Loading…
Creating and Restoring Equal Access to Equivalent Samples Act of 2018
Legislative Progress
Momentum (last 30 days)
0
score
0 actions · 0 new cosponsors · 0 votes
Speed vs cohort
97pct
420d open
vs 3,805 other S bills in the 115th — cohort avg 41d
Creating and Restoring Equal Access To Equivalent Samples Act of 2017 or the CREATES Act of 2017 This bill permits the developer of a drug or biological product to bring a civil action against the license holder of an approved drug or biological product if the holder has declined to make available sufficient quantities of the approved drug or product for the developer's testing.
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 (87)
Placed on Senate Legislative Calendar under General Orders. Calendar No. 482.
Committee on the Judiciary. Reported by Senator Grassley with an amendment in the nature of a substitute. Without written report.
Committee on the Judiciary. Ordered to be reported with an amendment in the nature of a substitute favorably.
Read twice and referred to the Committee on the Judiciary. (Sponsor introductory remarks on measure: CR S2619)
Introduced in Senate
Bills with similar content found using semantic analysis.
Sources: Congress.gov
2019 · third_quarter · Health Issues
H.R. 4710 - 340B Protecting Access for the Underserved and Safety-Net Entities (PAUSE) Act S. 2312 - The Helping Ensure Low-income Patients have Access to Care and Treatment Act S. 2453 - Ensuring the Value of the 340B Program Act of 2018 HR 4392 - Reversing the HOPPS rule reimbursement cut to 340B hospitals HR 5598 - 340B Optimization Act HR 2889 - Closing Loopholes for Orphan Drugs Act HR 6240 - Drug Discount Accountability Act (user fees) H.R.6071 - SERV Communities Act of 2018 S.204/H.R.878, Trickett-Wendler Right to Try Act of 2017 P.L.109-417, Pandemic and All-Hazards Preparedness Act (PAHPA) S.2852 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 H.R.6294 - Re-Valuing Anti-Microbial Products (REVAMP) Act of 2018 S.974 - CREATES Act of 2017 H.R. 2113 - The Prescription Drug STAR Act H.R. 1520, the Purple Book Continuity Act; H.R. 1503, the Orange Book Transparency Act; H.R. 1499, the Protecting Consumer Access to Generic Drugs Act; and H.R. 965, the CREATES Act; -Issues related to the 340B Drug Discount Program -Issues relating to drug pricing -Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives. -Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety and counterfeiting, and biosimilars. -General education about policies impacting pharmaceutical development, approval, reimbursement and pricing.
Client expense: $2,620,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office
2019 · second_quarter · Health Issues
H.R. 4710 - 340B Protecting Access for the Underserved and Safety-Net Entities (PAUSE) Act S. 2312 - The Helping Ensure Low-income Patients have Access to Care and Treatment Act S. 2453 - Ensuring the Value of the 340B Program Act of 2018 HR 4392 - Reversing the HOPPS rule reimbursement cut to 340B hospitals HR 5598 - 340B Optimization Act HR 2889 - Closing Loopholes for Orphan Drugs Act HR 6240 - Drug Discount Accountability Act (user fees) H.R.6071 - SERV Communities Act of 2018 S.204/H.R.878, Trickett-Wendler Right to Try Act of 2017 P.L.109-417, Pandemic and All-Hazards Preparedness Act (PAHPA) S.2852 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 H.R.6294 - Re-Valuing Anti-Microbial Products (REVAMP) Act of 2018 S.974 - CREATES Act of 2017 H.R. 2113 - The Prescription Drug STAR Act H.R. 1520, the Purple Book Continuity Act; H.R. 1503, the Orange Book Transparency Act; H.R. 1499, the Protecting Consumer Access to Generic Drugs Act; and H.R. 965, the CREATES Act; - Issues related to the 340B Drug Discount Program - Issues relating to drug pricing - Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives. - Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety and counterfeiting, and biosimilars. - General education about policies impacting pharmaceutical development, approval, reimbursement and pricing.
Client expense: $1,620,000 · Firm income: Not reported
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
2019 · third_quarter · Health Issues
H.R. 4710 - 340B Protecting Access for the Underserved and Safety-Net Entities (PAUSE) Act S. 2312 - The Helping Ensure Low-income Patients have Access to Care and Treatment Act S. 2453 - Ensuring the Value of the 340B Program Act of 2018 HR 4392 - Reversing the HOPPS rule reimbursement cut to 340B hospitals HR 5598 - 340B Optimization Act HR 2889 - Closing Loopholes for Orphan Drugs Act HR 6240 - Drug Discount Accountability Act (user fees) H.R.6071 - SERV Communities Act of 2018 S.204/H.R.878, Trickett-Wendler Right to Try Act of 2017 P.L.109-417, Pandemic and All-Hazards Preparedness Act (PAHPA) S.2852 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 H.R.6294 - Re-Valuing Anti-Microbial Products (REVAMP) Act of 2018 S.974 - CREATES Act of 2017 H.R. 2113 - The Prescription Drug STAR Act H.R. 1520, the Purple Book Continuity Act; H.R. 1503, the Orange Book Transparency Act; H.R. 1499, the Protecting Consumer Access to Generic Drugs Act; and H.R. 965, the CREATES Act; -Issues related to the 340B Drug Discount Program -Issues relating to drug pricing -Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives. -Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety and counterfeiting, and biosimilars. -General education about policies impacting pharmaceutical development, approval, reimbursement and pricing.
Client expense: $2,610,000 · Firm income: Not reported
2019 · second_quarter · Health Issues
Center for Medicare & Medicaid Innovation, Medicare Part D, S.974 - CREATES Act of 2017; issues related to drug pricing.
Client expense: Not reported · Firm income: $90,000
Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
| Democratic |
| MO |
| Cory A. Booker | Democratic | NJ |
| Deb Fischer | Republican | NE |
| Debbie Stabenow | Democratic | MI |
| Dianne Feinstein | Democratic | CA |
| John Kennedy | Republican | LA |
| John McCain | Republican | AZ |
| Jon Tester | Democratic | MT |
| Joni Ernst | Republican | IA |
| Lindsey Graham | Republican | SC |
| Lisa Murkowski | Republican | AK |
| Margaret Wood Hassan | Democratic | NH |
| Mike Lee | Republican | UT |
| Mike Rounds | Republican | SD |
| Rand Paul | Republican | KY |
| Richard Blumenthal | Democratic | CT |
| Richard J. Durbin | Democratic | IL |
| Robert Menendez | Democratic | NJ |
| Sheldon Whitehouse | Democratic | RI |
| Sherrod Brown | Democratic | OH |
| Steve Daines | Republican | MT |
| Susan M. Collins | Republican | ME |
| Tammy Baldwin | Democratic | WI |
| Ted Cruz | Republican | TX |
| Tina Smith | Democratic | MN |
| Todd Young | Republican | IN |
| Tom Cotton | Republican | AR |
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, White House Office
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
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, White House Office
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 · second_quarter · Health Issues
H.R. 4710 - 340B Protecting Access for the Underserved and Safety-Net Entities (PAUSE) Act S. 2312 - The Helping Ensure Low-income Patients have Access to Care and Treatment Act S. 2453 - Ensuring the Value of the 340B Program Act of 2018 HR 4392 - Reversing the HOPPS rule reimbursement cut to 340B hospitals HR 5598 - 340B Optimization Act HR 2889 - Closing Loopholes for Orphan Drugs Act HR 6240 - Drug Discount Accountability Act (user fees) H.R.6071 - SERV Communities Act of 2018 S.204/H.R.878, Trickett-Wendler Right to Try Act of 2017 P.L.109-417, Pandemic and All-Hazards Preparedness Act (PAHPA) S.2852 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 H.R.6294 - Re-Valuing Anti-Microbial Products (REVAMP) Act of 2018 S.974 - CREATES Act of 2017 H.R. 2113 - The Prescription Drug STAR Act H.R. 1520, the Purple Book Continuity Act; H.R. 1503, the Orange Book Transparency Act; H.R. 1499, the Protecting Consumer Access to Generic Drugs Act; and H.R. 965, the CREATES Act; - Issues related to the 340B Drug Discount Program - Issues relating to drug pricing - Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives. - Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety and counterfeiting, and biosimilars. - General education about policies impacting pharmaceutical development, approval, reimbursement and pricing.
Client expense: $1,610,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office
2019 · first_quarter · Copyright/Patent/Trademark
- Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act (S. 974/H.R. 2212)
Client expense: Not reported · Firm income: $80,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2019 · first_quarter · Health Issues
Center for Medicare & Medicaid Innovation, Medicare Part D, S.974 - CREATES Act of 2017; issues related to drug pricing.
Client expense: Not reported · Firm income: $60,000
Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
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
2019 · first_quarter · Health Issues
H.R. 4710 - 340B Protecting Access for the Underserved and Safety-Net Entities (PAUSE) Act S. 2312 - The Helping Ensure Low-income Patients have Access to Care and Treatment Act S. 2453 - Ensuring the Value of the 340B Program Act of 2018 HR 4392 - Reversing the HOPPS rule reimbursement cut to 340B hospitals HR 5598 - 340B Optimization Act HR 2889 - Closing Loopholes for Orphan Drugs Act HR 6240 - Drug Discount Accountability Act (user fees) H.R.6071 - SERV Communities Act of 2018 S.204/H.R.878, Trickett-Wendler Right to Try Act of 2017 P.L.109-417, Pandemic and All-Hazards Preparedness Act (PAHPA) S.2852 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 H.R.6294 - Re-Valuing Anti-Microbial Products (REVAMP) Act of 2018 S.974 - CREATES Act of 2017 H.R. 2113 - The Prescription Drug STAR Act H.R. 1520, the Purple Book Continuity Act; H.R. 1503, the Orange Book Transparency Act; H.R. 1499, the Protecting Consumer Access to Generic Drugs Act; and H.R. 965, the CREATES Act; - Issues related to the 340B Drug Discount Program - Issues relating to drug pricing - Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives. - Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety, and counterfeiting, and biosimilars. - General education about policies impacting pharmaceutical development, approval, reimbursement, and pricing. - Issues related to healthcare legislation
Client expense: $2,950,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office
2018 · fourth_quarter · Health Issues
Issues related to Short-Term, Limited-Duration Insurance Proposed Rule H.J. Res. 125 Continuing Appropriations Act H.R. 2212/S. 974 Creating and Restoring Equal Access to Equivalent Samples(CREATES) Act H.R. 4618 To amend the Internal Revenue Code of 1986 to provide for a temporary moratorium on certain taxes affecting purchases of prescription medication H.R.4894 Harmful Tax Prevention Act Issues related to Medicare Part D Issues related to Drug Pricing Issues related to Short: Term, Limited: Duration Insurance Proposed Rule CMS-5528 - Issues related to International Pricing Index
Client expense: $100,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2018 · third_quarter · Health Issues
Blueprint on Drug Pricing State Reinsurance Program H.R. 6 - The Support for Patients and Communities Act HR 4666 - Relief Act of 2017. Costello (R-PA) S 1835 - Lower Premiums through Reinsurance Act of 2017. Collins (R-ME) HR 3545 - Overdose Prevention and Patient Safety Act. Murphy (R-PA) S 1850 - Protecting Jessica Grubbs Legacy Act. Manchin (D-WV) HR 4200 & S 2052 - To provide for temporary funding for health insurance cost-sharing reduction payments and provide targeted tax relief, and for other purposes. HR 2212 & S 974 - Creating and Restoring Equal Access To Equivalent Samples Act of 2017: A bill to promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products. Marino (R-PA) & Leahy (D-VT) HR 3922 - Community Health And Medical Professionals Improve Our Nation Act of 2017: To extend funding for certain public health programs, and for other purposes. Walden (R-OR) S 1354 - Individual Health Insurance Marketplace Improvement Act: A bill to establish an individual market reinsurance fund to provide funding for state individual market stabilization reinsurance programs. Carper (D-DE) S 1859 - Healthcare Tax Relief Act: A bill to extend the moratorium on the