Ryan Haight Online Pharmacy Consumer Protection Act of 2008

Issues related to pharmaceutical supply chain and distribution, including the following: (1) federal pedigree legislation including HR 5839, Safeguarding America's Pharmaceuticals Act of 2008 and possible amendment to HR 3610, Food and Drug Safety Import Act; and (2) Internet pharmacy issues including related provisions in S. 980 and HR 6353, Ryan Haight Online Pharmacy Consumer Protection Act. Healthcare associated infections/MRSA.

Client expense: Not reported · Firm income: $70,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues pertaining to health information technology, generic drugs, comparative effectiveness, internet pharmacy, and changes to federal privacy laws. HR 6353, Ryan Haight Online Pharmacy Consumer Protection Act of 2008 S 980, Online Pharmacy Consumer Protection Act of 2007 S 1814, Health Information Privacy and Security Act, HR 5442, Technologies for Restoring Users Security & Trust Act of 2008 HR 6898, Health-e Information Technology Act of 2008 HR 6357, The PRO(TECH)T Act S 1693, Health Information Privacy and Security Act HR 5442, Technologies for Restoring Users Security and Trust in Health Information Act of 2008 HR1038, To amend the Public Health Service Act to provide for the licensing of comparable and interchangeable biological products, and for other purposes. S 623, A bill to amend the Public Health Service Act to provide for the licensing of comparable and interchangeable biological products, and for other purposes. HR 5629, Pathway for Biosimilars Act S 3408, Comparative Effectiveness Research Act of 2008

Client expense: $1,870,000 · 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

H.R. 5839, Safeguarding America's Pharmaceuticals Act S. 242, Pharmaceutical Market Access and Drug Safety Act of 2007 H.R. 380, Pharmaceutical Market Access and Drug Safety Act of 2007 S. 596, Safe Internet Pharmacy Act of 2007 S. 251, Pharmaceutical Market Access Act of 2007 S. 207, Combat Methamphetamine Enhancement Act of 2007 H.R. 971, Community Pharmacy Fairness Act of 2007 S. 885, Community Pharmacy Fairness Act of 2007 H.R. 3140, Saving Our Community Pharmacies Act of 2007 H.R. 3193, Access to Community Pharmacy Preservation Act of 2007 H.R. 780, Counterfeit Drug Prevention Act of 2007 S. 2085, Patient and Pharmacy Protection Act of 2007 H.R. 6353, Online Pharmacy Consumer Act S. 1954, Pharmacy Access Improvement Act of 2007 H.R. 5629, Pathway for Biosimilars Act H.R. 3610, Food and Drug Import Safety Act of 2007 H.R. 5619, Combat Methamphetamine Enhancement Act of 2008

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

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

General issues involving interchange fees, including: H.R. 5546 (the Credit Card Fair Fee Act), S. 3086 (the Credit Card Fair Fee Act), H.R. 6248 (the Credit Card Interchange Fees Act of 2008), and H.R. 6620 (the Gas Pump Fair Payment Act), S. 3629 (the Consumer Credit Safety Commission Act) and H.R. 7258 (companion legislation to S. 3629); Issues relating to payment card issuer practices, including: provisions in S. 1395 (the Stop Unfair Practices in Credit Cards Act), H.R. 873 (the Credit Card Payment Fee Act), H.R. 2911 (the Electronic Funds Transfer Equal Consumer Protection Act), H.R. 2146 (the Universal Default Prohibition Act), H.R. 946 (the Consumer Overdraft Protection Fair Practices Act), H.R. 5244 (the Credit Cardholders Bill of Rights Act), S. 2753 (the Credit Card Reform Act), S. 2411 (the Credit Card Safety Star Act), and S. 3252 (the Credit Card Accountability Responsibility and Disclosure Act); Issues pertaining to data security, customer notification of security breaches, and mitigation of harm resulting from security breaches, including: provisions in S. 1178 (the Identity Theft Prevention Act), S. 239 (the Notification of Risk to Personal Data Act), S. 495 (the Personal Data Privacy and Security Act), H.R. 958 (the Data Accountability and Trust Act), and H.R. 3046 (the Social Security Number Privacy and Identity Theft Prevention Act); Issues related to the use of payment cards in connection with the purchase of prescription medications over the Internet, including: provisions in S. 980 (the Ryan Haight Online Pharmacy Consumer Protection Act), H.R. 6353 (companion legislation to S. 980), and S. 1082 (the Food and Drug Administration Revitalization Act); Issues relating to the use of payment systems in connection with transactions infringing on intellectual property rights, including: S. 3325 (the Prioritizing Resources and Organization for Intellectual Property Act) and H.R. 4279 (companion legislation to S. 3325); Issues related to retail theft, including: H.R. 6491 (the Organized Retail Crime Act), and S. 3434 (companion legislation to H.R. 6491).

Client expense: $510,000 · Firm income: Not reported

Government targets: Federal Reserve System, HOUSE OF REPRESENTATIVES, SENATE, Treasury, Dept of

Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (H.R. 6353) Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (S.980) Military Pain Care Policy Act of 2008 (H.R. 5465) National Pain Care Policy Act of 2007 (H.R. 2994) Physician Payments Sunshine Act of 2007 (S.2029) Safeguarding American's Pharmaceuticals Act (H.R. 5839) Veterans Pain Care Act (S. 2160) Hearings related to prescription drug abuse and prevention

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

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

Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (H.R. 6353) Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (S.980) Military Pain Care Policy Act of 2008 (H.R. 5465) National Pain Care Policy Act of 2007 (H.R. 2994) Physician Payments Sunshine Act of 2007 (S.2029) Safeguarding American's Pharmaceuticals Act (H.R. 5839) Veterans Pain Care Act (S. 2160) Hearings related to prescription drug abuse and prevention

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

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

S.1951/H.R. 3700 Fair Medicaid Drug Payment Act of 2007 regarding Medicaid reimbursement for generic drugs as related to average manufacturers price (AMP) and federal upper limits (FULs); H.R. 3140 Saving Our Community Pharmacies Act of 2007 regarding Medicaid reimbursement of generic drugs as related to AMP and FULs; S. 334 Healthy Americans Act regarding the role of pharmacy in healthcare and Title VI regarding shared responsibilities; S.980/H.R. 6353 Online Pharmacy Consumer Protection Act of 2007 regarding amendments to the Control Substances Act relating to the delivery of control substances over the internet; S.3101/H.R. 6331 Medicare Improvements for Patients and Providers Act of 2008 Sec. 132 regarding incentives for electronic prescribing, Sec. 171 regarding prompt pay by PDPs and MA-PDs for prescriptions dispensed in Medicare Part D, Sec. 203 regarding reimbursement for generic drugs dispensed in the Medicaid program; S. 2408 "E-Meds Act of 2007 regarding amendments to the Social Security Act requiring physicians to utilize electronic prescribing for Medicare prescriptions; H.R. 2900 Food and Drug Amendments Act of 2007 Sec. 910 regarding pharmaceutical safety; H.R. 5839 Safeguarding Americas Pharmaceuticals Act of 2008 regarding amending the Food, Drug & Cosmetics Act to improve the safety of drugs; Electronic Prescribing of Controlled Substances regarding the need for the DEA to publish rules that would allow for electronic prescribing of controlled substances no specific legislation; S. 3001/ H.R. 5658 National Defense Authorization Act for Fiscal Year 2009 Sec. 702 regarding a freeze on current copays at retail pharmacies for medications dispensed in the TRICARE pharmacy program; MedGuides regarding improvements needed to the Medication Guide program no specific legislation; S. 1693 Wired for Healthcare Quality Act of 2007- Title IV Sec 401 Privacy and Security regarding changes in the definition of marketing under HIPAA and breach notification; H.R. 6357 PRO(TECH)T Act of 2008 - Title III regarding impact of privacy and security provisions on pharnacies, H.R. 6898 Health-e Information Technology Act of 2008 - Title IV regarding impact of privacy and security provisions on pharmacies.

Client expense: $470,000 · Firm income: Not reported

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

Legislative and regulatory issues affecting pharmacies and retailers, including health care funding, health care programs, and the delivery of prescription drugs. H.R. 971, The Community Pharmacy Fairness Act. H.R. 3700 and S. 1951, The Fair Medicaid Drug Payment Act of 2007. H.R. 3580, Food and Drug Administration Amendments Act of 2007. H.R. 1585, Fiscal 2008 Defense Authorization - TRICARE provisions. S. 980, Ryan Haight Internet Controlled Substances Act. S. 1693, Wired for Health Care Act. H.R. 5539, the Safeguarding America's Pharmaceuticals Act of 2008. H.R. 6353, Ryan Haight Online Pharmacy Consumer Protection Act of 2008. H.R. 6331, the Medicare Patients and Providers Protection Act of 2008. H.R. 6357, Protecting Records, Optimizing Treatment, and Easing Communication through Healthcare Technology Act of 2008. H.R. 6898, Health-e Information Technology Act of 2008.

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

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

S. 242/H.R. 380- Pharmaceutical Market Access and Drug Safety Act of 2007- entire bill. S. 586/H.R. 1968- Community Health Workers Act of 2007- entire bill. S. 980/H.R. 6353- Online Pharmacy Consumer Protection Act of 2007- entire bill. S. 1240/H.R. 464- Compassionate Assistance for Rape Emergencies Act of 2007- entire bill. S. 1375- Mom's Opportunity to Access Health, Education, Research, and Support for Postpartum Depression Act/MOTHERS Act- entire bill. S. 1376/H.R. 2606- 340B Program Improvement and Integrity Act of 2007- entire bill. S. 2347/H.R. 4054- Prevention Through Affordable Access Act- entire bill. S. 1555/H.R. 2596- Access to Birth Control Act- entire bill. S.1800/H.R. 2064- Compassionate Care for Servicewomen Act- entire bill. S. 2731/ H.R. 5501- The Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008- provisions related to family planning, sex education, abstinence, and abortion. H.R. 20- Melanie Blocker-Stokes Postpartum Depression Research and Care Act- entire bill. H.R. 1424- Paul Wellstone Mental Health and Addiction Equity Act of 2007- potential provision related to abortion and possible provision related to nominal drug pricing. H.R. 3014- The Health Equity and Accountability Act of 2007- entire bill. H.Res. 1131- Recognizing that the Centers for Disease Control and Prevention observes the month of April as National STD Awareness Month and urging the House of Representatives to focus greater attention on activities related to the prevention of STDs and screening and treatment for STDs- entire resolution. H.R. 6357- Protecting Records, Optimizing Treatment, and Easing Communication Through Health Care Technology Act- provisions on health care technology transition. H.R. 6100/S. 3040- Kid-Safe Chemicals Act of 2008- entire bill. H.R. 6906- H.I.V. Education and Prevention Act of 2008- entire bill. H.R. 6680- Community AIDS and Hepatitis Prevention Act- entire bill. H.R. 6358- Stop Abuse in Residential Treatment Programs Act of 2008- provision related to contraceptive access. H.R. 1237/S. 2510- Cytology Proficiency Improvement Act of 2008- entire bill. S. 20/ H.R. 7310- Protecting Patients and Health Care Act- entire bill. H.R. 7296- Midnight Rule Act- provision relating to the Department of Health and Human Services physician conscience regulation. S. 3297- Advancing Americas Priorities Act- provision related to nominal drug pricing. H.Con.Res. 400- Expressing the support of the Congress regarding the need to ensure health care for women and health care for all in national health care reform- entire resolution.

Client expense: $121,667 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.980 and HR 6353, Ryan Haight Online Pharmacy Consumer Protection Act of 2008.

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

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

H.R. 6353 - Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (Public Law 110-425) H.R. 5839 - Safeguarding Americas Pharmaceuticals Act of 2008 H. Res. 1437 - Designates October as American Pharmacists Month H.R. 971 - Community Pharmacy Fairness Act H.R. 6357 - Protecting Records, Optimizing Treatment, and Easing Communication through Healthcare Technology (PRO(TECH)T) Act of 2008 (Docket Number: FDA-2008-N-0162) Agency Information Collection Activities; Submission for Office of management and Budget Review; Comment Request; Prescription Drug Product Labeling: Medication Guide Requirements (Docket Number: CMS0009P) HHS Proposed Rule on Health Insurance Reform; Modifications to the Health Insurance Portability and Accountability Act (HIPAA) Electronic Transaction Standards (Docket Number: CMS-0013-P) HHS Proposed Rule HIPAA Administrative Simplification: Modification to Medical Data Code Set Standards To Adopt ICD-10-CM and ICD-10-PCS (Docket Number: DEA-2008-0009) DEA Proposed Rule for Electronic Prescriptions for Controlled Substances (Docket Number: FDA-2008-N-0466) FDA Over the Counter Cough and Cold Medications for Pediatric Use; Notice of Public Hearing (Docket Number: FDA-2008-N-0038) FDA Joint Meeting of the Antiviral Drugs Advisory Committee and the Nonprescription Drugs Advisory Committee; Notice of Meeting (Docket Number: FDA-2008-N-0038) FDA Joint Meeting of the Anesthetic and Life Support Drug Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting (Docket Number: FDA2008D0417) Draft Guidance for the Public and the Food and Drug Administration Staff on Convening Advisory Committee Meetings (Docket No. FDA2003N0313 (formerly Docket No. 2003N0342)) FDA Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products (Docket Number: FDA-2008-P-0380) Citizen Petition: Requesting FDA Action on a "One Document Solution" for all Pharmacy-Based Communications (Docket Number: FDA2008N0612) Sentinel Initiative: Structure, Function, and Scope; Public Workshop; Request for Comments (Public Law 110-85) Food and Drug Administration Amendments Act of 2007 Section on Adverse Event Reporting Requirement Concept (No Bill Language): Role of Pharmacist-Provided Patient Care Services in Health Care Reform Concept (No Bill Language): U.S. Office of Inspector General (OIG) Exclusions List of Certain Health Care Providers who Have Engaged in Fraudulent or Abusive Behavior from Participating in Federally Funded Health Care Programs

Client expense: $220,970 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE

General issues involving interchange fees, including H.R. 5546 (the Credit Card Fair Fee Act), S. 3086 (the Credit Card Fair Fee Act), H.R. 6248 (the Credit Card Interchange Fees Act of 2008), and H.R. 6620 (the Gas Pump Fair Payment Act), S. 3629 (the Consumer Credit Safety Commission Act) and H.R. 7258 (companion legislation to S. 3629); issues relating to payment card issuer practices, including provisions in S. 1395 (the Stop Unfair Practices in Credit Cards Act), H.R. 873 (the Credit Card Payment Fee Act), H.R. 2911 (the Electronic Funds Transfer Equal Consumer Protection Act), H.R. 2146 (the Universal Default Prohibition Act), H.R. 946 (the Consumer Overdraft Protection Fair Practices Act), H.R. 5244 (the Credit Cardholders Bill of Rights Act), S. 2753 (the Credit Card Reform Act), S. 2411 (the Credit Card Safety Star Act), and S. 3252 (the Credit Card Accountability Responsibility and Disclosure Act); issues pertaining to data security, customer notification of security breaches, and mitigation of harm resulting from security breaches, including provisions in S. 1178 (the Identity Theft Prevention Act), S. 239 (the Notification of Risk to Personal Data Act), S. 495 (the Personal Data Privacy and Security Act), H.R. 958 (the Data Accountability and Trust Act), and H.R. 3046 (the Social Security Number Privacy and Identity Theft Prevention Act); issues involving the use of payment cards in connection with Internet gambling, including H.R. 5767 (the Payment Systems Protection Act) and H.R. 6870 (the Payments System Protection Act); issues related to the use of payment cards in connection with the purchase of prescription medications over the Internet, including provisions in S. 980 (the Ryan Haight Online Pharmacy Consumer Protection Act), H.R. 6353 (companion legislation to S. 980), and S. 1082 (the Food and Drug Administration Revitalization Act); issues relating to the use of payment systems in connection with transactions infringing on intellectual property rights, including S. 3325 (the Prioritizing Resources and Organization for Intellectual Property Act) and H.R. 4279 (companion legislation to S. 3325); and issues related to retail theft, including H.R. 6491 (the Organized Retail Crime Act), and S. 3434 (companion legislation to H.R. 6491).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 1038/HR 1956/HR5629--creation of a regulatory pathway for generic biologics S 1088/S 28/S 316/HR 1902--issues related to bringing generics to market in a timely fashion S. 596/S 980/HR 6353--internet pharmacy regulations HR 5839--issues relating to prescription drug pedigree/drug safety

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Legal Services Corporation, Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), SENATE

See Addendum HR 971 and S 885 / S 2161- Community Pharmacy Fairness Act of 2007 HR 6353 and S. 980 - Ryan Haight Online Pharmacy Consumer Protection Act of 2007 HR 1474 - Fair and Speedy Treatment (FAST) of Medicare Prescription Drug Claims Act of 2007 HR 3140 - Saving Our Community Pharmacies Act of 2007 HR 3090 - Patient and Pharmacy Protection Act of 2007 HR 3193 Access to Community Pharmacy Preservation Act of 2007 S 596 - Safe Internet Pharmacy Act of 2007 S 1954 - Pharmacy Access Improvement (PhAIm) Act of 2007 S 2161 - Community Pharmacy Fairness Act of 2007 S 877 - Controlling the Abuse of Prescription Act of 2007

Client expense: $314,868 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Drug Enforcement Administration (DEA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), SENATE, White House Office

S.980: Online Pharmacy Consumer Protection Act of 2007 - Track and monitor. S.596: Safe Internet Pharmacy Act of 2007 - Track and monitor. S.554: Act For Our Kids - Track and monitor. HR 380: Pharmaceutical Market Access and Drug Safety Act of 2007 - Track and monitor. S. 242: Pharmaceutical Market Access and Drug Safety Act of 2007 - Track and monitor. H.R. 6353: Ryan Haight Online Pharmacy Consumer Protection Act of 2008 - Track and monitor.

Client expense: Not reported · Firm income: $7,500

Government targets: HOUSE OF REPRESENTATIVES, SENATE

**see addendum page Importation of prescription drugs (H.R. 3161) (S. 1644) (S. 3409) Rx Pedigree (H.R. 5839) Methamphetamine/Pseudoephedrine Regulatioin (S. 2071) Internet Pharmacy (S. 980) (H.R. 6353)

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

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

Issue - Third Party Liability: S. 980/H.R. 6353, Ryan Haight Online Pharmacy Consumer Protection Act of 2008; General issues related to competition law and consolidation in the online advertising industry; Issue - Organized Retail Crime: H.R. 6491, Organized Rtail Crime Act of 2008; H.R. 6713, E-Fencing Enforcement Act of 2008; S. 3434, Combatting Organized Retail Crime Act of 2008; Issue - Retail Price Maintenance: S. 2261, Discount Pricing Consumer Protection Act

Client expense: $382,500 · Firm income: Not reported

Government targets: Consumer Product Safety Commission (CPSC), Federal Communications Commission (FCC), Financial Crimes Enforcement Network (FinCEN), HOUSE OF REPRESENTATIVES, SENATE, Treasury, Dept of, U.S. Trade Representative (USTR)

Importation of prescription drugs (H.R. 3161) (S. 1644) (S. 3409) Rx Pedigree (H.R. 5839) Methamphetamine/Pseudoephedrine Regulation (S. 2071) Internet Pharmacy (S. 980) (H.R. 6353)

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

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

H.R. 6353 - Ryan Haight Online Pharmacy Consumer Protection Act of 2008

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.970, the Dextromethorphan Distribution Act, as related to the abuse of dextromethorphan. H.R.971, the Community Pharmacy Fairness Act, as related to provider negotiations in the Medicare program. H.R.1424, the Emergency Economic Stabilization Act of 2008, as related to fiscal sustainablity of healthcare services. H.R.1474, the Fair and Speedy Treatment (FAST) of Medicare Prescription Drug Claims Act, as related to provider reimbursement in the Medicare program. H.R.3700, the Fair Medicaid Drug Payment Act, as related to pharmacy reimbursement in the Medicaid program. H.R.5613, Protecting the Medicaid Safety Net Act of 2008, as related to provider participation in the Medicaid program. H.R.5839, Safeguarding America's Pharmaceuticals Act of 2008, as related to drug safety and electronic tracking of pharmaceuticals. H.R.6353/S.980, Ryan Haight Online Pharmacy Consumer Protection Act of 2008, as related to online pharmacies. H.R.6357, PRO(TECH)T Act of 2008, as related to pharmacy involvement in health information technology. H.R. 6898, the Health-e Information Technology Act of 2008 as related to pharmacy involvement in health information technology H.R. 7110, the Job Creation and Unemployment Relief Act of 2008, as related to increased funding for state Medicaid programs. S.484, the Enhancing Drug Safety and Innovation Act, all provisions related to the safety of prescription medicines. S. 1276, the Methamphetamine Production Prevention Act as related to recordkeeping requirements for pharmacies. S.1693, Wired for Health Care Quality Act, as related to health information technology. S.1827, Pharmacists Access and Recognition in Medicare (PhARM) Act, as related to provider participation in the Medicare program. S.1915, Electronic Prescribing Drug Act, as related to the regulation of electronic prescribing of pharmaceuticals. S.1951, the Fair Medicaid Drug Payment Act, as related to pharmacy reimbursement in the Medicaid program. S.1954, Pharmacy Access Improvement (PhAIm) Act, as related to access standards to pharmacies. S.2013/H.R.390, Patient and Pharmacy Protection Act, as related to prescription requirements in the Medicaid program. S.2071, Combat Methamphetamine Enhancement Act, as related to the distribution of legal substances used in the production of methamphetamine. S.2274, Dextromethorphan Abuse Reduction Act, as related to the abuse of dextromethorphan. S.2408/H.R.4296, Medicare Electronic Medication and Safety Protection (E-MEDS) Act of 2007, as related to electronic health care in the Medicare program. S.3101/H.R.6331, Medicare Improvements for Patients and Providers Act of 2008, as related to pharmacy reimbursement in the Medicaid and Medicare programs and electronic health care. Various issues related to the disposal of prescription drugs and drug Take Back programs, no specific legislation

Client expense: $320,000 · 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), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Natl Drug Control Policy (NDCP), SENATE, White House Office

S. 242, Pharmaceutical Market Access and Drug Safety Act of 2007 H.R. 380, Pharmaceutical Market Access and Drug Safety Act of 2007 S. 251, Pharmaceutical Market Access Act of 2007 S. 596, Safe Internet Pharmacy Act of 2007 H.R. 5839, Safeguarding America's Pharmaceuticals Act S. 207, Combat Methamphetamine Enhancement Act of 2007 H.R. 971, Community Pharmacy Fairness Act of 2007 S. 885, Community Pharmacy Fairness Act of 2007 H.R. 3140, Saving Our Community Pharmacies Act of 2007 H.R. 3193, Access to Community Pharmacy Preservation Act of 2007 H.R. 780, Counterfeit Drug Prevention Act of 2007 S. 2085, Patient and Pharmacy Protection Act of 2007 H.R. 6353, Online Pharmacy Consumer Act S. 1954, Pharmacy Access Improvement Act of 2007 H.R. 5629, Pathway for Biosimilars Act H.R. 3610, Food and Drug Import Safety Act of 2007 H.R. 5619, Combat Methamphetamine Enhancement Act of 2008

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

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

Ryan Haight Online Pharmacy Consumer Protection Act of 2008, H.R.6353

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 6353 - Ryan Haight Online Pharmacy Consumer Protecction Act of 2008

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Monitor legislation concerning fraudulent online identity sanctions and Internet governance. S. 980 and HR 6353.

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

Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, SENATE

HR 719, KIDS Act of 2007; HR 3845, PROTECT Our Children Act of 2007; HR 3461, Safeguarding America's Families by Enhancing and Reorganizing New and Efficient Technologies Act of 2007; HR 3791, SAFE Act of 2007; HR 2517, Protecting Our Children Comes First Act of 2007; HR4120, Effective Child Pornography Prosecution Act of 2007; HR 4134, To direct the Attorney General to provide grants for Internet crime prevention education programs; HR 4136, Enhancing the Effective Prosecution of Child Pornography Act of 2007; S. 1965, Protecting Children in the 21st Century Act; S. 431, KIDS Act of 2008; S. 1738, PROTECT Our Children Act of 2008 - Child Safety Bills related to funding for DOJ and Internet Crimes Against Children task forces, online child safety education, reporting requirements to the National Center for Missing and Exploited Children, and Liability provisions related to reporting child pornography and interacting with government sexual predator registries. S. 1625, Counter Spy Act, provisions related to downloadable applications and Good Samaraitan provisions. HR 6353 and S. 980, Ryan Haight Online Pharmacy Consumer Protection Act of 2008. Organized Retail Crime (ORC) Bill. Online Advertising - potential legislation and hearings related to the online advertising business model.

Client expense: $570,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Federal Communications Commission (FCC), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Justice, Dept of (DOJ), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Copyright Office, U.S. Trade Representative (USTR)

S.980, Ryan Haight Online Pharmacy Consumer Protection Act. H.R. 6353, Ryan Haight Online Pharmacy Consumer Protection Act of 2008. Internet tobacco sales and pharmacy sales, and online piracy legislation in general.

Client expense: Not reported · Firm income: $70,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.980, Ryan Haight Online Pharmacy Consumer Protection Act. H.R. 6353, Ryan Haight Online Pharmacy Consumer Protection Act of 2008. Internet tobacco sales and pharmacy sales, and online piracy legislation in general.

Client expense: Not reported · Firm income: $70,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.5839, Safeguarding America's Pharmaceuticals Act S. 242, Pharmaceutical Market Access and Drug Safety Act of 2007 H.R. 380, Pharmaceutical Market Access and Drug Safety Act of 2007 S. 251, Pharmaceutical Market Access Act of 2007 S. 596, Safe Internet Pharmacy Act of 2007 S. 207, Combat Methamphetamine Enhancement Act of 2007 H.R. 971, Community Pharmacy Fairness Act of 2007 S. 885, Community Pharmacy Fairness Act of 2007 H.R. 3140, Saving Our Community Pharmacies Act of 2007 H.R. 3193, Access to Community Pharmacy Preservation Act of 2007 H.R. 780, Counterfeit Drug Prevention Act of 2007 S. 2085, Patient and Pharmacy Protection Act of 2007 H.R. 6353, Online Pharmacy Consumer Act S. 1954, Pharmacy Access Improvement Act of 2007 H.R. 5629, Pathway for Biosimilars Act H.R. 3610, Food and Drug Import Safety Act of 2007 H.R. 5619, Combat Methamphetamine Enhancement Act of 2008

Client expense: $205,000 · Firm income: Not reported

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

Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (H.R. 6353) Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (S.980) Military Pain Care Policy Act of 2008 (H.R. 5465) National Pain Care Policy Act of 2007 (H.R. 2994) Physician Payments Sunshine Act of 2007 (S.2029) Safeguarding American's Pharmaceuticals Act (H.R. 5839) Veterans Pain Care Act (S. 2160) Hearings related to prescription drug abuse and prevention

Client expense: $155,000 · Firm income: Not reported

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

Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (H.R. 6353) Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (S.980) Military Pain Care Policy Act of 2008 (H.R. 5465) National Pain Care Policy Act of 2007 (H.R. 2994) Physician Payments Sunshine Act of 2007 (S.2029) Safeguarding American's Pharmaceuticals Act (H.R. 5839) Veterans Pain Care Act (S. 2160) Hearings related to prescription drug abuse and prevention

Client expense: $155,000 · Firm income: Not reported

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

Issue - Third Party Liability: S. 980/H.R. 6353, Ryan Haight Online Pharmacy Consumer Protection Act of 2008; General issues related to competition law and consolidation in the online advertising industry; Issue - Organized Retail Crime: H.R. 6491, Organized Rtail Crime Act of 2008; H.R. 6713, E-Fencing Anforcement Act of 2008; S. 3434, Combatting Organized Retail Crime Act of 2008; Issue - Retail Price Maintenance: S. 2261, Discount Pricing Consumer Protection Act

Client expense: $494,500 · Firm income: Not reported

Government targets: Federal Trade Commission (FTC), Financial Crimes Enforcement Network (FinCEN), HOUSE OF REPRESENTATIVES, SENATE, Treasury, Dept of, U.S. Trade Representative (USTR)

See Addendum HR 971 and S 885 / S 2161- Community Pharmacy Fairness Act of 2007 HR 6353 and S. 980 - Ryan Haight Online Pharmacy Consumer Protection Act of 2007 HR 1474 - Fair and Speedy Treatment (FAST) of Medicare Prescription Drug Claims Act of 2007 HR 3140 - Saving Our Community Pharmacies Act of 2007 HR 3090 - Patient and Pharmacy Protection Act of 2007 HR 3193 Access to Community Pharmacy Preservation Act of 2007 S 596 - Safe Internet Pharmacy Act of 2007 S 1954 - Pharmacy Access Improvement (PhAIm) Act of 2007 S 2161 - Community Pharmacy Fairness Act of 2007 S 877 - Controlling the Abuse of Prescription Act of 2007

Client expense: $324,944 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Drug Enforcement Administration (DEA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), SENATE, White House Office

H.R. 380, Pharmaceutical Market Access and Drug Safety Act of 2007: importation H.R. 1014, Heart Disease Education, Analysis Research, and Treatment for Women Act: reporting and analysis of patient data H.R. 1038, Access to Life-Saving Medicine Act: follow-on biologics H.R. 1956, Patient Protection and Innovative Biologic Medicines Act of 2007: follow-on biologics H.R. 3610, Food and Drug Import Safety Act of 2007: import safety H.R. 5501, Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008: public health H.R. 5629, Pathway for Biosimilars Act: follow-on biologics H.R. 5683, The Government Accountability Office Act: disclosure of data H.R. 5839, Safeguarding America's Pharmaceuticals Act of 2008: anti-counterfeiting H.R. 6151, Responsibility in Drug and Device Advertising Act of 2008: direct-to-consumer drug advertising H.R. 6353, Ryan Haight Online Pharmacy Consumer Protection Act of 2008: on-line pharmacy issues H.R. 6378, Strengthening of FDA Integrity Act of 2008: debarment H.R. 6381, Medical Device Safety Act of 2008: preemption issues H.R. 6388 The Government Accountability Office Improvement Act of 2008: disclosure of data H.R. 6432, Animal Drug User Fee Amendments of 2008: technical corrections to FDAAA H.R. 6820, Water Assessment and Treatment Evaluation Research Study Act of 2008: pharmaceuticals in drinking water and human health S. 242, Pharmaceutical Market Access and Drug Safety Act of 2007: importation S. 334, Healthy Americans Act: non-interference S. 623, Access to Life-Saving Medicine Act: follow-on biologics S. 1693, Wired for Health Care Quality Act: health information technology and health care quality and costs S. 1695, Biologics Price Competition and Innovation Act of 2007: follow-on biologics S. 2663, CPSC Reform Act: importation S. 2731, Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008: public health S. 3046, Access, Compassion, Care, and Ethics for Seriously Ill Patients Act (ACCESS Act): access to investigational drugs and related issues S. 3398, Medical Device Safety Act of 2008: preemption issues S. 3409, Drug and Device Accountability Act of 2008: import safety S. 3560, QI Program Supplemental Funding Act of 2008: antibiotic exclusivity provisions S. 3633, Transparency in Drug Labeling Act: country of origin labeling for drugs

Client expense: $5,420,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Natl Economic Council (NEC), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

Health Information Technology S.1693: Wired for Health Care Quality Act H.R. 6357: PRO(TECH)T Act of 2008 H.R. 6898: Health-e Information Technology Act of 2008 Anti-trust H.R.971/S.2161: Community Pharmacy Fairness Act Pharmacy Reimbursement H.R.1474: Fair and Speedy Treatment of Medicare Drug Claims Act S.1954: Pharmacy Access Improvement Act of 2007 H.R. 6353: Ryan Haight Online Pharmacy Consumer Protection Act of 2008

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

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

H.R. 6353 - Ryan Haight Online Pharmacy Consumer Protection Act of 2008 H.R. 5839 - Safeguarding Americas Pharmaceuticals Act of 2008 H. Res. 1437 - Designates October as American Pharmacists Month Under Line 17: We would like to include Office of the National Coordinator (ONC) for Health Information Technology H.R. 6357 - Protecting Records, Optimizing Treatment, and Easing Communication through Healthcare Technology (PRO(TECH)T) Act of 2008 H.R. 5491 - Pharmacy Technician Training and Registration Act of 2008 H.R. 4054 - Prevention Through Affordable Access Act (Docket Number: CMS0009P) HHS Proposed Rule on Health Insurance Reform; Modifications to the Health Insurance Portability and Accountability Act (HIPAA) Electronic Transaction Standards (Docket Number: CMS-0013-P) HHS Proposed Rule HIPPA Administrative Simplification: Modification to Medical Data Code Set Standards To Adopt ICD-10-CM and ICD-10-PCS (Docket Number: FDA-2006-N-5015) FDA Proposed Rule on Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling (Docket Number: DEA-2008-0009) DEA Proposed Rule for Electronic Prescriptions for Controlled Substances (Docket Number: FDA-2008-N-0466) FDA Over the Counter Cough and Cold Medications for Pediatric Use; Notice of Public Hearing (Docket Number: FDA-2008-N-0038) FDA Joint Meeting of the Antiviral Drugs Advisory Committee and the Nonprescription Drugs Advisory Committee; Notice of Meeting (Docket Number: FDA2008D0417) Draft Guidance for the Public and the Food and Drug Administration Staff on Convening Advisory Committee Meetings (Docket Number: FDA-2005-N-0464) FDA Proposed Rule on Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs (Public Law 110-85) Food and Drug Administration Amendments Act of 2007 Section on Adverse Event Reporting Requirement (Public Law 100-293) Prescription Drug Marketing Act of 1987 (PDMA) (Public Law 102-353) Prescription Drug Amendment of 1992 (PDA) Comments to ONC on Use Case Draft Medication Gaps Document Draft AHIC Extension/Gap

Client expense: $196,642 · 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), Health Resources & Services Administration (HRSA), SENATE, White House Office

Health Information Technology S.1693: Wired for Health Care Quality Act H.R. 6357: PRO(TECH)T Act of 2008 H.R. 6898: Health-e Information Technology Act of 2008 Anti-trust H.R.971/S.2161: Community Pharmacy Fairness Act Pharmacy Reimbursement H.R.1474: Fair and Speedy Treatment of Medicare Drug Claims Act S.1954: Pharmacy Access Improvement Act of 2007 H.R. 6353: Ryan Haight Online Pharmacy Consumer Protection Act of 2008

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

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

Issues pertaining to health information technology, generic drugs, internet pharmacy, and privacy. HR 6353, Ryan Haight Online Pharmacy Consumer Protection Act of 2008 S. 980, Online Pharmacy Consumer Protection Act of 2007 S. 1814, Health Information Privacy and Security Act H.R. 5442, Technologies for Restoring Users Security & Trust Act of 2008 HR 6898, Health-e Information Technology Act of 2008 HR 4296, Medicare Electronic Medication and Safety Protection (E-MEDS) Act of 2007 S. 2408, Medicare Electronic Medication and Safety Protection (E-MEDS) Act of 2007 H.R.1038 To amend the Public Health Service Act to provide for the licensing of comparable and interchangeable biological products, and for other purposes. S.623 A bill to amend the Public Health Service Act to provide for the licensing of comparable and interchangeable biological products, and for other purposes. HR 5629, Pathway for Biosimilars Act S 3408, Comparative Effectiveness Research Act of 2008

Client expense: $1,316,532 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Issues related to pharmaceutical supply chain and distribution, including the following: (1) federal pedigree legislation including HR 5839, Safeguarding America's Pharmaceuticals Act of 2008 and possible amendment to HR 3610, Food and Drug Safety Import Act; and (2) Internet pharmacy issues including related provisions in S. 980 and HR 6353, Ryan Haight Online Pharmacy Consumer Protection Act. Healthcare associated infections/MRSA.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 980 and HR 6353, Ryan Haight Online Pharmacy Consumer Protection Act of 2008

Client expense: $320,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Legislative and regulatory issues affecting pharmacies and retailers, including health care funding, health care programs, and the delivery of prescription drugs. H.R. 971, The Community Pharmacy Fairness Act. H.R. 3700 and S. 1951, The Fair Medicaid Drug Payment Act of 2007. H.R. 3580, Food and Drug Administration Amendments Act of 2007. H.R. 1585, Fiscal 2008 Defense Authorization - TRICARE provisions. S. 980, Ryan Haight Internet Controlled Substances Act. S. 1693, Wired for Health Care Act. H.R. 5539, the Safeguarding America's Pharmaceuticals Act of 2008. H.R. 6353, Ryan Haight Online Pharmacy Consumer Protection Act of 2008. H.R. 6331, the Medicare Patients and Providers Protection Act of 2008. H.R. 6357, Protecting Records, Optimizing Treatment, and Easing Communication through Healthcare Technology Act of 2008. H.R. 6898, Health-e Information Technology Act of 2008.

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

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

General issues involving interchange fees, including H.R. 5546 (the Credit Card Fair Fee Act), S. 3086 (the Credit Card Fair Fee Act), H.R. 6248 (the Credit Card Interchange Fees Act of 2008), and H.R. 6620 (the Gas Pump Fair Payment Act); issues relating to payment card issuer practices, including provisions in S. 1395 (the Stop Unfair Practices in Credit Cards Act), H.R. 873 (the Credit Card Payment Fee Act), H.R. 2911 (the Electronic Funds Transfer Equal Consumer Protection Act), H.R. 2146 (the Universal Default Prohibition Act), H.R. 946 (the Consumer Overdraft Protection Fair Practices Act), H.R. 5244 (the Credit Cardholders Bill of Rights Act), S. 2753 (the Credit Card Reform Act), and S. 3252 (the Credit Card Accountability Responsibility and Disclosure Act); issues pertaining to data security, customer notification of security breaches, and mitigation of harm resulting from security breaches, including provisions in S. 1178 (the Identity Theft Prevention Act), S. 495 (the Personal Data Privacy and Security Act), H.R. 958 (the Data Accountability and Trust Act), and H.R. 3046 (the Social Security Number Privacy and Identity Theft Prevention Act); issues relating to cardholder compliance with the Internal Revenue Code and the reporting of transaction information to the Internal Revenue Service, including section 3091 of H.R. 3221 (the Housing and Economic Recovery Act) relating to payments made in settlement of payment card and third party network transactions; issues involving the use of payment cards in connection with Internet gambling, including H.R. 5767 (the Payment Systems Protection Act) and H.R. 6870 (the Payments System Protection Act); issues related to the use of payment cards in connection with the purchase of prescription medications over the Internet, including provisions in S. 980 (the Ryan Haight Online Pharmacy Consumer Protection Act), H.R. 6353 (companion legislation to S. 980), and S. 1082 (the Food and Drug Administration Revitalization Act); issues relating to the use of payment systems in connection with transactions infringing on intellectual property rights, including S. 3325 (the Prioritizing Resources and Organization for Intellectual Property Act) and H.R. 4279 (companion legislation to S. 3325).

Client expense: Not reported · Firm income: $280,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.980, Online Pharmacy Consumer Protection Act of 2007 HR.6353, The Ryan Haight Online Pharmacy Consumer Protection Act of 2008

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 6353, Ryan Haight Online Pharmacy Consumer Protection Act of 2008

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

**see addendum page Importation of prescription drugs (H.R. 3161) (S. 1644) Rx Pedigree (H.R. 5839) Methamphetamine/Pseudoephedrine Regulation (S. 2071) Internet Pharmacy (S. 980) (H.R. 6353)

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

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