Preserve Access to Affordable Generics Act

H.R. 2795, Patent Reform Act. Provisions related to pharmaceutical patents. H.R. 5418, Establishing a pilot program for patent cases; S. 3582, Preserve Access to Affordable Generics Act; H.R. 1432, To prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market. H.R. 2642, Military Construction and Veteran's Affairs Appropriations Act, 2008.

Client expense: $531,219 · 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), Natl Institutes of Health (NIH), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA)

HCR (Legislative Issues): H.R. 5: "HEALTH Act" (Gingrey); H.R. 1227: "Genetic Information Nondiscrimination Act" (Biggert); H.R. 1402: "Mental Health Equitable Treatment Act" (Kennedy-Ramstad); H.R. 2259: "Patients' Bill of Rights Act" (Dingell) (continued) H.R. 2650: "Patient Protection Act" (Norwood); H.R. 3204: "State High Risk Pool Funding Extension Act" (Shadegg); H.R. 4157: "Health Information Technology Promotion Act" (Johnson); H.R. 4519: "State High Risk Pool Funding Extension Act" (Shadegg); H.R. 4859: "Federal Family Health Information Technology Act" (Porter); H.R. 5559: "Independent Health Record Bank Act"; H.R. 6053: "Health Care Price Transparency Act" (Burgess); S. 4: "Healthy America Act" (Frist); S. 22: "Medical Care Access Protection Act" (Ensign); S. 23: "Healthy Mothers and Healthy Babies Access to Care Act" (Santorum); S. 288: "State High Risk Pool Funding Extension Act" (Gregg); S. 306: "Genetic Information Nondiscrimination Act" (Snowe); S. 1012: "Patients' Bill of Rights Act" (Kennedy); S. 1262: "Health Technology to Enhance Quality Act" (Frist-Clinton); S. 1337: "Fair and Reliable Medical Justice Act" (Enzi-Baucus); S. 1355: "Health Information Technology Quality and Improvement Act" (Enzi-Kennedy); S. 1418: "Wired for Health Care Quality Act" (Enzi); S. 2300: "Lower Prices Reduced with Increased Competition and Efficient Development of Drugs Act" (Stabenow-Lott); S. 2772: "Health Partnership Act" (Voinovich-Bingaman); S. 3454: "Independent Health Record Bank Act" (Brownback); S. 3582: "Preserve Access to Affordable Generics Act" (Kohl); S. 3701 "Catastrophic Health Coverage Promotion Act" (Smith-Wyden); S. 3776 "State-Based Health Care Reform Act" (Feingold); and S. 3846 "Federal Employees Electronic Personal Health Records Act" (Carper). HCR (Regulatory Issues): HIPAA administrative simplification issues, including privacy, security, and electronic transactions and code sets; FEHBP enrollment data clearinghouse initiative; FEHBP community rating policies, including similarly sized subscriber group (SSSG) requirements; health plan compliance with Executive Order 13224; implementation of the health savings account provisions of the Medicare Act; issues related to implementation of the National Health Information Infrastructure; implementation of the National Provider Identifier (NPI) standards; issues relating to market consolidation; issues relating to quality improvement; issues related to potential priority research topics for the effective health care program; and ERISA requirements for benefit plan reporting.

federal drug approval process for generic drugs and appropriated funding (H.R. 376); revision of BioShield provisions of S.3; development of a biogeneric drug approval framework; procedures for drug approval harmonization in prospective trade agreements; implementation of the Medicare Prescription Drug improvement and Modernization Act of 2003 (P.L. 108-391). Issues affecting pharmaeuticals, including: Settlements legislation, S.3582; opposition to legislation proposing patent filing deadline extensions; authorized generics (H.R. 5384); patent reform legislation (H.R. 2795 and S.3818); FDA reform and regulation, and the

Client expense: Not reported · Firm income: $100,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 5418, To establish a pilot program in certain United States district courts to encourage enhancement of expertise in patent cases among district judges. Patent reform matters. H.R. 5120, To amend title 35, United States Code, to conform certain filing provisions within the Patent and Trademark Office. H.R. 5096, Patents Depend on Quality Act of 2006. S. 3582, Preserve Access to Affordable Generics Act.

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

Government targets: Agency for Healthcare Research & Quality (AHRQ), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)

S. 3981, the Citizen Petition Fairness and Accuracy Act Abbreviated New Drug Application No. 76-396 for calcitonin-salmon nasal spray Hatch-Waxman Amendments S. 3582, the Preserve Access to Affordable Generics Act S. 3695, HR. 5993, to prohibit Authorized Generics during 180 day exclusivity HR 6257 & S. 4016, the Access to Life Saving Medicines Act S. 2300 & HR 6022, the Lower Priced Drugs Act

Client expense: $102,200 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

S 3582, Preserve Access to Affordable Generics Act, patent issues HR 2795, Patent Reform Act of 2005, patent issues HR 5416, pilot program on patent cases S 2300, Lower Priced Drugs Act, patent issues S 3818, Patent Reform Act of 2006, patent issues

Client expense: $8,840,000 · Firm income: Not reported

H.R. 5 - Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2005; H.R. 4544 - 340B Program Revision and Expansion Act of 2005; S. 1840/H.R. 3547 Safety Net Inpatient Drug Affordability Act of 2005; S.4/S. 1503 - Healthy America Act of 2005; S. 1420/H.R. 3423 - Medical Device User Fee Stabilization Act of 2005; H.R. 2234 - 21st Century Health Information Act of 2005; S. 3685/H.R. 5993 - To amend the Federal Food, Drug and Comestic Act to prohinit the marketing of authorized generic drug; S. 1903 - Generic Presription Drug Fairness Act of 2005; S. 3582 - Preserve Access to Affordable Generic Act of 2006; S. 4016/H.R. 6257 - Access to Life-Saving Medicine Act of 2006; S. 306/H.R. 1227 - Genetic Information Non-Discrimination act of 2005 S. 334/S. 109 - Pharmacetuical Market Access and Drug Safety Act of 2005; S. 1418 - Wired for Health Care Quality Act of 2005; S. 1233 - Information Technology for Health Care Quality Act of 2005

Client expense: $1,040,000 · Firm income: Not reported

H.R. 2650: “Patient Protection Act” (Norwood); H.R. 3204: “State High Risk Pool Funding Extension Act” (Shadegg); H.R. 4157: “Health Information Technology Promotion Act” (Johnson); H.R. 4519: “State High Risk Pool Funding Extension Act” (Shadegg); H.R. 4859: “Federal Family Health Information Technology Act” (Porter); H.R. 5559: “Independent Health Record Bank Act”; H.R. 6053: "Health Care Price Transparency Act" (Burgess); S. 4: “Healthy America Act” (Frist); S. 22: “Medical Care Access Protection Act” (Ensign); S. 23: “Healthy Mothers and Healthy Babies Access to Care Act” (Santorum); S. 288: “State High Risk Pool Funding Extension Act” (Gregg); S. 306: “Genetic Information Nondiscrimination Act” (Snowe); S. 1012: “Patients’ Bill of Rights Act” (Kennedy); S. 1262: “Health Technology to Enhance Quality Act” (Frist-Clinton); S. 1337: “Fair and Reliable Medical Justice Act” (Enzi-Baucus); S. 1355: “Health Information Technology Quality and Improvement Act” (Enzi-Kennedy); S. 1418: “Wired for Health Care Quality Act” (Enzi); S. 2300: “Lower Prices Reduced with Increased Competition and Efficient Development of Drugs Act” (Stabenow-Lott); S. 2772: “Health Partnership Act” (Voinovich-Bingaman); S. 3454: “Independent Health Record Bank Act” (Brownback); S. 3582: "Preserve Access to Affordable Generics Act" (Kohl); S. 3701 "Catastrophic Health Coverage Promotion Act" (Smith-Wyden); S. 3776 "State-Based Health Care Reform Act" (Feingold); and S. 3846 "Federal Employees Electronic Personal Health Records Act" (Carper). HCR (Regulatory Issues): HIPAA administrative simplification issues, including privacy, security, and electronic transactions and code sets; FEHBP enrollment data clearinghouse initiative; FEHBP community rating policies, including similarly sized subscriber group (SSSG) requirements; health plan compliance with Executive Order 13224; implementation of the health savings account provisions of the Medicare Act; issues related to implementation of the National Health Information Infrastructure; implementation of the National Provider Identifier (NPI) standards; issues relating to market consolidation; issues relating to quality improvement; issues related to potential priority research topics for the effective health care program; and ERISA requirements for benefit plan reporting. HCR (Legislative Issues): H.R. 5: “HEALTH Act” (Gingrey); H.R. 1227: “Genetic Information Nondiscrimination Act” (Biggert); H.R. 1402: “Mental Health Equitable Treatment Act” (Kennedy-Ramstad); H.R. 2259: “Patients’ Bill of Rights Act” (Dingell) (continued)

"Conscience Clause" Bills (HR1539/HR1652/S809); Generic Drugs (S1903/S2300/S3582); Prescription Drug Importation; Counterfeit Drugs

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Lobbied to prevent provisions adverse to prescription drug approval process.H.R.5647, Department of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2007, Lobbied for increased funding for AIDS Drug Assistance Program. H.R.328, Pharmaceutical Market Access Act of 2005, Lobbied to ensure safety of prescription drugs. H.R.700, Pharmaceutical Market Access Act of 2005, Lobbied to ensure safety of prescription drugs. H.R.870, Federal Food, Drug and Cosmetic Act, Lobbied to ensure safety of prescription drugs. H.R.898, Stroke Treatment and Ongoing Prevention Act, Lobbied for passage of the bill. H.R.4550, The National Hepatitis B Awareness Act, Lobbied to raise awareness about Hepatitis B and for passage of the bill. H.R.3559, Medicare DME Access Act, Lobbied to ensure access to medical devices and DME services. H.R. 6143, Ryan White Care Act Reauthorization, Lobbied to ensure safe access to prescription drugs. S.1064, Stroke Treatment and Ongoing Prevention Act, Lobbied for passage of the bill. S.2300, Lower Priced Drugs Act of 2006, Lobbied to preserve incentives for R&D for pediatric populations. S.3558, The National Hepatitis B Awareness Act, Lobbied to raise awareness about Hepatitis B and for passage of the bill. S.3582, to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, Lobbied to ensure the orderly transition of drugs from "innovation" to "generic" status. S.3650, Helping Fill the Medicare Rx Gap Act, Lobbied to ensure safe access to prescription drugs. WIC (no bill), Lobbied for improved nutrition and funding sources for the Supplemental Feeding Program for Women, Infants, and Children. S.Res 556, Lobbied to raise awareness of P.A.D. and for passage of the bill. H.Res 982, Lobbied to raise awareness of P.A.D. and for passage of the bill. H.Con.Res.130, Expressing the sense of the Congress with respect to the awareness, prevention, early detection, and effective treatment of viral hepatitis, and for other purposes. Lobbied for awareness of Hepatitis B. H.R.2090, Food and Drug Administration Improvement Act of 2005.

S 1262, Health Technology to Enhance Quality Act of 2005. State high-risk health insurance pools - HR 4519, State High Risk Pool Funding Extension Act of 2005. Association health plans - HR 525, Small Business Health Fairness Act of 2005; HR 1872, Health Coverage for the Uninsured Act of 2005; HR 5288, Small Business Health Plans Act of 2006; HR 5262, Tax Free Health Savings Act of 2006; HR 6134, Health Opportunity Patient Empowerment Act of 2006; S 406, Small Business Health Fairness Act of 2005; S 1955, Health Insurance Marketplace Modernization and Affordability Act of 2005; S 2510, Small Employers Health Benefits Program Act of 2006 HR 5, HEALTH Act; HR 1227, Genetic Information Non discrimination Act; HR 1402, Mental Health Equitable Treatment Act; HR 2259, Patients' Bill of Rights Act; HR 2650, Patient Protection Act; HR 3204, State High Risk Pool Funding Extension Act; HR 4859, Federal Family Health Information Technology Act; HR 5559, Independent Health Record Bank Act; HR 6053, Health Care Price Transparency Promotion Act; S 4, Healthy America Act; S 22, Medical Care Access Protection Act; S 23, Healthy Mothers and Healthy Babies Access to Care Act; S 288, State high Risk Pool Extension Act; S 306, Genetic Information Nondiscrimination Act; S 1012, Patients' Bill of Rights Act; S 1337, Fair and Reliable Medical Justice Act; S 2300 Lower Prices Reduced with Increased Competition and Efficient Development of Drugs Act; S 2772, Health Partnership Act; S 3454, Independent Health Record Act; S 3582, Preserve Access to Affordable Generics Act; S 3701, Catastrophic Health Coverage Promotion Act; S 3776, State-based Health Care Reform Act; S 3846, Federal Employees Electronic Personal Health Records Act Healthcare for the uninsured - Legislative proposal concerning this issue. Health information technology - HR 4157, Health Information Technology Promotion Act of 2005; S 1418, Wired for Health Care Quality Act; S 1355, Better Healthcare Through Information Technology Act;

H.Con.Res.130, Expressing the sense of the Congress with respect to the awareness, prevention, early detection, and effective treatment of viral hepatitis, and for other purposes. Lobbied for awareness of Hepatitis B. H.R.2090, Food and Drug Administration Improvement Act of 2005. Lobbied to prevent provisions adverse to prescription drug approval process. H.R.5647, Department of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2007, Lobbied for increased funding for AIDS Drug Assistance Program. H.R.328, Pharmaceutical Market Access Act of 2005, Lobbied to ensure safety of prescription drugs. H.R.700, Pharmaceutical Market Access Act of 2005, Lobbied to ensure safety of prescription drugs. H.R.870,Federal Food, Drug and Cosmetic Act , Lobbied to ensure the safety of prescription drugs. H.R.898, Stroke Treatment and Ongoing Prevention Act, Lobbied for passage of the bill. H.R. 4550, The National Hepatitis B Awareness Act, Lobbied to raise awareness about Hepatitis B and for passage of the bill. H.R. 3559, Medicare DME Access Act, Lobbied to remove certain DME services from competitive bidding, implement quality standards, and passage of the bill. S.1064, Stroke Treatment and Ongoing Prevention Act, Lobbied for passage of the bill. S.3558, The National Hepatitis B Awareness Act of 2006, lobbied to raise awareness about Hepatitis B and for passage of the bill. S.3582, to prohibit bran name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, Lobbied to ensure the orderly transition of drugs from "innovation" to "generic" status. WIC (no bill), Lobbied for improved nutrition and funding sources for the Supplemental Feeding Program for Women, Infants, and Children.

Client expense: $2,760,000 · Firm income: Not reported