annual fee on health insurance providers. Gardner (R-CO) H.R. 1215 - Protecting Access to Care Act of 2017: To improve patient access to health care services and provide improved medical care by reducing the excessive burden the liability system places on the health care delivery system. King (R-IA) H.R.1101 - Small Business Health Fairness Act of 2017: To amend title I of the Employee Retirement Income Security Act of 1974 to improve access and choice for entrepreneurs with small businesses with respect to medical care for their employees. Johnson (R-TX). S. 974 and H.R. 2212 - Creates Act of 2017: To promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products. Leahy (D-VT) & Marino (R-PA). HR 173 and S 40 - Middle Class Health Benefits Tax Repeal Act of 2017: To amend the Internal Revenue Code of 1986 to repeal the excise tax on high cost employer-sponsored health coverage. Kelly (R-PA) & Heller (R-NV). HR 708 - State Age Rating Flexibility Act of 2017: To amend title XXVII of the Public Health Service Act to change the permissible age variation in health insurance premium rates. Buschon (R-IN). HR 710 -Health Coverage State Flexibility Act of 2017: To amend the Patient Protection and Affordable Care Act to better align the grace period required for non-payment of premiums before discontinuing coverage under qualified health plans with such grace periods provided for under State law. Flores (R-TX). HR 749 - Lower Drug Costs through Competition Act: To increase competition in the pharmaceutical industry. Schrader (D-OR) H.R.1121 - Pre-existing Conditions Protection Act of 2017: To amend the Public Health Service Act to prohibit application of pre-existing condition exclusions and to guarantee availability of health insurance coverage in the individual and group market, contingent on the enactment of legislation repealing the Patient Protection and Affordable Care Act, and for other purposes. Walden (R-OR). HR 1175 and S 403 - Health Savings Act of 2017: To amend the Internal Revenue Code of 1986 to improve access to health care through expanded health savings accounts, and for other purposes. Paulsen (R-MN) & Hatch (R-UT). HR 1304 - Self-Insurance Protection Act: To amend the Employee Retirement Income Security Act of 1974, the Public Health Service Act, and the Internal Revenue Code of 1986 to exclude from the definition of health insurance coverage certain medical stop-loss insurance obtained by certain plan sponsors of group health plans. Roe (R-TN) HR 1776 & S 771 Improving Access To Affordable Prescription Drugs Act: To improve access to affordable prescription drugs. Schakowsky (D-IL) & Franken (D-MN) HR 2051 - To amend the Federal Food, Drug, and Cosmetic Act to ensure that eligible product developers have competitive access to approved drugs and licensed biological products, so as to enable eligible product developers to develop and test new products, and for other purposes. McKinley (R-WV) S 191 - Patient Freedom Act of 2017: To improve patient choice by allowing States to adopt market based alternatives to the Affordable Care Act that increase access to affordable health insurance and reduce costs while ensuring important consumer protections and improving patient care. Cassidy (R-LA) S 637 - Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017: To amend titles XI and XVIII of the Social Security Act to provide greater transparency of discounts provided by drug manufacturers. Wyden (D-OR) HR - 6082 Overdose Prevention and Patient Safety Act S 2554 Patient Right to Know Drug Prices Act
Client expense: $210,000 · Firm income: Not reported
Government targets: Defense, Dept of (DOD), Energy, Dept of, HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2018 · fourth_quarter · Health Issues
Bipartisan Health Care Stabilization Act, support bipartisan efforts led by Senators Alexander and Murray to stabilize and improve the individual health insurance market while protecting people with chronic conditions. -H.R. 2439/S. 1131, FAIR Drug Pricing Act, support passage. - H.R. 2212/ S. 974, Creating and Restoring Equal Access To Equivalent Samples Act of 2017 (CREATES Act), support passage. -H.R. 2077, Restoring Patients Voice Act, support passage. -S. 637, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act, support passage. -H.R. 4841/S. 2908, Standardizing Electronic Prior Authorization for Safe Prescribing Act, support passage. - H.R. 2051, Fair Access for Safe and Timely Generics Act of 2017 (FAST Generics Act), support passage. -H.R. 750, support passage of the Ensuring Access to Quality Complex Rehabilitation Technology Act. -H.R. 1361/S. 486/H.R. 3730, support passage to protect access to complex rehabilitative technology accessories. -H.R. 2535/S. 1188, Lifespan Respite Care Reauthorization Act, support reauthorization of the Lifespan Respite Care Program. -HR 2575/S. 1909, Beneficiary Enrollment Notification and Eligibility Simplification (BENES) Act
Client expense: $59,856 · Firm income: Not reported
Government targets: Army, Dept of (Other), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Health Issues
H.R. 2051: "FAST Generics Act of 2017", To amend the Federal Food, Drug, and Cosmetic Act to ensure that eligible product developers have competitive access to approved drugs and licensed biological products, so as to enable eligible product developers to develop and test new products, issues pertaining to drug pricing. S. 974, H.R. 2212: "CREATES Act of 2017", regarding all provisions. H.R. 3976: "Access to Marketplace Insurance Act", issues pertaining to Third Party Payment Premiums (TPPs). S. 2680, H.R. 6: "The Opioid Crisis Response Act of 2018", regarding all provisions. S. 3042, H.R. 2: "Agriculture Improvement Act of 2018", issues pertaining to federal funding for AHPs. H.R. 302, FAA Reauthorization Act of 2018, issues pertaining to air ambulance pricing transparency. H.R. 6294: "REVAMP Act" - To amend the Federal Food, Drug and Cosmetic Act to encourage the development of priority antimicrobial products through the award of transferable exclusivity extension period, regarding all provisions. H.R. 6733: "Know the Cost Act" - To amend title XXVII of the Public Health Service Act and title XVIII of the Social Security Act to prohibit group health plans, health insurance issuers, prescription drug plan sponsors and Medicare Advantage organizations from limiting certain information on drug prices, regarding all provisions. Issues pertaining to the Affordable Care Act; Annual Appropriations; Reinsurance; Cost Sharing Reductions (CSRs); Individual Market; Short Term Limited Duration Plans; Part D Donut Hole fix; Free standing ERs; ESRD coverage by private health plans; Risk adjustment.
Client expense: $1,280,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
2018 · fourth_quarter · Pharmacy
S. 297, Increasing Competition in Pharmaceuticals Act (Collins-McCaskill) - prescription drug costs S. 974, CREATES Act (Leahy-Grassley) - access to generic drugs and biosimilars S. 1115, Making Pharmaceutical Markets More Competitive Act (Collins-McCaskill) - accelerated approval of generic therapies S. 1131, FAIR Drug Pricing Act (Baldwin-McCain) - transparency in prescription drug pricing S. 2553, Know the Lowest Price Act (Stabenow) - pharmacist-patient communications S. 2554, Patient Right to Know Drug Prices Act (Collins) - pharmacist-patient communications, reporting of biosimilar pay-for-delay settlements S. 3194, Capping Prescription Costs Act (Warren) - capping prescription copays S. 3738, Hatch-Waxman Integrity Act (Hatch) - inter partes review process S. 3792, Preserve Access to Affordable Generics and Biosimilars Act (Klobuchar-Grassley) - pay-for-delay settlements H.R. 749, Lower Drug Costs Through Competition Act (Schrader-Bilirakis) - prescription drug costs H.R. 1703, Medical Product Communication Act (Griffith) - off-label exchange of information H.R. 2026, Pharmaceutical Information Exchange Act (Guthrie) - pre-approval health care economic information to payors H.R. 2051, Fair Access for Safe and Timely Generics Act (McKinley-Welch) - access to generic drugs H.R. 2212, CREATES Act (Marino-Cicilline) - access to generic drugs and biosimilars H.R. 2439, FAIR Drug Pricing Act (Schakowsky) - transparency in prescription drug pricing H.R. 2562, Making Pharmaceutical Markets More Competitive Act (Kelly) - accelerated approval of generic therapies H.R. 2999, Patients' Access to Treatments Act (McKinley) - limiting cost sharing in specialty drug tiers H.R. 5247, Right to Try Act (Fitzpatrick) - use of unapproved investigational drugs by patients with life-threatening conditions H.R. 6142, Reducing Drug Waste Act (Doggett) - packaging of medications H.R. 6157, Defense-Labor-HHS-Education Appropriations Act (Granger) -pharmaceutical price transparency in DTC advertising H.R. 6340, Capping Prescription Costs Act (Rosen) - capping prescription copays H.R. 6478, Biosimilars Competition Act (Sarbanes) - reporting of pay-for-delay settlements H.R. 6576, Drug-Price Transparency in Communications Act (Schakowsky) - disclosure of drug prices in DTC advertising H.R. 6733, Know the Cost Act (Carter) - pharmacist-patient communications H.R. 7251, Hatch-Waxman Integrity Act (Flores) - inter partes review process Regulatory Issues: Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to price of drugs and biologics; issues related to pharmacy benefit managers; issues related to biosimilars; issues related to approval of drugs and biologics; issues relating to opioids; issues relating to prescription drug rebates; issues relating to prescription drug price blueprint; direct-to-consumer advertising for prescription drugs; issues relating to access for investigational drugs; and other issues relating to health care reform implementation.
Client expense: $1,550,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, Treasury, Dept of, White House Office
2018 · fourth_quarter · Health Issues
S 3702/HR 7223 - Tax legislation, provisions regarding generic drugs S 3738/HR 7251 - Patent legislation regarding inter partes review HR 302 - FAA Re-authorization (provisions related to air ambulance services HR 7217 - IMPROVE Act Blueprint on Drug Pricing State Reinsurance Program H.R. 6 - The Support for Patients and Communities Act S 1835 - Lower Premiums through Reinsurance Act of 2017. Collins (R-ME) HR 3545 - Overdose Prevention and Patient Safety Act. Murphy (R-PA) S 1850 - Protecting Jessica Grubbs Legacy Act. Manchin (D-WV) HR 4200 & S 2052 - To provide for temporary funding for health insurance cost-sharing reduction payments and provide targeted tax relief, and for other purposes. HR 2212 & S 974 - Creating and Restoring Equal Access To Equivalent Samples Act of 2017: A bill to promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products. Marino (R-PA) & Leahy (D-VT) S 1354 - Individual Health Insurance Marketplace Improvement Act: A bill to establish an individual market reinsurance fund to provide funding for state individual market stabilization reinsurance programs. Carper (D-DE) S 1859 - Healthcare Tax Relief Act: A bill to extend the moratorium on the annual fee on health insurance providers. Gardner (R-CO) H.R. 1215 - Protecting Access to Care Act of 2017: To improve patient access to health care services and provide improved medical care by reducing the excessive burden the liability system places on the health care delivery system. King (R-IA) H.R.1101 - Small Business Health Fairness Act of 2017: To amend title I of the Employee Retirement Income Security Act of 1974 to improve access and choice for entrepreneurs with small businesses with respect to medical care for their employees. Johnson (R-TX). S. 974 and H.R. 2212 - Creates Act of 2017: To promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products. Leahy (D-VT) & Marino (R-PA). HR 173 and S 40 - Middle Class Health Benefits Tax Repeal Act of 2017: To amend the Internal Revenue Code of 1986 to repeal the excise tax on high cost employer-sponsored health coverage. Kelly (R-PA) & Heller (R-NV). HR 708 - State Age Rating Flexibility Act of 2017: To amend title XXVII of the Public Health Service Act to change the permissible age variation in health insurance premium rates. Buschon (R-IN). HR 710 -Health Coverage State Flexibility Act of 2017: To amend the Patient Protection and Affordable Care Act to better align the grace period required for non-payment of premiums before discontinuing coverage under qualified health plans with such grace periods provided for under State law. Flores (R-TX). HR 749 - Lower Drug Costs through Competition Act: To increase competition in the pharmaceutical industry. Schrader (D-OR) H.R.1121 - Pre-existing Conditions Protection Act of 2017: To amend the Public Health Service Act to prohibit application of pre-existing condition exclusions and to guarantee availability of health insurance coverage in the individual and group market, contingent on the enactment of legislation repealing the Patient Protection and Affordable Care Act, and for other purposes. Walden (R-OR). HR 1175 and S 403 - Health Savings Act of 2017: To amend the Internal Revenue Code of 1986 to improve access to health care through expanded health savings accounts, and for other purposes. Paulsen (R-MN) & Hatch (R-UT). HR 1304 - Self-Insurance Protection Act: To amend the Employee Retirement Income Security Act of 1974, the Public Health Service Act, and the Internal Revenue Code of 1986 to exclude from the definition of health insurance coverage certain medical stop-loss insurance obtained by certain plan sponsors of group health plans. Roe (R-TN) HR 1776 & S 771 Improving Access To Affordable Prescription Drugs Act: To improve access to affordable prescription drugs. Schakowsky (D-IL) & Franken (D-MN) HR 2051 - To amend the Federal Food, Drug, and Cosmetic Act to ensure that eligible product developers have competitive access to approved drugs and licensed biological products, so as to enable eligible product developers to develop and test new products, and for other purposes. McKinley (R-WV) S 191 - Patient Freedom Act of 2017: To improve patient choice by allowing States to adopt market based alternatives to the Affordable Care Act that increase access to affordable health insurance and reduce costs while ensuring important consumer protections and improving patient care. Cassidy (R-LA) S 637 - Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017: To amend titles XI and XVIII of the Social Security Act to provide greater transparency of discounts provided by drug manufacturers. Wyden (D-OR) HR - 6082 Overdose Prevention and Patient Safety Act S 2554 Patient Right to Know Drug Prices Act
Client expense: $1,190,000 · Firm income: Not reported
Government targets: Defense, Dept of (DOD), Energy, Dept of, HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2018 · fourth_quarter · Pharmacy
S. 974, HR 2212 The Creates Act, increasing access to generic pharmaceuticals,
Client expense: Not reported · Firm income: $20,000
Government targets: Office of the Vice President of the United States, White House Office
2018 · fourth_quarter · Pharmacy
S. 974, HR 2212 The Creates Act, increasing access to generic pharmaceuticals,
Client expense: Not reported · Firm income: $60,000
Government targets: Office of the Vice President of the United States, White House Office
2018 · fourth_quarter · Health Issues
S. 974 - Creating and Restoring Equal Access To Equivalent Samples Act of 2017 (CREATES Act) American Patients First (Drug Pricing Blueprint)
Client expense: Not reported · Firm income: $20,000
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office
2018 · fourth_quarter · Health Issues
S. 974, the Creating and Restoring Equal Access to Equivalent Samples, or CREATES Act, a bipartisan bill that would stop drug companies from delaying the introduction of less expensive generic drugs into the marketplace. A Proposed Rule by the Internal Revenue Service, the Employee Benefits Security Administration, and the Health and Human Services Department on 10/29/2018, for Health Reimbursement Arrangements and Other Account-Based Group Health Plans, Document Citation:83 FR 54420 H.R. 5963, the Health Insurance Premium Reduction Act, as of July 4, to delay the reimposition of the Health Insurance Tax (HIT) annual fee on health insurance providers until after 2020. H.R. 6496, the Continuing Coverage for Preexisting Conditions Act of 2018.
Client expense: Not reported · Firm income: $9,999
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), SENATE, Treasury, Dept of
2018 · fourth_quarter · Health Issues
Issues related to pharmaceutical manufacturer and pharmacy contracting with respect to drug pricing. Issues included in the Proposed Part D Rule and accompanying RFI and the Administrations Blueprint on drug pricing RFI . Issues related to Medicaid Provider Enrollment. Issues related to prescription drug abuse. Issues related to the Medicare Coverage Gap Discount. Regulatory design and coverage of pharmacy benefits in health reform exchanges and the commercial market (essential health benefits, e-prescribing, PBM disclosure requirements, specialty pharmacy, mail-service pharmacy, formulary transparency, and medical loss ratio). H.R.749/S.297, Lower Drug Costs through Competition Act HR.1038/S.413, Improving Transparency and Accuracy in Part D Spending Act H.R.1316, Prescription Drug Price Transparency Act S.637, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017 S.771, Improving Access to Affordable Prescription Drug Act H.R.1939/S.1044, Ensuring Seniors Access to Local Pharmacies Act H.R. 2026, Pharmaceutical Information Exchange Act H.R.2051, FAST Generics Act H.R.2212/S.974, Creating and Restoring Equal Access To Equivalent Samples Act of 2017 H.R.2077 Restoring the Patient's Voice Act of 2017 S.2553/H.R.6144, Know the Lowest Price Act of 2018 S.2554/H.R.6143, Patient Right to Know Drug Prices Act H.R.3528/S.2460, The Every Prescription Carried Safely Act H.R.5343, Prescription Transparency Act of 2018 H.R.4841, Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018 Issues related to the affordability of prescription drugs and competitive marketplace, including: pedigree, manufacturer market and data exclusivity, REMS, accelerated generic approval, biosimilars.
Client expense: $611,446 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), SENATE
2018 · fourth_quarter · Pharmacy
CREATES Act (S.974/H.R.2212) - Addresses REMS and market entry issues.
Client expense: $83,374 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Manufacturing
CREATES Act (S.974/H.R.2212) - Addresses REMS and market entry issues.
Client expense: $83,374 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Copyright/Patent/Trademark
CREATES Act (S.974/H.R.2212) - addresses REMS and market entry issues. Patent settlements legislation USMCA - regarding IP standards in USMCA. IPR - regarding PTO authority to administrative review of patents.
Client expense: $83,374 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Medicare/Medicaid
CREATES Act (S.974/H.R.2212) - Addresses REMS and market entry issues.
Client expense: $83,374 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Health Issues
CREATES Act (S.974/H.R.2212) - Addresses REMS and market entry issues. PACED Act (S.2514) - Restores PTO's authority to review patents despite assertion of sovereign immunity. Patent settlements legislation.
Client expense: $83,374 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Pharmacy
Legislation and policies related to: Draft legislation to reauthorize and modernize the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act H.R. 6 - Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act H.R. 749 - Lower Drug Costs through Competition Act H.R. 3692/S. 2317 - Addiction Treatment Access Improvement Act S. 204/H.R. 5247 - Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 S. 297 - Increasing Competition in Pharmaceuticals Act S. 771/H.R. 1776 - Improving Access to Affordable Prescription Drugs Act S. 892 - Opioid Addiction Prevention Act of 2017 S. 974 - Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2018 S. 2456 - CARA 2.0 Act of 2018 S. 2680 - Opioid Crisis Response Act of 2018 S. 3680 - Low Drug Prices Act S. 3754 - Combatting Unreasonable Rises and Excessively (CURE) High Drug Prices Act S. 3775 - Affordable Drug Manufacturing Act of 2018
Client expense: Not reported · Firm income: $23,450
Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Education, Dept of, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Homeland Security, Dept of (DHS), Housing & Urban Development, Dept of (HUD), Justice, Dept of (DOJ), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA)
2018 · fourth_quarter · Health Issues
Issues related to Short-Term, Limited-Duration Insurance Proposed Rule H.J. Res. 125 Continuing Appropriations Act H.R. 2212/S. 974 Creating and Restoring Equal Access to Equivalent Samples(CREATES) Act H.R. 4618 To amend the Internal Revenue Code of 1986 to provide for a temporary moratorium on certain taxes affecting purchases of prescription medication H.R.4894 Harmful Tax Prevention Act Issues related to Medicare Part D Issues related to Drug Pricing Issues related to Short: Term, Limited: Duration Insurance Proposed Rule CMS-5528 - Issues related to International Pricing Index
Client expense: $100,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Labor, Dept of (DOL), 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 · Health Issues
H.R. 749: Lower Drug Costs through Competition Act - Provisions related to generic drug approvals H.R. 1245: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 1480: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation H.R. 1628: American Health Care Act of 2017 - Provisions related to the biopharmaceutical industry including repeal of brand pharmaceutical manufacturer fee and individual and employer mandates, insurance affordability provisions, and Medicaid reforms H.R. 1776: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing H.R. 2051: FAST Generics Act of 2017 - Provisions related to REMS and limited distribution systems H.R. 2212: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 4710: 340B Protecting Access for the Underserved and Safety-net Entities Act or PAUSE Act - Provisions related to the 340B program H.R. 5041: The Safe Disposal of Unused Medication Act - Provisions related to drug disposal H.R. 5228: SCREEN Act - Provisions related to drug recall authority H.R. 5311: CARA 2.0 Act of 2018 - Provisions to reauthorize and expand the Comprehensive Addiction and Recovery Act H.R. 5598: 340B Optimization Act - Provisions related to transparency in the 340B program H.R. 6574: Medicare Fair Drug Pricing Act of 2018 - Provisions related to drug pricing HR 5333 - Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018 S 2315 - Over-the-Counter Drug Safety, Innovation, and Reform Act HR 7328 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 HR 394/S85 - Restoring Access to Medication Ac HR 6199 - Restoring Access to Medication and Modernizing Health Savings Accounts Act of 2018 Medicare Doughnjt hole -House/Senate Labor HHS AppropriationsHouse/Senate DoD AppropriationsDoggett bill Trump Administration IPI proposal, Trump Administration proposed changes to six protected classes. HR6378, Pandemic and All Hazards Preparedness and Advancing Innovation Act; HR4993/S3253, Vaccine Access Improvement Act; HR 4297/S2103, Protecting Seniors Through Immunization Act; H.R.4710 - 340B PAUSE ActH.R.4297 - Protecting Seniors Through Immunization Act of 2017 S. 3477 - Protecting Seniors through Immunization Act S. 64: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 92: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 469: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 771: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing S. 974: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017 - Provisions related to drug pricing S. 2312: HELP Act - Provisions related to 340B program S. 2453: Ensuring the Value of the 340B Program Act of 2018 - Provisions to increase transparency in the 340B program S. 2553: Know the Lowest Price Act of 2018 - Provisions related to drug pricing S. 2554: Patient Right to Know Drug Prices Act - To ensure that health insurance issuers and group health plans do not prohibit pharmacy providers from providing certain information to enrollees -Know the Lowest Price Act of 2018Medicare Part D Six Protected Classes HHS Proposal on Medicare Part B International Pricing Index (IPI)340B Drug Discount Program S. 3519: A bill to establish a process for the Food and Drug Administration to determine whether to modify the labeling of drugs whose labeling may be outdated, including drugs with accepted uses that are not reflected in the approved labeling S. 3775: Affordable Drug Manufacturing Act of 2018 Drug cost and pricing policy issues Transparency policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues Expanded access policy issues Generic drug approval process policy issues High deductible health plans/HSA policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues Compulsory licensing policy issues Foreign reference pricing policy issues 340B drug discount program policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Cancer drug vial size policy issues TRICARE pharmacy pilot program Drug shortages policy issues Reauthorization of the Pandemic and All-Hazards Preparedness Act Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49)
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 · Health Issues
Monitor implementation of the 340B Prescription Drug Discount Program; legislative issues related to access to samples of prescription drugs, including S.974/H.R.2212 - the CREATES Act of 2017s.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2018 · fourth_quarter · Pharmacy
Issues related to Orphan Drug Act, Drug Quality and Security Act, drug pricing, H.R. 6, Opioid legislation and provisions concerning opioid-sparing; H.R. 2051, Fast Generics Act; S. 974, CREATES Act; FDA issues.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Health Issues
H.R. 2051, "FAST Generics Act of 2017", provisions regarding REMS. H.R. 1409, "Cancer Drug Parity Act of 2017", regarding all provisions. H.R. 2077, "Restoring the Patient's Voice Act of 2017", Step Therapy / Fail First. S. 974/ H.R. 2212, "CREATES Act of 2017", provisions regarding REMS. Issues relating to Cancer Drug Coverage Parity. Issues relating to Step Therapy / Fail First. Issues relating to Medicare Part D / Part B. Issues relating to Reimbursement for and patient access to Chimeric Antigen Receptor (CAR) T-cell therapies.
Client expense: $400,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Pharmacy
Issues relating to generic drugs, drug pricing, S. 974 - CREATES Act of 2017, H.R.2212 - CREATES Act of 2017, Hatch Waxman Integrity Act
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Health Issues
CREATES Act HR 2212 / S 974
Client expense: Not reported · Firm income: $30,000
Government targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE
2018 · fourth_quarter · Copyright/Patent/Trademark
CREATES Act HR 2212 / S 974 Issues relating to the Patent Trial and Appeals Board S. 1948 (patents and tribal sovereign immunity) Issues relating to patents as affecting drug pricing
Client expense: Not reported · Firm income: $30,000
Government targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE
2018 · fourth_quarter · Pharmacy
S. 974- CREATES Act of 2017, H.R.2212 - CREATES Act of 2017, Issues relating to biodefense
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Health Issues
Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugs Risk Evaluation and Mitigation Strategies (REMS), H.R. 2051 - FAST Generics Act of 2017, S.974, H.R. 2212 - CREATES Act of 2017 Biologics Price Competition and Innovation Act (BPCIA) transition provisions affecting Insulins, complex generics Medicare reimbursement for biosimilars, Pass through payments for biosimilars
Client expense: $520,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), SENATE, White House Office
2018 · fourth_quarter · Health Issues
H.R. 2212 & S. 974-The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act; HHS Blueprint to lower drug prices and reduce out-of-pocket costs.
Client expense: Not reported · Firm income: $10,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
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
Repeal of the Affordable Care Act H.R. 1628 The American Health Care Act Development of legislation to protect essential hospitals Issues related to telehealth Mental Health Essential Health Benefits created by the Affordable Care Act Access to hospital emergency services Issues related to the 340B Drug Pricing Program HR1628 Better Care Reconciliation Act ACA Cost Sharing Reduction Subsidies Graham-Cassidy Amendment to HR 1628 340B drug pricing program HR3545-Overdose, Prevention and Patient Advocacy Act HR4392 CMS OPPS 340b rule moratorium HR4710 340b PAUSE Act Bipartisan Healthcare Stabilization Act of 2017 Opioid Crisis Response Act of 2018 42 CFR Part 2 IMD Exclusion Prescription drug monitoring programs H.R. 5197, S. 2516, Alternatives to opioids in the emergency dept Act H.R. 5102, Substance Use Disorder Workforce Loan Repayment Act H.R. 5261, Treatment, Education, and Community Help to Combat Opioid Addiction Act Poison Center Network Enhancement Act A Bill to support the peer support specialist workforce HR6 Support for Patients and Communities Act H.R. 4710 PAUSE Act HELP Act S. 2312 HR6378 Pandemic and All Hazards Preparedness and Advancing Innovation Act S.974 CREATES Act S.2843 Opioid Workforce Act HEAL Act S.3120 SERV Communities Act H. R. 6071 S.428, H.R. 3325 The Advancing Care for Exceptional (ACE) Kids Act Cassidy Surprise Billing Draft H.R.6 Support for Patients and Communities Act Protecting Patients from Surprise Medical Bills Hassan Surprise Billing-S. 3592, No more Surprise Medical Bills Act H.R. 7328, Pandemic and All-Hazards Preparedness and Advancing Innovation Act
Client expense: $460,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office
2018 · fourth_quarter · Health Issues
H.R. 2212 & S. 974-The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act.
Client expense: Not reported · Firm income: $10,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Copyright/Patent/Trademark
Policy and oversight related to the generic pharmaceutical industry H.R.2212/S. 974 - CREATES Act of 2017 H.R. 7251/S.3738 - Hatch-Waxman Integrity Act of 2018 H.R.6294 - REVAMP Act
Client expense: Not reported · Firm income: $20,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Insurance
ACA implementation (exchange operations and functionality, risk mitigation programs, risk adjustment) ACA reform (reconciliation, individual mandate, cost sharing reduction subsidies, reinsurance transitional policies) The Bipartisan Budget Act of 2018 (H.R. 1892) Creating and Restoring Equal Access To Equivalent Samples (CREATES) Act of 2017 (S. 974 and H.R. 2212) Overdose Prevention and Patient Safety Act (H.R. 3545 and H.R. 6082) Jessies Law (H.R. 5009) Mental health and substance use (42 CFR Part 2) Individual market and exchange stabilization Association health plans Short Term Limited Duration Plans Out of network billing (FAA Reauthorization Act of 2018, H.R. 302) ACA third party payments Telehealth Price of prescription drugs Opioid addiction issues and response (prescription drug monitoring programs) Prior authorization SUPPORT for Patients and Communities Act (H.R. 6) Veterans health care Task Force on the Impact of Affordable Housing Crisis Act of 2018 (S. 3231) Readiness for Elders and Americans with Disabilities Inclusion (READI) for Disaster Act (S. 3679)
Client expense: $1,840,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Communications Commission (FCC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, White House Office
2018 · fourth_quarter · Health Issues
ACA implementation (exchange operations and functionality, risk mitigation programs, risk adjustment) ACA reform (reconciliation, individual mandate, cost sharing reduction subsidies, reinsurance transitional policies) The Bipartisan Budget Act of 2018 (H.R. 1892) Creating and Restoring Equal Access To Equivalent Samples (CREATES) Act of 2017 (S. 974 and H.R. 2212) Overdose Prevention and Patient Safety Act (H.R. 3545 and H.R. 6082) Jessies Law (H.R. 5009) Mental health and substance use (42 CFR Part 2) Individual market and exchange stabilization Association health plans Short Term Limited Duration Plans Out of network billing (FAA Reauthorization Act of 2018, H.R. 302) ACA third party payments Telehealth Price of prescription drugs Opioid addiction issues and response (prescription drug monitoring programs) Prior authorization SUPPORT for Patients and Communities Act (H.R. 6) Veterans health care Task Force on the Impact of Affordable Housing Crisis Act of 2018 (S. 3231) Readiness for Elders and Americans with Disabilities Inclusion (READI) for Disaster Act (S. 3679)
Client expense: $1,840,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Communications Commission (FCC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, White House Office
2018 · fourth_quarter · Copyright/Patent/Trademark
- Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act (S. 974/H.R. 2212)
Client expense: Not reported · Firm income: $80,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Health Issues
H.R. 4710 - 340B Protecting Access for the Underserved and Safety-Net Entities (PAUSE) Act S. 2312 - The Helping Ensure Low-income Patients have Access to Care and Treatment Act S. 2453 - Ensuring the Value of the 340B Program Act of 2018 HR 4392 - Reversing the HOPPS rule reimbursement cut to 340B hospitals HR 5598 - 340B Optimization Act HR 2889 - Closing Loopholes for Orphan Drugs Act HR 6240 - Drug Discount Accountability Act (user fees) H.R.6071 - SERV Communities Act of 2018 S.204/H.R.878, Trickett-Wendler Right to Try Act of 2017 P.L.109-417, Pandemic and All-Hazards Preparedness Act (PAHPA) S.2852 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 H.R.6294 - Re-Valuing Anti-Microbial Products (REVAMP) Act of 2018 S.974 - CREATES Act of 2017 - Issues related to the 340B Drug Discount Program - Issues relating to drug pricing - Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives. - Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety and counterfeiting, and biosimilars. - General education about policies impacting pharmaceutical development, approval, reimbursement and pricing. - Issues related to healthcare legislation
Client expense: $1,480,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office
2018 · fourth_quarter · Health Issues
H.R. 6: SUPPORT for Patients and Communities Act - To provide for opioid use disorder prevention, recovery, and treatment, and for other purposes H.R. 449: Synthetic Drug Awareness Act: Provisions related to synthetic drug report H.R. 749: Lower Drug Costs through Competition Act - Provisions related to generic drug approvals H.R. 1245: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 1480: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation H.R. 1628: American Health Care Act of 2017 - Provisions related to the biopharmaceutical industry including repeal of brand pharmaceutical manufacturer fee and individual and employer mandates, insurance affordability provisions, and Medicaid reforms H.R. 1776: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing H.R. 2051: FAST Generics Act of 2017 - Provisions related to REMS and limited distribution systems H.R. 2063: Opioid Preventing Abuse through Continuing Education (PACE) Act of 2017 - Provisions related to prescriber training H.R. 2212: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 4710: 340B Protecting Access for the Underserved and Safety-net Entities Act or PAUSE Act - Provisions related to the 340B program H.R. 5041: The Safe Disposal of Unused Medication Act - Provisions related to drug disposal H.R. 5228: SCREEN Act - Provisions related to drug recall authority H.R. 5311: CARA 2.0 Act of 2018 - Provisions to reauthorize and expand the Comprehensive Addiction and Recovery Act H.R. 5598: 340B Optimization Act - Provisions related to transparency in the 340B program H.R. 6574: Medicare Fair Drug Pricing Act of 2018 - Provisions related to drug pricing S. 64: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 92: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 469: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 771: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing S. 974: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017 - Provisions related to drug pricing S. 2312: HELP Act - Provisions related to 340B program S. 2453: Ensuring the Value of the 340B Program Act of 2018 - Provisions to increase transparency in the 340B program S. 2553: Know the Lowest Price Act of 2018 - Provisions related to drug pricing S. 2554: Patient Right to Know Drug Prices Act - To ensure that health insurance issuers and group health plans do not prohibit pharmacy providers from providing certain information to enrollees S. 2665: A bill to require guidance on how the Food and Drug Administration will consider claims of opioid sparing and on the conditions under which the Food and Drug Administration will consider misuse and abuse of drugs in making certain determinations of safety S. 2680: Opioid Crisis Response Act of 2018 - Provisions related to opioids S. 3519: A bill to establish a process for the Food and Drug Administration to determine whether to modify the labeling of drugs whose labeling may be outdated, including drugs with accepted uses that are not reflected in the approved labeling S. 3775: Affordable Drug Manufacturing Act of 2018 Drug cost and pricing policy issues Transparency policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues Policy issues related to prescription drug abuse and opioids Expanded access policy issues Generic drug approval process policy issues High deductible health plans/HSA policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues Compulsory licensing policy issues Foreign reference pricing policy issues 340B drug discount program policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Cancer drug vial size policy issues TRICARE pharmacy pilot program Drug shortages policy issues Reauthorization of the Pandemic and All-Hazards Preparedness Act Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49)
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)