Generic Drug and Biosimilar User Fee Act of 2012

Patent Reform, Patent Settlements/Reverse Payments/Exclusionary Payments, Patent Term Extensions, Generic Drugs H.R. 2182 Generating Antibiotic Incentives Now Act of 2011 H.R. 3497 - MODDERN Cures Act of 2011 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 S. 27 Preserve Access to Affordable Generics Act S. 373 Fair Prescription Drug Competition Act S. 1734 - Generating Antibiotic Incentives Now Act of 2011 S. 1882 - The Fair and Immediate Release of Generic Drugs Act S. 2516 - Food and Drug Administration Safety and Innovation Act S. 3187 Food and Drug Administration Safety and Innovation Act

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

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. 319, Pharmaceutical Market Access and Drug Safety Act of 2011 H.R. 3988, Generic Drug and Biosimilar User Fee Act of 2012 S. 3187, FDA Safety and Innovation Act Issues relating to bioequivalence and related administrative procedures Issues relating to DEA quotas for controlled substances Oversight of DEA Issues relating to prescription drug abuse Issues relating to incentives for tamper-resistant formulations

Client expense: $520,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 319 - Pharmaceutical Market Access and Drug Safety Act of 2011. H.R. 3988 - Generic Drug and Biosimilar User Fee Act of 2012. S. 3187 - Food and Drug Administration Safety and Innovation Act. Issues relating to bioequivalence and related administrative procedures. Issues relating to DEA quotas for controlled substances. Oversight of DEA. Issues relating to prescription drug abuse. Issues relating to incentives for tamper-resistant formulations.

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

Government targets: HOUSE OF REPRESENTATIVES

Generic Drug User Fees, Funding for FDA, Funding for the Office of Generic Drugs, FY12 Presidential Budget Request, FY12 and FY13 Budget H.R. 3988 - Generic Drug and Biosimilar User Fee Act of 2012 H.R. 5651 - Food and Drug Administration Reform Act of 2012 H.R. 6433 - FDA User Fee Corrections Act of 2012 H.J.RES.117 - Continuing Appropriations Resolution, 2013 H.RES.778 - Providing for consideration of the joint resolution (H.J. Res. 117) making continuing appropriations for fiscal year 2013 S. 2516 - Food and Drug Administration Safety and Innovation Act S. 3187 Food and Drug Administration Safety and Innovation Act

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

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

Patent Reform, Patent Settlements/Reverse Payments/Exclusionary Payments, Patent Term Extensions, Generic Drugs H.R. 2182 Generating Antibiotic Incentives Now Act of 2011 H.R. 3497 - MODDERN Cures Act of 2011 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 S. 27 Preserve Access to Affordable Generics Act S. 373 Fair Prescription Drug Competition Act S. 1734 - Generating Antibiotic Incentives Now Act of 2011 S. 1882 - The Fair and Immediate Release of Generic Drugs Act S. 2516 - Food and Drug Administration Safety and Innovation Act S. 3187 Food and Drug Administration Safety and Innovation Act

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

S 2516-Food and Drug Administration Safety and Innovation Act: provisions and amendments related to telemedicine/pharmacy issues S 3187-Food and Drug Administration Safety and Innovation Act: provisions and amendments related to telemedicine and pharmacy issues HR 3988 Generic Drug and Biosimilar User Fee Act of 2012: provisions and amendments related to telemedicine and pharmacy issues S 2002 Online Pharmacy Safety Act: entire bill HR 4095 Online Pharmacy Safety Act: entire bill

Client expense: $197,224 · Firm income: Not reported

Government targets: Administration for Children & Families (ACF), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID)

**see addendum page PL 111-148 - The Patient Protection and Affordable Care Act, implementation H.R. 1217 - to Repeal the Prevention and Public Health Fund H.R. 2405 and S. 1855 - Pandemic and All-Hazards Preparedness Reauthorization Act of 2011 FDA User Fee Reauthorizations, drug development policies, accelerated approval S. 3187 - The Food and Drug Administration Safety and Innovation Act (H.R. 3988, H.R. 4087, H.R. 5334, S. 2236, S. 2289, S. 2516) ***, no specific bill, Raising Awareness of Hepatitis C, HHS National Strategy, Raising Awareness of Cystic Fibrosis ***, no specific bill, public health funding for Hepatitis, appropriations for the Department of Health and Human Services, screening guidelines, PDUFA, federal flu policy

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

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

**see addendum page Prescription drug importation S. 319 Pharmaceutical Market Access and Drug Safety Act of 2011 H.R. 147 - Prescription Drug Affordability Act S. 3187 - The Food and Drug Administration Safety and Innovation Act (H.R. 3988, H.R. 4087, H.R. 5334, S. 2236, S. 2289, S. 2516) ***, no specific bill(s), prescription drug importation, import safety, supply chain integrity, Prescription Drug User Fee Act and associated policies

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

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

**see addendum page PL 111-148 - The Patient Protection and Affordable Care Act, implementation FDA User Fee Reauthorization - S. 3187 - The Food and Drug Administration Safety and Innovation Act (H.R. 3988, H.R. 4087, H.R. 5334, S. 2236, S. 2289, S. 2516) S. 1700 - The Medical Device Regulatory Improvement Act S. 1865 - Patient Access to Medical Innovation Act S. 1995 Medical Device Patient Safety Act H.R. 3209 - Premarket Predictability Act H.R. 3203 - Novel Device Regulatory Relief Act H.R. 3230 - Keeping America Competitive through Harmonization Act H.R. 3205 - FDA Renewing Efficiency from Outside Review Management Act H.R. 3211 - Humanitarian Device Reform Act H.R. 3208 - Patients Come First Act H.R. 3206 - Cultivating Scientific Experts to Foster Innovation Act H.R. 3214 - Food and Drug Administration Mission Reform Act H.R. 3207 - Modernizing Laboratory Test Standards for Patients Act H.R. 3204 - Guidance Accountability and Transparency Act ***, no specific bill(s), 510k reform, imaging policy, medical device user fee reauthorization and all related policies

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

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

**see addendum page Prescription drug importation S. 319 Pharmaceutical Market Access and Drug Safety Act of 2011 H.R. 147 - Prescription Drug Affordability Act S. 296 - Drug Shortage Act S. 3187 - The Food and Drug Administration Safety and Innovation Act (H.R. 3988, H.R. 4087, H.R. 5334, S. 2236, S. 2289, S. 2516) ***, no specific bill(s), Drug Safety, Prescription Drug Importation, Import Safety, supply chain integrity, biosimlars, PDUFA and associated policies, patent settlements, accelerated approval, break through therapies

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

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

1099 Taxpayer Protection and Repayment of Exchange Subsidy Overpayments Act (H.R.4) Access to Independent Health Insurance Advisors Act (S.2068/S.2288) Access to Professional Health Insurance Advisors Act of 2011 (H.R.1206) Draft Legislation to Prevent Enforcement of Grandfathered Health Plan Regulation Draft Research Priorities (PCORI) EMS Quality, Innovation, and Cost Effectiveness Improvements Act of 2011 (H.R.3144) Essential Health Benefits Data Collection Proposed Rule (HHS) Experimental Study on Consumer Responses to Nutrition Facts Labels with Various Footnote Formats and Declaration of Amount of Added Sugars (FDA-2012-N-0495) Food and Drug Administration Safety and Innovation Act (FDA User Fee bills, S.3187/H.R.3988) Guidance on Defining Minimum Essential Value of Employer-Sponsored Insurance (Treasury) Guidance on Federally Facilitated Exchanges (HHS) Health Benefit Exchanges (H.R.1213) Health Care Cost Reduction Act (H.R.436) Health Equity and Accountability Act (H.R.2954/S.2474) Health Risk Assessments in Medicare Comments (CDC) Heart Disease Education, Analysis and Research, and Treatment for Women Act (HEART for Women Act) (S.438/H.R.3526) H.R. 436, Health Care Cost Reduction Act Interest Rate Reduction Act (H.R.4628/S.2366) and other legislation using Prevention Fund to offset student loans Josh Miller Helping Everyone Access Responsive Treatment in Schools (HEARTS) Act (H.R.1377) Menu Labeling (ACA Section 4205) Middle Class Tax Relief and Job Promotion Act (H.R.3630) National Prevention Strategy, Request for Comments (HHS - Surgeon General) Patient Protection and Affordable Care Act (P.L. 111-148; P.L. 111-152) - Implementation Prevention and Public Health Fund (ACA Section 4002) Qualified Health Plan Accreditation Proposed Rule (HHS) Repealing the Job-Killing Health Care Law Act (H.R.2) Sequester Replacement Reconciliation Act (H.R.5652) State Flexibility Act (H.R.1683/S.868) To Repeal Mandatory Funding Provided to States in the Patient Protection and Affordable Care Act to Establish American To Repeal the Patient Protection and Affordable Care Act (H.R.6079) Temporary Payroll Tax Cut Continuation Act (H.R.3630 - Medicare therapy caps exceptions process) To Repeal Mandatory Funding to States to Establish American Health Benefit Exchanges (H.R.1213) To Repeal Medical Loss Ratio Requirements (H.R.2077) To Repeal the Prevention and Public Health Fund (H.R.1217)

Client expense: $136,382 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Education, Dept of, Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Treasury, Dept of

**see addendum page PL 111-148 The Patient Protection and Affordable Care Act, implementation, health care reform, drug importation, follow-on biologics, 340b, comparative effectiveness, gift disclosure S. 3187 - The Food and Drug Administration Safety and Innovation Act (H.R. 3988, H.R. 4087, H.R. 5334, S. 2236, S. 2289, S. 2516) ***, no specific bills, PDUFA, antimicrobial resistance, importation, companion diagnostics

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

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

**see addendum page Prescription drug importation S. 319 Pharmaceutical Market Access and Drug Safety Act of 2011 H.R. 147 - Prescription Drug Affordability Act H.R. 2182/S. 1734 - Generating Antibiotics Incentives Now Act S. 3187 - The Food and Drug Administration Safety and Innovation Act (H.R. 3988, H.R. 4087, H.R. 5334, S. 2236, S. 2289, S. 2516) ***, no specific bill(s), Import Safety, Prescription Drug User Fee Act renewal, drug development policy, drug shortages, supply chain integrity, patent settlements

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

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

S. 319, Pharmaceutical Market Access and Drug Safety Act of 2011 H.R. 3988, Generic Drug and Biosimilar User Fee Act of 2012 S. 3187, FDA Safety and Innovation Act H.R. 5998, USPSTF Transparency and Accountability Act H.R. 6544, Manufacturing Innovation in America Act H.R. 6160, Stop Tampering of Prescription Pills Act H.R. 436, Health Care Cost Reduction Act regarding medical device excise tax repeal Issues relating to bioequivalence and related administrative procedures Issues relating to DEA quotas for controlled substances Oversight of DEA Issues relating to prescription drug abuse Issues relating to incentives for tamper-resistant formulations

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Policies related to the Federal Employees Health Benefit Program's pharmacy benefit (HR 979); Regulatory design and coverage of pharmacy benefits in health reform Exchanges and the commercial market (EHB, grandfathering, Rx quality, eRx, PBM disclosure requirements, MLR); legislation to promote generic drugs (S. 27); regulatory implementation of a pathway for the approval of biosimilars; REMs; 340b program; legislation placing restrictions on pharmacy benefit design (HR 1971, S 1058). FDA Safety and Innovation Act: S. 3187, H.R.3988, H.R.4087, H.R.5334, S.2236, S.2289, S.2516: issues regarding making prescription drugs more affordable (generic user fees; pedigree; pathway for biosimilars; REMs). General issues dealing with prescription drug abuse

Client expense: $423,292 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Labor, Dept of (DOL), SENATE, White House Office

Regulatory policies related to health reform legislation: structure, drug benefits, disclosure Regulatory implementation of HITECH/Accounting of Disclosures FDA Safety and Innovation Act: S. 3187, H.R.3988, H.R.4087, H.R.5334, S.2236, S.2289, S.2516: issues regarding making prescription drugs more affordable (generic user fees; pedigree; pathway for biosimilars; REMs).

Client expense: $423,292 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Labor, Dept of (DOL), SENATE, White House Office

Workforce preparedness; the role of technology in teaching and education; enhancing the public-private research partnerships necessary to improve education (list of specific legislation and regulations following on next page). Implementation and Reauthorization of PL 107-110, the No Child Left Behind Act (Elementary and Secondary Education Act) Implementation of PL 108-446, the Individuals with Disabilities Education Improvement Act of 2004 Telecommunications Act Reauthorization Higher Education Opportunity Act implementation (PL 110-315) E-Rate, including Anti-Deficiency Act Exemption Achievement through Technology and Innovation Act (S. 1128) Regulations implementing the Family Educational Rights and Privacy Act (FERPA; 20 U.S.C. 1232g; 34 CFR Part 99) American Recovery and Reinvestment Act (PL 111-5) implementation U.S. Department of Education's National Technology Plan FCC National Broadband Plan (provisions related to educational access) Implementation and Reauthorization of Competes Act (PL 110-69) Advanced Research Projects Agency for Education (ARPA-ED) Federal legislation and grants to develop open licensed educational content, including implementation of the U.S. Department of Labors Trade Adjustment Assistance Community College and Career Training (TAACCT) grant program Implementation of the U.S. Department of Education Recovery Acts Race to the Top Assessment grants U.S. DoEd Accessibility of Instructional Materials (AIM) Commission STEM education programs Student Success Act (H.R. 3988) Encouraging Innovation and Effective Teachers Act (H.R. 3990) Race to the Top, including Race to the Top Assessment grants and district grants

Client expense: $210,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Education, Dept of, Executive Office of the President (EOP), Federal Communications Commission (FCC), Federal Trade Commission (FTC), General Services Administration (GSA), HOUSE OF REPRESENTATIVES, Labor, Dept of (DOL), Natl Institute of Standards & Technology (NIST), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Copyright Office, U.S. Trade Representative (USTR)

**add addendum page S. 3187 - The Food and Drug Administration Safety and Innovation Act (H.R. 3988, H.R. 4087, H.R. 5334, S. 2236, S. 2289, S. 2516) ***, no specific bill, Prescription Drug User Fee Act (PDUFA) and associated policies

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

**see addendum page PL 111-148 The Patient Protection and Affordable Care Act, implementation, care coordination, long-term care PL 111-375 - The National Alzheimer's Project Act, implementation H.R. 1897 - Alzheimer's Breakthrough Act FDA User Fee Reauthorizations, drug innovation policies S. 3187 - The Food and Drug Administration Safety and Innovation Act (H.R. 3988, H.R. 4087, H.R. 5334, S. 2236, S. 2289, S. 2516)

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

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

**add addendum page Implementation of the Special Diabetes Program, renewal of the Special Diabetes Program H.R. 6309 - reauthorization of SDP S. 3187 - The Food and Drug Administration Safety and Innovation Act (H.R. 3988, H.R. 4087, H.R. 5334, S. 2236, S. 2289, S. 2516), medical device policies, accelerated approval, breakthrough therapies ***, no specific bill, artificial pancreas program

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

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office

**see addendum page PL 111-148 - The Patient Protection and Affordable Care Act, implementation S. 3187 - The Food and Drug Administration Safety and Innovation Act (H.R. 3988, H.R. 4087, H.R. 5334, S. 2236, S. 2289, S. 2516) S. 1700 - The Medical Device Regulatory Improvement Act S. 1865 - Patient Access to Medical Innovation Act S. 1995 - Medical Device Patient Safety Act H.R. 3209 - Premarket Predictability Act H.R. 3203 - Novel Device Regulatory Relief Act H.R. 3230 - Keeping America Competitive through Harmonization Act H.R. 3205 - FDA Renewing Efficiency from Outside Review Management Act H.R. 3211 - Humanitarian Device Reform Act H.R. 3208 - Patients Come First Act H.R. 3206 - Cultivating Scientific Experts to Foster Innovation Act H.R. 3214 - Food and Drug Administration Mission Reform Act H.R. 3207 - Modernizing Laboratory Test Standards for Patients Act H.R. 3204 - Guidance Accountability and Transparency Act ***, no specific bill(s), import safety, health care reform, 510K reform, medical device user fee program, companion diagnostics

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

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

**see addendum page S. 660 - PATIENTS Act of 2011, comparative effectiveness S. 296/H.R. 2245 - Preserving Access to Life Saving Medications Act Health care reform, drug importation, 340b, biosimilars PL 111-148 - The Patient Protection and Affordable Care Act, PL 111-152 - The Reconciliation Act of 2010, implementation S. 3187 - The Food and Drug Administration Safety and Innovation Act (H.R. 3988, H.R. 4087, H.R. 5334, S. 2236, S. 2289, S. 2516) ***no specific bills, importation, Prescription Drug User Fee Act Renewal and associated policies, supply chain integrity

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

**add addendum page PL 111-148 - The Patient Protection and Affordable Care Act, implementation S. 3187 - The Food and Drug Administration Safety and Innovation Act (H.R. 3988, H.R. 4087, H.R. 5334, S. 2236, S. 2289, S. 2516) FDA User Fee Reauthorizations S. 1700 - The Medical Device Regulatory Improvement Act S. 1865 - Patient Access to Medical Innovation Act S. 1995 Medical Device Patient Safety Act H.R. 3209 - Premarket Predictability Act H.R. 3203 - Novel Device Regulatory Relief Act H.R. 3230 - Keeping America Competitive through Harmonization Act H.R. 3205 - FDA Renewing Efficiency from Outside Review Management Act H.R. 3211 - Humanitarian Device Reform Act H.R. 3208 - Patients Come First Act H.R. 3206 - Cultivating Scientific Experts to Foster Innovation Act H.R. 3214 - Food and Drug Administration Mission Reform Act H.R. 3207 - Modernizing Laboratory Test Standards for Patients Act H.R. 3204 - Guidance Accountability and Transparency Act ***, no specific bills, FDA related issues, diagnostics, drug shortages

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

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

S. 3187 - The Food and Drug Administration Safety and Innovation Act (H.R. 3988, H.R. 4087, H.R. 5334, S. 2236, S. 2289, S. 2516) ***, no specific bills, drug safety

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 319 - Pharmaceutical Market Access and Drug Safety Act of 2011. H.R. 3988 - Generic Drug and Biosimilar User Fee Act of 2012. S. 3187 - Food and Drug Administration Safety and Innovation Act. Issues relating to bioequivalence and related administrative procedures. Issues relating to DEA quotas for controlled substances. Oversight of DEA. Issues relating to prescription drug abuse. Issues relating to incentives for tamper-resistant formulations.

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

Government targets: HOUSE OF REPRESENTATIVES

S. 3187, Food and Drug Administration Safety and Innovation Act -issues related to bioequivalence for locally-acting drugs; H.R. 5651, Food and Drug Administration Reform Act of 2012 - issues related to bioequivalence for locally-acting drugs; H.R. 3988, Generic Drug and Biosimilar User Fee Act of 2012 - issues related to bioequivalence for locally-acting drugs; Senate working drafts of PDUFA (Prescription Drug User Fee Act) Reauthorization - issues related to bioequivalence for locally-acting drugs

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S 2516-Food and Drug Administration Safety and Innovation Act: provisions and amendments related to telemedicine/pharmacy issues S 3187-Food and Drug Administration Safety and Innovation Act: provisions and amendments related to telemedicine and pharmacy issues HR 3988 Generic Drug and Biosimilar User Fee Act of 2012: provisions and amendments related to telemedicine and pharmacy issues S 2002 Online Pharmacy Safety Act: entire bill HR 4095 Online Pharmacy Safety Act: entire bill

Client expense: $197,224 · Firm income: Not reported

Government targets: Administration for Children & Families (ACF), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID)

H.R. 452: MEDICARE DECISIONS ACCOUNTABILITY ACT OF 2011; ALL PROVISIONS OF THE BILL H.R. 3988: GENERIC DRUG AND BIOSIMILAR USER FEE ACT OF 2012; ALL PROVISIONS OF THE BILL H.R. 4687: TO EXTEND THE TEMPORARY SUSPENSION OF DUTY ON PHENMEDIPHAM; ALL PROVISIONS OF THE BILL H.R. 5334: TO AMEND CHAPTER V OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT TO EXPEDITE THE DEVELOPMENT AND REVIEW OF BREAKTHROUGH THERAPIES; ALL PROVISIONS OF THE BILL S. 668: HEALTH CARE BUREAUCRATS ELIMINATION ACT; ALL PROVISIONS OF THE BILL S. 2236: ADVANCING BREAKTHROUGH THERAPIES FOR PATIENTS ACT OF 2012; ALL PROVISIONS OF THE BILL S. 2289: BETTER PHARMACEUTICALS AND DEVICES FOR CHILDREN ACT OF 2012; ALL PROVISIONS OF THE BILL S. 2516/ S. 3187: FOOD AND DRUG ADMINISTRATION SAFETY AND INNOVATION ACT; ALL PROVISIONS OF THE BILLS IMPLEMENTATION OF PATIENT PROTECTION AND AFFORDABLE CARE ACT

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Workforce preparedness; the role of technology in teaching and education; enhancing the public-private research partnerships necessary to improve education (list of specific legislation and regulations following on next page). Implementation and Reauthorization of PL 107-110, the No Child Left Behind Act (Elementary and Secondary Education Act) Implementation of PL 108-446, the Individuals with Disabilities Education Improvement Act of 2004 Telecommunications Act Reauthorization Higher Education Opportunity Act implementation (PL 110-315) E-Rate, including Anti-Deficiency Act Exemption Achievement through Technology and Innovation Act (S. 1128) Regulations implementing the Family Educational Rights and Privacy Act (FERPA; 20 U.S.C. 1232g; 34 CFR Part 99) American Recovery and Reinvestment Act (PL 111-5) implementation U.S. Department of Education's National Technology Plan FCC National Broadband Plan (provisions related to educational access) Implementation and Reauthorization of Competes Act (PL 110-69) Advanced Research Projects Agency for Education (ARPA-ED) Federal legislation and grants to develop open licensed educational content, including implementation of the U.S. Department of Labors Trade Adjustment Assistance Community College and Career Training (TAACCT) grant program Implementation of the U.S. Department of Education Recovery Acts Race to the Top Assessment grants U.S. DoEd Accessibility of Instructional Materials (AIM) Commission STEM education programs Student Success Act (H.R. 3988) Encouraging Innovation and Effective Teachers Act (H.R. 3990)

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

Government targets: Commerce, Dept of (DOC), Education, Dept of, Executive Office of the President (EOP), Federal Communications Commission (FCC), Federal Trade Commission (FTC), General Services Administration (GSA), HOUSE OF REPRESENTATIVES, Labor, Dept of (DOL), Natl Institute of Standards & Technology (NIST), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Copyright Office, U.S. Trade Representative (USTR)

H.R. 979, FEHBP Prescription Drug Integrity, Transparency, and Cost Savings Act (Lynch) FEHBP prescription drugs H.R.1946, Preserving Hometown Independent Pharmacies Act (Marino) antitrust exemption for independent pharmacies H.R. 3988, Generic Drug and Biosimilar User Fee Act (Murphy/Pitts/Waxman) FDA user fee programs 16. Specific Lobbying Issues (continued): H.R. 3995, Protecting Consumer Access to Generic Drugs Act (Rush) pay-for-delay settlements H.R. 5651, FDA Reform Act (Upton) pharmaceutical, medical device issues S. 27, Preserve Access to Affordable Generics Act (Kohl) pay-for-delay settlements S. 2193, Ensuring Safe Medical Devices for Patients (Merkley) FDA oversight of medical devices S. 2516, the FDA Safety and Innovation Act (Harkin) pharmaceutical, medical device issues S. 3187, the FDA Safety and Innovation Act (Harkin) pharmaceutical, medical device issues S. 2002, Online Pharmacy Safety Act (Feinstein) establishes standards for on-line pharmacies Regulatory Issues: Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; and issues relating to access for investigational drugs; and other issues relating to health care reform implementation.

Client expense: $2,240,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Federal Bureau of Investigation (FBI), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Office of Personnel Management (OPM), Pension & Welfare Benefits Administration, SENATE, Treasury, Dept of, White House Office

S. 319, Pharmaceutical Market Access and Drug Safety Act of 2011; H.R. 3988, Generic Drug and Biosimilar User Fee Act of 2012; S. 3187, FDA Safety and Innovation Act; issues relating to bioequivalence and related administrative procedures; issues relating to DEA quotas for controlled substances; oversight of DEA; issues relating to prescription drug abuse.

Client expense: $480,000 · Firm income: Not reported

Government targets: Drug Enforcement Administration (DEA), HOUSE OF REPRESENTATIVES, SENATE

H.R. 979, FEHBP Prescription Drug Integrity, Transparency, and Cost Savings Act (Lynch) - FEHBP prescription drugs H.R.1946, Preserving Hometown Independent Pharmacies Act (Marino) - antitrust exemption for independent pharmacies H.R. 3988, Generic Drug and Biosimilar User Fee Act (Murphy/Pitts/Waxman) - FDA user fee programs H.R. 3995, Protecting Consumer Access to Generic Drugs Act (Rush) - pay-for-delay settlements H.R. 5651, FDA Reform Act (Upton) - pharmaceutical, medical device issues S. 27, Preserve Access to Affordable Generics Act (Kohl) - pay-for-delay settlements S. 2193, Ensuring Safe Medical Devices for Patients (Merkley) - FDA oversight of medical devices S. 2516, the FDA Safety and Innovation Act (Harkin) - pharmaceutical, medical device issues S. 3187, the FDA Safety and Innovation Act (Harkin) - pharmaceutical, medical device issues S. 2002, Online Pharmacy Safety Act (Feinstein) - establishes standards for on-line pharmacies

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 3988, Generic Drug and Biosimilar User Fee Act of 2012, all sections relating to vision. HR 5651, To suspend temporarily the rate of duty on 1-Hydroxy cyclohexyl phenyl ketone. S 2297, A bill to amend the Controlled Substances Act to make any substance containing hydrocodone a schedule II drug, all sections relating to vision. S 2516, Food and Drug Administration Safety and Innovation Act. All Sections related to the practice of optometry including, but not limited to, the reclassification of controlled substances (i.e. hydrocodone). S 3187, Food and Drug Administration Safety and Innovation Act, All Sections related to the practice of optometry including, but not limited to, the reclassification of controlled substances (i.e. hydrocodone).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 353, Glaucoma Screening Act of 2011, all sections. HR 364, Common Sense Health Reform Americans Actually Want Act, all sections. HR 451, Healthcare Truth and Transparency Act of 2011, all sections. HR 452, Medicare Decisions Accountability Act of 2011, all sections relating to vision. HR 531, Access to Frontline Health Care Act of 2011, all sections relating to vision. HR 605, Patients Freedom to Choose Act, all sections relating to vision. HR 969, Medical Practice Freedom Act of 2011, all sections relating to vision. HR 1195, National Health Service Corps Improvement Act of 2011, all sections relating to vision HR 1206, Access to Professional Health Insurance Advisors Act of 2011, all sections relating to vision. HR 1219, Optometric Equity in Medicaid Act, all sections relating to vision. HR 3183, To amend title XXVII of the Public Health Service Act to exempt licensed independent insurance producer remuneration from the medical loss ratio, all sections relating to vision. HR 3207, Modernizing Laboratory Test Standards for Patients Act of 2011, all sections relating to vision. HR 3216, VHA Ophthalmologic Service Establishment Act of 2011, all sections relating to vision. H.R.3988, Generic Drug and Biosimilar User Fee Act of 2012, all sections related to the practice of optometry including, but not limited to, the reclassification of controlled substances (i.e. hydrocodone). HR 5651, Food and Drug Administration Reform Act of 2012, All Sections related to the practice of optometry including, but not limited to, the reclassification of controlled substances (i.e. hydrocodone). S 312, Patients Freedom to Choose Act, all sections relating to vision. S 2068, Access to Independent Health Insurance Advisors Act of 2012, all sections relating to vision. S 2192, National Health Service Corps Improvement Act of 2012, , all sections relating to vision. S 2297, A bill to amend the Controlled Substances Act to make any substance containing hydrocodone a schedule II drug, all sections relating to vision. S 2516, Food and Drug Administration Safety and Innovation Act. All Sections related to the practice of optometry including, but not limited to, the reclassification of controlled substances (i.e. hydrocodone). S 3187, Food and Drug Administration Safety and Innovation Act, all sections related to the practice of optometry including, but not limited to, the reclassification of controlled substances (i.e. hydrocodone).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 451, Healthcare Truth and Transparency Act of 2011, all sections relating to vision. HR 605, Patients Freedom to Choose Act, all sections relating to vision. HR 3207, Modernizing Laboratory Test Standards for Patients Act of 2011, all sections relating to vision. HR 3988, Generic Drug and Biosimilar User Fee Act of 2012, all sections related to the practice of optometry including, but not limited to, the reclassification of controlled substances (i.e. hydrocodone). HR 5651, Food and Drug Administration Reform Act of 2012, all sections related to the practice of optometry including, but not limited to, the reclassification of controlled substances (i.e. hydrocodone). S 312, Patients Freedom to Choose Act, all sections relating to vision. S 2297, A bill to amend the Controlled Substances Act to make any substance containing hydrocodone a schedule II drug, all sections relating to vision. S 2516, Food and Drug Administration Safety and Innovation Act. All Sections related to the practice of optometry including, but not limited to, the reclassification of controlled substances (i.e. hydrocodone). S 3187, Food and Drug Administration Safety and Innovation Act, All Sections related to the practice of optometry including, but not limited to, the reclassification of controlled substances (i.e. hydrocodone).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 3988, Generic Drug and Biosimilar User Fee Act of 2012, all sections related to the practice of optometry including, but not limited to, the reclassification of controlled substances (i.e. hydrocodone). HR 5651, Food and Drug Administration Reform Act of 2012, all sections related to the practice of optometry including, but not limited to, the reclassification of controlled substances (i.e. hydrocodone). S 2297, A bill to amend the Controlled Substances Act to make any substance containing hydrocodone a schedule II drug. A bill to amend the Controlled Substances Act to make any substance containing hydrocodone a schedule II drug, all sections relating to vision. S 2516, Food and Drug Administration Safety and Innovation Act, all sections related to the practice of optometry including, but not limited to, the reclassification of controlled substances (i.e. hydrocodone). S 3187, Food and Drug Administration Safety and Innovation Act, all sections related to the practice of optometry including, but not limited to, the reclassification of controlled substances (i.e. hydrocodone).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 3187 - The Food and Drug Administration Safety and Innovation Act (H.R. 3988, H.R. 4087, H.R. 5334, S. 2236, S. 2289, S. 2516)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

**see addendum page Prescription drug importation S. 319 Pharmaceutical Market Access and Drug Safety Act of 2011 H.R. 147 - Prescription Drug Affordability Act S. 296 - Drug Shortage Act S. 3187 - The Food and Drug Administration Safety and Innovation Act (H.R. 3988, H.R. 4087, H.R. 5334, S. 2236, S. 2289, S. 2516) ***, no specific bill(s), Drug Safety, Prescription Drug Importation, Import Safety, supply chain integrity, biosimlars, PDUFA and associated policies, patent settlements, accelerated approval, break through therapies

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

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

**see addendum page Prescription drug importation S. 319 Pharmaceutical Market Access and Drug Safety Act of 2011 H.R. 147 - Prescription Drug Affordability Act H.R. 2182/S. 1734 - Generating Antibiotics Incentives Now Act S. 3187 - The Food and Drug Administration Safety and Innovation Act (H.R. 3988, H.R. 4087, H.R. 5334, S. 2236, S. 2289, S. 2516) ***, no specific bill(s), Import Safety, Prescription Drug User Fee Act renewal, drug development policy, drug shortages, supply chain integrity, patent settlements

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

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

**see addendum page PL 111-148 The Patient Protection and Affordable Care Act, implementation, health care reform, drug importation, follow-on biologics, 340b, comparative effectiveness, gift disclosure S. 3187 - The Food and Drug Administration Safety and Innovation Act (H.R. 3988, H.R. 4087, H.R. 5334, S. 2236, S. 2289, S. 2516) ***, no specific bills, PDUFA, antimicrobial resistance, importation, companion diagnostics

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

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

**add addendum page Implementation of the Special Diabetes Program, renewal of the Special Diabetes Program S. 3187 - The Food and Drug Administration Safety and Innovation Act (H.R. 3988, H.R. 4087, H.R. 5334, S. 2236, S. 2289, S. 2516), medical device policies, accelerated approval, breakthrough therapies ***, no specific bill, artificial pancreas program

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

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office

**see addendum page Prescription drug importation S. 319 Pharmaceutical Market Access and Drug Safety Act of 2011 H.R. 147 - Prescription Drug Affordability Act S. 3187 - The Food and Drug Administration Safety and Innovation Act (H.R. 3988, H.R. 4087, H.R. 5334, S. 2236, S. 2289, S. 2516) ***, no specific bill(s), prescription drug importation, import safety, supply chain integrity, Prescription Drug User Fee Act and associated policies

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

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

**see addendum page PL 111-148 - The Patient Protection and Affordable Care Act, implementation H.R. 1217 - to Repeal the Prevention and Public Health Fund H.R. 2405 and S. 1855 - Pandemic and All-Hazards Preparedness Reauthorization Act of 2011 FDA User Fee Reauthorizations, drug development policies, accelerated approval S. 3187 - The Food and Drug Administration Safety and Innovation Act (H.R. 3988, H.R. 4087, H.R. 5334, S. 2236, S. 2289, S. 2516) ***, no specific bill, Raising Awareness of Hepatitis C, HHS National Strategy ***, no specific bill, public health funding for Hepatitis, appropriations for the Department of Health and Human Services, screening guidelines, PDUFA, federal flu policy

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

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE