Enhancing Drug Safety and Innovation Act of 2006

Biogenetic Bill; PDUFA Reform; prescription drug safety; generic drugs; best buy drugs; comparative effectiveness; Medicare Part D; FDA drug safety; FDA reform; drug reimportation; HR 1561; S484; HR 4 S 1082; S467; S468; S424; HR 2184; HR 2090; S3807; S623

Client expense: $216,381 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Consumer Product Safety Commission (CPSC), Federal Communications Commission (FCC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Natl Highway Traffic Safety Administration (NHTSA), Office of the Comptroller of the Currency (OCC), SENATE, UNDETERMINED

S 3807, Enhancing Drug Safety and Innovation Act of 2006, drug safety, DTC

Client expense: $6,580,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

P.L. 109-57, implementation of export regulations for controlled substances S.3807, Senators Enzy, Kennedy, Drug Safety legislation, "Enhancing Drug Safety & Innovation Act of 2006." Section 1. riskmaps; section 4. Advisory committees; approval standards for pharmaceuticals. H.R. 3162 SCIP; H.R. 4, Medicare Prescription Drug Price Negotiation Act of 2007.

Client expense: $531,219 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Drug Enforcement Administration (DEA), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE, State, Dept of (DOS), Substance Abuse & Mental Health Services Administration (SAMHSA)

S 3807, Enhancing Drug Safety and Innovation Act of 2006, drug safety, DTC

Client expense: $7,220,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

P.L. 109-57, implementation of export regulations for controlled substances. S. 3807, Sens Enzy, Kennedy, Drug Safety legislation, "Enhancing Drug Safety and Innovation Act of 2006." Section 1. riskmaps; section 4. Advisory committees; approval standards for pharmaceuticals. H.R. 3162 SCHIP; H.R. 4, Medicare Prescription Drug Price Negotiation Act of 2007

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)

Issues relating to support of Office of Women's Health and Public Education Initiatives Childhood immunizations Dietary supplement issues FDA reform issues S.3 Protecting America in the War on Terror H.R. 650 Vaccines Act of 2005 H.R. 2863 Department of Defense Appropriations Act of 2006 Medicare reimbursement for certain drugs Importation Bioterrorism Direct to consumer advertising S.334 Pharmaceutical Market Access and Drug Safety Act of 2005 Implementation issues concerning P.L. 108-173 - The Medicare Prescription Drug, Improvement and Modernization Act of 2003 Issues concerning Medicaid in the Concurrent Resolution on the Budget - Fiscal Year 2006 Medical coverage of self-injective biologicals Issues related to vaccine injury compensation program Follow developments within the Bush Administration relating to global health policies concerning U.S. government participation in WHO and UN health initiatives; international public health issues; U.S. sanctions policies Issues relating to Medicaid reimbursement for drugs/biologics in Title VI of S.1932-the Deficit Reduction Act of 2005 Pandemic Influenza S.3678 S. Con. Res 83, "Concurrent Resolution on the Budget for Fiscal Year 2007,: issues relating to amending the Medicare Prescription Drug and Modernization Act of 2003 (P.L.108-173) to authorize the Secretary of HHS to negotiate drug prices for the Part D Medicare prescription drug benefit. H.R. 5384, "Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations Act of 2007," issues related to the importation of prescription drugs. Issues related to vaccine injury compensation program S.843 - The Combating Autism Act of 2005 H.R. 4939 - Supplemental Appropriations H.R. 5441 - FY 2007 Homeland Security Appropriations Drug Compounding H.R. 5122, S.2767 - Department of Defense Authorizations S.3807 - Enhancing Drug Safety and Innovation Act of 2006 Alzheimer's care HR 5211; S.2767 - Department of Defense Authorizations H.R. 5384 - "Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations Act of 2007," issues related to the importation of prescription drugs; issues related to the Vaccine Injury Compensation Program Issues related to hormone therapy and the use of HT and BHRT products. Vaccine Injury Compensation Program Follow developments within the Bush Administration relating to global health policies concerning U.S. government participation in WHO and UN health initiatives; international public health issues; U.S. sanctions policies

Client expense: $1,986,000 · Firm income: Not reported

Government targets: Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Security Council (NSC), Office of the Vice President of the United States, SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

S 3807, Enhancing Drug Safety and Innovation Act of 2006 HR 6257, Access to LIfe-Saving Medicine Act Drug Approval Issues, Drug Safety Issues, FDA Issues Clinical Trials Conflict of Interest, Follow-On Biologics, PDUFA IV Issues relating to generics, biotechnology and drug reimportation HR 700/S334 Pharmaceutical Market Access and Drug and Safety Act of 2005/S334 HR 328/S109 Pharmaceutical market Acces Act of 2005 S930 Food and Drug Administration Safety Act of 2005

Client expense: $730,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

S. 3807 - Enhancing Drug Safety and Innovation Act of 2006 - provisions related to FDA advisory panels

Client expense: $700,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 2122, The Project BioShield Act of 2003, pharmaceutical research and development, security S 3807, Enhancing Drug Safety and Innovation Act of 2006, drug safety, DTC

Client expense: $5,800,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

H.R. 3428 OTC Medicine Tax Fairness Act of 2005 S. 1514 OTC Medicine Tax Fairness Act of 2005 S. 3807 To amend the Federal Food, Drug and Cosmetic Act to provide for the regulation of all contact lenses as medical devices,and for other purposes H.R. 371 To amend the Federal Food, Drug and Cosmetic Act to provide for the regulation of all contaact lenses as medical devices, and for other purposes H.R. 5280 Distribution Act of 2006 H.R. 6111 Tax Relief and health Care Act (Medicare) S.3678 Pandemic All Hazards Preparedness Act (Biodefense) S.103 Combat Meth Act of 2005 H.R. 314 Combat Meth Act of 2005 S.950 Elimination of Neglected Diseases Act of 2005 H.R. 3057 Dept. of State, Foreign Operations, and Related Programs Appropriations Act, 2006 H.R. 2744 Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations Act, 2006 Federal Food, Drug and Cosmetic Act (Section 767) H.R. 5762 Contact Lens Consumer Protection Act H.R. 5337 National Security Foreign Investment Reform and Strengthened Transparency Act of 2006 Access to Life Saving Medicines Act Citizens Petition Access to Generics Public Health Service Act Drug Importation Medicare Part B and Part D Sickle Cell Anemia Immunosuppressant Legislation Cancer Therapies Legislation Gene Therapy Direct to Consumer Advertising Medicare Prescription Drugs and Modernization Act Follow-on Biologics Patent Law Reform Authorized Generics Drug Safety Legislation 1-800 Contacts DoD Authorization Language H.R. 2218 Regulation of non corrective contact lens as medical devises S. 930 Food and Drug Administration Safety Act of 2005 H.R. 2090 Food and Drug Administration Improvement Act of 2005 S. 470 FACT Act

Client expense: $1,860,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Agency for International Development (USAID)

S 470, S 930, S 3807 - prescription drugs safety; generic drugs; best buy drugs; contact lens prescription non-discrimination; prescription drugs affordability' S 2342, HR 752 - Medicare Part D; FDA drugs safety

Client expense: $269,784 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Education, Dept of, Federal Communications Commission (FCC), Federal Reserve System, Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Justice, Dept of (DOJ), Natl Highway Traffic Safety Administration (NHTSA), Natl Telecommunications & Information Administration (NTIA), Office of the Comptroller of the Currency (OCC), Patent & Trademark Office (PTO), SENATE

S 334, Pharmaceutical Market Access and Drug Safety Act of 2005. S 471, Stem Cell Research Enhancement Act of 2005. Biologics, generics, importation issues. FDA issues. Drug safety issues. Clinical trial issues. Conflict of interest, follow on biologics, steroid abuse, stem cells. PDUFA. HR 2090, Food and Drug Administration Improvement Act of 2005. S 2766, National Defense Authorization Act for Fiscal Year 2007; Drug pricing issues. HR 328, Pharmaceutical Market Access Act of 2005. HR 6143, Ryan White HIV/AIDS Treatment Modernization Act of 2006. S 3807, Bill to amend the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act to improve drug safety and oversight, and for other purposes. S 4016 & HR 6257, Bill to amend the Public Health Service Act to provide for the licensing of comparable biological products, and for other purposes HR 2565, Office of National Drug Control Reauthorization Act. HR 700, Pharmaceutical Market Access and Drug Safety Act of 2005. HR 810, Stem Cell Research Enhancement Act of 2005. S 109, Pharmaceutical Market Access Act of 2005.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

FDA, drug approval, generics biologics, importation, clinical trial, drug and safety, PDUFA, conflict of interest HR 2090, Food and Drug Administration Improvement Act of 2005 HR 6257, Access to Life-Saving Medicine Act S 3807, Enhancing Drug Safety and Innovation Act of 2006 S 4016, Access to Life-Saving Medicine Act H.R.700, Pharmaceutical Market Access and Drug Safety Act of 2005, Importation S.109/H.R.328, Pharmaceutical Market Access Act of 2005 S.334, Pharmaceutical Market and Drug Safety Act of 2005 S.930, Food and Drug Administration Safety Act of 2005

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

S 3807, Enhancing Drug Safety and Innovation Act of 2006 FDA Drug Safety Oversight Follow-On-Biologics HR 6257, Access to Life-Saving Medicine Act S 4016, Access to Life-Saving Medicine Act

Client expense: Not reported · Firm income: $300,000

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

Drug safety clinical trials importation issues; conflict of interest. PDUFA S 3802, To amend the Consolidated Omnibus Budget Reconciliation Act of 1985 to expand the county organized health insuring organizations authorized to enroll Medicaid beneficiaries. HR 700, Pharmaceutical Market Access and Drug Safety Act of 2005 S 3807, Enhancing Drug Safety and Innovation Act of 2006 S 328, Pharmaceutical Market Access Act of 2005. S 334, Pharmaceutical Market Access and Drug Safety Act of 2005. S 930, Food and Drug Administration Safety Act of 2005

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

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Securities & Exchange Commission (SEC)

Bioshield reauthorization. S 1873 - Biodefense and Pandemic Vaccine and Drug Development Act of 2005. S 1437 - Bioterror and Pandemic Preparedness Protection Act. HR 5533 - Biodefense and Pandemic Vaccine and Drug Development Act of 2006. S 3807, Enhancing Drug Safety and Innovation Act of 2006. HR 6257, Access to Life-Saving Medicine Act. S 4016, Access to Life-Saving Medicine Act. HR 6143, Ryan White HIV/AIDS Treatment Modernization Act of 2006 Drug Safety, Clinical Trials, drug importation. HR 700/S 334 - Pharmaceutical Market Access and Drug Safety Act of 2005. S 109/HR 328 - Pharmaceutical Market Access Act of 2005. S 930 - Food and Drug Administration Safety Act of 2005.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

H.R. 6257: Access to Life-Saving Medicine Act S. 4016: Access to Life-Saving Medicine Act S. 3807: Enhancing Drug Safety and Innovation Act of 2006 Implementation of H.R. 1 Medicare Prescription Drug & Modernization Act of 2003 Medicare and Medicaid Reimbursement Follow-On-Biologics FDA Drug Safety Oversight

Client expense: $5,620,000 · Firm income: Not reported

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

HR 2122, The Project BioShield Act of 2003, pharmaceutical research and development, security S 3807, Enhancing Drug Safety and Innovation Act of 2006, drug safety, DTC

Client expense: $7,720,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

Direct to Consumer Advertising issues. S.334-Pharmaceutical Market Access & Drug Safety Act of 2005 - re drug importation. S.3807-Enhancing Drug Safety & Innovation of 2006. H.R.5441-Homeland Security Appropriations Bill-re importation issues.

Client expense: $1,380,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

H.R. 1652 Access to Legal Pharmaceuticals Act H.R. 1808 Safe Online Drug Act of 2005 H.R. 1815 National Defense Authorization Act for Fiscal Year 2006 – Pharmacy Program H.R. 4769 Prescription Drug Abuse Elimination Act of 2006 H.R. 5122 John Warner National Defense Authorization Act for Fiscal Year 2007 – Pharmacy Program H.R. 5280 Dextromethorphan Distribution Act of 2006 H.R. 5384 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2007 – Prescription Drug Importation H.R. 5441 Department of Homeland Security Appropriations Act, 2007 – Prescription Drug Importation S. 334 Pharmaceutical Market Access and Drug Safety Act of 2005 S. 778 Pharmacy Consumer Protection Act of 2005 S. 809 Access to Legal Pharmaceuticals Act S. 2766 John Warner National Defense Authorization Act for Fiscal Year 2007 – Pharmacy Program S. 3807 Enhancing Drug Safety and Innovation Act of 2006 S. 3546 Dietary Supplement and Nonprescription Drug Consumer Protection Act Pharmacy Compounding Counterfeit Drugs Health Information Technology Implementation of the Combat Methamphetamine Epidemic Act of 2005 FDA Draft Compliance Policy Guide 160.900 on pedigree requirements under the Prescription Drug Marketing Act (PDMA) FDA Docket No. 2006N-0283 re: the proposed survey of physicians’ perceptions on the impact of early risk communication about medical products DEA Docket No. DEA-2911 re: retail sales of scheduled listed chemical products and self-certification of regulated sellers of scheduled listed chemical products CMS-1321-P re: proposed revisions to the payment policies under the physician fee schedule for calendar year 2007 DEA-287N re the issuing of multiple prescriptions for Schedule II Controlled Substances FDA Re: Draft Compliance Policy Guide 160.900 on pedigree requirements under the Prescription Drug Marketing Act Proposed revisions to the United States Pharmacopeia (USP) General Chapter <797> Pharmaceutical Compounding – Sterile Preparations. H.R. 1539 A bill to amend the Public Health Service Act with respect to the responsibilities of a pharmacy when a pharmacist employed by the pharmacy refuses to fill a valid prescription for a drug on the basis of religious beliefs or moral convictions, and for other purposes.

Client expense: $299,853 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Ryan White Reauthorization Act HR 575 - Say No to Drug Ads Act HR 810 - Stem Cell HR 870 - PhRMA Act of 2005 HR 1457 - Health Information Technology Act of 2005 HR 2090 - Food and Drug Administration Improvement Act of 2005 HR 3196, S 470 - Fair Access to Clinical Trails Act HR 3204 - Public Health Service Act HR 3696 - Medical Advertising Reform Act HR 4157, S 1418 - Health Information Technology S 1955 - Small Business Health Plans S 3546 - Dietary Supplement and Non-Prescription Drug Consumer Protection Act S 3807 - Enhancing Drug Safety and Innovation Act of 2006 S 3897 - Medicare Access & Data S 4098 - Pediatric Medical Device Safety and Improvement Act of 2006 FDA Regulation of Single-Use Device Re-Processing Hospital Group Purchasing Organizations Pediatric Medical Devices Pharmaceutical Reimportation

Client expense: $2,080,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA), White House Office

S 3807, Enhancing Drug Safety and Innovation Act of 2006 HR 6257, Access to Life-Saving Medicine Act Drug Approval Issues, Drug Safety Issues, FDA Issues Clinical Trials Conflict of Interest, Follow-on Biologics, PDUFA IV Issues relating to generics, biotechnology, and drug reimportation H.R.700/S334 Pharmaceutical Market Access and Drug and Safety Act of 2005/S334 H.R.328/S109 Pharmaceutical Market Access Act of 2005 S930 Food and Drug Administration Safety Act of 2005

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

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

NIH Reform Act (HR 6164), Enhancing Drug Safety and Innovation Act (S.3807), SAFE Drug Act (HR 5922), Food and Drug Administration Safety Act (S 930)

Client expense: $15,790 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Drug Safety: S. 3807, Enhancing Drug Safety and Innovation Act of 2006.

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

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

S. 3807 - Enhancing Drug Safety and Innovation Act of 2006 - provisions related to FDA advisory panels

Client expense: $700,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Biodefense and Pandemic: Hr. 5533, S. 1973 (prev. S. 2564), Biodefense and Pandemic Vaccine and Drug Development Act; HR. 3678, Pandemic and All-Hazards Preparedness Act. Tricare Retail Pharmacy, HR. 5122, S.2767: Department of Defense Authorization. Follow-On Biologics: HR. 6237, Access to Lifesaving Medicines Act. Drug Safety: S. 3807, Enhancing Drug Safety and Innovation Act of 2006. ***, no specific bill, Critical Path.

Client expense: Not reported · Firm income: $160,000

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

Drug Importation: HR. 5384, Agriculture and Related Agencies Appropriation; HR. 5441, FY 2007 Homeland Security Appropriations. Drug Safety: S. 3807, Enhancing Drug Safety and Innovation Act of 2006.

Client expense: Not reported · Firm income: $160,000

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

Tricare Retatil Pharmacy, HR. 5122, S. 2767: Department of Defense Authorizations. Drug Safety: S. 3807, Enhancing Drug Safety and Innovation Act of 2006.

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

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

Drug Safety: S. 3807, Enhancing Drug Safety and Innovation Act of 2006. ***, no specific bill, Transparency. S. 4098, Pediatric Medical Devices and Safety Improvement Act of 2006.

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

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE, Small Business Administration (SBA), White House Office

Tricare Retail Pharmacy, HR. 5122, S. 2767: Department of Defense Authorization. Drug Safety: S. 3807 Enhancing Drug Safety and Innovation Act of 2006.

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

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

Drug Importation: HR.5384, Agriculture and Related Agencies Appropriations; HR. 5441, FY 2007 Homeland Security Appropriations. Drug Safety: S. 3807 Enhancing Drug Safety and Innovation Act of 2006.

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

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

Drug Safety: S. 3807, Enhancing Drug Safety and Innovation Act of 2006.

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

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

Tricare Retail Pharmacy, HR. 5122, S. 2767: Department of Defense Authorizations. ***, no specific bill, Alzheimer's Care. Drug Safety: S. 3807, Enhancing Drug Safety and Innovation Act of 2006.

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

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

H.R.5906 : To establish a Consortium on the Impact of Technology in Aging Health Services. H.R.6071 : To amend the USA PATRIOT Act. H.R.6349 : To establish within the Department of Homeland Security an Office of Emergency Communications. H.R.6350 : To provide for the continuing operation of the Metropolitan Medical Response Program. H.R.6351 : To establish a voluntary framework through which commercial mobile service providers can elect to transmit emergency alerts to subscribers. S.3724 : A bill to enhance scientific research and competitiveness through the Experimental Program. S.3739 : A bill to establish a Consortium on the Impact of Technology in Aging Health Services. S.3807 : A bill to amend the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act. S.3902 : A bill to provide for education competitiveness. S.3936 : A bill to invest in innovation and education to improve the competitiveness of the United States in the global economy. S.4005 : A bill to establish the National Hurricane Research Initiative to improve hurricane preparedness, and for other purposes. S.4027 : A bill to amend the Internal Revenue Code of 1986. S.4032 : A bill to discourage international assistance to the nuclear program of Iran and transfers to Iran of advanced conventional weapons and missiles. S.4063 : A bill to provide for additional section 8 vouchers, to reauthorize the Public and Assisted Housing Drug Elimination Program, and for other purposes. See Addendum

Client expense: $2,669,687 · Firm income: Not reported

Government targets: Federal Reserve System, Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Office of the Comptroller of the Currency (OCC), SENATE, Treasury, Dept of

S. 3807 - Enhancing Drug Safety and Innovation Act of 2006 H.R. 1420 - Families for ED Advertising Decency Act H.R. 3696 - Medical Advertising Reform Act H.R. 3950 - Responsibility in Drug Advertising Act of 2005 H.R. 4429 - Food and Drug Administration Safety Act of 2005 Responded to GAO report on prescription drug advertising. Proposals to end, restrict, or limit the marketing of pharmaceutical products to consumers and physicians. S. 930 - Food and Drug Administration Safety Act of 2005 S. 1128 - Pharmaceutical Advertising and Prudent Purchasing Act

Client expense: $440,000 · Firm income: Not reported

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

National Institutes of Health Reform Act (H.R. 6164) Enhancing Drug Safety and Innovation Act (S. 3807)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Drug safety and importation issues, Clinical trials. Generics Biologics HR 328, Pharmaceuticals Market Access Act of 2005. HR 2090, Food and Drug Administration Improvement Act of 2005. S 2766, National Defense Authorization Act for Fiscal Year 2007; Drug pricing. S 3807, Enhancing Drug Safety and Innovation Act of 2006. HR 700, Pharmaceutical Market Access and Drug Safety Act of 2005. S 109, Pharmaceutical Market Access Act of 2005. S 334, Pharmaceutical Market Access and Drug Safety Act of 2005. S 930, Food and Drug Administration Safety Act of 2005.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE

S 3807, The Enhancing Drug Safety Act

Client expense: $554,400 · Firm income: Not reported

Government targets: Federal Communications Commission (FCC), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, Treasury, Dept of, U.S. Copyright Office, U.S. Postal Service (USPS)

HR 5115-U.S Healthcare Technologies Competitiveness Act of 2006 (Bill to modernize the tax treatment as related to medical devices and biomedical research corporations) HR 4388-Tax Revision Act of 2005 (Bills to amend the Internal Revenue Code of 1986 to extend certain expiring provisions) HR 4297-Tax Relief Extension Reconciliation Act of 2005 (Bill to extend credit for increasing research activities) HR 4845-Innovation and Competitiveness Act HR 1736/S 627-Investment in America Act of 2005 (Bills to make permanent the tax credit for increasing research activities) S 978-Healthcare Tax Relief for the Uninsured Act of 2005 HR 1872-Health Coverage for the Uninsured Act of 2005 (Bills to provide tax incentives for the purchase of quality health care, and for other purposes) HR 5-Help Efficient, Accessible, Low-Cost, Timely Healthcare (HEALTH) Act of 2005 (Bill to provide improved medical care by reducing the excessive burden the liability system places on the health care delivery system) HR 6406-The Tax Relief and Health Care Act of 2006 (Bill to improve temporarily certain rates of duty and make other technical amendments to the trade laws, and to extend certain trade preference programs) S Cong Res 67/H Cong Res 311-Concurrent resolution urging Japan to honor its commitments under the 1986 Market-Oriented Sector-Selective (MOSS) Agreement on Medical Equipment and for other purposes (Bill to reduce regulatory barriers to the approval and adoption of new medical technologies) S 2467-United States Trade Enhancement Act of 2006 (Congressional resolutions on trade enforcement efforts as relates to trade with China) S 295-To authorize appropriate action if the negotiations with the People’s Republic of China’s undervalued currency are not successful) (Bill to impose an additional duty of 27.5% on Chinese imports) HR 3004-Currency Harmonization Initiative through Neutralizing Action Act of 2005 (Bill to impose additional tariffs on Chinese imports on the basis of the rate of manipulation by that country of the rate of exchange between the Chinese currency and the U.S dollar) HR 3283/S 1421-United States Trade Rights Enforcement Act (Bills to enhance resources to enforce U.S trade rights) HR 4157-Health Information Technology Promotion Act of 2005 (Bill to provide for establishment of uniform confidentiality and security standards with respect to individually identifiable patient health information) S 1355-Better Healthcare Through Information Technology Act S 1418-Wired for Health Care Quality Act (Bills to enhance the adoption of health information technology and to improve the quality and reduce the cost of healthcare in the United States) S 1952-Critical Access to Health Information Technology Act of 2005 (Bill to provide for grants to states to increase access to health care in rural areas by improving health information technology) S 1223-Information Technology for Health Care Quality and Improvement Act (Bill to improve the quality and efficiency of health care delivery through improvements in health care information technology) S 1262-Health Technology to Enhance Quality Act of 2005 (Bill to reduce healthcare costs, improve efficiency and healthcare quality through the development of a nation-wide interoperable health information technology system) S 2480-Contact Lens Consumer Protection Act (Bill to amend the Fairness to Contact Lens Consumers Act with respect to the availability of contact lenses) HR 6111-Tax Relief and Health Care Act of 2006 (President Bush signed into Public Law # 109-432 on 12/20/2006) HR 5975-Prescription Drug Comparative Effectiveness Act of 2006 (Bill to require the Agency for Healthcare Research and Quality, in consultation with NIH Director, to conduct research to develop valid scientific evidence regarding clinical effectiveness, outcomes, and appropriateness as relates to medical devices and procedures and for other purposes) S 4098-Pediatric Medical Devices and Safety Improvement Act of 2006 (Bill to improve the process for development of needed pediatric medical devices) S 3778-Small Business Reauthorization and Improvements Act of 2006 HR 5352-Small Business Reauthorization Act of 2006 (Bills to reauthorize programs to assist small business concerns) S 1263-Save America’s Biotechnology Innovative Research Act of 2005 HR 2943-Save Biotechnology Innovative Research Act of 2005 (Bills to establish eligibility requirements for business concerns to receive awards under the Small Business Innovative Research program) S 3678-Pandemic and All Hazards Preparedness Act (Bill with respect to public health security and all-hazards preparedness and response, and for other purposes) HR2863-Division E – Public Readiness and Emergency Preparedness Act (Division E provisions of the bill as relates to targeted liability for pandemic and epidemic products and security countermeasures) S 2564/HR 5533-Biodefense and Pandemic Vaccine and Drug Development Act of 2006 S 1873-Biodefense and Pandemic Vaccine and Drug Development Act of 2005 (Bills to prepare and strengthen the development of countermeasures or pandemic or epidemic products against deliberate, accidental, and natural outbreaks of illness) S-1880-National Biodefense and Pandemic Preparedness Act of 2005 (Bill to enhance biodefense and pandemic preparedness activities) S 2792-Emergency Preparedness and Response Security, Accountability, and Flexibility Enhancement Act (SAFE Act) (Bill to revise provisions relating to bioterrorism and other public health emergencies preparedness grants including development of measurable critical benchmarks and performance standards) S 3-Protecting American in the War on Terror Act of 2005 (Bill sets provisions concerning bioterrorism preparedness and defense as pertaining to medical devices and for other purposes) S 975-The Project Bioshield II Act of 2005 (Bill to provide incentives to increase research by private sector entities to develop medial countermeasures to prevent, detect, identify, contain, and treat illnesses, including those associated with biological, chemical, nuclear, or radiological weapons attack or an infectious disease outbreak) S 22/S23-Malpractice Liability Reform Bill (a.k.a. Medical Care Access Protection Act of 2006, MCAP Act) (Bills setting forth provisions regulating lawsuits for health care liability claims related to the provision of health care services) HR 2090- Food and Drug Administration Improvement Act of 2005 (Bill related to FDA Advisory panels) S. 3807-Enhancing Drug Safety and Innovation Act of 2006 (Draft bill to improve oversight as related to drugs includes medical devices in some provisions)

Client expense: $1,404,102 · Firm income: Not reported

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

Drug importation, drug safety issues, clinical trials Conflict of Interest, PDUFA, Drug pricing S 2766, national Defense Authorization Act for Fiscal Year 2007; drug pricing. HR 2090, Food and Drug Administration Improvement Act of 2005 HR 328, Pharmaceutical Market Access Act of 2005. S 3807, Enhancing Drug Safety and Innovation Act of 2006 S 4016, Access to Life-Saving Medicine Act HR 6257, Access to Life-Saving Medicine Act HR 700, Pharmaceutical Market Access and Drug Safety Act of 2005, Importation. S 109, Pharmaceutical Market Access Act of 2005. S 334 Pharmaceutical Market Access and Drug Safety Act of 2005. S 930, Food and Drug Administration Safety Act of 2005.

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

Government targets: Centers For Disease Control & Prevention (CDC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of the Vice President of the United States, SENATE

43. H.R. 1539, a bill to amend the Public Health Service Act with respect to the responsibilities of a pharmacy when a pharmacist employed by the pharmacy refuses to fill a valid prescription for a drug 44. S. 338, the Bipartisan Commission on Medicaid Act of 2005 45. H.R. 985, the Bipartisan Commission on Medicaid Act of 2005 46. S. Con.Res.18, Budget FY2006 Appropriations resolution 47. H. Con.Res.95, 18, Budget FY2006 Appropriations resolution 48. S. 1262, the Health Technology to Enhance Quality Act of 2005 49. S.3678, the Pandemic and All-Hazards Preparedness Act 50. S.2564, the Biodefense and Pandemic Vaccine and Drug Development Act of 2006 51. H.R. 5533, the Biodefense and Pandemic Vaccine and Drug Development Act 52. H.R. 5262, Tax Free Savings Act of 2006 53. S. 3546, the Dietary Supplement and Nonprescription Drug Consumer Protection Act 54. H.R. 4157, the Health Information Technology Promotion Act of 2006 55. S. 2766, the National Defense Authorization Act for Fiscal Year 2007 56. H.R.5122, the National Defense Authorization Act for Fiscal Year 2007 57. S.2810, the Medicare Late Enrollment Assistance Act of 2006 58. H.R.5399, the Medicare Drug Benefit Enrollment Fairness Act of 2006 59. H.R. 5182, the Fair and Speedy Treatment (FAST) of Medicare Prescription Drug Claims Act of 2006 60. S. 2563, the Pharmacist Access and Recognition in Medicare (PhARM) Act of 2006 61. S. 2664, the Pharmacy Access Improvement (PhAIm) Act of 2006 62. H.R. 4769, the Prescription Drug Elimination Act of 2006 63. S. 2300, the Lower Prices With Increased Competition and Efficient Development of Drugs Act (the Lower Priced Drugs Act) 64. H.R. 5166 – The Independent Pharmacy Protection Act of 2006 65. S. 2181, the Medicare State Reimbursement Act 66. S. 2183, the Requiring Emergency Pharmaceutical Access for Individual Relief (REPAIR) Act 67. H.R. 4297, the Tax Relief Extension Reconciliation Act 68. H.R. 5384, the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2007 69. H.R.5441, the Department of Homeland Security Appropriations Act, 2007 70. S. 2020, Tax Relief Act of 2005 71. HR 5122 - FY2007 National Defense Authorization Act (joint project with the National Community Pharmacists Association for Coalition for Community Pharmacy Action) 72. HR 5182 - Fair and Speedy Treatment (FAST) of Medicare Prescription Drug Claims Act of 2006 (joint project with the National Community Pharmacists Association for Coalition for Community Pharmacy Action) 73. S. 2563 - Pharmacist Access and Recognition in Medicare (PHARM) Act of 2006 (joint project with the National Community Pharmacists Association for Coalition for Community Pharmacy Action) 74. S. 1932 - Deficit Reduction Act (joint project with the National Community Pharmacists Association for Coalition for Community Pharmacy Action) 1. H.R. 4241, the Deficit Reduction Act of 2005 2. S. 1932, the Senate Deficit Reduction Act of 2005 3. H.R. 6111, the Tax Relief and Health Care Act of 2006 4. H.R. 5280, the Dextromethorphan Distribution Act of 2006 5. S.3807. the Enhancing Drug Safety and Innovation Act of 2006 6. H.R. 6257, the Access to Life-Saving Medicine Act 7. H.R. 5970, the Estate Tax and Extension of Tax Relief Act of 2006 8. S. 1716, Emergency Health Care Relief Act of 2005 9. H.R. 4297, the Tax Relief Extension Reconciliation Act 10. H.R. 3010, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2006 11. S. 544, the Patient Safety and Quality Improvement Act of 2005 12. H.R. 3205, the Patient Safety and Quality Improvement Act of 2005 13. H.R. 1132, the National All Schedules Prescription Electronic Reporting Act of 2005 14. S. 518, the National All Schedules Prescription Electronic Reporting Act of 2005 15. S. 1392, the Federal Trade Commission Reauthorization Act of 2005 16. S. 334, the Pharmaceutical Market Access and Drug Safety Act 17. H.R. 700, the Pharmaceutical Market Access and Drug Safety Act of 2005 18. S. 309, the Pharmaceutical Market Access Act 19. H.R. 328, the Pharmaceutical Market Access Act 20. H.R. 3010, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2006 21. H.R. 1808, the Safe Online Drug Act of 2005 22. S. 399, the Ryan Haight Internet Pharmacy Consumer Protection Act of 2005 23. H.R. 840, the Ryan Haight Internet Pharmacy Consumer Protection Act of 2005 24. S. 14, the Fair Wage, Competition, and Investment Act of 2005 25. S. 534, the Health Efficient, Accessible, Low-Cost, Timely Healthcare Act of 2005 26. H.R. 5, the Health Efficient, Accessible, Low-Cost, Timely Healthcare Act of 2005 27. H.R. 1669, the Pharmacy Benefit Manager Transparency Act of 2005 28. H.R. 1671, the Community Pharmacy Fairness Act of 2005 29. S. 103, the Combat Meth Act of 2005 30. H.R. 314, the Combat Meth Act of 2005 31. S. 102, the Exile Meth Act 32. H.R. 313, the Exile Meth Act 33. H.R. 3889, Meth Epidemic Elimination Act 34. H.R. 1378, the Ephedrine Alkaloids Regulation Act of 2005 35. H.R. 2829, the Office of National Drug Control Policy Reauthorization Act of 2005 36. H.R. 3617, the Medicare Value-Based Purchasing for Physicians' Services Act of 2005 37. S. 1356, the Medicare Value Purchasing Act of 2005 38. S. 1408, the Identity Theft Protection Act 39. S. 1332, the Personal Data Privacy and Security Act of 2005 40. S. 930, the Food and Drug Administration Safety Act of 2005 41. H.R. 1652, the Access to Legal Pharmaceuticals Act 42. S. 809, the Access to Legal Pharmaceuticals Act See addendum

Client expense: $300,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Consumer Product Safety Commission (CPSC), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Office of Personnel Management (OPM), SENATE, White House Office

HR. 5009, Ryan White CARE Act Amendments of 2006 Issues relating to pharmaceutical compounding Issues relating to Medicare Part D Issues relating to CFC Supply and essentiality S. 3807, Enhancing Drug Safety and Innovation Act of 2006 S. 4016 and HR. 6257, Access to Life Saving Medicine Act S. 3695, relating to the prohibition of authorized generic drugs HR. 328, Pharmaceutical Market Access Act of 2005 S. 109, Pharmaceutical Market Access Act of 2005 HR. 6143, The Ryan White HIV/AIDS Treatment Modernization Act S. 2339, Ryan White CARE Act Amendments of 2006

Client expense: $713,336 · Firm income: Not reported

Government targets: Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, State, Dept of (DOS)