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Re-Valuing Anti-Microbial Products Act of 2018 or the REVAMP Act This bill amends the Federal Food, Drug, and Cosmetic Act to provide for an award of 12 additional months of market exclusivity to a drug manufacturer for a drug designated as a "priority antimicrobial product." (A priority antimicrobial product is intended to treat or prevent a disease attributable to a multi-drug resistant bacterial or fungal pathogen for which there is a critical unmet medical need.)
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Filing registrants (12)
Referred to the House Committee on Energy and Commerce.
Introduced in House
Congress.gov source codes: 1000, Intro-H
Bills with similar content found using semantic analysis.
Sources: Congress.gov
2020 · first_quarter · Health Issues
S. 3548 - CARES Act (Coronavirus Stimulus 3) H.R.6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R.6201 - Families First Coronavirus Response Act H.R.6294 - Re-Valuing Anti-Microbial Products (REVAMP) Act of 2018 S.340- CREATES Act of 2019 H.R. 2113 - The Prescription Drug STAR Act H.R. 1520, the Purple Book H.R. 1499, the Protecting Cok Continuity Act; H.R. 1503, the Orange Book Transparency Act;consumer Access to Generic Drugs Act; and H.R. 965, the CREATES Act; H.R.3: Lower Drug Costs Now Act of 2019 S.1895, Lower Health Care Costs Act of 2019 S.551, REFUND Act of 2019 - 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 - Patient access to Part B medicines during the COVID-19 public health emergency
Client expense: $2,790,000 · 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
2020 · first_quarter · Health Issues
S. 3548 - CARES Act (Coronavirus Stimulus 3) H.R.6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R.6201 - Families First Coronavirus Response Act H.R.6294 - Re-Valuing Anti-Microbial Products (REVAMP) Act of 2018 S.340- CREATES Act of 2019 H.R. 2113 - The Prescription Drug STAR Act H.R. 1520, the Purple Book H.R. 1499, the Protecting Cok Continuity Act; H.R. 1503, the Orange Book Transparency Act;consumer Access to Generic Drugs Act; and H.R. 965, the CREATES Act; H.R.3: Lower Drug Costs Now Act of 2019 S.1895, Lower Health Care Costs Act of 2019 S.551, REFUND Act of 2019 - 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 - Patient access to Part B medicines during the COVID-19 public health emergency
Client expense: $2,710,000 · Firm income: Not reported
2019 · fourth_quarter · Health Issues
H.R.6294 - Re-Valuing Anti-Microbial Products (REVAMP) Act of 2018 S.340- CREATES Act of 2019 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; H.R.3: Lower Drug Costs Now Act of 2019 S.1895, Lower Health Care Costs Act of 2019 S.551, REFUND Act of 2019 -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: $1,580,000 · 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: $2,620,000 · Firm income: Not reported
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
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), 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), 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), 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 · fourth_quarter · Health Issues
H.R.6294 - Re-Valuing Anti-Microbial Products (REVAMP) Act of 2018 S.340- CREATES Act of 2019 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; H.R.3: Lower Drug Costs Now Act of 2019 S.1895, Lower Health Care Costs Act of 2019 S.551, REFUND Act of 2019 -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: $1,520,000 · 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 · 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
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: $1,610,000 · 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 · 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
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 · Health Issues
Development of policies to advance the antimicrobial research and novel product development environment, including advancing new market incentives. Support for H.R. 6294 - REVAMP Act.
