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Legislative Progress
Momentum (last 30 days)
0
score
0 actions · 0 new cosponsors · 0 votes
Speed vs cohort
49pct
4d open
vs 7,393 other HR bills in the 115th — cohort avg 50d
Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017 or the OPEN Act This bill amends the Federal Food, Drug, and Cosmetic Act to require the Department of Health and Human Services (HHS) to extend by six months the exclusivity period for a drug or biological product approved by the Food and Drug Administration (FDA) when the product is additionally approved to prevent, diagnose, or treat a new indication that is a rare disease or condition (also known as an orphan disease). HHS may revoke an extension if the application submitted to the FDA for the new indication contained an untrue material statement. HHS must notify the public of products that receive this extension and patents related to those products. Products may receive only one extension under this bill. Extensions under this bill are in addition to other extensions. The bill applies only to products approved after enactment of this bill for a new indication that is a rare disease or condition.
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 (8)
Referred to the Subcommittee on Health.
Referred to the House Committee on Energy and Commerce.
Introduced in House
Congress.gov source codes: 1000, Intro-H
Bills with similar content found using semantic analysis.
Sources: Congress.gov
2018 · third_quarter · Pharmacy
Pharmaceutical issues impacting patients with rare diseases. H.R.1223/S.1509: Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017. Patient-focused drug development. Biological products marketplace. HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs.
Client expense: $70,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE
2018 · second_quarter · Pharmacy
Pharmaceutical issues impacting patients with rare diseases. Orphan Drug Act. H.R.1223/S.1509: Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017. Accelerated Approval. S.3000: Patient Advocacy Transparency Act. HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs.
Client expense: $60,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE
2018 · first_quarter · Pharmacy
Pharmaceutical issues impacting patients with rare diseases. Orphan Drug Act. H.R.1223/S.1509: Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017. H.R.5062: Advancing Access to Precision Medicine Act.
Client expense: $60,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE
2018 · fourth_quarter · Pharmacy
Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. S.3519: MODERN Labeling Act. Drug Compounding. Drug Shortages. Biosimilars Naming. Pass Through Payments for Biosimilars. Prescription Drug Costs. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. S.3792: Preserve Access to Affordable Generics and Biosimilars Act. H.R.449: Synthetic Drug Awareness Act of 2018. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Pharmaceutical Exclusivity. H.R.6577: PRICED Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. H.R.7348/S.3775: Affordable Drug Manufacturing Act of 2018. H.R.2212/S.974: CREATES Act of 2017. H.R.5002: Advancing Cutting Edge Research Act. H.R.2439/S.1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. S.3680: Low Drug Prices Act. Public Law 115-52: FDA Reauthorization Act of 2017. H.R.1223/S.1509: Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017. H.R.6: SUPPORT for Patients and Communities Act.
Client expense: $1,570,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR)
2018 · fourth_quarter · Health Issues
Issues pertaining to accelerating the drug approval process for ultra rare diseases [Orphan Product Extensions Now Accelerating Cures & Treatments - OPEN ACT (H.R. 1223/S.1509) -- all provisions
Client expense: Not reported · Firm income: $20,000
Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, SENATE
2018 · third_quarter · Pharmacy
Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. S.3519: MODERN Labeling Act. Drug Compounding. Biosimilars Naming. Pass Through Payments for Biosimilars. Prescription Drug Costs. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.449: Synthetic Drug Awareness Act of 2018. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. H.R.6577: PRICED Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. H.R.2212/S.974: CREATES Act of 2017. H.R.5002: Advancing Cutting Edge Research Act. H.R.2439/S.1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Public Law 115-52: FDA Reauthorization Act of 2017. H.R.1223/S.1509: Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017. Discussion Draft of H.R.__, Packaging and Disposal. H.R.6: SUPPORT for Patients and Communities Act.
Client expense: $870,000 · Firm income: Not reported
2018 · second_quarter · Pharmacy
Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Drug Compounding. Biosimilars Naming. Pass Through Payments for Biosimilars. Prescription Drug Costs. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.449: Synthetic Drug Awareness Act of 2018. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. H.R.2212/S.974: CREATES Act of 2017. H.R.5002: Advancing Cutting Edge Research Act. H.R.2439/S.1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Public Law 115-52: FDA Reauthorization Act of 2017. H.R.1223/S.1509: Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017. Discussion Draft of H.R.__, FDA Accelerated Approval and Breakthrough Therapy Status. Discussion Draft of H.R.__, FDA and International Mail. Discussion Draft of H.R.__, Opioid Sparing. Discussion Draft of H.R.__, Packaging and Disposal. Discussion Draft of H.R.__, Long-term Efficiency. Discussion Draft of H.R.__, Misuse/Abuse.
Client expense: $900,000 · Firm income: Not reported
2018 · first_quarter · Pharmacy
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Drug Compounding. Biosimilars Naming. Pass Through Payments for Biosimilars. Prescription Drug Costs. Opioid abuse. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. H.R.1892: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. H.R.2212/S.974: CREATES Act of 2017. H.R.2439/S.1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. H.R.2430/S.934: FDA Reauthorization Act of 2017. H.R.1223/S.1509: Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017. Discussion Draft of H.R.__, FDA Accelerated Approval and Breakthrough Therapy Status. Discussion Draft of H.R.__, FDA and International Mail. Discussion Draft of H.R.__, Opioid Sparing. Discussion Draft of H.R.__, Packaging and Disposal. Discussion Draft of H.R.__, Long-term Efficiency. Discussion Draft of H.R.__, Misuse/Abuse.
Client expense: $1,040,000 · Firm income: Not reported
2018 · third_quarter · Pharmacy
Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. S.3519: MODERN Labeling Act. Drug Compounding. Biosimilars Naming. Pass Through Payments for Biosimilars. Prescription Drug Costs. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.449: Synthetic Drug Awareness Act of 2018. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. H.R.6577: PRICED Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. H.R.2212/S.974: CREATES Act of 2017. H.R.5002: Advancing Cutting Edge Research Act. H.R.2439/S.1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Public Law 115-52: FDA Reauthorization Act of 2017. H.R.1223/S.1509: Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017. Discussion Draft of H.R.__, Packaging and Disposal. H.R.6: SUPPORT for Patients and Communities Act.
Client expense: $860,000 · Firm income: Not reported
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 pertaining to accelerating the drug approval process for ultra rare diseases [Orphan Product Extensions Now Accelerating Cures & Treatments - OPEN ACT (H.R. 1223/S.1509) -- all provisions
Client expense: Not reported · Firm income: $20,000
Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, SENATE
2018 · second_quarter · Pharmacy
Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Drug Compounding. Biosimilars Naming. Pass Through Payments for Biosimilars. Prescription Drug Costs. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.449: Synthetic Drug Awareness Act of 2018. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. H.R.2212/S.974: CREATES Act of 2017. H.R.5002: Advancing Cutting Edge Research Act. H.R.2439/S.1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Public Law 115-52: FDA Reauthorization Act of 2017. H.R.1223/S.1509: Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017. Discussion Draft of H.R.__, FDA Accelerated Approval and Breakthrough Therapy Status. Discussion Draft of H.R.__, FDA and International Mail. Discussion Draft of H.R.__, Opioid Sparing. Discussion Draft of H.R.__, Packaging and Disposal. Discussion Draft of H.R.__, Long-term Efficiency. Discussion Draft of H.R.__, Misuse/Abuse.
Client expense: $800,000 · Firm income: Not reported
2018 · second_quarter · Health Issues
Issues pertaining to accelerating the drug approval process for ultra rare diseases [Orphan Product Extensions Now Accelerating Cures & Treatments - OPEN ACT (H.R. 1223/S.1509) -- all provisions
Client expense: Not reported · Firm income: $20,000
Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, SENATE
2018 · first_quarter · Health Issues
Bipartisan Health Care Stabilization Act Medicare Part D Right to Try Act; H.R.5247, S.204 Rare disease Advancement, Research, and Education Act of 2018; H.R.5115 National Institutes of Health Funding Food and Drug Administration Funding Orphan Drug Act Medical Nutrition Equity Act; H.R.2587, S.1194 Advancing Care for Exceptional Kids Act; S.428 Pediatric Device Consortia Grant Program Congressionally Directed Medical Research Program Rare Disease Day Resolution; S.Res.423 Short-term, limited-duration health plans Association health plans OPEN Act; H.R.1223, S.1509 Advancing Access to Precision Medicine Act of 2018; H.R.5062 Restoring the Patient's Voice Act of 2017; H.R.2077
Client expense: Not reported · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE
2018 · first_quarter · Pharmacy
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Drug Compounding. Biosimilars Naming. Pass Through Payments for Biosimilars. Prescription Drug Costs. Opioid abuse. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. H.R.1892: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. H.R.2212/S.974: CREATES Act of 2017. H.R.2439/S.1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. H.R.2430/S.934: FDA Reauthorization Act of 2017. H.R.1223/S.1509: Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017. Discussion Draft of H.R.__, FDA Accelerated Approval and Breakthrough Therapy Status. Discussion Draft of H.R.__, FDA and International Mail. Discussion Draft of H.R.__, Opioid Sparing. Discussion Draft of H.R.__, Packaging and Disposal. Discussion Draft of H.R.__, Long-term Efficiency. Discussion Draft of H.R.__, Misuse/Abuse.
Client expense: $970,000 · Firm income: Not reported
2018 · first_quarter · Health Issues
Issues pertaining to accelerating the drug approval process for ultra rare diseases [Orphan Product Extensions Now Accelerating Cures & Treatments - OPEN ACT (H.R. 1223/S.1509) -- all provisions
Client expense: Not reported · Firm income: $20,000
Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, SENATE
2018 · first_quarter · Pharmacy
S. 771/HR 1776-Improving access to affordable Prescription Drugs act, S 2157-Drug Price transparency in Communications Act, S 2011/HR 4138-Medicare drug price negotiation act of 2017, S 1688-Empowering medicare seniors to negotiate drug prices of 2017, S 252-Medicare drug savings act of 2017, S 1369/HR 2974-Stop Price gouging act, S 124-Preserve access to affordable generics act, S 974/HR 2212-CREATES Act of 2017, S 495-Medical Innovation and Prize Fund Act, S 1131/HR 2439-FAIR drug pricing act, Over-the-counter Monograph Safety, Innovation, and Reform Act of 2018, HR 4117-Competitive DRUGS Act of 2017), HR 2051- FAST Generics Act of 2017), Prescription drug pricing, PACED Act, S 771/HR 1776 (Improving access to affordable prescription drugs act, S 1509/HR 1223 OPEN Act), S 1309-Stronger patents act, HR 5150 Protecting Medicare from excessive price increases act, S 2476-Expanding access to low cost generics act, S 637 (c-thru act), S 1348-SPIKE act,
Client expense: $60,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Labor, Dept of (DOL), SENATE, Securities & Exchange Commission (SEC), U.S. Trade Representative (USTR)
2017 · fourth_quarter · Pharmacy
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. H.R.1314: Bipartisan Budget Act of 2015. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. H.R.2212/S.974: CREATES Act of 2017. H.R.2439/S.1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. H.R.2430/S.934: FDA Reauthorization Act of 2017. H.R.1223/S.1509: Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017.
Client expense: $1,290,000 · Firm income: Not reported
2017 · fourth_quarter · Pharmacy
S 771/HR1776-Improving access to affordable prescription drugs act, S 2011/HR 4138-Medicare Price Negotiation Act of 2017, S 252-Medicare Drug Savings Act of 2017, S 1369/HR 2974-Stop Price Gouging Act, S 124-Preserve access to affordable generics act, HR 4117-Competitive DRUGS Act of 2017, S 974/HR 2212-CREATES act of 2017, HR 2051-FAST generics Act of 2017, S 495-Medicare Innovation Prize Fund Act, S 1131.HR 2439-FAIR Drug Pricing act, HR 4116-Transparent Drug Pricing Act of 2017, S 1509-Orphan Products extension accelerating cures and treatments, HR 1223-OPEN act, S 1390-Stronger Patriots Act of 2017, S 1827-KIDS Act of 2017, HR 1628-American Health care act of 2017, HR 3921-Healthy KIDS Act, HR 4116-Transparent drug pricing act of 2017, Bipartisan Health Care Stabilization Act of 2017, biologic market exclusivity, inter partes review, direct to consumer advertising, Over-the-counter Monograph Safety Innovation and Reform act of 2017, Azar HHS nomination,
Client expense: $70,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Education, Dept of, Federal Communications Commission (FCC), HOUSE OF REPRESENTATIVES, Office of Government Ethics (OGE), SENATE, Securities & Exchange Commission (SEC), U.S. Trade Representative (USTR), White House Office
2017 · fourth_quarter · Health Issues
Issues pertaining to accelerating the drug approval process for ultra rare diseases [Orphan Product Extensions Now Accelerating Cures & Treatments - OPEN ACT (H.R. 1223/S.1509) -- all provisions
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2017 · third_quarter · Pharmacy
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. H.R.1314: Bipartisan Budget Act of 2015. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. H.R.2212/S.974: CREATES Act of 2017. H.R.6043/S.3335: Fair Accountability and Innovative Research Drug Pricing Act of 2016. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. H.R.2430/S.934: FDA Reauthorization Act of 2017. H.R.1223/S.1509: Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017.
Client expense: $660,000 · Firm income: Not reported
2017 · third_quarter · Health Issues
Issues pertaining to accelerating the drug approval process for ultra rare diseases [Orphan Product Extensions Now Accelerating Cures & Treatments - OPEN ACT (H.R. 1223/S.1509) -- all provisions
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2017 · third_quarter · Health Issues
Single Payer Health Care, S 934/HR 2430-FDA re-authorization Act of 2017, S 974/HR 2212-CREATES Act, S 771/HR 1776-Improving access to affordable prescription drugs act, S 204-Trickett Wendler Right to try act of 2017, S 1509/HR 1223-OPEN act, S 1369/HR 2974-Stop Price Gouging Act,
Client expense: $70,000 · Firm income: Not reported
Government targets: Consumer Product Safety Commission (CPSC), Federal Communications Commission (FCC), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, SENATE, Securities & Exchange Commission (SEC), U.S. Trade Representative (USTR)
2017 · third_quarter · Pharmacy
S 934/HR 2430-FDA re-authorization Act of 2017, S 974/HR 2212-CREATES Act, S 771/HR 1776-Improving access to affordable prescription drugs act, S 204-Trickett Wendler Right to try act of 2017, S 1509/HR 1223-OPEN act, S 1369/HR 2974-Stop Price Gouging Act, Preserve access to affordable generics act, HR 205-to amend the Food, Drug & Cosmetic Act to require labeling of genetically engineered fish, S 495-Medicaid Innovation Price Fund Act, S 252-Medicaid Drug Savings Act of 2017,S 1131/HR 2439-Fair Accountability and Innovative Research Drug Pricing Act of 2017, HR 1628-American Health Care Act of 2017, S 297-Increasing Competition in Pharmaceuticals Act, HR 749 Lower drugs through Competition act, S 1390-stronger patents act of 2017, S 168/HR 3536-A bill to require persons who undertake federally funded research and development of drugs to enter into reasonable pricing agreements with Secretary of HHS.
Client expense: $70,000 · Firm income: Not reported
Government targets: Consumer Product Safety Commission (CPSC), Federal Communications Commission (FCC), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, SENATE, Securities & Exchange Commission (SEC), U.S. Trade Representative (USTR)
2017 · third_quarter · Health Issues
Promoting awareness of the biopharmaceutical and medical technology sectors Opposing the imposition of price controls in the Medicare program Generally supporting intellectual property rights Generally supporting the full repeal of the medical device excise tax Supporting improvements to the FDA's medical device inspection process, specifically S. 404 and H 1736 Supporting the OPEN ACT, HR. 1223 and companion legislation in the Senate to be introduced Opposing S. 771 and HR 1776. Supporting the repeal of the Independent Payment Advisory Board, specifically HR 849 and S 251.
Client expense: $59,519 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2017 · second_quarter · Pharmacy
S 297-Increased competition in Pharmaceuticals Act, HR 1703-Medical Prudent Communications Act of 2017, HR 2026- Pharmaceutical Information Exchange Act, S-252-Medicare Drug Savings act of 2017, Right to try legislation, Prescription Drug Importation, and HR 1223-OPEN Act.
Client expense: $100,000 · Firm income: Not reported
Government targets: Consumer Product Safety Commission (CPSC), Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA)
2017 · second_quarter · Health Issues
Issues related to Affordable Care Act repeal and replace; health issues related Zika vaccine development; issues related to H.R. 749 Lower Cost Through Drug Competition Act, ; issues related to drug importation; issues related to H.R. 1245 Affordable and Safe Prescription Drug Importation Act; issues related to S. 64 Safe and Affordable Drugs from Canada Act of 2017; issues related to Over the Counter (OTC) Monograph reform; general issues related to drug pricing; issues related to S.183 Short on Competition Act; issues related to S.934 FDA Reauthorization Act of 2017; issues related to H.R. 2212 CREATES Act of 2017; issues related to H.R. 1231 RACE for Children Act; drug price transparency issues related to H.R. 2439 Fair Accountability and Innovative Research Drug Pricing Act of 2017; drug price transparency related to S. 1131 Fair Accountability and Innovative Research Drug Pricing Act of 2017; issues related to H.R. 1703Medical Product Communications Act of 2017; issues related to H.R. 1148 FAST Act of 2017; issues related to S. 456 RACE for Children Act; issues related to H.R. 2368 Right to Try Act; issues related to H.R. 1223 OPEN Act; issues related to H.R. 2430 FDA Reauthorization Act of 201; issues related to S. 204 Right to Try Act; issues related to H.R. 1480 Safe and Affordable Drugs from Canada Act of 2017; issues related to H.R. 3165 REVAMP Act of 2017 (draft); issues related to H.J. Res. 51 Approving the discontinuation of the process for consideration and automatic implementation of the annual proposal of the Independent Medicare Advisory Board under section 1899A of the Social Security Act; general issues related to the Food and Drug Administration User Fee Reauthorization
Client expense: $740,000 · Firm income: Not reported
2017 · second_quarter · Health Issues
American Health Care Act; H.R.1628 Better Care Reconciliation Act Children's Health Insurance Program Reauthorization Medical Nutrition Equity Act; H.R.2587, S.1194 FDA Reauthorization Act; H.R.2430 FDA Office of Patient Affairs Enhanced Clinical Trial Design Act; S.1048 Orphan Drug Tax Credit Right to Try Act; H.R.878, S.204 OPEN Act; H.R.1223 FDA Funding NIH Funding RACE for Children Act; H.R.1231 Zika Appropriations Newborn Screening Appropriations
Client expense: Not reported · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE, Social Security Administration (SSA), White House Office
2017 · second_quarter · Health Issues
Issues pertaining to accelerating the drug approval process for ultra rare diseases [Orphan Product Extensions Now Accelerating Cures & Treatments - OPEN ACT (H.R. 1223/S.1509) -- all provisions
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2017 · second_quarter · Health Issues
Promoting awareness of the biopharmaceutical and medical technology sectors Opposing the imposition of price controls in the Medicare program Generally supporting intellectual property rights Generally supporting the full repeal of the medical device excise tax Opposing the importation of medicines, specifically HR 1245 and S. 469 Supporting improvements to the FDA's medical device inspection process, specifically S. 404 and H 1736 Supporting the OPEN ACT, HR. 1223 and companion legislation in the Senate to be introduced Opposing S. 771 and HR 1776. Supporting the repeal of the Independent Payment Advisory Board, specifically HR 849 and S 251.
Client expense: $56,199 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2017 · first_quarter · Health Issues
Health care issues affecting individuals with neuromuscular disease, including transitional health care, drug development, and appropriations issues, newborn screening, reauthorization of the Prescription Drug User Fee Act (PDUFA), and health care reform (H.R. 1628, American Health Care Act of 2017) H.R. 1223, Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017 (OPEN Act); S. 486/H.R. 750, Ensuring Access to Quality Complex Rehabilitation Technology Act of 2015; S. 818/H.R. 1896, ABLE to Work Act; S. 816/H.R. 1897, ABLE Financial Planning Act; S. 817/H.R. 1874, ABLE Age Adjustment Act; H.R. 529, 529 and ABLE Account Improvement Act; S. 379/H.R. 1171, ALS Disability Insurance Act
Client expense: $80,000 · Firm income: Not reported
Government targets: Executive Office of the President (EOP), Federal Aviation Administration (FAA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE, Transportation, Dept of (DOT)
2017 · first_quarter · Health Issues
Issues related to access to rare and orphan disease therapeutics under the enactment of ACA (no specific bills); Issues related to FDA regulatory pathways for pharmaceuticals (no specific bills); H.R. 1628 - American Health Care Act of 2017, issues related to the repeal of the Affordable Care Act (ACA); H.R. 1223 - OPEN Act, provisions related to amending the Federal Food, Drug, and Cosmetic Act to authorize extension of exclusivity periods for certain drugs approved for a new indication for a rare disease or condition.
Client expense: $450,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2017 · first_quarter · Health Issues
Issues pertaining to accelerating the drug approval process for ultra rare diseases [Orphan Product Extensions Now Accelerating Cures & Treatments - OPEN ACT (H.R. 1223) -- all provisions
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2017 · first_quarter · Health Issues
American Health Care Act; H.R.1628 Preserving Employee Wellness Act, H.R.1313 Medical Nutrition Equity Act Prescription Drug User Fee Act Reauthorization Medical Device User Fee Act Reauthorization Orphan Drug Tax Credit Right to Try Act; H.R.878, S.204 Pre-existing Conditions Protection Act of 2017; H.R.1121 OPEN Act; H.R.1223 FDA Funding NIH Funding RACE for Children Act; H.R.1231 Zika Appropriations Newborn Screening Appropriations
Client expense: Not reported · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE, Social Security Administration (SSA), White House Office
2017 · first_quarter · Health Issues
Promoting awareness of the biopharmaceutical and medical technology sectors Opposing the imposition of price controls in the Medicare program Generally supporting intellectual property rights Generally supporting the full repeal of the medical device excise tax Opposing the importation of medicines, specifically HR 1245 and S. 469 Supporting improvements to the FDA's medical device inspection process, specifically S. 404 Supporting the OPEN ACT, HR. 1223 and companion legislation in the Senate to be introduced
Client expense: $68,426 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
| Republican |
| VA |
| Bill Posey | Republican | FL |
| Billy Long | Republican | MO |
| Bonnie Watson Coleman | Democratic | NJ |
| Brian K. Fitzpatrick | Republican | PA |
| Carol Shea-Porter | Democratic | NH |
| Cathy McMorris Rodgers | Republican | WA |
| Christopher H. Smith | Republican | NJ |
| Daniel M. Donovan, Jr. | Republican | NY |
| Daniel Webster | Republican | FL |
| Darren Soto | Democratic | FL |
| David E. Price | Democratic | NC |
| David G. Reichert | Republican | WA |
| David Young | Republican | IA |
| Don Bacon | Republican | NE |
| Donald Norcross | Democratic | NJ |
| Eric Swalwell | Democratic | CA |
| Francis Rooney | Republican | FL |
| Fred Upton | Republican | MI |
| G. K. Butterfield | Democratic | NC |
| Jared Huffman | Democratic | CA |
| Jeff Fortenberry | Republican | NE |
| John Abney Culberson | Republican | TX |
| Kathleen M. Rice | Democratic | NY |
| Leonard Lance | Republican | NJ |
| Luke Messer | Republican | IN |
| Markwayne Mullin | Republican | OK |
| Michael T. McCaul | Republican | TX |
| Michelle Lujan Grisham | Democratic | NM |
| Mo Brooks | Republican | AL |
| Pete Olson | Republican | TX |
| Peter J. Roskam | Republican | IL |
| Peter J. Visclosky | Democratic | IN |
| Rodney P. Frelinghuysen | Republican | NJ |
| Steve Stivers | Republican | OH |
| Steven M. Palazzo | Republican | MS |
| Ted Poe | Republican | TX |
| Tim Murphy | Republican | PA |
| Wm. Lacy Clay | Democratic | MO |
| Zoe Lofgren | Democratic | CA |
Government targets: Commerce, Dept of (DOC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)
Government targets: Commerce, Dept of (DOC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR)
Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR)
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE