Drug Price Competition Act of 2009

H.R. 1260, S. 515 and S. 610, Patent Reform Act of 2009; H.R. 1706, Protecting Consumer Access to Generic Drugs Act of 2009; S. 369, Preserve Access to Affordable Generics Act; and S. 1315, Drug Price Competition Act of 2009

Client expense: $620,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, U.S. Customs & Border Protection, U.S. Trade Representative (USTR)

Discussions regarding health information technology, health care reform principles, cost containment, generic drugs, and Medicare Part D, Pay for Delay S.1315, Drug Price Competition Act of 2009 S.369, Preserve Access to Affordable Generics Act

Client expense: $1,390,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Council of Economic Advisers (CEA), Federal Highway Administration (FHA), Federal Motor Carrier Safety Administration, Federal Reserve System, Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Economic Council (NEC), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), Treasury, Dept of, U.S. Customs & Border Protection, U.S. Trade Representative (USTR), White House Office

S. 1315 & H.R. 3777 - The Drug Price Competition Act of 2009; H.R. 1706 Protecting Consumer Access to Generic Drugs Act; S. 369 - Preserve Access to Affordable Generics Act; House Energy and Commerce Committee Drug Import Safety Discussion Draft Amend FDCA concerning correction of Orange Book listings

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Budget Reconcilliation, Implementation of Health Care Reform, Prescription Drug Safety, Counterfeit Drugs/Import Safety/Pedigree, Prescription Drug Shortages, Authorized Generics, Prescription Drug Importation/Re-Importation, 340B Drug Pricing Program, and generic drugs S.501 - Fair Prescription Drug Competition Act, all provisions S.882 - Drug and Device Accountability Act of 2009, Title I Subtitle A, B, C, and D and Title II H.R. 759 - Food and Drug Administration Globalization Act of 2009, Title II S.525, S.1232, and H.R.1298 - Pharmaceutical Market Access and Drug Safety Act of 2009 H.R.3590 - Patient Protection and Affordable Care Act, Title VII - Improving Access to Innovative Medical Therapies H.R.4872 - Reconciliation Bill, Section 1101, Closing the Medicare Prescription Drug "Donut Hole" H.R.4213 - American Jobs and Closing Tax Loopholes Act H.R.4899 - War Supplemental S.1315 - Drug Price Competition Act of 2009

Client expense: $342,888 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office

Patent Reform, Patent Settlements/Reverse Payments/Exclusionary Payments, Patent term extensions, Generic drugs S.515, S.610 and H.R.1260 - the Patent Reform Act of 2009, all provisions S.369 - Preserve Access to Affordable Generics Act, all provisions H.R.1706 - Protecting Consumers Access to Generic Drugs Act of 2009, all provisions H.R.3590 - Patient Protection and Affordable Care Act, Title VII Subtitle A - Biologics Price Competition and Innovation H.R.4899 - War Supplemental Bill, Preserving Access to Affordable Generic Drugs Provision H.R.4213 - American Jobs and Closing Tax Loopholes Act of 2010 S.3677 - Financial Services and General Government Appropriations Act for FY 2011 S.1315 - Drug Price Competition Act of 2009

Client expense: $342,888 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office

S. 1315/HR 3777 the Drug Price Competition Act of 2009, all provisions S. 369 Preserve Access to Affordable Pharmaceuticals Act, all provisions Draft legislation concerning pharmaceutical manufacturing facility inspections, provision concerning registration fees for manufacturing facilities FDA Docket No. FDA-2010-N-0381 concerning generic drug user fees Propective action on legislation concerning the establishment of a generic drug user fee program Amending section 505(j)(5)(C)(ii)(I) of the Food, Drug and Cosmetic Act, concerning the ability of generic drug manufacturers to file counterclaims seeking the correction of incorrect information submitted to FDA's Orange Book by patent owners or holders of approved New Drug Applications.

Client expense: $140,000 · Firm income: Not reported

Government targets: Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

H.R. 1260, S. 515 and S. 610, Patent Reform Act of 2009; H.R. 1706, Protecting Consumer Access to Generic Drugs Act of 2009; S. 369, Preserve Access to Affordable Generics Act; and S. 1315, Drug Price Competition Act of 2009

Client expense: $610,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, U.S. Customs & Border Protection, U.S. Trade Representative (USTR)

H.R. 1260, S. 515 and S. 610, Patent Reform Act of 2009; H.R. 1706, Protecting Consumer Access to Generic Drugs Act of 2009; S. 369, Preserve Access to Affordable Generics Act; and S. 1315, Drug Price Competition Act of 2009

Client expense: $580,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, U.S. Customs & Border Protection, U.S. Trade Representative (USTR)

S. 1315/HR 3777 the Drug Price Competition Act of 2009 S. 369, the Preserve Access to Affordable Pharmaceuticals Act SA 4361 to HR 4213 concerning market blockages caused by pharmaceutical patent settlements HR 759, Food and Drug Administration Globalization Act of 2009 Draft legislation concerning pharmaceutical manufacturing facility inspections Establishment of a generic drug user fee program

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

Government targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, SENATE

H.R. 1260, S. 515 and S. 610, Patent Reform Act of 2009; H.R. 1706, Protecting Consumer Access to Generic Drugs Act of 2009; S. 369, Preserve Access to Affordable Generics Act; and S. 1315, Drug Price Competition Act of 2009

Client expense: $840,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, U.S. Customs & Border Protection, U.S. Trade Representative (USTR)

S.525/H.R.1298/S.1232, Pharmaceutical Market Access and Drug Safety Act of 2009 - Discussed legislation which would create a system of safe importation of prescription drugs from abroad. S.726/H.R.1427, Promoting Innovation and Access to Life-Saving Medicine Act - Discussed legislation which would create a pathway for the approval of safe, effective biosimilar and generic biologic drugs. H.R.1706, Protecting Consumer Access to Generic Drugs Act of 2009 - Discussed legislation that would prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and for other purposes. S. 369, Preserve Access to Affordable Generics Act - Discussed legislation that would prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market,and for other purposes. S.515/H.R.1260/S.610, Patent Reform Act of 2009 - Discussed legislation that would amend federal patent law to rewrite provisions concerning the conditions for patentability. Specifically, AARP weighed in on the inequitable conduct provisions of the legislation. S. 301, Physician Payments Sunshine Act of 2009 - Discussed legislation that would provide for disclosure of gifts given by pharmaceutical and device manufacturers to physicians. S.1315, Federal Food, Drug and Cosmetic Act Amendment/H.R.3777 Drug Price Competition Act - Lobbied to expand the definition of "first applicant" under such Act to allow a generic drug manufacturer that is currently considered an applicant subsequent to a brand-name manufacturer's 180-day exclusivity period to qualify as a first applicant for purposes of filing an abbreviated application for a new drug. Requires such applicant ot submit a substantially complete application that contains and lawfully maintains a certification for such drug. H.R. 3590, Patient Protection and Affordable Care Act - Lobbied in support of and implementation of health care legislation to reform the health care system to provide quality health care and expand access to long-term services and supports. H.R. 4872, Health Care and Education Reconciliation Act - Lobbied in support of and implementation of health care law which makes improvements, such as closing the Part D coverage gap, in the Patient Protection and Affordable Care Act. S. 3606, Agriculture, Rural Development, FDA and related agencies Appropriations Act, FY 2011 - Lobbied for increased funding for the FDA Office of Generic Drugs to reduction of application backlog. H.R. 3081, Continuing Resolution, FY 2011 - Lobbied for funding for FDA Office of Generic Drugs and nutrition assistance.

Discussions regarding health information technology, health care reform principles, cost containment, generic drugs, and Medicare Part D, Pay for Delay S.1315, Drug Price Competition Act of 2009 S.369, Preserve Access to Affordable Generics Act

Client expense: $1,190,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Council of Economic Advisers (CEA), Federal Highway Administration (FHA), Federal Motor Carrier Safety Administration, Federal Reserve System, Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Economic Council (NEC), Natl Security Council (NSC), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

Budget Reconcilliation, Implementation of Health Care Reform, Prescription Drug Safety, Counterfeit Drugs/Import Safety/Pedigree, Authorized Generics, Prescription Drug Importation/Re-Importation, 340B Drug Pricing Program, and generic drugs S.501 - Fair Prescription Drug Competition Act, all provisions S.882 - Drug and Device Accountability Act of 2009, Title I Subtitle A, B, C, and D and Title II H.R. 759 - Food and Drug Administration Globalization Act of 2009, Title II S.525, S.1232, and H.R.1298 - Pharmaceutical Market Access and Drug Safety Act of 2009 H.R.3590 - Patient Protection and Affordable Care Act, Title VII - Improving Access to Innovative Medical Therapies H.R.4872 - Reconciliation Bill, Section 1101, Closing the Medicare Prescription Drug "Donut Hole" H.R.4213 - American Jobs and Closing Tax Loopholes Act H.R.4899 - War Supplemental S.1315 - Drug Price Competition Act of 2009

Client expense: $372,750 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office

Patent Reform, Patent Settlements/Reverse Payments/Exclusionary Payments, Patent term extensions, Generic drugs S.515, S.610 and H.R.1260 - the Patent Reform Act of 2009, all provisions S.369 - Preserve Access to Affordable Generics Act, all provisions H.R.1706 - Protecting Consumers Access to Generic Drugs Act of 2009, all provisions H.R.3590 - Patient Protection and Affordable Care Act, Title VII Subtitle A - Biologics Price Competition and Innovation H.R.4899 - War Supplemental Bill, Preserving Access to Affordable Generic Drugs Provision H.R.4213 - American Jobs and Closing Tax Loopholes Act of 2010 S.3677 - Financial Services and General Government Appropriations Act for FY 2011 S.1315 - Drug Price Competition Act of 2009

Client expense: $372,750 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office

S. 1315 & H.R. 3777 - The Drug Price Competition Act of 2009; H.R. 1706 Protecting Consumer Access to Generic Drugs Act; S. 369 - Preserve Access to Affordable Generics Act; House Energy and Commerce Committee Drug Import Safety Discussion Draft

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 1315 & H.R. 3777 - The Drug Price Competition Act of 2009; H.R. 1706 Protecting Consumer Access to Generic Drugs Act; S. 369 - Preserve Access to Affordable Generics Act; H.R. 759 - Food and Drug Administration Globalization Act of 2009 Issues relating to drug disposal.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Discussions regarding health information technology, health care reform principles, cost containment, generic drugs, and Medicare Part D S.1315, Drug Price Competition Act of 2009 S.369, Preserve Access to Affordable Generics Act S. 1152 & H.R. 2460, The Healthy Families Act, a bill to allow Americans to earn paid sick time so that they can address their own health needs and the health needs of their families

Client expense: $1,430,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Federal Highway Administration (FHA), Federal Motor Carrier Safety Administration, Federal Reserve System, Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Intl Trade Administration (ITA), Labor, Dept of (DOL), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office

S.525/H.R.1298/S.1232, Pharmaceutical Market Access and Drug Safety Act of 2009 - Discussed legislation which would create a system of safe importation of prescription drugs from abroad. S.726/H.R.1427, Promoting Innovation and Access to Life-Saving Medicine Act - Discussed legislation which would create a pathway for the approval of safe, effective biosimilar and generic biologic drugs. H.R.1706, Protecting Consumer Access to Generic Drugs Act of 2009 - Discussed legislation that would prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and for other purposes. S. 369, Preserve Access to Affordable Generics Act - Discussed legislation that would prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market,and for other purposes. S.515/H.R.1260/S.610, Patent Reform Act of 2009 - Discussed legislation that would amend federal patent law to rewrite provisions concerning the conditions for patentability. Specifically, AARP weighed in on the inequitable conduct provisions of the legislation. S. 301, Physician Payments Sunshine Act of 2009 - Discussed legislation that would provide for disclosure of gifts given by pharmaceutical and device manufacturers to physicians. S.1315, Federal Food, Drug and Cosmetic Act Amendment/H.R.3777 Drug Price Competition Act - Lobbied to expand the definition of "first applicant" under such Act to allow a generic drug manufacturer that is currently considered an applicant subsequent to a brand-name manufacturer's 180-day exclusivity period to qualify as a first applicant for purposes of filing an abbreviated application for a new drug. Requires such applicant ot submit a substantially complete application that contains and lawfully maintains a certification for such drug. H.R. 3590, Patient Protection and Affordable Care Act - Lobbied in support of and implementation of health care legislation to reform the health care system to provide quality health care and expand access to long-term services and supports. H.R. 4872, Health Care and Education Reconciliation Act - Lobbied in support of and implementation of health care law which makes improvements, such as closing the Part D coverage gap, in the Patient Protection and Affordable Care Act.

S. 1315/HR 3777 the Drug Price Competition Act of 2009 S. 369, the Preserve Access to Affordable Generics Act HR 4899 EAH, Supplemental Disaster Relief and Summer Jobs Act of 2010, Chapter 2, Section 4201, Preserve Access to Affordable Generics Act SA 4361 to HR 4213 concerning market blockages caused by pharmaceutical patent settlements HR 759, Food and Drug Administration Globalization Act of 2009 Pharmaceutical waste disposal

Client expense: $150,000 · Firm income: Not reported

Government targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, SENATE

S.525/H.R.1298/S.1232, Pharmaceutical Market Access and Drug Safety Act of 2009 - Discussed legislation which would create a system of safe importation of prescription drugs from abroad. S.726/H.R.1427, Promoting Innovation and Access to Life-Saving Medicine Act - Discussed legislation which would create a pathway for the approval of safe, effective biosimilar and generic biologic drugs. H.R.1706, Protecting Consumer Access to Generic Drugs Act of 2009 - Discussed legislation that would prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and for other purposes. S. 369, Preserve Access to Affordable Generics Act - Discussed legislation that would prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market,and for other purposes. S.515/H.R.1260/S.610, Patent Reform Act of 2009 - Discussed legislation that would amend federal patent law to rewrite provisions concerning the conditions for patentability. Specifically, AARP weighed in on the inequitable conduct provisions of the legislation. S. 301, Physician Payments Sunshine Act of 2009 - Discussed legislation that would provide for disclosure of gifts given by pharmaceutical and device manufacturers to physicians. S.1315, Federal Food, Drug and Cosmetic Act Amendment/H.R.3777 Drug Price Competition Act - Lobbied to expand the definition of "first applicant" under such Act to allow a generic drug manufacturer that is currently considered an applicant subsequent to a brand-name manufacturer's 180-day exclusivity period to qualify as a first applicant for purposes of filing an abbreviated application for a new drug. Requires such applicant ot submit a substantially complete application that contains and lawfully maintains a certification for such drug. H.R. 3590, Patient Protection and Affordable Care Act - Lobbied in support of and implementation of health care legislation to reform the health care system to provide quality health care and expand access to long-term services and supports. H.R. 4872, Health Care and Education Reconciliation Act - Lobbied in support of and implementation of health care law which makes improvements, such as closing the Part D coverage gap, in the Patient Protection and Affordable Care Act.

S. 1315/HR 3777 the Drug Price Competition Act of 2009 S. 369, the Preserve Access to Affordable Generics Act HR 4899 EAH, Supplemental Disaster Relief and Summer Jobs Act of 2010, Chapter 2, Section 4201, Preserve Access to Affordable Generics Act SA 4361 to HR 4213 concerning market blockages caused by pharmaceutical patent settlements HR 759, Food and Drug Administration Globalization Act of 2009 Pharmaceutical waste disposal

Client expense: $150,000 · Firm income: Not reported

Government targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, SENATE

S. 1315/HR 3777 the Drug Price Competition Act of 2009 S. 369, the Preserve Access to Affordable Generics Act HR 4899 EAH, Supplemental Disaster Relief and Summer Jobs Act of 2010, Chapter 2, Section 4201, Preserve Access to Affordable Generics Act SA 4361 to HR 4213 concerning market blockages caused by pharmaceutical patent settlements HR 759, Food and Drug Administration Globalization Act of 2009 Pharmaceutical waste disposal

Client expense: $150,000 · Firm income: Not reported

Government targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, SENATE

H.R. 1260, S. 515 and S. 610, Patent Reform Act of 2009; H.R. 1706, Protecting Consumer Access to Generic Drugs Act of 2009; S. 369, Preserve Access to Affordable Generics Act; and S. 1315, Drug Price Competition Act of 2009

Client expense: $840,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, U.S. Customs & Border Protection, U.S. Trade Representative (USTR)

S.525/H.R.1298/S.1232, Pharmaceutical Market Access and Drug Safety Act of 2009 - Discussed legislation which would create a system of safe importation of prescription drugs from abroad. S.726/H.R.1427, Promoting Innovation and Access to Life-Saving Medicine Act - Discussed legislation which would create a pathway for the approval of safe, effective biosimilar and generic biologic drugs. H.R.1706, Protecting Consumer Access to Generic Drugs Act of 2009 - Discussed legislation that would prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and for other purposes. S. 369, Preserve Access to Affordable Generics Act - Discussed legislation that would prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market,and for other purposes. S.515/H.R.1260/S.610, Patent Reform Act of 2009 - Discussed legislation that would amend federal patent law to rewrite provisions concerning the conditions for patentability. Specifically, AARP weighed in on the inequitable conduct provisions of the legislation. S. 301, Physician Payments Sunshine Act of 2009 - Discussed legislation that would provide for disclosure of gifts given by pharmaceutical and device manufacturers to physicians. S.1315, Federal Food, Drug and Cosmetic Act Amendment/H.R.3777 Drug Price Competition Act - Lobbied to expand the definition of "first applicant" under such Act to allow a generic drug manufacturer that is currently considered an applicant subsequent to a brand-name manufacturer's 180-day exclusivity period to qualify as a first applicant for purposes of filing an abbreviated application for a new drug. Requires such applicant ot submit a substantially complete application that contains and lawfully maintains a certification for such drug. H.R. 3200 America's Affordable Health Choices Act/S. 1679, Americas Health Choices Act/S.1796, America's Healthy Future Act - Discussed need for affordable quality healthcare, delivery system reform, ending age discrimination in the health ending rating by health condition or any proxy, insurance industry, closing the doughnut hole, creating a pathway for generic biologics, allowing and funding states to provide home and community based services, creating a transitional benefit or other transitional care proposals in medicare and expanding the asset limit to qualify for low-income programs in medicare. H.R. 3590, Patient Protection and Affordable Care Act - Lobbied in support of health care legislation to reform the health care system to provide quality health care and expand access to long-term services and supports. H.R. 4872, Health Care and Education Reconciliation Act - Lobbied in support of health care legislation which makes improvements, such as closing the Part D coverage gap, in the Patient Protection and Affordable Care Act.

S.525/H.R.1298/S.1232, Pharmaceutical Market Access and Drug Safety Act of 2009 - Discussed legislation which would create a system of safe importation of prescription drugs from abroad. S.726/H.R.1427, Promoting Innovation and Access to Life-Saving Medicine Act - Discussed legislation which would create a pathway for the approval of safe, effective biosimilar and generic biologic drugs. H.R.1706, Protecting Consumer Access to Generic Drugs Act of 2009 - Discussed legislation that would prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and for other purposes. S. 369, Preserve Access to Affordable Generics Act - Discussed legislation that would prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market,and for other purposes. S.515/H.R.1260/S.610, Patent Reform Act of 2009 - Discussed legislation that would amend federal patent law to rewrite provisions concerning the conditions for patentability. Specifically, AARP weighed in on the inequitable conduct provisions of the legislation. S. 301, Physician Payments Sunshine Act of 2009 - Discussed legislation that would provide for disclosure of gifts given by pharmaceutical and device manufacturers to physicians. S.1315, Federal Food, Drug and Cosmetic Act Amendment/H.R.3777 Drug Price Competition Act - Lobbied to expand the definition of "first applicant" under such Act to allow a generic drug manufacturer that is currently considered an applicant subsequent to a brand-name manufacturer's 180-day exclusivity period to qualify as a first applicant for purposes of filing an abbreviated application for a new drug. Requires such applicant ot submit a substantially complete application that contains and lawfully maintains a certification for such drug. H.R. 3200 America's Affordable Health Choices Act/S. 1679, Americas Health Choices Act/S.1796, America's Healthy Future Act - Discussed need for affordable quality healthcare, delivery system reform, ending age discrimination in the health ending rating by health condition or any proxy, insurance industry, closing the doughnut hole, creating a pathway for generic biologics, allowing and funding states to provide home and community based services, creating a transitional benefit or other transitional care proposals in medicare and expanding the asset limit to qualify for low-income programs in medicare. H.R. 3590, Patient Protection and Affordable Care Act - Lobbied in support of health care legislation to reform the health care system to provide quality health care and expand access to long-term services and supports. H.R. 4872, Health Care and Education Reconciliation Act - Lobbied in support of health care legislation which makes improvements, such as closing the Part D coverage gap, in the Patient Protection and Affordable Care Act.

S. 369, the Preserve Access to Affordable Pharmaceuticals Act S. 1315, the Drug Price Competition Act of 2009 H.R. 3777, the Drug Price Competition Act of 2009 H.R. 3962, Affordable Health Care for America Act, Section 2573, Protecting Consumer Access to Generic Drugs Act H.R. 3962, Affordable Heatlh Care for America Act, Section 2375, Licensure Pathway for Biosimilar Products H.R. 3590, the Patient Protection and Affordable Care Act, Title VII, Subtitle A, Biologics Price Competition and Innovation H.R. 4872, the Health Care and Education Reconciliation Act of 2010 pertaining to patent settlements between brand and generic pharmaceutical manufacturers

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

Government targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, SENATE

S. 1315 & H.R. 3777 - The Drug Price Competition Act of 2009; H.R. 3962 - Affordable Healthcare for American Act; H.R. 3590 - Patient Protection and Affordability Act; H.R. 1706 Protecting Consumer Access to Generic Drugs Act; S. 369 - Preserve Access to Affordable Generics Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.525/H.R.1298/S.1232, Pharmaceutical Market Access and Drug Safety Act of 2009 - Discussed legislation which would create a system of safe importation of prescription drugs from abroad. S.726/H.R.1427, Promoting Innovation and Access to Life-Saving Medicine Act - Discussed legislation which would create a pathway for the approval of safe, effective biosimilar and generic biologic drugs. H.R.1706, Protecting Consumer Access to Generic Drugs Act of 2009 - Discussed legislation that would prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and for other purposes. S. 369, Preserve Access to Affordable Generics Act - Discussed legislation that would prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market,and for other purposes. S.515/H.R.1260/S.610, Patent Reform Act of 2009 - Discussed legislation that would amend federal patent law to rewrite provisions concerning the conditions for patentability. Specifically, AARP weighed in on the inequitable conduct provisions of the legislation. S. 301, Physician Payments Sunshine Act of 2009 - Discussed legislation that would provide for disclosure of gifts given by pharmaceutical and device manufacturers to physicians. H.R.2997 Agriculture, Rural Development, FDA and related agencies Appropriations bill for FY2010-Lobbied in support of funding for the Commodity Supplemental Food Program and FDA Office of Generic Drugs. FDA research on bioequivalency of generic epilepsy drugs, rural housing assistance and repair (no bill). S.1315, Federal Food, Drug and Cosmetic Act Amendment/H.R.3777 Drug Price Competition Act - Lobbied to expand the definition of "first applicant" under such Act to allow a generic drug manufacturer that is currently considered an applicant subsequent to a brand-name manufacturer's 180-day exclusivity period to qualify as a first applicant for purposes of filing an abbreviated application for a new drug. Requires such applicant ot submit a substantially complete application that contains and lawfully maintains a certification for such drug. H.R. 3200 America's Affordable Health Choices Act/S. 1679, Americas Health Choices Act, America's Healthy Future Act (no Senate bill)- Discussed need for affordable quality healthcare, delivery system reform, ending age discrimination in the health ending rating by health condition or any proxy, insurance industry, closing the doughnut hole, creating a pathway for generic biologics, allowing and funding states to provide home and community based services, creating a transitional benefit or other transitional care proposals in medicare and expanding the asset limit to qualify for low-income programs in medicare.

S.525/H.R.1298/S.1232, Pharmaceutical Market Access and Drug Safety Act of 2009 - Discussed legislation which would create a system of safe importation of prescription drugs from abroad. S.726/H.R.1427, Promoting Innovation and Access to Life-Saving Medicine Act - Discussed legislation which would create a pathway for the approval of safe, effective biosimilar and generic biologic drugs. H.R.1706, Protecting Consumer Access to Generic Drugs Act of 2009 - Discussed legislation that would prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and for other purposes. S. 369, Preserve Access to Affordable Generics Act - Discussed legislation that would prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market,and for other purposes. S.515/H.R.1260/S.610, Patent Reform Act of 2009 - Discussed legislation that would amend federal patent law to rewrite provisions concerning the conditions for patentability. Specifically, AARP weighed in on the inequitable conduct provisions of the legislation. S. 301, Physician Payments Sunshine Act of 2009 - Discussed legislation that would provide for disclosure of gifts given by pharmaceutical and device manufacturers to physicians. H.R.2997 Agriculture, Rural Development, FDA and related agencies Appropriations bill for FY2010-Lobbied in support of funding for the Commodity Supplemental Food Program and FDA Office of Generic Drugs. FDA research on bioequivalency of generic epilepsy drugs, rural housing assistance and repair (no bill). S.1315, Federal Food, Drug and Cosmetic Act Amendment/H.R.3777 Drug Price Competition Act - Lobbied to expand the definition of "first applicant" under such Act to allow a generic drug manufacturer that is currently considered an applicant subsequent to a brand-name manufacturer's 180-day exclusivity period to qualify as a first applicant for purposes of filing an abbreviated application for a new drug. Requires such applicant ot submit a substantially complete application that contains and lawfully maintains a certification for such drug. H.R. 3200 America's Affordable Health Choices Act/S. 1679, Americas Health Choices Act, America's Healthy Future Act (no Senate bill)- Discussed need for affordable quality healthcare, delivery system reform, ending age discrimination in the health ending rating by health condition or any proxy, insurance industry, closing the doughnut hole, creating a pathway for generic biologics, allowing and funding states to provide home and community based services, creating a transitional benefit or other transitional care proposals in medicare and expanding the asset limit to qualify for low-income programs in medicare.

S. 501 - Fair Prescription Drug Competition Act; H.R. 573 - Relating to marketing of authorized generic drugs; H.R. 1548 - The Pathway to Biosimilars Act; S. 726 & H.R. 1427 - The Promoting Innovation and Access to Life- Savings Medicine Act; S. 1315 - The Drug Price Competition Act of 2009; H.R.3777 - Drug Price Competition Act of 2009; H.R. 3962 - Affordable Healthcare for American Act; S. 1796 - America's Healthy Future Act of 2009; H.R. 3590 - Patient Protection and Affordability Act

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

Government targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, SENATE

S 369, the Preserve Access to Affordable Pharmaceuticals Act HR 1706, the Protecting Consumer Access to Generic Drugs Act S. 1315, the Drug Price Competition Act of 2009 HR 3777, the Drug Price Competition Act of 2009 HR 3200, Subtitle C, Food & Drug Administration, Secrtion 2563, Protecting Consumer Access to Generic Drugs Act HR 3962, Affordable Health Care for America Act, Section 2573, Protecting Consumer Access to Generic Drugs Act, Section 2575, Lincensure Pathway for Biosimilar Products HR 3590, the Patient Protection and Affordable Care Act, Title VII, Subtitle A, Biologics Price Competition and Innovation

Client expense: $140,000 · Firm income: Not reported

Government targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, SENATE

Issues relating to comprehensive health care reform, insurance reforms, delivery system, expanding coverage for the uninsured, and increasing health care value. Other specific issues include PBM disclosure requirements, generic drug reimbursement under Medicaid, tax issues, changes to Medicare Part D and prevention & wellness issues. Expanding access to generic drugs and creating an FDA pathway to bring generic versions of biologics to market; realignment of incentives for generic manufacturers to challenge brand patents for earlier market entry. H.R. 3200 Americas Affordable Health Choices Act of 2009 S. 1679 Affordable Health Choices Act Americas Healthy Future Act of 2009 H.R. 1706 - Protecting Consumer Access to Generic Drugs Act of 2009 H.R. 1427 - Promoting Innovation and Access to Life-Saving Medicine Act S.726 - Promoting Innovation and Access to Life-Saving Medicine Act S. 1315-Drug Price Competition Act of 2009 H.R. 1548 - Pathway for Biosimilars Act

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

Generics Issues/Biologics-Expanding access to generic drugs and creating an FDA pathway to bring generic versions of biologics to market; realignment of incentives for generic manufacturers to challenge brand patents for earlier market entry. H.R. 1706 - Protecting Consumer Access to Generic Drugs Act of 2009 H.R. 1427 - Promoting Innovation and Access to Life-Saving Medicine Act S.726 - Promoting Innovation and Access to Life-Saving Medicine Act S. 1315-Drug Price Competition Act of 2009 H.R. 1548 - Pathway for Biosimilars Act

Client expense: $1,950,000 · Firm income: Not reported

S.525/H.R.1298/S.1232, Pharmaceutical Market Access and Drug Safety Act of 2009 - Discussed legislation which would create a system of safe importation of prescription drugs from abroad. S.726/H.R.1427, Promoting Innovation and Access to Life-Saving Medicine Act - Discussed legislation which would create a pathway for the approval of safe, effective biosimilar and generic biologic drugs. H.R.1706, Protecting Consumer Access to Generic Drugs Act of 2009 - Discussed legislation that would prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and for other purposes. S. 369, Preserve Access to Affordable Generics Act - Discussed legislation that would prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market,and for other purposes. S.515/H.R.1260/S.610, Patent Reform Act of 2009 - Discussed legislation that would amend federal patent law to rewrite provisions concerning the conditions for patentability. Specifically, AARP weighed in on the inequitable conduct provisions of the legislation. S. 301, Physician Payments Sunshine Act of 2009 - Discussed legislation that would provide for disclosure of gifts given by pharmaceutical and device manufacturers to physicians. H.R.2997 Agriculture, Rural Development, FDA and related agencies Appropriations bill for FY2010-Lobbied in support of funding for the Commodity Supplemental Food Program and FDA Office of Generic Drugs. FDA research on bioequivalency of generic epilepsy drugs, rural housing assistance and repair (no bill). S.1315, Federal Food, Drug and Cosmetic Act Amendment/H.R.3777 Drug Price Competition Act - Lobbied to expand the definition of "first applicant" under such Act to allow a generic drug manufacturer that is currently considered an applicant subsequent to a brand-name manufacturer's 180-day exclusivity period to qualify as a first applicant for purposes of filing an abbreviated application for a new drug. Requires such applicant ot submit a substantially complete application that contains and lawfully maintains a certification for such drug. H.R. 3200 America's Affordable Health Choices Act/S. 1679, Americas Health Choices Act, America's Healthy Future Act (no Senate bill)- Discussed need for affordable quality healthcare, delivery system reform, ending age discrimination in the health insurance industry, closing the doughnut hole, creating a pathway for generic biologics, allowing and funding states to provide home and community based services, creating a transitional benefit in medicare and expanding the asset limit to qualify for low-income programs in medicare.

S.525/H.R.1298/S.1232, Pharmaceutical Market Access and Drug Safety Act of 2009 - Discussed legislation which would create a system of safe importation of prescription drugs from abroad. S.726/H.R.1427, Promoting Innovation and Access to Life-Saving Medicine Act - Discussed legislation which would create a pathway for the approval of safe, effective biosimilar and generic biologic drugs. H.R.1706, Protecting Consumer Access to Generic Drugs Act of 2009 - Discussed legislation that would prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and for other purposes. S. 369, Preserve Access to Affordable Generics Act - Discussed legislation that would prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market,and for other purposes. S.515/H.R.1260/S.610, Patent Reform Act of 2009 - Discussed legislation that would amend federal patent law to rewrite provisions concerning the conditions for patentability. Specifically, AARP weighed in on the inequitable conduct provisions of the legislation. S. 301, Physician Payments Sunshine Act of 2009 - Discussed legislation that would provide for disclosure of gifts given by pharmaceutical and device manufacturers to physicians. H.R.2997 Agriculture, Rural Development, FDA and related agencies Appropriations bill for FY2010-Lobbied in support of funding for the Commodity Supplemental Food Program and FDA Office of Generic Drugs. FDA research on bioequivalency of generic epilepsy drugs, rural housing assistance and repair (no bill). S.1315, Federal Food, Drug and Cosmetic Act Amendment/H.R.3777 Drug Price Competition Act - Lobbied to expand the definition of "first applicant" under such Act to allow a generic drug manufacturer that is currently considered an applicant subsequent to a brand-name manufacturer's 180-day exclusivity period to qualify as a first applicant for purposes of filing an abbreviated application for a new drug. Requires such applicant ot submit a substantially complete application that contains and lawfully maintains a certification for such drug. H.R. 3200 America's Affordable Health Choices Act/S. 1679, Americas Health Choices Act, America's Healthy Future Act (no Senate bill)- Discussed need for affordable quality healthcare, delivery system reform, ending age discrimination in the health insurance industry, closing the doughnut hole, creating a pathway for generic biologics, allowing and funding states to provide home and community based services, creating a transitional benefit in medicare and expanding the asset limit to qualify for low-income programs in medicare.

S. 369, the Preserve Access to Affordable Pharmaceuticals Act HR 1706, the Protecting Consumer Access to Generic Drugs Act S. 1315, the Drug Price Competition Act of 2009 HR 3200, Subtitle C - Food & Drug Administration, Section 2563, Protecting Consumer Access to Generic Drugs HR 3200, Subtitle C, Food & Drug Administration, Part 2, Biosimilars Section 2565, Licensure Pathway for Biosimilar Biological Products HR 1427, the Promoting Innovation and Access to Life Savings Medicine Act HR 1548, Pathway for Biosimilars Act

Client expense: $150,000 · Firm income: Not reported

Government targets: Congressional Budget Office (CBO), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, SENATE

S. 501 - Fair Prescription Drug Competition Act; H.R. 573 - Relating to marketing of authorized generic drugs; H.R. 1548 - The Pathway to Biosimilars Act; S. 726 & H.R. 1427 - The Promoting Innovation and Access to Life- Savings Medicine Act; S. 1315 - The Drug Price Competition Act of 2009; issues relating to electronic drug labeling; H.R. 3200 - America's Affordable Health Choices Act; America's Healthy Future Act of 2009 - Senate Finance mark

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

Government targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, SENATE

S. 369, the Preserve Access to Affordable Pharmaceuticals Act HR 1706, the Protecting Consumer Access to Generic Drugs Act HR 1427, the Promoting Innovation and Access to Life Saving Medicine Act S. 726, the Promoting Innovation and Access to Life Saving Medicine Act HR 1548, Pathway for Biosimilars Act S. 501, the Fair Prescription Drug Competition Act S. 767, the Independent Drug Education and Outreach Act S. 1315, the Price Competition Act of 2009 HR 2997, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2010, Title VI, FDA, concerning funding for the Office of Generic Drugs Electronic labeling for pharmaceuticals

Client expense: $170,000 · Firm income: Not reported

Government targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, SENATE

Items related to reverse settlement payments between manufacturers, HR 1706 Changing the definition of first-to-file between manufacturers, S 1315 Items related to oversight of the federal employees health benefit program and its pharmacy benefit

Client expense: $410,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Defense, Dept of (DOD), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, SENATE

S. 501 - Fair Prescription Drug Competition Act; H.R. 573 - Relating to marketing of authorized generic drugs; H.R. 1548 - The Pathway to Biosimilars Act; S. 726 & H.R. 1427 - The Promoting Innovation and Access to Life- Savings Medicine Act; S. 1315 - The Drug Price Competition Act of 2009; issues relating to electronic drug labeling

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

Government targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, SENATE