Client expense: Not reported · Firm income: $50,000
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), 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 · 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
Affordable Care Act (ACA); ACA Regulations; ACA Stabilization; Health Reform; Rural Healthcare; Risk Adjustment; State Flexibility; Point of Sale; Fall Priorities; Opioids; Sober Homes; Marketplace Stability; Individual Market Reform; FAA (Air Ambulance); CREATES Act; Sec. 1332 Waivers; Short Term Limited Duration (STLD): AHPs; Value-based Care; Health Care Costs; Mental Health; Small Business Plans; Single Payer; Reinsurance; CSRs; SNPs; Health Savings Accounts (HSAs); Postal Reform; FEHBP Options; 42 CFR Part 2; Transparency; Silverloading; Health IT Interoperability; Urban Affairs/Deterrence (Opioid epidemic); Texas lawsuit; Air Ambulance; Surprise billing, Transparency, Small Business, State Flexibility; Lyme Disease HR 6 SUPPORT for Patients and Communities Act Introduced June 13, 2018 by Greg Walden (R-OR) includes Medicaid, Medicare, and public health reforms to combat the opioid crisis by advancing treatment and recovery initiatives, improving prevention, protecting communities, and bolstering efforts to combat illicit synthetic drugs like fentanyl. The policies contained in the legislation were advanced through regular order by the House Energy and Commerce Committee and the Ways and Means Committee. HR 2051 FAST Generics Act Introduced April 6, 2017 by David McKinley (R-WV) 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. HR 2212 CREATES Act Introduced April 27, 2017 by Tom Marino (R-PA) 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. HR 3325 ACE Kids Act Introduced July 20, 2017 by Joe Barton (R-TX) To amend title XIX of the Social Security Act to provide States with the option of providing coordinated care for children with complex medical conditions through a health home, and for other purposes. HR 6294 REVAMP Act Introduced June 28, 2018 by John Shimkus (R-IL) To amend the Federal Food, Drug, and Cosmetic Act to encourage the development of priority antimicrobial products through the award of a transferable exclusivity extension period, and for other purposes. HR 6733 Know the Cost Act of 2018 Introduced September 7, 2018 by Buddy Carter (R-GA) 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.
Client expense: $1,590,000 · 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), Office of Personnel Management (OPM), Office of the Vice President of the United States, SENATE, Vice President of the U.S., White House Office
2018 · fourth_quarter · Health Issues
- S. 469/H.R. 1245, "Affordable and Safe Prescription Drug Importation Act", regarding all provisions. - S. 771/H.R. 1776, "Improving Access To Affordable Prescription Drugs Act", regarding all provisions. - H.R. 575, "Cosmetic Modernization Amendments of 2017", regarding all provisions. - H.R. 1271, "DXM Abuse Prevention Act of 2017", regarding all provisions. - S. 404/H.R. 1736, "To amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments and for granting export certifications.", regarding all provisions. - Issues regarding drug pricing. - Issues related to diagnostic reform. - S 260/SJ Res 17/HR 849, Protecting Seniors' Access to Medicare Act of 2017, regarding all provisions - S 251/SJ Res 16, Protecting Medicare from Executive Action Act of 2017, regarding all provisions - S 204/HR 878, Right to Try Act of 2017, regarding all provisions - HR 2026, Pharmaceutical Information Exchange Act, regarding all provisions - HR 1703, Medical Product Communications Act of 2017, regarding all provisions - Issues related to VA procurement of medical devices - HR 2474, Medical Product Review Harmonization Act, regarding all provisions - HR 2144, Risk Based Classification of Accessories Act - Issues related to AMA resolution 208(A-16) regarding attorney ads on drug side effects - S.1113, "Personal Care Products Safety Act", regarding all provisions - HR 2790, "Humane Cosmetics Act", regarding all provisions - HR 3271, "Protecting Access to Diabetes Supplies Act", regarding all provisions - Issues regarding medical device repeal - Issues regarding NIH Funding - HR 2164, "Medical Device Safety Act", regarding all provisions - Issues related to 340B - Issues related to HIV vaccines - S. 2852, "Pandemic & All Hazards Preparedness and Advancing Innovations Act of 2018", regarding all provisions. - Issues related to reauthorization of the Pandemic All-Hazards Preparedness Act programs. (House version) - HR 5492, "MOTHER Act of 2018", regarding all provisions. - Issues related to access to essential surgery - Issues related to contact lens safety - HR 6, "SUPPORT for Patients and Communities Act", regarding all provisions. - S. 2315, "Over-the-Counter Drug Safety, Innovation, and Reform Act", regarding all provisions. - HR 5333 "Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018", regarding all provisions. - Issues related to antimicrobial resistance - Issues related to regulations on medication product packaging - H.R. 6294, " Re-Valuing Anti-Microbial Products Act of 2018", regarding all provisions - H.R. 1318, "Preventing Maternal Deaths Act of 2018", regarding all provisions
Client expense: $2,340,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, Veterans Affairs, Dept of (VA), White House Office
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 · Health Issues
Value of Prescription Drugs, Senate & House; Issues related to march-in rights under Bayh-Dole Act (Pub. L. 96-517); PAHPA (S. 2852/H.R. 6378) Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018; REVAMP (H.R. 6294) Re-Valuing Anti-Microbial Products Act of 2018.
