Federal Aviation Administration Extension Act of 2010

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

Medical device tax; IC-DISC; implementation of Patient Protection and Affordable Care Act (H.R. 3590/Pub. L. No. 111-148); Health Care and Education Reconciliation Act (H.R. 4872/Pub. L. No. 111-152); H.R. 523, Protect Medical Innovation of 2013; FY 2015 budget; implementation of S. 3187, the Food and Drug Administration Safety and Innovation Act

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Technology research; community health centers and school health; telemedicine; implementation of Patient Protection and Affordable Care Act (H.R. 3590/P.L. No. 111-148); Health Care and Educatin Reconciliation Act (H.R. 4872/P.L. No. 111-152); the Protect Medical Innovation Act (H.R. 523); accountable care organizations; implementation of S. 3187, the Food and Drug Administration Safety and Innovation Act; Safeguarding America's Pharmaceuticals Act (H.R. 1919); SGR reform; FY 2015 budget;Protecting Access to Medicare Act (H.R. 4302); Common Sense Medicare SGR Repeal and Beneficiary Access Improvement Act (S. 2157)

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Technology research; Community Health Centers and School Health; Telemedicine; Implementation of Patient Protection & Affordable Care Act (H.R. 3590/P.L. 111-148) and Health Care and Education Reconciliation Act (H.R. 4872/P.L. 111-152); The Protect Medical Innovation Act (H.R. 523); FY2014 Budget, accountable care organizations ; implementation of S.3187, the Food and Drug Administration Safety and Innovation Act; Safeguarding America's Pharmaceuticals Act (H.R. 1919); SGR Reform; FY2015 Budget; Protecting Access to Medicare Act (H.R. 4302); Commensense Medicare SGR Repeal and Beneficiary Access Improvement Act (S. 2157).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medical device tax; IC-DISC; Implementation of Patient Protection & Affordable Care Act (H.R. 3590/Pub.L.No.111-148); Health Care and Education Reconciliation Act (H.R. 4872/Pub.L.No. 111-152). H.R. 523 Protect Medical Innovation of 2013, FY2015 Budget, implementation of S.3187, the Food and Drug Administration Safety and Innovation Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 3187, The Food and Drug Safety and Innovation Act (user fee sequester) Biosimilars, no specific bill Health Resources and Services Administration (HRSA) policy regarding rebates on drugs used in the outpatient setting to help low-income/uninsured populations (340B), no specific bill

Client expense: $2,560,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)

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

Technology research; Community Health Centers and School Health; Telemedicine; Implementation of Patient Protection & Affordable Care Act (H.R. 3590/P.L. 111-148) and Health Care and Education Reconciliation Act (H.R. 4872/P.L. 111-152); The Protect Medical Innovation Act (H.R. 523); FY2014 Budget, accountable care organizations ; implementation of S.3187, the Food and Drug Administration Safety and Innovation Act; Safeguarding America's Pharmaceuticals Act (H.R. 1919); SGR Reform; FY2015 Budget; Protecting Access to Medicare Act (H.R. 4302); Commensense Medicare SGR Repeal and Beneficiary Access Improvement Act (S. 2157).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medical device tax; IC-DISC; Implementation of Patient Protection & Affordable Care Act (H.R. 3590/Pub.L.No.111-148); Health Care and Education Reconciliation Act (H.R. 4872/Pub.L.No. 111-152). H.R. 523 Protect Medical Innovation of 2013, FY2015 Budget, implementation of S.3187, the Food and Drug Administration Safety and Innovation Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 3204, The Drug Quality and Security Act (Track and Trace) S. 3187, The Food and Drug Safety and Innovation Act (User Fee Sequester) Biosimilars, no specific bill

Client expense: $2,330,000 · Firm income: Not reported

Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)

Technology research; Community Health Centers and School Health; Telemedicine; Implementation of Patient Protection & Affordable Care Act (H.R. 3590/P.L. 111-148) and Health Care and Education Reconciliation Act (H.R. 4872/P.L. 111-152); The Protect Medical Innovation Act (H.R. 523); FY2014 Budget, accountable care organizations; implementation of S.3187, the Food and Drug Administration Safety and Innovation Act; Safeguarding America's Pharmaceuticls Act (H.R. 1919); Bipartisan Budget Actof 2013 (H.J. Res. 59); SGR Reform.

Client expense: $81,252 · Firm income: Not reported

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)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

H.R.2410/S.1244, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, FY2014, FDA initiatives; Critical Path initiative; and Human nutrition issues and initiatives. S.3187/H.R.5651, Food and Drug Administration Safety and Innovation Act, FDA initiatives; Critical Path issues. S.1197/H.R.1960, National Defense Authorization Act for Fical Year FY2014, Defensewide RDT&E and Defense Health Program; and Medication Therapy Management.

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Technology research; Community Health Centers and School Health; Telemedicine; Implementation of Patient Protection & Affordable Care Act (H.R. 3590/P.L. 111-148) and Health Care and Education Reconciliation Act (H.R. 4872/P.L. 111-152); The Protect Medical Innovation Act (H.R. 523); FY2014 Budget, accountable care organizations ; implementation of S.3187, the Food and Drug Administration Safety and Innovation Act; Safeguarding America's Pharmaceuticals Act (H.R. 1919); Bipartisan Budget Act of 2013 (H.J. Res. 59); SGR Reform.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Establish a voluntary program for companies' supply chains to ensure imports are secure, compliant and safe; House appropriations bills; Food and Drug Administration Safety and Innovation Act (S. 3187); the Customs Trade Facilitation and Enforcement Act of 2012 (H.R. 6642); the Customs Enhanced Enforcement and Trade Facilitation Act of 2012 (H.R. 6656); the Trade Facilitation and Trade Enforcement Reauthorization Act of 2013 (S. 662)

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

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

Establish a voluntary program for companies' supply chains to ensure imports are secure, compliant and safe; House appropriations bills; Food and Drug Administration Safety and Innovation Act (S. 3187); the Customs Trade Facilitation and Enforcement Act of 2012 (H.R. 6642); the Customs Enhanced Enforcement and Trade Facilitation Act of 2012 (H.R. 6656); the Trade Facilitation and Trade Enforcement Reauthorization Act of 2013 (S. 662)

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

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

S.957, The Drug Supply Chain Security Act (Track and Trace) S.959, The Pharmaceutical Quality Security and Accountability Act (Track and Trace; Compounding) H.R.1919, Safeguarding America's Pharmaceuticals Act of 2013 (Track and Trace) S.3187, The Food and Drug Safety and Innovation Act (Prescription Drug User Fee Act Reauthorization; Track and Trace)Biosimilars, no specific bill Health Resources and Services Administration policy regarding rebates on drugs used in the outpatient setting to help low-income/uninsured populations (340B), no specific bill

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)

S. 3187, Title II Subtitle B, Medical Gas Product Regulation, FDA approval and regulation of medical gases.

Client expense: $30,000 · Firm income: Not reported

S. 3187, Title II Subtitle B, Medical Gas Product Regulation, FDA approval and regulation of medical gases.

Client expense: $30,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 3187, Title II Subtitle B, Medical Gas Product Regulation, FDA approval and regulation of medical gases.

Client expense: $30,000 · Firm income: Not reported

Establish a voluntary program for companies' supply chains to ensure imports are secure, compliant and safe; House appropriations bills; Food and Drug Administration Safety and Innovation Act (S. 3187); the Customs Trade Facilitation and Enforcement Act of 2012 (H.R. 6642); the Customs Enhanced Enforcement and Trade Facilitation Act of 2012 (H.R. 6656); the Trade Facilitation and Trade Enforcement Reauthorization Act of 2013 (S. 662)

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

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

Establish a voluntary program for companies' supply chains to ensure imports are secure, compliant and safe; House appropriations bills; Food and Drug Administration Safety and Innovation Act (S. 3187); the Customs Trade Facilitation and Enforcement Act of 2012 (H.R. 6642); the Customs Enhanced Enforcement and Trade Facilitation Act of 2012 (H.R. 6656); the Trade Facilitation and Trade Enforcement Reauthorization Act of 2013 (S. 662)

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

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

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

Appropriations for Patient Protection and Affordable Care Act (ACA) Behavioral Health Information Technology Act (HR 2005) - (S 1517) State Flexibility Act (HR 1683) The BPCA and PREA Reauthorization Act (HR 4274)Preserving Access to Life Saving Medications Act (S 296) - (HR 2245) Drug Shortage Prevention Act (HR 3839) Food and Drug Administration Safety and Innovation Act (S 3187) - (HR 5651) Synthetic Drug Abuse Prevention Act (S 3190) - (HR 1254) Synthetics are Dangerous Act (HR 4205) Department of Labor, Health and Human Services and Education and Related Agencies Appropriations Act 2013 (S 3295) - (HR 3070) Mental Health Awareness and Improvement Act (S 689) HR 2757 to Ammend Title XIX of the Social Security Act Native American Psychiatric and Mental Health Care Improvement Act (HR 2037) Excellence in Mental Health Act (HR 1262)

Client expense: Not reported · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA)

H.R.2410/S.1244, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, FY2014, FDA initiatives; Critical Path initiative; and Human nutrition issues and initiatives. S.3187/H.R.5651, Food and Drug Administration Safety and Innovation Act, FDA initiatives; Critical Path issues. S.1034/H.R.1960, National Defense Authorization Act for Fical Year FY2014, Defensewide RDT&E and Defense Health Program; and Medication Therapy Management.

Client expense: Not reported · Firm income: $30,000

Government targets: Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, Natl Aeronautics & Space Administration (NASA), SENATE

Technology research; Community Health Centers and School Health; Telemedicine; Implementation of Patient Protection & Affordable Care Act (H.R. 3590/P.L. 111-148) and Health Care and Education Reconciliation Act (H.R. 4872/P.L. 111-152); The Protect Medical Innovation Act (H.R. 523); Budget Control Act (P.L. 112-25), FY2014 Budget, accountable care organizations ; implementation of S.3187, the Food and Drug Administration Safety and Innovation Act; Safeguarding America's Pharmaceuticals Act (H.R. 1919).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S 3187 - Food and Drug Administration Safety and Innovation Act: A bill to amend the Federal Food, Drug and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes. Sponsor: Harkin (IA)

Client expense: $110,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Technology research; Community Health Centers and School Health; Telemedicine; Implementation of Patient Protection & Affordable Care Act (H.R. 3590/P.L. 111-148) and Health Care and Education Reconciliation Act (H.R. 4872/P.L. 111-152); The Protect Medical Innovation Act (H.R. 523); Budget Control Act (P.L. 112-25), FY2014 Budget, accountable care organizations; implementation of S.3187, (continued on addendum page).the Food and Drug Administration Safety and Innovation Act; Safeguarding America's Pharmaceuticals Act (H.R. 1919).

Client expense: $81,252 · Firm income: Not reported

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); Implementation of S. 3187, Food and Drug Administration Safety and Innovation; S. 214, Preserve Access to Affordable Generics Act; H.R. 933, Consolidated and Further Continuing Appropriations Act; H.Con.Res. 25, the House Budget Resolution; S.Con.Res 8, the Senate Budget Resolution; S. 959, Pharmaceutical Compounding Quality and Accountability Act; S. 957, Drug Supply Chain Security Act; H.R. 1919, Safeguarding America's Pharmaceuticals Act of 2013; H.R. 2186, Verifying Authority and Legality In Drug Compounding Act of 2013.

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Regulation of medical gas product manufacturing; Implementation of S.3187, the Food and Drug Administration Safety and Innovation Act; drug pedigree federal requirements; S.959, Pharmaceutical Quality, Security, and Accountability Act; H.R. 1919, the Safeguarding America's Pharmaceuticals Act.

Client expense: Not reported · Firm income: $30,000

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

OTC medication eligibility under Flexible Spending Accounts, S.312/H.R.605, The Patients' Freedom to Choose Act; Drug Regulation; FDA reform; PDUFA, H.R.3630. Pharmaceutical traceability. Rx OTC switch. Rx TEC. GDUFA H.R.5651, S.3187. Fairness to Pet Owners Act.

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

Government targets: HOUSE OF REPRESENTATIVES, 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 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

Discussions regarding generic drugs (no bill) S.3187, Food and Drug Administration Safety and Innovation Act S.Amdt. 2151 to S.3187, to amend the Controlled Substances Act to make any substance containing hydrocodone a schedule II drug

Client expense: $1,970,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Interior, Dept of (DOI), Labor, Dept of (DOL), SENATE, Small Business Administration (SBA), State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office

Technology research; Community Health Centers and School Health; Telemedicine; Implementation of Patient Protection & Affordable Care Act (H.R. 3590/P.L. 111-148) and Health Care and Education Reconciliation Act (H.R. 4872/P.L. 111-152); The Protect Medical Innovation Act (H.R. 523); Budget Control Act (P.L. 112-25), FY2014 Budget, accountable care organizations ; implementation of S.3187, the Food and Drug Administration Safety and Innovation Act; Safeguarding America's Pharmaceuticals Act (H.R. 1919).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Establish a voluntary program for companies' supply chains to ensure imports are secure, compliant and safe; House appropriations bills; Food and Drug Administration Safety and Innovation Act (S. 3187); the Customs Trade Facilitation and Enforcement Act of 2012 (H.R. 6642); the Customs Enhanced Enforcement and Trade Facilitation Act of 2012 (H.R. 6656); the Trade Facilitation and Trade Enforcement Reauthorization Act of 2013 (S. 662)

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

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

Establish a voluntary program for companies' supply chains to ensure imports are secure, compliant and safe; House appropriations bills; Food and Drug Administration Safety and Innovation Act (S. 3187); the Customs Trade Facilitation and Enforcement Act of 2012 (H.R. 6642); the Customs Enhanced Enforcement and Trade Facilitation Act of 2012 (H.R. 6656); the Trade Facilitation and Trade Enforcement Reauthorization Act of 2013 (S. 662)

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

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

Patient Protection and Affordable Care Act (P.L. 111-148); Health Care and Education Reconciliation Act of 2010 (P.L. 111-152); Implementation of S. 3187, Food and Drug Administration Safety and Innovation; S. 214, Preserve Access to Affordable Generics Act; H.R. 933, Consolidated and Further Continuing Appropriations Act; H.Con.Res. 25, the House Budget Resolution; S.Con.Res 8,the Senate Buudget Resolution; S. 959, Pharmaceutical Compounding Quality and Accountability Act; S. 957, Drug Supply Chain Security Act,H.R. 1919, Safeguarding America's Pharmaceuticals Act of 2013; H.R. 2186, Verifying Authority and Legality In Drug Compounding Act of 2013

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Regulation of medical gas product manufacturing; Implementation of S.3187, the Food and Drug Administration Safety and Innovation Act; drug pedigree federal requirements; S.959, Pharmaceutical Quality, Security, and Accountability Act; H.R. 1919, the Safeguarding America's Pharmaceuticals Act.

Client expense: Not reported · Firm income: $30,000

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

S. 3187, Title II Subtitle B, Medical Gas Product Regulation, FDA approval and regulation of medical gases.

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

H.R.2410/S.1244, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, FY2014, FDA initiatives; Critical Path initiative; and Human nutrition issues and initiatives. S.3187/H.R.5651, Food and Drug Administration Safety and Innovation Act, FDA initiatives; Critical Path issues. S.1034/H.R.1960, National Defense Authorization Act for Fical Year FY2014, Defensewide RDT&E and Defense Health Program; and Medication Therapy Management.

Client expense: Not reported · Firm income: $30,000

Government targets: Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, Natl Aeronautics & Space Administration (NASA), SENATE

Pandemic preparedness, Tamiflu, Medicare coverage of Cancer Drugs, Appropriations.; S.959, Pharmaceutical Compounding Quality and Accountability Act; H.R. 1416, Cancer Patient Protection Act of 2013; S. 957, Drug Supply Chain Security Act; H.R. 1919, Safeguarding America's Pharmaceuticals Act of 2013; compounding issues; FY 13 Labor HHS Appropriations legislation; issues related to FDA user fee reauthorization; H.R. 942 S. 1577; S. 3187; Pedigree and biologics issues; H.R. 905: ASP issues; H.R. 5651; issues concerning drug compounding. Implementation of Patient Protection and Affordable Care Act; Legislation on public health preparedness and response related to pandemic influenza. Influenza Pandemic Preparedness federal, state and local levels. Legislation on screening, care and treatment for hepatitis; implementation of section 340B of the Public Health Service Act (42 U.S.C. 256b); Implementation of H.R. 1: Medicare Prescription Drug and Modernization Act of 2003; Issues relating to PDUFA stimulus. Avastin-use in breast cancer treatment: general patient reform isse: implementation of the Affordable Care Act of 2010; Issues relating to the treatment of biologics in international health programs.

Client expense: $1,077,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

OTC medication eligibility under Flexible Spending Accounts, S.312/H.R.605, The Patients' Freedom to Choose Act; Drug Regulation; FDA reform; PDUFA, H.R.3630. Pharmaceutical traceability. Rx OTC switch. Rx TEC. GDUFA H.R.5651, S.3187. Fairness to Pet Owners Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to medical imaging and radiation therapy and implementation of S.3187, the Food and Drug Administration Safety and Innovation Act. Issues related to medical device user fees including sequestration and the US Preventive Task Force diagnostic recommendations and policies; issues related to reimbursement of medical imaging; issues relating to Health IT as they impact medical imaging and radiation therapy manufacturers.

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

Government targets: HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA)

S3187 - Food and Drug Administration Safety and Innovation Act: A bill to amend the Federal Food, Drug and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes. Sponsor: Harkin (IA)

Client expense: $120,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE