Pharmaceutical Stewardship Act of 2016

Monitor legislative issues related to energy policy, climate change, renewable portfolio standards, and the production tax credit. Monitor Administrative action on Utility Maximum Achievable Control Technology (MACT) Standard. Monitor legislative issues and action regarding Master Limited Partnership (MLP) expansion. Monitor legislative and administrative action related to EPA Rulemaking on Mercury and Air Toxics Standards for Solid Waste Incineration Units. Monitor legislative and administrative action related to EPA New Source Performance Standards for new and existing power plants and guidelines for existing plants. Monitor legislative and administrative action related to EPA Clean Power Plan. Monitor the implementation of Consolidated Appropriations Act, 2016 (P.L. 114-113). Monitor legislative and administrative action related to the Public Utility Regulatory Policies Act (PURPA) (P.L. 95-617) Monitor legislation and FERC technical conference regarding changes to FERC oversight of PURPA. Monitor legislative and administrative action related to regulation of methane emissions from landfills. Notice of Proposed Rulemaking, Electric Storage Participation in Markets Operated by Regional Transmission Organizations and Independent System Operators [RM16-23-000]. H.R. 8, North American Energy Security and Infrastructure Act of 2015. H.R. 22, FAST Act. H.R. 702, To adapt to changing crude oil market conditions. H.R. 1027, Healthy Climate and Family Security Act of 2015. H.R. 1960, Land-Based Marine Debris Reduction Act. H.R. 2028, Further Continuing and Security Assistance Appropriations Act, 2017. H.R. 2029, Consolidated Appropriations Act, 2016. H.R. 2202, Tax Pollution, Not Profits Act. H.R. 2883, Master Limited Partnerships Parity Act. H.R. 3426, American Renewable Energy and Efficiency Act. H.R. 4931, Pharmaceutical Stewardship Act of 2016 H.R.5055, Energy and Water Development and Related Agencies Appropriations Act, 2017 H.R. 5802, To amend title 31, United States Code, to provide for the issuance of Green Bonds and to establish the United States Green Bank, and for other purposes. S. 524, Comprehensive Addiction and Recovery Act of 2016 S. 913, An original bill to amend the Internal Revenue Code of 1986 to provide an investment tax credit for waste heat to power technology. S. 1063, American Energy Efficiency Act. S. 1222, Continuity of Electric Capacity Resources Act. S. 1283, PURPA PLUS Act. S. 1246, Protecting America's Paper for Recycling Act. S. 1264, Renewable Electricity Standard Act. S. 1277, Federal Energy Savings Enhancement Act of 2015. S. 1516, POWER Act. S. 1548, American Opportunity Carbon Fee Act of 2015. S. 1656, Master Limited Partnerships Parity Act. S. 1946, Tax Relief Extension Act of 2015. S. 1953, TRASH Act. S. 2012, Energy Policy Modernization Act. S. 2804, Energy and Water Development and Related Agencies Appropriations Act, 2017 S. 3264, A bill to amend the Internal Revenue Code of 1986 to modify the credit for production of electricity from renewable resources for certain open-loop biomass and trash facilities placed in service before the date of the enactment of this Act. S. 3382, A bill to amend title 31, United States Code, to provide for the issuance of Green Bonds and to establish the United States Green Bank, and for other purposes.

Client expense: Not reported · Firm income: $80,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Monitor legislative issues related to energy policy, climate change, renewable portfolio standards, and the production tax credit. Monitor Administrative action on Utility Maximum Achievable Control Technology (MACT) Standard. Monitor legislative issues and action regarding Master Limited Partnership (MLP) expansion. Monitor legislative and administrative action related to EPA Rulemaking on Mercury and Air Toxics Standards for Solid Waste Incineration Units. Monitor legislative and administrative action related to EPA New Source Performance Standards for new and existing power plants and guidelines for existing plants. Monitor legislative and administrative action related to EPA Clean Power Plan. Monitor the implementation of Consolidated Appropriations Act, 2016 (P.L. 114-113). Monitor legislative and administrative action related to the Public Utility Regulatory Policies Act (PURPA) (P.L. 95-617) Monitor legislation and FERC technical conference regarding changes to FERC oversight of PURPA. Monitor legislative and administrative action related to regulation of methane emissions from landfills. Notice of Proposed Rulemaking, Electric Storage Participation in Markets Operated by Regional Transmission Organizations and Independent System Operators [RM16-23-000]. H.R. 8, North American Energy Security and Infrastructure Act of 2015. H.R. 22, FAST Act. H.R. 702, To adapt to changing crude oil market conditions. H.R. 1027, Healthy Climate and Family Security Act of 2015. H.R. 1960, Land-Based Marine Debris Reduction Act. H.R. 2028, Further Continuing and Security Assistance Appropriations Act, 2017. H.R. 2029, Consolidated Appropriations Act, 2016. H.R. 2202, Tax Pollution, Not Profits Act. H.R. 2883, Master Limited Partnerships Parity Act. H.R. 3426, American Renewable Energy and Efficiency Act. H.R. 4931, Pharmaceutical Stewardship Act of 2016 H.R.5055, Energy and Water Development and Related Agencies Appropriations Act, 2017 H.R. 5802, To amend title 31, United States Code, to provide for the issuance of Green Bonds and to establish the United States Green Bank, and for other purposes. S. 524, Comprehensive Addiction and Recovery Act of 2016 S. 913, An original bill to amend the Internal Revenue Code of 1986 to provide an investment tax credit for waste heat to power technology. S. 1063, American Energy Efficiency Act. S. 1222, Continuity of Electric Capacity Resources Act. S. 1283, PURPA PLUS Act. S. 1246, Protecting America's Paper for Recycling Act. S. 1264, Renewable Electricity Standard Act. S. 1277, Federal Energy Savings Enhancement Act of 2015. S. 1516, POWER Act. S. 1548, American Opportunity Carbon Fee Act of 2015. S. 1656, Master Limited Partnerships Parity Act. S. 1946, Tax Relief Extension Act of 2015. S. 1953, TRASH Act. S. 2012, Energy Policy Modernization Act. S. 2804, Energy and Water Development and Related Agencies Appropriations Act, 2017 S. 3264, A bill to amend the Internal Revenue Code of 1986 to modify the credit for production of electricity from renewable resources for certain open-loop biomass and trash facilities placed in service before the date of the enactment of this Act. S. 3382, A bill to amend title 31, United States Code, to provide for the issuance of Green Bonds and to establish the United States Green Bank, and for other purposes.

Monitor legislative issues related to energy policy, climate change, renewable portfolio standards, and the production tax credit. Monitor Administrative action on Utility Maximum Achievable Control Technology (MACT) Standard. Monitor legislative issues and action regarding Master Limited Partnership (MLP) expansion. Monitor legislative and administrative action related to EPA Rulemaking on Mercury and Air Toxics Standards for Solid Waste Incineration Units. Monitor legislative and administrative action related to EPA New Source Performance Standards for new and existing power plants and guidelines for existing plants. Monitor legislative and administrative action related to EPA Clean Power Plan. Monitor the implementation of Consolidated Appropriations Act, 2016 (P.L. 114-113). Monitor legislative and administrative action related to the Public Utility Regulatory Policies Act (PURPA) (P.L. 95-617) Monitor legislation and FERC technical conference regarding changes to FERC oversight of PURPA. Monitor legislative and administrative action related to regulation of methane emissions from landfills. Notice of Proposed Rulemaking, Electric Storage Participation in Markets Operated by Regional Transmission Organizations and Independent System Operators [RM16-23-000]. H.R. 8, North American Energy Security and Infrastructure Act of 2015. H.R. 22, FAST Act. H.R. 702, To adapt to changing crude oil market conditions. H.R. 1027, Healthy Climate and Family Security Act of 2015. H.R. 1960, Land-Based Marine Debris Reduction Act. H.R. 2028, Further Continuing and Security Assistance Appropriations Act, 2017. H.R. 2029, Consolidated Appropriations Act, 2016. H.R. 2202, Tax Pollution, Not Profits Act. H.R. 2883, Master Limited Partnerships Parity Act. H.R. 3426, American Renewable Energy and Efficiency Act. H.R. 4931, Pharmaceutical Stewardship Act of 2016 H.R.5055, Energy and Water Development and Related Agencies Appropriations Act, 2017 H.R. 5802, To amend title 31, United States Code, to provide for the issuance of Green Bonds and to establish the United States Green Bank, and for other purposes. S. 524, Comprehensive Addiction and Recovery Act of 2016 S. 913, An original bill to amend the Internal Revenue Code of 1986 to provide an investment tax credit for waste heat to power technology. S. 1063, American Energy Efficiency Act. S. 1222, Continuity of Electric Capacity Resources Act. S. 1283, PURPA PLUS Act. S. 1246, Protecting America's Paper for Recycling Act. S. 1264, Renewable Electricity Standard Act. S. 1277, Federal Energy Savings Enhancement Act of 2015. S. 1516, POWER Act. S. 1548, American Opportunity Carbon Fee Act of 2015. S. 1656, Master Limited Partnerships Parity Act. S. 1946, Tax Relief Extension Act of 2015. S. 1953, TRASH Act. S. 2012, Energy Policy Modernization Act. S. 2804, Energy and Water Development and Related Agencies Appropriations Act, 2017 S. 3264, A bill to amend the Internal Revenue Code of 1986 to modify the credit for production of electricity from renewable resources for certain open-loop biomass and trash facilities placed in service before the date of the enactment of this Act. S. 3382, A bill to amend title 31, United States Code, to provide for the issuance of Green Bonds and to establish the United States Green Bank, and for other purposes.

Monitor legislative issues related to energy policy, climate change, renewable portfolio standards, and the production tax credit. Monitor Administrative action on Utility Maximum Achievable Control Technology (MACT) Standard. Monitor legislative issues and action regarding Master Limited Partnership (MLP) expansion. Monitor legislative and administrative action related to EPA Rulemaking on Mercury and Air Toxics Standards for Solid Waste Incineration Units. Monitor legislative and administrative action related to EPA New Source Performance Standards for new and existing power plants and guidelines for existing plants. Monitor legislative and administrative action related to EPA Clean Power Plan. Monitor the implementation of Consolidated Appropriations Act, 2016 (P.L. 114-113). Monitor legislative and administrative action related to the Public Utility Regulatory Policies Act (PURPA) (P.L. 95-617) Monitor legislation and FERC technical conference regarding changes to FERC oversight of PURPA. Monitor legislative and administrative action related to regulation of methane emissions from landfills. Notice of Proposed Rulemaking, Electric Storage Participation in Markets Operated by Regional Transmission Organizations and Independent System Operators [RM16-23-000]. H.R. 8, North American Energy Security and Infrastructure Act of 2015. H.R. 22, FAST Act. H.R. 702, To adapt to changing crude oil market conditions. H.R. 1027, Healthy Climate and Family Security Act of 2015. H.R. 1960, Land-Based Marine Debris Reduction Act. H.R. 2028, Further Continuing and Security Assistance Appropriations Act, 2017. H.R. 2029, Consolidated Appropriations Act, 2016. H.R. 2202, Tax Pollution, Not Profits Act. H.R. 2883, Master Limited Partnerships Parity Act. H.R. 3426, American Renewable Energy and Efficiency Act. H.R. 4931, Pharmaceutical Stewardship Act of 2016 H.R.5055, Energy and Water Development and Related Agencies Appropriations Act, 2017 H.R. 5802, To amend title 31, United States Code, to provide for the issuance of Green Bonds and to establish the United States Green Bank, and for other purposes. S. 524, Comprehensive Addiction and Recovery Act of 2016 S. 913, An original bill to amend the Internal Revenue Code of 1986 to provide an investment tax credit for waste heat to power technology. S. 1063, American Energy Efficiency Act. S. 1222, Continuity of Electric Capacity Resources Act. S. 1283, PURPA PLUS Act. S. 1246, Protecting America's Paper for Recycling Act. S. 1264, Renewable Electricity Standard Act. S. 1277, Federal Energy Savings Enhancement Act of 2015. S. 1516, POWER Act. S. 1548, American Opportunity Carbon Fee Act of 2015. S. 1656, Master Limited Partnerships Parity Act. S. 1946, Tax Relief Extension Act of 2015. S. 1953, TRASH Act. S. 2012, Energy Policy Modernization Act. S. 2804, Energy and Water Development and Related Agencies Appropriations Act, 2017 S. 3264, A bill to amend the Internal Revenue Code of 1986 to modify the credit for production of electricity from renewable resources for certain open-loop biomass and trash facilities placed in service before the date of the enactment of this Act. S. 3382, A bill to amend title 31, United States Code, to provide for the issuance of Green Bonds and to establish the United States Green Bank, and for other purposes.

Policy matters related to generic pharmaceuticals and biosimilars including naming, labeling, access and interchangeability and changes to the Risk Evaluation and Mitigation Strategies (REMS) program, H.R.2841, FAST Generics Act of 2015 and S.3056, The CREATES Act, access to samples for generic testing, including S.3455, the Pharmaceutical Supply and Value Enhancement (SAVE) Act. The 21st Century Cures Act included in H. R. 2028, Further Continuing and Security Assistance Appropriations Act for Fiscal Year 2017. Affordability and pricing of pharmaceuticals. Issues related to drug takeback and opioid addiction. H. R. 4931, The Pharmaceutical Stewardship Act of 2016 and S.2977, The Budgeting for Opioid Addiction Treatment Act.

Client expense: Not reported · Firm income: $60,000

Pseudoephedrine Potential legislation to implement real-time, stop-sale electronic tracking system for sales of medications containing pseudoephedrine in order to preserve consumer access to the ingredient, common in popular cold and allergy medications (no bill number) and oppose prescription requirement (no bill number). Extended Producer Responsibility/Pharmaceutical Stewardship (Drug Take-Back) H.R. 4931 - Pharmaceutical Stewardship Act of 2016. Requires the Drug Enforcement Administration to establish and implement a national pharmaceutical stewardship program to collect and dispose of prescription medications; all sections. H.R. 5046 - Comprehensive Opioid Abuse Reduction Act of 2016 (COARA). Amends the Omnibus Crime Control and Safe Streets Act of 1968 to authorize the Attorney General to make grants to assist State and local governments in addressing the national epidemic of opioid abuse, and for other purposes (all sections). S. 524 - Comprehensive Addiction and Recovery Act of 2016 (CARA; became P.L. 114-198 on 7/22/2016). Authorizes the Attorney General and Secretary of Health and Human Services to award grants to address the national epidemics of prescription opioid abuse and heroin use, and to provide for the establishment of an inter-agency task force to review, modify, and update best practices for pain management and prescribing pain medication, and for other purposes (Section 201 - expands eligible uses of grant funds to include drug take-back efforts; Section 203 requires coordination among multiple government agencies to develop a prescription drug take-back program). Oral Contraceptives H.R. 5138 - Over-the-Counter Contraceptives Act of 2016. Grants priority review of applications to switch oral contraceptive drugs from prescription to nonprescription (over-the-counter) status; all sections. S. 1438 - Allowing Greater Access to Safe and Effective Contraception Act. Grants priority review of applications to switch oral contraceptive drugs from prescription to nonprescription (over-the-counter) status; all sections. H.R. 3163/S. 1532 - Affordability is Access Act. Clarifies that all oral contraceptive products be covered by insurance and provided to consumers without cost, regardless of prescription/nonprescription (over-the-counter) status; all sections. Over-the-counter (OTC) medicines; Manufacturing and importation of OTC drugs; Mandatory recall authority of the FDA; Rx-to-OTC Switch Supporting a process within FDA that ensures clarity and timely outcomes for the FDA, applicants and stakeholders, as well as utilizing existing technologies to further streamline the prescription-to-nonprescription switch application process without changing the existing clear distinction between prescription and nonprescription medicines.

H.R. 471 - Ensuring Patient Access and Effective Drug Enforcement Act of 2015 S. 483 - Ensuring Patient Access and Effective Drug Enforcement Act of 2015 S.524 - Comprehensive Addiction and Recovery Act of 2016 H.R.953 - Comprehensive Addiction and Recovery Act of 2015 HR 3250 - DXM Abuse Prevention Act S. 2294 - DXM Abuse Prevention Act H.R. 5046 - Comprehensive Opioid Abuse Reduction Act of 2016 H.R.4931 - Pharmaceutical Stewardship Act of 2016 S. 3075 - Addiction Prevention and Responsible Opioid Practices Act

Client expense: $380,000 · Firm income: Not reported

Monitoring regulations and legislation pertaining to medical and pharmaceutical waste management, including S 524, and amendments pertaining to controlled substances "take back" programs, and HR 4931, Pharmaceutical Stewardship Act (drug "take back" programs)

Client expense: Not reported · Firm income: $40,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Drug Importation. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). S.2615: Increasing Competition in Pharmaceuticals Act. Pharmaceutical exclusivity. H.R.4931: Pharmaceutical Stewardship Act of 2016. H.R.953: Comprehensive Addiction and Recovery Act of 2015 (CARA). S.3056: CREATES Act of 2016.

Client expense: $569,598 · Firm income: Not reported

H.R. 471 - Ensuring Patient Access and Effective Drug Enforcement Act of 2015 S. 483 - Ensuring Patient Access and Effective Drug Enforcement Act of 2015 S.524 - Comprehensive Addiction and Recovery Act of 2016 H.R.953 - Comprehensive Addiction and Recovery Act of 2015 HR 3250 - DXM Abuse Prevention Act S. 2294 - DXM Abuse Prevention Act H.R. 5046 - Comprehensive Opioid Abuse Reduction Act of 2016 H.R.4931 - Pharmaceutical Stewardship Act of 2016 S. 3075 - Addiction Prevention and Responsible Opioid Practices Act

Client expense: $920,000 · Firm income: Not reported

Monitor legislative issues related to energy policy, climate change, renewable portfolio standards, and the production tax credit. Monitor Administrative action on Utility Maximum Achievable Control Technology (MACT) Standard. Monitor legislative issues and action regarding Master Limited Partnership (MLP) expansion. Monitor legislative and administrative action related to EPA Rulemaking on Mercury and Air Toxics Standards for Solid Waste Incineration Units. Monitor legislative and administrative action related to EPA New Source Performance Standards for new and existing power plants and guidelines for existing plants. Monitor legislative and administrative action related to EPA Clean Power Plan. Monitor the implementation of Consolidated Appropriations Act, 2016 (P.L. 114-113). Monitor legislative and administrative action related to the Public Utility Regulatory Policies Act (PURPA) (P.L. 95-617) Monitor legislation and FERC technical conference regarding changes to FERC oversight of PURPA. Monitor legislative and administrative action related to regulation of methane emissions from landfills. H.R. 8, North American Energy Security and Infrastructure Act of 2015. H.R. 22, FAST Act. H.R. 702, To adapt to changing crude oil market conditions. H.R. 1027, Healthy Climate and Family Security Act of 2015. H.R. 1960, Land-Based Marine Debris Reduction Act. H.R. 2028, Energy and Water Development and Related Agencies Appropriations Act, 2017 H.R. 2029, Consolidated Appropriations Act, 2016. H.R. 2202, Tax Pollution, Not Profits Act. H.R. 2883, Master Limited Partnerships Parity Act. H.R. 3426, American Renewable Energy and Efficiency Act. H.R. 4931, Pharmaceutical Stewardship Act of 2016 H.R.5055, Energy and Water Development and Related Agencies Appropriations Act, 2017 H.R. 5802, To amend title 31, United States Code, to provide for the issuance of Green Bonds and to establish the United States Green Bank, and for other purposes. S. 524, Comprehensive Addiction and Recovery Act of 2016 S. 913, An original bill to amend the Internal Revenue Code of 1986 to provide an investment tax credit for waste heat to power technology. S. 1063, American Energy Efficiency Act. S. 1222, Continuity of Electric Capacity Resources Act. S. 1283, PURPA PLUS Act. S. 1246, Protecting America's Paper for Recycling Act. S. 1264, Renewable Electricity Standard Act. S. 1277, Federal Energy Savings Enhancement Act of 2015. S. 1516, POWER Act. S. 1548, American Opportunity Carbon Fee Act of 2015. S. 1656, Master Limited Partnerships Parity Act. S. 1946, Tax Relief Extension Act of 2015. S. 1953, TRASH Act. S. 2012, Energy Policy Modernization Act. S. 2804, Energy and Water Development and Related Agencies Appropriations Act, 2017 S. 3264, A bill to amend the Internal Revenue Code of 1986 to modify the credit for production of electricity from renewable resources for certain open-loop biomass and trash facilities placed in service before the date of the enactment of this Act. S. 3382, A bill to amend title 31, United States Code, to provide for the issuance of Green Bonds and to establish the United States Green Bank, and for other purposes.

Monitor legislative issues related to energy policy, climate change, renewable portfolio standards, and the production tax credit. Monitor Administrative action on Utility Maximum Achievable Control Technology (MACT) Standard. Monitor legislative issues and action regarding Master Limited Partnership (MLP) expansion. Monitor legislative and administrative action related to EPA Rulemaking on Mercury and Air Toxics Standards for Solid Waste Incineration Units. Monitor legislative and administrative action related to EPA New Source Performance Standards for new and existing power plants and guidelines for existing plants. Monitor legislative and administrative action related to EPA Clean Power Plan. Monitor the implementation of Consolidated Appropriations Act, 2016 (P.L. 114-113). Monitor legislative and administrative action related to the Public Utility Regulatory Policies Act (PURPA) (P.L. 95-617) Monitor legislation and FERC technical conference regarding changes to FERC oversight of PURPA. Monitor legislative and administrative action related to regulation of methane emissions from landfills. H.R. 8, North American Energy Security and Infrastructure Act of 2015. H.R. 22, FAST Act. H.R. 702, To adapt to changing crude oil market conditions. H.R. 1027, Healthy Climate and Family Security Act of 2015. H.R. 1960, Land-Based Marine Debris Reduction Act. H.R. 2028, Energy and Water Development and Related Agencies Appropriations Act, 2017 H.R. 2029, Consolidated Appropriations Act, 2016. H.R. 2202, Tax Pollution, Not Profits Act. H.R. 2883, Master Limited Partnerships Parity Act. H.R. 3426, American Renewable Energy and Efficiency Act. H.R. 4931, Pharmaceutical Stewardship Act of 2016 H.R.5055, Energy and Water Development and Related Agencies Appropriations Act, 2017 H.R. 5802, To amend title 31, United States Code, to provide for the issuance of Green Bonds and to establish the United States Green Bank, and for other purposes. S. 524, Comprehensive Addiction and Recovery Act of 2016 S. 913, An original bill to amend the Internal Revenue Code of 1986 to provide an investment tax credit for waste heat to power technology. S. 1063, American Energy Efficiency Act. S. 1222, Continuity of Electric Capacity Resources Act. S. 1283, PURPA PLUS Act. S. 1246, Protecting America's Paper for Recycling Act. S. 1264, Renewable Electricity Standard Act. S. 1277, Federal Energy Savings Enhancement Act of 2015. S. 1516, POWER Act. S. 1548, American Opportunity Carbon Fee Act of 2015. S. 1656, Master Limited Partnerships Parity Act. S. 1946, Tax Relief Extension Act of 2015. S. 1953, TRASH Act. S. 2012, Energy Policy Modernization Act. S. 2804, Energy and Water Development and Related Agencies Appropriations Act, 2017 S. 3264, A bill to amend the Internal Revenue Code of 1986 to modify the credit for production of electricity from renewable resources for certain open-loop biomass and trash facilities placed in service before the date of the enactment of this Act. S. 3382, A bill to amend title 31, United States Code, to provide for the issuance of Green Bonds and to establish the United States Green Bank, and for other purposes.

Monitor legislative issues related to energy policy, climate change, renewable portfolio standards, and the production tax credit. Monitor Administrative action on Utility Maximum Achievable Control Technology (MACT) Standard. Monitor legislative issues and action regarding Master Limited Partnership (MLP) expansion. Monitor legislative and administrative action related to EPA Rulemaking on Mercury and Air Toxics Standards for Solid Waste Incineration Units. Monitor legislative and administrative action related to EPA New Source Performance Standards for new and existing power plants and guidelines for existing plants. Monitor legislative and administrative action related to EPA Clean Power Plan. Monitor the implementation of Consolidated Appropriations Act, 2016 (P.L. 114-113). Monitor legislative and administrative action related to the Public Utility Regulatory Policies Act (PURPA) (P.L. 95-617) Monitor legislation and FERC technical conference regarding changes to FERC oversight of PURPA. Monitor legislative and administrative action related to regulation of methane emissions from landfills. H.R. 8, North American Energy Security and Infrastructure Act of 2015. H.R. 22, FAST Act. H.R. 702, To adapt to changing crude oil market conditions. H.R. 1027, Healthy Climate and Family Security Act of 2015. H.R. 1960, Land-Based Marine Debris Reduction Act. H.R. 2028, Energy and Water Development and Related Agencies Appropriations Act, 2017 H.R. 2029, Consolidated Appropriations Act, 2016. H.R. 2202, Tax Pollution, Not Profits Act. H.R. 2883, Master Limited Partnerships Parity Act. H.R. 3426, American Renewable Energy and Efficiency Act. H.R. 4931, Pharmaceutical Stewardship Act of 2016 H.R.5055, Energy and Water Development and Related Agencies Appropriations Act, 2017 H.R. 5802, To amend title 31, United States Code, to provide for the issuance of Green Bonds and to establish the United States Green Bank, and for other purposes. S. 524, Comprehensive Addiction and Recovery Act of 2016 S. 913, An original bill to amend the Internal Revenue Code of 1986 to provide an investment tax credit for waste heat to power technology. S. 1063, American Energy Efficiency Act. S. 1222, Continuity of Electric Capacity Resources Act. S. 1283, PURPA PLUS Act. S. 1246, Protecting America's Paper for Recycling Act. S. 1264, Renewable Electricity Standard Act. S. 1277, Federal Energy Savings Enhancement Act of 2015. S. 1516, POWER Act. S. 1548, American Opportunity Carbon Fee Act of 2015. S. 1656, Master Limited Partnerships Parity Act. S. 1946, Tax Relief Extension Act of 2015. S. 1953, TRASH Act. S. 2012, Energy Policy Modernization Act. S. 2804, Energy and Water Development and Related Agencies Appropriations Act, 2017 S. 3264, A bill to amend the Internal Revenue Code of 1986 to modify the credit for production of electricity from renewable resources for certain open-loop biomass and trash facilities placed in service before the date of the enactment of this Act. S. 3382, A bill to amend title 31, United States Code, to provide for the issuance of Green Bonds and to establish the United States Green Bank, and for other purposes.

Monitor legislative issues related to energy policy, climate change, renewable portfolio standards, and the production tax credit. Monitor Administrative action on Utility Maximum Achievable Control Technology (MACT) Standard. Monitor legislative issues and action regarding Master Limited Partnership (MLP) expansion. Monitor legislative and administrative action related to EPA Rulemaking on Mercury and Air Toxics Standards for Solid Waste Incineration Units. Monitor legislative and administrative action related to EPA New Source Performance Standards for new and existing power plants and guidelines for existing plants. Monitor legislative and administrative action related to EPA Clean Power Plan. Monitor the implementation of Consolidated Appropriations Act, 2016 (P.L. 114-113). Monitor legislative and administrative action related to the Public Utility Regulatory Policies Act (PURPA) (P.L. 95-617) Monitor legislation and FERC technical conference regarding changes to FERC oversight of PURPA. Monitor legislative and administrative action related to regulation of methane emissions from landfills. H.R. 8, North American Energy Security and Infrastructure Act of 2015. H.R. 22, FAST Act. H.R. 702, To adapt to changing crude oil market conditions. H.R. 1027, Healthy Climate and Family Security Act of 2015. H.R. 1960, Land-Based Marine Debris Reduction Act. H.R. 2028, Energy and Water Development and Related Agencies Appropriations Act, 2017 H.R. 2029, Consolidated Appropriations Act, 2016. H.R. 2202, Tax Pollution, Not Profits Act. H.R. 2883, Master Limited Partnerships Parity Act. H.R. 3426, American Renewable Energy and Efficiency Act. H.R. 4931, Pharmaceutical Stewardship Act of 2016 H.R.5055, Energy and Water Development and Related Agencies Appropriations Act, 2017 H.R. 5802, To amend title 31, United States Code, to provide for the issuance of Green Bonds and to establish the United States Green Bank, and for other purposes. S. 524, Comprehensive Addiction and Recovery Act of 2016 S. 913, An original bill to amend the Internal Revenue Code of 1986 to provide an investment tax credit for waste heat to power technology. S. 1063, American Energy Efficiency Act. S. 1222, Continuity of Electric Capacity Resources Act. S. 1283, PURPA PLUS Act. S. 1246, Protecting America's Paper for Recycling Act. S. 1264, Renewable Electricity Standard Act. S. 1277, Federal Energy Savings Enhancement Act of 2015. S. 1516, POWER Act. S. 1548, American Opportunity Carbon Fee Act of 2015. S. 1656, Master Limited Partnerships Parity Act. S. 1946, Tax Relief Extension Act of 2015. S. 1953, TRASH Act. S. 2012, Energy Policy Modernization Act. S. 2804, Energy and Water Development and Related Agencies Appropriations Act, 2017 S. 3264, A bill to amend the Internal Revenue Code of 1986 to modify the credit for production of electricity from renewable resources for certain open-loop biomass and trash facilities placed in service before the date of the enactment of this Act. S. 3382, A bill to amend title 31, United States Code, to provide for the issuance of Green Bonds and to establish the United States Green Bank, and for other purposes.

Monitor legislative issues related to energy policy, climate change, renewable portfolio standards, and the production tax credit. Monitor Administrative action on Utility Maximum Achievable Control Technology (MACT) Standard. Monitor legislative issues and action regarding Master Limited Partnership (MLP) expansion. Monitor legislative and administrative action related to EPA Rulemaking on Mercury and Air Toxics Standards for Solid Waste Incineration Units. Monitor legislative and administrative action related to EPA New Source Performance Standards for new and existing power plants and guidelines for existing plants. Monitor legislative and administrative action related to EPA Clean Power Plan. Monitor the implementation of Consolidated Appropriations Act, 2016 (P.L. 114-113). Monitor legislative and administrative action related to the Public Utility Regulatory Policies Act (PURPA) (P.L. 95-617) Monitor legislation and FERC technical conference regarding changes to FERC oversight of PURPA. Monitor legislative and administrative action related to regulation of methane emissions from landfills. H.R. 8, North American Energy Security and Infrastructure Act of 2015. H.R. 22, FAST Act. H.R. 702, To adapt to changing crude oil market conditions. H.R. 1027, Healthy Climate and Family Security Act of 2015. H.R. 1960, Land-Based Marine Debris Reduction Act. H.R. 2028, Energy and Water Development and Related Agencies Appropriations Act, 2017 H.R. 2029, Consolidated Appropriations Act, 2016. H.R. 2202, Tax Pollution, Not Profits Act. H.R. 2883, Master Limited Partnerships Parity Act. H.R. 3426, American Renewable Energy and Efficiency Act. H.R. 4931, Pharmaceutical Stewardship Act of 2016 H.R.5055, Energy and Water Development and Related Agencies Appropriations Act, 2017 H.R. 5802, To amend title 31, United States Code, to provide for the issuance of Green Bonds and to establish the United States Green Bank, and for other purposes. S. 524, Comprehensive Addiction and Recovery Act of 2016 S. 913, An original bill to amend the Internal Revenue Code of 1986 to provide an investment tax credit for waste heat to power technology. S. 1063, American Energy Efficiency Act. S. 1222, Continuity of Electric Capacity Resources Act. S. 1283, PURPA PLUS Act. S. 1246, Protecting America's Paper for Recycling Act. S. 1264, Renewable Electricity Standard Act. S. 1277, Federal Energy Savings Enhancement Act of 2015. S. 1516, POWER Act. S. 1548, American Opportunity Carbon Fee Act of 2015. S. 1656, Master Limited Partnerships Parity Act. S. 1946, Tax Relief Extension Act of 2015. S. 1953, TRASH Act. S. 2012, Energy Policy Modernization Act. S. 2804, Energy and Water Development and Related Agencies Appropriations Act, 2017 S. 3264, A bill to amend the Internal Revenue Code of 1986 to modify the credit for production of electricity from renewable resources for certain open-loop biomass and trash facilities placed in service before the date of the enactment of this Act. S. 3382, A bill to amend title 31, United States Code, to provide for the issuance of Green Bonds and to establish the United States Green Bank, and for other purposes.

Policy matters related to generic pharmaceuticals and biosimilars including naming, labeling, access and interchangeability and changes to the Risk Evaluation and Mitigation Strategies (REMS) program, H.R.2841, FAST Generics Act of 2015 and S.3056, The CREATES Act, access to samples for generic testing, including S.3455, the Pharmaceutical Supply and Value Enhancement (SAVE) Act. H. R. 6, 21st Century Cures Act and the Senate Health, Education, Labor and Pensions Committee Initiative for Healthier Americans. Affordability and pricing of pharmaceuticals. Issues related to drug takeback and opioid addiction, including S.524 and H.R. 953, The Comprehensive Addiction and Recovery Act of 2016. H. R. 4931, The Pharmaceutical Stewardship Act of 2016 and S.2977, The Budgeting for Opioid Addiction Treatment Act.

Client expense: Not reported · Firm income: $60,000

Pseudoephedrine Potential legislation to implement real-time, stop-sale electronic tracking system for sales of medications containing pseudoephedrine in order to preserve consumer access to the ingredient, common in popular cold and allergy medications (no bill number) and oppose prescription requirement (no bill number). Extended Producer Responsibility/Pharmaceutical Stewardship (Drug Take-Back) H.R. 4931 - Pharmaceutical Stewardship Act of 2016. Requires the Drug Enforcement Administration to establish and implement a national pharmaceutical stewardship program to collect and dispose of prescription medications; all sections. H.R. 5046 - Comprehensive Opioid Abuse Reduction Act of 2016 (COARA). Amends the Omnibus Crime Control and Safe Streets Act of 1968 to authorize the Attorney General to make grants to assist State and local governments in addressing the national epidemic of opioid abuse, and for other purposes (all sections). S. 524 - Comprehensive Addiction and Recovery Act of 2016 (CARA; became P.L. 114-198 on 7/22/2016). Authorizes the Attorney General and Secretary of Health and Human Services to award grants to address the national epidemics of prescription opioid abuse and heroin use, and to provide for the establishment of an inter-agency task force to review, modify, and update best practices for pain management and prescribing pain medication, and for other purposes (Section 201 - expands eligible uses of grant funds to include drug take-back efforts; Section 203 requires coordination among multiple government agencies to develop a prescription drug take-back program). Oral Contraceptives H.R. 5138 - Over-the-Counter Contraceptives Act of 2016. Grants priority review of applications to switch oral contraceptive drugs from prescription to nonprescription (over-the-counter) status; all sections. S. 1438 - Allowing Greater Access to Safe and Effective Contraception Act. Grants priority review of applications to switch oral contraceptive drugs from prescription to nonprescription (over-the-counter) status; all sections. H.R. 3163/S. 1532 - Affordability is Access Act. Clarifies that all oral contraceptive products be covered by insurance and provided to consumers without cost, regardless of prescription/nonprescription (over-the-counter) status; all sections. Over-the-counter (OTC) medicines; Manufacturing and importation of OTC drugs; Mandatory recall authority of the FDA; Rx-to-OTC Switch Supporting a process within FDA that ensures clarity and timely outcomes for the FDA, applicants and stakeholders, as well as utilizing existing technologies to further streamline the prescription-to-nonprescription switch application process without changing the existing clear distinction between prescription and nonprescription medicines.

Medical and pharmaceutical waste management S 524, and amendments pertaining to controlled substances "take back" programs Monitoring HR 4931, Pharmaceutical Stewardship Act (drug "take back" programs)

Client expense: Not reported · Firm income: $40,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Monitor legislative issues related to energy policy, climate change, renewable portfolio standards, and the production tax credit. Monitor Administrative action on Utility Maximum Achievable Control Technology (MACT) Standard. Monitor legislative issues and action regarding Master Limited Partnership (MLP) expansion. Monitor legislative and administrative action related to EPA Rulemaking on Mercury and Air Toxics Standards for Solid Waste Incineration Units. Monitor legislative and administrative action related to EPA New Source Performance Standards for new and existing power plants and guidelines for existing plants. Monitor legislative and administrative action related to EPA Clean Power Plan. Monitor the implementation of Consolidated Appropriations Act, 2016 (P.L. 114-113). Monitor legislative and administrative action related to the Public Utility Regulatory Policies Act (PURPA) (P.L. 95-617) H.R. 8, North American Energy Security and Infrastructure Act of 2015. H.R. 22, FAST Act. H.R. 702, To adapt to changing crude oil market conditions. H.R. 1027, Healthy Climate and Family Security Act of 2015. H.R. 1960, Land-Based Marine Debris Reduction Act. H.R. 2028, Energy and Water Development and Related Agencies Appropriations Act, 2017 H.R. 2029, Consolidated Appropriations Act, 2016. H.R. 2202, Tax Pollution, Not Profits Act. H.R. 2883, Master Limited Partnerships Parity Act. H.R. 3426, American Renewable Energy and Efficiency Act. H.R. 4931, Pharmaceutical Stewardship Act of 2016 H.R.5055, Energy and Water Development and Related Agencies Appropriations Act, 2017 S. 524, Comprehensive Addiction and Recovery Act of 2016 S. 913, An original bill to amend the Internal Revenue Code of 1986 to provide an investment tax credit for waste heat to power technology. S. 1063, American Energy Efficiency Act. S. 1222, Continuity of Electric Capacity Resources Act. S. 1283, PURPA PLUS Act. S. 1246, Protecting America's Paper for Recycling Act. S. 1264, Renewable Electricity Standard Act. S. 1277, Federal Energy Savings Enhancement Act of 2015. S. 1516, POWER Act. S. 1548, American Opportunity Carbon Fee Act of 2015. S. 1656, Master Limited Partnerships Parity Act. S. 1946, Tax Relief Extension Act of 2015. S. 1953, TRASH Act. S. 2012, Energy Policy Modernization Act. S. 2804, Energy and Water Development and Related Agencies Appropriations Act, 2017 Draft, A bill to amend the Internal Revenue Code of 1986 to modify the credit for production of electricity from renewable resources for certain open-loop biomass and trash facilities placed in service before the date of the enactment of this Act.

Monitor legislative issues related to energy policy, climate change, renewable portfolio standards, and the production tax credit. Monitor Administrative action on Utility Maximum Achievable Control Technology (MACT) Standard. Monitor legislative issues and action regarding Master Limited Partnership (MLP) expansion. Monitor legislative and administrative action related to EPA Rulemaking on Mercury and Air Toxics Standards for Solid Waste Incineration Units. Monitor legislative and administrative action related to EPA New Source Performance Standards for new and existing power plants and guidelines for existing plants. Monitor legislative and administrative action related to EPA Clean Power Plan. Monitor the implementation of Consolidated Appropriations Act, 2016 (P.L. 114-113). Monitor legislative and administrative action related to the Public Utility Regulatory Policies Act (PURPA) (P.L. 95-617) H.R. 8, North American Energy Security and Infrastructure Act of 2015. H.R. 22, FAST Act. H.R. 702, To adapt to changing crude oil market conditions. H.R. 1027, Healthy Climate and Family Security Act of 2015. H.R. 1960, Land-Based Marine Debris Reduction Act. H.R. 2028, Energy and Water Development and Related Agencies Appropriations Act, 2017 H.R. 2029, Consolidated Appropriations Act, 2016. H.R. 2202, Tax Pollution, Not Profits Act. H.R. 2883, Master Limited Partnerships Parity Act. H.R. 3426, American Renewable Energy and Efficiency Act. H.R. 4931, Pharmaceutical Stewardship Act of 2016 H.R.5055, Energy and Water Development and Related Agencies Appropriations Act, 2017 S. 524, Comprehensive Addiction and Recovery Act of 2016 S. 913, An original bill to amend the Internal Revenue Code of 1986 to provide an investment tax credit for waste heat to power technology. S. 1063, American Energy Efficiency Act. S. 1222, Continuity of Electric Capacity Resources Act. S. 1283, PURPA PLUS Act. S. 1246, Protecting America's Paper for Recycling Act. S. 1264, Renewable Electricity Standard Act. S. 1277, Federal Energy Savings Enhancement Act of 2015. S. 1516, POWER Act. S. 1548, American Opportunity Carbon Fee Act of 2015. S. 1656, Master Limited Partnerships Parity Act. S. 1946, Tax Relief Extension Act of 2015. S. 1953, TRASH Act. S. 2012, Energy Policy Modernization Act. S. 2804, Energy and Water Development and Related Agencies Appropriations Act, 2017 Draft, A bill to amend the Internal Revenue Code of 1986 to modify the credit for production of electricity from renewable resources for certain open-loop biomass and trash facilities placed in service before the date of the enactment of this Act.

Monitor legislative issues related to energy policy, climate change, renewable portfolio standards, and the production tax credit. Monitor Administrative action on Utility Maximum Achievable Control Technology (MACT) Standard. Monitor legislative issues and action regarding Master Limited Partnership (MLP) expansion. Monitor legislative and administrative action related to EPA Rulemaking on Mercury and Air Toxics Standards for Solid Waste Incineration Units. Monitor legislative and administrative action related to EPA New Source Performance Standards for new and existing power plants and guidelines for existing plants. Monitor legislative and administrative action related to EPA Clean Power Plan. Monitor the implementation of Consolidated Appropriations Act, 2016 (P.L. 114-113). Monitor legislative and administrative action related to the Public Utility Regulatory Policies Act (PURPA) (P.L. 95-617) H.R. 8, North American Energy Security and Infrastructure Act of 2015. H.R. 22, FAST Act. H.R. 702, To adapt to changing crude oil market conditions. H.R. 1027, Healthy Climate and Family Security Act of 2015. H.R. 1960, Land-Based Marine Debris Reduction Act. H.R. 2028, Energy and Water Development and Related Agencies Appropriations Act, 2017 H.R. 2029, Consolidated Appropriations Act, 2016. H.R. 2202, Tax Pollution, Not Profits Act. H.R. 2883, Master Limited Partnerships Parity Act. H.R. 3426, American Renewable Energy and Efficiency Act. H.R. 4931, Pharmaceutical Stewardship Act of 2016 H.R.5055, Energy and Water Development and Related Agencies Appropriations Act, 2017 S. 524, Comprehensive Addiction and Recovery Act of 2016 S. 913, An original bill to amend the Internal Revenue Code of 1986 to provide an investment tax credit for waste heat to power technology. S. 1063, American Energy Efficiency Act. S. 1222, Continuity of Electric Capacity Resources Act. S. 1283, PURPA PLUS Act. S. 1246, Protecting America's Paper for Recycling Act. S. 1264, Renewable Electricity Standard Act. S. 1277, Federal Energy Savings Enhancement Act of 2015. S. 1516, POWER Act. S. 1548, American Opportunity Carbon Fee Act of 2015. S. 1656, Master Limited Partnerships Parity Act. S. 1946, Tax Relief Extension Act of 2015. S. 1953, TRASH Act. S. 2012, Energy Policy Modernization Act. S. 2804, Energy and Water Development and Related Agencies Appropriations Act, 2017 Draft, A bill to amend the Internal Revenue Code of 1986 to modify the credit for production of electricity from renewable resources for certain open-loop biomass and trash facilities placed in service before the date of the enactment of this Act.

Monitor legislative issues related to energy policy, climate change, renewable portfolio standards, and the production tax credit. Monitor Administrative action on Utility Maximum Achievable Control Technology (MACT) Standard. Monitor legislative issues and action regarding Master Limited Partnership (MLP) expansion. Monitor legislative and administrative action related to EPA Rulemaking on Mercury and Air Toxics Standards for Solid Waste Incineration Units. Monitor legislative and administrative action related to EPA New Source Performance Standards for new and existing power plants and guidelines for existing plants. Monitor legislative and administrative action related to EPA Clean Power Plan. Monitor the implementation of Consolidated Appropriations Act, 2016 (P.L. 114-113). Monitor legislative and administrative action related to the Public Utility Regulatory Policies Act (PURPA) (P.L. 95-617) H.R. 8, North American Energy Security and Infrastructure Act of 2015. H.R. 22, FAST Act. H.R. 702, To adapt to changing crude oil market conditions. H.R. 1027, Healthy Climate and Family Security Act of 2015. H.R. 1960, Land-Based Marine Debris Reduction Act. H.R. 2028, Energy and Water Development and Related Agencies Appropriations Act, 2017 H.R. 2029, Consolidated Appropriations Act, 2016. H.R. 2202, Tax Pollution, Not Profits Act. H.R. 2883, Master Limited Partnerships Parity Act. H.R. 3426, American Renewable Energy and Efficiency Act. H.R. 4931, Pharmaceutical Stewardship Act of 2016 H.R.5055, Energy and Water Development and Related Agencies Appropriations Act, 2017 S. 524, Comprehensive Addiction and Recovery Act of 2016 S. 913, An original bill to amend the Internal Revenue Code of 1986 to provide an investment tax credit for waste heat to power technology. S. 1063, American Energy Efficiency Act. S. 1222, Continuity of Electric Capacity Resources Act. S. 1283, PURPA PLUS Act. S. 1246, Protecting America's Paper for Recycling Act. S. 1264, Renewable Electricity Standard Act. S. 1277, Federal Energy Savings Enhancement Act of 2015. S. 1516, POWER Act. S. 1548, American Opportunity Carbon Fee Act of 2015. S. 1656, Master Limited Partnerships Parity Act. S. 1946, Tax Relief Extension Act of 2015. S. 1953, TRASH Act. S. 2012, Energy Policy Modernization Act. S. 2804, Energy and Water Development and Related Agencies Appropriations Act, 2017 Draft, A bill to amend the Internal Revenue Code of 1986 to modify the credit for production of electricity from renewable resources for certain open-loop biomass and trash facilities placed in service before the date of the enactment of this Act.

Monitor legislative issues related to energy policy, climate change, renewable portfolio standards, and the production tax credit. Monitor Administrative action on Utility Maximum Achievable Control Technology (MACT) Standard. Monitor legislative issues and action regarding Master Limited Partnership (MLP) expansion. Monitor legislative and administrative action related to EPA Rulemaking on Mercury and Air Toxics Standards for Solid Waste Incineration Units. Monitor legislative and administrative action related to EPA New Source Performance Standards for new and existing power plants and guidelines for existing plants. Monitor legislative and administrative action related to EPA Clean Power Plan. Monitor the implementation of Consolidated Appropriations Act, 2016 (P.L. 114-113). Monitor legislative and administrative action related to the Public Utility Regulatory Policies Act (PURPA) (P.L. 95-617) H.R. 8, North American Energy Security and Infrastructure Act of 2015. H.R. 22, FAST Act. H.R. 702, To adapt to changing crude oil market conditions. H.R. 1027, Healthy Climate and Family Security Act of 2015. H.R. 1960, Land-Based Marine Debris Reduction Act. H.R. 2028, Energy and Water Development and Related Agencies Appropriations Act, 2017 H.R. 2029, Consolidated Appropriations Act, 2016. H.R. 2202, Tax Pollution, Not Profits Act. H.R. 2883, Master Limited Partnerships Parity Act. H.R. 3426, American Renewable Energy and Efficiency Act. H.R. 4931, Pharmaceutical Stewardship Act of 2016 H.R.5055, Energy and Water Development and Related Agencies Appropriations Act, 2017 S. 524, Comprehensive Addiction and Recovery Act of 2016 S. 913, An original bill to amend the Internal Revenue Code of 1986 to provide an investment tax credit for waste heat to power technology. S. 1063, American Energy Efficiency Act. S. 1222, Continuity of Electric Capacity Resources Act. S. 1283, PURPA PLUS Act. S. 1246, Protecting America's Paper for Recycling Act. S. 1264, Renewable Electricity Standard Act. S. 1277, Federal Energy Savings Enhancement Act of 2015. S. 1516, POWER Act. S. 1548, American Opportunity Carbon Fee Act of 2015. S. 1656, Master Limited Partnerships Parity Act. S. 1946, Tax Relief Extension Act of 2015. S. 1953, TRASH Act. S. 2012, Energy Policy Modernization Act. S. 2804, Energy and Water Development and Related Agencies Appropriations Act, 2017 Draft, A bill to amend the Internal Revenue Code of 1986 to modify the credit for production of electricity from renewable resources for certain open-loop biomass and trash facilities placed in service before the date of the enactment of this Act.

Policy matters related to generic pharmaceuticals and biosimilars including naming, labeling, access and interchangeability and changes to the Risk Evaluation and Mitigation Strategies (REMS) program, H.R.2841, FAST Generics Act of 2015 and S.3075, The CREATES Act, access to samples for generic testing. Issues related to House Energy and Commerce Committee's draft on H. R. 6, 21st Century Cures Act and the Senate Health, Education, Labor and Pensions Committee Initiative for Healthier Americans. Affordability and pricing of pharmaceuticals. Issues related to drug takeback and opioid addiction, including S.524 and H.R. 953, The Comprehensive Addiction and Recovery Act of 2016. H. R. 4931, The Pharmaceutical Stewardship Act of 2016 and S.2977, The Budgeting for Opioid Addiction Treatment Act.

Client expense: Not reported · Firm income: $60,000

Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Drug Importation. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). S.2615: Increasing Competition in Pharmaceuticals Act. Pharmaceutical exclusivity. H.R.4931: Pharmaceutical Stewardship Act of 2016. H.R.953: Comprehensive Addiction and Recovery Act of 2015 (CARA). S.3056: CREATES Act of 2016.

Client expense: $802,333 · Firm income: Not reported

Pseudoephedrine Potential legislation to implement real-time, stop-sale electronic tracking system for sales of medications containing pseudoephedrine in order to preserve consumer access to the ingredient, common in popular cold and allergy medications (no bill number) and oppose prescription requirement (no bill number). Extended Producer Responsibility/Pharmaceutical Stewardship (Drug Take-Back) H.R. 4931 - Pharmaceutical Stewardship Act of 2016. Requires the Drug Enforcement Administration to establish and implement a national pharmaceutical stewardship program to collect and dispose of prescription medications; all sections. H.R. 5046 - Comprehensive Opioid Abuse Reduction Act of 2016 (COARA). Amends the Omnibus Crime Control and Safe Streets Act of 1968 to authorize the Attorney General to make grants to assist State and local governments in addressing the national epidemic of opioid abuse, and for other purposes (all sections). S. 524 - Comprehensive Addiction and Recovery Act of 2016 (CARA). Authorizes the Attorney General and Secretary of Health and Human Services to award grants to address the national epidemics of prescription opioid abuse and heroin use, and to provide for the establishment of an inter-agency task force to review, modify, and update best practices for pain management and prescribing pain medication, and for other purposes (Section 201 - expands eligible uses of grant funds to include drug take-back efforts; Section 203 requires coordination among multiple government agencies to develop a prescription drug take-back program). Oral Contraceptives H.R. 5138 - Over-the-Counter Contraceptives Act of 2016. Grants priority review of applications to switch oral contraceptive drugs from prescription to nonprescription (over-the-counter) status; all sections. S. 1438 - Allowing Greater Access to Safe and Effective Contraception Act. Grants priority review of applications to switch oral contraceptive drugs from prescription to nonprescription (over-the-counter) status; all sections. H.R. 3163/S. 1532 - Affordability is Access Act. Clarifies that all oral contraceptive products be covered by insurance and provided to consumers without cost, regardless of prescription/nonprescription (over-the-counter) status; all sections. Over-the-counter (OTC) medicines; Manufacturing and importation of OTC drugs; Mandatory recall authority of the FDA; Rx-to-OTC Switch Supporting a process within FDA that ensures clarity and timely outcomes for the FDA, applicants and stakeholders, as well as utilizing existing technologies to further streamline the prescription-to-nonprescription switch application process without changing the existing clear distinction between prescription and nonprescription medicines.

Medical and pharmaceutical waste management Monitoring S 524, and amendments pertaining to controlled substances "take back" programs Monitoring HR 4931, Pharmaceutical Stewardship Act (drug "take back" programs)

Client expense: Not reported · Firm income: $40,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 471 - Ensuring Patient Access and Effective Drug Enforcement Act of 2015 S. 483 - Ensuring Patient Access and Effective Drug Enforcement Act of 2015 S.524 - Comprehensive Addiction and Recovery Act of 2016 H.R.953 - Comprehensive Addiction and Recovery Act of 2015 HR 3250 - DXM Abuse Prevention Act S. 2294 - DXM Abuse Prevention Act H.R. 5046 - Comprehensive Opioid Abuse Reduction Act of 2016 H.R.4931 - Pharmaceutical Stewardship Act of 2016 S. 3075 - Addiction Prevention and Responsible Opioid Practices Act

Client expense: $920,000 · Firm income: Not reported