Client expense: $460,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Health Issues
Affordable Care Act (ACA) Regulations; ACA Stabilization; Health Reform; Risk Adjustment; State Flexibility; Opioids; Sober Homes, Marketplace Stability; Individual Market Reform; FAA (Air Ambulance); CREATES Act; Section 1332 Waivers; Short Term Limited Duration Insurance (STLDI); Association Health Plans (AHPs); Value-based Care; Health Care Costs; Mental Health; Single Payer; Reinsurance; Cost Sharing Reductions (CSRs); Health Savings Accounts (HSAs); Silver Loading; Texas v. U.S. Lawsuit; Surprise Billing HR 6 Introduced June 13, 2018 by Greg Walden (R-OR). The SUPPORT for Patients and Communities Act includes Medicaid, Medicare, and public health reforms to combat the opioid crisis by advancing treatment and recovery initiatives, improving prevention, protecting communities, and bolstering efforts to combat illicit synthetic drugs like fentanyl. The policies contained in the legislation were advanced through regular order by the House Energy and Commerce Committee and the Ways and Means Committee. HR 2051 Introduced April 6, 2017 by David McKinley (R-WV). The FAST Generics Act amends 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. HR 2212 Introduced April 27, 2017 by Tom Marino (R-PA). The CREATES Act promotes 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. HR 3325 Introduced July 20, 2017 by Joe Barton (R-TX). This bill amends title XIX of the Social Security Act to provide states with the option of providing coordinated care for children with complex medical conditions through a health home, and for other purposes. HR 6294 Introduced June 28, 2018 by John Shimkus (R-IL). The REVAMP Act would amend the Federal Food, Drug, and Cosmetic Act to encourage the development of priority antimicrobial products through the award of a transferable exclusivity extension period, and for other purposes. HR 6733 Introduced September 7,2018 by Buddy Carter (R-GA). The Know the Cost Act of 2018 amends 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.
Client expense: $250,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), 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
General health care coverage and reimbursement; issues related to infectious disease drug development and procurement; legislative and regulatory issues related to biodefense countermeasure development and procurement; development of policies to advance the antimicrobial research and development environment. Support for H.R. 6294 - REVAMP Act.
Client expense: Not reported · Firm income: $10,000
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
2018 · third_quarter · Health Issues
H.R. 6294, the Re-Valuing Anti-Microbial Products Act of 2018
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES
2018 · third_quarter · Health Issues
Value of Prescription Drugs, Senate & House; Issues related to march-in rights under Bayh-Dole Act (Pub. L. 96-517); PAHPA (S. 2852/H.R. 6378) Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018; REVAMP (H.R. 6294) Re-Valuing Anti-Microbial Products Act of 2018.
Client expense: $560,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · third_quarter · Health Issues
Development of policies to advance the antimicrobial research and novel product development environment, including advancing new market incentives. Support for H.R. 6294 - REVAMP Act.
Client expense: Not reported · Firm income: $50,000
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Office of Personnel Management (OPM), SENATE
2018 · third_quarter · Health Issues
- S. 469/H.R. 1245, "Affordable and Safe Prescription Drug Importation Act", regarding all provisions. - S. 771/H.R. 1776, "Improving Access To Affordable Prescription Drugs Act", regarding all provisions. - H.R. 575, "Cosmetic Modernization Amendments of 2017", regarding all provisions. - H.R. 1271, "DXM Abuse Prevention Act of 2017", regarding all provisions. - S. 404/H.R. 1736, "To amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments and for granting export certifications.", regarding all provisions. - Issues regarding drug pricing. - Issues related to diagnostic reform. - S 260/SJ Res 17/HR 849, Protecting Seniors' Access to Medicare Act of 2017, regarding all provisions - S 251/SJ Res 16, Protecting Medicare from Executive Action Act of 2017, regarding all provisions - S 204/HR 878, Right to Try Act of 2017, regarding all provisions - HR 2026, Pharmaceutical Information Exchange Act, regarding all provisions - HR 1703, Medical Product Communications Act of 2017, regarding all provisions - Issues related to VA procurement of medical devices - HR 2474, Medical Product Review Harmonization Act, regarding all provisions - HR 2144, Risk Based Classification of Accessories Act - Issues related to AMA resolution 208(A-16) regarding attorney ads on drug side effects - S.1113, "Personal Care Products Safety Act", regarding all provisions - HR 2790, "Humane Cosmetics Act", regarding all provisions - HR 3271, "Protecting Access to Diabetes Supplies Act", regarding all provisions - Issues regarding medical device repeal - Issues regarding NIH Funding - HR 2164, "Medical Device Safety Act", regarding all provisions - Issues related to 340B - Issues related to HIV vaccines - S. 2852, "Pandemic & All Hazards Preparedness and Advancing Innovations Act of 2018", regarding all provisions. - Issues related to reauthorization of the Pandemic All-Hazards Preparedness Act programs. (House version) - HR 5492, "MOTHER Act of 2018", regarding all provisions. - Issues related to access to essential surgery - Issues related to contact lens safety - HR 6, "SUPPORT for Patients and Communities Act", regarding all provisions. - S. 2315, "Over-the-Counter Drug Safety, Innovation, and Reform Act", regarding all provisions. - HR 5333 "Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018", regarding all provisions. - Issues related to antimicrobial resistance - Issues related to regulations on medication product packaging - H.R. 6294, " Re-Valuing Anti-Microbial Products Act of 2018", regarding all provisions
Client expense: $1,980,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, Veterans Affairs, Dept of (VA), White House Office
2018 · third_quarter · Health Issues
H.R. 6294, the Re-Valuing Anti-Microbial Products Act of 2018
Client expense: Not reported · Firm income: Not reported
2018 · 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 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. 6378 - To reauthorize certain programs under the Pandemic and All-Hazards Preparedness Reauthorization Act 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, reimbursement, step therapy, anti-kickback statute, biosimilars 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: $1,370,000 · 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 · third_quarter · Health Issues
General health care coverage and reimbursement; issues related to infectious disease drug development and procurement; legislative and regulatory issues related to biodefense countermeasure development and procurement; development of policies to advance the antimicrobial research and development environment. Support for H.R. 6294 - REVAMP Act.
Client expense: Not reported · Firm income: $30,000
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
2018 · third_quarter · Health Issues
Affordable Care Act (ACA); ACA Regulations; ACA Stabilization; Health Reform; Rural Healthcare; Risk Adjustment; State Flexibility; Point of Sale; Fall Priorities; Opioids; Sober Homes; Marketplace Stability; Individual Market Reform; TCPA (Robocalls); FAA (Air Ambulance); CREATES Act; Sec. 1332 Waivers; Short Term Limited Duration (STLD): AHPs; Value-based Care; Health Care Costs; Mental Health; Small Business Plans; Single Payer; Reinsurance; CSRs; SNPs; Health Savings Accounts (HSAs); Postal Reform; 42 CFR Part 2; Transparency; HR 4 FAA Reauthorization Act of 2018 Introduced April 13, 2018 by Bill Shuster (R-PA) Air Ambulance HR 6 SUPPORT for Patients and Communities Act Introduced June 13, 2018 by Greg Walden (R-OR) includes Medicaid, Medicare, and public health reforms to combat the opioid crisis by advancing treatment and recovery initiatives, improving prevention, protecting communities, and bolstering efforts to combat illicit synthetic drugs like fentanyl. The policies contained in the legislation were advanced through regular order by the House Energy and Commerce Committee and the Ways and Means Committee. HR 2051 FAST Generics Act Introduced April 6, 2017 by David McKinley (R-WV) 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. HR 2212 CREATES Act Introduced April 27, 2017 by Tom Marino (R-PA) 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. HR 3325 ACE Kids Act Introduced July 20, 2017 by Joe Barton (R-TX) To amend title XIX of the Social Security Act to provide States with the option of providing coordinated care for children with complex medical conditions through a health home, and for other purposes. HR 6082 Overdose Prevention and Patient Safety Act Introduced June 13, 2018 by Markwayne Mullin (R-OK) Amends the Public Health Service Act to permit substance use disorder (SUD) records to be shared among covered entities and Part 2 programs in accordance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA), for the purposes of treatment, payment, and healthcare operations. In order to protect individuals seeking and receiving SUD treatment, the bill enhances the protections on the disclosure of SUD treatment records to non-covered entities and non-Part 2 programs by, except for authorization by court order or by consent of the patient, prohibiting the use of these records in any criminal, civil, or administrative investigations, actions, or proceedings. The legislation increases the penalties in the event of unlawful disclosure of SUD treatment records and establishes breach notification requirements in accordance with the Health Information Technology for Economic and Clinical Health (HITECH) Act. Finally, the bill requires the Secretary of Health and Human Services to issue regulations prohibiting discrimination based on data disclosed from such medical records, to issue regulations requiring covered entities to provide written notice of privacy practices, and to develop model training programs and materials for health care providers and patients and their families. HR 6294 REVAMP Act Introduced June 28, 2018 by John Shimkus (R-IL) To amend the Federal Food, Drug, and Cosmetic Act to encourage the development of priority antimicrobial products through the award of a transferable exclusivity extension period, and for other purposes. HR 6733 Know the Cost Act of 2018 Introduced September 7, 2018 by Buddy Carter (R-GA) 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. S 974 Creating and Restoring Equal Access to Equivalent Samples Act of 2018 Introduced April 27, 2017 by Patrick Leahy (D-VT). 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. S 1354 Individual Health Insurance Marketplace Improvement Act introduced June 14, 2017 by Thomas Carper (D-DE) A bill to establish an Individual Market Reinsurance fund to provide funding for State individual market stabilization reinsurance programs.
Client expense: $1,700,000 · 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), Office of the Vice President of the United States, SENATE, Vice President of the U.S., White House Office
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 · Health Issues
Affordable Care Act (ACA) Regulations; ACA Stabilization; Health Reform; Risk Adjustment; State Flexibility; Opioids; Sober Homes, Marketplace Stability; Individual Market Reform; FAA (Air Ambulance); CREATES Act; Section 1332 Waivers; Short Term Limited Duration Insurance (STLDI); Association Health Plans (AHPs); Value-based Care; Health Care Costs; Mental Health; Single Payer; Reinsurance; Cost Sharing Reductions (CSRs); Health Savings Accounts (HSAs) HR 4 Introduced April 13, 2018 by Bill Shuster (R-PA). The FAA Reauthorization Act of 2018 includes several provisions addressing air ambulance issues. The bill would establish an Advisory Committee on Air Ambulance and Patient Billing (including representatives of health insurance providers and other stakeholders) to make recommendations on the disclosure of charges and fees for air ambulance services and insurance coverage, consumer protections, the enforcement authorities of both the Department of Transportation and state authorities, and the prevention of balance billing to consumers; direct the Secretary of Transportation to consider the Advisory Committees recommendations and then issue regulations or guidance on specific issues, including consumer protections for customers of air ambulance providers; and provide an avenue through which consumers may submit complaints to the Secretary of Transportation about unfair and deceptive practices or unfair methods of competition by air ambulances. HR 6 Introduced June 13, 2018 by Greg Walden (R-OR). The SUPPORT for Patients and Communities Act includes Medicaid, Medicare, and public health reforms to combat the opioid crisis by advancing treatment and recovery initiatives, improving prevention, protecting communities, and bolstering efforts to combat illicit synthetic drugs like fentanyl. The policies contained in the legislation were advanced through regular order by the House Energy and Commerce Committee and the Ways and Means Committee. HR 2051 Introduced April 6, 2017 by David McKinley (R-WV). The FAST Generics Act amends 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. HR 2212 Introduced April 27, 2017 by Tom Marino (R-PA). The CREATES Act promotes 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. HR 3325 Introduced July 20, 2017 by Joe Barton (R-TX). This bill amends title XIX of the Social Security Act to provide states with the option of providing coordinated care for children with complex medical conditions through a health home, and for other purposes. HR 6082 Introduced June 13, 2018 by Markwayne Mullin (R-OK). The Overdose Prevention and Patient Safety Act amends the Public Health Service Act to permit substance use disorder (SUD) records to be shared among covered entities and Part 2 programs in accordance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA), for the purposes of treatment, payment, and healthcare operations. In order to protect individuals seeking and receiving SUD treatment, the bill enhances the protections on the disclosure of SUD treatment records to non-covered entities and non-Part 2 programs, except for authorization by court order or by consent of the patient, by prohibiting the use of these records in any criminal, civil, or administrative investigations, actions, or proceedings. The legislation increases the penalties in the event of unlawful disclosure of SUD treatment records and establishes breach notification requirements in accordance with the Health Information Technology for Economic and Clinical Health (HITECH) Act. Finally, the bill requires the Secretary of Health and Human Services to issue regulations prohibiting discrimination based on data disclosed from such medical records, to issue regulations requiring covered entities to provide written notice of privacy practices, and to develop model training programs and materials for health care providers and patients and their families. HR 6294 Introduced June 28, 2018 by John Shimkus (R-IL). The REVAMP Act would amend the Federal Food, Drug, and Cosmetic Act to encourage the development of priority antimicrobial products through the award of a transferable exclusivity extension period, and for other purposes. HR 6733 Introduced September 7,2018 by Buddy Carter (R-GA). The Know the Cost Act of 2018 amends 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. S 974 Introduced April 27, 2017 by Patrick Leahy (D-VT). The Creating and Restoring Equal Access to Equivalent Samples Act of 2018 promotes 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. S 1354 Introduced June 14, 2017 by Thomas Carper (D-DE). The Individual Health Insurance Marketplace Improvement Act would establish an individual market reinsurance fund to provide funding for state individual market stabilization reinsurance programs.
Client expense: $300,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE
2018 · third_quarter · Pharmacy
S. 2852/HR 3678-Pandemic and all-hazards preparedness and advancing innovation act of 2018, HR 6294-REVAMP Act, Medicare Part D negotiation, prescription drug pricing, HR 6505-Medicare negotiation and competitive licensing act, HR 6577-PRICED act, HR 6576-Drug Price Transparency in Communications act, medicare prescription drug savings and choice act, HR 1223/S 1509 OPEN Act, S 1369-Stop Price gouging act.
Client expense: $50,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Office of Government Ethics (OGE), SENATE, Securities & Exchange Commission (SEC), U.S. Trade Representative (USTR)
2018 · third_quarter · Health Issues
Issues related to P.L. 96-517, the Bayh-Dole Act; issues related to drug pricing; issues related to Medicare Part D Coverage; HR 6505 Medicare Negotiation and Compulsory Act; HR 6294 REVAMP Act; Conference report to HR 6157.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · second_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. 878: Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness 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. 2212: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 2851: Stop Importation and Trafficking of Synthetic Analogues (SITSA) Act - Provisions related to controlled substances H.R. 4710: 340B Protecting Access for the Underserved and Safety-net Entities Act or PAUSE Act - Provisions related to the 340B program HR 4993 Vaccine Access Improvement Act HR 4297/S 2103 Protecting Seniors Through Immunization Act 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. 5687: SOUND Disposal and Packaging Act - To require improved packaging and disposal methods with respect to certain drugs H.R. 6142: Reducing Drug Waste Act of 2018 - Action plan and report on vial size waste HR 6378/S 2852 Pandemic and All Hazards Preparedness Act reauthorization HR 6294 REVAMP 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. 974: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 1327: SITSA Act - Provisions related to controlled substances 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 Drug cost and pricing policy issues Transparency policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues Risk Evaluation and Mitigation Strategy (REMS) policy issues FDA modernization policy issues 340B drug discount program policy issues 21st Century Cures Act (Public Law 114-255) - Provisions related to biopharmaceutical discovery, development, delivery, and transparency Senate HELP Committee Innovation Agenda - Provisions related to biopharmaceutical discovery and development of FDA policy TRICARE pharmacy pilot program 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) Pandemic and All-Hazards Preparedness Act, provisions related to emerging infectious diseases and antimicrobial resistance. HR 6 - SUPPORT for Patients and Communities Act HR 5687 - SOUND Disposal and Packaging ActHR 5333 - Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018 S 2315 - Over-the-Counter Drug Safety, Innovation, and Reform ActHR 394/S 85 - Restoring Access to Medication Act of 2017 HR 6199 - To amend the Internal Revenue Code of 1986 to include certain over-the-counter medical products as qualified medical expenses. HR 6157 - FY19 Defense Appropriations ActS 3159 - FY19 Defense Appropriations ActS 3158 - FY19 Labor-HHS-Education Appropriations ActHouse Draft - FY19 Labor-HHS-Education Appropriations ActPatient Access in Medicaid program340B Discount Drug ProgramHR 4710 - 340B PAUSE ActHR 5598 - 340B Optimization Act HR 5958 - Phair Pricing Act of 2018
Client expense: $1,400,000 · 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), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE
2018 · second_quarter · Health Issues
Value of Prescription Drugs, Senate & House; Issues related to march-in rights under Bayh-Dole Act (Pub. L. 96-517); PAHPA (S. 2852/H.R. 6378) Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018; REVAMP (H.R. 6294) Re-Valuing Anti-Microbial Products Act of 2018.
Client expense: $490,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · 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 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 Issues related to public health protection including influenza development and preparedness
Client expense: $1,530,000 · 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 · second_quarter · Health Issues
General health care coverage and reimbursement; issues related to infectious disease drug development and procurement; legislative and regulatory issues related to biodefense countermeasure development and procurement; development of policies to advance the antimicrobial research and development environment. Support for H.R. 6294 - REVAMP Act.
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · second_quarter · Health Issues
Development of policies to advance the antimicrobial research and novel product development environment, including advancing new market incentives. Support for H.R. 6294 - REVAMP Act. Support for antimicrobial incentives to be included in S. 2852 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE