ALYSON PUSEY

Funding for National Institutes of Health H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014Funding for Centers for Disease Control and Prevention Vaccine Programs Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 Vaccine Access/Financing Tax for Seasonal Influenza Funding H.R. 425/S. 391: A bill to amend the Internal Revenue Code of 1986 to include vaccines against seasonal influenza within the definition of taxable vaccines Adult Immunization Policies Adult Immunization Senate Discussion Draft 340B Drug Pricing Program HRSA Implementation of Program Changes Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Drug Safety and Review Implementation of S. 3187: The Food and Drug Administration Safety and Innovation Act Regulatory Reforms for Innovative Products Expedited Approval Pathways E-Pedigree and Anti-Counterfeiting Supply Chain Integrity Pharmacy Compounding Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 Independent Payment Advisory Board Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development, and Procurement Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 H.R. 307: Pandemic and All-Hazards Preparedness Reauthorization Act Cures Acceleration Network Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Biodefense Research, Development, and Procurement (Non-Funding Issues) H.R. 307: Pandemic and All-Hazards Preparedness Reauthorization Act Reimbursement for Innovative Products Medicare Part D Prescription Drug Program Medicare Part B Physician-Administered Products H.Con.Res. 25: House Budget Resolution (Democratic Caucus Substitute) H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 U.S./European Union High-Level Dialogue on Regulatory IssuesSequestration of PDUFA Fees H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 Implementation of S. 365: Budget Control Act TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuitcalsl Regulatory Transparency

Funding for National Institutes of Health H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014Funding for Centers for Disease Control and Prevention Vaccine Programs Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 Vaccine Access/Financing Tax for Seasonal Influenza Funding H.R. 425/S. 391: A bill to amend the Internal Revenue Code of 1986 to include vaccines against seasonal influenza within the definition of taxable vaccines Adult Immunization Policies Adult Immunization Senate Discussion Draft 340B Drug Pricing Program HRSA Implementation of Program Changes Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Drug Safety and Review Implementation of S. 3187: The Food and Drug Administration Safety and Innovation Act Regulatory Reforms for Innovative Products Expedited Approval Pathways E-Pedigree and Anti-Counterfeiting Supply Chain Integrity Pharmacy Compounding Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 Independent Payment Advisory Board Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development, and Procurement Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 H.R. 307: Pandemic and All-Hazards Preparedness Reauthorization Act Cures Acceleration Network Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Biodefense Research, Development, and Procurement (Non-Funding Issues) H.R. 307: Pandemic and All-Hazards Preparedness Reauthorization Act Reimbursement for Innovative Products Medicare Part D Prescription Drug Program Medicare Part B Physician-Administered Products H.Con.Res. 25: House Budget Resolution (Democratic Caucus Substitute) H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 U.S./European Union High-Level Dialogue on Regulatory IssuesSequestration of PDUFA Fees H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 Implementation of S. 365: Budget Control Act TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuitcalsl Regulatory Transparency

Funding for National Institutes of Health H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014Funding for Centers for Disease Control and Prevention Vaccine Programs Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 Vaccine Access/Financing Tax for Seasonal Influenza Funding H.R. 425/S. 391: A bill to amend the Internal Revenue Code of 1986 to include vaccines against seasonal influenza within the definition of taxable vaccines Adult Immunization Policies Adult Immunization Senate Discussion Draft 340B Drug Pricing Program HRSA Implementation of Program Changes Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Drug Safety and Review Implementation of S. 3187: The Food and Drug Administration Safety and Innovation Act Regulatory Reforms for Innovative Products Expedited Approval Pathways E-Pedigree and Anti-Counterfeiting Supply Chain Integrity Pharmacy Compounding Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 Independent Payment Advisory Board Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development, and Procurement Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 H.R. 307: Pandemic and All-Hazards Preparedness Reauthorization Act Cures Acceleration Network Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Biodefense Research, Development, and Procurement (Non-Funding Issues) H.R. 307: Pandemic and All-Hazards Preparedness Reauthorization Act Reimbursement for Innovative Products Medicare Part D Prescription Drug Program Medicare Part B Physician-Administered Products H.Con.Res. 25: House Budget Resolution (Democratic Caucus Substitute) H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 U.S./European Union High-Level Dialogue on Regulatory IssuesSequestration of PDUFA Fees H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 Implementation of S. 365: Budget Control Act TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuitcalsl Regulatory Transparency

Funding for National Institutes of Health H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014Funding for Centers for Disease Control and Prevention Vaccine Programs Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 Vaccine Access/Financing Tax for Seasonal Influenza Funding H.R. 425/S. 391: A bill to amend the Internal Revenue Code of 1986 to include vaccines against seasonal influenza within the definition of taxable vaccines Adult Immunization Policies Adult Immunization Senate Discussion Draft 340B Drug Pricing Program HRSA Implementation of Program Changes Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Drug Safety and Review Implementation of S. 3187: The Food and Drug Administration Safety and Innovation Act Regulatory Reforms for Innovative Products Expedited Approval Pathways E-Pedigree and Anti-Counterfeiting Supply Chain Integrity Pharmacy Compounding Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 Independent Payment Advisory Board Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development, and Procurement Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 H.R. 307: Pandemic and All-Hazards Preparedness Reauthorization Act Cures Acceleration Network Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Biodefense Research, Development, and Procurement (Non-Funding Issues) H.R. 307: Pandemic and All-Hazards Preparedness Reauthorization Act Reimbursement for Innovative Products Medicare Part D Prescription Drug Program Medicare Part B Physician-Administered Products H.Con.Res. 25: House Budget Resolution (Democratic Caucus Substitute) H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 U.S./European Union High-Level Dialogue on Regulatory IssuesSequestration of PDUFA Fees H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 Implementation of S. 365: Budget Control Act TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuitcalsl Regulatory Transparency

Biosimilars Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Reimbursement Issues Comparative Effectiveness Research Initiatives Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Funding for National Institutes of Health Cures Acceleration Network National Center for Advancing Translation Science (NCATS) S. 3295: Departments of Labor, HHS, and Education, and Related Agencies Appropriations Act for FY 2013 Funding for Centers for Disease Control and Prevention Vaccine Programs S. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Reporting of Physician Payments Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Vaccine Access/Financing Tax for Seasonal Influenza Funding Adult Immunization Policies Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act 340B Drug Pricing Program HRSA Implementation of Program Changes Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Rare Pediatric & Tropical Disease Drug Development Drug Safety and Review/Prescription Drug User Fee Act (PDUFA) Reauthorization Critical Path Initiative E-Pedigree and Anti-Counterfeiting Regulatory Reforms for Innovative Products Supply Chain Integrity Conflicts of Interest FDA Mission Drug Shortages Expedited Approval Pathways Access to External Experts FDA Globalization Act (Discussion Draft) Senate HELP Committee Discussion Draft House Energy and Commerce Committee Discussion Draft H.R.4132: Faster Access to Specialized Treatments (FAST) Act S. 3187:The Food and Drug Administration Safety and Innovation Act S. 2113: Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act of 2011 H.R.2182: Generating Antibiotic Incentives Now Act of 2011 H.R.3214: Food and Drug Administration Mission Reform Act of 2011 H.R.1483: Drug Safety Enhancement Act of 2011 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Independent Payment Advisory Board H.R. 5: Protecting Access to Healthcare Act of 2011 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Biodefense Research, Development and Procurement (Non-Funding Issues) S. 1855: Pandemic and All Hazards Preparedness Act (PAHPA) Reauthorization of 2011 Reimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Regulatory Transparency Therapeutic Discovery Project Tax Credit Extension S.3232: A Bill to Amend the Internal Revenue Code of 1986 and the Patient Protection and Affordable Care Act to Extend, Expand, and Improve the Qualifying Therapeutic Discovery Project Program

Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning USDA/APHIS Agricultural Biotechnology Regulations Efficient Science-Based Review of Biotech Products National Environmental Policy Act Requirements Coexistence of Production Systems Genetically Engineered (GE) Animals Labeling FDA Approval Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Amendment to Restrict FDA Approval of GE Salmon Labeling of Genetically Engineered Crops U.S. Government Policy Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Drug Safety and Review/Prescription Drug User Fee Act (PDUFA) Reauthorization Critical Path Initiative E-Pedigree and Anti-Counterfeiting Regulatory Reforms for Innovative Products Supply Chain Integrity Conflicts of Interest FDA Mission Drug Shortages Expedited Approval Pathways Access to External Experts Senate HELP Committee Discussion Draft House Energy and Commerce Committee Discussion Draft FDA Globalization Act (Discussion Draft) H.R. 2245: Preserving Access to Life Saving Medicines Act of 2011 S. 296: Preserving Access to Life-Savings Medicines Act of 2011 S. 2113: Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act of 2011 H.R.3214: Food and Drug Administration Mission Reform Act of 2011 H.R.4132: Faster Access to Specialized Treatments (FAST) Act H.R.3206: Cultivating Scientific Expertise to Foster Innovation for Patients Act of 2011 H.R.1483: Drug Safety Enhancement Act of 2011 H.R.2182: Generating Antibiotic Incentives Now Act of 2011 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Center for Veterinary Medicine, Scientific Infrastructure) Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013

Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning USDA/APHIS Agricultural Biotechnology Regulations Efficient Science-Based Review of Biotech Products National Environmental Policy Act Requirements Coexistence of Production Systems S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Federal Agriculture Reform and Risk Management Act of 2012 (House Farm Bill Discussion Draft) Genetically Engineered Animals Labeling FDA Approval S. 1717: Prevention of Escapement of Genetically Altered Salmon in the United States Act of 2012 S.R.2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Amendment to Restrict FDA Approval of GE Salmon S. 3187: Food and Drug Administration Safety and Innovation Act of 2012 Amendment to Restrict FDA Approval of GE Salmon Labeling of Genetically Engineered Crops S.R.2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Amendment to Require Labeling of Biotech Food Drug Safety and Review/Prescription Drug User Fee Act (PDUFA) Reauthorization Critical Path Initiative E-Pedigree and Anti-Counterfeiting Regulatory Reforms for Innovative Products Supply Chain Integrity Conflicts of Interest FDA Mission Drug Shortages Expedited Approval Pathways Access to External Experts FDA Globalization Act (Discussion Draft) Senate HELP Committee Discussion Draft House Energy and Commerce Committee Discussion Draft H.R.4132: Faster Access to Specialized Treatments (FAST) Act S. 3187:The Food and Drug Administration Safety and Innovation Act S. 2113: Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act of 2011 H.R.2182: Generating Antibiotic Incentives Now Act of 2011 H.R.3214: Food and Drug Administration Mission Reform Act of 2011 H.R.1483: Drug Safety Enhancement Act of 2011 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) S.R.2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Reporting of Physician Payments Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act

Biosimilars Biosimilars User Fee Act of 2012 (Discussion Draft) Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Funding for National Institutes of Health Cures Acceleration Network National Center of Advancing Translational Science (NCATS) Departments of Labor, HHS, and Education, and Related Agencies Appropriations Act for FY 2013 Funding for Centers for Disease Control and Prevention Vaccine Programs Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Vaccine Access/Financing Adult Immunization Policies Tax for Seasonal Influenza Funding 340B Drug Pricing Program HRSA Implementation of Program Changes Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Therapeutic Discovery Project Tax Credit Extension Rare Pediatric & Tropical Disease Drug Development Drug Safety and Review/Prescription Drug User Fee Act (PDUFA) Reauthorization Critical Path Initiative E-Pedigree and Anti-Counterfeiting Regulatory Reforms for Innovative Products Supply Chain Integrity Conflicts of Interest FDA Mission Drug Shortages Expedited Approval Pathways Access to External Experts Senate HELP Committee Discussion Draft House Energy and Commerce Committee Discussion Draft FDA Globalization Act (Discussion Draft) H.R. 2245: Preserving Access to Life Saving Medicines Act of 2011 S. 296: Preserving Access to Life-Savings Medicines Act of 2011 S. 2113: Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act of 2011 H.R.3214: Food and Drug Administration Mission Reform Act of 2011 H.R.4132: Faster Access to Specialized Treatments (FAST) Act H.R.3206: Cultivating Scientific Expertise to Foster Innovation for Patients Act of 2011 H.R.1483: Drug Safety Enhancement Act of 2011 H.R.2182: Generating Antibiotic Incentives Now Act of 2011 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Center for Veterinary Medicine, Scientific Infrastructure) Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Independent Payment Advisory Board H.R. 5: Protecting Access to Healthcare Act of 2011 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Biodefense Research, Development and Procurement S 1855: Pandemic and All Hazards Preparedness Act (PAHPA) Reauthorization of 2011 TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Reimbursement for Innovative Products Medicare Part B Physician-Administered Products

Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning USDA/APHIS Agricultural Biotechnology Regulations Efficient Science-Based Review of Biotech Products National Environmental Policy Act Requirements Coexistence of Production Systems S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Federal Agriculture Reform and Risk Management Act of 2012 (House Farm Bill Discussion Draft) Genetically Engineered Animals Labeling FDA Approval S. 1717: Prevention of Escapement of Genetically Altered Salmon in the United States Act of 2012 S.R.2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Amendment to Restrict FDA Approval of GE Salmon S. 3187: Food and Drug Administration Safety and Innovation Act of 2012 Amendment to Restrict FDA Approval of GE Salmon Labeling of Genetically Engineered Crops S.R.2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Amendment to Require Labeling of Biotech Food Drug Safety and Review/Prescription Drug User Fee Act (PDUFA) Reauthorization Critical Path Initiative E-Pedigree and Anti-Counterfeiting Regulatory Reforms for Innovative Products Supply Chain Integrity Conflicts of Interest FDA Mission Drug Shortages Expedited Approval Pathways Access to External Experts FDA Globalization Act (Discussion Draft) Senate HELP Committee Discussion Draft House Energy and Commerce Committee Discussion Draft H.R.4132: Faster Access to Specialized Treatments (FAST) Act S. 3187:The Food and Drug Administration Safety and Innovation Act S. 2113: Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act of 2011 H.R.2182: Generating Antibiotic Incentives Now Act of 2011 H.R.3214: Food and Drug Administration Mission Reform Act of 2011 H.R.1483: Drug Safety Enhancement Act of 2011 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) S.R.2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Reporting of Physician Payments Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act

Biosimilars Biosimilars User Fee Act of 2012 (Discussion Draft) Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Funding for National Institutes of Health Cures Acceleration Network National Center of Advancing Translational Science (NCATS) Departments of Labor, HHS, and Education, and Related Agencies Appropriations Act for FY 2013 Funding for Centers for Disease Control and Prevention Vaccine Programs Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Vaccine Access/Financing Adult Immunization Policies Tax for Seasonal Influenza Funding 340B Drug Pricing Program HRSA Implementation of Program Changes Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Therapeutic Discovery Project Tax Credit Extension Rare Pediatric & Tropical Disease Drug Development Drug Safety and Review/Prescription Drug User Fee Act (PDUFA) Reauthorization Critical Path Initiative E-Pedigree and Anti-Counterfeiting Regulatory Reforms for Innovative Products Supply Chain Integrity Conflicts of Interest FDA Mission Drug Shortages Expedited Approval Pathways Access to External Experts Senate HELP Committee Discussion Draft House Energy and Commerce Committee Discussion Draft FDA Globalization Act (Discussion Draft) H.R. 2245: Preserving Access to Life Saving Medicines Act of 2011 S. 296: Preserving Access to Life-Savings Medicines Act of 2011 S. 2113: Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act of 2011 H.R.3214: Food and Drug Administration Mission Reform Act of 2011 H.R.4132: Faster Access to Specialized Treatments (FAST) Act H.R.3206: Cultivating Scientific Expertise to Foster Innovation for Patients Act of 2011 H.R.1483: Drug Safety Enhancement Act of 2011 H.R.2182: Generating Antibiotic Incentives Now Act of 2011 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Center for Veterinary Medicine, Scientific Infrastructure) Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Independent Payment Advisory Board H.R. 5: Protecting Access to Healthcare Act of 2011 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Biodefense Research, Development and Procurement S 1855: Pandemic and All Hazards Preparedness Act (PAHPA) Reauthorization of 2011 TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Reimbursement for Innovative Products Medicare Part B Physician-Administered Products

Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning USDA/APHIS Agricultural Biotechnology Regulations Efficient Science-Based Review of Biotech Products National Environmental Policy Act Requirements Coexistence of Production Systems Genetically Engineered (GE) Animals Labeling FDA Approval Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Amendment to Restrict FDA Approval of GE Salmon Labeling of Genetically Engineered Crops U.S. Government Policy Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Drug Safety and Review/Prescription Drug User Fee Act (PDUFA) Reauthorization Critical Path Initiative E-Pedigree and Anti-Counterfeiting Regulatory Reforms for Innovative Products Supply Chain Integrity Conflicts of Interest FDA Mission Drug Shortages Expedited Approval Pathways Access to External Experts Senate HELP Committee Discussion Draft House Energy and Commerce Committee Discussion Draft FDA Globalization Act (Discussion Draft) H.R. 2245: Preserving Access to Life Saving Medicines Act of 2011 S. 296: Preserving Access to Life-Savings Medicines Act of 2011 S. 2113: Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act of 2011 H.R.3214: Food and Drug Administration Mission Reform Act of 2011 H.R.4132: Faster Access to Specialized Treatments (FAST) Act H.R.3206: Cultivating Scientific Expertise to Foster Innovation for Patients Act of 2011 H.R.1483: Drug Safety Enhancement Act of 2011 H.R.2182: Generating Antibiotic Incentives Now Act of 2011 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Center for Veterinary Medicine, Scientific Infrastructure) Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013

Biosimilars Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Reimbursement Issues Comparative Effectiveness Research Initiatives Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Funding for National Institutes of Health Cures Acceleration Network National Center for Advancing Translation Science (NCATS) S. 3295: Departments of Labor, HHS, and Education, and Related Agencies Appropriations Act for FY 2013 Funding for Centers for Disease Control and Prevention Vaccine Programs S. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Reporting of Physician Payments Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Vaccine Access/Financing Tax for Seasonal Influenza Funding Adult Immunization Policies Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act 340B Drug Pricing Program HRSA Implementation of Program Changes Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Rare Pediatric & Tropical Disease Drug Development Drug Safety and Review/Prescription Drug User Fee Act (PDUFA) Reauthorization Critical Path Initiative E-Pedigree and Anti-Counterfeiting Regulatory Reforms for Innovative Products Supply Chain Integrity Conflicts of Interest FDA Mission Drug Shortages Expedited Approval Pathways Access to External Experts FDA Globalization Act (Discussion Draft) Senate HELP Committee Discussion Draft House Energy and Commerce Committee Discussion Draft H.R.4132: Faster Access to Specialized Treatments (FAST) Act S. 3187:The Food and Drug Administration Safety and Innovation Act S. 2113: Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act of 2011 H.R.2182: Generating Antibiotic Incentives Now Act of 2011 H.R.3214: Food and Drug Administration Mission Reform Act of 2011 H.R.1483: Drug Safety Enhancement Act of 2011 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Independent Payment Advisory Board H.R. 5: Protecting Access to Healthcare Act of 2011 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Biodefense Research, Development and Procurement (Non-Funding Issues) S. 1855: Pandemic and All Hazards Preparedness Act (PAHPA) Reauthorization of 2011 Reimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Regulatory Transparency Therapeutic Discovery Project Tax Credit Extension S.3232: A Bill to Amend the Internal Revenue Code of 1986 and the Patient Protection and Affordable Care Act to Extend, Expand, and Improve the Qualifying Therapeutic Discovery Project Program

Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning USDA/APHIS Agricultural Biotechnology Regulations Efficient Science-Based Review of Biotech Products National Environmental Policy Act Requirements Coexistence of Production Systems Genetically Engineered (GE) Animals Labeling FDA Approval Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Amendment to Restrict FDA Approval of GE Salmon Labeling of Genetically Engineered Crops U.S. Government Policy Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Drug Safety and Review/Prescription Drug User Fee Act (PDUFA) Reauthorization Critical Path Initiative E-Pedigree and Anti-Counterfeiting Regulatory Reforms for Innovative Products Supply Chain Integrity Conflicts of Interest FDA Mission Drug Shortages Expedited Approval Pathways Access to External Experts Senate HELP Committee Discussion Draft House Energy and Commerce Committee Discussion Draft FDA Globalization Act (Discussion Draft) H.R. 2245: Preserving Access to Life Saving Medicines Act of 2011 S. 296: Preserving Access to Life-Savings Medicines Act of 2011 S. 2113: Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act of 2011 H.R.3214: Food and Drug Administration Mission Reform Act of 2011 H.R.4132: Faster Access to Specialized Treatments (FAST) Act H.R.3206: Cultivating Scientific Expertise to Foster Innovation for Patients Act of 2011 H.R.1483: Drug Safety Enhancement Act of 2011 H.R.2182: Generating Antibiotic Incentives Now Act of 2011 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Center for Veterinary Medicine, Scientific Infrastructure) Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013

Biosimilars Biosimilars User Fee Act of 2012 (Discussion Draft) Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Funding for National Institutes of Health Cures Acceleration Network National Center of Advancing Translational Science (NCATS) Departments of Labor, HHS, and Education, and Related Agencies Appropriations Act for FY 2013 Funding for Centers for Disease Control and Prevention Vaccine Programs Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Vaccine Access/Financing Adult Immunization Policies Tax for Seasonal Influenza Funding 340B Drug Pricing Program HRSA Implementation of Program Changes Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Therapeutic Discovery Project Tax Credit Extension Rare Pediatric & Tropical Disease Drug Development Drug Safety and Review/Prescription Drug User Fee Act (PDUFA) Reauthorization Critical Path Initiative E-Pedigree and Anti-Counterfeiting Regulatory Reforms for Innovative Products Supply Chain Integrity Conflicts of Interest FDA Mission Drug Shortages Expedited Approval Pathways Access to External Experts Senate HELP Committee Discussion Draft House Energy and Commerce Committee Discussion Draft FDA Globalization Act (Discussion Draft) H.R. 2245: Preserving Access to Life Saving Medicines Act of 2011 S. 296: Preserving Access to Life-Savings Medicines Act of 2011 S. 2113: Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act of 2011 H.R.3214: Food and Drug Administration Mission Reform Act of 2011 H.R.4132: Faster Access to Specialized Treatments (FAST) Act H.R.3206: Cultivating Scientific Expertise to Foster Innovation for Patients Act of 2011 H.R.1483: Drug Safety Enhancement Act of 2011 H.R.2182: Generating Antibiotic Incentives Now Act of 2011 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Center for Veterinary Medicine, Scientific Infrastructure) Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Independent Payment Advisory Board H.R. 5: Protecting Access to Healthcare Act of 2011 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Biodefense Research, Development and Procurement S 1855: Pandemic and All Hazards Preparedness Act (PAHPA) Reauthorization of 2011 TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Reimbursement for Innovative Products Medicare Part B Physician-Administered Products

Funding for National Institutes of Health National Center for Advancing Translational Sciences (NCATS) S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Vaccine Access/Financing Federal Response to the Rising Rates of Autism Tax for Seasonal Influenza Funding H.R. 6687/S.3716: A Bill to Amend the Internal Revenue Code of 1986 to Include Vaccines against Seasonal Influenza within the Definition of Taxable Vaccines 340B Drug Pricing Program HRSA Implementation of Program Changes Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act of 2010 Average Manufacturer Price Calculations Therapeutic Discovery Project Tax Credit S.3232: A Bill to Amend the Internal Revenue Code of 1986 and the Patient Protection and Affordable Care Act to Extend, Expand, and Improve the Qualifying Therapeutic Discovery Project Program Drug Safety and Review E-Pedigree and Anti-Counterfeiting (Sens. Michael Bennett/Richard Burr Discuss Draft) Supply Chain Integrity Implementation of P.L. No: 112-144: The Food and Drug Administration Safety and Innovation Act of 2012 Pharmacy Compounding Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Independent Payment Advisory Board H.R. 5: Protecting Access to Healthcare Act of 2011 Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act of 2010 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development, and Procurement S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Biodefense Research, Development, and Procurement S 1855/H.R. 2405: Pandemic and All Hazards Preparedness Act Reauthorization of 2011 HHS Countermeasures Review TransPacific Partnership Data and Intellectual Property Protections for Pharmaceuticals Regulatory Transparency Reimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program Sequestration of PDUFA Fees Implementation of P.L. No: 112-25: Budget Control Act Medicaid Rebates

Pharmaceutical Industry Annual Fee Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act Treasury and IRS Regulations Implementing the Law Biosimilars Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act Colombia Biologics Regulations Funding for National Institutes of Health Cures Acceleration Network National Center for Advancing Translations Science (NCATS) S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Funding for Centers for Disease Control and Prevention Vaccine Programs S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Reporting of Physician Payments Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act Vaccine Access/Financing Tax for Seasonal Influenza Funding Taxable Vaccines Act (Discussion Draft) 340B Drug Pricing Program HRSA Implementation of Program Changes Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act Average Manufacturer Price Calculations Therapeutic Discovery Project Tax Credit S.3232: A Bill to Amend the Internal Revenue Code of 1986 and the Patient Protection and Affordable Care Act to Extend, Expand, and Improve the Qualifying Therapeutic Discovery Project Program Extension Rare Pediatric & Tropical Disease Drug Development Drug Safety and Review/Prescription Drug User Fee Act (PDUFA) Reauthorization Access to External Experts Conflicts of Interest Drug Shortages E-Pedigree and Anti-Counterfeiting (Sens. Michael Bennett/Richard Burr Discussion Draft) Expedited Approval Pathways FDA Mission Regulatory Reforms for Innovative Products Supply Chain Integrity Implementation of P.L. No: 112-144: The Food and Drug Administration Safety and Innovation Act Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) (2) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY2013 Independent Payment Advisory Board H.R. 5: Protecting Access to Healthcare Act of 2011 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Biodefense Research, Development, and Procurement HHS Countermeasures Review S.1855/H.R. 2405: Pandemic and All Hazards Preparedness Act Reauthorization of 2011 TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Regulatory Transparency Reimbursement for Innovative Products Medicare Part D Prescription Drug Program Medicare Part B Physician-Administered Products Sequestration of PDUFA Fees Implementation of P.L. No: 112-25: Budget Control Act

Pharmaceutical Industry Annual Fee Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act Treasury and IRS Regulations Implementing the Law Biosimilars Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act Colombia Biologics Regulations Funding for National Institutes of Health Cures Acceleration Network National Center for Advancing Translations Science (NCATS) S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Funding for Centers for Disease Control and Prevention Vaccine Programs S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Reporting of Physician Payments Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act Vaccine Access/Financing Tax for Seasonal Influenza Funding Taxable Vaccines Act (Discussion Draft) 340B Drug Pricing Program HRSA Implementation of Program Changes Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act Average Manufacturer Price Calculations Therapeutic Discovery Project Tax Credit S.3232: A Bill to Amend the Internal Revenue Code of 1986 and the Patient Protection and Affordable Care Act to Extend, Expand, and Improve the Qualifying Therapeutic Discovery Project Program Extension Rare Pediatric & Tropical Disease Drug Development Drug Safety and Review/Prescription Drug User Fee Act (PDUFA) Reauthorization Access to External Experts Conflicts of Interest Drug Shortages E-Pedigree and Anti-Counterfeiting (Sens. Michael Bennett/Richard Burr Discussion Draft) Expedited Approval Pathways FDA Mission Regulatory Reforms for Innovative Products Supply Chain Integrity Implementation of P.L. No: 112-144: The Food and Drug Administration Safety and Innovation Act Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) (2) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY2013 Independent Payment Advisory Board H.R. 5: Protecting Access to Healthcare Act of 2011 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Biodefense Research, Development, and Procurement HHS Countermeasures Review S.1855/H.R. 2405: Pandemic and All Hazards Preparedness Act Reauthorization of 2011 TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Regulatory Transparency Reimbursement for Innovative Products Medicare Part D Prescription Drug Program Medicare Part B Physician-Administered Products Sequestration of PDUFA Fees Implementation of P.L. No: 112-25: Budget Control Act

Biosimilars Biosimilars User Fee Act of 2012 (Discussion Draft) Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Funding for National Institutes of Health Cures Acceleration Network National Center of Advancing Translational Science (NCATS) Departments of Labor, HHS, and Education, and Related Agencies Appropriations Act for FY 2013 Funding for Centers for Disease Control and Prevention Vaccine Programs Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Vaccine Access/Financing Adult Immunization Policies Tax for Seasonal Influenza Funding 340B Drug Pricing Program HRSA Implementation of Program Changes Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Therapeutic Discovery Project Tax Credit Extension Rare Pediatric & Tropical Disease Drug Development Drug Safety and Review/Prescription Drug User Fee Act (PDUFA) Reauthorization Critical Path Initiative E-Pedigree and Anti-Counterfeiting Regulatory Reforms for Innovative Products Supply Chain Integrity Conflicts of Interest FDA Mission Drug Shortages Expedited Approval Pathways Access to External Experts Senate HELP Committee Discussion Draft House Energy and Commerce Committee Discussion Draft FDA Globalization Act (Discussion Draft) H.R. 2245: Preserving Access to Life Saving Medicines Act of 2011 S. 296: Preserving Access to Life-Savings Medicines Act of 2011 S. 2113: Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act of 2011 H.R.3214: Food and Drug Administration Mission Reform Act of 2011 H.R.4132: Faster Access to Specialized Treatments (FAST) Act H.R.3206: Cultivating Scientific Expertise to Foster Innovation for Patients Act of 2011 H.R.1483: Drug Safety Enhancement Act of 2011 H.R.2182: Generating Antibiotic Incentives Now Act of 2011 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Center for Veterinary Medicine, Scientific Infrastructure) Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Independent Payment Advisory Board H.R. 5: Protecting Access to Healthcare Act of 2011 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Biodefense Research, Development and Procurement S 1855: Pandemic and All Hazards Preparedness Act (PAHPA) Reauthorization of 2011 TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Reimbursement for Innovative Products Medicare Part B Physician-Administered Products

Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning USDA/APHIS Agricultural Biotechnology Regulations Efficient Science-Based Review of Biotech Products National Environmental Policy Act Requirements Coexistence of Production Systems Genetically Engineered (GE) Animals Labeling FDA Approval Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Amendment to Restrict FDA Approval of GE Salmon Labeling of Genetically Engineered Crops U.S. Government Policy Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Drug Safety and Review/Prescription Drug User Fee Act (PDUFA) Reauthorization Critical Path Initiative E-Pedigree and Anti-Counterfeiting Regulatory Reforms for Innovative Products Supply Chain Integrity Conflicts of Interest FDA Mission Drug Shortages Expedited Approval Pathways Access to External Experts Senate HELP Committee Discussion Draft House Energy and Commerce Committee Discussion Draft FDA Globalization Act (Discussion Draft) H.R. 2245: Preserving Access to Life Saving Medicines Act of 2011 S. 296: Preserving Access to Life-Savings Medicines Act of 2011 S. 2113: Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act of 2011 H.R.3214: Food and Drug Administration Mission Reform Act of 2011 H.R.4132: Faster Access to Specialized Treatments (FAST) Act H.R.3206: Cultivating Scientific Expertise to Foster Innovation for Patients Act of 2011 H.R.1483: Drug Safety Enhancement Act of 2011 H.R.2182: Generating Antibiotic Incentives Now Act of 2011 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Center for Veterinary Medicine, Scientific Infrastructure) Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013

Biosimilars Biosimilars User Fee Act of 2012 (Discussion Draft) Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Funding for National Institutes of Health Cures Acceleration Network National Center of Advancing Translational Science (NCATS) Departments of Labor, HHS, and Education, and Related Agencies Appropriations Act for FY 2013 Funding for Centers for Disease Control and Prevention Vaccine Programs Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Vaccine Access/Financing Adult Immunization Policies Tax for Seasonal Influenza Funding 340B Drug Pricing Program HRSA Implementation of Program Changes Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Therapeutic Discovery Project Tax Credit Extension Rare Pediatric & Tropical Disease Drug Development Drug Safety and Review/Prescription Drug User Fee Act (PDUFA) Reauthorization Critical Path Initiative E-Pedigree and Anti-Counterfeiting Regulatory Reforms for Innovative Products Supply Chain Integrity Conflicts of Interest FDA Mission Drug Shortages Expedited Approval Pathways Access to External Experts Senate HELP Committee Discussion Draft House Energy and Commerce Committee Discussion Draft FDA Globalization Act (Discussion Draft) H.R. 2245: Preserving Access to Life Saving Medicines Act of 2011 S. 296: Preserving Access to Life-Savings Medicines Act of 2011 S. 2113: Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act of 2011 H.R.3214: Food and Drug Administration Mission Reform Act of 2011 H.R.4132: Faster Access to Specialized Treatments (FAST) Act H.R.3206: Cultivating Scientific Expertise to Foster Innovation for Patients Act of 2011 H.R.1483: Drug Safety Enhancement Act of 2011 H.R.2182: Generating Antibiotic Incentives Now Act of 2011 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Center for Veterinary Medicine, Scientific Infrastructure) Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Independent Payment Advisory Board H.R. 5: Protecting Access to Healthcare Act of 2011 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Biodefense Research, Development and Procurement S 1855: Pandemic and All Hazards Preparedness Act (PAHPA) Reauthorization of 2011 TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Reimbursement for Innovative Products Medicare Part B Physician-Administered Products

Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning USDA/APHIS Agricultural Biotechnology Regulations Efficient Science-Based Review of Biotech Products National Environmental Policy Act Requirements Coexistence of Production Systems Genetically Engineered (GE) Animals Labeling FDA Approval Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Amendment to Restrict FDA Approval of GE Salmon Labeling of Genetically Engineered Crops U.S. Government Policy Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Drug Safety and Review/Prescription Drug User Fee Act (PDUFA) Reauthorization Critical Path Initiative E-Pedigree and Anti-Counterfeiting Regulatory Reforms for Innovative Products Supply Chain Integrity Conflicts of Interest FDA Mission Drug Shortages Expedited Approval Pathways Access to External Experts Senate HELP Committee Discussion Draft House Energy and Commerce Committee Discussion Draft FDA Globalization Act (Discussion Draft) H.R. 2245: Preserving Access to Life Saving Medicines Act of 2011 S. 296: Preserving Access to Life-Savings Medicines Act of 2011 S. 2113: Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act of 2011 H.R.3214: Food and Drug Administration Mission Reform Act of 2011 H.R.4132: Faster Access to Specialized Treatments (FAST) Act H.R.3206: Cultivating Scientific Expertise to Foster Innovation for Patients Act of 2011 H.R.1483: Drug Safety Enhancement Act of 2011 H.R.2182: Generating Antibiotic Incentives Now Act of 2011 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Center for Veterinary Medicine, Scientific Infrastructure) Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013

Biosimilars Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Reimbursement Issues Comparative Effectiveness Research Initiatives Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Funding for National Institutes of Health Cures Acceleration Network National Center for Advancing Translation Science (NCATS) S. 3295: Departments of Labor, HHS, and Education, and Related Agencies Appropriations Act for FY 2013 Funding for Centers for Disease Control and Prevention Vaccine Programs S. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Reporting of Physician Payments Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Vaccine Access/Financing Tax for Seasonal Influenza Funding Adult Immunization Policies Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act 340B Drug Pricing Program HRSA Implementation of Program Changes Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Rare Pediatric & Tropical Disease Drug Development Drug Safety and Review/Prescription Drug User Fee Act (PDUFA) Reauthorization Critical Path Initiative E-Pedigree and Anti-Counterfeiting Regulatory Reforms for Innovative Products Supply Chain Integrity Conflicts of Interest FDA Mission Drug Shortages Expedited Approval Pathways Access to External Experts FDA Globalization Act (Discussion Draft) Senate HELP Committee Discussion Draft House Energy and Commerce Committee Discussion Draft H.R.4132: Faster Access to Specialized Treatments (FAST) Act S. 3187:The Food and Drug Administration Safety and Innovation Act S. 2113: Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act of 2011 H.R.2182: Generating Antibiotic Incentives Now Act of 2011 H.R.3214: Food and Drug Administration Mission Reform Act of 2011 H.R.1483: Drug Safety Enhancement Act of 2011 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Independent Payment Advisory Board H.R. 5: Protecting Access to Healthcare Act of 2011 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Biodefense Research, Development and Procurement (Non-Funding Issues) S. 1855: Pandemic and All Hazards Preparedness Act (PAHPA) Reauthorization of 2011 Reimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Regulatory Transparency Therapeutic Discovery Project Tax Credit Extension S.3232: A Bill to Amend the Internal Revenue Code of 1986 and the Patient Protection and Affordable Care Act to Extend, Expand, and Improve the Qualifying Therapeutic Discovery Project Program

Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning USDA/APHIS Agricultural Biotechnology Regulations Efficient Science-Based Review of Biotech Products National Environmental Policy Act Requirements Coexistence of Production Systems S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Federal Agriculture Reform and Risk Management Act of 2012 (House Farm Bill Discussion Draft) Genetically Engineered Animals Labeling FDA Approval S. 1717: Prevention of Escapement of Genetically Altered Salmon in the United States Act of 2012 S.R.2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Amendment to Restrict FDA Approval of GE Salmon S. 3187: Food and Drug Administration Safety and Innovation Act of 2012 Amendment to Restrict FDA Approval of GE Salmon Labeling of Genetically Engineered Crops S.R.2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Amendment to Require Labeling of Biotech Food Drug Safety and Review/Prescription Drug User Fee Act (PDUFA) Reauthorization Critical Path Initiative E-Pedigree and Anti-Counterfeiting Regulatory Reforms for Innovative Products Supply Chain Integrity Conflicts of Interest FDA Mission Drug Shortages Expedited Approval Pathways Access to External Experts FDA Globalization Act (Discussion Draft) Senate HELP Committee Discussion Draft House Energy and Commerce Committee Discussion Draft H.R.4132: Faster Access to Specialized Treatments (FAST) Act S. 3187:The Food and Drug Administration Safety and Innovation Act S. 2113: Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act of 2011 H.R.2182: Generating Antibiotic Incentives Now Act of 2011 H.R.3214: Food and Drug Administration Mission Reform Act of 2011 H.R.1483: Drug Safety Enhancement Act of 2011 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) S.R.2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Reporting of Physician Payments Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act

Biosimilars Biosimilars User Fee Act of 2012 (Discussion Draft) Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Funding for National Institutes of Health Cures Acceleration Network National Center of Advancing Translational Science (NCATS) Departments of Labor, HHS, and Education, and Related Agencies Appropriations Act for FY 2013 Funding for Centers for Disease Control and Prevention Vaccine Programs Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Vaccine Access/Financing Adult Immunization Policies Tax for Seasonal Influenza Funding 340B Drug Pricing Program HRSA Implementation of Program Changes Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Therapeutic Discovery Project Tax Credit Extension Rare Pediatric & Tropical Disease Drug Development Drug Safety and Review/Prescription Drug User Fee Act (PDUFA) Reauthorization Critical Path Initiative E-Pedigree and Anti-Counterfeiting Regulatory Reforms for Innovative Products Supply Chain Integrity Conflicts of Interest FDA Mission Drug Shortages Expedited Approval Pathways Access to External Experts Senate HELP Committee Discussion Draft House Energy and Commerce Committee Discussion Draft FDA Globalization Act (Discussion Draft) H.R. 2245: Preserving Access to Life Saving Medicines Act of 2011 S. 296: Preserving Access to Life-Savings Medicines Act of 2011 S. 2113: Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act of 2011 H.R.3214: Food and Drug Administration Mission Reform Act of 2011 H.R.4132: Faster Access to Specialized Treatments (FAST) Act H.R.3206: Cultivating Scientific Expertise to Foster Innovation for Patients Act of 2011 H.R.1483: Drug Safety Enhancement Act of 2011 H.R.2182: Generating Antibiotic Incentives Now Act of 2011 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Center for Veterinary Medicine, Scientific Infrastructure) Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Independent Payment Advisory Board H.R. 5: Protecting Access to Healthcare Act of 2011 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Biodefense Research, Development and Procurement S 1855: Pandemic and All Hazards Preparedness Act (PAHPA) Reauthorization of 2011 TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Reimbursement for Innovative Products Medicare Part B Physician-Administered Products

Comparative Effectiveness Research Initiatives Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Rare Pediatric & Tropical Disease Drug Development Funding for National Institutes of Health Cures Acceleration Network National Center for Advancing Translation Science (NCATS) S.R. 3295: Departments of Labor, HHS, and Education, and Related Agencies Appropriations Act for FY 2013 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S.R.3295: Departments of Labor, HHS, and Education, and Related Agencies Appropriations Act for FY 2013 Biodefense Research, Development and Procurement (Non-Funding Issues) S. 1855: Pandemic and All Hazards Preparedness Act Reauthorization of 2011

Biosimilars Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Reimbursement Issues Comparative Effectiveness Research Initiatives Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Funding for National Institutes of Health Cures Acceleration Network National Center for Advancing Translation Science (NCATS) S. 3295: Departments of Labor, HHS, and Education, and Related Agencies Appropriations Act for FY 2013 Funding for Centers for Disease Control and Prevention Vaccine Programs S. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Reporting of Physician Payments Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Vaccine Access/Financing Tax for Seasonal Influenza Funding Adult Immunization Policies Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act 340B Drug Pricing Program HRSA Implementation of Program Changes Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Rare Pediatric & Tropical Disease Drug Development Drug Safety and Review/Prescription Drug User Fee Act (PDUFA) Reauthorization Critical Path Initiative E-Pedigree and Anti-Counterfeiting Regulatory Reforms for Innovative Products Supply Chain Integrity Conflicts of Interest FDA Mission Drug Shortages Expedited Approval Pathways Access to External Experts FDA Globalization Act (Discussion Draft) Senate HELP Committee Discussion Draft House Energy and Commerce Committee Discussion Draft H.R.4132: Faster Access to Specialized Treatments (FAST) Act S. 3187:The Food and Drug Administration Safety and Innovation Act S. 2113: Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act of 2011 H.R.2182: Generating Antibiotic Incentives Now Act of 2011 H.R.3214: Food and Drug Administration Mission Reform Act of 2011 H.R.1483: Drug Safety Enhancement Act of 2011 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Independent Payment Advisory Board H.R. 5: Protecting Access to Healthcare Act of 2011 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Biodefense Research, Development and Procurement (Non-Funding Issues) S. 1855: Pandemic and All Hazards Preparedness Act (PAHPA) Reauthorization of 2011 Reimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Regulatory Transparency Therapeutic Discovery Project Tax Credit Extension S.3232: A Bill to Amend the Internal Revenue Code of 1986 and the Patient Protection and Affordable Care Act to Extend, Expand, and Improve the Qualifying Therapeutic Discovery Project Program

Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning USDA/APHIS Agricultural Biotechnology Regulations Efficient Science-Based Review of Biotech Products National Environmental Policy Act Requirements Coexistence of Production Systems S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Federal Agriculture Reform and Risk Management Act of 2012 (House Farm Bill Discussion Draft) Genetically Engineered Animals Labeling FDA Approval S. 1717: Prevention of Escapement of Genetically Altered Salmon in the United States Act of 2012 S.R.2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Amendment to Restrict FDA Approval of GE Salmon S. 3187: Food and Drug Administration Safety and Innovation Act of 2012 Amendment to Restrict FDA Approval of GE Salmon Labeling of Genetically Engineered Crops S.R.2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Amendment to Require Labeling of Biotech Food Drug Safety and Review/Prescription Drug User Fee Act (PDUFA) Reauthorization Critical Path Initiative E-Pedigree and Anti-Counterfeiting Regulatory Reforms for Innovative Products Supply Chain Integrity Conflicts of Interest FDA Mission Drug Shortages Expedited Approval Pathways Access to External Experts FDA Globalization Act (Discussion Draft) Senate HELP Committee Discussion Draft House Energy and Commerce Committee Discussion Draft H.R.4132: Faster Access to Specialized Treatments (FAST) Act S. 3187:The Food and Drug Administration Safety and Innovation Act S. 2113: Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act of 2011 H.R.2182: Generating Antibiotic Incentives Now Act of 2011 H.R.3214: Food and Drug Administration Mission Reform Act of 2011 H.R.1483: Drug Safety Enhancement Act of 2011 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) S.R.2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Reporting of Physician Payments Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act

Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning USDA/APHIS Agricultural Biotechnology Regulations Efficient Science-Based Review of Biotech Products National Environmental Policy Act Requirements Coexistence of Production Systems Genetically Engineered (GE) Animals Labeling FDA Approval Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Amendment to Restrict FDA Approval of GE Salmon Labeling of Genetically Engineered Crops U.S. Government Policy Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Drug Safety and Review/Prescription Drug User Fee Act (PDUFA) Reauthorization Critical Path Initiative E-Pedigree and Anti-Counterfeiting Regulatory Reforms for Innovative Products Supply Chain Integrity Conflicts of Interest FDA Mission Drug Shortages Expedited Approval Pathways Access to External Experts Senate HELP Committee Discussion Draft House Energy and Commerce Committee Discussion Draft FDA Globalization Act (Discussion Draft) H.R. 2245: Preserving Access to Life Saving Medicines Act of 2011 S. 296: Preserving Access to Life-Savings Medicines Act of 2011 S. 2113: Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act of 2011 H.R.3214: Food and Drug Administration Mission Reform Act of 2011 H.R.4132: Faster Access to Specialized Treatments (FAST) Act H.R.3206: Cultivating Scientific Expertise to Foster Innovation for Patients Act of 2011 H.R.1483: Drug Safety Enhancement Act of 2011 H.R.2182: Generating Antibiotic Incentives Now Act of 2011 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Center for Veterinary Medicine, Scientific Infrastructure) Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013

Biosimilars Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Reimbursement Issues Comparative Effectiveness Research Initiatives Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Funding for National Institutes of Health Cures Acceleration Network National Center for Advancing Translation Science (NCATS) S. 3295: Departments of Labor, HHS, and Education, and Related Agencies Appropriations Act for FY 2013 Funding for Centers for Disease Control and Prevention Vaccine Programs S. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Reporting of Physician Payments Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Vaccine Access/Financing Tax for Seasonal Influenza Funding Adult Immunization Policies Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act 340B Drug Pricing Program HRSA Implementation of Program Changes Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Rare Pediatric & Tropical Disease Drug Development Drug Safety and Review/Prescription Drug User Fee Act (PDUFA) Reauthorization Critical Path Initiative E-Pedigree and Anti-Counterfeiting Regulatory Reforms for Innovative Products Supply Chain Integrity Conflicts of Interest FDA Mission Drug Shortages Expedited Approval Pathways Access to External Experts FDA Globalization Act (Discussion Draft) Senate HELP Committee Discussion Draft House Energy and Commerce Committee Discussion Draft H.R.4132: Faster Access to Specialized Treatments (FAST) Act S. 3187:The Food and Drug Administration Safety and Innovation Act S. 2113: Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act of 2011 H.R.2182: Generating Antibiotic Incentives Now Act of 2011 H.R.3214: Food and Drug Administration Mission Reform Act of 2011 H.R.1483: Drug Safety Enhancement Act of 2011 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Independent Payment Advisory Board H.R. 5: Protecting Access to Healthcare Act of 2011 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Biodefense Research, Development and Procurement (Non-Funding Issues) S. 1855: Pandemic and All Hazards Preparedness Act (PAHPA) Reauthorization of 2011 Reimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Regulatory Transparency Therapeutic Discovery Project Tax Credit Extension S.3232: A Bill to Amend the Internal Revenue Code of 1986 and the Patient Protection and Affordable Care Act to Extend, Expand, and Improve the Qualifying Therapeutic Discovery Project Program

Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning USDA/APHIS Agricultural Biotechnology Regulations Efficient Science-Based Review of Biotech Products National Environmental Policy Act Requirements Coexistence of Production Systems S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Federal Agriculture Reform and Risk Management Act of 2012 (House Farm Bill Discussion Draft) Genetically Engineered Animals Labeling FDA Approval S. 1717: Prevention of Escapement of Genetically Altered Salmon in the United States Act of 2012 S.R.2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Amendment to Restrict FDA Approval of GE Salmon S. 3187: Food and Drug Administration Safety and Innovation Act of 2012 Amendment to Restrict FDA Approval of GE Salmon Labeling of Genetically Engineered Crops S.R.2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Amendment to Require Labeling of Biotech Food Drug Safety and Review/Prescription Drug User Fee Act (PDUFA) Reauthorization Critical Path Initiative E-Pedigree and Anti-Counterfeiting Regulatory Reforms for Innovative Products Supply Chain Integrity Conflicts of Interest FDA Mission Drug Shortages Expedited Approval Pathways Access to External Experts FDA Globalization Act (Discussion Draft) Senate HELP Committee Discussion Draft House Energy and Commerce Committee Discussion Draft H.R.4132: Faster Access to Specialized Treatments (FAST) Act S. 3187:The Food and Drug Administration Safety and Innovation Act S. 2113: Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act of 2011 H.R.2182: Generating Antibiotic Incentives Now Act of 2011 H.R.3214: Food and Drug Administration Mission Reform Act of 2011 H.R.1483: Drug Safety Enhancement Act of 2011 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) S.R.2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Reporting of Physician Payments Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act

Biosimilars Biosimilars User Fee Act of 2012 (Discussion Draft) Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Funding for National Institutes of Health Cures Acceleration Network National Center of Advancing Translational Science (NCATS) Departments of Labor, HHS, and Education, and Related Agencies Appropriations Act for FY 2013 Funding for Centers for Disease Control and Prevention Vaccine Programs Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Vaccine Access/Financing Adult Immunization Policies Tax for Seasonal Influenza Funding 340B Drug Pricing Program HRSA Implementation of Program Changes Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Therapeutic Discovery Project Tax Credit Extension Rare Pediatric & Tropical Disease Drug Development Drug Safety and Review/Prescription Drug User Fee Act (PDUFA) Reauthorization Critical Path Initiative E-Pedigree and Anti-Counterfeiting Regulatory Reforms for Innovative Products Supply Chain Integrity Conflicts of Interest FDA Mission Drug Shortages Expedited Approval Pathways Access to External Experts Senate HELP Committee Discussion Draft House Energy and Commerce Committee Discussion Draft FDA Globalization Act (Discussion Draft) H.R. 2245: Preserving Access to Life Saving Medicines Act of 2011 S. 296: Preserving Access to Life-Savings Medicines Act of 2011 S. 2113: Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act of 2011 H.R.3214: Food and Drug Administration Mission Reform Act of 2011 H.R.4132: Faster Access to Specialized Treatments (FAST) Act H.R.3206: Cultivating Scientific Expertise to Foster Innovation for Patients Act of 2011 H.R.1483: Drug Safety Enhancement Act of 2011 H.R.2182: Generating Antibiotic Incentives Now Act of 2011 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Center for Veterinary Medicine, Scientific Infrastructure) Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Independent Payment Advisory Board H.R. 5: Protecting Access to Healthcare Act of 2011 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Biodefense Research, Development and Procurement S 1855: Pandemic and All Hazards Preparedness Act (PAHPA) Reauthorization of 2011 TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Reimbursement for Innovative Products Medicare Part B Physician-Administered Products

Pharmaceutical Industry Annual Fee Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act Treasury and IRS Regulations Implementing the Law Biosimilars Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act Colombia Biologics Regulations Funding for National Institutes of Health Cures Acceleration Network National Center for Advancing Translations Science (NCATS) S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Funding for Centers for Disease Control and Prevention Vaccine Programs S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Reporting of Physician Payments Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act Vaccine Access/Financing Tax for Seasonal Influenza Funding Taxable Vaccines Act (Discussion Draft) 340B Drug Pricing Program HRSA Implementation of Program Changes Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act Average Manufacturer Price Calculations Therapeutic Discovery Project Tax Credit S.3232: A Bill to Amend the Internal Revenue Code of 1986 and the Patient Protection and Affordable Care Act to Extend, Expand, and Improve the Qualifying Therapeutic Discovery Project Program Extension Rare Pediatric & Tropical Disease Drug Development Drug Safety and Review/Prescription Drug User Fee Act (PDUFA) Reauthorization Access to External Experts Conflicts of Interest Drug Shortages E-Pedigree and Anti-Counterfeiting (Sens. Michael Bennett/Richard Burr Discussion Draft) Expedited Approval Pathways FDA Mission Regulatory Reforms for Innovative Products Supply Chain Integrity Implementation of P.L. No: 112-144: The Food and Drug Administration Safety and Innovation Act Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) (2) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY2013 Independent Payment Advisory Board H.R. 5: Protecting Access to Healthcare Act of 2011 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Biodefense Research, Development, and Procurement HHS Countermeasures Review S.1855/H.R. 2405: Pandemic and All Hazards Preparedness Act Reauthorization of 2011 TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Regulatory Transparency Reimbursement for Innovative Products Medicare Part D Prescription Drug Program Medicare Part B Physician-Administered Products Sequestration of PDUFA Fees Implementation of P.L. No: 112-25: Budget Control Act

Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning USDA/APHIS Agricultural Biotechnology Regulations Efficient Science-Based Review of Biotech Products National Environmental Policy Act Requirements Coexistence of Production Systems S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Federal Agriculture Reform and Risk Management Act of 2012 (House Farm Bill Discussion Draft) Genetically Engineered Animals Labeling FDA Approval S. 1717: Prevention of Escapement of Genetically Altered Salmon in the United States Act of 2012 S.R.2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Amendment to Restrict FDA Approval of GE Salmon S. 3187: Food and Drug Administration Safety and Innovation Act of 2012 Amendment to Restrict FDA Approval of GE Salmon Labeling of Genetically Engineered Crops S.R.2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Amendment to Require Labeling of Biotech Food Drug Safety and Review/Prescription Drug User Fee Act (PDUFA) Reauthorization Critical Path Initiative E-Pedigree and Anti-Counterfeiting Regulatory Reforms for Innovative Products Supply Chain Integrity Conflicts of Interest FDA Mission Drug Shortages Expedited Approval Pathways Access to External Experts FDA Globalization Act (Discussion Draft) Senate HELP Committee Discussion Draft House Energy and Commerce Committee Discussion Draft H.R.4132: Faster Access to Specialized Treatments (FAST) Act S. 3187:The Food and Drug Administration Safety and Innovation Act S. 2113: Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act of 2011 H.R.2182: Generating Antibiotic Incentives Now Act of 2011 H.R.3214: Food and Drug Administration Mission Reform Act of 2011 H.R.1483: Drug Safety Enhancement Act of 2011 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) S.R.2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Reporting of Physician Payments Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act

Biosimilars Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Reimbursement Issues Comparative Effectiveness Research Initiatives Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Funding for National Institutes of Health Cures Acceleration Network National Center for Advancing Translation Science (NCATS) S. 3295: Departments of Labor, HHS, and Education, and Related Agencies Appropriations Act for FY 2013 Funding for Centers for Disease Control and Prevention Vaccine Programs S. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Reporting of Physician Payments Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Vaccine Access/Financing Tax for Seasonal Influenza Funding Adult Immunization Policies Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act 340B Drug Pricing Program HRSA Implementation of Program Changes Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Rare Pediatric & Tropical Disease Drug Development Drug Safety and Review/Prescription Drug User Fee Act (PDUFA) Reauthorization Critical Path Initiative E-Pedigree and Anti-Counterfeiting Regulatory Reforms for Innovative Products Supply Chain Integrity Conflicts of Interest FDA Mission Drug Shortages Expedited Approval Pathways Access to External Experts FDA Globalization Act (Discussion Draft) Senate HELP Committee Discussion Draft House Energy and Commerce Committee Discussion Draft H.R.4132: Faster Access to Specialized Treatments (FAST) Act S. 3187:The Food and Drug Administration Safety and Innovation Act S. 2113: Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act of 2011 H.R.2182: Generating Antibiotic Incentives Now Act of 2011 H.R.3214: Food and Drug Administration Mission Reform Act of 2011 H.R.1483: Drug Safety Enhancement Act of 2011 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Independent Payment Advisory Board H.R. 5: Protecting Access to Healthcare Act of 2011 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Biodefense Research, Development and Procurement (Non-Funding Issues) S. 1855: Pandemic and All Hazards Preparedness Act (PAHPA) Reauthorization of 2011 Reimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Regulatory Transparency Therapeutic Discovery Project Tax Credit Extension S.3232: A Bill to Amend the Internal Revenue Code of 1986 and the Patient Protection and Affordable Care Act to Extend, Expand, and Improve the Qualifying Therapeutic Discovery Project Program

Pharmaceutical Industry Annual Fee Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act Treasury and IRS Regulations Implementing the Law Biosimilars Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act Colombia Biologics Regulations Funding for National Institutes of Health Cures Acceleration Network National Center for Advancing Translations Science (NCATS) S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Funding for Centers for Disease Control and Prevention Vaccine Programs S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Reporting of Physician Payments Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act Vaccine Access/Financing Tax for Seasonal Influenza Funding Taxable Vaccines Act (Discussion Draft) 340B Drug Pricing Program HRSA Implementation of Program Changes Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act Average Manufacturer Price Calculations Therapeutic Discovery Project Tax Credit S.3232: A Bill to Amend the Internal Revenue Code of 1986 and the Patient Protection and Affordable Care Act to Extend, Expand, and Improve the Qualifying Therapeutic Discovery Project Program Extension Rare Pediatric & Tropical Disease Drug Development Drug Safety and Review/Prescription Drug User Fee Act (PDUFA) Reauthorization Access to External Experts Conflicts of Interest Drug Shortages E-Pedigree and Anti-Counterfeiting (Sens. Michael Bennett/Richard Burr Discussion Draft) Expedited Approval Pathways FDA Mission Regulatory Reforms for Innovative Products Supply Chain Integrity Implementation of P.L. No: 112-144: The Food and Drug Administration Safety and Innovation Act Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) (2) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY2013 Independent Payment Advisory Board H.R. 5: Protecting Access to Healthcare Act of 2011 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Biodefense Research, Development, and Procurement HHS Countermeasures Review S.1855/H.R. 2405: Pandemic and All Hazards Preparedness Act Reauthorization of 2011 TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Regulatory Transparency Reimbursement for Innovative Products Medicare Part D Prescription Drug Program Medicare Part B Physician-Administered Products Sequestration of PDUFA Fees Implementation of P.L. No: 112-25: Budget Control Act

Funding for National Institutes of Health National Center for Advancing Translational Sciences (NCATS) S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Vaccine Access/Financing Federal Response to the Rising Rates of Autism Tax for Seasonal Influenza Funding H.R. 6687/S.3716: A Bill to Amend the Internal Revenue Code of 1986 to Include Vaccines against Seasonal Influenza within the Definition of Taxable Vaccines 340B Drug Pricing Program HRSA Implementation of Program Changes Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act of 2010 Average Manufacturer Price Calculations Therapeutic Discovery Project Tax Credit S.3232: A Bill to Amend the Internal Revenue Code of 1986 and the Patient Protection and Affordable Care Act to Extend, Expand, and Improve the Qualifying Therapeutic Discovery Project Program Drug Safety and Review E-Pedigree and Anti-Counterfeiting (Sens. Michael Bennett/Richard Burr Discuss Draft) Supply Chain Integrity Implementation of P.L. No: 112-144: The Food and Drug Administration Safety and Innovation Act of 2012 Pharmacy Compounding Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Independent Payment Advisory Board H.R. 5: Protecting Access to Healthcare Act of 2011 Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act of 2010 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development, and Procurement S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Biodefense Research, Development, and Procurement S 1855/H.R. 2405: Pandemic and All Hazards Preparedness Act Reauthorization of 2011 HHS Countermeasures Review TransPacific Partnership Data and Intellectual Property Protections for Pharmaceuticals Regulatory Transparency Reimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program Sequestration of PDUFA Fees Implementation of P.L. No: 112-25: Budget Control Act Medicaid Rebates

Funding for National Institutes of Health National Center for Advancing Translational Sciences (NCATS) S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Vaccine Access/Financing Federal Response to the Rising Rates of Autism Tax for Seasonal Influenza Funding H.R. 6687/S.3716: A Bill to Amend the Internal Revenue Code of 1986 to Include Vaccines against Seasonal Influenza within the Definition of Taxable Vaccines 340B Drug Pricing Program HRSA Implementation of Program Changes Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act of 2010 Average Manufacturer Price Calculations Therapeutic Discovery Project Tax Credit S.3232: A Bill to Amend the Internal Revenue Code of 1986 and the Patient Protection and Affordable Care Act to Extend, Expand, and Improve the Qualifying Therapeutic Discovery Project Program Drug Safety and Review E-Pedigree and Anti-Counterfeiting (Sens. Michael Bennett/Richard Burr Discuss Draft) Supply Chain Integrity Implementation of P.L. No: 112-144: The Food and Drug Administration Safety and Innovation Act of 2012 Pharmacy Compounding Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Independent Payment Advisory Board H.R. 5: Protecting Access to Healthcare Act of 2011 Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act of 2010 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development, and Procurement S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Biodefense Research, Development, and Procurement S 1855/H.R. 2405: Pandemic and All Hazards Preparedness Act Reauthorization of 2011 HHS Countermeasures Review TransPacific Partnership Data and Intellectual Property Protections for Pharmaceuticals Regulatory Transparency Reimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program Sequestration of PDUFA Fees Implementation of P.L. No: 112-25: Budget Control Act Medicaid Rebates

Medicaid Rebates Dual Eligibles Generic Fill Incentives Medicare Prescription Drug Coverage Transfer of Certain Drugs from Part B to Part D Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Drug Shortages H.R. 2245: Preserving Access to Life Saving Medicines Act of 2011 S. 296: Preserving Access to Life-Savings Medicines Act of 2011

Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning USDA/APHIS Agricultural Biotechnology Regulations Coexistence of Production Systems Genetically Engineered (GE) Animals Labeling FDA Approval S. 1717: Prevention of Escapement of Genetically Altered Salmon in the United States Act of 2012 H.R. 2112: Consolidated and Further Continuing Appropriations Act of 2012 Amendment to Restrict FDA Approval of GE Salmon Drug Importation H.R. 2112: Consolidated and Further Continuing Appropriations Act of 2012 Labeling of Genetically Engineered Crops U.S. Government Policy Drug Safety and Review FDA Globalization Act (Discussion Draft) Prescription Drug User Fee Act (PDUFA) Reauthorization Regulatory Reforms for Innovative Products TREAT Act (Senate Discussion Draft) E-Pedigree and Anti-Counterfeiting Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Center for Veterinary Medicine, Scientific Infrastructure) H.R.2112: Consolidated and Further Continuing Appropriations Act of 2012 Drug Shortages S. 296: Preserving Access to Life-Savings Medicines Act of 2011 H.R. 2245: Preserving Access to Life Saving Medicines Act of 2011

Drug Importation H.R. 2112: Consolidated and Further Continuing Appropriations Act of 2012 Medicaid Rebates Dual Eligibles S. 365: Budget Control Act of 2011 Drug Shortages S. 296: Preserving Access to Life-Savings Medicines Act of 2011 H.R. 2245: Preserving Access to Life Saving Medicines Act of 2011 Reimbursement for Innovative Products Medicare Part D Prescription Drug Program

TransPacific Partnership Data and Intellectual Property Protections for Pharmaceuticals Biosimilars Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Funding for National Institutes of Health S.R. 1599: Departments of Labor, HHS, Education, and Related Agencies Appropriations for FY 2012 Funding for Centers for Disease Control and Prevention Vaccine Programs S.R. 1599: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2012 Reporting of Physician Payments Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Vaccine Access/Financing Adult Immunization Policies Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act 340B Drug Pricing Program Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act HRSA Implementation of Program Changes Federal Supply Schedule Access During Emergencies Expanded Access to Experimental Products Medicaid Rebates Dual Eligibles S 365: Budget Control Act of 2011 Drug Importation H.R. 2112: Consolidated and Further Continuing Appropriations Act of 2012 Diagnostics and Personalized Medicine Regulation and Oversight Therapeutic Discovery Project Tax Credit Extension Rare Pediatric & Tropical Disease Drug Development Drug Safety and Review FDA Globalization Act (Discussion Draft) Prescription Drug User Fee Act (PDUFA) Reauthorization Regulatory Reforms for Innovative Products TREAT Act (Senate Discussion Draft) E-Pedigree and Anti-Counterfeiting Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Center for Veterinary Medicine, Scientific Infrastructure) H.R. 2112: Consolidated and Further Continuing Appropriations Act of 2012 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S.R. 1599: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2012 Cures Acceleration Network S. R. 1599: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2012 National Center for Advancing Translational Sciences S.R. 1599: Departments of Labor, HHS, Education, and Related Agencies Appropriations for FY 2012 Biodefense Research, Development and Procurement HHS Countermeasures Review S. 1855: Pandemic and All Hazards Preparedness Act Reauthorization of 2011 Drug Shortages S. 296: Preserving Access to Life-Savings Medicines Act of 2011 H.R. 2245: Preserving Access to Life Saving Medicines Act of 2011 Reimbursement for Innovative Products Part B Physician-Administered Products Medicare Part D Prescription Drug Program International Biosecurity Policies Biologics and Toxins Weapons Convention

Medicaid Rebates Dual Eligibles Generic Fill Incentives Medicare Prescription Drug Coverage Transfer of Certain Drugs from Part B to Part D Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Biosimilars Implementation of H.R. 3590:(Senate) Patient Protection and Affordable Care Act Reimbursement Issues Funding for National Institutes of Health S.R. 1599: Departments of Labor, Health and Human Services, Education, and Related Agencies Appropriations for FY 2012 Funding for Centers for Disease Control and Prevention Vaccine Programs S.R. 1599: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2012 Expansion of 340B Drug Pricing Program Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Diagnostics and Personalized Medicine Regulation and Oversight Therapeutic Discovery Project Tax Credit Extension Rare Pediatric & Tropical Disease Drug Development Drug Safety and Review S. 1584: Drug Safety and Accountability Act of 2011 Prescription Drug User Fee Act (PDUFA) Reauthorization Regulatory Reforms for Innovative Products Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Center for Veterinary Medicine, Scientific Infrastructure) H.R. 2112: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2012 Independent Payment Advisory Board Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S.R. 1599: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2012 Cures Acceleration Network S. 1599: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2012 Biodefense Research, Development and Procurement (Non-Funding Issues) Pandemic and All-Hazards Preparedness Act Reauthorization HHS Countermeasures Review Drug Shortages H.R. 2245: Preserving Access to Life Saving Medicines Act of 2011 S. 296: Preserving Access to Life-Savings Medicines Act of 2011 TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Reimbursement for Innovative Products Part B Physician-Administered Products Medicare Policies and Regulation

Medicaid Rebates Dual Eligibles Generic Fill Incentives Medicare Prescription Drug Coverage Transfer of Certain Drugs from Part B to Part D Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Drug Shortages H.R. 2245: Preserving Access to Life Saving Medicines Act of 2011 S. 296: Preserving Access to Life-Savings Medicines Act of 2011

Medicaid Rebates Dual Eligibles Medicare Prescription Drug Coverage Transfer of Certain Drugs from Part B to Part D Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Independent Payment Advisory Board Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Reimbursement for Innovative Products Part B Physician-Administered Products Medicare Policies and Regulation

TransPacific Partnership Data and Intellectual Property Protections for Pharmaceuticals Biosimilars Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Funding for National Institutes of Health S.R. 1599: Departments of Labor, HHS, Education, and Related Agencies Appropriations for FY 2012 Funding for Centers for Disease Control and Prevention Vaccine Programs S.R. 1599: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2012 Reporting of Physician Payments Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Vaccine Access/Financing Adult Immunization Policies Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act 340B Drug Pricing Program Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act HRSA Implementation of Program Changes Federal Supply Schedule Access During Emergencies Expanded Access to Experimental Products Medicaid Rebates Dual Eligibles S 365: Budget Control Act of 2011 Drug Importation H.R. 2112: Consolidated and Further Continuing Appropriations Act of 2012 Diagnostics and Personalized Medicine Regulation and Oversight Therapeutic Discovery Project Tax Credit Extension Rare Pediatric & Tropical Disease Drug Development Drug Safety and Review FDA Globalization Act (Discussion Draft) Prescription Drug User Fee Act (PDUFA) Reauthorization Regulatory Reforms for Innovative Products TREAT Act (Senate Discussion Draft) E-Pedigree and Anti-Counterfeiting Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Center for Veterinary Medicine, Scientific Infrastructure) H.R. 2112: Consolidated and Further Continuing Appropriations Act of 2012 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S.R. 1599: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2012 Cures Acceleration Network S. R. 1599: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2012 National Center for Advancing Translational Sciences S.R. 1599: Departments of Labor, HHS, Education, and Related Agencies Appropriations for FY 2012 Biodefense Research, Development and Procurement HHS Countermeasures Review S. 1855: Pandemic and All Hazards Preparedness Act Reauthorization of 2011 Drug Shortages S. 296: Preserving Access to Life-Savings Medicines Act of 2011 H.R. 2245: Preserving Access to Life Saving Medicines Act of 2011 Reimbursement for Innovative Products Part B Physician-Administered Products Medicare Part D Prescription Drug Program International Biosecurity Policies Biologics and Toxins Weapons Convention

Medicaid Rebates Dual Eligibles Generic Fill Incentives Medicare Prescription Drug Coverage Transfer of Certain Drugs from Part B to Part D Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Biosimilars Implementation of H.R. 3590:(Senate) Patient Protection and Affordable Care Act Reimbursement Issues Funding for National Institutes of Health S.R. 1599: Departments of Labor, Health and Human Services, Education, and Related Agencies Appropriations for FY 2012 Funding for Centers for Disease Control and Prevention Vaccine Programs S.R. 1599: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2012 Expansion of 340B Drug Pricing Program Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Diagnostics and Personalized Medicine Regulation and Oversight Therapeutic Discovery Project Tax Credit Extension Rare Pediatric & Tropical Disease Drug Development Drug Safety and Review S. 1584: Drug Safety and Accountability Act of 2011 Prescription Drug User Fee Act (PDUFA) Reauthorization Regulatory Reforms for Innovative Products Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Center for Veterinary Medicine, Scientific Infrastructure) H.R. 2112: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2012 Independent Payment Advisory Board Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S.R. 1599: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2012 Cures Acceleration Network S. 1599: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2012 Biodefense Research, Development and Procurement (Non-Funding Issues) Pandemic and All-Hazards Preparedness Act Reauthorization HHS Countermeasures Review Drug Shortages H.R. 2245: Preserving Access to Life Saving Medicines Act of 2011 S. 296: Preserving Access to Life-Savings Medicines Act of 2011 TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Reimbursement for Innovative Products Part B Physician-Administered Products Medicare Policies and Regulation