prescription drugs act, S 252-Medicare Drug Savings act of 2017, S 1369-Stop Price Gouging Act, S 495-Medical innovation and prize fund act, S 1131/HR 2439-FAIR drug pricing act, HR 4117-Competitive Drugs act of 2017, S 771/HR 1776-Improving access to affordable prescription drugs act, S 637-C-THRU Act, S 1347-RxCap Act of 2017, S 1348-SPIKE Act of 2017, HR 5156-Protecting Medicare from Excessive Price Increases Act of 2018, S 2691-Opioid Crisis accountability act of 2018, S 2315-Over the counter drug safety, innovation, and reform act, S 2700/HR 5545-Comprehensive Addiction Resources Emergency (CARE) act, Drug Pricing-Medicare Part D HR 2051-FAST Generics Act of 2017, HR 4116-Transparent Drug Pricing Act, S 2852-Pandemic and All-Hazards Preparedness Act and advancing innovative Act of 2018,
Client expense: $70,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, Securities & Exchange Commission (SEC), U.S. Trade Representative (USTR)