ROBERT FILIPPONE

H.R. 1263, Excellence in Mental Health Act: Sets forth criteria for the certification of federally-qualified community behavioral health centers H.R. 2674, 340B Program Improvement Act: Provisions related to 340B (112th Congress) H.R. 6288, Patient Choice Act: To permit provisional approval of fast track products (112th Congress)H.R. 6342, Compassionate Freedom of Choice Act: Provisions related to access to investigational drugs or devices for terminally ill patients (112th Congress) H.R. 6584, Verifying Authority and Legality In Drug Compounding Act: Provisions relating to drug compounding (112th Congress) S. 264, Excellence in Mental Health Act: Sets forth criteria for the certification of federally-qualified community behavioral health centers S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages (112th Congress) S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B (112th Congress) S. 3187, Food and Drug Administration Safety and Innovation Act: Provisions related to user fee reauthorization and FDA reform (112th Congress) Implementation issues relating to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including PPACA; Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking Comparative effectiveness policy issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues Pharmaceutical supply chain security issues Pharmaceutical compounding policy issues Prescription drug abuse policy issues FDA Accelerated Approval policy issues Unapproved Use/Off-label policy issues 340B policy issues

H.R. 1263, Excellence in Mental Health Act: Sets forth criteria for the certification of federally-qualified community behavioral health centers H.R. 2674, 340B Program Improvement Act: Provisions related to 340B (112th Congress) H.R. 1919, Safeguarding America's Pharmaceuticals Act of 2013: Provisions related to supply chain securityH.R. 2090, Patient Choice Act of 2013: To permit provisional approval of fast track products H.R. 2415, Treat and Reduce Obesity Act of 2013: To include coverage of obesity drugs in Part D H.R. 6584, Verifying Authority and Legality In Drug Compounding Act: Provisions relating to drug compounding (112th Congress) S. 264, Excellence in Mental Health Act: Sets forth criteria for the certification of federally-qualified community behavioral health centers S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B (112th Congress) S. 3187, Food and Drug Administration Safety and Innovation Act: Provisions related to user fee reauthorization and FDA reform (112th Congress) S. 957, Drug Supply Chain Security Act: Provisions related to supply chain security S. 959, Pharmaceutical Compounding Quality and Accountability Act: Provisions related to pharmaceutical compounding S. 2295, Patient Safety and Generic Labeling Improvement Act: Provisions related to drug safety labeling (112th Congress) Implementation issues relating to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including PPACA; Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking Comparative effectiveness policy issues Academic detailing policy issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues Pharmaceutical supply chain security issues Pharmaceutical compounding policy issues Prescription drug abuse policy issues FDA accelerated approval policy issues Unapproved use policy issues 340B policy issues

H.R. 8, American Taxpayer Relief Act of 2012: Medicare and tax related provisions (112th Congress) H.R. 351, Protecting Seniors Access to Medicare Act of 2013: Provisions related to the Independent Payment Advisory Board H.R. 460, Patients Access to Treatments Act of 2013: Provisions related to capping specialty tier drugs and no cost-sharing above the non-preferred brand tierH.R. 928, Medicare Prescription Drug Savings and Choice Act of 2013: Provisions related to Part D issues H.R. 1588, Medicare Drug Savings Act of 2013: Provisions related to Part D issues H.R. 2827, To amend title XVIII of the Social Security Act to allow for fair application of the exceptions process for drugs in tiers in formularies in prescription drug plans under Medicare part D: Provisions related to Medicare Part D Drug Tier Formularies H.R. 2925, Strengthening Medicare Anti-Fraud Measures Act of 2013 S. 117, Medicare Prescription Drug Price Negotiation Act of 2013: Provisions related to Part D issues S. 351, Protecting Seniors Access to Medicare Act of 2013: Provisions related to Independent Payment Advisory Board S. 408, Medicare Prescription Drug Savings and Choice Act of 2013: Provision related to Part D issues S. 740, Medicare Drug Savings Act of 2013: Provisions related to Part D issues Deficit reduction policy issues Medicaid Program, Covered Outpatient Drugs rulemaking Dual eligibles coordination policy issues Implementation issues relating to the Physician Payment Sunshine Act, including Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking

H.R. 8, American Taxpayer Relief Act of 2012: Medicare and tax related provisions (112th Congress) H.R. 351, Protecting Seniors' Access to Medicare Act of 2013: Provisions related to Independent Payment Advisory Board H.R. 928, Medicare Prescription Drug Savings and Choice Act of 2013: Provisions related to Part D issues H.R. 1588, Medicare Drug Savings Act of 2013: Provisions related to Part D issuesH.R. 460, Patients Access to Treatments Act of 2013: Provisions related to capping specialty tier drugs and no cost-sharing above the non-preferred brand tier S. 117, Medicare Prescription Drug Price Negotiation Act of 2013: Provisions related to Part D issues S. 351, Protecting Seniors Access to Medicare Act of 2013: Provisions related to Independent Payment Advisory Board S. 408, Medicare Prescription Drug Savings and Choice Act of 2013: Provisions related to Part D issues S. 740, Medicare Drug Savings Act of 2013: Provisions related to Part D issues Deficit reduction policy issues Medicaid Program, Covered Outpatient Drugs rulemaking Dual eligibles coordination policy issues Implementation issues relating to the Physician Payment Sunshine Act, including Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking

H.R. 1263, Excellence in Mental Health Act: Sets forth criteria for the certification of federally-qualified community behavioral health centers H.R. 2674, 340B Program Improvement Act: Provisions related to 340B (112th Congress) H.R. 1919, Safeguarding America's Pharmaceuticals Act of 2013: Provisions related to supply chain securityH.R. 2090, Patient Choice Act of 2013: To permit provisional approval of fast track products H.R. 2415, Treat and Reduce Obesity Act of 2013: To include coverage of obesity drugs in Part D H.R. 6584, Verifying Authority and Legality In Drug Compounding Act: Provisions relating to drug compounding (112th Congress) S. 264, Excellence in Mental Health Act: Sets forth criteria for the certification of federally-qualified community behavioral health centers S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B (112th Congress) S. 3187, Food and Drug Administration Safety and Innovation Act: Provisions related to user fee reauthorization and FDA reform (112th Congress) S. 957, Drug Supply Chain Security Act: Provisions related to supply chain security S. 959, Pharmaceutical Compounding Quality and Accountability Act: Provisions related to pharmaceutical compounding S. 2295, Patient Safety and Generic Labeling Improvement Act: Provisions related to drug safety labeling (112th Congress) Implementation issues relating to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including PPACA; Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking Comparative effectiveness policy issues Academic detailing policy issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues Pharmaceutical supply chain security issues Pharmaceutical compounding policy issues Prescription drug abuse policy issues FDA accelerated approval policy issues Unapproved use policy issues 340B policy issues

H.R. 1263, Excellence in Mental Health Act: Sets forth criteria for the certification of federally-qualified community behavioral health centers H.R. 2674, 340B Program Improvement Act: Provisions related to 340B (112th Congress) H.R. 1919, Safeguarding America's Pharmaceuticals Act of 2013: Provisions related to supply chain securityH.R. 2090, Patient Choice Act of 2013: To permit provisional approval of fast track products H.R. 2415, Treat and Reduce Obesity Act of 2013: To include coverage of obesity drugs in Part D H.R. 3204, Drug Quality and Security Act: Provisions relating to pharmacy compounding and supply chain H.R. 6584, Verifying Authority and Legality In Drug Compounding Act: Provisions relating to drug compounding (112th Congress) S. 264, Excellence in Mental Health Act: Sets forth criteria for the certification of federally-qualified community behavioral health centers S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B (112th Congress) S. 3187, Food and Drug Administration Safety and Innovation Act: Provisions related to user fee reauthorization and FDA reform (112th Congress) S. 957, Drug Supply Chain Security Act: Provisions related to supply chain security S. 959, Pharmaceutical Compounding Quality and Accountability Act: Provisions related to pharmaceutical compounding S. 2295, Patient Safety and Generic Labeling Improvement Act: Provisions relating to drug safety labeling (112th Congress) Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including PPACA; Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking Comparative effectiveness policy issues Academic detailing policy issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues Prescription drug abuse policy issues FDA accelerated approval policy issues Unapproved use policy issues 340B policy issues

H.R. 22, Foreign Counterfeit Merchandise Prevention Act: Provisions related to counterfeiting H.R. 845, Saving High-Tech Innovators from Egregious Legal Disputes Act of 2013 (the SHIELD Act): Provisions related to patent litigation H.R. 2024, End Anonymous Patents Act: Patent owner information provisionsH.R. 2582, PATENT Jobs Act: Provisions related to patent user fees H.R. 2605, Manufacturing Innovation in America Act of 2013: Provisions related to patent tax boxes S. 214, Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 504, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements S. 626, Prize Fund for HIV/AIDS Act: Medical prize provisions S. 627, Medical Innovation Prize Fund Act: Medical prize provisions S. 712, Patents for Humanity Program Improvement Act of 2013: Transferability of PTO vouchers provisions S. 866, Patent Quality Improvement Act of 2013: Business methods patents provisions S. 1013, Patent Abuse Reduction Act of 2013: Patent litigation provisions Biopharmaceutical innovation policy issues Potential legislation regarding patent litigation issues America Invents Act issues including estoppel for post grant review Biologics data protection issues Counterfeit drug issues Premerger Notification; Reporting and Waiting Period Requirements; Notice of proposed rulemaking (77 Federal Register 50057)

H.R. 22, Foreign Counterfeit Merchandise Prevention Act: Provisions related to counterfeiting H.R. 845, Saving High-Tech Innovators from Egregious Legal Disputes Act of 2013 (the SHIELD Act): Provisions related to patent litigation H.R. 2024, End Anonymous Patents Act: Patent owner information provisionsH.R. 2582, PATENT Jobs Act: Provisions related to patent user fees H.R. 2605, Manufacturing Innovation in America Act of 2013: Provisions related to patent tax boxes H.R. 2639, Patent Litigation and Innovation Act: Patent litigation proposals H.R. 2766, STOP Act: Provisions related to business method patents H.R. 2985: Combination Drug Development Incentive Act of 2013: Provisions related to drug exclusivity H.R. 3116, Moddern Cures Act of 2013: Provisions related to drug exclusivity S. 214, Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 504, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements S. 626, Prize Fund for HIV/AIDS Act: Medical prize provisions S. 627, Medical Innovation Prize Fund Act: Medical prize provisions S. 712, Patents for Humanity Program Improvement Act of 2013: Transferability of PTO vouchers provisions S. 866, Patent Quality Improvement Act of 2013: Business methods patents provisions S. 1013, Patent Abuse Reduction Act of 2013: Patent litigation provisions Biopharmaceutical innovation policy issues Potential legislation regarding patent litigation issues America Invents Act issues including estoppel for post grant review Biologics data protection issues

H.R. 22, Foreign Counterfeit Merchandise Prevention Act: Provisions related to counterfeiting H.R. 845, Saving High-Tech Innovators from Egregious Legal Disputes Act of 2013 (the SHIELD Act): Provisions related to patent litigation H.R. 2024, End Anonymous Patents Act: Patent owner information provisionsH.R. 2582, PATENT Jobs Act: Provisions related to patent user fees H.R. 2605, Manufacturing Innovation in America Act of 2013: Provisions related to patent tax boxes H.R. 2639, Patent Litigation and Innovation Act: Patent litigation proposals H.R. 2766, STOP Act: Provisions related to business method patents H.R. 2985: Combination Drug Development Incentive Act of 2013: Provisions related to drug exclusivity H.R. 3116, Moddern Cures Act of 2013: Provisions related to drug exclusivity S. 214, Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 504, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements S. 626, Prize Fund for HIV/AIDS Act: Medical prize provisions S. 627, Medical Innovation Prize Fund Act: Medical prize provisions S. 712, Patents for Humanity Program Improvement Act of 2013: Transferability of PTO vouchers provisions S. 866, Patent Quality Improvement Act of 2013: Business methods patents provisions S. 1013, Patent Abuse Reduction Act of 2013: Patent litigation provisions Biopharmaceutical innovation policy issues Potential legislation regarding patent litigation issues America Invents Act issues including estoppel for post grant review Biologics data protection issues

H.R. 22, Foreign Counterfeit Merchandise Prevention Act: Provisions relating to counterfeiting H.R. 845, Saving High-Tech Innovators from Egregious Legal Disputes Act of 2013 (the SHIELD Act): Provisions related to patent litigation S. 214, The Preserve Access to Affordable Generics Act: Provisions related to patent settlementsS. 504, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements Patents for Humanity Program Biopharmaceutical innovation policy issues Potential legislation regarding patent litigation issues America Invents Act issues including estoppel for post grant review Biologics data protection issues Counterfeit drug issues Premerger Notification; Reporting and Waiting Period Requirements; Notice of proposed rulemaking (77 Federal Register 50057)

H.R. 22, Foreign Counterfeit Merchandise Prevention Act: Provisions related to counterfeiting H.R. 845, Saving High-Tech Innovators from Egregious Legal Disputes Act of 2013 (the SHIELD Act): Provisions related to patent litigation H.R. 2024, End Anonymous Patents Act: Patent owner information provisionsH.R. 2582, PATENT Jobs Act: Provisions related to patent user fees H.R. 2605, Manufacturing Innovation in America Act of 2013: Provisions related to patent tax boxes S. 214, Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 504, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements S. 626, Prize Fund for HIV/AIDS Act: Medical prize provisions S. 627, Medical Innovation Prize Fund Act: Medical prize provisions S. 712, Patents for Humanity Program Improvement Act of 2013: Transferability of PTO vouchers provisions S. 866, Patent Quality Improvement Act of 2013: Business methods patents provisions S. 1013, Patent Abuse Reduction Act of 2013: Patent litigation provisions Biopharmaceutical innovation policy issues Potential legislation regarding patent litigation issues America Invents Act issues including estoppel for post grant review Biologics data protection issues Counterfeit drug issues Premerger Notification; Reporting and Waiting Period Requirements; Notice of proposed rulemaking (77 Federal Register 50057)

H.R. 2410, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2014: Provisions related to FDA regulation and funding, sequestration, drug importation H.R. 2217, Department of Homeland Security Appropriations Act, 2014: Provisions related to Customs and Border Control Agency funding, drug importsH.R. 2216, Military Construction and Veterans Affairs, and Related Agencies Appropriations Act, 2014: Provisions related to Veterans Affairs Administration regulation and funding, VA health benefits Department of Defense Appropriations Act, 2014 [no bill number]: Provisions related to bio-defense

H.J. Res. 59, FY14 Continuing Resolution Issues related to implementation of The Budget Control Act of 2011: Public Law No. 112-25 H.R. 2410, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2014: Provisions related to FDA regulation and funding, sequestration, drug importationH.R. 2217, Department of Homeland Security Appropriations Act, 2014: Provisions related to Customs and Border Control Agency funding, drug imports H.R. 2216, Military Construction and Veterans Affairs, and Related Agencies Appropriations Act, 2014: Provisions related to Veterans Affairs Administration regulation and funding, VA health benefits H.R. 2397, Department of Defense Appropriations Act, 2014: Provisions related to bio-defense H.R. 2725, Food and Drug Administration Safety Over Sequestration Act of 2013: Provisions related to FDA user fees

H.R. 1263, Excellence in Mental Health Act: Sets forth criteria for the certification of federally-qualified community behavioral health centers H.R. 2674, 340B Program Improvement Act: Provisions related to 340B (112th Congress) H.R. 1919, Safeguarding America's Pharmaceuticals Act of 2013: Provisions related to supply chain securityH.R. 2090, Patient Choice Act of 2013: To permit provisional approval of fast track products H.R. 2415, Treat and Reduce Obesity Act of 2013: To include coverage of obesity drugs in Part D H.R. 3204, Drug Quality and Security Act: Provisions relating to pharmacy compounding and supply chain H.R. 6584, Verifying Authority and Legality In Drug Compounding Act: Provisions relating to drug compounding (112th Congress) S. 264, Excellence in Mental Health Act: Sets forth criteria for the certification of federally-qualified community behavioral health centers S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B (112th Congress) S. 3187, Food and Drug Administration Safety and Innovation Act: Provisions related to user fee reauthorization and FDA reform (112th Congress) S. 957, Drug Supply Chain Security Act: Provisions related to supply chain security S. 959, Pharmaceutical Compounding Quality and Accountability Act: Provisions related to pharmaceutical compounding S. 2295, Patient Safety and Generic Labeling Improvement Act: Provisions relating to drug safety labeling (112th Congress) Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including PPACA; Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking Comparative effectiveness policy issues Academic detailing policy issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues Prescription drug abuse policy issues FDA accelerated approval policy issues Unapproved use policy issues 340B policy issues

H.R. 1263, Excellence in Mental Health Act: Sets forth criteria for the certification of federally-qualified community behavioral health centers H.R. 2674, 340B Program Improvement Act: Provisions related to 340B (112th Congress) H.R. 1919, Safeguarding America's Pharmaceuticals Act of 2013: Provisions related to supply chain securityH.R. 2090, Patient Choice Act of 2013: To permit provisional approval of fast track products H.R. 2415, Treat and Reduce Obesity Act of 2013: To include coverage of obesity drugs in Part D H.R. 6584, Verifying Authority and Legality In Drug Compounding Act: Provisions relating to drug compounding (112th Congress) S. 264, Excellence in Mental Health Act: Sets forth criteria for the certification of federally-qualified community behavioral health centers S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B (112th Congress) S. 3187, Food and Drug Administration Safety and Innovation Act: Provisions related to user fee reauthorization and FDA reform (112th Congress) S. 957, Drug Supply Chain Security Act: Provisions related to supply chain security S. 959, Pharmaceutical Compounding Quality and Accountability Act: Provisions related to pharmaceutical compounding S. 2295, Patient Safety and Generic Labeling Improvement Act: Provisions related to drug safety labeling (112th Congress) Implementation issues relating to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including PPACA; Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking Comparative effectiveness policy issues Academic detailing policy issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues Pharmaceutical supply chain security issues Pharmaceutical compounding policy issues Prescription drug abuse policy issues FDA accelerated approval policy issues Unapproved use policy issues 340B policy issues

H.R. 22, Foreign Counterfeit Merchandise Prevention Act: Provisions related to counterfeiting H.R. 845, Saving High-Tech Innovators from Egregious Legal Disputes Act of 2013 (the SHIELD Act): Provisions related to patent litigation H.R. 2024, End Anonymous Patents Act: Patent owner information provisionsH.R. 2582, PATENT Jobs Act: Provisions related to patent user fees H.R. 2605, Manufacturing Innovation in America Act of 2013: Provisions related to patent tax boxes S. 214, Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 504, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements S. 626, Prize Fund for HIV/AIDS Act: Medical prize provisions S. 627, Medical Innovation Prize Fund Act: Medical prize provisions S. 712, Patents for Humanity Program Improvement Act of 2013: Transferability of PTO vouchers provisions S. 866, Patent Quality Improvement Act of 2013: Business methods patents provisions S. 1013, Patent Abuse Reduction Act of 2013: Patent litigation provisions Biopharmaceutical innovation policy issues Potential legislation regarding patent litigation issues America Invents Act issues including estoppel for post grant review Biologics data protection issues Counterfeit drug issues Premerger Notification; Reporting and Waiting Period Requirements; Notice of proposed rulemaking (77 Federal Register 50057)

H.R. 22, Foreign Counterfeit Merchandise Prevention Act: Provisions related to counterfeiting H.R. 845, Saving High-Tech Innovators from Egregious Legal Disputes Act of 2013 (the SHIELD Act): Provisions related to patent litigation H.R. 2024, End Anonymous Patents Act: Patent owner information provisionsH.R. 2582, PATENT Jobs Act: Provisions related to patent user fees H.R. 2605, Manufacturing Innovation in America Act of 2013: Provisions related to patent tax boxes H.R. 2639, Patent Litigation and Innovation Act: Patent litigation proposals H.R. 2766, STOP Act: Provisions related to business method patents H.R. 2985: Combination Drug Development Incentive Act of 2013: Provisions related to drug exclusivity H.R. 3116, Moddern Cures Act of 2013: Provisions related to drug exclusivity S. 214, Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 504, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements S. 626, Prize Fund for HIV/AIDS Act: Medical prize provisions S. 627, Medical Innovation Prize Fund Act: Medical prize provisions S. 712, Patents for Humanity Program Improvement Act of 2013: Transferability of PTO vouchers provisions S. 866, Patent Quality Improvement Act of 2013: Business methods patents provisions S. 1013, Patent Abuse Reduction Act of 2013: Patent litigation provisions Biopharmaceutical innovation policy issues Potential legislation regarding patent litigation issues America Invents Act issues including estoppel for post grant review Biologics data protection issues

H.R. 22, Foreign Counterfeit Merchandise Prevention Act: Provisions related to counterfeiting H.R. 845, Saving High-Tech Innovators from Egregious Legal Disputes Act of 2013 (the SHIELD Act): Provisions related to patent litigation H.R. 2024, End Anonymous Patents Act: Patent owner information provisionsH.R. 2582, PATENT Jobs Act: Provisions related to patent user fees H.R. 2605, Manufacturing Innovation in America Act of 2013: Provisions related to patent tax boxes H.R. 2639, Patent Litigation and Innovation Act: Patent litigation proposals H.R. 2766, STOP Act: Provisions related to business method patents H.R. 2985: Combination Drug Development Incentive Act of 2013: Provisions related to drug exclusivity H.R. 3116, Moddern Cures Act of 2013: Provisions related to drug exclusivity S. 214, Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 504, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements S. 626, Prize Fund for HIV/AIDS Act: Medical prize provisions S. 627, Medical Innovation Prize Fund Act: Medical prize provisions S. 712, Patents for Humanity Program Improvement Act of 2013: Transferability of PTO vouchers provisions S. 866, Patent Quality Improvement Act of 2013: Business methods patents provisions S. 1013, Patent Abuse Reduction Act of 2013: Patent litigation provisions Biopharmaceutical innovation policy issues Potential legislation regarding patent litigation issues America Invents Act issues including estoppel for post grant review Biologics data protection issues

H.J. Res. 59, FY14 Continuing Resolution Issues related to implementation of The Budget Control Act of 2011: Public Law No. 112-25 H.R. 2410, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2014: Provisions related to FDA regulation and funding, sequestration, drug importationH.R. 2217, Department of Homeland Security Appropriations Act, 2014: Provisions related to Customs and Border Control Agency funding, drug imports H.R. 2216, Military Construction and Veterans Affairs, and Related Agencies Appropriations Act, 2014: Provisions related to Veterans Affairs Administration regulation and funding, VA health benefits H.R. 2397, Department of Defense Appropriations Act, 2014: Provisions related to bio-defense H.R. 2725, Food and Drug Administration Safety Over Sequestration Act of 2013: Provisions related to FDA user fees

H.R. 22, Foreign Counterfeit Merchandise Prevention Act: Provisions related to counterfeiting H.R. 845, Saving High-Tech Innovators from Egregious Legal Disputes Act of 2013 (the SHIELD Act): Provisions related to patent litigation H.R. 2024, End Anonymous Patents Act: Patent owner information provisionsH.R. 2582, PATENT Jobs Act: Provisions related to patent user fees H.R. 2605, Manufacturing Innovation in America Act of 2013: Provisions related to patent tax boxes H.R. 2639, Patent Litigation and Innovation Act: Patent litigation proposals H.R. 2766, STOP Act: Provisions related to business method patents H.R. 2985: Combination Drug Development Incentive Act of 2013: Provisions related to drug exclusivity H.R. 3116, Moddern Cures Act of 2013: Provisions related to drug exclusivity S. 214, Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 504, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements S. 626, Prize Fund for HIV/AIDS Act: Medical prize provisions S. 627, Medical Innovation Prize Fund Act: Medical prize provisions S. 712, Patents for Humanity Program Improvement Act of 2013: Transferability of PTO vouchers provisions S. 866, Patent Quality Improvement Act of 2013: Business methods patents provisions S. 1013, Patent Abuse Reduction Act of 2013: Patent litigation provisions Biopharmaceutical innovation policy issues Potential legislation regarding patent litigation issues America Invents Act issues including estoppel for post grant review Biologics data protection issues

H.R. 8, American Taxpayer Relief Act of 2012: Medicare and tax related provisions (112th Congress) H.R. 351, Protecting Seniors Access to Medicare Act of 2013: Provisions related to the Independent Payment Advisory Board H.R. 460, Patients Access to Treatments Act of 2013: Provisions related to capping specialty tier drugs and no cost-sharing above the non-preferred brand tierH.R. 928, Medicare Prescription Drug Savings and Choice Act of 2013: Provisions related to Part D issues H.R. 1588, Medicare Drug Savings Act of 2013: Provisions related to Part D issues H.R. 2827, To amend title XVIII of the Social Security Act to allow for fair application of the exceptions process for drugs in tiers in formularies in prescription drug plans under Medicare part D: Provisions related to Medicare Part D Drug Tier Formularies H.R. 2925, Strengthening Medicare Anti-Fraud Measures Act of 2013 S. 117, Medicare Prescription Drug Price Negotiation Act of 2013: Provisions related to Part D issues S. 351, Protecting Seniors Access to Medicare Act of 2013: Provisions related to Independent Payment Advisory Board S. 408, Medicare Prescription Drug Savings and Choice Act of 2013: Provision related to Part D issues S. 740, Medicare Drug Savings Act of 2013: Provisions related to Part D issues Deficit reduction policy issues Medicaid Program, Covered Outpatient Drugs rulemaking Dual eligibles coordination policy issues Implementation issues relating to the Physician Payment Sunshine Act, including Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking

H.R. 8, American Taxpayer Relief Act of 2012: Medicare and tax related provisions (112th Congress) H.R. 351, Protecting Seniors Access to Medicare Act of 2013: Provisions related to the Independent Payment Advisory Board H.R. 460, Patients Access to Treatments Act of 2013: Provisions related to capping specialty tier drugs and no cost-sharing above the non-preferred brand tierH.R. 928, Medicare Prescription Drug Savings and Choice Act of 2013: Provisions related to Part D issues H.R. 1588, Medicare Drug Savings Act of 2013: Provisions related to Part D issues H.R. 2827, To amend title XVIII of the Social Security Act to allow for fair application of the exceptions process for drugs in tiers in formularies in prescription drug plans under Medicare part D: Provisions related to Medicare Part D Drug Tier Formularies H.R. 2925, Strengthening Medicare Anti-Fraud Measures Act of 2013 S. 117, Medicare Prescription Drug Price Negotiation Act of 2013: Provisions related to Part D issues S. 351, Protecting Seniors Access to Medicare Act of 2013: Provisions related to Independent Payment Advisory Board S. 408, Medicare Prescription Drug Savings and Choice Act of 2013: Provision related to Part D issues S. 740, Medicare Drug Savings Act of 2013: Provisions related to Part D issues Deficit reduction policy issues Medicaid Program, Covered Outpatient Drugs rulemaking Dual eligibles coordination policy issues Implementation issues relating to the Physician Payment Sunshine Act, including Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking

H.R. 22, Foreign Counterfeit Merchandise Prevention Act: Provisions related to counterfeiting H.R. 845, Saving High-Tech Innovators from Egregious Legal Disputes Act of 2013 (the SHIELD Act): Provisions related to patent litigation H.R. 2024, End Anonymous Patents Act: Patent owner information provisionsH.R. 2582, PATENT Jobs Act: Provisions related to patent user fees H.R. 2605, Manufacturing Innovation in America Act of 2013: Provisions related to patent tax boxes H.R. 2639, Patent Litigation and Innovation Act: Patent litigation proposals H.R. 2766, STOP Act: Provisions related to business method patents H.R. 2985: Combination Drug Development Incentive Act of 2013: Provisions related to drug exclusivity H.R. 3116, Moddern Cures Act of 2013: Provisions related to drug exclusivity S. 214, Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 504, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements S. 626, Prize Fund for HIV/AIDS Act: Medical prize provisions S. 627, Medical Innovation Prize Fund Act: Medical prize provisions S. 712, Patents for Humanity Program Improvement Act of 2013: Transferability of PTO vouchers provisions S. 866, Patent Quality Improvement Act of 2013: Business methods patents provisions S. 1013, Patent Abuse Reduction Act of 2013: Patent litigation provisions Biopharmaceutical innovation policy issues Potential legislation regarding patent litigation issues America Invents Act issues including estoppel for post grant review Biologics data protection issues

H.R. 22, Foreign Counterfeit Merchandise Prevention Act: Provisions related to counterfeiting H.R. 845, Saving High-Tech Innovators from Egregious Legal Disputes Act of 2013 (the SHIELD Act): Provisions related to patent litigation H.R. 2024, End Anonymous Patents Act: Patent owner information provisionsH.R. 2582, PATENT Jobs Act: Provisions related to patent user fees H.R. 2605, Manufacturing Innovation in America Act of 2013: Provisions related to patent tax boxes H.R. 2639, Patent Litigation and Innovation Act: Patent litigation proposals H.R. 2766, STOP Act: Provisions related to business method patents H.R. 2985: Combination Drug Development Incentive Act of 2013: Provisions related to drug exclusivity H.R. 3116, Moddern Cures Act of 2013: Provisions related to drug exclusivity S. 214, Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 504, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements S. 626, Prize Fund for HIV/AIDS Act: Medical prize provisions S. 627, Medical Innovation Prize Fund Act: Medical prize provisions S. 712, Patents for Humanity Program Improvement Act of 2013: Transferability of PTO vouchers provisions S. 866, Patent Quality Improvement Act of 2013: Business methods patents provisions S. 1013, Patent Abuse Reduction Act of 2013: Patent litigation provisions Biopharmaceutical innovation policy issues Potential legislation regarding patent litigation issues America Invents Act issues including estoppel for post grant review Biologics data protection issues

H.R. 1263, Excellence in Mental Health Act: Sets forth criteria for the certification of federally-qualified community behavioral health centers H.R. 2674, 340B Program Improvement Act: Provisions related to 340B (112th Congress) H.R. 1919, Safeguarding America's Pharmaceuticals Act of 2013: Provisions related to supply chain securityH.R. 2090, Patient Choice Act of 2013: To permit provisional approval of fast track products H.R. 2415, Treat and Reduce Obesity Act of 2013: To include coverage of obesity drugs in Part D H.R. 3204, Drug Quality and Security Act: Provisions relating to pharmacy compounding and supply chain H.R. 6584, Verifying Authority and Legality In Drug Compounding Act: Provisions relating to drug compounding (112th Congress) S. 264, Excellence in Mental Health Act: Sets forth criteria for the certification of federally-qualified community behavioral health centers S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B (112th Congress) S. 3187, Food and Drug Administration Safety and Innovation Act: Provisions related to user fee reauthorization and FDA reform (112th Congress) S. 957, Drug Supply Chain Security Act: Provisions related to supply chain security S. 959, Pharmaceutical Compounding Quality and Accountability Act: Provisions related to pharmaceutical compounding S. 2295, Patient Safety and Generic Labeling Improvement Act: Provisions relating to drug safety labeling (112th Congress) Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including PPACA; Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking Comparative effectiveness policy issues Academic detailing policy issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues Prescription drug abuse policy issues FDA accelerated approval policy issues Unapproved use policy issues 340B policy issues

H.R. 8, American Taxpayer Relief Act of 2012: Medicare and tax related provisions (112th Congress) H.R. 351, Protecting Seniors Access to Medicare Act of 2013: Provisions related to the Independent Payment Advisory Board H.R. 460, Patients Access to Treatments Act of 2013: Provisions related to capping specialty tier drugs and no cost-sharing above the non-preferred brand tierH.R. 928, Medicare Prescription Drug Savings and Choice Act of 2013: Provisions related to Part D issues H.R. 1588, Medicare Drug Savings Act of 2013: Provisions related to Part D issues H.R. 2827, To amend title XVIII of the Social Security Act to allow for fair application of the exceptions process for drugs in tiers in formularies in prescription drug plans under Medicare part D: Provisions related to Medicare Part D Drug Tier Formularies H.R. 2925, Strengthening Medicare Anti-Fraud Measures Act of 2013 S. 117, Medicare Prescription Drug Price Negotiation Act of 2013: Provisions related to Part D issues S. 351, Protecting Seniors Access to Medicare Act of 2013: Provisions related to Independent Payment Advisory Board S. 408, Medicare Prescription Drug Savings and Choice Act of 2013: Provision related to Part D issues S. 740, Medicare Drug Savings Act of 2013: Provisions related to Part D issues Deficit reduction policy issues Medicaid Program, Covered Outpatient Drugs rulemaking Dual eligibles coordination policy issues Implementation issues relating to the Physician Payment Sunshine Act, including Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking

H.R. 8, American Taxpayer Relief Act of 2012: Medicare and tax related provisions (112th Congress) H.R. 351, Protecting Seniors' Access to Medicare Act of 2013: Provisions related to Independent Payment Advisory Board H.R. 928, Medicare Prescription Drug Savings and Choice Act of 2013: Provisions related to Part D issues H.R. 1588, Medicare Drug Savings Act of 2013: Provisions related to Part D issuesH.R. 460, Patients Access to Treatments Act of 2013: Provisions related to capping specialty tier drugs and no cost-sharing above the non-preferred brand tier S. 117, Medicare Prescription Drug Price Negotiation Act of 2013: Provisions related to Part D issues S. 351, Protecting Seniors Access to Medicare Act of 2013: Provisions related to Independent Payment Advisory Board S. 408, Medicare Prescription Drug Savings and Choice Act of 2013: Provisions related to Part D issues S. 740, Medicare Drug Savings Act of 2013: Provisions related to Part D issues Deficit reduction policy issues Medicaid Program, Covered Outpatient Drugs rulemaking Dual eligibles coordination policy issues Implementation issues relating to the Physician Payment Sunshine Act, including Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking

H.R. 8, American Taxpayer Relief Act of 2012: Medicare and tax related provisions (112th Congress) H.R. 351, Protecting Seniors Access to Medicare Act of 2013 H.R. 928, Medicare Prescription Drug Savings and Choice Act of 2013: Provisions related to Part D issues H.R. 2190, Medicare Drug Savings Act of 2011: Provisions related to Part D issues (112th Congress)H.R. 4209, Patients Access to Treatments Act of 2012: Capping specialty tier drugs and no cost-sharing above the non-preferred brand tier (112th Congress) S. 117, Medicare Prescription Drug Price Negotiation Act of 2013 S. 351, Protecting Seniors Access to Medicare Act of 2012 S. 408, Medicare Prescription Drug Savings and Choice Act of 2013 Deficit reduction policy issues Medicaid Program, Covered Outpatient Drugs rulemaking Dual eligibles coordination policy issues Implementation issues relating to the Physician Payment Sunshine Act, including Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking

H.R. 8, American Taxpayer Relief Act of 2012: Medicare and tax related provisions (112th Congress) H.R. 351, Protecting Seniors Access to Medicare Act of 2013: Provisions related to the Independent Payment Advisory Board H.R. 460, Patients Access to Treatments Act of 2013: Provisions related to capping specialty tier drugs and no cost-sharing above the non-preferred brand tierH.R. 928, Medicare Prescription Drug Savings and Choice Act of 2013: Provisions related to Part D issues H.R. 1588, Medicare Drug Savings Act of 2013: Provisions related to Part D issues H.R. 2827, To amend title XVIII of the Social Security Act to allow for fair application of the exceptions process for drugs in tiers in formularies in prescription drug plans under Medicare part D: Provisions related to Medicare Part D Drug Tier Formularies H.R. 2925, Strengthening Medicare Anti-Fraud Measures Act of 2013 S. 117, Medicare Prescription Drug Price Negotiation Act of 2013: Provisions related to Part D issues S. 351, Protecting Seniors Access to Medicare Act of 2013: Provisions related to Independent Payment Advisory Board S. 408, Medicare Prescription Drug Savings and Choice Act of 2013: Provision related to Part D issues S. 740, Medicare Drug Savings Act of 2013: Provisions related to Part D issues Deficit reduction policy issues Medicaid Program, Covered Outpatient Drugs rulemaking Dual eligibles coordination policy issues Implementation issues relating to the Physician Payment Sunshine Act, including Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking

H.R. 22, Foreign Counterfeit Merchandise Prevention Act: Provisions relating to counterfeiting H.R. 845, Saving High-Tech Innovators from Egregious Legal Disputes Act of 2013 (the SHIELD Act): Provisions related to patent litigation S. 214, The Preserve Access to Affordable Generics Act: Provisions related to patent settlementsS. 504, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements Patents for Humanity Program Biopharmaceutical innovation policy issues Potential legislation regarding patent litigation issues America Invents Act issues including estoppel for post grant review Biologics data protection issues Counterfeit drug issues Premerger Notification; Reporting and Waiting Period Requirements; Notice of proposed rulemaking (77 Federal Register 50057)

H.R. 22, Foreign Counterfeit Merchandise Prevention Act: Provisions related to counterfeiting H.R. 845, Saving High-Tech Innovators from Egregious Legal Disputes Act of 2013 (the SHIELD Act): Provisions related to patent litigation H.R. 2024, End Anonymous Patents Act: Patent owner information provisionsH.R. 2582, PATENT Jobs Act: Provisions related to patent user fees H.R. 2605, Manufacturing Innovation in America Act of 2013: Provisions related to patent tax boxes H.R. 2639, Patent Litigation and Innovation Act: Patent litigation proposals H.R. 2766, STOP Act: Provisions related to business method patents H.R. 2985: Combination Drug Development Incentive Act of 2013: Provisions related to drug exclusivity H.R. 3116, Moddern Cures Act of 2013: Provisions related to drug exclusivity S. 214, Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 504, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements S. 626, Prize Fund for HIV/AIDS Act: Medical prize provisions S. 627, Medical Innovation Prize Fund Act: Medical prize provisions S. 712, Patents for Humanity Program Improvement Act of 2013: Transferability of PTO vouchers provisions S. 866, Patent Quality Improvement Act of 2013: Business methods patents provisions S. 1013, Patent Abuse Reduction Act of 2013: Patent litigation provisions Biopharmaceutical innovation policy issues Potential legislation regarding patent litigation issues America Invents Act issues including estoppel for post grant review Biologics data protection issues

H.R. 22, Foreign Counterfeit Merchandise Prevention Act: Provisions related to counterfeiting H.R. 845, Saving High-Tech Innovators from Egregious Legal Disputes Act of 2013 (the SHIELD Act): Provisions related to patent litigation H.R. 2024, End Anonymous Patents Act: Patent owner information provisionsH.R. 2582, PATENT Jobs Act: Provisions related to patent user fees H.R. 2605, Manufacturing Innovation in America Act of 2013: Provisions related to patent tax boxes S. 214, Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 504, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements S. 626, Prize Fund for HIV/AIDS Act: Medical prize provisions S. 627, Medical Innovation Prize Fund Act: Medical prize provisions S. 712, Patents for Humanity Program Improvement Act of 2013: Transferability of PTO vouchers provisions S. 866, Patent Quality Improvement Act of 2013: Business methods patents provisions S. 1013, Patent Abuse Reduction Act of 2013: Patent litigation provisions Biopharmaceutical innovation policy issues Potential legislation regarding patent litigation issues America Invents Act issues including estoppel for post grant review Biologics data protection issues Counterfeit drug issues Premerger Notification; Reporting and Waiting Period Requirements; Notice of proposed rulemaking (77 Federal Register 50057)

H.R. 8, American Taxpayer Relief Act of 2012: Medicare and tax related provisions (112th Congress) H.R. 351, Protecting Seniors Access to Medicare Act of 2013 H.R. 928, Medicare Prescription Drug Savings and Choice Act of 2013: Provisions related to Part D issues H.R. 2190, Medicare Drug Savings Act of 2011: Provisions related to Part D issues (112th Congress)H.R. 4209, Patients Access to Treatments Act of 2012: Capping specialty tier drugs and no cost-sharing above the non-preferred brand tier (112th Congress) S. 117, Medicare Prescription Drug Price Negotiation Act of 2013 S. 351, Protecting Seniors Access to Medicare Act of 2012 S. 408, Medicare Prescription Drug Savings and Choice Act of 2013 Deficit reduction policy issues Medicaid Program, Covered Outpatient Drugs rulemaking Dual eligibles coordination policy issues Implementation issues relating to the Physician Payment Sunshine Act, including Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking

H.R. 8, American Taxpayer Relief Act of 2012: Medicare and tax related provisions (112th Congress) H.R. 351, Protecting Seniors' Access to Medicare Act of 2013: Provisions related to Independent Payment Advisory Board H.R. 928, Medicare Prescription Drug Savings and Choice Act of 2013: Provisions related to Part D issues H.R. 1588, Medicare Drug Savings Act of 2013: Provisions related to Part D issuesH.R. 460, Patients Access to Treatments Act of 2013: Provisions related to capping specialty tier drugs and no cost-sharing above the non-preferred brand tier S. 117, Medicare Prescription Drug Price Negotiation Act of 2013: Provisions related to Part D issues S. 351, Protecting Seniors Access to Medicare Act of 2013: Provisions related to Independent Payment Advisory Board S. 408, Medicare Prescription Drug Savings and Choice Act of 2013: Provisions related to Part D issues S. 740, Medicare Drug Savings Act of 2013: Provisions related to Part D issues Deficit reduction policy issues Medicaid Program, Covered Outpatient Drugs rulemaking Dual eligibles coordination policy issues Implementation issues relating to the Physician Payment Sunshine Act, including Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking

H.R. 22, Foreign Counterfeit Merchandise Prevention Act: Provisions related to counterfeiting H.R. 845, Saving High-Tech Innovators from Egregious Legal Disputes Act of 2013 (the SHIELD Act): Provisions related to patent litigation H.R. 2024, End Anonymous Patents Act: Patent owner information provisionsH.R. 2582, PATENT Jobs Act: Provisions related to patent user fees H.R. 2605, Manufacturing Innovation in America Act of 2013: Provisions related to patent tax boxes S. 214, Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 504, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements S. 626, Prize Fund for HIV/AIDS Act: Medical prize provisions S. 627, Medical Innovation Prize Fund Act: Medical prize provisions S. 712, Patents for Humanity Program Improvement Act of 2013: Transferability of PTO vouchers provisions S. 866, Patent Quality Improvement Act of 2013: Business methods patents provisions S. 1013, Patent Abuse Reduction Act of 2013: Patent litigation provisions Biopharmaceutical innovation policy issues Potential legislation regarding patent litigation issues America Invents Act issues including estoppel for post grant review Biologics data protection issues Counterfeit drug issues Premerger Notification; Reporting and Waiting Period Requirements; Notice of proposed rulemaking (77 Federal Register 50057)

H.R. 22, Foreign Counterfeit Merchandise Prevention Act: Provisions related to counterfeiting H.R. 845, Saving High-Tech Innovators from Egregious Legal Disputes Act of 2013 (the SHIELD Act): Provisions related to patent litigation H.R. 2024, End Anonymous Patents Act: Patent owner information provisionsH.R. 2582, PATENT Jobs Act: Provisions related to patent user fees H.R. 2605, Manufacturing Innovation in America Act of 2013: Provisions related to patent tax boxes H.R. 2639, Patent Litigation and Innovation Act: Patent litigation proposals H.R. 2766, STOP Act: Provisions related to business method patents H.R. 2985: Combination Drug Development Incentive Act of 2013: Provisions related to drug exclusivity H.R. 3116, Moddern Cures Act of 2013: Provisions related to drug exclusivity S. 214, Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 504, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements S. 626, Prize Fund for HIV/AIDS Act: Medical prize provisions S. 627, Medical Innovation Prize Fund Act: Medical prize provisions S. 712, Patents for Humanity Program Improvement Act of 2013: Transferability of PTO vouchers provisions S. 866, Patent Quality Improvement Act of 2013: Business methods patents provisions S. 1013, Patent Abuse Reduction Act of 2013: Patent litigation provisions Biopharmaceutical innovation policy issues Potential legislation regarding patent litigation issues America Invents Act issues including estoppel for post grant review Biologics data protection issues

H.R. 8, American Taxpayer Relief Act of 2012: Medicare and tax related provisions (112th Congress) H.R. 351, Protecting Seniors' Access to Medicare Act of 2013: Provisions related to Independent Payment Advisory Board H.R. 928, Medicare Prescription Drug Savings and Choice Act of 2013: Provisions related to Part D issues H.R. 1588, Medicare Drug Savings Act of 2013: Provisions related to Part D issuesH.R. 460, Patients Access to Treatments Act of 2013: Provisions related to capping specialty tier drugs and no cost-sharing above the non-preferred brand tier S. 117, Medicare Prescription Drug Price Negotiation Act of 2013: Provisions related to Part D issues S. 351, Protecting Seniors Access to Medicare Act of 2013: Provisions related to Independent Payment Advisory Board S. 408, Medicare Prescription Drug Savings and Choice Act of 2013: Provisions related to Part D issues S. 740, Medicare Drug Savings Act of 2013: Provisions related to Part D issues Deficit reduction policy issues Medicaid Program, Covered Outpatient Drugs rulemaking Dual eligibles coordination policy issues Implementation issues relating to the Physician Payment Sunshine Act, including Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking

H.R. 8, American Taxpayer Relief Act of 2012: Medicare and tax related provisions (112th Congress) H.R. 351, Protecting Seniors Access to Medicare Act of 2013 H.R. 928, Medicare Prescription Drug Savings and Choice Act of 2013: Provisions related to Part D issues H.R. 2190, Medicare Drug Savings Act of 2011: Provisions related to Part D issues (112th Congress)H.R. 4209, Patients Access to Treatments Act of 2012: Capping specialty tier drugs and no cost-sharing above the non-preferred brand tier (112th Congress) S. 117, Medicare Prescription Drug Price Negotiation Act of 2013 S. 351, Protecting Seniors Access to Medicare Act of 2012 S. 408, Medicare Prescription Drug Savings and Choice Act of 2013 Deficit reduction policy issues Medicaid Program, Covered Outpatient Drugs rulemaking Dual eligibles coordination policy issues Implementation issues relating to the Physician Payment Sunshine Act, including Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking

H.R. 8, American Taxpayer Relief Act of 2012: Medicare and tax related provisions (112th Congress) H.R. 351, Protecting Seniors Access to Medicare Act of 2013: Provisions related to the Independent Payment Advisory Board H.R. 460, Patients Access to Treatments Act of 2013: Provisions related to capping specialty tier drugs and no cost-sharing above the non-preferred brand tierH.R. 928, Medicare Prescription Drug Savings and Choice Act of 2013: Provisions related to Part D issues H.R. 1588, Medicare Drug Savings Act of 2013: Provisions related to Part D issues H.R. 2827, To amend title XVIII of the Social Security Act to allow for fair application of the exceptions process for drugs in tiers in formularies in prescription drug plans under Medicare part D: Provisions related to Medicare Part D Drug Tier Formularies H.R. 2925, Strengthening Medicare Anti-Fraud Measures Act of 2013 S. 117, Medicare Prescription Drug Price Negotiation Act of 2013: Provisions related to Part D issues S. 351, Protecting Seniors Access to Medicare Act of 2013: Provisions related to Independent Payment Advisory Board S. 408, Medicare Prescription Drug Savings and Choice Act of 2013: Provision related to Part D issues S. 740, Medicare Drug Savings Act of 2013: Provisions related to Part D issues Deficit reduction policy issues Medicaid Program, Covered Outpatient Drugs rulemaking Dual eligibles coordination policy issues Implementation issues relating to the Physician Payment Sunshine Act, including Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking

H.R. 22, Foreign Counterfeit Merchandise Prevention Act: Provisions relating to counterfeiting H.R. 845, Saving High-Tech Innovators from Egregious Legal Disputes Act of 2013 (the SHIELD Act): Provisions related to patent litigation S. 214, The Preserve Access to Affordable Generics Act: Provisions related to patent settlementsS. 504, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements Patents for Humanity Program Biopharmaceutical innovation policy issues Potential legislation regarding patent litigation issues America Invents Act issues including estoppel for post grant review Biologics data protection issues Counterfeit drug issues Premerger Notification; Reporting and Waiting Period Requirements; Notice of proposed rulemaking (77 Federal Register 50057)

H.R. 22, Foreign Counterfeit Merchandise Prevention Act: Provisions related to counterfeiting H.R. 845, Saving High-Tech Innovators from Egregious Legal Disputes Act of 2013 (the SHIELD Act): Provisions related to patent litigation H.R. 2024, End Anonymous Patents Act: Patent owner information provisionsH.R. 2582, PATENT Jobs Act: Provisions related to patent user fees H.R. 2605, Manufacturing Innovation in America Act of 2013: Provisions related to patent tax boxes H.R. 2639, Patent Litigation and Innovation Act: Patent litigation proposals H.R. 2766, STOP Act: Provisions related to business method patents H.R. 2985: Combination Drug Development Incentive Act of 2013: Provisions related to drug exclusivity H.R. 3116, Moddern Cures Act of 2013: Provisions related to drug exclusivity S. 214, Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 504, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements S. 626, Prize Fund for HIV/AIDS Act: Medical prize provisions S. 627, Medical Innovation Prize Fund Act: Medical prize provisions S. 712, Patents for Humanity Program Improvement Act of 2013: Transferability of PTO vouchers provisions S. 866, Patent Quality Improvement Act of 2013: Business methods patents provisions S. 1013, Patent Abuse Reduction Act of 2013: Patent litigation provisions Biopharmaceutical innovation policy issues Potential legislation regarding patent litigation issues America Invents Act issues including estoppel for post grant review Biologics data protection issues

H.R. 22, Foreign Counterfeit Merchandise Prevention Act: Provisions related to counterfeiting H.R. 845, Saving High-Tech Innovators from Egregious Legal Disputes Act of 2013 (the SHIELD Act): Provisions related to patent litigation H.R. 2024, End Anonymous Patents Act: Patent owner information provisionsH.R. 2582, PATENT Jobs Act: Provisions related to patent user fees H.R. 2605, Manufacturing Innovation in America Act of 2013: Provisions related to patent tax boxes S. 214, Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 504, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements S. 626, Prize Fund for HIV/AIDS Act: Medical prize provisions S. 627, Medical Innovation Prize Fund Act: Medical prize provisions S. 712, Patents for Humanity Program Improvement Act of 2013: Transferability of PTO vouchers provisions S. 866, Patent Quality Improvement Act of 2013: Business methods patents provisions S. 1013, Patent Abuse Reduction Act of 2013: Patent litigation provisions Biopharmaceutical innovation policy issues Potential legislation regarding patent litigation issues America Invents Act issues including estoppel for post grant review Biologics data protection issues Counterfeit drug issues Premerger Notification; Reporting and Waiting Period Requirements; Notice of proposed rulemaking (77 Federal Register 50057)

H.R. 1263, Excellence in Mental Health Act: Sets forth criteria for the certification of federally-qualified community behavioral health centers H.R. 2674, 340B Program Improvement Act: Provisions related to 340B (112th Congress) H.R. 1919, Safeguarding America's Pharmaceuticals Act of 2013: Provisions related to supply chain securityH.R. 2090, Patient Choice Act of 2013: To permit provisional approval of fast track products H.R. 2415, Treat and Reduce Obesity Act of 2013: To include coverage of obesity drugs in Part D H.R. 3204, Drug Quality and Security Act: Provisions relating to pharmacy compounding and supply chain H.R. 6584, Verifying Authority and Legality In Drug Compounding Act: Provisions relating to drug compounding (112th Congress) S. 264, Excellence in Mental Health Act: Sets forth criteria for the certification of federally-qualified community behavioral health centers S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B (112th Congress) S. 3187, Food and Drug Administration Safety and Innovation Act: Provisions related to user fee reauthorization and FDA reform (112th Congress) S. 957, Drug Supply Chain Security Act: Provisions related to supply chain security S. 959, Pharmaceutical Compounding Quality and Accountability Act: Provisions related to pharmaceutical compounding S. 2295, Patient Safety and Generic Labeling Improvement Act: Provisions relating to drug safety labeling (112th Congress) Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including PPACA; Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking Comparative effectiveness policy issues Academic detailing policy issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues Prescription drug abuse policy issues FDA accelerated approval policy issues Unapproved use policy issues 340B policy issues

H.R. 1263, Excellence in Mental Health Act: Sets forth criteria for the certification of federally-qualified community behavioral health centers H.R. 2674, 340B Program Improvement Act: Provisions related to 340B (112th Congress) H.R. 6288, Patient Choice Act: To permit provisional approval of fast track products (112th Congress)H.R. 6342, Compassionate Freedom of Choice Act: Provisions related to access to investigational drugs or devices for terminally ill patients (112th Congress) H.R. 6584, Verifying Authority and Legality In Drug Compounding Act: Provisions relating to drug compounding (112th Congress) S. 264, Excellence in Mental Health Act: Sets forth criteria for the certification of federally-qualified community behavioral health centers S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages (112th Congress) S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B (112th Congress) S. 3187, Food and Drug Administration Safety and Innovation Act: Provisions related to user fee reauthorization and FDA reform (112th Congress) Implementation issues relating to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including PPACA; Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking Comparative effectiveness policy issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues Pharmaceutical supply chain security issues Pharmaceutical compounding policy issues Prescription drug abuse policy issues FDA Accelerated Approval policy issues Unapproved Use/Off-label policy issues 340B policy issues

H.R. 1263, Excellence in Mental Health Act: Sets forth criteria for the certification of federally-qualified community behavioral health centers H.R. 2674, 340B Program Improvement Act: Provisions related to 340B (112th Congress) H.R. 1919, Safeguarding America's Pharmaceuticals Act of 2013: Provisions related to supply chain securityH.R. 2090, Patient Choice Act of 2013: To permit provisional approval of fast track products H.R. 2415, Treat and Reduce Obesity Act of 2013: To include coverage of obesity drugs in Part D H.R. 6584, Verifying Authority and Legality In Drug Compounding Act: Provisions relating to drug compounding (112th Congress) S. 264, Excellence in Mental Health Act: Sets forth criteria for the certification of federally-qualified community behavioral health centers S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B (112th Congress) S. 3187, Food and Drug Administration Safety and Innovation Act: Provisions related to user fee reauthorization and FDA reform (112th Congress) S. 957, Drug Supply Chain Security Act: Provisions related to supply chain security S. 959, Pharmaceutical Compounding Quality and Accountability Act: Provisions related to pharmaceutical compounding S. 2295, Patient Safety and Generic Labeling Improvement Act: Provisions related to drug safety labeling (112th Congress) Implementation issues relating to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including PPACA; Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking Comparative effectiveness policy issues Academic detailing policy issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues Pharmaceutical supply chain security issues Pharmaceutical compounding policy issues Prescription drug abuse policy issues FDA accelerated approval policy issues Unapproved use policy issues 340B policy issues

H.R. 8, American Taxpayer Relief Act of 2012: Medicare and tax related provisions (112th Congress) H.R. 351, Protecting Seniors' Access to Medicare Act of 2013: Provisions related to Independent Payment Advisory Board H.R. 928, Medicare Prescription Drug Savings and Choice Act of 2013: Provisions related to Part D issues H.R. 1588, Medicare Drug Savings Act of 2013: Provisions related to Part D issuesH.R. 460, Patients Access to Treatments Act of 2013: Provisions related to capping specialty tier drugs and no cost-sharing above the non-preferred brand tier S. 117, Medicare Prescription Drug Price Negotiation Act of 2013: Provisions related to Part D issues S. 351, Protecting Seniors Access to Medicare Act of 2013: Provisions related to Independent Payment Advisory Board S. 408, Medicare Prescription Drug Savings and Choice Act of 2013: Provisions related to Part D issues S. 740, Medicare Drug Savings Act of 2013: Provisions related to Part D issues Deficit reduction policy issues Medicaid Program, Covered Outpatient Drugs rulemaking Dual eligibles coordination policy issues Implementation issues relating to the Physician Payment Sunshine Act, including Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking

H.R. 8, American Taxpayer Relief Act of 2012: Medicare and tax related provisions (112th Congress) H.R. 351, Protecting Seniors Access to Medicare Act of 2013: Provisions related to the Independent Payment Advisory Board H.R. 460, Patients Access to Treatments Act of 2013: Provisions related to capping specialty tier drugs and no cost-sharing above the non-preferred brand tierH.R. 928, Medicare Prescription Drug Savings and Choice Act of 2013: Provisions related to Part D issues H.R. 1588, Medicare Drug Savings Act of 2013: Provisions related to Part D issues H.R. 2827, To amend title XVIII of the Social Security Act to allow for fair application of the exceptions process for drugs in tiers in formularies in prescription drug plans under Medicare part D: Provisions related to Medicare Part D Drug Tier Formularies H.R. 2925, Strengthening Medicare Anti-Fraud Measures Act of 2013 S. 117, Medicare Prescription Drug Price Negotiation Act of 2013: Provisions related to Part D issues S. 351, Protecting Seniors Access to Medicare Act of 2013: Provisions related to Independent Payment Advisory Board S. 408, Medicare Prescription Drug Savings and Choice Act of 2013: Provision related to Part D issues S. 740, Medicare Drug Savings Act of 2013: Provisions related to Part D issues Deficit reduction policy issues Medicaid Program, Covered Outpatient Drugs rulemaking Dual eligibles coordination policy issues Implementation issues relating to the Physician Payment Sunshine Act, including Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking

H.R. 8, American Taxpayer Relief Act of 2012: Medicare and tax related provisions (112th Congress) H.R. 351, Protecting Seniors Access to Medicare Act of 2013: Provisions related to the Independent Payment Advisory Board H.R. 460, Patients Access to Treatments Act of 2013: Provisions related to capping specialty tier drugs and no cost-sharing above the non-preferred brand tierH.R. 928, Medicare Prescription Drug Savings and Choice Act of 2013: Provisions related to Part D issues H.R. 1588, Medicare Drug Savings Act of 2013: Provisions related to Part D issues H.R. 2827, To amend title XVIII of the Social Security Act to allow for fair application of the exceptions process for drugs in tiers in formularies in prescription drug plans under Medicare part D: Provisions related to Medicare Part D Drug Tier Formularies H.R. 2925, Strengthening Medicare Anti-Fraud Measures Act of 2013 S. 117, Medicare Prescription Drug Price Negotiation Act of 2013: Provisions related to Part D issues S. 351, Protecting Seniors Access to Medicare Act of 2013: Provisions related to Independent Payment Advisory Board S. 408, Medicare Prescription Drug Savings and Choice Act of 2013: Provision related to Part D issues S. 740, Medicare Drug Savings Act of 2013: Provisions related to Part D issues Deficit reduction policy issues Medicaid Program, Covered Outpatient Drugs rulemaking Dual eligibles coordination policy issues Implementation issues relating to the Physician Payment Sunshine Act, including Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking

H.R. 8, American Taxpayer Relief Act of 2012: Medicare and tax related provisions (112th Congress) H.R. 351, Protecting Seniors' Access to Medicare Act of 2013: Provisions related to Independent Payment Advisory Board H.R. 928, Medicare Prescription Drug Savings and Choice Act of 2013: Provisions related to Part D issues H.R. 1588, Medicare Drug Savings Act of 2013: Provisions related to Part D issuesH.R. 460, Patients Access to Treatments Act of 2013: Provisions related to capping specialty tier drugs and no cost-sharing above the non-preferred brand tier S. 117, Medicare Prescription Drug Price Negotiation Act of 2013: Provisions related to Part D issues S. 351, Protecting Seniors Access to Medicare Act of 2013: Provisions related to Independent Payment Advisory Board S. 408, Medicare Prescription Drug Savings and Choice Act of 2013: Provisions related to Part D issues S. 740, Medicare Drug Savings Act of 2013: Provisions related to Part D issues Deficit reduction policy issues Medicaid Program, Covered Outpatient Drugs rulemaking Dual eligibles coordination policy issues Implementation issues relating to the Physician Payment Sunshine Act, including Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking

H.R. 8, American Taxpayer Relief Act of 2012: Medicare and tax related provisions (112th Congress) H.R. 351, Protecting Seniors Access to Medicare Act of 2013 H.R. 928, Medicare Prescription Drug Savings and Choice Act of 2013: Provisions related to Part D issues H.R. 2190, Medicare Drug Savings Act of 2011: Provisions related to Part D issues (112th Congress)H.R. 4209, Patients Access to Treatments Act of 2012: Capping specialty tier drugs and no cost-sharing above the non-preferred brand tier (112th Congress) S. 117, Medicare Prescription Drug Price Negotiation Act of 2013 S. 351, Protecting Seniors Access to Medicare Act of 2012 S. 408, Medicare Prescription Drug Savings and Choice Act of 2013 Deficit reduction policy issues Medicaid Program, Covered Outpatient Drugs rulemaking Dual eligibles coordination policy issues Implementation issues relating to the Physician Payment Sunshine Act, including Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking

H.R. 22, Foreign Counterfeit Merchandise Prevention Act: Provisions related to counterfeiting H.R. 845, Saving High-Tech Innovators from Egregious Legal Disputes Act of 2013 (the SHIELD Act): Provisions related to patent litigation H.R. 2024, End Anonymous Patents Act: Patent owner information provisionsH.R. 2582, PATENT Jobs Act: Provisions related to patent user fees H.R. 2605, Manufacturing Innovation in America Act of 2013: Provisions related to patent tax boxes S. 214, Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 504, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements S. 626, Prize Fund for HIV/AIDS Act: Medical prize provisions S. 627, Medical Innovation Prize Fund Act: Medical prize provisions S. 712, Patents for Humanity Program Improvement Act of 2013: Transferability of PTO vouchers provisions S. 866, Patent Quality Improvement Act of 2013: Business methods patents provisions S. 1013, Patent Abuse Reduction Act of 2013: Patent litigation provisions Biopharmaceutical innovation policy issues Potential legislation regarding patent litigation issues America Invents Act issues including estoppel for post grant review Biologics data protection issues Counterfeit drug issues Premerger Notification; Reporting and Waiting Period Requirements; Notice of proposed rulemaking (77 Federal Register 50057)

H.R. 22, Foreign Counterfeit Merchandise Prevention Act: Provisions related to counterfeiting H.R. 845, Saving High-Tech Innovators from Egregious Legal Disputes Act of 2013 (the SHIELD Act): Provisions related to patent litigation H.R. 2024, End Anonymous Patents Act: Patent owner information provisionsH.R. 2582, PATENT Jobs Act: Provisions related to patent user fees H.R. 2605, Manufacturing Innovation in America Act of 2013: Provisions related to patent tax boxes H.R. 2639, Patent Litigation and Innovation Act: Patent litigation proposals H.R. 2766, STOP Act: Provisions related to business method patents H.R. 2985: Combination Drug Development Incentive Act of 2013: Provisions related to drug exclusivity H.R. 3116, Moddern Cures Act of 2013: Provisions related to drug exclusivity S. 214, Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 504, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements S. 626, Prize Fund for HIV/AIDS Act: Medical prize provisions S. 627, Medical Innovation Prize Fund Act: Medical prize provisions S. 712, Patents for Humanity Program Improvement Act of 2013: Transferability of PTO vouchers provisions S. 866, Patent Quality Improvement Act of 2013: Business methods patents provisions S. 1013, Patent Abuse Reduction Act of 2013: Patent litigation provisions Biopharmaceutical innovation policy issues Potential legislation regarding patent litigation issues America Invents Act issues including estoppel for post grant review Biologics data protection issues

H.R. 22, Foreign Counterfeit Merchandise Prevention Act: Provisions related to counterfeiting H.R. 845, Saving High-Tech Innovators from Egregious Legal Disputes Act of 2013 (the SHIELD Act): Provisions related to patent litigation H.R. 2024, End Anonymous Patents Act: Patent owner information provisionsH.R. 2582, PATENT Jobs Act: Provisions related to patent user fees H.R. 2605, Manufacturing Innovation in America Act of 2013: Provisions related to patent tax boxes H.R. 2639, Patent Litigation and Innovation Act: Patent litigation proposals H.R. 2766, STOP Act: Provisions related to business method patents H.R. 2985: Combination Drug Development Incentive Act of 2013: Provisions related to drug exclusivity H.R. 3116, Moddern Cures Act of 2013: Provisions related to drug exclusivity S. 214, Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 504, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements S. 626, Prize Fund for HIV/AIDS Act: Medical prize provisions S. 627, Medical Innovation Prize Fund Act: Medical prize provisions S. 712, Patents for Humanity Program Improvement Act of 2013: Transferability of PTO vouchers provisions S. 866, Patent Quality Improvement Act of 2013: Business methods patents provisions S. 1013, Patent Abuse Reduction Act of 2013: Patent litigation provisions Biopharmaceutical innovation policy issues Potential legislation regarding patent litigation issues America Invents Act issues including estoppel for post grant review Biologics data protection issues

H.R. 22, Foreign Counterfeit Merchandise Prevention Act: Provisions related to counterfeiting H.R. 845, Saving High-Tech Innovators from Egregious Legal Disputes Act of 2013 (the SHIELD Act): Provisions related to patent litigation H.R. 2024, End Anonymous Patents Act: Patent owner information provisionsH.R. 2582, PATENT Jobs Act: Provisions related to patent user fees H.R. 2605, Manufacturing Innovation in America Act of 2013: Provisions related to patent tax boxes S. 214, Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 504, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements S. 626, Prize Fund for HIV/AIDS Act: Medical prize provisions S. 627, Medical Innovation Prize Fund Act: Medical prize provisions S. 712, Patents for Humanity Program Improvement Act of 2013: Transferability of PTO vouchers provisions S. 866, Patent Quality Improvement Act of 2013: Business methods patents provisions S. 1013, Patent Abuse Reduction Act of 2013: Patent litigation provisions Biopharmaceutical innovation policy issues Potential legislation regarding patent litigation issues America Invents Act issues including estoppel for post grant review Biologics data protection issues Counterfeit drug issues Premerger Notification; Reporting and Waiting Period Requirements; Notice of proposed rulemaking (77 Federal Register 50057)

H.R. 22, Foreign Counterfeit Merchandise Prevention Act: Provisions related to counterfeiting H.R. 845, Saving High-Tech Innovators from Egregious Legal Disputes Act of 2013 (the SHIELD Act): Provisions related to patent litigation H.R. 2024, End Anonymous Patents Act: Patent owner information provisionsH.R. 2582, PATENT Jobs Act: Provisions related to patent user fees H.R. 2605, Manufacturing Innovation in America Act of 2013: Provisions related to patent tax boxes H.R. 2639, Patent Litigation and Innovation Act: Patent litigation proposals H.R. 2766, STOP Act: Provisions related to business method patents H.R. 2985: Combination Drug Development Incentive Act of 2013: Provisions related to drug exclusivity H.R. 3116, Moddern Cures Act of 2013: Provisions related to drug exclusivity S. 214, Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 504, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements S. 626, Prize Fund for HIV/AIDS Act: Medical prize provisions S. 627, Medical Innovation Prize Fund Act: Medical prize provisions S. 712, Patents for Humanity Program Improvement Act of 2013: Transferability of PTO vouchers provisions S. 866, Patent Quality Improvement Act of 2013: Business methods patents provisions S. 1013, Patent Abuse Reduction Act of 2013: Patent litigation provisions Biopharmaceutical innovation policy issues Potential legislation regarding patent litigation issues America Invents Act issues including estoppel for post grant review Biologics data protection issues

H.R. 22, Foreign Counterfeit Merchandise Prevention Act: Provisions related to counterfeiting H.R. 845, Saving High-Tech Innovators from Egregious Legal Disputes Act of 2013 (the SHIELD Act): Provisions related to patent litigation H.R. 2024, End Anonymous Patents Act: Patent owner information provisionsH.R. 2582, PATENT Jobs Act: Provisions related to patent user fees H.R. 2605, Manufacturing Innovation in America Act of 2013: Provisions related to patent tax boxes S. 214, Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 504, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements S. 626, Prize Fund for HIV/AIDS Act: Medical prize provisions S. 627, Medical Innovation Prize Fund Act: Medical prize provisions S. 712, Patents for Humanity Program Improvement Act of 2013: Transferability of PTO vouchers provisions S. 866, Patent Quality Improvement Act of 2013: Business methods patents provisions S. 1013, Patent Abuse Reduction Act of 2013: Patent litigation provisions Biopharmaceutical innovation policy issues Potential legislation regarding patent litigation issues America Invents Act issues including estoppel for post grant review Biologics data protection issues Counterfeit drug issues Premerger Notification; Reporting and Waiting Period Requirements; Notice of proposed rulemaking (77 Federal Register 50057)

H.R. 22, Foreign Counterfeit Merchandise Prevention Act: Provisions related to counterfeiting H.R. 845, Saving High-Tech Innovators from Egregious Legal Disputes Act of 2013 (the SHIELD Act): Provisions related to patent litigation H.R. 2024, End Anonymous Patents Act: Patent owner information provisionsH.R. 2582, PATENT Jobs Act: Provisions related to patent user fees H.R. 2605, Manufacturing Innovation in America Act of 2013: Provisions related to patent tax boxes S. 214, Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 504, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements S. 626, Prize Fund for HIV/AIDS Act: Medical prize provisions S. 627, Medical Innovation Prize Fund Act: Medical prize provisions S. 712, Patents for Humanity Program Improvement Act of 2013: Transferability of PTO vouchers provisions S. 866, Patent Quality Improvement Act of 2013: Business methods patents provisions S. 1013, Patent Abuse Reduction Act of 2013: Patent litigation provisions Biopharmaceutical innovation policy issues Potential legislation regarding patent litigation issues America Invents Act issues including estoppel for post grant review Biologics data protection issues Counterfeit drug issues Premerger Notification; Reporting and Waiting Period Requirements; Notice of proposed rulemaking (77 Federal Register 50057)

H.R. 22, Foreign Counterfeit Merchandise Prevention Act: Provisions related to counterfeiting H.R. 845, Saving High-Tech Innovators from Egregious Legal Disputes Act of 2013 (the SHIELD Act): Provisions related to patent litigation H.R. 2024, End Anonymous Patents Act: Patent owner information provisionsH.R. 2582, PATENT Jobs Act: Provisions related to patent user fees H.R. 2605, Manufacturing Innovation in America Act of 2013: Provisions related to patent tax boxes H.R. 2639, Patent Litigation and Innovation Act: Patent litigation proposals H.R. 2766, STOP Act: Provisions related to business method patents H.R. 2985: Combination Drug Development Incentive Act of 2013: Provisions related to drug exclusivity H.R. 3116, Moddern Cures Act of 2013: Provisions related to drug exclusivity S. 214, Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 504, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements S. 626, Prize Fund for HIV/AIDS Act: Medical prize provisions S. 627, Medical Innovation Prize Fund Act: Medical prize provisions S. 712, Patents for Humanity Program Improvement Act of 2013: Transferability of PTO vouchers provisions S. 866, Patent Quality Improvement Act of 2013: Business methods patents provisions S. 1013, Patent Abuse Reduction Act of 2013: Patent litigation provisions Biopharmaceutical innovation policy issues Potential legislation regarding patent litigation issues America Invents Act issues including estoppel for post grant review Biologics data protection issues

H.R. 8, American Taxpayer Relief Act of 2012: Medicare and tax related provisions (112th Congress) H.R. 351, Protecting Seniors' Access to Medicare Act of 2013: Provisions related to Independent Payment Advisory Board H.R. 928, Medicare Prescription Drug Savings and Choice Act of 2013: Provisions related to Part D issues H.R. 1588, Medicare Drug Savings Act of 2013: Provisions related to Part D issuesH.R. 460, Patients Access to Treatments Act of 2013: Provisions related to capping specialty tier drugs and no cost-sharing above the non-preferred brand tier S. 117, Medicare Prescription Drug Price Negotiation Act of 2013: Provisions related to Part D issues S. 351, Protecting Seniors Access to Medicare Act of 2013: Provisions related to Independent Payment Advisory Board S. 408, Medicare Prescription Drug Savings and Choice Act of 2013: Provisions related to Part D issues S. 740, Medicare Drug Savings Act of 2013: Provisions related to Part D issues Deficit reduction policy issues Medicaid Program, Covered Outpatient Drugs rulemaking Dual eligibles coordination policy issues Implementation issues relating to the Physician Payment Sunshine Act, including Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking

H.R. 8, American Taxpayer Relief Act of 2012: Medicare and tax related provisions (112th Congress) H.R. 351, Protecting Seniors Access to Medicare Act of 2013: Provisions related to the Independent Payment Advisory Board H.R. 460, Patients Access to Treatments Act of 2013: Provisions related to capping specialty tier drugs and no cost-sharing above the non-preferred brand tierH.R. 928, Medicare Prescription Drug Savings and Choice Act of 2013: Provisions related to Part D issues H.R. 1588, Medicare Drug Savings Act of 2013: Provisions related to Part D issues H.R. 2827, To amend title XVIII of the Social Security Act to allow for fair application of the exceptions process for drugs in tiers in formularies in prescription drug plans under Medicare part D: Provisions related to Medicare Part D Drug Tier Formularies H.R. 2925, Strengthening Medicare Anti-Fraud Measures Act of 2013 S. 117, Medicare Prescription Drug Price Negotiation Act of 2013: Provisions related to Part D issues S. 351, Protecting Seniors Access to Medicare Act of 2013: Provisions related to Independent Payment Advisory Board S. 408, Medicare Prescription Drug Savings and Choice Act of 2013: Provision related to Part D issues S. 740, Medicare Drug Savings Act of 2013: Provisions related to Part D issues Deficit reduction policy issues Medicaid Program, Covered Outpatient Drugs rulemaking Dual eligibles coordination policy issues Implementation issues relating to the Physician Payment Sunshine Act, including Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking

H.R. 22, Foreign Counterfeit Merchandise Prevention Act: Provisions related to counterfeiting H.R. 845, Saving High-Tech Innovators from Egregious Legal Disputes Act of 2013 (the SHIELD Act): Provisions related to patent litigation H.R. 2024, End Anonymous Patents Act: Patent owner information provisionsH.R. 2582, PATENT Jobs Act: Provisions related to patent user fees H.R. 2605, Manufacturing Innovation in America Act of 2013: Provisions related to patent tax boxes H.R. 2639, Patent Litigation and Innovation Act: Patent litigation proposals H.R. 2766, STOP Act: Provisions related to business method patents H.R. 2985: Combination Drug Development Incentive Act of 2013: Provisions related to drug exclusivity H.R. 3116, Moddern Cures Act of 2013: Provisions related to drug exclusivity S. 214, Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 504, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements S. 626, Prize Fund for HIV/AIDS Act: Medical prize provisions S. 627, Medical Innovation Prize Fund Act: Medical prize provisions S. 712, Patents for Humanity Program Improvement Act of 2013: Transferability of PTO vouchers provisions S. 866, Patent Quality Improvement Act of 2013: Business methods patents provisions S. 1013, Patent Abuse Reduction Act of 2013: Patent litigation provisions Biopharmaceutical innovation policy issues Potential legislation regarding patent litigation issues America Invents Act issues including estoppel for post grant review Biologics data protection issues

H.R. 22, Foreign Counterfeit Merchandise Prevention Act: Provisions related to counterfeiting H.R. 845, Saving High-Tech Innovators from Egregious Legal Disputes Act of 2013 (the SHIELD Act): Provisions related to patent litigation H.R. 2024, End Anonymous Patents Act: Patent owner information provisionsH.R. 2582, PATENT Jobs Act: Provisions related to patent user fees H.R. 2605, Manufacturing Innovation in America Act of 2013: Provisions related to patent tax boxes S. 214, Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 504, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements S. 626, Prize Fund for HIV/AIDS Act: Medical prize provisions S. 627, Medical Innovation Prize Fund Act: Medical prize provisions S. 712, Patents for Humanity Program Improvement Act of 2013: Transferability of PTO vouchers provisions S. 866, Patent Quality Improvement Act of 2013: Business methods patents provisions S. 1013, Patent Abuse Reduction Act of 2013: Patent litigation provisions Biopharmaceutical innovation policy issues Potential legislation regarding patent litigation issues America Invents Act issues including estoppel for post grant review Biologics data protection issues Counterfeit drug issues Premerger Notification; Reporting and Waiting Period Requirements; Notice of proposed rulemaking (77 Federal Register 50057)

H.R. 1263, Excellence in Mental Health Act: Sets forth criteria for the certification of federally-qualified community behavioral health centers H.R. 2674, 340B Program Improvement Act: Provisions related to 340B (112th Congress) H.R. 1919, Safeguarding America's Pharmaceuticals Act of 2013: Provisions related to supply chain securityH.R. 2090, Patient Choice Act of 2013: To permit provisional approval of fast track products H.R. 2415, Treat and Reduce Obesity Act of 2013: To include coverage of obesity drugs in Part D H.R. 6584, Verifying Authority and Legality In Drug Compounding Act: Provisions relating to drug compounding (112th Congress) S. 264, Excellence in Mental Health Act: Sets forth criteria for the certification of federally-qualified community behavioral health centers S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B (112th Congress) S. 3187, Food and Drug Administration Safety and Innovation Act: Provisions related to user fee reauthorization and FDA reform (112th Congress) S. 957, Drug Supply Chain Security Act: Provisions related to supply chain security S. 959, Pharmaceutical Compounding Quality and Accountability Act: Provisions related to pharmaceutical compounding S. 2295, Patient Safety and Generic Labeling Improvement Act: Provisions related to drug safety labeling (112th Congress) Implementation issues relating to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including PPACA; Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking Comparative effectiveness policy issues Academic detailing policy issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues Pharmaceutical supply chain security issues Pharmaceutical compounding policy issues Prescription drug abuse policy issues FDA accelerated approval policy issues Unapproved use policy issues 340B policy issues

H.R. 1263, Excellence in Mental Health Act: Sets forth criteria for the certification of federally-qualified community behavioral health centers H.R. 2674, 340B Program Improvement Act: Provisions related to 340B (112th Congress) H.R. 1919, Safeguarding America's Pharmaceuticals Act of 2013: Provisions related to supply chain securityH.R. 2090, Patient Choice Act of 2013: To permit provisional approval of fast track products H.R. 2415, Treat and Reduce Obesity Act of 2013: To include coverage of obesity drugs in Part D H.R. 3204, Drug Quality and Security Act: Provisions relating to pharmacy compounding and supply chain H.R. 6584, Verifying Authority and Legality In Drug Compounding Act: Provisions relating to drug compounding (112th Congress) S. 264, Excellence in Mental Health Act: Sets forth criteria for the certification of federally-qualified community behavioral health centers S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B (112th Congress) S. 3187, Food and Drug Administration Safety and Innovation Act: Provisions related to user fee reauthorization and FDA reform (112th Congress) S. 957, Drug Supply Chain Security Act: Provisions related to supply chain security S. 959, Pharmaceutical Compounding Quality and Accountability Act: Provisions related to pharmaceutical compounding S. 2295, Patient Safety and Generic Labeling Improvement Act: Provisions relating to drug safety labeling (112th Congress) Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including PPACA; Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking Comparative effectiveness policy issues Academic detailing policy issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues Prescription drug abuse policy issues FDA accelerated approval policy issues Unapproved use policy issues 340B policy issues

H.R. 1263, Excellence in Mental Health Act: Sets forth criteria for the certification of federally-qualified community behavioral health centers H.R. 2674, 340B Program Improvement Act: Provisions related to 340B (112th Congress) H.R. 1919, Safeguarding America's Pharmaceuticals Act of 2013: Provisions related to supply chain securityH.R. 2090, Patient Choice Act of 2013: To permit provisional approval of fast track products H.R. 2415, Treat and Reduce Obesity Act of 2013: To include coverage of obesity drugs in Part D H.R. 3204, Drug Quality and Security Act: Provisions relating to pharmacy compounding and supply chain H.R. 6584, Verifying Authority and Legality In Drug Compounding Act: Provisions relating to drug compounding (112th Congress) S. 264, Excellence in Mental Health Act: Sets forth criteria for the certification of federally-qualified community behavioral health centers S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B (112th Congress) S. 3187, Food and Drug Administration Safety and Innovation Act: Provisions related to user fee reauthorization and FDA reform (112th Congress) S. 957, Drug Supply Chain Security Act: Provisions related to supply chain security S. 959, Pharmaceutical Compounding Quality and Accountability Act: Provisions related to pharmaceutical compounding S. 2295, Patient Safety and Generic Labeling Improvement Act: Provisions relating to drug safety labeling (112th Congress) Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including PPACA; Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking Comparative effectiveness policy issues Academic detailing policy issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues Prescription drug abuse policy issues FDA accelerated approval policy issues Unapproved use policy issues 340B policy issues

H.R. 1263, Excellence in Mental Health Act: Sets forth criteria for the certification of federally-qualified community behavioral health centers H.R. 2674, 340B Program Improvement Act: Provisions related to 340B (112th Congress) H.R. 1919, Safeguarding America's Pharmaceuticals Act of 2013: Provisions related to supply chain securityH.R. 2090, Patient Choice Act of 2013: To permit provisional approval of fast track products H.R. 2415, Treat and Reduce Obesity Act of 2013: To include coverage of obesity drugs in Part D H.R. 6584, Verifying Authority and Legality In Drug Compounding Act: Provisions relating to drug compounding (112th Congress) S. 264, Excellence in Mental Health Act: Sets forth criteria for the certification of federally-qualified community behavioral health centers S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B (112th Congress) S. 3187, Food and Drug Administration Safety and Innovation Act: Provisions related to user fee reauthorization and FDA reform (112th Congress) S. 957, Drug Supply Chain Security Act: Provisions related to supply chain security S. 959, Pharmaceutical Compounding Quality and Accountability Act: Provisions related to pharmaceutical compounding S. 2295, Patient Safety and Generic Labeling Improvement Act: Provisions related to drug safety labeling (112th Congress) Implementation issues relating to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including PPACA; Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking Comparative effectiveness policy issues Academic detailing policy issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues Pharmaceutical supply chain security issues Pharmaceutical compounding policy issues Prescription drug abuse policy issues FDA accelerated approval policy issues Unapproved use policy issues 340B policy issues

H.R. 8, American Taxpayer Relief Act of 2012: Medicare and tax related provisions (112th Congress) H.R. 351, Protecting Seniors Access to Medicare Act of 2013 H.R. 928, Medicare Prescription Drug Savings and Choice Act of 2013: Provisions related to Part D issues H.R. 2190, Medicare Drug Savings Act of 2011: Provisions related to Part D issues (112th Congress)H.R. 4209, Patients Access to Treatments Act of 2012: Capping specialty tier drugs and no cost-sharing above the non-preferred brand tier (112th Congress) S. 117, Medicare Prescription Drug Price Negotiation Act of 2013 S. 351, Protecting Seniors Access to Medicare Act of 2012 S. 408, Medicare Prescription Drug Savings and Choice Act of 2013 Deficit reduction policy issues Medicaid Program, Covered Outpatient Drugs rulemaking Dual eligibles coordination policy issues Implementation issues relating to the Physician Payment Sunshine Act, including Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking

H.R. 1263, Excellence in Mental Health Act: Sets forth criteria for the certification of federally-qualified community behavioral health centers H.R. 2674, 340B Program Improvement Act: Provisions related to 340B (112th Congress) H.R. 1919, Safeguarding America's Pharmaceuticals Act of 2013: Provisions related to supply chain securityH.R. 2090, Patient Choice Act of 2013: To permit provisional approval of fast track products H.R. 2415, Treat and Reduce Obesity Act of 2013: To include coverage of obesity drugs in Part D H.R. 6584, Verifying Authority and Legality In Drug Compounding Act: Provisions relating to drug compounding (112th Congress) S. 264, Excellence in Mental Health Act: Sets forth criteria for the certification of federally-qualified community behavioral health centers S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B (112th Congress) S. 3187, Food and Drug Administration Safety and Innovation Act: Provisions related to user fee reauthorization and FDA reform (112th Congress) S. 957, Drug Supply Chain Security Act: Provisions related to supply chain security S. 959, Pharmaceutical Compounding Quality and Accountability Act: Provisions related to pharmaceutical compounding S. 2295, Patient Safety and Generic Labeling Improvement Act: Provisions related to drug safety labeling (112th Congress) Implementation issues relating to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including PPACA; Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking Comparative effectiveness policy issues Academic detailing policy issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues Pharmaceutical supply chain security issues Pharmaceutical compounding policy issues Prescription drug abuse policy issues FDA accelerated approval policy issues Unapproved use policy issues 340B policy issues

H.R. 1263, Excellence in Mental Health Act: Sets forth criteria for the certification of federally-qualified community behavioral health centers H.R. 2674, 340B Program Improvement Act: Provisions related to 340B (112th Congress) H.R. 1919, Safeguarding America's Pharmaceuticals Act of 2013: Provisions related to supply chain securityH.R. 2090, Patient Choice Act of 2013: To permit provisional approval of fast track products H.R. 2415, Treat and Reduce Obesity Act of 2013: To include coverage of obesity drugs in Part D H.R. 3204, Drug Quality and Security Act: Provisions relating to pharmacy compounding and supply chain H.R. 6584, Verifying Authority and Legality In Drug Compounding Act: Provisions relating to drug compounding (112th Congress) S. 264, Excellence in Mental Health Act: Sets forth criteria for the certification of federally-qualified community behavioral health centers S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B (112th Congress) S. 3187, Food and Drug Administration Safety and Innovation Act: Provisions related to user fee reauthorization and FDA reform (112th Congress) S. 957, Drug Supply Chain Security Act: Provisions related to supply chain security S. 959, Pharmaceutical Compounding Quality and Accountability Act: Provisions related to pharmaceutical compounding S. 2295, Patient Safety and Generic Labeling Improvement Act: Provisions relating to drug safety labeling (112th Congress) Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including PPACA; Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking Comparative effectiveness policy issues Academic detailing policy issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues Prescription drug abuse policy issues FDA accelerated approval policy issues Unapproved use policy issues 340B policy issues

H.R. 1263, Excellence in Mental Health Act: Sets forth criteria for the certification of federally-qualified community behavioral health centers H.R. 2674, 340B Program Improvement Act: Provisions related to 340B (112th Congress) H.R. 6288, Patient Choice Act: To permit provisional approval of fast track products (112th Congress)H.R. 6342, Compassionate Freedom of Choice Act: Provisions related to access to investigational drugs or devices for terminally ill patients (112th Congress) H.R. 6584, Verifying Authority and Legality In Drug Compounding Act: Provisions relating to drug compounding (112th Congress) S. 264, Excellence in Mental Health Act: Sets forth criteria for the certification of federally-qualified community behavioral health centers S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages (112th Congress) S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B (112th Congress) S. 3187, Food and Drug Administration Safety and Innovation Act: Provisions related to user fee reauthorization and FDA reform (112th Congress) Implementation issues relating to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including PPACA; Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking Comparative effectiveness policy issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues Pharmaceutical supply chain security issues Pharmaceutical compounding policy issues Prescription drug abuse policy issues FDA Accelerated Approval policy issues Unapproved Use/Off-label policy issues 340B policy issues

H.R. 8, American Taxpayer Relief Act of 2012: Medicare and tax related provisions (112th Congress) H.R. 351, Protecting Seniors Access to Medicare Act of 2013 H.R. 928, Medicare Prescription Drug Savings and Choice Act of 2013: Provisions related to Part D issues H.R. 2190, Medicare Drug Savings Act of 2011: Provisions related to Part D issues (112th Congress)H.R. 4209, Patients Access to Treatments Act of 2012: Capping specialty tier drugs and no cost-sharing above the non-preferred brand tier (112th Congress) S. 117, Medicare Prescription Drug Price Negotiation Act of 2013 S. 351, Protecting Seniors Access to Medicare Act of 2012 S. 408, Medicare Prescription Drug Savings and Choice Act of 2013 Deficit reduction policy issues Medicaid Program, Covered Outpatient Drugs rulemaking Dual eligibles coordination policy issues Implementation issues relating to the Physician Payment Sunshine Act, including Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking

H.R. 1263, Excellence in Mental Health Act: Sets forth criteria for the certification of federally-qualified community behavioral health centers H.R. 2674, 340B Program Improvement Act: Provisions related to 340B (112th Congress) H.R. 6288, Patient Choice Act: To permit provisional approval of fast track products (112th Congress)H.R. 6342, Compassionate Freedom of Choice Act: Provisions related to access to investigational drugs or devices for terminally ill patients (112th Congress) H.R. 6584, Verifying Authority and Legality In Drug Compounding Act: Provisions relating to drug compounding (112th Congress) S. 264, Excellence in Mental Health Act: Sets forth criteria for the certification of federally-qualified community behavioral health centers S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages (112th Congress) S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B (112th Congress) S. 3187, Food and Drug Administration Safety and Innovation Act: Provisions related to user fee reauthorization and FDA reform (112th Congress) Implementation issues relating to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including PPACA; Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking Comparative effectiveness policy issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues Pharmaceutical supply chain security issues Pharmaceutical compounding policy issues Prescription drug abuse policy issues FDA Accelerated Approval policy issues Unapproved Use/Off-label policy issues 340B policy issues

H.R. 1263, Excellence in Mental Health Act: Sets forth criteria for the certification of federally-qualified community behavioral health centers H.R. 2674, 340B Program Improvement Act: Provisions related to 340B (112th Congress) H.R. 6288, Patient Choice Act: To permit provisional approval of fast track products (112th Congress)H.R. 6342, Compassionate Freedom of Choice Act: Provisions related to access to investigational drugs or devices for terminally ill patients (112th Congress) H.R. 6584, Verifying Authority and Legality In Drug Compounding Act: Provisions relating to drug compounding (112th Congress) S. 264, Excellence in Mental Health Act: Sets forth criteria for the certification of federally-qualified community behavioral health centers S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages (112th Congress) S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B (112th Congress) S. 3187, Food and Drug Administration Safety and Innovation Act: Provisions related to user fee reauthorization and FDA reform (112th Congress) Implementation issues relating to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including PPACA; Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking Comparative effectiveness policy issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues Pharmaceutical supply chain security issues Pharmaceutical compounding policy issues Prescription drug abuse policy issues FDA Accelerated Approval policy issues Unapproved Use/Off-label policy issues 340B policy issues

H.R. 1263, Excellence in Mental Health Act: Sets forth criteria for the certification of federally-qualified community behavioral health centers H.R. 2674, 340B Program Improvement Act: Provisions related to 340B (112th Congress) H.R. 1919, Safeguarding America's Pharmaceuticals Act of 2013: Provisions related to supply chain securityH.R. 2090, Patient Choice Act of 2013: To permit provisional approval of fast track products H.R. 2415, Treat and Reduce Obesity Act of 2013: To include coverage of obesity drugs in Part D H.R. 6584, Verifying Authority and Legality In Drug Compounding Act: Provisions relating to drug compounding (112th Congress) S. 264, Excellence in Mental Health Act: Sets forth criteria for the certification of federally-qualified community behavioral health centers S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B (112th Congress) S. 3187, Food and Drug Administration Safety and Innovation Act: Provisions related to user fee reauthorization and FDA reform (112th Congress) S. 957, Drug Supply Chain Security Act: Provisions related to supply chain security S. 959, Pharmaceutical Compounding Quality and Accountability Act: Provisions related to pharmaceutical compounding S. 2295, Patient Safety and Generic Labeling Improvement Act: Provisions related to drug safety labeling (112th Congress) Implementation issues relating to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including PPACA; Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking Comparative effectiveness policy issues Academic detailing policy issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues Pharmaceutical supply chain security issues Pharmaceutical compounding policy issues Prescription drug abuse policy issues FDA accelerated approval policy issues Unapproved use policy issues 340B policy issues

H.R. 1263, Excellence in Mental Health Act: Sets forth criteria for the certification of federally-qualified community behavioral health centers H.R. 2674, 340B Program Improvement Act: Provisions related to 340B (112th Congress) H.R. 1919, Safeguarding America's Pharmaceuticals Act of 2013: Provisions related to supply chain securityH.R. 2090, Patient Choice Act of 2013: To permit provisional approval of fast track products H.R. 2415, Treat and Reduce Obesity Act of 2013: To include coverage of obesity drugs in Part D H.R. 3204, Drug Quality and Security Act: Provisions relating to pharmacy compounding and supply chain H.R. 6584, Verifying Authority and Legality In Drug Compounding Act: Provisions relating to drug compounding (112th Congress) S. 264, Excellence in Mental Health Act: Sets forth criteria for the certification of federally-qualified community behavioral health centers S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B (112th Congress) S. 3187, Food and Drug Administration Safety and Innovation Act: Provisions related to user fee reauthorization and FDA reform (112th Congress) S. 957, Drug Supply Chain Security Act: Provisions related to supply chain security S. 959, Pharmaceutical Compounding Quality and Accountability Act: Provisions related to pharmaceutical compounding S. 2295, Patient Safety and Generic Labeling Improvement Act: Provisions relating to drug safety labeling (112th Congress) Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including PPACA; Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking Comparative effectiveness policy issues Academic detailing policy issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues Prescription drug abuse policy issues FDA accelerated approval policy issues Unapproved use policy issues 340B policy issues

H.R. 1263, Excellence in Mental Health Act: Sets forth criteria for the certification of federally-qualified community behavioral health centers H.R. 2674, 340B Program Improvement Act: Provisions related to 340B (112th Congress) H.R. 6288, Patient Choice Act: To permit provisional approval of fast track products (112th Congress)H.R. 6342, Compassionate Freedom of Choice Act: Provisions related to access to investigational drugs or devices for terminally ill patients (112th Congress) H.R. 6584, Verifying Authority and Legality In Drug Compounding Act: Provisions relating to drug compounding (112th Congress) S. 264, Excellence in Mental Health Act: Sets forth criteria for the certification of federally-qualified community behavioral health centers S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages (112th Congress) S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B (112th Congress) S. 3187, Food and Drug Administration Safety and Innovation Act: Provisions related to user fee reauthorization and FDA reform (112th Congress) Implementation issues relating to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including PPACA; Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking Comparative effectiveness policy issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues Pharmaceutical supply chain security issues Pharmaceutical compounding policy issues Prescription drug abuse policy issues FDA Accelerated Approval policy issues Unapproved Use/Off-label policy issues 340B policy issues

H.R. 8, American Taxpayer Relief Act of 2012: Medicare and tax related provisions (112th Congress) H.R. 351, Protecting Seniors' Access to Medicare Act of 2013: Provisions related to Independent Payment Advisory Board H.R. 928, Medicare Prescription Drug Savings and Choice Act of 2013: Provisions related to Part D issues H.R. 1588, Medicare Drug Savings Act of 2013: Provisions related to Part D issuesH.R. 460, Patients Access to Treatments Act of 2013: Provisions related to capping specialty tier drugs and no cost-sharing above the non-preferred brand tier S. 117, Medicare Prescription Drug Price Negotiation Act of 2013: Provisions related to Part D issues S. 351, Protecting Seniors Access to Medicare Act of 2013: Provisions related to Independent Payment Advisory Board S. 408, Medicare Prescription Drug Savings and Choice Act of 2013: Provisions related to Part D issues S. 740, Medicare Drug Savings Act of 2013: Provisions related to Part D issues Deficit reduction policy issues Medicaid Program, Covered Outpatient Drugs rulemaking Dual eligibles coordination policy issues Implementation issues relating to the Physician Payment Sunshine Act, including Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking

H.R. 8, American Taxpayer Relief Act of 2012: Medicare and tax related provisions (112th Congress) H.R. 351, Protecting Seniors Access to Medicare Act of 2013: Provisions related to the Independent Payment Advisory Board H.R. 460, Patients Access to Treatments Act of 2013: Provisions related to capping specialty tier drugs and no cost-sharing above the non-preferred brand tierH.R. 928, Medicare Prescription Drug Savings and Choice Act of 2013: Provisions related to Part D issues H.R. 1588, Medicare Drug Savings Act of 2013: Provisions related to Part D issues H.R. 2827, To amend title XVIII of the Social Security Act to allow for fair application of the exceptions process for drugs in tiers in formularies in prescription drug plans under Medicare part D: Provisions related to Medicare Part D Drug Tier Formularies H.R. 2925, Strengthening Medicare Anti-Fraud Measures Act of 2013 S. 117, Medicare Prescription Drug Price Negotiation Act of 2013: Provisions related to Part D issues S. 351, Protecting Seniors Access to Medicare Act of 2013: Provisions related to Independent Payment Advisory Board S. 408, Medicare Prescription Drug Savings and Choice Act of 2013: Provision related to Part D issues S. 740, Medicare Drug Savings Act of 2013: Provisions related to Part D issues Deficit reduction policy issues Medicaid Program, Covered Outpatient Drugs rulemaking Dual eligibles coordination policy issues Implementation issues relating to the Physician Payment Sunshine Act, including Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking

H.R. 8, American Taxpayer Relief Act of 2012: Medicare and tax related provisions (112th Congress) H.R. 351, Protecting Seniors Access to Medicare Act of 2013 H.R. 928, Medicare Prescription Drug Savings and Choice Act of 2013: Provisions related to Part D issues H.R. 2190, Medicare Drug Savings Act of 2011: Provisions related to Part D issues (112th Congress)H.R. 4209, Patients Access to Treatments Act of 2012: Capping specialty tier drugs and no cost-sharing above the non-preferred brand tier (112th Congress) S. 117, Medicare Prescription Drug Price Negotiation Act of 2013 S. 351, Protecting Seniors Access to Medicare Act of 2012 S. 408, Medicare Prescription Drug Savings and Choice Act of 2013 Deficit reduction policy issues Medicaid Program, Covered Outpatient Drugs rulemaking Dual eligibles coordination policy issues Implementation issues relating to the Physician Payment Sunshine Act, including Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking

H.J. Res. 59, FY14 Continuing Resolution Issues related to implementation of The Budget Control Act of 2011: Public Law No. 112-25 H.R. 2410, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2014: Provisions related to FDA regulation and funding, sequestration, drug importationH.R. 2217, Department of Homeland Security Appropriations Act, 2014: Provisions related to Customs and Border Control Agency funding, drug imports H.R. 2216, Military Construction and Veterans Affairs, and Related Agencies Appropriations Act, 2014: Provisions related to Veterans Affairs Administration regulation and funding, VA health benefits H.R. 2397, Department of Defense Appropriations Act, 2014: Provisions related to bio-defense H.R. 2725, Food and Drug Administration Safety Over Sequestration Act of 2013: Provisions related to FDA user fees

H.R.1316, Stop Oxy Abuse Act of 2011: To limit the approval of any drug containing controlled-release oxycodone hydrochloride H.R. 1513, Great Ape Protection and Cost Savings Act of 2011: Provisions related to pre-clinical testing H.R. 2674, 340B Program Improvement Act: Provisions related to 340B H.R. 4132, FAST Act: Provisions related to accelerated approval and other FDA matters H.R. 4156, Expanding and Promoting Expertise in Rare Treatments Act of 2012: To strengthen the FDAs ability to seek advice from external experts regarding rare diseases H.R. 4209, Patients Access to Treatments Act: To limit cost-sharing requirements applicable to prescription drugs in a specialty drug tier H.R. 4274, To amend title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act of 2003 H.R. 6288, Patient Choice Act: To permit provisional approval of fast track products H.R. 6342, Compassionate Freedom of Choice Act: Provisions related to access to investigational drugs or devices for terminally ill patients H.R. 6584, Verifying Authority and Legality In Drug Compounding Act: Provisions relating to drug compounding H.R. 6611, Patient Access to Drugs in Shortage Act of 2012: Promote public notification and provide incentives to reduce drug shortages S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages S. 810, Great Ape Protection and Cost Savings Act of 2011: Provisions related to pre-clinical testing S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B S. 2002, Online Pharmacy Safety Act: To improve the safety of Internet pharmacies S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act: Provisions related to accelerated approval and other FDA matters S. 2236, Advancing Breakthrough Therapies for Patients Act of 2012: Provisions related to FDA regulation S.2281, Expanding and Promoting Expertise in Rare Treatments Act of 2012: To strengthen the FDAs ability to seek advice from external experts regarding rare diseases S. 3187, Food and Drug Administration Safety and Innovation Act: Provisions related to user fee reauthorization and FDA reform Implementation issues relating to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including PPACA; Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking Vaccine-related policy issues Comparative effectiveness policy issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues Pharmaceutical supply chain security issues

H.R. 1483, Drug Safety Enhancement Act of 2011: Provisions related to supply chain issues H.R. 2227, Medical Gas Safety Act: Provisions regarding the regulation of medical gases H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011: Provisions related to prescription drug shortages H.R. 2674, 340B Program Improvement Act: Provisions related to 340B H.R. 3204, Guidance Accountability and Transparency Act: Provisions to set forth interpretation policy of FDA guidance H.R. 3214, Food and Drug Administration Mission Reform Act of 2011: Provisions to revise the mission of the Food and Drug Administration H.R. 3839, Drug Shortage Prevention Act of 2012: Provisions related to prescription drug shortages H.R. 4095, Online Pharmacy Safety Act: Provisions to improve the safety of Internet pharmacies H.R. 4132, FAST Act: Provisions related to accelerated approval and other FDA matters H.R. 4156, Expanding and Promoting Expertise in Rare Treatments Act of 2012: Provisions to strengthen the FDAs ability to seek advice from external experts regarding rare diseases H.R. 4223, Safe Doses Act: Provisions related to supply chain security H.R. 4274, To amend title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act of 2003 S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages S. 1002, Safe Doses Act: Provisions related to supply chain security S. 1584, Drug Safety and Accountability Act of 2011: Provisions related to supply chain issues S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B S.2002, Online Pharmacy Safety Act: Provisions to improve the safety of Internet pharmacies S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act: Provisions related to accelerated approval and other FDA matters S.2236, Advancing Breakthrough Therapies for Patients Act of 2012: Provisions related to FDA regulation S.2281, Expanding and Promoting Expertise in Rare Treatments Act of 2012: Provisions to strengthen the FDAs ability to seek advice from external experts regarding rare diseases. Prescription Drug User Fee Act (PDUFA) reauthorization and related issues Comparative effectiveness policy issues Health care reform implementation issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues

H.R. 1483, Drug Safety Enhancement Act of 2011: Provisions related to supply chain issues H.R. 2227, Medical Gas Safety Act: Provisions regarding the regulation of medical gases H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011: Provisions related to prescription drug shortages H.R. 2674, 340B Program Improvement Act: Provisions related to 340B H.R. 3204, Guidance Accountability and Transparency Act: Provisions to set forth interpretation policy of FDA guidance H.R. 3214, Food and Drug Administration Mission Reform Act of 2011: Provisions to revise the mission of the Food and Drug Administration H.R. 3261, Stop Online Piracy Act: Provisions related to anti-counterfeiting H.R. 3468, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti-counterfeiting H.R. 3839, Drug Shortage Prevention Act of 2012: Provisions related to prescription drug shortages H.R. 4095, Online Pharmacy Safety Act: To improve the safety of Internet pharmacies H.R. 4132, FAST Act: Provisions related to accelerated approval and other FDA matters H.R. 4156, Expanding and Promoting Expertise in Rare Treatments Act of 2012: To strengthen the FDAs ability to seek advice from external experts regarding rare diseases H.R. 4223, Safe Doses Act: Provisions related to supply chain security H.R. 4274, To amend title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act of 2003 H.R. 4332, Generic Drug Application Review Fairness Act of 2012: Provisions related to FDA review and exclusivity H.R. 5651, Food and Drug Administration Reform Act of 2012: Provisions related to user fee reauthorization and FDA reform S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages S. 1002, Safe Doses Act: Provisions related to supply chain security S. 1584, Drug Safety and Accountability Act of 2011: Provisions related to supply chain issues S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B S. 1886, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti- counterfeiting S. 2002, Online Pharmacy Safety Act: To improve the safety of Internet pharmacies S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act: Provisions related to accelerated approval and other FDA matters S. 2236, Advancing Breakthrough Therapies for Patients Act of 2012: Provisions related to FDA regulation S.2281, Expanding and Promoting Expertise in Rare Treatments Act of 2012: To strengthen the FDAs ability to seek advice from external experts regarding rare diseases S. 3187, Food and Drug Administration Safety and Innovation Act: Provisions related to user fee reauthorization and FDA reform Comparative effectiveness policy issues Health care reform implementation issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues

H.R. 1483, Drug Safety Enhancement Act of 2011: Provisions related to supply chain issues H.R. 2227, Medical Gas Safety Act: Provisions regarding the regulation of medical gases H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011: Provisions related to prescription drug shortages H.R. 2674, 340B Program Improvement Act: Provisions related to 340B H.R. 3839, Drug Shortage Prevention Act of 2012: Provisions related to prescription drug shortages H.R. 4095, Online Pharmacy Safety Act: To improve the safety of Internet pharmacies H.R. 4132, FAST Act: Provisions related to accelerated approval and other FDA matters H.R. 4156, Expanding and Promoting Expertise in Rare Treatments Act of 2012: To strengthen the FDAs ability to seek advice from external experts regarding rare diseases H.R. 4223, Safe Doses Act: Provisions related to supply chain security H.R. 4274, To amend title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act of 2003 H.R. 4332, Generic Drug Application Review Fairness Act of 2012: Provisions related to FDA review and exclusivity H.R. 5651, Food and Drug Administration Reform Act of 2012: Provisions related to user fee reauthorization and FDA reform S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages S. 810, Great Ape Protection and Cost Savings Act of 2011: Provisions related to pre-clinical testing S. 1002, Safe Doses Act: Provisions related to supply chain security S. 1584, Drug Safety and Accountability Act of 2011: Provisions related to supply chain issues S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B S. 2002, Online Pharmacy Safety Act: To improve the safety of Internet pharmacies S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act: Provisions related to accelerated approval and other FDA matters S. 2236, Advancing Breakthrough Therapies for Patients Act of 2012: Provisions related to FDA regulation S.2281, Expanding and Promoting Expertise in Rare Treatments Act of 2012: To strengthen the FDAs ability to seek advice from external experts regarding rare diseases S. 3187, Food and Drug Administration Safety and Innovation Act: Provisions related to user fee reauthorization and FDA reform Comparative effectiveness policy issues Health care reform implementation issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues

H.R.1316, Stop Oxy Abuse Act of 2011: To limit the approval of any drug containing controlled-release oxycodone hydrochloride H.R. 1513, Great Ape Protection and Cost Savings Act of 2011: Provisions related to pre-clinical testing H.R. 2674, 340B Program Improvement Act: Provisions related to 340B H.R. 4132, FAST Act: Provisions related to accelerated approval and other FDA matters H.R. 4156, Expanding and Promoting Expertise in Rare Treatments Act of 2012: To strengthen the FDAs ability to seek advice from external experts regarding rare diseases H.R. 4209, Patients Access to Treatments Act: To limit cost-sharing requirements applicable to prescription drugs in a specialty drug tier H.R. 4274, To amend title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act of 2003 H.R. 6288, Patient Choice Act: To permit provisional approval of fast track products H.R. 6342, Compassionate Freedom of Choice Act: Provisions related to access to investigational drugs or devices for terminally ill patients H.R. 6584, Verifying Authority and Legality In Drug Compounding Act: Provisions relating to drug compounding H.R. 6611, Patient Access to Drugs in Shortage Act of 2012: Promote public notification and provide incentives to reduce drug shortages S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages S. 810, Great Ape Protection and Cost Savings Act of 2011: Provisions related to pre-clinical testing S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B S. 2002, Online Pharmacy Safety Act: To improve the safety of Internet pharmacies S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act: Provisions related to accelerated approval and other FDA matters S. 2236, Advancing Breakthrough Therapies for Patients Act of 2012: Provisions related to FDA regulation S.2281, Expanding and Promoting Expertise in Rare Treatments Act of 2012: To strengthen the FDAs ability to seek advice from external experts regarding rare diseases S. 3187, Food and Drug Administration Safety and Innovation Act: Provisions related to user fee reauthorization and FDA reform Implementation issues relating to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including PPACA; Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking Vaccine-related policy issues Comparative effectiveness policy issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues Pharmaceutical supply chain security issues

H.R. 741, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: Provisions related to authorized generics H.R. 2182, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives H.R. 3261, Stop Online Piracy Act: Provisions related to anti-counterfeiting H.R. 3468, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti-counterfeiting H.R. 3497, MODDERN Cures Act of 2011: Provisions related to data protection H.R. 3995, Protect Consumer Access to Generic Drugs Act: Provisions related to patent settlements S. 27, The Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 373, The Fair Prescription Drug Competition Act: Provisions related to authorized generics S. 968, Preventing Online Threats to Economic Creativity and Theft of Intellectual Property Act of 2011: Provisions related to anti-counterfeiting S. 1734, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives S. 1882, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements S. 1886, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti- counterfeiting S. 3486, Patent Law Treaties Implementation Act of 2012: Patent law treaties Patents for Humanity Program Improvements Act of 2012: Provisions related to transferability of PTO acceleration certificates [no bill number] Technical changes to America Invents Act [H.R. 1249 and S.23] International intellectual property issues Biopharmaceutical innovation policy issues

H.R. 741, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: Provisions related to authorized generics H.R. 2182, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives H.R. 3261, Stop Online Piracy Act: Provisions related to anti-counterfeiting H.R. 3497, MODDERN Cures Act of 2011: Provisions related to data protection H.R. 3995, Protect Consumer Access to Generic Drugs Act: Provisions related to patent settlements S. 27, The Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 373, The Fair Prescription Drug Competition Act: Provisions related to authorized generics S. 968, Preventing Online Threats to Economic Creativity and Theft of Intellectual Property Act of 2011: Provisions related to anti-counterfeiting S. 1734, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives S. 1882, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements Patents for Humanity Program Improvements Act of 2012: Provisions related to transferability of PTO acceleration certificates [no bill number] Technical changes to America Invents Act [H.R. 1249 and S.23] International intellectual property issues Biopharmaceutical innovation policy issues

H.R. 741, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: Provisions related to authorized generics H.R. 2182, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives H.R. 3261, Stop Online Piracy Act: Provisions related to anti-counterfeiting H.R. 3468, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti-counterfeiting H.R. 3497, MODDERN Cures Act of 2011: Provisions related to data protection H.R. 3995, Protect Consumer Access to Generic Drugs Act: Provisions related to patent settlements S. 27, The Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 373, The Fair Prescription Drug Competition Act: Provisions related to authorized generics S. 968, Preventing Online Threats to Economic Creativity and Theft of Intellectual Property Act of 2011: Provisions related to anti-counterfeiting S. 1734, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives S. 1882, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements S. 1886, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti- counterfeiting International intellectual property issues Biopharmaceutical innovation policy issues

H.R. 5, Protecting Access to Healthcare Act: Provisions related to Independent Payment Advisory Board (IPAB) H.R. 8, American Taxpayer Relief Act of 2012: Medicare and tax related provisions H.R. 452, Medicare Decisions Accountability Act of 2011: Provisions related to Independent Payment Advisory Board (IPAB) H.R. 999, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues H.R. 2190 Medicare Drug Savings Act of 2011: Provisions related to Part D issues H.R. 4209, Patients Access to Treatments Act of 2012: Provisions related to capping specialty tier drugs and no cost-sharing above the non-preferred brand tier S. 365, Budget Control Act of 2011: Deficit reduction issues related to Medicare/Medicaid S. 668, Health Care Bureaucrats Elimination Act: Provisions related to Independent Payment Advisory Board (IPAB) S. 1206, Medicare Prescription Drug Savings Act of 2011: Provisions related to Part D issues S. 1699, Prescription Drug Cost Reduction Act: Provisions related to Medicare Part B, 340B, least costly alternative, and other provisions Deficit reduction policy issues Medicaid Program, Covered Outpatient Drugs rulemaking Dual eligibles coordination policy issues Implementation issues relating to the Physician Payment Sunshine Act, including Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking

H.R. 452, Medicare Decisions Accountability Act of 2011: Provisions related to Independent Payment Advisory Board (IPAB) H.R. 999, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues H.R. 2190 Medicare Drug Savings Act of 2011: Provisions related to Part D issues S. 365, Budget Control Act of 2011: Deficit reduction issues related to Medicare/Medicaid S. 668, Health Care Bureaucrats Elimination Act: Provisions related to Independent Payment Advisory Board (IPAB) S. 1206, Medicare Prescription Drug Savings Act of 2011: Provisions related to Part D issues S. 1251, Medicare and Medicaid FAST Act: Provisions related to Part D issues. S. 1699, Prescription Drug Cost Reduction Act: Provisions related to Medicare Part B, 340B, least costly alternative, and other provisions Deficit reduction policy issues Medicaid Program, Covered Outpatient Drugs rulemaking Dual eligibles coordination policy issues Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking

H.R. 5, Protecting Access to Healthcare Act: Provisions related to Independent Payment Advisory Board (IPAB) H.R. 452, Medicare Decisions Accountability Act of 2011: Provisions related to Independent Payment Advisory Board (IPAB) H.R. 999, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues H.R. 2190 Medicare Drug Savings Act of 2011: Provisions related to Part D issues H.R. 4209, Patients Access to Treatments Act of 2012: Capping specialty tier drugs and no cost-sharing above the non-preferred brand tier S. 365, Budget Control Act of 2011: Deficit reduction issues related to Medicare/Medicaid S. 668, Health Care Bureaucrats Elimination Act: Provisions related to Independent Payment Advisory Board (IPAB) S. 1206, Medicare Prescription Drug Savings Act of 2011: Provisions related to Part D issues S. 1251, Medicare and Medicaid FAST Act: Provisions related to Part D issues. S. 1699, Prescription Drug Cost Reduction Act: Provisions related to Medicare Part B, 340B, least costly alternative, and other provisions Deficit reduction policy issues Medicaid Program, Covered Outpatient Drugs rulemaking Dual eligibles coordination policy issues Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking

H.R. 452, Medicare Decisions Accountability Act of 2011: Provisions related to Independent Payment Advisory Board (IPAB) H.R. 999, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues H.R. 2190 Medicare Drug Savings Act of 2011: Provisions related to Part D issues S. 365, Budget Control Act of 2011: Deficit reduction issues related to Medicare/Medicaid S. 668, Health Care Bureaucrats Elimination Act: Provisions related to Independent Payment Advisory Board (IPAB) S. 1206, Medicare Prescription Drug Savings Act of 2011: Provisions related to Part D issues S. 1251, Medicare and Medicaid FAST Act: Provisions related to Part D issues. S. 1699, Prescription Drug Cost Reduction Act: All provisions including Medicare Part B and 340B Deficit reduction policy issues Medicaid Program, Covered Outpatient Drugs rulemaking: Provisions related to the AMP calculation, definition of line extension, and extension of the rebate to the territories Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking: Provisions related to implementation of the Sunshine reporting provisions of the Affordable Care Act Dual eligibles coordination policy issues

H.R. 1483, Drug Safety Enhancement Act of 2011: Provisions related to supply chain issues H.R. 2227, Medical Gas Safety Act: Provisions regarding the regulation of medical gases H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011: Provisions related to prescription drug shortages H.R. 2674, 340B Program Improvement Act: Provisions related to 340B H.R. 3839, Drug Shortage Prevention Act of 2012: Provisions related to prescription drug shortages H.R. 4095, Online Pharmacy Safety Act: To improve the safety of Internet pharmacies H.R. 4132, FAST Act: Provisions related to accelerated approval and other FDA matters H.R. 4156, Expanding and Promoting Expertise in Rare Treatments Act of 2012: To strengthen the FDAs ability to seek advice from external experts regarding rare diseases H.R. 4223, Safe Doses Act: Provisions related to supply chain security H.R. 4274, To amend title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act of 2003 H.R. 4332, Generic Drug Application Review Fairness Act of 2012: Provisions related to FDA review and exclusivity H.R. 5651, Food and Drug Administration Reform Act of 2012: Provisions related to user fee reauthorization and FDA reform S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages S. 810, Great Ape Protection and Cost Savings Act of 2011: Provisions related to pre-clinical testing S. 1002, Safe Doses Act: Provisions related to supply chain security S. 1584, Drug Safety and Accountability Act of 2011: Provisions related to supply chain issues S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B S. 2002, Online Pharmacy Safety Act: To improve the safety of Internet pharmacies S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act: Provisions related to accelerated approval and other FDA matters S. 2236, Advancing Breakthrough Therapies for Patients Act of 2012: Provisions related to FDA regulation S.2281, Expanding and Promoting Expertise in Rare Treatments Act of 2012: To strengthen the FDAs ability to seek advice from external experts regarding rare diseases S. 3187, Food and Drug Administration Safety and Innovation Act: Provisions related to user fee reauthorization and FDA reform Comparative effectiveness policy issues Health care reform implementation issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues

H.R. 1483, Drug Safety Enhancement Act of 2011: Provisions related to supply chain issues H.R. 2227, Medical Gas Safety Act: Provisions regarding the regulation of medical gases H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011: Provisions related to prescription drug shortages H.R. 2674, 340B Program Improvement Act: Provisions related to 340B H.R. 3204, Guidance Accountability and Transparency Act: Provisions to set forth interpretation policy of FDA guidance H.R. 3214, Food and Drug Administration Mission Reform Act of 2011: Provisions to revise the mission of the Food and Drug Administration H.R. 3261, Stop Online Piracy Act: Provisions related to anti-counterfeiting H.R. 3468, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti-counterfeiting H.R. 3839, Drug Shortage Prevention Act of 2012: Provisions related to prescription drug shortages H.R. 4095, Online Pharmacy Safety Act: To improve the safety of Internet pharmacies H.R. 4132, FAST Act: Provisions related to accelerated approval and other FDA matters H.R. 4156, Expanding and Promoting Expertise in Rare Treatments Act of 2012: To strengthen the FDAs ability to seek advice from external experts regarding rare diseases H.R. 4223, Safe Doses Act: Provisions related to supply chain security H.R. 4274, To amend title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act of 2003 H.R. 4332, Generic Drug Application Review Fairness Act of 2012: Provisions related to FDA review and exclusivity H.R. 5651, Food and Drug Administration Reform Act of 2012: Provisions related to user fee reauthorization and FDA reform S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages S. 1002, Safe Doses Act: Provisions related to supply chain security S. 1584, Drug Safety and Accountability Act of 2011: Provisions related to supply chain issues S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B S. 1886, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti- counterfeiting S. 2002, Online Pharmacy Safety Act: To improve the safety of Internet pharmacies S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act: Provisions related to accelerated approval and other FDA matters S. 2236, Advancing Breakthrough Therapies for Patients Act of 2012: Provisions related to FDA regulation S.2281, Expanding and Promoting Expertise in Rare Treatments Act of 2012: To strengthen the FDAs ability to seek advice from external experts regarding rare diseases S. 3187, Food and Drug Administration Safety and Innovation Act: Provisions related to user fee reauthorization and FDA reform Comparative effectiveness policy issues Health care reform implementation issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues

H.R. 1483, Drug Safety Enhancement Act of 2011: Provisions related to supply chain issues H.R. 2227, Medical Gas Safety Act: Provisions regarding the regulation of medical gases H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011: Provisions related to prescription drug shortages H.R. 2674, 340B Program Improvement Act: Provisions related to 340B H.R. 3204, Guidance Accountability and Transparency Act: Provisions to set forth interpretation policy of FDA guidance H.R. 3214, Food and Drug Administration Mission Reform Act of 2011: Provisions to revise the mission of the Food and Drug Administration H.R. 3839, Drug Shortage Prevention Act of 2012: Provisions related to prescription drug shortages H.R. 4095, Online Pharmacy Safety Act: Provisions to improve the safety of Internet pharmacies H.R. 4132, FAST Act: Provisions related to accelerated approval and other FDA matters H.R. 4156, Expanding and Promoting Expertise in Rare Treatments Act of 2012: Provisions to strengthen the FDAs ability to seek advice from external experts regarding rare diseases H.R. 4223, Safe Doses Act: Provisions related to supply chain security H.R. 4274, To amend title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act of 2003 S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages S. 1002, Safe Doses Act: Provisions related to supply chain security S. 1584, Drug Safety and Accountability Act of 2011: Provisions related to supply chain issues S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B S.2002, Online Pharmacy Safety Act: Provisions to improve the safety of Internet pharmacies S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act: Provisions related to accelerated approval and other FDA matters S.2236, Advancing Breakthrough Therapies for Patients Act of 2012: Provisions related to FDA regulation S.2281, Expanding and Promoting Expertise in Rare Treatments Act of 2012: Provisions to strengthen the FDAs ability to seek advice from external experts regarding rare diseases. Prescription Drug User Fee Act (PDUFA) reauthorization and related issues Comparative effectiveness policy issues Health care reform implementation issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues

H.R. 1483, Drug Safety Enhancement Act of 2011: Provisions related to supply chain issues H.R. 2227, Medical Gas Safety Act: Provisions regarding the regulation of medical gases H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011: Provisions related to prescription drug shortages H.R. 2674, 340B Program Improvement Act: Provisions related to 340B H.R. 3839, Drug Shortage Prevention Act of 2012: Provisions related to prescription drug shortages H.R. 4095, Online Pharmacy Safety Act: To improve the safety of Internet pharmacies H.R. 4132, FAST Act: Provisions related to accelerated approval and other FDA matters H.R. 4156, Expanding and Promoting Expertise in Rare Treatments Act of 2012: To strengthen the FDAs ability to seek advice from external experts regarding rare diseases H.R. 4223, Safe Doses Act: Provisions related to supply chain security H.R. 4274, To amend title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act of 2003 H.R. 4332, Generic Drug Application Review Fairness Act of 2012: Provisions related to FDA review and exclusivity H.R. 5651, Food and Drug Administration Reform Act of 2012: Provisions related to user fee reauthorization and FDA reform S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages S. 810, Great Ape Protection and Cost Savings Act of 2011: Provisions related to pre-clinical testing S. 1002, Safe Doses Act: Provisions related to supply chain security S. 1584, Drug Safety and Accountability Act of 2011: Provisions related to supply chain issues S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B S. 2002, Online Pharmacy Safety Act: To improve the safety of Internet pharmacies S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act: Provisions related to accelerated approval and other FDA matters S. 2236, Advancing Breakthrough Therapies for Patients Act of 2012: Provisions related to FDA regulation S.2281, Expanding and Promoting Expertise in Rare Treatments Act of 2012: To strengthen the FDAs ability to seek advice from external experts regarding rare diseases S. 3187, Food and Drug Administration Safety and Innovation Act: Provisions related to user fee reauthorization and FDA reform Comparative effectiveness policy issues Health care reform implementation issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues