Patient Safety and Drug Labeling Improvement Act

H.R.1873/S.987 (Arbitration Fairness Act); to prohibit mandatory binding arbitration in consumer contracts. H.R.6351 (Fairness in Nursing Home Arbitration Act); relating to the use of arbitration agreements to resolve disputes involving nursing home care and nursing home contracts. Lobbying with regard to the enforceability of mandatory, pre-disdpute arbitration provisions in employment and consumer contracts, including financial consumer contracts. S.1946/H.R.3646 (Foreign Manufacturers Legal Accountability Act); to require foreign manufacturers of products imported into the United States to establish registered agents in the United States who are authorized to accept service of process against such manufacturers, and for other purposes. Lobbying with regard to the preemption of state causes of action involving medical device and drug manufacturers. S.3076/H.R.4369 (Furthering Asbestos Claim Transparency Act); to amend title 11 of the United States Code to require the public disclosure by trusts established under section 524(g) of such title, of quarterly reports that contain detailed information regarding the receipt and disposition of claims for injuries based on exposure to asbestos, and the filing of such reports with the Executive Office for United States Trustees. S.2295/H.R.4384 (Patient Safety and Generic Labeling Improvement Act); to permit manufacturers of generic drugs to provide additional warnings with respect to such drugs in the same manner that the Food and Drug Administration allows brand name drug manufactuers to do so. H.R.6065 (no short title); to make improvements to the Children's Gasoline Burn Prevention Act; specific interest in provisions to limit the liability of gasoline container manufacturers. H.R. 6584 (Verifying Authority and Legality In Drug Compounding Act of 2012), to amend the Federal Food, Drug, and Cosmetic Act to provide for the compounding of drug products; specific interest in preservation of state-based causes of action. General lobbying with regard to the regulation of compoudning pharmacies and preservation of state-based causes of action. S.1223 (Location Privacy Protection Act of 2012); to address voluntary location tracking of electronic communications devices; specific interest in creation of enforcement actions and Grassley Amendment (failed in Committee) to require transparency for outside counsel retained by State Attorneys General.

Client expense: $790,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office

1. Educating policymakers on the need to work towards energy independence through a true "all of the above" domestic energy policy which makes responsible use of the full range of the nation's domestic energy resources. Legislation supported: H.R. 1287, H.R. 2016, H.R. 1719, H.R. 3407, H.R. 3408, H.R. 3410, H.R. 4381, H.R. 4382, H.R. 4384, S. 706, S. 629, S. 631. 2. Educating policymakers on the need to strengthen and expand the nation's electric transmission system. 3. Educating policymakers on the cumulative negative consequences of the growing body of regulations being instituted that impact the nation's electric generation fleet's reliability and which inflict growing costs on consumers (further discussed in the Air, Waste and Water pages of this report.) 4. Educating policymakers on the nexus between a robust energy policy and a strong minerals policy. Particular emphasis has been on critical minerals and their importance as inputs to a vast array of clean energy, electronics, high tech, health, defense, transportation and other applications. Past activities have included input for S. 1113 and support for H.R. 2011 and H.R. 4402. 5. Stressing with policymakers the implications of proposed Executive Branch requirements (NEPA, GHG, climate adaptation, Clean Air Act, Clean Water Act, Resource Conservation and Recovery Act, federal land management policies, etc.) -- that hamper energy and natural resource development projects across the West -- on the nation's energy and economic security. Support for various reform efforts to constrain regulatory overreach (listed under relevant issue pages of this report). 6. Educating policymakers on the need to focus on policies that encourage development of the nation's full range of "clean energy" resources/supporting technologies, including hydropower. 7. Support for H.R. 1996 and S. 1061. 8. Continuing to educate policymakers on the impacts to Western energy consumers of DOE Secretary Chu's proposed shift in the mission of the federal PMAs. 9. Support for House passage of the alternative offshore drilling plan for 2012-17 (H.R. 6082). 10. Support for House passage of the "Stop the War on Coal" Act of 2012 (H.R. 3409, H.R. 910, H.R. 2401, H.R. 2273, H.R. 2018).

H.R. 5651, S. 3187 (Prescription Drug User Fee Act (PFUFA)) FDA funding issues, including issues such as user fees and future appropriations HR 4274 (PREA Authorization Act of 2012, Best Pharmaceuticals for Children Act and Pediatric Research Equity Act of 2003) and related legislation related to issues of pediatric exclusivity S. 2295, H.R. 4384 and related legislation regarding pharmaceutical labeling changes

Client expense: $370,000 · Firm income: Not reported

S. 2295, H.R. 4384 and related legislation regarding pharmaceutical labeling changes

Client expense: $980,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)

Public Law 111-148 - Patient Protection and Affordable Care Act - PPACA (Implementation) H.R. 2 - Repealing Jobs - Killing Health Care Law Act H.R. 5 - Help Efficient, Accessible, Low-Cost Timely Health Care (HEALTH) Act H.R. 1150 - Competitive Health Insurance Reform Act (McCarran Repeal) H.R. 1217 - To Repeal the Prevention and Public Health Fund H.R. 1309 / Public Law 112-141 - Flood Insurance Reform and Modernization Act of 2011 (Rulemaking and Implementation) S. 528 - Safe Teen and Novice Driver Uniform Protection (STANDUP) Act S. 637 - Earthquake Insurance Affordablity Act S. 886 - Catastrophe Obligation Guarantee Act S. 3994 - Flood Insurance Affordability and Risk Notification Act S. 137 / H.R. 416 - Health Insurance Rate Review Act H.R. 2126 - Risk Retention Modernization Act H.R. 623 - The National Commission on State Workers' Comp Laws H.R. 1063 - Strengthening Medicare and Repaying Taxpayers Act of 2011 (SMART) Act S. 1091 - Consumer option for an Alternative System to Allocate Losses Act of 2011 H.R. 5860 - Executive Compensation Clawback Full Enforcement Act H.R. 5284 - Medicare Secondary Payer and Workers' Compensation Settlement Agreements Act of 2012 Public Law 112-141 - Moving Ahead for Progress in the 21st Century Act (Rulemakings and Implementation) Public Law 112-106 - Jumpstart our Business Start Ups (JOBS) Act (Rulemakings and Implementation) H.R. 5891 - Defense Base Act and Insurance Improvement Act S. 2295 - Patient Safety and Generic Labeling Improvement Act H.R. 4384 - Patient Safety and Drug Labeling Improvement Act H.R. 6477 - Taxpayer Protection Act H.R. 6186 - To require a study of voluntary community-based flood insurance options and how such options could be incorporated into the National Flood Insurance Program, and for other purposes. H.R. 6129 - Ban the Use of Credit Scores in Auto Insurance Act Potential legislation similar to H.R. 1346 / S. 540, Medical Device Safety Act (111th Congress) Department of Justice FY2012 budget submission dealing with medical liability grants Various issues relating to the Patient Protection and Affordable Care Act

S. 3187, Food and Drug Administration Safety and Innovation Act, provisions relating to drug shortages, antibiotic incentives, and combating diversion H.R. 5998, USPSTF Transparency and Accountability Act of 2012, all provisions H.R. 2119, Ryan Creedon Act of 2011, all provisions H.R. 3497, MODDERN Cures Act of 2011, all provisions H.R. 3207, Modernizing Laboratory Test Standards for Patients Act of 2011, all provisions H.R. 866, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2011, all provisions H.R. 2182, Generating Antibiotic Incentives Now Act of 2011, all provisions H.R. 2960, National Diabetes Clinical Care Commission Act, all provisions H.R. 4384, Patient Safety and Drug Labeling Improvement Act, all provisions Clinical Registries ACA Implementation Insurance Exchanges Prescription Drug Abuse Drug diversion/mandatory CME for DEA Registrants/violence prevention Drug shortages Flexible Spending Accounts (FSAs) Delivery and Payment Reform Personalized Medicine Health Information Technology HIPAA Administrative Simplifications Health Insurance Reform Medical Licensing Boards and Scope of Practice

Client expense: $3,680,000 · Firm income: Not reported

Patient Protection and Affordable Care Act (P.L. 111-148); Health Care and Education Reconciliation Act of 2010 (P.L. 111-152); S. 2295/H.R. 4384, the Patient Safety and Generic Labeling Improvement Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Patient Protection and Affordable Care Act (P.L. 111-148); Health Care and Education Reconciliation Act of 2010 (P.L. 111-152); S. 3187, Food and Drug Administration Safety and Innovation Act; H.R. 5651, Food and Drug Administration Reform Act of 2012; H.Con.Res. 112, House FY 2013 Budget; S. 2295/H.R. 4384, Patient Safety and Generic Labeling Improvement Act; Sequestration Transparency Act of 2012 (P.L. 112-155).

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

H.R.1873/S.987 (Arbitration Fairness Act); to prohibit mandatory binding arbitration in consumer contracts. H.R.6351 (Fairness in Nursing Home Arbitration Act); relating to the use of arbitration agreements to resolve disputes involving nursing home care and nursing home contracts. Lobbying with regard to the enforceability of mandatory, pre-disdpute arbitration provisions in employment and consumer contracts, including financial consumer contracts. S.1946/H.R.3646 (Foreign Manufacturers Legal Accountability Act); to require foreign manufacturers of products imported into the United States to establish registered agents in the United States who are authorized to accept service of process against such manufacturers, and for other purposes. Lobbying with regard to the preemption of state causes of action involving medical device and drug manufacturers. S.3076/H.R.4369 (Furthering Asbestos Claim Transparency Act); to amend title 11 of the United States Code to require the public disclosure by trusts established under section 524(g) of such title, of quarterly reports that contain detailed information regarding the receipt and disposition of claims for injuries based on exposure to asbestos, and the filing of such reports with the Executive Office for United States Trustees. H.R.3356 (ADA Compliance for Customer Entry to Stores and Services); to amend the Americans with Disabilities Act of 1990 to impose notice and a compliance opportunity to be provided before commencement of a private civil action. S.2295/H.R.4384 (Patient Safety and Generic Labeling Improvement Act); to permit manufacturers of generic drugs to provide additional warnings with respect to such drugs in the same manner that the Food and Drug Administration allows brand name drug manufactuers to do so. S.3204/H.R.4367 (no short title); to amend the Electronic Fund Transfer Act to limit the fee disclosure requirement for an automatic teller machine to the screen of that machine. H.R.6065 (no short title); to make improvements to the Children's Gasoline Burn Prevention Act; specific interest in provisions to limit the liability of gasoline container manufacturers.

1. Educating policymakers on the need to work towards energy independence through a true "all of the above" domestic energy policy which makes responsible use of the full range of the nation's domestic energy resources. Legislation supported: H.R. 1287, H.R. 2016, H.R. 1719, H.R. 3407, H.R. 3408, H.R. 3410, H.R. 4381, H.R. 4382, H.R. 4384, S. 706, S. 629, S. 631. 2. Educating policymakers on the need to strengthen and expand the nation's electric transmission system. 3. Educating policymakers on the cumulative negative consequences of the growing body of regulations being instituted that impact the nation's electric generation fleet's reliability and which inflict growing costs on consumers (further discussed in the Air, Waste and Water pages of this report.) 4. Educating policymakers on the nexus between a robust energy policy and a strong minerals policy. Particular emphasis has been on critical minerals and their importance as inputs to a vast array of clean energy, electronics, high tech, health, defense, transportation and other applications. Past activities have included input for S. 1113 and support for H.R. 2011 and H.R. 4402. 5. Stressing with policymakers the implications of proposed Executive Branch requirements (NEPA, GHG, climate adaptation, Clean Air Act, Clean Water Act, Resource Conservation and Recovery Act, federal land management policies, etc.) -- that hamper energy and natural resource development projects across the West -- on the nation's energy and economic security. Support for various reform efforts to constrain regulatory overreach (listed under relevant issue pages of this report). 6. Educating policymakers on the need to focus on policies that encourage development of the nation's full range of "clean energy" resources/supporting technologies, including hydropower. 7. Support for H.R. 1996 and S. 1061. 8. Continuing to educate policymakers on the impacts to Western energy consumers of DOE Secretary Chu's proposed shift in the mission of the federal PMAs. 9. Support for House passage of the alternative offshore drilling plan for 2012-17 (H.R. 6082). 10. Support for House passage of the "Stop the War on Coal" Act of 2012 (H.R. 3409, H.R. 910, H.R. 2401, H.R. 2273, H.R. 2018).

H.R. 5651, S. 3187 (Prescription Drug User Fee Act (PFUFA)) FDA funding issues, including issues such as user fees and future appropriations HR 4274 (PREA Authorization Act of 2012, Best Pharmaceuticals for Children Act and Pediatric Research Equity Act of 2003) and related legislation related to issues of pediatric exclusivity S. 2295, H.R. 4384 and related legislation regarding pharmaceutical labeling changes

Client expense: $360,000 · Firm income: Not reported

H.R. 4384, Patient Safety and Drug Labeling Improvement Act H.R. 5651, Food and Drug Administration Reform Act of 2012 S. 27, Preserve Access to Affordable Generics Act, provisions related to reverse payout settlements S. 2295, Patient Safety and Generic Labeling Improvement Act S. 3187, Amendments to the Food and Drug Administration Safety and Innovation Act relating to market exclusivity and patent settlements (S. Amdt. 2009 and S. Amdt. 2111)

Client expense: $6,260,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Justice, Dept of (DOJ), SENATE, Securities & Exchange Commission (SEC)

H.R.1873/S.987 (Arbitration Fairness Act); to prohibit mandatory binding arbitration in consumer contracts. (Fairness in Nursing Home Arbitration Act), draft legislation not formally introduced as of 6-30-2012; relating to the use of arbitration agreements to resolve disputes involving nursing home care and nursing home contracts. Lobbying with regard to the enforceability of mandatory, pre-disdpute arbitration provisions in employment and consumer contracts, including financial consumer contracts. S.1946/H.R.3646 (Foreign Manufacturers Legal Accountability Act); to require foreign manufacturers of products imported into the United States to establish registered agents in the United States who are authorized to accept service of process against such manufacturers, and for other purposes. Lobbying with regard to the preemption of state causes of action involving medical device and drug manufacturers. Lobbying with regard to the preemption of state causes of action involving cosmetics. S.3076/H.R.4369 (Furthering Asbestos Claim Transparency Act); to amend title 11 of the United States Code to require the public disclosure by trusts established under section 524(g) of such title, of quarterly reports that contain detailed information regarding the receipt and disposition of claims for injuries based on exposure to asbestos, and the filing of such reports with the Executive Office for United States Trustees. H.R.3356 (ADA Compliance for Customer Entry to Stores and Services); to amend the Americans with Disabilities Act of 1990 to impose notice and a compliance opportunity to be provided before commencement of a private civil action. S.2295/H.R.4384 (Patient Safety and Generic Labeling Improvement Act); to permit manufacturers of generic drugs to provide additional warnings with respect to such drugs in the same manner that the Food and Drug Administration allows brand name drug manufactuers to do so. S.2156/S.3187 (Food and Drug Administration Safety and Innovation Act)/H.R.5651(Food and Drug Administration Reform Act); specific interest in preemption of state causes of action involving prescription drug manufacturers, medical device manufacturers and online pharmacies. S.3204/H.R.4367 (no short title); to amend the Electronic Fund Transfer Act to limit the fee disclosure requirement for an automatic teller machine to the screen of that machine.

Patient Protection and Affordable Care Act (P.L. 111-148); Health Care and Education Reconciliation Act of 2010 (P.L. 111-152); S. 2295/H.R. 4384, the Patient Safety and Generic Labeling Improvement Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Patient Protection and Affordable Care Act (P.L. 111-148); Health Care and Education Reconciliation Act of 2010 (P.L. 111-152); S. 3187, the Food and Drug Administration Safety and Innovation Act; H.R. 5651, the Food and Drug Administration Reform Act of 2012; H.Con.Res. 112, the House FY 2013 Budget; S 2295/H.R. 4384, the Patient Safety and Generic Labeling Improvement Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

1. Educating policymakers on the need to work towards energy independence. Continued emphasis on responsible development of the full range of the nation's domestic resources. Legislation supported: H.R. 1287, H.R. 2016, H.R. 1719, H.R. 3407, H.R. 3408, H.R. 3410, H.R. 4381, H.R. 4382, H.R. 4384, S. 706, S. 629, S. 631. 2. Educating policymakers on the need to strengthen and expand the nation's electric transmission system. 3. Educating policymakers on the cumulative negative consequences of the growing body of regulations being instituted that impact the nation's electric generation fleet's reliability and inflict growing costs on consumers (discussed in Air, Waste and Water pages of this report). 4. Educating policymakers on the nexus between a robust energy policy and a strong minerals policy. Particular emphasis has been on critical minerals and their importance as inputs to a vast array of clean energy, electronics, high tech and defense applications. Past activities have included providing input for S. 1113 and support for H.R. 2011 and H.R. 4402. 5. Stressing with policymakers the implications of proposed Executive Branch requirements (NEPA, GHG, climate adaptation, Clean Air Act, Clean Water Act, Resource Conservation and Recovery Act, federal land management policies, etc.) -- that hamper energy and natural resource development projects throughout the West -- on the nation's energy and economic security. Support for various reform efforts to constrain regulatory overreach (listed under relevant issue pages of this report.) 6. Educating policymakers on the need to focus on policies that encourage devleopment of the nation's full range of "clean energy" resources / supporting technologies, including hydropower. 7. Support for H.R. 1996 and S. 1061. 8. Educating policymakers on impacts to Western energy consumers of DOE Secretary Chu's proposed shift in the missions of federal PMAs.