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Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017
Legislative Progress
Momentum (last 30 days)
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0 actions · 0 new cosponsors · 0 votes
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vs 3,805 other S bills in the 115th — cohort avg 41d
Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017 This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to extend by six months the exclusivity period for an approved drug or biological product 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). The FDA may revoke an extension if the application for the new indication contained an untrue material statement. The FDA must notify the public of products that receive this extension and patents related to those products. Products may receive only one of these extensions. This extension is in addition to other extensions. Only products approved after enactment of this bill for a new indication that is a rare disease or condition are eligible for an extension. For a medication to be approved as an orphan drug with seven years of marketing exclusivity when it is the same medication for the same condition as an already approved orphan drug, the sponsor of the new medication must demonstrate that the new medication is clinically superior to the approved medication. The bill expands to cover brand name drugs provisions that allow generic drugs to be approved and marketed without labeling for pediatric indications when the pediatric indications are protected by patent or marketing exclusivity.
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 (4)
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.
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced in Senate
Bills with similar content found using semantic analysis.
Sources: Congress.gov
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 · 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
| Democratic |
| NJ |
| Tim Scott | Republican | SC |
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)