Drug Safety Enhancement Act of 2011

Implementation of Public Law 111-148, The Patient Protection and Affordable Care Act Implementation of Public Law 111-152, The Reconciliation Act of 2010 Implementation of Public Law 112-144, Food and Drug Administration Safety and Innovation Act H.R. 1483, Drug Safety Enhancement Act of 2011S.214, Preserve Access to Affordable Generics Act S.621 Safe Prescribing Act of 2013 Proposals to increase security of US drug distribution supply chain Proposals to improve viral hepatitis screening

Client expense: $630,000 · Firm income: Not reported

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

S.27, Preserve Acess to Affordable Generics; H.R. 1483, Drug Safety Enhancement Act; Implementation of P.L. 111-148, Patient Protection & Affordable Care; Prescription Drug User Fee Reauthorization issues; S. 959 Pharmaceutical Compounding Quality and Accountability Act; S. 957, Drug Supply Chain Security Act; H.R. 1919, Safeguarding America's Pharmaceuticals Act of 2013; H.R. 2186, Verifying Authority and Legality In Drug Compounding Act of 2013.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Health care reform implementation; the 340B program of the Health Resources and Services Administration (HRSA), specifically 340B drug pricing program issues, including program expansion and specific issues include: HRSA oversight, definition of patient, the ACA's expansion of covered 340B entities, issues concerning incenting antibiotic development; issues related to track and trace of pharmaceuticalsImplementation & Rule Making related to Generating Antibiotics Incentives Now (GAIN) Act (PL 112-144) and ongoing discussions surrounding next steps for protecting and promoting incentives for the developement of resistant pathogens including breakpoints Reauthorization of the Prescription Drug User Fee Act; Reauthorization of the Medical Device User Fee Act; H.R. 1483, Drug Safety Enhancement Act of 2011 H.R. 2182, Generating Antibiotic Now (GAIN) Act (S.1734) Implementation of Patient Protection and Affordable Care Act of 2010 (Pub. L. 111-148); Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152) Implementation of the American Taxpayer Relief Act of 2012 Pub. L. 112-240, H.R. 8

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Implementation of Public Law 111-148, The Patient Protection and Affordable Care Act Implementation of Public Law 111-152, The Reconciliation Act of 2010 Implementation of Public Law 112-144, Food and Drug Administration Safety and Innovation Act H.R. 1483, Drug Safety Enhancement Act of 2011S.214, Preserve Access to Affordable Generics Act S.621 Safe Prescribing Act of 2013 Proposals to increase security of US drug distribution supply chain Proposals to improve viral hepatitis screening

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

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

S.27, Preserve Acess to Affordable Generics; H.R. 1483, Drug Safety Enhancement Act; Implementation of P.L. 111-148, Patient Protection & Affordable Care; Prescription Drug User Fee Reauthorization issues; S. 959 Pharmaceutical Compounding Quality and Accountability Act; S. 957, Drug Supply Chain Security Act; H.R. 1919, Safeguarding America's Pharmaceuticals Act of 2013; H.R. 2186, Verifying Authority and Legality In Drug Compounding Act of 2013.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Reauthorization of the Prescription Drug User Fee Act; Reauthorization of the Medical Device User Fee Act; H.R. 1483, Drug Safety Enhancement Act of 2011

Client expense: Not reported · Firm income: $15,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Reauthorization of the Prescription Drug User Fee Act; Reauthorization of the Medical Device User Fee Act; H.R. 1483, Drug Safety Enhancement Act of 2011.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Reauthorization of the Prescription Drug User Fee Act; Reauthorization of the Medical Device User Fee Act; H.R. 1483, Drug Safety Enhancement Act of 2011

Client expense: Not reported · Firm income: $54,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.296, H.R. 2245 Preserving Access to Life-Saving Medications Acts; 340B Drug Discount; H.R. 1483 , Drug Safety Enhancement Act; Devise Tax; AdvaMed Competitiveness Agenda; 510(k) Clearance Reforms; FDA Regulatory Environment. Raise awareness with legislators about the benefits of home dialysis and try to increase awareness in the veteran population.HELP and Energy and Commerce Drug shortage draft legislation. S. 3187, Food and Drug Administration Safety and Innovation Act. MDUFA, PDUFA, BSUFA, GDUFA. Traceability and drug supply chain reforms. Medical device reforms. Medical Gases Safety Act. Raise Awareness with legislators about survey and certification issues as it relates to home dialysis. Seeking appropriate reimbursement and access for an investigational indication of our product, GammaGard, to treat Alzheimers Disease.

Client expense: $660,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.27, Preserve Acess to Affordable Generics; H.R. 1483, Drug Safety Enhancement Act; Implementation of P.L. 111-148, Patient Protection & Affordable Care; Prescription Drug User Fee Reauthorization issues.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.296, H.R. 2245 Preserving Access to Life-Saving Medications Acts; 340B Drug Discount; H.R. 1483 , Drug Safety Enhancement Act; Devise Tax; AdvaMed Competitiveness Agenda; 510(k) Clearance Reforms; FDA Regulatory Environment. Raise awareness with legislators about the benefits of home dialysis and try to increase awareness in the veteran population.HELP and Energy and Commerce Drug shortage draft legislation. S. 3187, Food and Drug Administration Safety and Innovation Act. MDUFA, PDUFA, BSUFA, GDUFA. Traceability and drug supply chain reforms. Medical device reforms. Medical Gases Safety Act. Raise Awareness with legislators about survey and certification issues as it relates to home dialysis. Seeking appropriate reimbursement and access for an investigational indication of our product, GammaGard, to treat Alzheimers Disease.

Client expense: $820,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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 inspectionsH.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: $900,000 · Firm income: Not reported

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

S. 319, Pharmaceutical Market Access and Drug Safety Act - Lobbied against passage of legislation to allow for the importation of unsafe prescription drugs. S. 752, Lung Cancer Mortality Reduction Act of 2011 - Lobbied for passage of bill to reduce lung cancer mortality.NO BILL, Health Care Reform Implementation - Lobbied on implementation of provisions in the health care reform bill regarding biosimilars, the Independent Payment Advisory Board and the Annual Fee. S. 296 and H.R. 2245, Preserving Access to Life-Savings Medications Act - Lobbied to improve provisions in the drug shortage legislation. H.R. 1483, Drug Safety Enhancement Act of 2011 - Lobbied to pass meaningful drug safety legislation. S. 3187, the "Food and Drug Administration Safety and Innovation Act - Lobbied for passage of PDUFA legislation. S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments - Lobbied to pass meaningful FDA reform legislation. S. 2236, Advancing Breakthrough Therapies for Patients Act of 2012 - Lobbied to pass meaningful FDA reform legislation. H.R. 4274, BCPA and PREA Reauthorization Act of 2012 - Lobbied for permanence of BCPA and PREA. H.R. 3497, MODERN Cures Act of 2011 - Lobbied for incentives for development of pharmacodiagnostics and dormant therapies. H.R. 3737, Unlocking Lifesaving Treatments for Rare-Diseases Act - Lobbied to pass meaningful FDA reform legislation. H.R. 4132, Faster Access to Specialized Treatments Act - Lobbied to pass meaningful FDA reform legislation. Labor, HHS Appropriations. Lobbied for increased access to HIV/AIDS drugs in the AIDS Drug Assistance Program.

Client expense: $560,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), SENATE, Treasury, Dept of

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

S.296, H.R. 2245 Preserving Access to Life-Saving Medications Acts; 340B Drug Discount; H.R. 1483 , Drug Safety Enhancement Act; Devise Tax; AdvaMed Competitiveness Agenda; 510(k) Clearance Reforms; FDA Regulatory Environment. Raise awareness with legislators about the benefits of home dialysis and try to increase awareness in the veteran population. HELP and Energy and Commerce Drug shortage draft legislation. S. 3187, Food and Drug Administration Safety and Innovation Act. MDUFA, PDUFA, BSUFA, GDUFA. Traceability and drug supply chain reforms. Medical device reforms. Medical Gases Safety Act. Raise Awareness with legislators about survey and certification issues as it relates to home dialysis. Seeking appropriate reimbursement and access for an investigational indication of our product, GammaGard, to treat Alzheimers Disease.

Client expense: $820,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

S. 319, Pharmaceutical Market Access and Drug Safety Act - Lobbied against passage of legislation to allow for the importation of unsafe prescription drugs. S. 752, Lung Cancer Mortality Reduction Act of 2011 - Lobbied for passage of bill to reduce lung cancer mortality. NO BILL, Health Care Reform Implementation - Lobbied on implementation of provisions in the health care reform bill regarding biosimilars, the Independent Payment Advisory Board and the Annual Fee. S. 296 and H.R. 2245, Preserving Access to Life-Savings Medications Act - Lobbied to improve provisions in the drug shortage legislation. H.R. 1483, Drug Safety Enhancement Act of 2011 - Lobbied to pass meaningful drug safety legislation. S. 3187, the "Food and Drug Administration Safety and Innovation Act - Lobbied for passage of PDUFA legislation. S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments - Lobbied to pass meaningful FDA reform legislation. S. 2236, Advancing Breakthrough Therapies for Patients Act of 2012 - Lobbied to pass meaningful FDA reform legislation. H.R. 4274, BCPA and PREA Reauthorization Act of 2012 - Lobbied for permanence of BCPA and PREA. H.R. 3497, MODERN Cures Act of 2011 - Lobbied for incentives for development of pharmacodiagnostics and dormant therapies. H.R. 3737, Unlocking Lifesaving Treatments for Rare-Diseases Act - Lobbied to pass meaningful FDA reform legislation. H.R. 4132, Faster Access to Specialized Treatments Act - Lobbied to pass meaningful FDA reform legislation. Labor, HHS Appropriations. Lobbied for increased access to HIV/AIDS drugs in the AIDS Drug Assistance Program. NO BILL, Supply chain draft legislation - Lobbied for passage of legisaltion to increase security of the drug distribution supply chain.

Client expense: $1,280,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), SENATE, Treasury, Dept of

- 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)

S. 3187, Food and Drug Administration Safety and Innovation Act; Reauthorization of the Prescription Drug User Fee Act; Reauthorization of the Medical Device User Fee Act; H.R. 1483, Drug Safety Enhancement Act of 2011 H.R. 2182, Generating Antibiotic Incentives Now (GAIN) Act (S. 1734), issues concerning technical clarifications; issues related to track and trace of pharmaceuticals; issues concerning Patient Centered Outcomes Research Institute grants. Implementation of Patient Protection and Affordable Care Act of 2010 (Pub. L. 111-148); Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152) Technical changes to Food and Drug Administration Safety and Innovation Act (PL 112-144) Medical research Antibiotic resistance issues H.R. 2182 / S. 1734, Generating Antibiotic Incentives Now Act of 2011 H.R. 5651, Food and Drug Administration Reform Act of 2012 S. 3295, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2013 H.J. Res. 117, Continuing Appropriations Resolution

Client expense: $340,000 · Firm income: Not reported

Government targets: 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

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

S.27, Preserve Acess to Affordable Generics; H.R. 1483, Drug Safety Enhancement Act; Implementation of P.L. 111-148, Patient Protection & Affordable Care; Prescription Drug User Fee Reauthorization issues.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 27, Preserve Access to Affordable Generics; H.R. 1483, Drug Safety Enhancement Act; Implementation of P.L. 111-148, Patient Protection & Affordable Care Act; Prescription Drug User Fee Reauthorization issues; H.R. 8, the American Taxpayer Relief Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

The Prescription Drug Marketing Act and issues relating to anti-counterfeiting/pedigree issues Drug importation issues; Drug safety and inspection of drug manufacturing facilities; Prescription Drug Abuse; H.R. 1316, Stop Oxy Abuse Act; H.R. 1065, Pill Mill Crackdown Act; Patient Protection and Affordable Care Act; H.R. 1483, Drug Safety Enhancement Act; Drug shortages; Preserving Access to Life-Saving Medications Act (S. 296); H.R.2245,Preserving Access to Life-Saving Medications Act of 2011

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

Government targets: Federal Communications Commission (FCC), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE

S.3187, Food and Drug Administration Safety and Innovation Act; Reauthorization of the Prescription Drug User Fee Act; Reauthorization of the Medical Device User Fee Act; H.R. 1483, Drug Safety Enhancement Act of 2011

Client expense: Not reported · Firm income: $36,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

The Prescription Drug Marketing Act and issues relating to anti-counterfeiting/pedigree issues Drug importation issues; Drug safety and inspection of drug manufacturing facilities; Prescription Drug Abuse; H.R. 1316, Stop Oxy Abuse Act; H.R. 1065, Pill Mill Crackdown Act; Patient Protection and Affordable Care Act; H.R. 1483, Drug Safety Enhancement Act; Drug shortages; Preserving Access to Life-Saving Medications Act (S. 296); H.R.2245,Preserving Access to Life-Saving Medications Act of 2011

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

Government targets: Federal Communications Commission (FCC), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE

Implementation of Pub. Law No. 111-148, the Patient Protection and Affordable Care Act, primarily patient protection provisions and provisions on breast health education, research and clinical trials. (Continued on Addendum) H.R.2245/S.296, Preserving Access to Life-Saving Medications Act of 2011, primarily matters related to establishing notification requirements to mitigate drug shortages. H.R. 3839, Drug Shortage Prevention Act of 2012. H.R.2499, Lymphedema Diagnosis and Treatment Cost-Saving Act of 2011. H.R.3102, Breast Density and Mammography Reporting Act of 2011. H.R.3705, Comprehensive Cancer Care Improvement Act of 2011. H.R.2746, Cancer Drug Coverage Parity Act of 2011. H.R.1483, Drug Safety Enhancement Act of 2011, primarily matters related to ensuring the safety and quality of the drug supply chain. H.R.3699, Research Works Act, primarily matters related to opposing it in order to protect the NIH Public Access Policy. S.2113, Transforming the Regulatory Environment to Accelerate Access to Treatments, primarily matters related to codifying and clarifying FDA authority to expedite approval of new treatments for life-threatening conditions. S.2236, Advancing Breakthrough Therapies for Patients Act of 2012. Pub. Law No. 112-144, Food and Drug Administration Safety and Innovation Act of 2012, primarily matters related to drug shortages, drug approval and patient access. H.R. 4209, Patients' Access to Treatments Act of 2012. H.R. 5937, Breast Cancer Patient Education Act of 2012. Pub. Law No. 112-240, American Taxpayer Relief Act of 2012, primarily matters related to funding for the National Breast and Cervical Cancer Early Detection Program and the National Institutes of Health.

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

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE

S. 1133 - Enforcing Orders and Reducting Customs Evasion Act of 2011 H.R. 1483 - Drug Safety Enhancement Act H.R. 3057 - Enforcing Orders and Reducing Customs Evasion Act of 2011 S. 1581 - FAIR Enforcement Against Duty Evasion Act of 2011 H.R. 6642 - Customs Trade Facilitation and Enforcement Act of 2012

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

Government targets: HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), 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 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)

S.606/H.R. 3059 - Creating Hope Act of 2011 Food and Drug Administration Safety and Innovation Act Implementation S. 296/H.R. 2245, Preserving Access to Life-Saving Medications Act H.R. 1483, Drug Safety Enhancement Act H.R. 3737, ULTRA (Unlocking Lifesaving Treatments for Rare Diseases) Act H.R. 4132, FAST (Faster Access to Specialized Treatments) Act Amendments to FDA Accelerated Approval Requirements H.R. 4156, EXPERRT (Expanding and Promoting Expertise in Review of Rare Treatments) Act H.R. 2182, GAIN (Generating Antibiotic Incentives Now) Act S. 1734, Generating Antibiotic Incentives Now Act Biosimilars User Fees Biosimilars Exclusivity Period in Administration's Budget Proposals Report on Innovation/FDA by President's Council of Advisors on Science and Technology (CPAST)

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

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

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

The Prescription Drug Marketing Act and issues relating to anti-counterfeiting/pedigree issues Drug importation issues; Drug safety and inspection of drug manufacturing facilities; Prescription Drug Abuse; H.R. 1316, Stop Oxy Abuse Act; H.R. 1065, Pill Mill Crackdown Act; Patient Protection and Affordable Care Act; H.R. 1483, Drug Safety Enhancement Act; Drug shortages; Preserving Access to Life-Saving Medications Act (S. 296); H.R.2245,Preserving Access to Life-Saving Medications Act of 2011

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

Government targets: Federal Communications Commission (FCC), 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. 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

S. 1133 - Enforcing Orders and Reducting Customs Evasion Act of 2011 H.R. 1483 - Drug Safety Enhancement Act H.R. 3057 - Enforcing Orders and Reducing Customs Evasion Act of 2011 S. 1581 - FAIR Enforcement Against Duty Evasion Act of 2011

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

Government targets: HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), SENATE

S.3187, Food and Drug Administration Safety and Innovation Act; Reauthorization of the Prescription Drug User Fee Act; Reauthorization of the Medical Device User Fee Act; H.R. 1483, Drug Safety Enhancement Act of 2011

Client expense: Not reported · Firm income: $36,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.3187, Food and Drug Administration Safety and Innovation Act; Reauthorization of the Prescription Drug User Fee Act; Reauthorization of the Medical Device User Fee Act; H.R. 1483, Drug Safety Enhancement Act of 2011

Client expense: Not reported · Firm income: $54,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.3187, Food and Drug Administration Safety and Innovation Act; Reauthorization of the Prescription Drug User Fee Act; Reauthorization of the Medical Device User Fee Act; H.R. 1483, Drug Safety Enhancement Act of 2011

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.296, H.R. 2245 Preserving Access to Life-Saving Medications Acts; 340B Drug Discount; H.R. 1483 , Drug Safety Enhancement Act; Devise Tax; AdvaMed Competitiveness Agenda; 510(k) Clearance Reforms; FDA Regulatory Environment. Raise awareness with legislators about the benefits of home dialysis and try to increase awareness in the veteran population. HELP and Energy and Commerce Drug shortage draft legislation. S. 3187, Food and Drug Administration Safety and Innovation Act. MDUFA, PDUFA, BSUFA, GDUFA. Traceability and drug supply chain reforms. Medical device reforms. Medical Gases Safety Act. Raise Awareness with legislators about survey and certification issues as it relates to home dialysis.

Client expense: $460,000 · Firm income: Not reported

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)