Preserving Access to Orphan Drugs Act of 2015

Pharmaceutical patent issues, including related provisions in H.R. 9, the Innovation Act, S. 1137, the PATENT Act, and H.R.3678, the Preserving Access to Orphan Drugs Act of 2015. Legislative issues related to the FDA Regulation of Biosimilars.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Biosimilars, no specific bill H.R. 6, 21st Century Cures Act FDA Reform; Senate Innovation for Healthier Americans Initiative (no bill number) H.R. 3678 Orphan Drugs Prescription drug value issues, no specific bill

Client expense: $2,280,000 · Firm income: Not reported

- orphan drug tax credit H.R. 3678 - Preserving Access to Orphan Drug Act of 2015 S. 1906/H.R. 3618 - Orphan Drug Fairness Act

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

Orphan drug exclusion within the pharmaceutical tax in the Patient Protection and Affordable Care Act H.R. 3678 (Preserving Access to Orphan Drugs Act of 2015), all provisions

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Pharmaceutical patent issues, including related provisions in H.R. 9, the Innovation Act, S. 1137, the PATENT Act, and H.R.3678, the Preserving Access to Orphan Drugs Act of 2015. Legislative issues related to the FDA Regulation of Biosimilars.

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

Implementation of Patient Protection & Affordable Health Care Act (P.L. 111-148) and Implementation of Health Care and Education Reconciliation Act (P.L. 111-152) Excise tax for drugs and biologics Issues and policies related to Orphan Drug Tax Credit Implementation of American Taxpayer Relief Act of 2012 Issues and policies related to tax reform H.R. 880, American Research and Competitiveness Act of 2015 S. 537, Competitiveness and Opportunity by Modernizing and Permanently Extending the Tax Credit for Experimentation Act of 2015(COMPETE Act) Corporate tax inversions issues Legislation pertaining to the applicability of the ACA tax carve out for non-orphan drug designated drugs, generally, including H.R. 3678, Preserving Access to Orphan Drugs Act of 2015 H.R. 3618 and S. 1906, Orphan Drug Fairness Act Protecting Americans From Tax Hikes Act of 2015 (PATH)

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

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

Implementation of Patient Protection & Affordable Health Care Act (P.L. 111-148) and Implementation of Health Care and Education Reconciliation Act (P.L. 111-152) 340B issues and legislative reform proposals Issues related to importation of prescription drugs, including those contained in S. 122, Safe and Affordable Drugs from Canada Act of 2015 Health technology assessment of orphan drugs Sequestration of FDA user fees H.R. 1376, Patient Choice Act of 2015 H.R. 790, Compassionate Freedom of Choice Act of 2015 H.R. 1600, Patients' Access to Treatments Act of 2015 21st Century Cures/Innovation initiatives including H.R. 6, 21st Century Cures Act and the Innovation for Healthier Americans Initiative, including the following: S. 2055, The Medical Countermeasures Innovation Act of 2015; S. 2512, Adding Zika Virus to the FDA Priority Review Voucher Program Act; S. 2030, The Advancing Targeted Therapies for Rare Diseases Act of 2015; S. 849, Advancing Research for Neurological Diseases Act of 2015; S. 2700, FDA and NIH Workfroces Authorities Modernization Act H.R. 909, Andrea Sloan CURE Act S. 1421 and H.R.971, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 Implementation of the FDA Safety and Innovation Act (FDASIA) (Pub. L. 112-144) Regulation of innovative biological products for neurodegenerative diseases Issues and policies related to implementation of Orphan Drug Act and orphan drug development S. 320, Medical Innovation Act H.R. 744, Medical Innovation Act S. 2615, Increasing Competition in Pharmaceuticals Act H.R. 1130, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 S. 598, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 H.R. 1078, Food and Drug Administration Safety Over Sequestration Act of 2015 H.R. 1531 and S.1878, Advancing Hope Act of 2015 Implementation of newborn screening programs Issues and policies related to biosimilars exclusivity period Issues and policies related to biosimilars FDA guidance Issues and policies related to FDA oversight and management Issues and policies related to expanded access programs Issues and policies related to patient involvement with FDA decision making S. 289 and H.R. 2104, American Cures Act Legislation pertaining to FDA priority review vouchers, generally Legislation pertaining to the applicability of the ACA tax carve out for non-orphan drug designated drugs, generally, including H.R. 3678, Preserving Access to Orphan Drugs Act of 2015 H.R. 3618 and S. 1906, Orphan Drug Fairness Act Issues related to the value of prescription medicines, generally, and including S. 2023, Prescription Drug Affordability Act of 2015 Drug shortage issues Issues related to health care transparency S. 2055, Medical Countermeasure Innovation Act of 2016 H.R. 3299, Strengthening Public Health Emergency Response Act S. 2700, FDA and NIH Workforce Authorities Modernization Act S. 2713, Advancing Precision Medicine Act of 2016 S. 2745, Advancing NIH Strategic Planning and Representation in Medical Research Act S. 2742, Promoting Biomedical Research and Public Health for Patients Act S. 3239, H.R. 5858, The RACE for Children Act S. 2689, The REGROW Act S. 1878, Advancing Hope Act of 2016

Biosimilars, no specific bill H.R. 6, 21st Century Cures Act FDA Reform; Senate Innovation for Healthier Americans Initiative (no bill number) H.R. 3678 Orphan Drugs Prescription drug value issues, no specific bill Drug vial size issue, S. 3040, FY2017 Labor Health and Human Services and Education Appropriations bill, and S. 2956, FY2017 Agriculture Appropriations bill

Client expense: $2,920,000 · Firm income: Not reported

Pharmaceutical patent issues, including related provisions in H.R. 9, the Innovation Act, S. 1137, the PATENT Act, and H.R.3678, the Preserving Access to Orphan Drugs Act of 2015. Legislative issues related to the FDA Regulation of Biosimilars.

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

Comprehensive tax reform (no specific bill), House Republican tax blueprint, international tax proposals (no specific bill), orphan drug legislation (HR 3678)

Client expense: $1,390,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to the Over The Counter (OTC) Monograph reform; general issues related to Zika Outbreaks;general issues related to the value of prescription medicines; issues related to S. 3900 Amendment for Zika Response and Preparedness; issues related to H.R. 5243 "Zika Response Appropriations Act, 2016"; education and awareness of Dengue; issues related to the Independent Payment Advisory Board IPAB; issues related to Center for Medicaid and Medicaid Services Innovation Center; all issues related to the Innovation for Healthier Americans Initiative; Issues related to research and development innovation and education; general issues related to emerging infectious diseases; general issues related to counterfeit pharmaceuticals; issues related to H.R. 3678 "Preserving Access to Orphan Drug Act of 2015"; general issues related to importation; general issues related to insulin pricing; general issues related to priority review vouchers; and general issues related to Tropical Disease PRV Program.

Client expense: $1,020,000 · Firm income: Not reported

- orphan drug tax credit H.R. 3678 - Preserving Access to Orphan Drug Act of 2015 S. 1906/H.R. 3618 - Orphan Drug Fairness Act

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

Orphan drug exclusion within the pharmaceutical tax in the Patient Protection and Affordable Care Act H.R. 3678 (Preserving Access to Orphan Drugs Act of 2015), all provisions

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Implementation of Patient Protection & Affordable Health Care Act (P.L. 111-148) and Implementation of Health Care and Education Reconciliation Act (P.L. 111-152) Excise tax for drugs and biologics Issues and policies related to Orphan Drug Tax Credit Implementation of American Taxpayer Relief Act of 2012 Issues and policies related to tax reform H.R. 880, American Research and Competitiveness Act of 2015 S. 537, Competitiveness and Opportunity by Modernizing and Permanently Extending the Tax Credit for Experimentation Act of 2015(COMPETE Act) Corporate tax inversions issues Legislation pertaining to the applicability of the ACA tax carve out for non-orphan drug designated drugs, generally, including H.R. 3678, Preserving Access to Orphan Drugs Act of 2015 H.R. 3618 and S. 1906, Orphan Drug Fairness Act Protecting Americans From Tax Hikes Act of 2015 (PATH)

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

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

Implementation of Patient Protection & Affordable Health Care Act (P.L. 111-148) and Implementation of Health Care and Education Reconciliation Act (P.L. 111-152) 340B issues and legislative reform proposals Issues related to importation of prescription drugs, including those contained in S. 122, Safe and Affordable Drugs from Canada Act of 2015 Health technology assessment of orphan drugs Sequestration of FDA user fees H.R. 1376, Patient Choice Act of 2015 H.R. 790, Compassionate Freedom of Choice Act of 2015 H.R. 1600, Patients' Access to Treatments Act of 2015 21st Century Cures/Innovation initiatives including H.R. 6, 21st Century Cures Act and the Innovation for Healthier Americans Initiative, including the following: S. 2055, The Medical Countermeasures Innovation Act of 2015; S. 2512, Adding Zika Virus to the FDA Priority Review Voucher Program Act; S. 2030, The Advancing Targeted Therapies for Rare Diseases Act of 2015; S. 849, Advancing Research for Neurological Diseases Act of 2015; S. 2700, FDA and NIH Workfroces Authorities Modernization Act H.R. 909, Andrea Sloan CURE Act S. 1421 and H.R.971, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 Implementation of the FDA Safety and Innovation Act (FDASIA) (Pub. L. 112-144) Regulation of innovative biological products for neurodegenerative diseases Issues and policies related to implementation of Orphan Drug Act and orphan drug development S. 320, Medical Innovation Act H.R. 744, Medical Innovation Act S. 2615, Increasing Competition in Pharmaceuticals Act H.R. 1130, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 S. 598, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 H.R. 1078, Food and Drug Administration Safety Over Sequestration Act of 2015 H.R. 1531 and S.1878, Advancing Hope Act of 2015 Implementation of newborn screening programs Issues and policies related to biosimilars exclusivity period Issues and policies related to biosimilars FDA guidance Issues and policies related to FDA oversight and management Issues and policies related to expanded access programs Issues and policies related to patient involvement with FDA decision making S. 289 and H.R. 2104, American Cures Act Legislation pertaining to FDA priority review vouchers, generally Legislation pertaining to the applicability of the ACA tax carve out for non-orphan drug designated drugs, generally, including H.R. 3678, Preserving Access to Orphan Drugs Act of 2015 H.R. 3618 and S. 1906, Orphan Drug Fairness Act Issues related to the value of prescription medicines, generally, and including S. 2023, Prescription Drug Affordability Act of 2015 Drug shortage issues Issues related to health care transparency S. 2055, Medical Countermeasure Innovation Act of 2016 H.R. 3299, Strengthening Public Health Emergency Response Act S. 2700, FDA and NIH Workforce Authorities Modernization Act S. 2713, Advancing Precision Medicine Act of 2016 S. 2745, Advancing NIH Strategic Planning and Representation in Medical Research Act S. 2742, Promoting Biomedical Research and Public Health for Patients Act S. 3239, H.R. 5858, The RACE for Children Act S. 2689, The REGROW Act

Pharmaceutical patent issues, including related provisions in H.R. 9, the Innovation Act, S. 1137, the PATENT Act, and H.R.3678, the Preserving Access to Orphan Drugs Act of 2015. Legislative issues related to the FDA Regulation of Biosimilars.

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

- orphan drug tax credit H.R. 3678 - Preserving Access to Orphan Drug Act of 2015 S. 1906/H.R. 3618 - Orphan Drug Fairness Act

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

Biosimilars, no specific bill Health Resources and Services Administration (HRSA) policy regarding rebates on drugs used in the outpatient setting to help low-income/uninsured populations (340B), no specific bill S. 1767, Combination Products Innovation Act of 2015 FDA Reform; Senate Innovation for Healthier Americans Initiative (no bill number) H.R. 3678 Orphan Drugs Prescription drug value issues, no specific bill

Client expense: $2,910,000 · Firm income: Not reported

Orphan drug exclusion within the pharmaceutical tax in the Patient Protection and Affordable Care Act H.R. 3678 (Preserving Access to Orphan Drugs Act of 2015), all provisions

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 6 - The 21st Century Cures Act H.R. 1537/S. 1878 - Advancing Hope Act of 2015 H.R. 3731 - RAD Fund Act H.R. 3678 - Preserving Access to Orphan Drug Act S. 2030 - Advancing Targeted Therapies for Rare Diseases Act S. 1421 - OPEN Act H.R. 3742 - Access to Marketplace Insurance Act S. 1597 - Patient-Focused Impact Assessment Act of 2016 H.R. 1600 - Patients' Access to Treatments Act of 2015 S. 1767 - Combination Product Regulatory Fairness Act of 2016 FDA Appropriations S. 2700 - FDA and NIH Workforce Authorities Modernization Act Dr. Robert Califf FDA Commissioner Nomination H.R. 4909 - Fiscal 2017 National Defense Authorization Act (NDAA) Funding for Pediatric Device Consortia Grant Program

Client expense: Not reported · Firm income: Not reported

Government targets: 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, Social Security Administration (SSA)

Implementation of Patient Protection & Affordable Health Care Act (P.L. 111-148) and Implementation of Health Care and Education Reconciliation Act (P.L. 111-152) Excise tax for drugs and biologics Issues and policies related to Orphan Drug Tax Credit Implementation of American Taxpayer Relief Act of 2012 Issues and policies related to tax reform H.R. 880, American Research and Competitiveness Act of 2015 S. 537, Competitiveness and Opportunity by Modernizing and Permanently Extending the Tax Credit for Experimentation Act of 2015(COMPETE Act) Corporate tax inversions issues Legislation pertaining to the applicability of the ACA tax carve out for non-orphan drug designated drugs, generally, including H.R. 3678, Preserving Access to Orphan Drugs Act of 2015 H.R. 3618 and S. 1906, Orphan Drug Fairness Act Protecting Americans From Tax Hikes Act of 2015 (PATH)

Client expense: $290,000 · Firm income: Not reported

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

Implementation of Patient Protection & Affordable Health Care Act (P.L. 111-148) and Implementation of Health Care and Education Reconciliation Act (P.L. 111-152) 340B issues and legislative reform proposals Issues related to importation of prescription drugs, including those contained in S. 122, Safe and Affordable Drugs from Canada Act of 2015 Health technology assessment of orphan drugs Sequestration of FDA user fees H.R. 1376, Patient Choice Act of 2015 H.R. 790, Compassionate Freedom of Choice Act of 2015 H.R. 1600, Patients' Access to Treatments Act of 2015 21st Century Cures/Innovation initiatives including H.R. 6, 21st Century Cures Act and the Innovation for Healthier Americans Initiative, including the following: S. 2055, The Medical Countermeasures Innovation Act of 2015; S. 2512, Adding Zika Virus to the FDA Priority Review Voucher Program Act; S. 2030, The Advancing Targeted Therapies for Rare Diseases Act of 2015; S. 849, Advancing Research for Neurological Diseases Act of 2015; S. 2700, FDA and NIH Workfroces Authorities Modernization Act H.R. 909, Andrea Sloan CURE Act S. 1421 and H.R.971, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 Implementation of the FDA Safety and Innovation Act (FDASIA) (Pub. L. 112-144) Regulation of innovative biological products for neurodegenerative diseases Issues and policies related to implementation of Orphan Drug Act and orphan drug development S. 320, Medical Innovation Act H.R. 744, Medical Innovation Act S. 2615, Increasing Competition in Pharmaceuticals Act H.R. 1130, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 S. 598, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 H.R. 1078, Food and Drug Administration Safety Over Sequestration Act of 2015 H.R. 1531 and S.1878, Advancing Hope Act of 2015 Implementation of newborn screening programs Issues and policies related to biosimilars exclusivity period Issues and policies related to biosimilars FDA guidance Issues and policies related to FDA oversight and management Issues and policies related to expanded access programs Issues and policies related to patient involvement with FDA decision making S. 289 and H.R. 2104, American Cures Act Legislation pertaining to FDA priority review vouchers, generally Legislation pertaining to the applicability of the ACA tax carve out for non-orphan drug designated drugs, generally, including H.R. 3678, Preserving Access to Orphan Drugs Act of 2015 H.R. 3618 and S. 1906, Orphan Drug Fairness Act Issues related to the value of prescription medicines, generally, and including S. 2023, Prescription Drug Affordability Act of 2015 Drug shortage issues Issues related to health care transparency

Biosimilars, no specific bill Health Resources and Services Administration (HRSA) policy regarding rebates on drugs used in the outpatient setting to help low-income/uninsured populations (340B), no specific bill S. 1767, Combination Products Innovation Act of 2015 FDA Reform, H.R. 6, 21st Century Cures H.R. 3678 Orphan Drugs Prescription drug value issues, no specific bill

Client expense: $1,750,000 · Firm income: Not reported

Orphan drug exclusion within the pharmaceutical tax in the Patient Protection and Affordable Care Act H.R. 3678 (Preserving Access to Orphan Drugs Act of 2015), all provisions Fundamental Tax Reform

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Pharmaceutical patent issues, including related provisions in H.R. 9, the Innovation Act, S. 1137, the PATENT Act, and H.R.3678, the Preserving Access to Orphan Drugs Act of 2015. Legislative issues related to the FDA Regulation of Biosimilars.

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

- orphan drug tax credit H.R. 3678 - Preserving Access to Orphan Drug Act of 2015 S. 1906/H.R. 3618 - Orphan Drug Fairness Act

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

H.R. 6 - The 21st Century Cures Act Orphan Drug Tax Credit H.R. 1537/S. 1878 - Advancing Hope Act of 2015 H.R. 209/S. 139 - Ensuring Access to Clinical Trials Act S. 2188 - Rare Disease Innovation Act H.R. 3731 - RAD Fund Act H.R. 3678 - Preserving Access to Orphan Drug Act S. 2030 - Advancing Targeted Therapies for Rare Diseases Act H.R. 2624 - Part D Beneficiaries Appeals Fairness Act S. 1421 - OPEN Act

Client expense: Not reported · Firm income: Not reported

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

Implementation of Patient Protection & Affordable Health Care Act (P.L. 111-148) and Implementation of Health Care and Education Reconciliation Act (P.L. 111-152) Excise tax for drugs and biologics Extension of R& D tax credit Issues and policies related to Orphan Drug Tax Credit Implementation of American Taxpayer Relief Act of 2012 Issues and policies related to tax reform H.R. 880, American Research and Competitiveness Act of 2015 S. 537, Competitiveness and Opportunity by Modernizing and Permanently Extending the Tax Credit for Experimentation Act of 2015(COMPETE Act) Corporate tax inversions issues Legislation pertaining to the applicability of the ACA tax carve out for non-orphan drug designated drugs, generally, including H.R. 3678, Preserving Access to Orphan Drugs Act of 2015 H.R. 3618 and S. 1906, Orphan Drug Fairness Act Protecting Americans From Tax Hikes Act of 2015 (PATH)

Client expense: $260,000 · Firm income: Not reported

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

Implementation of Patient Protection & Affordable Health Care Act (P.L. 111-148) and Implementation of Health Care and Education Reconciliation Act (P.L. 111-152) 340B issues and legislative reform proposals Issues related to importation of prescription drugs, including those contained in S. 122, Safe and Affordable Drugs from Canada Act of 2015 Health technology assessment of orphan drugs Sequestration of FDA user fees H.R. 1376, Patient Choice Act of 2015 H.R. 790, Compassionate Freedom of Choice Act of 2015 H.R. 1600, Patients' Access to Treatments Act of 2015 21st Century Cures/Innovation initiatives including H.R. 6, 21st Century Cures Act and the Innovation for Healthier Americans Initiative H.R. 909, Andrea Sloan CURE Act S. 1421 and H.R.971, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 Implementation of the FDA Safety and Innovation Act (FDASIA) (Pub. L. 112-144) Regulation of innovative biological products for neurodegenerative diseases Issues and policies related to implementation of Orphan Drug Act and orphan drug development S. 320, Medical Innovation Act H.R. 744, Medical Innovation Act H.R. 1130, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 S. 598, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 H.R. 1078, Food and Drug Administration Safety Over Sequestration Act of 2015 H.R. 1531 and S.1878, Advancing Hope Act of 2015 Implementation of newborn screening programs Issues and policies related to biosimilars exclusivity period Issues and policies related to biosimilars FDA guidance Issues and policies related to FDA oversight and management Issues and policies related to expanded access programs Issues and policies related to patient involvement with FDA decision making S. 289 and H.R. 2104, American Cures Act Legislation pertaining to FDA priority review vouchers, generally Legislation pertaining to the applicability of the ACA tax carve out for non-orphan drug designated drugs, generally, including H.R. 3678, Preserving Access to Orphan Drugs Act of 2015 H.R. 3618 and S. 1906, Orphan Drug Fairness Act Issues related to the value of prescription medicines, generally, and including S. 2023, Prescription Drug Affordability Act of 2015 Drug shortage issues

Orphan drug exclusion within the pharmaceutical tax in the Patient Protection and Affordable Care Act H.R. 3678 (Preserving Access to Orphan Drugs Act of 2015), all provisions H.R. 22 (FAST Act), potential inclusion of Preserving Access to Orphan Drugs Act H.R. 2029 (Consolidated Appropriations Act, 2016), Division Q, provisions concerning the orphan drug tax credit

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Biosimilars, no specific bill Health Resources and Services Administration (HRSA) policy regarding rebates on drugs used in the outpatient setting to help low-income/uninsured populations (340B), no specific bill FDA Reform, H.R. 6, 21st Century Cures H.R. 3678 Orphan Drugs Prescription drug value issues, no specific bill

Client expense: $2,670,000 · Firm income: Not reported

- orphan drug tax credit H.R. 3678 - Preserving Access to Orphan Drug Act of 2015 S. 1906/H.R. 3618 - Orphan Drug Fairness Act

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

Pharmaceutical patent issues, including related provisions in H.R. 9, the Innovation Act, S. 1137, the PATENT Act, and H.R.3678, the Preserving Access to Orphan Drugs Act of 2015. Legislative issues related to the FDA Regulation of Biosimilars.

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

Education and awareness of the 2015-2016 influenza season; education and awareness of pandemic and biodefense funding; education and awareness of Dengue; general issues related to FDA and NIH funding; all issues related to the Innovations for Healthier Americans Initiative and the 21st Century Cures Initiative including all provisions of HR6 "To accelerate the discovery, development, and delivery of 21st century cures, and for other purposes (21st Century Cures Act)"; all provisions of Preserving Access to Orphan Drugs Act (discussion draft), HR3678 "Preserving Access to Orphan Drugs Act" and HR3618 "Orphan Drug Fairness Act"; education and awareness of diabetes and related treatments; education about our new cholesterol lowering drug and policy issues related to cardiovascular disease; issues related to barriers to the export of domestically manufactured vaccines; general issues related to the value of prescription medicines; general issues related to the importation of prescription drugs including all progvisions of S122 "Safe and Affordable Drugs from Canada Act of 2015"; issues related to the Over The Counter (OTC) Monograph reform; and general issues related to access to adult vaccines.

Client expense: $990,000 · Firm income: Not reported

H.R. 6 - The 21st Century Cures Act Orphan Drug Tax Credit H.R. 1537/S. 1878 - Advancing Hope Act of 2015 H.R. 209/S. 139 - Ensuring Access to Clinical Trials Act S. 2188 - Rare Disease Innovation Act H.R. 3731 - RAD Fund Act H.R. 3678 - Preserving Access to Orphan Drug Act S. 2030 - Advancing Targeted Therapies for Rare Diseases Act H.R. 2624 - Part D Beneficiaries Appeals Fairness Act S. 1421 - OPEN Act

Client expense: Not reported · Firm income: Not reported

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

Implementation of P.L. 111-148, Patient Protection & Affordable Health Care Act and Implementation of Health Care and Education Reconciliation Act (P.L. 111-152) 340B Issues and Legislative Reform Proposals Drug Shortage Issues Health Technology Assessment of Orphan Drugs Sequestration of FDA User Fees H.R. 1376, Patient Choice Act of 2015 H.R. 790, Compassionate Freedom of Choice Act of 2015 H.R. 1600, Patients' Access to Treatments Act of 2015 21st Century Cures Initiative including H.R.6, 21st Century Cures Act and the Innovation for Healthier Americans Initiative H.R. 909, Andrea Sloan CURE Act S. 1421 and H.R.971, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 Implementation of the FDA Safety and Innovation Act (FDASIA) (Pub. L. 112-144) Regulation of innovative biological products for neurodegenerative diseases. Implementation of Orphan Drug Act and Orphan Drug Development S. 122, Safe and Affordable Drugs from Canada Act of 2015 S. 320, Medical Innovation Act H.R. 744, Medical Innovation Act H.R. 1130, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 S. 598, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 H.R. 1078, Food and Drug Administration Safety Over Sequestration Act of 2015 H.R. 1531 and S.1878, Advancing Hope Act of 2015 Implementation of Newborn Screening Programs Biosimilars Exclusivity Period Biosimilars FDA Guidance FDA Oversight and Management Expanded Access Programs Patient Involvement with FDA Decision Making S. 289 and H.R. 2104, American Cures Act Legislation pertaining to priority review vouchers, generally Legislation pertaining to the applicability of the ACA tax carve out for non-orphan drug designated drugs, generally, including H.R. 3678, Preserving Access to Orphan Drugs Act of 2015 H.R. 3618 and S. 1906, Orphan Drug Fairness Act Issues related to the value of prescription medicines, generally, and including S. 2023,Prescription Drug Affordability Act of 2015

Implementation of P.L. 111-148, Patient Protection & Affordable Health Care Act and Implementation of Health Care and Education Reconciliation Act (P.L. 111-152) Excise Tax for Drugs and Biologics Extension of R& D Tax Credit Orphan Drug Tax Credit Implementation of American Taxpayer Relief Act of 2012 Tax Reform H.R. 880, American Research and Competitiveness Act of 2015 S. 537, Competitiveness and Opportunity by Modernizing and Permanently Extending the Tax Credit for Experimentation Act of 2015(COMPETE Act) Corporate Tax Inversions Issues H.R.415, Stop Corporate Inversions Act of 2015 S. 198, Stop Corporate Inversions Act of 2015 Legislation pertaining to the applicability of the ACA tax carve out for non-orphan drug designated drugs, generally, including H.R. 3678, Preserving Access to Orphan Drugs Act of 2015 H.R. 3618 and S. 1906, Orphan Drug Fairness Act

Client expense: $235,000 · Firm income: Not reported

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

- orphan drug tax credit H.R. 3678 - Preserving Access to Orphan Drug Act of 2015 S. 1906/H.R. 3618 - Orphan Drug Fairness Act

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

Orphan drug exclusion within the pharmaceutical tax in the Patient Protection and Affordable Care Act H.R. 3678 (Preserving Access to Orphan Drugs Act of 2015), all provisions H.R. 22 (Developing a Reliable and Innovative Vision for the Economy Act), potential inclusion of Preserving Access to Orphan Drugs Act Tax reform regarding orphan drug credit, including tax extenders

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE