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Reported covered position: Chief of Staff/LD, Rep. Charles Bass; Chief of Staff, Dan Benishek; Policy Advisor, Rep. Mark Kirk
How to read the money
Income and expense are whole-filing amounts associated with this lobbyist, not personal compensation or an allocated share.
No topic inference: each bill number appears in source LDA issue text assigned to this lobbyist.
OPEN Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
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.
Specific issues are shown only where the LDA source assigned them to this lobbyist. Targets apply to the associated filing.
ASSOCIATION FOR ACCESSIBLE MEDICINES via ASSOCIATION FOR ACCESSIBLE MEDICINES
2017 · third_quarter · Q3
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.
Source: Senate LDA
Affordable and Safe Prescription Drug Importation Act
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.2841: FAST Generics Act of 2015. 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. S.3056: CREATES Act of 2016. 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. Drug Importation. H.R.2430/S.934: FDA Reauthorization Act of 2017. FDA Commissioner Nomination.
Affordable and Safe Prescription Drug Importation Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
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.
FAST Generics Act of 2017
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
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.2841: FAST Generics Act of 2015. 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. S.3056: CREATES Act of 2016. 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. Drug Importation. H.R.2430/S.934: FDA Reauthorization Act of 2017. FDA Commissioner Nomination.
FAST Generics Act of 2017
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
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.
CREATES Act of 2017
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
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.2841: FAST Generics Act of 2015. 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. S.3056: CREATES Act of 2016. 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. Drug Importation. H.R.2430/S.934: FDA Reauthorization Act of 2017. FDA Commissioner Nomination.
CREATES Act of 2017
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
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.
FDA Reauthorization Act of 2017
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
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.2841: FAST Generics Act of 2015. 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. S.3056: CREATES Act of 2016. 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. Drug Importation. H.R.2430/S.934: FDA Reauthorization Act of 2017. FDA Commissioner Nomination.
FDA Reauthorization Act of 2017
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
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.
Making Pharmaceutical Markets More Competitive Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
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.
Making Pharmaceutical Markets More Competitive Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
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.2841: FAST Generics Act of 2015. 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. S.3056: CREATES Act of 2016. 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. Drug Importation. H.R.2430/S.934: FDA Reauthorization Act of 2017. FDA Commissioner Nomination.
Lower Drug Costs through Competition Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
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.
Lower Drug Costs through Competition Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
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.2841: FAST Generics Act of 2015. 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. S.3056: CREATES Act of 2016. 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. Drug Importation. H.R.2430/S.934: FDA Reauthorization Act of 2017. FDA Commissioner Nomination.
Making Pharmaceutical Markets More Competitive Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
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.2841: FAST Generics Act of 2015. 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. S.3056: CREATES Act of 2016. 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. Drug Importation. H.R.2430/S.934: FDA Reauthorization Act of 2017. FDA Commissioner Nomination.
Making Pharmaceutical Markets More Competitive Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
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.
Preserve Access to Affordable Generics Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
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.
Preserve Access to Affordable Generics Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
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.2841: FAST Generics Act of 2015. 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. S.3056: CREATES Act of 2016. 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. Drug Importation. H.R.2430/S.934: FDA Reauthorization Act of 2017. FDA Commissioner Nomination.
STRONGER Patents Act of 2017
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Inter Partes Review (IPR) process. Patent Settlements. S.1390: STRONGER Patents Act of 2017.
Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
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.
Increasing Competition in Pharmaceuticals Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
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.
Increasing Competition in Pharmaceuticals Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
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.2841: FAST Generics Act of 2015. 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. S.3056: CREATES Act of 2016. 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. Drug Importation. H.R.2430/S.934: FDA Reauthorization Act of 2017. FDA Commissioner Nomination.
Affordable and Safe Prescription Drug Importation Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
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.2841: FAST Generics Act of 2015. 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. S.3056: CREATES Act of 2016. 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. Drug Importation. H.R.2430/S.934: FDA Reauthorization Act of 2017. FDA Commissioner Nomination.
Affordable and Safe Prescription Drug Importation Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
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.
Improving Access To Affordable Prescription Drugs Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
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.
Improving Access To Affordable Prescription Drugs Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
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.2841: FAST Generics Act of 2015. 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. S.3056: CREATES Act of 2016. 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. Drug Importation. H.R.2430/S.934: FDA Reauthorization Act of 2017. FDA Commissioner Nomination.
FDA Reauthorization Act of 2017
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
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.
FDA Reauthorization Act of 2017
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
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.2841: FAST Generics Act of 2015. 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. S.3056: CREATES Act of 2016. 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. Drug Importation. H.R.2430/S.934: FDA Reauthorization Act of 2017. FDA Commissioner Nomination.
Creating and Restoring Equal Access to Equivalent Samples Act of 2018
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
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.
Creating and Restoring Equal Access to Equivalent Samples Act of 2018
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
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.2841: FAST Generics Act of 2015. 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. S.3056: CREATES Act of 2016. 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. Drug Importation. H.R.2430/S.934: FDA Reauthorization Act of 2017. FDA Commissioner Nomination.
A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018 through 2026.
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
FDA Funding. S.2956: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. H.R.5054: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. S.Con.Res.3: A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018 through 2026. H.R.3354: Department of the Interior, Environment, and Related Agencies Appropriations Act, 2018.
A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018 through 2026.
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
FDA Funding. S.2956: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. H.R.5054: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. S.Con.Res.3: A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018 through 2026.
Bipartisan Budget Act of 2015
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
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.2841: FAST Generics Act of 2015. 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. S.3056: CREATES Act of 2016. 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. Drug Importation. H.R.2430/S.934: FDA Reauthorization Act of 2017. FDA Commissioner Nomination.
Bipartisan Budget Act of 2015
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
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.
FAST Generics Act of 2015
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
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.2841: FAST Generics Act of 2015. 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. S.3056: CREATES Act of 2016. 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. Drug Importation. H.R.2430/S.934: FDA Reauthorization Act of 2017. FDA Commissioner Nomination.
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
FDA Funding. S.2956: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. H.R.5054: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. S.Con.Res.3: A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018 through 2026.
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
FDA Funding. S.2956: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. H.R.5054: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. S.Con.Res.3: A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018 through 2026. H.R.3354: Department of the Interior, Environment, and Related Agencies Appropriations Act, 2018.
Fair Accountability and Innovative Research Drug Pricing Act of 2016
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
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.2841: FAST Generics Act of 2015. 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. S.3056: CREATES Act of 2016. 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. Drug Importation. H.R.2430/S.934: FDA Reauthorization Act of 2017. FDA Commissioner Nomination.
Fair Accountability and Innovative Research Drug Pricing Act of 2016
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
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.
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
FDA Funding. S.2956: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. H.R.5054: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. S.Con.Res.3: A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018 through 2026.
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
FDA Funding. S.2956: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. H.R.5054: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. S.Con.Res.3: A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018 through 2026. H.R.3354: Department of the Interior, Environment, and Related Agencies Appropriations Act, 2018.
CREATES Act of 2016
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
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.2841: FAST Generics Act of 2015. 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. S.3056: CREATES Act of 2016. 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. Drug Importation. H.R.2430/S.934: FDA Reauthorization Act of 2017. FDA Commissioner Nomination.
Fair Accountability and Innovative Research Drug Pricing Act of 2016
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
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.2841: FAST Generics Act of 2015. 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. S.3056: CREATES Act of 2016. 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. Drug Importation. H.R.2430/S.934: FDA Reauthorization Act of 2017. FDA Commissioner Nomination.
Fair Accountability and Innovative Research Drug Pricing Act of 2016
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
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.
General Trade Issues. Trans-Pacific Partnership (TPP). Transatlantic Trade and Investment Partnership (TTIP). Biologic Exclusivity. North American Free Trade Agreement.
FDA Funding. S.2956: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. H.R.5054: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. S.Con.Res.3: A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018 through 2026. H.R.3354: Department of the Interior, Environment, and Related Agencies Appropriations Act, 2018.
Taxation Issues Related to Opioid Pharmaceuticals. User Fee Programs.
Medicare Part D Program and Generic Drugs. Medicare reimbursement for biosimilars. Medicaid Rebate Penalty. Medicare Part D Low Income Subsidy (LIS) Program.
Inter Partes Review (IPR) process. Patent Settlements. S.1390: STRONGER Patents Act of 2017.
Filing 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)
ASSOCIATION FOR ACCESSIBLE MEDICINES via ASSOCIATION FOR ACCESSIBLE MEDICINES
2017 · first_quarter · RA
*Please see the current quarterly report for full details of specific lobbying issues.
*Please see the current quarterly report for full details of specific lobbying issues.
*Please see the current quarterly report for full details of specific lobbying issues.
*Please see the current quarterly report for full details of specific lobbying issues.
*Please see the current quarterly report for full details of specific lobbying issues.
*Please see the current quarterly report for full details of specific lobbying issues.
ASSOCIATION FOR ACCESSIBLE MEDICINES via ASSOCIATION FOR ACCESSIBLE MEDICINES
2017 · second_quarter · Q2
General Trade Issues. Trans-Pacific Partnership (TPP). Transatlantic Trade and Investment Partnership (TTIP). Biologic Exclusivity. USTR Confirmation. North American Free Trade Agreement.
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.2841: FAST Generics Act of 2015. 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. S.3056: CREATES Act of 2016. 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. Drug Importation. H.R.2430/S.934: FDA Reauthorization Act of 2017. FDA Commissioner Nomination.
Inter Partes Review (IPR) process. Patent Settlements.
Medicare Part D Program and Generic Drugs. Medicare reimbursement for biosimilars. Medicaid Rebate Penalty. Medicare Part D Low Income Subsidy (LIS) Program.
Taxation Issues Related to Opioid Pharmaceuticals. User Fee Programs.
FDA Funding. S.2956: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. H.R.5054: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. S.Con.Res.3: A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018 through 2026.
Filing 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)