Horse Protection Amendments Act of 2014

HR 4098 - Amendments to Horse Protection Act - all titles and provisions; S 2193 - Amendments to Horse Protection Act - all titles and provisions; HR 1518 - Amendments to Horse Protection Act - all titles and provisions; S 1406 - Amendments to Horse Protection Act - all titles and provisions.

Client expense: Not reported · Firm income: $20,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Discussed importance of potential savings both to consumers and to the federal government of granting Secretarial Negotiating Authority to Secretary of HHS on Medicare Part D. (no bill)Discussed legislative intent with respect to biologic drugs and the exclusivity period; and discussed importance of potential savings to the health care system generally. (no bill) Discussed need for greater consumer safety protections both in OTC and prescription drugs. (no bill) Discussed need for doctors to get unbiased information on prescription pharmaceuticals through programs like academic detailing. (no bill) Discussed possible savings and better health care outcomes that could result from Medication Therapy Management. (no bill) Pub. Law 111-148 and 111-152 - Discussed implementation of health care legislation to reform the health care system to provide quality healthcare, expand access to long-term services and supports, and reduced prescription drug costs. Discussed greater affordability of generic versions of both generic and biologic drugs. S. 319, Pharmaceutical Market Access and Drug Safety Act of 2011 - Discussed legislation that establishes a framework for the safe, legal importation of lower-priced prescription drugs from abroad. S. 1206, Medicare Drug Savings Act of 2011 - Discussed rebates in Medicare Part D as a cost savings measure in Medicare that does not harm beneficiaries. H. R. 3342, Affordable Medicines Utilization Act of 2011 - Lobbied on legislation to encourage state Medicaid programs to use safe, effective generic medications. S. 27, Preserve Access to Affordable Generics Act of 2011- Lobbied for this legislation preventing abuses in patent settlements between generic and brand name prescription drug companies. S. 1886/H.R. 3468 of 2011- Discussed counterfeit drug penalty enhancement. Discussed prescription drug safety, drug shortage, and medical device safety, and related user fee legislation. S. 2193 of 2012, the Ensuring Safe Medical Devices for Patients Act - Discussed legislation to include devices in the post-market risk identification and analysis system for prescription drugs and to expedite the implementation of the unique device identification system for medical devices. Discussed draft legislation to address the issue of whether generic drug manufacturers have a duty to include new warnings about potentially serious side effects on their labels as they become known by giving generic drug makers the same ability to update their labeling as manufacturers of brand name drugs. (no bill) S.3187, Food and Drug Administration safety and Innovation Act - FDA user fee agreement legislation focusing on the review process for prescription drugs and medical devices, prescription drug safety, drug shortages, medical device safety and access to generic drugs. S.3212, Cody Miller Initiative for Safer Prescriptions Act - To require the Secretary of Health and Human Services to promulgate regulations regarding the authorship, content, format, and dissemination of Patient Medication information. Discussed pay-for-delay agreements as tactic by drug manufacturers to block lower cost drugs from entering the market, and the Fair and Immediate Release of Generics Drugs Act that would address the underlying issue of "parked exclusivities" in the Hatch-Waxman Act (S.1882). Discussed the issue of biosimilar drug naming and how biosimilars should use a common International Non-proprietary name as reference originator biologic products. (no bill) S. 504, the Fair and Immediate Release of Generic Drugs Act/S.214, the Preserve Access to Affordable Generics Act - Discussed the Patient Safety and Generic Labeling Improvement Act. (no bill) H.R. 83, Consolidated and Further Continuing Appropriations, 2015 - Lobbied to protect and enhance funding levels for FDA to enable it to effectively manage it's food safety and medical product programs. H.J. Res. 124, Continuing Appropriations Resolutions, 2015 - Lobbied to protect senior housing and nutrition programs, and FDA programs from disproportionate reduction under the bill.Discussed Unique Device Identification (UDI) issues including proposed rules and implementation. (no bill) Discussed oversight of laboratory genetic testing. (no bill) Discussed AARP's concerns with prescription drug costs. (no bill) S.117, Medicare Prescription Drug Price Negotiation Act - Discussed bill that allows medicare to negotiate medicare prescription drug prices with drug companies. Discussed the exclusivity period for biologic drugs. (no bill) Discussed the Patient Safety and Generic Labeling Improvement Act. (no bill) Discussed biologic drug issues including implementation of the new approval pathway for biosimilar drugs. (no bill) Discussed the importance of potential savings to both consumers and the federal government of granting Secretarial negotiating authority to the HHS Secretary under Medicare Part D. (no bill) S. 504, the Fair and Immediate Release of Generics Drugs Act/S. 214, the Preserve Access to Affordable Generics - Discussed legislation to address pay-for-delay agreements used by drug manufacturers to block lower cost drugs from entering the market. Discussed the exclusivity period ofr biologic drugs. (no bill) Discussed the Food and Drug Administration proposed rule to enable generic drug makers to independently update their drug labeling. (no bill) Discussed biologic drug issues including implementation of the new approval pathway for biosimilar drugs. (no bill) S. 1720/S.2049/S.866, - Discussed patent reform legislation and related provisions. Discussed the importance of potential savings to both consumers and the federal government of granting Secretarial negotiating authority to the HHS Secretary under Medicare Part D. (no bill) Discussed legislation to address pay-for-delay agreements used by drug manufacturers to block lower cost drugs from entering the market (the Fair and Immediate Release of Generic Drugs Act (S. 504) and (the Preserve Access to Affordable Generics Act) (S.214). Discussed the Food and Drug Administration proposed rule to enable generic drug makers to independently update their drug labeling. (no bill) Discussed other prescription drug issues and potential legislation on drug importation and "least costly alternative" payment for Part B durgs. (no bill) S.504/S.214 - Discussed legislation to address pay-for-delay agreements used by drug manufacturers to block lower cost drugs from entering the market (the Fair and Immediate Release of Generics Drugs Act) and the Preserve Access to Affordable Generics Act. Discussed the Food and Drug Administration proposed rule to enable generic drug makers to independently update their drug labeling. (no bill) Discussed biologic drug issues including implementation of the new approval pathway for biosimilar drugs. (no bill) S.1720/S.2040/S.866 - Discussed patent reform legislation and related provisions. Discussed other prescription drug issues and potential legislation on drug importation and "least costly alternative" payment for Part B drugs. (no bill) Discussed the need to data transparency on prescription drug research and development costs and drug prices, and enhanced data reporting on coverage determinations, exception, and redeterminations under Part D appeals process. (no bill) Discussed the House Energy and Commerce Committee 21st Century Cures Initiative focused on drug and medical device innovation issues. (no bill)

