Safeguarding America's Pharmaceuticals Act of 2011

H.R. 905 and S. 733 (Medicare Prompt Pay Discount Exclusion), legislation to ensure more appropriate general payment amount for drugs and biologicals under Part B of the Medicare Program by excluding customary prompt-pay discounts extended to wholesalers from the manufacturer's average sales price. H.R. 1483, Drug Safety Enhancement Act of 2011, provisions related to pharmaceutical pedigree, wholesale transaction documentation, and electronic tracking. H.R. 3026, Safeguarding America's Pharmaceuticals Act, provisions related to pharmaceutical pedigree anti-counterfeiting. S. 1584, Drug Safety and Accountability Act of 2011, provisions related to pharmaceutical pedigree anti-counterfeiting. Preserving Access to Life-Saving Medications Act (H.R. 2245, S. 296), provisions related to drug shortages.

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

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

P.L. 111-148, Patient Protection and Affordable Care Act of 2009 (ACA) and P.L. 111-152, The Health Care & Education Affordability Reconciliation Act of 2010: Issues regarding comparative effectiveness, implementation of Physician Payment Sunshine provisions and Prescription Drug Sample reporting provisions; S.3187 FDA Safety and Innovation Act; H.R. 4274 Best Pharmaceuticals for Children Act/Pediatric Research Exclusivity Act; H.R. 3026 Safeguarding America's Pharmaceuticals Act of 2011; Pharmaceutical Traceability Enhancement Code (Rx TEC) Act and draft legislation on downstream supply chain safety/serialization; H.R. 5973 FY2013 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act (FDA funding); 340B; HR 1513 / S 810 Great Apes Protection Act

Client expense: $270,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), 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), Labor, Dept of (DOL), Natl Institutes of Health (NIH), SENATE

- Issues related to ensuring quality of supply chain for FDA regulated products. - Issues related to Accountable Care Organizations. - Issues related to Physician Payment Sunshine provisions. - Issues related to the "Regulation & Reimbursement of Diagnostics", regarding all provisions. - Implementation of the Health Care Reform Bill, regarding Medicare wellness benefit. - Issues related to maintaining the biosimilars statute without changes. - HR 2960, "National Diabetes Clinical Care Commission Act", regarding all provisions. - HR 3026, "Safeguarding America's Pharmaceutical Act of 2011", regarding all provisions. - Prescription Drug User Fee Act, regarding all provisions - Personalized Medicine Incentives and Regulation. - Issues related to Alzheimer's research. - HR 2939, "Pharmaceutical Stewardship Act of 2011", regarding all provisions. - HR 3497, "MODERN Cures Act of 2011", regarding all provisions. - HR 3207, "Modernizing Laboratory Test Standards for Patients Act of 2011", regarding all provisions. - S 1700, "Medical Device Regulatory Improvement Act", regarding all provisions. - S 1865, "Patient Access to Medical Innovation Act", regarding all provisions. - S 1995, "Medical Device Patient Safety Act", regarding all provisions. - Issues related to vision care coverage under PPACA. - Medical Device User Fee Act Reauthorization. - HR 1483, "The Drug Safety Enhancement Act of 2011", regarding all provisions. - HR 3847, "Safety of Untested and New Devices Act of 2012", regarding all provisions. - HR 3975, "A bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007", regarding all provisions. - S 2113, "A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve public health." regarding all provisions. - S 2193, "Ensuring Safe Medical Devices for Patients", regarding all provisions. - HR 5, "Protecting Access to Healthcare (PATH) Act", regarding all provisions. - HR 452, "Medicare Decisions Accountability Act of 2011", regarding all provisions. - Issues related to the repeal and/or reform of Independent Payment Advisory Boards. - HR 5937, "Breast Cancer Patient Education Act of 2012", regarding all provisions. - HR 5998, "USPSTF Transparency and Accountability Act of 2012", regarding all provisions. - S 3187, "Food and Drug Administration Safety and Innovation Act", regarding all provisions. - S 2516, "Food and Drug Administration Safety and Innovation Act", regarding all provisions. - HR 6584, Verifying Authority and Legality In Drug Compounding Act of 2012, regarding all provisions.

Client expense: $880,000 · Firm income: Not reported

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

H.R.905 and S.733, legislation to ensure more appropriate general payment amount for drugs and biologicals under Part B of the Medicare Program by excluding customary prompt-pay discounts extended to wholesalers from the manufacturer's average sales price. H.R. 1483, H.R.3026 and S.1584, pharmaceutical pedigree anti-counterfeiting legislation. H.R.2245 and S.296, legislation pertaining to drug manufacturing shortages.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 1041 Fairness in Medicare Bidding Act H.R. 3026 Safeguarding America's Pharmaceuticals Act Medical Device Tax HR 5651 / S 3187 -- Food and Drug Administration Reform Act of 2012 H.R. 6490 Medicare DMEPOS Market Pricing Program Act of 2012

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

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

Legislative proposals related to pharmaceutical pedigree anti-counterfeiting, wholesale transaction documentation, and electronic tracking, including H.R. 1483, H.R. 3026, and S. 1584; legislative proposals related to drug shortages, including H.R. 2245 and S. 296.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 3026 Safeguarding America's Pharmaceuticals Act of 2011; H.R. 1065 & S. 1760- Pill Mill Crackdown Act of 2011; S.2297 relating to hydrocodone rescheduling. H.R. 5853 - Gray Market Drug Reform and Transparency Act of 2012

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 3026 - Safeguarding America's Pharmaceuticals Act of 2011; P.L. 111-14 - Patient Protection and Affordable Health Care Act provisions relating to biosimilar products; S. 2295 - Patient Safety and Generic Labeling Improvement Act; Senate Draft Proposal to Improve Drug Distribution Security.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 3026 - Safeguarding America's Pharmaceuticals Act of 2011; P.L. 111-14 - Patient Protection and Affordable Health Care Act provisions relating to biosimilar products; S. 2295 - Patient Safety and Generic Labeling Improvement Act; Senate Draft Proposal to Improve Drug Distribution Security.

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

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

FY 2014 Budget, FY 2013 Budget, Implementation of Health Care Reform, Implementation of Generic Biologics, Prescription Drug Safety, Counterfeit Drugs/Import Safety/Pedigree, Prescription Drug Shortages, Authorized Generics, Prescription Drug Importation/Re-Importation, drug shortages, prescription drug abuse and generic drugs H.R. 2182 Generating Antibiotic Incentives Now Act of 2011 H.R. 3026 - Safeguarding America's Pharmaceuticals Act of 2011 H.R. 3839 - Drug Shortage Prevention Act of 2012 H.R. 3988 - Generic Drug and Biosimilar User Fee Act of 2012 H.R. 3995 - Protecting Consumer Access to Generic Drugs Act of 2012 H.R. 4332 - Generic Drug Application Review Fairness Act of 2012 H.R. 5651 - Food and Drug Administration Reform Act of 2012 H.R.6160 - Stop Tampering of Prescription Pills Act of 2012 H.R. 6433 - FDA User Fee Corrections Act of 2012 H.R.6584 - Verifying Authority and Legality In Drug Compounding Act of 2012 H.R.6611 - Patient Access to Drugs in Shortage Act of 2012 H.R.6638 - S.A.F.E. Compounded Drugs Act of 2012 S. 44 Medicare Prescription Drug Negotiation Act S. 296 and H.R.2245 Preserving Access to Life-Saving Medication Act S. 373 Fair Prescription Drug Competition Act S. 1584 - Drug Safety and Accountability Act of 2011 S. 1734 - Generating Antibiotic Incentives Now Act of 2011 S. 2295 - Patient Safety and Generic Labeling Improvement Act S. 2516 - Food and Drug Administration Safety and Innovation Act S. 3187 Food and Drug Administration Safety and Innovation Act S.1855 - Pandemic and All-Hazards Preparedness Act Reauthorization of 2011

Client expense: $486,262 · Firm income: Not reported

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

S. 27, Preserve Access to Affordable Generics Act S. 31, Prescription Drug and Health Improvement Act of 2011 S. 319, Pharmaceutical Market Access and Drug Safety Act of 2011 H.R. 147, Prescription Drug Affordability Act H.R. 741, To amend the Federal Food, Drug and Cosmetic Act to prohibit the marketing of authorized generic drugs H.R. 979, FEHBP Prescription Drug Integrity, Transparency, and Cost Savings Act H.R. 1971, Pharmacy Competition and consumer Choice Act of 2011 H.R. 2128, STEAM (Stripping the E-Prescribe Arbitrary Mandates) Act of 2011 S. 1058, Pharmacy Competition and Consumer Act of 2011 S. 1356, Affordable Medicines Utilization Act of 2011 S. 1584, Drug Safety and Accountability Act of 2011 H.R. 3026, Safeguarding America's Pharmaceuticals Act of 2011 S. 2002, To amend the Federal Food, Drug, and Cosmetic Act to improve the safety of Internet Pharmacies S. 3187, FDA Safety and Innovation Act

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Federal Reserve System, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Justice, Dept of (DOJ), SENATE

**see addendum page Importation of prescription drugs (S.319/H.R. 147) NASPER reauthorization (H.R. 866) Pill Mill Crackdown Act (H.R. 1065/S. 1760/S. 2297) Drug Abuse (S. 507) Drug Shortages (S. 296/H.R. 2245/H.R. 3839/PL 112-144/H.R. 5853/H.R. 5651) Rx Pedigree (H.R. 3026/PL 112-144) Cargo/Product Theft (S. 1002/H.R. 4223) Prescription Drug Monitoring Program (H.R. 2254/H.R. 4292/PL 112-144) Counterfeit Drugs (S. 1886/H.R. 3668/PL 112-144) ***, no specific bills, supply chain integrity, prescription drug abuse

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

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

H.R. 2182/S. 1734 - Generating Antibiotic Incentives Now Act . Supporting work to increase innovation and development of new antibiotics. S. 1584 - Drug Safety and Accountability Act- Supporting legislation and related Congressional activity regarding upstream supply stream safety. H.R. 3026- Safeguarding America's Pharmaceuticals Act. Supporting legislation and congressional activity regarding downstream supply chain safety. S. 3187 - The FDA Safety and Innovation Act- specific work on antibiotic innovation, up and down stream supply chain issues, and medical device policies. Policies related to the growing concerns regarding drug shortage issues in hospitals across the country. Potential language related to Track and Trace provisions regarding downstream supply chain safety being considered by the Senate HELP and House Energy and Commerce Committees. H.R. 6584 The Valid Compounding Act - Providing input regarding safe standards and practices for compounding pharmacies H.R. 6638 - S.A.F.E Compounded Drugs Act - Providing input regarding safe standards and practices for compounding pharmacies H.R. 8 - The American Taxpayer Relief Act of 2012- Focused on provisions that could have an impact on the nation's public health system.

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

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

Rx Pedigree (H.R. 3026/PL 112-144); NASPER Reauthorization (H.R. 866); Prescription Drug Monitoring Programs (S. 2254/H.R. 4292/PL 112-144); Pill Mill Crackdown Act (H.R. 1065/S. 1760/S. 2297); Drug Abuse (S. 507); Drug Shortages (S. 296/HR 2245/HR 3839/ PL 112-144/HR 5853/HR 5651); Cargo/Product Theft (S. 1002/H.R. 4223; PL 112-204); Counterfeit Drugs (S. 1886/H.R. 3668/PL 112-144)

Client expense: $228,000 · Firm income: Not reported

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

Implementation of Prescription Drug User Fee Act of 2007, provision affecting PET drugs and medical advisory committees. S. 319, Pharmaceutical Market Access and Drug Safety Act of 2011 H.R. 1483, Drug Safety Enhancement Act of 2011 H.R. 4095, Online Pharmacy Safety Act H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011 S. 296, Preserving Access to Life-Saving Medications Act H.R. 3630, Temporary Payroll Tax Cut Continuation Act of 2011 H.R. 3026, Safeguarding America's Pharmaceuticals Act of 2011 H.R. 5651, Food and Drug Administration Reform Act of 2012 S. 3187, Food and Drug Administration Safety and Innovation Act

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

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

H.R. 1409: All provisions of the Quality Health Care Coalition Act of 2011; H.R. 891/S. 274: All provisions of the Medication Therapy Management Benefits Act of 2011; H.R. 905 /S. 733:All provisions of the legislation to exclude customary prompt pay discounts from manufacturers to wholesalers from the average sales price for drugs and biologicals under Medicare; H.R. 979 - All provisions of the FEHBP Prescription Drug Integrity, Transparency, and Cost Savings Act H.R. 605 / S. 312 -All provisions of the Patients Freedom to Choose Act S. 27 - All provisions of the Preserve Access to Affordable Generics Act S. 31 - All provisions of the Prescription Drug and Health Improvement Act of 2011 S. 44 -All provisions of the Medicare Prescription Drug Price Negotiation Act of 2011 H.R. 999 / S. 560 - All provisions of the Medicare Prescription Drug Savings and Choice Act of 2011 H.R. 1839 - All provisions of the Community Pharmacy Fairness Act of 2011; H.R. 1946 - All provisions of the Preserving or Hometown Independent Pharmacies Act of 2011; H.R. 1971 / S. 1058 - All provisions of the Pharmacy Competition and Consumer Choice Act of 2011 Provisions of PL 111-148 and PL 111-152 impacting Medicare Part D such as formulary requirements, PBM disclosure provisions, closing the Part D coverage gap Regulatory design and coverage of pharmacy benefits in health reform exchanges and the commercial market (essential health benefits, grandfathering, value-based insurance design, e-prescribing, PBM disclosure requirements, and medical loss ratio) Regulatory and proposed legislative changes to Medicare part D including EGWP waivers, MTM expansion, long term care short-term fills, recovery audit contractors Implementation of changes to the definition of Average Manufacturer Price in Medicaid Issues related to the management of Medicaid prescription drug benefits Legislation to promote generic drugs FDA issues related to the Prescription Drug User Fee Act (PDUFA) (generic user fees, pedigree, REMs); implementation of approval pathway for generic biologic drugs 340b program H.R. 2672 the Preserving Access to Orphan Drugs Act H.R. 2182 the Generating Antibiotic Incentives Now Act H.R. 3026 the Safeguarding Americas Pharmaceuticals Act H.R. 2746 the Cancer Drug Coverage Parity Act H.R.4215 - All provisions of the Medicare Pharmacy Transparency and Fair Auditing Act

Client expense: $518,430 · 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), Health Resources & Services Administration (HRSA), Labor, Dept of (DOL), SENATE

FY 2013 Budget, Implementation of Health Care Reform, Implementation of Generic Biologics, Prescription Drug Safety, Counterfeit Drugs/Import Safety/Pedigree, Prescription Drug Shortages, Authorized Generics, Prescription Drug Importation/Re-Importation, drug shortages, prescription drug abuse and generic drugs H.R. 2182 Generating Antibiotic Incentives Now Act of 2011 H.R. 3026 - Safeguarding America's Pharmaceuticals Act of 2011 H.R. 3839 - Drug Shortage Prevention Act of 2012 H.R. 3988 - Generic Drug and Biosimilar User Fee Act of 2012 H.R. 3995 - Protecting Consumer Access to Generic Drugs Act of 2012 H.R. 4332 - Generic Drug Application Review Fairness Act of 2012 H.R. 5651 - Food and Drug Administration Reform Act of 2012 H.R.6160 - Stop Tampering of Prescription Pills Act of 2012 H.R. 6433 - FDA User Fee Corrections Act of 2012 S. 44 Medicare Prescription Drug Negotiation Act S. 296 and H.R.2245 Preserving Access to Life-Saving Medication Act S. 373 Fair Prescription Drug Competition Act S. 1584 - Drug Safety and Accountability Act of 2011 S. 1734 - Generating Antibiotic Incentives Now Act of 2011 S. 2295 - Patient Safety and Generic Labeling Improvement Act S. 2516 - Food and Drug Administration Safety and Innovation Act S. 3187 Food and Drug Administration Safety and Innovation Act S.1855 - Pandemic and All-Hazards Preparedness Act Reauthorization of 2011

Client expense: $487,850 · Firm income: Not reported

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

H.R. 1971/S. 1058 - the "Pharmacy Competition and Consumer Choice Act of 2011," all provisions related to requirement of Pharmacy Benefit Managers annual reporting to Part D plan sponsors of number and total cost of prescriptions under a contract, payments to pharmacies, payments from pharmaceuticals manufacturers and generic and brand name drugs dispensed. H.R. 4215 - the "Medicare Pharmacy Transparency and Fair Auditing Act," amends Medicare Part D to require each contract entered into with a prescripotion drug plan (PDP) sponsor for the offering of a prescription drug plan to prohibit PDP sponsor from contracting with any pharmacy benefits manager (PBM) to manage the prescription drug coverage under such plan or control the costs of such coverage, unless the manager satisfies specific PBM audit and disclosure requirements. H.R. 3026 - the "Safeguarding America's Pharmaceutical Act," all provisions; Requires the Secretary of Health and Human Services (HHS) to issue regulations to establish an effective drug identification and tracking system through which drug manufacturers, repackagers, wholesale distributors, and dispensers may authenticate the wholesale distribution history of any prescription drug that is subject to a requirement for a standardized numerical identifier. Issues relating to regulations that would establish an effective drug identification and tracking system through which drug manufacturers, repackagers, wholesale distributors and dispensers may authenticate the wholesale distribution history of any prescription drug that is subject to a requirement for a standardized numerical identifier. No specific legislation.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 2182, S. 1734 GAIN (Generating Antibiotic Incentives Now Act of 2011) issues related to the development of antibiotics H.R. 3026, S. 1882 and related legislative proposals regarding establishment/implementation of pharmaceutical pedigrees and tracking/tracing of pharmaceuticals from manufacturer to consumer HR 1483 - issues related to drug safety, supply chain, and facility inspections H.R. 2245, S.296, H.R. 3839 (Prescribing Access to Lifesaving Medications Act of 2011) and related legislative proposals regarding issues surrounding potential drug shortages, including notifications and public reporting H.R. 3668 issues related to increased penalties for counterfeiting drugs S. Amend. t.2107 and related legislative proposals regarding prescription drug importation

Client expense: $370,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

H.R. 3026, S. 1882 and related legislative proposals regarding establishment/implementation of pharmaceutical pedigrees and tracking/tracing of pharmaceuticals from manufacturer to consumer HR 1483 issues related to drug safety, supply chain, and facility inspections H.R. 2245, S.296, H.R. 3839 (Prescribing Access to Lifesaving Medications Act of 2011) and related legislative proposals regarding issues surrounding potential drug shortages, including notifications and public reporting H.R. 3668 issues related to increased penalties for counterfeiting drugs S. Amend. t.2107 and related legislative proposals regarding prescription drug importation

Client expense: $370,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

HR 2182, S1734, and S2187 (as passed in Pub. L. No. 112-144) issues related to the development of antibiotics H.R. 3026, S. 1882 and related legislative proposals regarding establishment/implementation of pharmaceutical pedigrees and tracking/tracing of pharmaceuticals from manufacturer to consumer HR 1483 - issues related to drug safety, supply chain, and facility inspections H.R. 2245, S.296, H.R. 3839 (Prescribing Access to Lifesaving Medications Act of 2011) and related legislative proposals regarding issues surrounding potential drug shortages, including notifications and public reporting H.R. 3668 issues related to increased penalties for counterfeiting drugs HR 3590, S 1790 (as enacted into PL 111-148 and PL 111-152) issues related to 340B program amendments and implementation of statutory changes. HR 3590, S 1790 (as enacted into PL 111-148 and PL 111-152) issues related to definition of essential health benefits and health insurance exchanges. HR 6160 - issues related to drug safety issues, including tamper resistent packaging HR 1513 - issues related to animal research HR 6502 - issues related to development of medicines for life-threatening illnesses HR 3497 - issues related to incentives for developing and improving diagnostic tests and related treatments HR 6272 - issues related to the expansion of clinical trial data banks and increase government reporting of same HR 6163 - issues related to incentives for increased research into pediatric treatments

Client expense: $980,000 · Firm income: Not reported

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

H.R. 3026, S. 1882 and related legislative proposals regarding establishment/implementation of pharmaceutical pedigrees and tracking/tracing of pharmaceuticals from manufacturer to consumer HR 1483 issues related to drug safety, supply chain, and facility inspections H.R. 2245, S.296, H.R. 3839 (Prescribing Access to Lifesaving Medications Act of 2011) and related legislative proposals regarding issues surrounding potential drug shortages, including notifications and public reporting H.R. 3668 issues related to increased penalties for counterfeiting drugs H.R. 6160 - issues related to drug safety, including tamper resistent packaging

Client expense: $980,000 · Firm income: Not reported

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

H.R. 905 and S. 733 (Medicare Prompt Pay Discount Exclusion), legislation to ensure more appropriate general payment amount for drugs and biologicals under Part B of the Medicare Program by excluding customary prompt-pay discounts extended to wholesalers from the manufacturer's average sales price. H.R. 1483, Drug Safety Enhancement Act of 2011, provisions related to pharmaceutical pedigree, wholesale transaction documentation, and electronic tracking. H.R. 3026, Safeguarding America's Pharmaceuticals Act, provisions related to pharmaceutical pedigree anti-counterfeiting. S. 1584, Drug Safety and Accountability Act of 2011, provisions related to pharmaceutical pedigree anti-counterfeiting. Preserving Access to Life-Saving Medications Act (H.R. 2245, S. 296), provisions related to drug shortages.

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

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

Issues related to the security and integrity of the domestic pharmaceutical distribution system. S.1584 & H.R. 3026 - Safeguarding Americas Pharmaceuticals Act of 2011 -- All 3rd Party Logistics Issues

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Legislative proposals related to pharmaceutical pedigree anti-counterfeiting, wholesale transaction documentation, and electronic tracking, including H.R. 1483, H.R. 3026, and S. 1584; legislative proposals related to drug shortages, including H.R. 2245 and S. 296.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 3026, Safeguarding America's Pharmaceuticals Act H.R. 2577, Safe Data Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 1041 Fairness in Medicare Bidding Act; H.R. 3026 Safeguarding America's Pharmaceuticals Act; Medical Device Tax; HR 5651 / S 3187 -- Food and Drug Administration Reform Act of 2012

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

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

H.R. 1483, H.R. 3026, & S. 1584 - Pharmaceutical pedigree anti-counterfeiting; H.R. 2245, S. 296. - drug shortages

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

- Issues related to ensuring quality of supply chain for FDA regulated products. - Issues related to Accountable Care Organizations. - Issues related to Physician Payment Sunshine provisions. - Issues generating antibiotic incentives. - HR 1282, "Generating Antibiotics Incentives Now Act of 2011", regarding all provisions. - Issues related to the "Regulation & Reimbursement of Diagnostics", regarding all provisions. - Implementation of the Health Care Reform Bill, regarding Medicare wellness benefit. - Issues related to maintaining the biosimilars statute without changes. - HR 2960, "National Diabetes Clinical Care Commission Act", regarding all provisions. - HR 3026, "Safeguarding America's Pharmaceutical Act of 2011", regarding all provisions. - Prescription Drug User Fee Act, regarding all provisions - Personalized Medicine Incentives and Regulation. - Issues related to Alzheimer's research. - HR 2939, "Pharmaceutical Stewardship Act of 2011", regarding all provisions. - HR 3497, "MODERN Cures Act of 2011", regarding all provisions. - HR 3207, "Modernizing Laboratory Test Standards for Patients Act of 2011", regarding all provisions. - S 1700, "Medical Device Regulatory Improvement Act", regarding all provisions. - S 1865, "Patient Access to Medical Innovation Act", regarding all provisions. - S 1995, "Medical Device Patient Safety Act", regarding all provisions. - Issues related to vision care coverage under PPACA. - Medical Device User Fee Act Reauthorization. - HR 1483, "The Drug Safety Enhancement Act of 2011", regarding all provisions. - HR 3847, "Safety of Untested and New Devices Act of 2012", regarding all provisions. - HR 3975, "A bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007", regarding all provisions. - S 2113, "A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve public health." regarding all provisions. - S 2193, "Ensuring Safe Medical Devices for Patients", regarding all provisions. - HR 5, "Protecting Access to Healthcare (PATH) Act", regarding all provisions. - HR 452, "Medicare Decisions Accountability Act of 2011", regarding all provisions. - Issues related to the repeal and/or reform of Independent Payment Advisory Boards. - HR 5937, "Breast Cancer Patient Education Act of 2012", regarding all provisions. - HR 5998, "USPSTF Transparency and Accountability Act of 2012", regarding all provisions. - S 3187, "Food and Drug Administration Safety and Innovation Act", regarding all provisions. - S 2516, "Food and Drug Administration Safety and Innovation Act", regarding all provisions.

Client expense: $1,420,000 · Firm income: Not reported

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

H.R.905 - To amend part B of title XVIII of the Social Security Act to exclude customary prompt pay discounts from manufacturers to wholesalers from the average sales price for drugs and biologicals under Medicare. S.733 - A bill to amend part B of title XVIII of the Social Security Act to exclude customary prompt pay discounts from manufacturers to wholesalers from the average sales price for drugs and biologicals under Medicare. S.89 - Withholding Tax Relief Act of 2011 S.164 - Withholding Tax Relief Act of 2011 H.R.1483 - Drug Safety Enhancement Act of 2011 H.R.3026 - Safeguarding America's Pharmaceuticals Act of 2011 S.1584 - Drug Safety and Accountability Act of 2011 H.R.2245 - Preserving Access to Life-Saving Medications Act of 2011 S.296 - Preserving Access to Life-Saving Medications Act H.R. 5651 - Food and Drug Administration Reform Act of 2012 S. 3187 - Food and Drug Administration Safety and Innovation Act

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

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), SENATE

H.R.905 - To amend part B of title XVIII of the Social Security Act to exclude customary prompt pay discounts from manufacturers to wholesalers from the average sales price for drugs and biologicals under Medicare. S.733 - A bill to amend part B of title XVIII of the Social Security Act to exclude customary prompt pay discounts from manufacturers to wholesalers from the average sales price for drugs and biologicals under Medicare. S.89 - Withholding Tax Relief Act of 2011 S.164 - Withholding Tax Relief Act of 2011 H.R.1483 - Drug Safety Enhancement Act of 2011 H.R.3026 - Safeguarding America's Pharmaceuticals Act of 2011 S.1584 - Drug Safety and Accountability Act of 2011 H.R.2245 - Preserving Access to Life-Saving Medications Act of 2011 S.296 - Preserving Access to Life-Saving Medications Act H.R. 5651 - Food and Drug Administration Reform Act of 2012 S. 3187 - Food and Drug Administration Safety and Innovation Act

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

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), SENATE

**see addendum page Importation of prescription drugs (S.319/H.R. 147) NASPER reauthorization (H.R. 866) Pill Mill Crackdown Act (H.R. 1065/S. 1760/S. 2297) Drug Abuse (S. 507) Drug Shortages (S. 296/H.R. 2245/H.R. 3839/S.3187/H.R. 5853/H.R. 5651) Rx Pedigree (H.R. 3026/S. 3187) Cargo/Product Theft (S. 1002/H.R. 4223) Prescription Drug Monitoring Program (H.R. 2254/H.R. 4292/S. 3187) Counterfeit Drugs (S. 1886/H.R. 3668/S. 3187) ***, no specific bills, supply chain integrity, prescription drug abuse

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

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

H.R.905 and S.733, legislation to ensure more appropriate general payment amount for drugs and biologicals under Part B of the Medicare Program by excluding customary prompt-pay discounts extended to wholesalers from the manufacturer's average sales price. H.R. 1483, H.R.3026 and S.1584, pharmaceutical pedigree anti-counterfeiting legislation. H.R.2245 and S.296, legislation pertaining to drug manufacturing shortages.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 27, Preserve Access to Affordable Generics Act S. 31, Prescription Drug and Health Improvement Act of 2011 S. 319, Pharmaceutical Market Access and Drug Safety Act of 2011 H.R. 147, Prescription Drug Affordability Act H.R. 741, To amend the Federal Food, Drug and Cosmetic Act to prohibit the marketing of authorized generic drugs H.R. 979, FEHBP Prescription Drug Integrity, Transparency, and Cost Savings Act H.R. 1971, Pharmacy Competition and consumer Choice Act of 2011 H.R. 2128, STEAM (Stripping the E-Prescribe Arbitrary Mandates) Act of 2011 S. 1058, Pharmacy Competition and Consumer Act of 2011 S. 1356, Affordable Medicines Utilization Act of 2011 S. 1584, Drug Safety and Accountability Act of 2011 H.R. 3026, Safeguarding America's Pharmaceuticals Act of 2011 S. 2002, To amend the Federal Food, Drug, and Cosmetic Act to improve the safety of Internet Pharmacies S. 3187, FDA Safety and Innovation Act

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Federal Reserve System, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Justice, Dept of (DOJ), SENATE

Drug Pedigree; Drug Shortages; Generic Drug Labeling; Generic Drugs; HR3026 Safeguarding America's Pharmaceutical Act of 2011; HR4223 Safe Doses Act; S1002 Safe Doses Act; HR5651 FDA Reform Act of 2012; S3187 FDA Safety and Innovation Act; HR6433 FDA User Fee Corrections Act of 2012; HR3590 Patient Protection and Affordable Health Care Act provisions relating to biosimilar medicines; S2295 Patient Safety and Generic Labeling Improvement Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Rx Pedigree (H.R. 3026/S. 3187); NASPER Reauthorization (H.R. 866); Prescription Drug Monitoring Programs (S. 2254/H.R. 4292/S.3187); Pill Mill Crackdown Act (H.R. 1065/S. 1760/S. 2297); Drug Abuse (S. 507); Drug Shortages (S. 296/ H.R. 2245/H.R. 3839/S. 3187/H.R. 5853/H.R. 5651); Cargo/Product Theft (S. 1002/H.R. 4223); Counterfeit Drugs (S. 1886/H.R. 3668/S. 3187)

Client expense: $222,819 · Firm income: Not reported

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

Implementation of Prescription Drug User Fee Act of 2007, provision affecting PET drugs and medical advisory committees. S. 319, Pharmaceutical Market Access and Drug Safety Act of 2011 H.R. 1483, Drug Safety Enhancement Act of 2011 H.R. 4095, Online Pharmacy Safety Act H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011 S. 296, Preserving Access to Life-Saving Medications Act H.R. 3630, Temporary Payroll Tax Cut Continuation Act of 2011 H.R. 3026, Safeguarding America's Pharmaceuticals Act of 2011 H.R. 5651, Food and Drug Administration Reform Act of 2012 S. 3187, Food and Drug Administration Safety and Innovation Act

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

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

H.R. 2182/S. 1734 - Generating Antibiotic Incentives Now Act . Supporting work to increase innovation and development of new antibiotics. S. 1584 - Drug Safety and Accountability Act- Supporting legislation and related Congressional activity regarding upstream supply stream safety. H.R. 3026- Safeguarding America's Pharmaceuticals Act. Supporting legislation and congressional activity regarding downstream supply chain safety. S. 3187 - The FDA Safety and Innovation Act- specific work on antibiotic innovation, up and down stream supply chain issues, and medical device policies. Policies related to the growing concerns regarding drug shortage issues in hospitals across the country. Potential language related to Track and Trace provisions regarding downstream supply chain safety being considered by the Senate HELP and House Energy and Commerce Committees.

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

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

H.R. 3026 - Safeguarding America's Pharmaceuticals Act of 2011; P.L. 111-14 - Patient Protection and Affordable Health Care Act provisions relating to biosimilar products; S. 2295 - Patient Safety and Generic Labeling Improvement Act

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

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

H.R. 3026 Safeguarding America's Pharmaceuticals Act of 2011; H.R. 1065 & S. 1760- Pill Mill Crackdown Act of 2011; S.2997 relating to hydrocodone rescheduling.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

P.L. 111-148, Patient Protection and Affordable Care Act of 2009 (ACA) and P.L. 111-152, The Health Care & Education Affordability Reconciliation Act of 2010: Issues regarding comparative effectiveness, implementation of Physician Payment Sunshine provisions and Prescription Drug Sample reporting provisions; S.3187 FDA Safety and Innovation Act; H.R. 4274 Best Pharmaceuticals for Children Act/Pediatric Research Exclusivity Act; H.R. 3026 Safeguarding America's Pharmaceuticals Act of 2011; Pharmaceutical Traceability Enhancement Code (Rx TEC) Act; H.R. 5973 FY2013 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act (FDA funding); 340B

Client expense: $400,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), 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), Labor, Dept of (DOL), Natl Institutes of Health (NIH), SENATE, White House Office

P.L. 111-148, Patient Protection and Affordable Care Act of 2009 (ACA) and P.L. 111-152, The Health Care & Education Affordability Reconciliation Act of 2010: Issues regarding comparative effectiveness, implementation of Physician Payment Sunshine provisions and Prescription Drug Sample transparency reporting provisions; S.3187 FDA Safety and Innovation Act (PDUFA V); H.R. 4274 Best Pharmaceuticals for Children Act/Pediatric Research Exclusivity Act; H.R. 3026 Safeguarding America's Pharmaceuticals Act of 2011; Pharmaceutical Traceability Enhancement Code (Rx TEC) Act; H.R. 5973 FY2013 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act (FDA funding); 340B

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

Government targets: Centers For Disease Control & Prevention (CDC), 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), Labor, Dept of (DOL), Natl Institutes of Health (NIH), SENATE

Perscription Drug User Fee Act Reauthorization FDA funding and agency effectiveness Drug importation issues Safeguarding America's Pharmaceuticals Act of 2011- H.R. 3026

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 3590, S 1790 (as enacted into PL 111-148 and PL 111-152) issues related to Medicare and Medicaid reform, including possible changes to Part D and changes to Medicaid price reporting requirements H.R. 2245, S. 296, H.R. 3839(Preserving Access to Life-Saving Medications Act of 2011) and related legislative proposals regarding issues surrounding potential drug shortages including notification and public reporting H.R. 2182, S. 1734 GAIN (Generating Antibiotic Incentives Now Act of 2011) - issues related to the development of antibiotics H.R. 452 IPAB (Independent Payment Advisory Board) Medicare Decisions Accountability Act of 2011 S.1882, H.R. 3026 and related legislative proposals regarding establishment/implementation of pharmaceutical pedigrees and tracking/tracing of pharmaceuticals from manufacturer to consumer; HR 1483 - issues related to drug safety, supply chain, and facility inspections HR 3468 - issues related to increased penalties for counterfeiting drugs Discussions regarding use of psychotropic drugs by children in foster care HR 1254 (Synthetic Drug Control Act) - issues related to propsed controlled substance amendments S 2113 (Transforming Regulatory Environment to Accelerate Access to Treatments Act) - issues related to acceleration of innovation and approvals of medical treatments

Client expense: $1,110,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)