To amend chapter V of the Federal Food, Drug, and Cosmetic Act to expedite the development and review of breakthrough therapies.

**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

**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

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

**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

**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

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

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

Issues related to raising awareness of Hepatitis C (no specific bills); Viral Hepatitis Testing Act of 2011 (H.R. 3381, S. 1809), all provisions; Pandemic and All-Hazards Preparedness Reauthorization Act of 2011 (H.R. 2405, S. 1855), all provisions; (cont'd next page) Expanding and Promoting Expertise in Review of Rare Treatments Act of 2012 (H.R.4156 , S.2281), all provisions; Transforming the Regulatory Environment to Accelerate Access to Treatments (S.2113), provisions; The Unlocking Lifesaving Treatments for Rare-Diseases Act (H.R.3737), all provisions; The Food and Drug Administration Safety and Innovation Act (S.3187), all provisions; To amend chapter V of the Federal Food, Drug, and Cosmetic Act to expedite the development and review of breakthrough therapies (H.R.5334), all provisions; The FAST Act (H.R.4132), all provisions; The Food and Drug Administration Reform Act of 2012 (H.R.5651), all provisions.

Client expense: $360,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), 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

Medicare Dental Benefits. S. 3272, H.R. 5909: provisions creating a Medicare Part B dental benefit. Medigap Benefits. S. 3271: provisions expanding access to Medicare supplemental insurance. Benefit Redesign. (No Bill): proposal to provide a catastrophic cap on Medicare out-of-pocket spending funded by a surcharge on private Medigap policies and employer-provided retiree health benefits. Independent Payment Advisory Board. H.R. 452, S. 668, H.R. 1 (Sec. 4050): proposals to repeal or modify the provisions of P.L. 111-148 and P.L. 111-152 reducing Medicare spending growth through an independent commission. Medicare Drug Savings. S. 1206, H.R. 2190: provisions extending Medicaid drug rebates to prescription drugs paid for by Medicare on behalf of Medicare-Medicaid dual-eligibles, and by Medicare Part D Low-Income Subsidy beneficiaries. Home Health Benefits. (No bill): proposal to require copayments from people receiving the Medicare home health benefit. Medicare Income-relating. (No bill): proposals to increase the percent of Medicare beneficiaries paying higher income-related premiums. Medicare Part A Hospital Inpatient Status. S. 818, H.R. 1543: provisions ensuring beneficiaries receiving hospital services are designated as inpatients, thereby assuring coverage of prescription drugs and post-acute care under Part A following a three-day hospitalization. Medicare Parts C and D. P.L. 110-275, P.L. 108-173: implementation of regulations and the issuance of guidance relating to beneficiary eligibility, enrollment, and effectiveness of exceptions and the appeals processes under Medicare Parts C and D. Medicare Part D Negotiation of Drug Prices. S. 31, S. 44, S. 560, H.R. 999, H.R. 3638: provisions creating a Medicare-operated prescription drug plan, allowing or requiring the Secretary of the Department of Health and Human Services to negotiate price concessions from pharmaceutical manufacturers for drugs purchased under the Part D program. Medicare Managed Care. H.R. 4254: provisions pertaining to revising the coding intensity adjustment factor in the demographic adjustment formula (used in calculating payments to Medicare Advantage organizations) for 2015 and subsequent years and setting the timing of prepayments beginning with January 2013. Medicare Supplemental Health Insurance. (No bill): proposals to increase costs for Medicare supplemental insurance. Medicare Physician Fees. P.L. 112-96, (H.R. 3630): provisions maintaining current levels of physician fees under Part B; extending the therapy caps exceptions process; and extending the Qualified Individual program. Medicare Privatization/Premium Support. (H. Con. Res. 112 and S. Con. Res. 37): provisions to convert Medicare from a defined benefit plan to a premium support/voucher system. Raising Medicare Eligibility Age. (H. Con. Res. 112 and S. Con. Res. 37): provisions to raise the Medicare eligibility age from 65 to 67. Prescription Drug Safety. P.L.112-144 (S. 3187, H.R. 3988, H.R. 4087, H.R. 5334, S. 2236, S. 2289 and S. 2516): provisions facilitating the importation of prescription drugs; preventing pharmaceutical fraud by requiring good corporate behavior; facilitating the adoption of modern information technology; and prohibiting brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market. Public Health Service Act Dental Care. S. 1878, H.R. 4091: provisions pertaining to offering grant support to national dental programs that provide pro-bono dental care to Medicare and Medicaid eligible low-income children and adults. Comprehensive Health Care Reform. P.L. 111-148, P.L. 111-152: provisions related to reducing Medicare Advantage plan payments; reducing the Part D coverage gap; requiring higher income Medicare beneficiaries to pay an increased share of Medicare Parts B and D premium costs; expanding benefits for low-income beneficiaries under the Medicare Savings Programs and the Part D Low-Income Subsidy (LIS); improving the process for reassigning LIS beneficiaries to new plans; expanding coverage of prevention services; establishing a Medicare Commission; providing expanded Medicaid coverage for home and community-based services; authorizing the collection of data regarding disparities in the provision of care; providing safeguards and subsidies to assure affordability of health coverage for seniors. Center for Medicare and Medicaid Innovations. (No bill): proposals related to planning for the Center for Medicare and Medicaid Innovations, and the approach this entity will take to test innovative payment and service delivery models to reduce program expenditures, while preserving or enhancing the quality of care for Medicare, Medicaid and CHIP beneficiaries. Federal Coordinated Health Care Office/Medicare-Medicaid Coordination Office. (No bill): proposals related to activities of the Federal Coordinated Health Care Office intended to improve the quality of care for Medicare and Medicaid dual-eligibles. Long-term Care Financing. (No bill): proposals to amend the Internal Revenue Code of 1986 to allow individuals a deduction for qualified long-term care insurance premiums; to permit the use of qualified long-term care insurance under cafeteria plans and flexible spending arrangements; and to provide a tax credit for individuals with long-term care needs. Long-term Services and Supports/Repeal of CLASS. S. 720, H.R. 1173: provisions repealing the Community Living Assistance Services and Supports (CLASS) Act.

policy ideas/legislation on innovation/science/tech and related start-up issues including: H.R. 3606 JOBS Act; S. 3217/H.R. 5893 Startup Act 2.0; S. 17/H.R. 436 Repeal of Medical Device Tax; S. 3187/H.R. 5651 FDA User Fee Reauthorization; H.R. 3203 Novel Device Regulatory Relief Act; H.R. 5334 Breakthroughs Therapy Act; issues related to innovation and domestic production; and issues related to wireless health and spectrum.

Client expense: $90,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Economic Development Administration, HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE, Small Business Administration (SBA)

**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

**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

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

**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

**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 ***, no specific bill, Prescription Drug User Fee Act (PDUFA) 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: $80,000

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

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: $470,000 · 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

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).

Client expense: $470,000 · 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