Client expense: $2,180,000 · Firm income: Not reported

Government targets: Administration on Aging, Agriculture, Dept of (USDA), Bureau of the Census, Centers For Medicare and Medicaid Services (CMS), Commodity Futures Trading Commission (CFTC), Congressional Budget Office (CBO), Energy, Dept of, Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Federal Communications Commission (FCC), Federal Highway Administration (FHA), Federal Reserve System, Federal Trade Commission (FTC), Federal Transit Administration (FTA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Housing & Urban Development, Dept of (HUD), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Natl Highway Traffic Safety Administration (NHTSA), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Personnel Management (OPM), Office of the Comptroller of the Currency (OCC), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Social Security Administration (SSA), Transportation, Dept of (DOT), Treasury, Dept of, Veterans Affairs, Dept of (VA), White House Office

H.R. 1094/S. 541 Safeguarding American Food Exports Act S. 1459/H.R. 4440 Horse Transportation Safety Act H.R. 4098/S. 2193 Horse Protection Amendments Act H.R. 1518/S.1406 Prevent All Soring Tactics Act

Client expense: $190,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Federal Trade Commission (FTC), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Discussed importance of potential savings both to consumers and to the federal government of granting Secretarial Negotiating Authority to Secretary of HHS on Medicare Part D. (no bill)Discussed legislative intent with respect to biologic drugs and the exclusivity period; and discussed importance of potential savings to the health care system generally. (no bill) Discussed need for greater consumer safety protections both in OTC and prescription drugs. (no bill) Discussed need for doctors to get unbiased information on prescription pharmaceuticals through programs like academic detailing. (no bill) Discussed possible savings and better health care outcomes that could result from Medication Therapy Management. (no bill) Pub. Law 111-148 and 111-152 - Discussed implementation of health care legislation to reform the health care system to provide quality healthcare, expand access to long-term services and supports, and reduced prescription drug costs. Discussed greater affordability of generic versions of both generic and biologic drugs. S. 319, Pharmaceutical Market Access and Drug Safety Act of 2011 - Discussed legislation that establishes a framework for the safe, legal importation of lower-priced prescription drugs from abroad. S. 1206, Medicare Drug Savings Act of 2011 - Discussed rebates in Medicare Part D as a cost savings measure in Medicare that does not harm beneficiaries. H. R. 3342, Affordable Medicines Utilization Act of 2011 - Lobbied on legislation to encourage state Medicaid programs to use safe, effective generic medications. S. 27, Preserve Access to Affordable Generics Act of 2011- Lobbied for this legislation preventing abuses in patent settlements between generic and brand name prescription drug companies. S. 1886/H.R. 3468 of 2011- Discussed counterfeit drug penalty enhancement. Discussed prescription drug safety, drug shortage, and medical device safety, and related user fee legislation. S. 2193 of 2012, the Ensuring Safe Medical Devices for Patients Act - Discussed legislation to include devices in the post-market risk identification and analysis system for prescription drugs and to expedite the implementation of the unique device identification system for medical devices. Discussed draft legislation to address the issue of whether generic drug manufacturers have a duty to include new warnings about potentially serious side effects on their labels as they become known by giving generic drug makers the same ability to update their labeling as manufacturers of brand name drugs. (no bill) S.3187, Food and Drug Administration safety and Innovation Act - FDA user fee agreement legislation focusing on the review process for prescription drugs and medical devices, prescription drug safety, drug shortages, medical device safety and access to generic drugs. S.3212, Cody Miller Initiative for Safer Prescriptions Act - To require the Secretary of Health and Human Services to promulgate regulations regarding the authorship, content, format, and dissemination of Patient Medication information. Discussed pay-for-delay agreements as tactic by drug manufacturers to block lower cost drugs from entering the market, and the Fair and Immediate Release of Generics Drugs Act that would address the underlying issue of "parked exclusivities" in the Hatch-Waxman Act (S.1882). Discussed the issue of biosimilar drug naming and how biosimilars should use a common International Non-proprietary name as reference originator biologic products. (no bill) S. 504, the Fair and Immediate Release of Generic Drugs Act/S.214, the Preserve Access to Affordable Generics Act - Discussed the Patient Safety and Generic Labeling Improvement Act. (no bill) H.R. 4800/S. 2389, Agriculture Appropriations bill, 2015 - Lobbied to protect and enhance funding levels for FDA to enable it to effectively manage it's food safety and medical product programs. H.J. Res. 124, Continuing Appropriations Resolutions, 2015 - Lobbied to protect senior housing and nutrition programs, and FDA programs from disproportionate reduction under the bill.Discussed Unique Device Identification (UDI) issues including proposed rules and implementation. (no bill) Discussed oversight of laboratory genetic testing. (no bill) Discussed AARP's concerns with prescription drug costs. (no bill) S.117, Medicare Prescription Drug Price Negotiation Act - Discussed bill that allows medicare to negotiate medicare prescription drug prices with drug companies. S.504/S.214, The Fair and Immediate Release of Generics Drugs Act/Preserve Access to Affordable Generics Act - Discussed legislation to address pay-for-delay agreements used by drug manufacturers to block lower cost drugs from entering the market. Discussed the exclusivity period for biologic drugs. (no bill) Discussed the Patient Safety and Generic Labeling Improvement Act. (no bill) Discussed biologic drug issues including implementation of the new approval pathway for biosimilar drugs. (no bill) Discussed the importance of potential savings to both consumers and the federal government of granting Secretarial negotiating authority to the HHS Secretary under Medicare Part D. (no bill) S. 504, the Fair and Immediate Release of Generics Drugs Act/S. 214, the Preserve Access to Affordable Generics - Discussed legislation to address pay-for-delay agreements used by drug manufacturers to block lower cost drugs from entering the market. Discussed the exclusivity period ofr biologic drugs. (no bill) Discussed the Food and Drug Administration proposed rule to enable generic drug makers to independently update their drug labeling. (no bill) Discussed biologic drug issues including implementation of the new approval pathway for biosimilar drugs. (no bill) S. 1720/S.2049/S.866, - Discussed patent reform legislation and related provisions. Discussed the importance of potential savings to both consumers and the federal government of granting Secretarial negotiating authority to the HHS Secretary under Medicare Part D. (no bill) Discussed legislation to address pay-for-delay agreements used by drug manufacturers to block lower cost drugs from entering the market (the Fair and Immediate Release of Generic Drugs Act (S. 504) and (the Preserve Access to Affordable Generics Act) (S.214). Discussed the exclusivity period for biologic drugs. (no bill) Discussed the Food and Drug Administration proposed rule to enable generic drug makers to independently update their drug labeling. (no bill) Discussed biologic drug issues including implementation of the new approval pathway for biosimilar drugs. (no bill) S. 1720/S. 2049/S.866 - Discussed patent reform legislation and related provisions. Discussed other prescription drug issues and potential legislation on drug importation and "least costly alternative" payment for Part B durgs. (no bill) Discussed the importance of potential savings to both consumers and the federal government of granting Secretarial negotiating authority to the HHS Secretary under Medicare Part D. (no bill) S.504/S.214 - Discussed legislation to address pay-for-delay agreements used by drug manufacturers to block lower cost drugs from entering the market (the Fair and Immediate Release of Generics Drugs Act) and the Preserve Access to Affordable Generics Act. Discussed the exclusivity period for biologic drugs. (no bill) Discussed the Food and Drug Administration proposed rule to enable generic drug makers to independently update their drug labeling. (no bill) Discussed biologic drug issues including implementation of the new approval pathway for biosimilar drugs. (no bill) S.1720/S.2040/S.866 - Discussed patent reform legislation and related provisions. Discussed other prescription drug issues and potential legislation on drug importation and "least costly alternative" payment for Part B drugs. (no bill) Discussed the need to data transparency on prescription drug research and development costs and drug prices, and enhanced data reporting on coverage determinations, exception, and redeterminations under Part D appeals process. (no bill) Discussed the House Energy and Commerce Committee 21st Century Cures Initiative focused on drug and medical device innovation issues. (no bill)

Client expense: $2,380,000 · Firm income: Not reported

Government targets: Administration on Aging, Agriculture, Dept of (USDA), Bureau of the Census, Centers For Medicare and Medicaid Services (CMS), Commodity Futures Trading Commission (CFTC), Congressional Budget Office (CBO), Energy, Dept of, Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Federal Communications Commission (FCC), Federal Highway Administration (FHA), Federal Reserve System, Federal Trade Commission (FTC), Federal Transit Administration (FTA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Housing & Urban Development, Dept of (HUD), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Natl Highway Traffic Safety Administration (NHTSA), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Personnel Management (OPM), Office of the Comptroller of the Currency (OCC), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Social Security Administration (SSA), Transportation, Dept of (DOT), Treasury, Dept of, Veterans Affairs, Dept of (VA), White House Office

H.R. 1094/S. 541 Safeguarding American Food Exports Act H.R. 1518/S. 1406 Prevent All Soaring Tactics Act S. 1459/H.R. 4440 Horse Transportation Safety Act H.R. 4098/S. 2193 Horse Protection Amendments Act

Client expense: $210,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

H.R. 1094/S. 541 Safeguarding American Food Exports Act H.R. 1518/S. 1406 Prevent All Soaring Tactics Act S. 1459/H.R. 4440 Horse Transportation Safety Act H.R. 4098/S. 2193 Horse Protection Amendments Act

Client expense: $210,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

HR 1518, HR 4098; S 1406, S 2193

Client expense: Not reported · Firm income: Not reported

HR 1518, HR 4098; S 1406, S 2193

Client expense: Not reported · Firm income: Not reported

Urge support fro HR 4432; Ag Appropriations, urge support for bill; Urge support for S. 2193; Urge support for HR 3080, Water Resources Reform & Development Act; Support Appointment for Darci Vetter appointment; Farm Bill, discuss concerns regarding Biomass Crop Assistance Program and Lifestock Forage Program; Urge Support for HR 4413;

Client expense: $72,046 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), HOUSE OF REPRESENTATIVES, SENATE

HR 4098 and S 2193 - Horse Protection Act amendments - all provisions

Client expense: Not reported · Firm income: $20,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Discussed importance of potential savings both to consumers and to the federal government of granting Secretarial Negotiating Authority to Secretary of HHS on Medicare Part D. (no bill)Discussed legislative intent with respect to biologic drugs and the exclusivity period; and discussed importance of potential savings to the health care system generally. (no bill) Discussed need for greater consumer safety protections both in OTC and prescription drugs. (no bill) Discussed need for doctors to get unbiased information on prescription pharmaceuticals through programs like academic detailing. (no bill) Discussed possible savings and better health care outcomes that could result from Medication Therapy Management. (no bill) Pub. Law 111-148 and 111-152 - Discussed implementation of health care legislation to reform the health care system to provide quality healthcare, expand access to long-term services and supports, and reduced prescription drug costs. Discussed greater affordability of generic versions of both generic and biologic drugs. S. 319, Pharmaceutical Market Access and Drug Safety Act of 2011 - Discussed legislation that establishes a framework for the safe, legal importation of lower-priced prescription drugs from abroad. S. 1206, Medicare Drug Savings Act of 2011 - Discussed rebates in Medicare Part D as a cost savings measure in Medicare that does not harm beneficiaries. H. R. 3342, Affordable Medicines Utilization Act of 2011 - Lobbied on legislation to encourage state Medicaid programs to use safe, effective generic medications. S. 27, Preserve Access to Affordable Generics Act of 2011- Lobbied for this legislation preventing abuses in patent settlements between generic and brand name prescription drug companies. S. 1886/H.R. 3468 of 2011- Discussed counterfeit drug penalty enhancement. Discussed prescription drug safety, drug shortage, and medical device safety, and related user fee legislation. S. 2193 of 2012, the Ensuring Safe Medical Devices for Patients Act - Discussed legislation to include devices in the post-market risk identification and analysis system for prescription drugs and to expedite the implementation of the unique device identification system for medical devices. Discussed draft legislation to address the issue of whether generic drug manufacturers have a duty to include new warnings about potentially serious side effects on their labels as they become known by giving generic drug makers the same ability to update their labeling as manufacturers of brand name drugs. (no bill) S.3187, Food and Drug Administration safety and Innovation Act - FDA user fee agreement legislation focusing on the review process for prescription drugs and medical devices, prescription drug safety, drug shortages, medical device safety and access to generic drugs. S.3212, Cody Miller Initiative for Safer Prescriptions Act - To require the Secretary of Health and Human Services to promulgate regulations regarding the authorship, content, format, and dissemination of Patient Medication information. Discussed pay-for-delay agreements as tactic by drug manufacturers to block lower cost drugs from entering the market, and the Fair and Immediate Release of Generics Drugs Act that would address the underlying issue of "parked exclusivities" in the Hatch-Waxman Act (S.1882). Discussed the issue of biosimilar drug naming and how biosimilars should use a common International Non-proprietary name as reference originator biologic products. (no bill) S. 504, the Fair and Immediate Release of Generic Drugs Act/S.214, the Preserve Access to Affordable Generics Act - Discussed the Patient Safety and Generic Labeling Improvement Act. (no bill) H.R. 4800/S. 2389, Agriculture Appropriations bill, 2015 - Lobbied to protect and enhance funding levels for FDA to enable it to effectively manage it's food safety and medical product programs.Discussed Unique Device Identification (UDI) issues including proposed rules and implementation. (no bill) Discussed oversight of laboratory genetic testing. (no bill) Discussed AARP's concerns with prescription drug costs. (no bill) S.117, Medicare Prescription Drug Price Negotiation Act - Discussed bill that allows medicare to negotiate medicare prescription drug prices with drug companies. S.504/S.214, The Fair and Immediate Release of Generics Drugs Act/Preserve Access to Affordable Generics Act - Discussed legislation to address pay-for-delay agreements used by drug manufacturers to block lower cost drugs from entering the market. Discussed the exclusivity period for biologic drugs. (no bill) Discussed the Patient Safety and Generic Labeling Improvement Act. (no bill) Discussed biologic drug issues including implementation of the new approval pathway for biosimilar drugs. (no bill) Discussed the importance of potential savings to both consumers and the federal government of granting Secretarial negotiating authority to the HHS Secretary under Medicare Part D. (no bill) S. 504, the Fair and Immediate Release of Generics Drugs Act/S. 214, the Preserve Access to Affordable Generics - Discussed legislation to address pay-for-delay agreements used by drug manufacturers to block lower cost drugs from entering the market. Discussed the exclusivity period ofr biologic drugs. (no bill) Discussed the Food and Drug Administration proposed rule to enable generic drug makers to independently update their drug labeling. (no bill) Discussed biologic drug issues including implementation of the new approval pathway for biosimilar drugs. (no bill) S. 1720/S.2049/S.866, - Discussed patent reform legislation and related provisions. Discussed the importance of potential savings to both consumers and the federal government of granting Secretarial negotiating authority to the HHS Secretary under Medicare Part D. (no bill) Discussed legislation to address pay-for-delay agreements used by drug manufacturers to block lower cost drugs from entering the market (the Fair and Immediate Release of Generic Drugs Act (S. 504) and (the Preserve Access to Affordable Generics Act) (S.214). Discussed the exclusivity period for biologic drugs. (no bill) Discussed the Food and Drug Administration proposed rule to enable generic drug makers to independently update their drug labeling. (no bill) Discussed biologic drug issues including implementation of the new approval pathway for biosimilar drugs. (no bill) S. 1720/S. 2049/S.866 - Discussed patent reform legislation and related provisions. Discussed other prescription drug issues and potential legislation on drug importation and "least costly alternative" payment for Part B durgs. (no bill)

Client expense: $2,360,000 · Firm income: Not reported

Government targets: Administration on Aging, Agriculture, Dept of (USDA), Bureau of the Census, Centers For Medicare and Medicaid Services (CMS), Commodity Futures Trading Commission (CFTC), Energy, Dept of, Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Federal Communications Commission (FCC), Federal Highway Administration (FHA), Federal Reserve System, Federal Trade Commission (FTC), Federal Transit Administration (FTA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Housing & Urban Development, Dept of (HUD), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Natl Highway Traffic Safety Administration (NHTSA), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Personnel Management (OPM), Office of the Comptroller of the Currency (OCC), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Social Security Administration (SSA), Transportation, Dept of (DOT), Treasury, Dept of, Veterans Affairs, Dept of (VA), White House Office

S. 2193 - Horse Protection Act Amendments of 2014 S. 1406 - Prevent All Soring Tactics Act (PAST) H.R. 4098 - House version of S. 2193 BSE Foot and Mouth Disease (FMD) Honeybee Losses Porcine Epidemic Diarrhea Virus (PEDv)

Client expense: $590,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Army, Dept of (Corps of Engineers), Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Environmental Protection Agency (EPA), Federal Aviation Administration (FAA), Federal Communications Commission (FCC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Internal Revenue Service (IRS), Justice, Dept of (DOJ), SENATE, Transportation, Dept of (DOT), U.S. Trade Representative (USTR)

S. 2193 Horse Protection Act Amendments of 2014 S. 1460 Prevent All Soaring Tactics Act H.R. 4098 Horse Soaring

Client expense: $20,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Army, Dept of (Corps of Engineers), Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, SENATE

Support for HR 4098/S 2193, the Horse Protection Act Amendments of 2013 (2014), that would make the practice of soring illegal and set up an independent horse industry organization Oppostion to HR 1518/S 1406, the Prevent All Soring Tactics (PAST) Act of 2013, that would make the practice of soring illegal, ban all action devices, and turn over inspections of horse shows solely to USDA

Client expense: $50,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

In opposition to the Horse Protection Amendments Act of 2013 (H.R.4098), (S. 2193)

Client expense: $10,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 1459/H.R. 4440, Horse Transportation Act H.R. 1518/S. 1406, Prevent All Soring Tactics Act H.R., 1094/S. 541, Safeguarding American Food Exports Act H.R. 4098/S. 2193, Horse Protection Amendments Act

Client expense: $240,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), HOUSE OF REPRESENTATIVES, SENATE

S. 2193 - Horse Protection Amendments Act of 2014; H.R. 4098 - Horse Protection Amendments Act of 2013; H.R. 4308 - Interstate Milk Freedom Act of 2014; H.R. 4413 - Customer Protection and End User Relief Act; USDA Producer Tools Grant

Client expense: $10,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), HOUSE OF REPRESENTATIVES, SENATE

S. 2193 - Horse Protection Amendments Act of 2014; H.R. 4098 - Horse Protection Amendments Act of 2013; H.R. 4308 - Interstate Milk Freedom Act of 2014; H.R. 4413 - Customer Protection and End User Relief Act; USDA Producer Tools Grant

Client expense: $5,422 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), HOUSE OF REPRESENTATIVES, SENATE

H.R. 4098/S. 2193 Horse Protection Amendments Act H.R. 1518/S. 1406 Prevent All Soaring Tactics (SOAR) Act

Client expense: $180,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), SENATE

Discussed importance of potential savings both to consumers and to the federal government of granting Secretarial Negotiating Authority to Secretary of HHS on Medicare Part D. (no bill)Discussed legislative intent with respect to biologic drugs and the exclusivity period; and discussed importance of potential savings to the health care system generally. (no bill) Discussed need for greater consumer safety protections both in OTC and prescription drugs. (no bill) Discussed need for doctors to get unbiased information on prescription pharmaceuticals through programs like academic detailing. (no bill) Discussed possible savings and better health care outcomes that could result from Medication Therapy Management. (no bill) Pub. Law 111-148 and 111-152 - Discussed implementation of health care legislation to reform the health care system to provide quality healthcare, expand access to long-term services and supports, and reduced prescription drug costs. Discussed greater affordability of generic versions of both generic and biologic drugs. S. 319, Pharmaceutical Market Access and Drug Safety Act of 2011 - Discussed legislation that establishes a framework for the safe, legal importation of lower-priced prescription drugs from abroad. S. 1206, Medicare Drug Savings Act of 2011 - Discussed rebates in Medicare Part D as a cost savings measure in Medicare that does not harm beneficiaries. H. R. 3342, Affordable Medicines Utilization Act of 2011 - Lobbied on legislation to encourage state Medicaid programs to use safe, effective generic medications. S. 27, Preserve Access to Affordable Generics Act of 2011- Lobbied for this legislation preventing abuses in patent settlements between generic and brand name prescription drug companies. S. 1886/H.R. 3468 of 2011- Discussed counterfeit drug penalty enhancement. Discussed prescription drug safety, drug shortage, and medical device safety, and related user fee legislation. S. 2193 of 2012, the Ensuring Safe Medical Devices for Patients Act - Discussed legislation to include devices in the post-market risk identification and analysis system for prescription drugs and to expedite the implementation of the unique device identification system for medical devices. Discussed draft legislation to address the issue of whether generic drug manufacturers have a duty to include new warnings about potentially serious side effects on their labels as they become known by giving generic drug makers the same ability to update their labeling as manufacturers of brand name drugs. (no bill) S.3187, Food and Drug Administration safety and Innovation Act - FDA user fee agreement legislation focusing on the review process for prescription drugs and medical devices, prescription drug safety, drug shortages, medical device safety and access to generic drugs. S.3212, Cody Miller Initiative for Safer Prescriptions Act - To require the Secretary of Health and Human Services to promulgate regulations regarding the authorship, content, format, and dissemination of Patient Medication information. Discussed pay-for-delay agreements as tactic by drug manufacturers to block lower cost drugs from entering the market, and the Fair and Immediate Release of Generics Drugs Act that would address the underlying issue of "parked exclusivities" in the Hatch-Waxman Act (S.1882). Discussed the issue of biosimilar drug naming and how biosimilars should use a common International Non-proprietary name as reference originator biologic products. (no bill) S. 504, the Fair and Immediate Release of Generic Drugs Act/S.214, the Preserve Access to Affordable Generics Act - Discussed the Patient Safety and Generic Labeling Improvement Act. (no bill)Discussed Unique Device Identification (UDI) issues including proposed rules and implementation. (no bill) Discussed oversight of laboratory genetic testing. (no bill) Discussed AARP's concerns with prescription drug costs. (no bill) S.117, Medicare Prescription Drug Price Negotiation Act - Discussed bill that allows medicare to negotiate medicare prescription drug prices with drug companies. S.504/S.214, The Fair and Immediate Release of Generics Drugs Act/Preserve Access to Affordable Generics Act - Discussed legislation to address pay-for-delay agreements used by drug manufacturers to block lower cost drugs from entering the market. Discussed the exclusivity period for biologic drugs. (no bill) Discussed the Patient Safety and Generic Labeling Improvement Act. (no bill) Discussed biologic drug issues including implementation of the new approval pathway for biosimilar drugs. (no bill) Discussed the importance of potential savings to both consumers and the federal government of granting Secretarial negotiating authority to the HHS Secretary under Medicare Part D. (no bill) S. 504, the Fair and Immediate Release of Generics Drugs Act/S. 214, the Preserve Access to Affordable Generics - Discussed legislation to address pay-for-delay agreements used by drug manufacturers to block lower cost drugs from entering the market. Discussed the exclusivity period ofr biologic drugs. (no bill) Discussed the Food and Drug Administration proposed rule to enable generic drug makers to independently update their drug labeling. (no bill) Discussed biologic drug issues including implementation of the new approval pathway for biosimilar drugs. (no bill) S. 1720/S.2049/S.866, - Discussed patent reform legislation and related provisions

Client expense: $1,990,000 · Firm income: Not reported

Government targets: Administration on Aging, Agriculture, Dept of (USDA), Bureau of the Census, Centers For Medicare and Medicaid Services (CMS), Commodity Futures Trading Commission (CFTC), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Federal Communications Commission (FCC), Federal Highway Administration (FHA), Federal Reserve System, Federal Trade Commission (FTC), Federal Transit Administration (FTA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Housing & Urban Development, Dept of (HUD), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Natl Highway Traffic Safety Administration (NHTSA), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Personnel Management (OPM), Office of the Comptroller of the Currency (OCC), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Social Security Administration (SSA), Transportation, Dept of (DOT), Treasury, Dept of, Veterans Affairs, Dept of (VA), White House Office

Discussed importance of potential savings both to consumers and to the federal government of granting Secretarial Negotiating Authority to Secretary of HHS on Medicare Part D. (no bill)Discussed legislative intent with respect to biologic drugs and the exclusivity period; and discussed importance of potential savings to the health care system generally. (no bill) Discussed need for greater consumer safety protections both in OTC and prescription drugs. (no bill) Discussed need for doctors to get unbiased information on prescription pharmaceuticals through programs like academic detailing. (no bill) Discussed possible savings and better health care outcomes that could result from Medication Therapy Management. (no bill) Pub. Law 111-148 and 111-152 - Discussed implementation of health care legislation to reform the health care system to provide quality healthcare, expand access to long-term services and supports, and reduced prescription drug costs. Discussed greater affordability of generic versions of both generic and biologic drugs. S. 319, Pharmaceutical Market Access and Drug Safety Act of 2011 - Discussed legislation that establishes a framework for the safe, legal importation of lower-priced prescription drugs from abroad. S. 1206, Medicare Drug Savings Act of 2011 - Discussed rebates in Medicare Part D as a cost savings measure in Medicare that does not harm beneficiaries. H. R. 3342, Affordable Medicines Utilization Act of 2011 - Lobbied on legislation to encourage state Medicaid programs to use safe, effective generic medications. S. 27, Preserve Access to Affordable Generics Act of 2011- Lobbied for this legislation preventing abuses in patent settlements between generic and brand name prescription drug companies. S. 1886/H.R. 3468 of 2011- Discussed counterfeit drug penalty enhancement. Discussed prescription drug safety, drug shortage, and medical device safety, and related user fee legislation. S. 2193 of 2012, the Ensuring Safe Medical Devices for Patients Act - Discussed legislation to include devices in the post-market risk identification and analysis system for prescription drugs and to expedite the implementation of the unique device identification system for medical devices. Discussed draft legislation to address the issue of whether generic drug manufacturers have a duty to include new warnings about potentially serious side effects on their labels as they become known by giving generic drug makers the same ability to update their labeling as manufacturers of brand name drugs. (no bill) S.3187, Food and Drug Administration safety and Innovation Act - FDA user fee agreement legislation focusing on the review process for prescription drugs and medical devices, prescription drug safety, drug shortages, medical device safety and access to generic drugs. S.3212, Cody Miller Initiative for Safer Prescriptions Act - To require the Secretary of Health and Human Services to promulgate regulations regarding the authorship, content, format, and dissemination of Patient Medication information. Discussed pay-for-delay agreements as tactic by drug manufacturers to block lower cost drugs from entering the market, and the Fair and Immediate Release of Generics Drugs Act that would address the underlying issue of "parked exclusivities" in the Hatch-Waxman Act (S.1882). Discussed the issue of biosimilar drug naming and how biosimilars should use a common International Non-proprietary name as reference originator biologic products. (no bill) S. 504, the Fair and Immediate Release of Generic Drugs Act/S.214, the Preserve Access to Affordable Generics Act - Discussed the Patient Safety and Generic Labeling Improvement Act. (no bill)Discussed Unique Device Identification (UDI) issues including proposed rules and implementation. (no bill) Discussed oversight of laboratory genetic testing. (no bill) Discussed AARP's concerns with prescription drug costs. (no bill) S.117, Medicare Prescription Drug Price Negotiation Act - Discussed bill that allows medicare to negotiate medicare prescription drug prices with drug companies. S.504/S.214, The Fair and Immediate Release of Generics Drugs Act/Preserve Access to Affordable Generics Act - Discussed legislation to address pay-for-delay agreements used by drug manufacturers to block lower cost drugs from entering the market. Discussed the exclusivity period for biologic drugs. (no bill) Discussed the Patient Safety and Generic Labeling Improvement Act. (no bill) Discussed biologic drug issues including implementation of the new approval pathway for biosimilar drugs. (no bill)

Client expense: $2,500,000 · Firm income: Not reported

Government targets: Administration on Aging, Agriculture, Dept of (USDA), Bureau of the Census, Centers For Medicare and Medicaid Services (CMS), Commodity Futures Trading Commission (CFTC), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Federal Communications Commission (FCC), Federal Highway Administration (FHA), Federal Reserve System, Federal Trade Commission (FTC), Federal Transit Administration (FTA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Housing & Urban Development, Dept of (HUD), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Natl Council on Disability, Natl Highway Traffic Safety Administration (NHTSA), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Personnel Management (OPM), Office of the Comptroller of the Currency (OCC), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Social Security Administration (SSA), Transportation, Dept of (DOT), Treasury, Dept of, Veterans Affairs, Dept of (VA), White House Office

Discussed legislative intent with respect to Biologic drugs and exclusivity period.(no bill) Discussed importance of potential savings both to consumers and to the federal government of granting Secretarial Negotiating Authority to Secretary of HHS on Medicare Part D. (no bill)Discussed legislative intent with respect to biologic drugs and the exclusivity period; and discussed importance of potential savings to the health care system generally. (no bill) Discussed need for greater consumer safety protections both in OTC and prescription drugs. (no bill) Discussed need to end industry tactics like Pay for Delay which inappropriately extends patents with effect of keeping prices high for consumers and government. (no bill) Discussed need for doctors to get unbiased information on prescription pharmaceuticals through programs like academic detailing. (no bill) Discussed possible savings and better health care outcomes that could result from Medication Therapy Management. (no bill) Pub. Law 111-148 and 111-152 - Discussed implementation of health care legislation to reform the health care system to provide quality healthcare, expand access to long-term services and supports, and reduced prescription drug costs. Discussed greater affordability of generic versions of both generic and biologic drugs. S. 319, Pharmaceutical Market Access and Drug Safety Act of 2011 - Discussed legislation that establishes a framework for the safe, legal importation of lower-priced prescription drugs from abroad. S. 1206, Medicare Drug Savings Act of 2011 - Discussed rebates in Medicare Part D as a cost savings measure in Medicare that does not harm beneficiaries. H. R. 3342, Affordable Medicines Utilization Act of 2011 - Lobbied on legislation to encourage state Medicaid programs to use safe, effective generic medications. S. 27, Preserve Access to Affordable Generics Act of 2011- Lobbied for this legislation preventing abuses in patent settlements between generic and brand name prescription drug companies. S. 1886/H.R. 3468 of 2011- Discussed counterfeit drug penalty enhancement. Discussed prescription drug safety, drug shortage, and medical device safety, and related user fee legislation. S. 2193 of 2012, the Ensuring Safe Medical Devices for Patients Act - Discussed legislation to include devices in the post-market risk identification and analysis system for prescription drugs and to expedite the implementation of the unique device identification system for medical devices. Discussed draft legislation to address the issue of whether generic drug manufacturers have a duty to include new warnings about potentially serious side effects on their labels as they become known by giving generic drug makers the same ability to update their labeling as manufacturers of brand name drugs. (no bill) S.3187, Food and Drug Administration safety and Innovation Act - FDA user fee agreement legislation focusing on the review process for prescription drugs and medical devices, prescription drug safety, drug shortages, medical device safety and access to generic drugs. S.3212, Cody Miller Initiative for Safer Prescriptions Act - To require the Secretary of Health and Human Services to promulgate regulations regarding the authorship, content, format, and dissemination of Patient Medication information. Discussed the importance of potential savings to both consumers and the federal government of granting Secretarial negotiating authority to the HHS Secretary under Medicare Part D. (no bill) Discussed pay-for-delay agreements as tactic by drug manufacturers to block lower cost drugs from entering the market, and the Fair and Immediate Release of Generics Drugs Act that would address the underlying issue of "parked exclusivities" in the Hatch-Waxman Act (S.1882). Discussed the issue of biosimilar drug naming and how biosimilars should use a common International Non-proprietary name as reference originator biologic products. (no bill) S. 504, the Fair and Immediate Release of Generic Drugs Act/S.214, the Preserve Access to Affordable Generics Act - Discussed legislation to address pay-for-delay agreements used by drug manufacturers to block lower cost drugs from entering the market. Discussed the Patient Safety and Generic Labeling Improvement Act. (no bill)Discussed Unique Device Identification (UDI) issues including proposed rules and implementation. (no bill) Discussed oversight of laboratory genetic testing. (no bill) Discussed AARP's concerns with prescription drug costs. (no bill) S.117, Medicare Prescription Drug Price Negotiation Act - Discussed bill that allows medicare to negotiate medicare prescription drug prices with drug companies. Discussed the importance of potential savings to both consumers and the federal government of granting Secretarial negotiating authority to the HHS Secretary under Medicare Part D. (no bill) S.504/S.214, The Fair and Immediate Release of Generics Drugs Act/Preserve Access to Affordable Generics Act - Discussed legislation to address pay-for-delay agreements used by drug manufacturers to block lower cost drugs from entering the market. Discussed the exclusivity period for biologic drugs. (no bill) Discussed the Patient Safety and Generic Labeling Improvement Act. (no bill) Discussed biologic drug issues including implementation of the new approval pathway for biosimilar drugs. (no bill)

Client expense: $2,520,000 · Firm income: Not reported

Government targets: Administration on Aging, Agriculture, Dept of (USDA), Bureau of the Census, Centers For Medicare and Medicaid Services (CMS), Commodity Futures Trading Commission (CFTC), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Federal Communications Commission (FCC), Federal Highway Administration (FHA), Federal Reserve System, Federal Trade Commission (FTC), Federal Transit Administration (FTA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Housing & Urban Development, Dept of (HUD), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Natl Council on Disability, Natl Highway Traffic Safety Administration (NHTSA), Office of Management & Budget (OMB), Office of Personnel Management (OPM), Office of the Comptroller of the Currency (OCC), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Social Security Administration (SSA), Transportation, Dept of (DOT), Treasury, Dept of, White House Office

Discussed legislative intent with respect to Biologic drugs and exclusivity period.(no bill) Discussed importance of potential savings both to consumers and to the federal government of granting Secretarial Negotiating Authority to Secretary of HHS on Medicare Part D. (no bill)Discussed legislative intent with respect to biologic drugs and the exclusivity period; and discussed importance of potential savings to the health care system generally. (no bill) Discussed need for greater consumer safety protections both in OTC and prescription drugs. (no bill) Discussed need to end industry tactics like Pay for Delay which inappropriately extends patents with effect of keeping prices high for consumers and government. (no bill) Discussed need for doctors to get unbiased information on prescription pharmaceuticals through programs like academic detailing. (no bill) Discussed possible savings and better health care outcomes that could result from Medication Therapy Management. (no bill) Pub. Law 111-148 and 111-152 - Discussed implementation of health care legislation to reform the health care system to provide quality healthcare, expand access to long-term services and supports, and reduced prescription drug costs. Discussed greater affordability of generic versions of both generic and biologic drugs. S. 319, Pharmaceutical Market Access and Drug Safety Act of 2011 - Discussed legislation that establishes a framework for the safe, legal importation of lower-priced prescription drugs from abroad. S. 1206, Medicare Drug Savings Act of 2011 - Discussed rebates in Medicare Part D as a cost savings measure in Medicare that does not harm beneficiaries. H. R. 3342, Affordable Medicines Utilization Act of 2011 - Lobbied on legislation to encourage state Medicaid programs to use safe, effective generic medications. S. 27, Preserve Access to Affordable Generics Act of 2011- Lobbied for this legislation preventing abuses in patent settlements between generic and brand name prescription drug companies. S. 1886/H.R. 3468 of 2011- Discussed counterfeit drug penalty enhancement. Discussed prescription drug safety, drug shortage, and medical device safety, and related user fee legislation. S. 2193 of 2012, the Ensuring Safe Medical Devices for Patients Act - Discussed legislation to include devices in the post-market risk identification and analysis system for prescription drugs and to expedite the implementation of the unique device identification system for medical devices. Discussed draft legislation to address the issue of whether generic drug manufacturers have a duty to include new warnings about potentially serious side effects on their labels as they become known by giving generic drug makers the same ability to update their labeling as manufacturers of brand name drugs. (no bill) S.3187, Food and Drug Administration safety and Innovation Act - FDA user fee agreement legislation focusing on the review process for prescription drugs and medical devices, prescription drug safety, drug shortages, medical device safety and access to generic drugs. S.3212, Cody Miller Initiative for Safer Prescriptions Act - To require the Secretary of Health and Human Services to promulgate regulations regarding the authorship, content, format, and dissemination of Patient Medication information. Discussed the importance of potential savings to both consumers and the federal government of granting Secretarial negotiating authority to the HHS Secretary under Medicare Part D. (no bill) Discussed pay-for-delay agreements as tactic by drug manufacturers to block lower cost drugs from entering the market, and the Fair and Immediate Release of Generics Drugs Act that would address the underlying issue of "parked exclusivities" in the Hatch-Waxman Act (S.1882). Discussed the issue of biosimilar drug naming and how biosimilars should use a common International Non-proprietary name as reference originator biologic products. (no bill) S. 504, the Fair and Immediate Release of Generic Drugs Act/S.214, the Preserve Access to Affordable Generics Act - Discussed legislation to address pay-for-delay agreements used by drug manufacturers to block lower cost drugs from entering the market. Discussed the Patient Safety and Generic Labeling Improvement Act. (no bill)Discussed Unique Device Identification (UDI) issues including proposed rules and implementation. (no bill) Discussed oversight of laboratory genetic testing. (no bill) Discussed AARP's concerns with prescription drug costs. (no bill) S.117, Medicare Prescription Drug Price Negotiation Act - Discussed bill that allows medicare to negotiate medicare prescription drug prices with drug companies.

Client expense: $2,460,000 · Firm income: Not reported

Government targets: Administration on Aging, Agriculture, Dept of (USDA), Bureau of the Census, Centers For Medicare and Medicaid Services (CMS), Commodity Futures Trading Commission (CFTC), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Federal Communications Commission (FCC), Federal Highway Administration (FHA), Federal Reserve System, Federal Trade Commission (FTC), Federal Transit Administration (FTA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Housing & Urban Development, Dept of (HUD), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Natl Council on Disability, Natl Highway Traffic Safety Administration (NHTSA), Office of Management & Budget (OMB), Office of Personnel Management (OPM), Office of the Comptroller of the Currency (OCC), SENATE, Securities & Exchange Commission (SEC), Social Security Administration (SSA), Transportation, Dept of (DOT), Treasury, Dept of, White House Office

Implementation of Health Reform (PPACA) The Health Information Technology for Economic and Clinical Health Act (HITECH), Regarding Implementation of Act Pharmacy Track and Trace Legislation Issues Related to the Medicare & Medicaid Protection Act of 1987 that Regulate Group Purchasing Organizations Under HHSMedical Device Manufacturers Gag Clause on Hospital Contracting Medicare Physician Payment - Sustainable Growth Rate S.2193 - Ensuring Safe Medical Devices for Patients - Comments to FDA on Proposed Regulation 2011 Budget Control Act H.R. 8 - American Taxpayer Relief Act Senator Hatch's Deficit Reduction Package Physician Payment Sunshine Act Children's Graduate Medical Education (GME) Reauthorization Act of 2013 (H.K. 297) Tavenner Appointment as CMS Administrator SGR Reform Data Access Extension of Stark Exceptions for EHR

Client expense: $353,724 · Firm income: Not reported

Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Discussed legislative intent with respect to Biologic drugs and exclusivity period.(no bill) Discussed importance of potential savings both to consumers and to the federal government of granting Secretarial Negotiating Authority to Secretary of HHS on Medicare Part D. (no bill)Discussed legislative intent with respect to biologic drugs and the exclusivity period; and discussed importance of potential savings to the health care system generally. (no bill) Discussed need for greater consumer safety protections both in OTC and prescription drugs. (no bill) Discussed need to end industry tactics like Pay for Delay which inappropriately extends patents with effect of keeping prices high for consumers and government. (no bill) Discussed need for doctors to get unbiased information on prescription pharmaceuticals through programs like academic detailing. (no bill) Discussed possible savings and better health care outcomes that could result from Medication Therapy Management. (no bill) Pub. Law 111-148 and 111-152 - Discussed implementation of health care legislation to reform the health care system to provide quality healthcare, expand access to long-term services and supports, and reduced prescription drug costs. Discussed greater affordability of generic versions of both generic and biologic drugs. S. 319, Pharmaceutical Market Access and Drug Safety Act of 2011 - Discussed legislation that establishes a framework for the safe, legal importation of lower-priced prescription drugs from abroad. S. 1206, Medicare Drug Savings Act of 2011 - Discussed rebates in Medicare Part D as a cost savings measure in Medicare that does not harm beneficiaries. H. R. 3342, Affordable Medicines Utilization Act of 2011 - Lobbied on legislation to encourage state Medicaid programs to use safe, effective generic medications. S. 27, Preserve Access to Affordable Generics Act of 2011- Lobbied for this legislation preventing abuses in patent settlements between generic and brand name prescription drug companies. S. 1886/H.R. 3468 of 2011- Discussed counterfeit drug penalty enhancement. Discussed prescription drug safety, drug shortage, and medical device safety, and related user fee legislation. S. 2193 of 2012, the Ensuring Safe Medical Devices for Patients Act - Discussed legislation to include devices in the post-market risk identification and analysis system for prescription drugs and to expedite the implementation of the unique device identification system for medical devices. Discussed draft legislation to address the issue of whether generic drug manufacturers have a duty to include new warnings about potentially serious side effects on their labels as they become known. The bill would accomplish this by giving generic drug makers the same ability to update their labeling as currently exists for manufacturers of brand name drugs. (no bill) S.3187, Food and Drug Administration safety and Innovation Act - FDA user fee agreement legislation focusing on the review process for prescription drugs and medical devices, prescription drug safety, drug shortages, medical device safety and access to generic drugs. S.3212, Cody Miller Initiative for Safer Prescriptions Act - To require the Secretary of Health and Human Services to promulgate regulations regarding the authorship, content, format, and dissemination of Patient Medication information. Discussed prescription drugs. S. 3604, Improving Preventive Care Treatment in Older Adults Act - Discussed legislation to address the inaproppriate use of antipsychotics in nursing home facilities. Discussed the importance of potential savings to both consumers and the federal government of granting Secretarial negotiating authority to the HHS Secretary under Medicare Part D. (no bill) Discussed pay-for-delay agreements as tactic by drug manufacturers to block lower cost drugs from entering the market, and the Fair and Immediate Release of Generics Drugs Act that would address the underlying issue of "parked exclusivities" in the Hatch-Waxman Act (S.1882). Discussed the issue of biosimilar drug naming and how biosimilars should use a common International Non-proprietary name as reference originator biologic products. (no bill) Discussed the importance of potential savings to both consumers and the federal government of granting Secretarial negotiating authority to the HHS Secretary under Medicare Part D. (no bill) S. 504, the Fair and Immediate Release of Generic Drugs Act/S.214, the Preserve Access to Affordable Generics Act - Discussed legislation to address pay-for-delay agreements used by drug manufacturers to block lower cost drugs from entering the market. Discussed the exclusivity period for biologic drugs. (no bill) Discussed the Patient Safety and Generic Labeling Improvement Act. (no bill)Discussed Unique Device Identification (UDI) issues including proposed rules and implementation. (no bill) Discussed oversight of laboratory genetic testing. (no bill) Discussed AARP's concerns with prescription drug costs. (no bill) S.117, Medicare Prescription Drug Price Negotiation Act - Discussed bill that allows medicare to negotiate medicare prescription drug prices with drug companies. Discussed use of anti-psychaotic drugs in nursing home residents and the Long-Term Services and Supports Scorecard. (no bill)

Client expense: $2,130,000 · Firm income: Not reported

Government targets: Administration on Aging, Agriculture, Dept of (USDA), Bureau of the Census, Centers For Medicare and Medicaid Services (CMS), Commodity Futures Trading Commission (CFTC), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Federal Communications Commission (FCC), Federal Highway Administration (FHA), Federal Reserve System, Federal Trade Commission (FTC), Federal Transit Administration (FTA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Housing & Urban Development, Dept of (HUD), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Natl Council on Disability, Natl Highway Traffic Safety Administration (NHTSA), Office of Management & Budget (OMB), Office of Personnel Management (OPM), Office of the Comptroller of the Currency (OCC), SENATE, Securities & Exchange Commission (SEC), Social Security Administration (SSA), Transportation, Dept of (DOT), Treasury, Dept of, White House Office

Implementation of Health Reform (PPACA) The Health Information Technology for Economic and Clinical Health Act (HITECH), Regarding Implementation of Act Pharmacy Track and Trace Legislation Issues Related to the Medicare & Medicaid Protection Act of 1987 that Regulate Group Purchasing Organizations Under HHSMedical Device Manufacturers Gag Clause on Hospital Contracting Medicare Physician Payment - Sustainable Growth Rate S.2193 - Ensuring Safe Medical Devices for Patients - Comments to FDA on Proposed Regulation 2011 Budget Control Act H.R. 8 - American Taxpayer Relief Act Senator Hatch's Deficit Reduction Package Physician Payment Sunshine Act Children's Graduate Medical Education (GME) Reauthorization Act of 2013 (H.K. 297) Tavenner Appointment as CMS Administrator SGR Reform Data Access Extension of Stark Exceptions for EHR

Client expense: $332,340 · Firm income: Not reported

Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE