Orphan Drug Fairness Act

H.R.3618, Orphan Drug Fairness Act; P.L.114-113, Protecting Americans from Tax Hikes Act of 2015 and Consolidated Appropriations Act, 2016; issues related to the Orphan Drug Tax.

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: $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

ACA Pharmaceutical Industry Fee Exclusions Anti-Inversion Tax H.R.3618 - Orphan Drug Fairness Act S.1906 - Orphan Drug Fairness Act Medical Device Tax Repeal & Suspension Section 385 Tax Regulation H.R.2315 - Mobile Workforce State Income Tax Simplification Act of 2015

Client expense: $1,460,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office

- 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.3618, Orphan Drug Fairness Act; P.L.114-113, Protecting Americans from Tax Hikes Act of 2015 and Consolidated Appropriations Act, 2016; issues related to the Orphan Drug Tax.

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

- 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

ACA Pharmaceutical Industry Fee Exclusions R&D Tax Credit Anti-Inversion Tax H.R.3618 - Orphan Drug Fairness Act S.1906 - Orphan Drug Fairness Act Medical Device Tax Repeal & Suspension Section 385 Tax Regulation

Client expense: $1,200,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office

H.R.3618, Orphan Drug Fairness Act; P.L.114-113, Protecting Americans from Tax Hikes Act of 2015 and Consolidated Appropriations Act, 2016; issues related to the Orphan Drug Tax.

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

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: $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

ACA Pharmaceutical Industry Fee Exclusions R&D Tax Credit Anti-Inversion Tax H.R.3618 - Orphan Drug Fairness Act S.1906 - Orphan Drug Fairness Act Medical Device Tax Repeal & Suspension

Client expense: $3,093,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office

Monitor Orphan Drug Fairness Act (S. 1906, H.R. 3618); Prescription drug pricing; Prescription drug importation; Support delay of CMS final rule to change Medicare reimbursement policy for biosimilars; Oppose CMMI proposed rule for Medicare Part B Drug Payment Model demo; Monitor nomination of Dr. Robert Califf as FDA Commissioner; Monitor Senate Finance activity on biomedical innovation bills

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

ACA Pharmaceutical Industry Fee Exclusions R&D Tax Credit Anti-Inversion Tax H.R.3618 - Orphan Drug Fairness Act S.1906 - Orphan Drug Fairness Act Medical Device Tax Repeal & Suspension

Client expense: $3,150,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office

H.R.3618, Orphan Drug Fairness Act; P.L.114-113, Protecting Americans from Tax Hikes Act of 2015 and Consolidated Appropriations Act, 2016; issues related to the Orphan Drug Tax.

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

Government targets: 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

H.R.3618, Orphan Drug Fairness Act; P.L.114-113, Protecting Americans from Tax Hikes Act of 2015 and Consolidated Appropriations Act, 2016; issues related to the Orphan Drug Tax.

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

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 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 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, 21st Century Cures Act. S.2041, Promoting Life-Saving New Therapies for Neonates Act of 2015. H.R.3618, Orphan Drug Fairness Act. P.L.114-113, Consolidated Appropriations Act, 2016. Healthcare issues affecting pharmaceuticals, biologics, medical devices, and biosimilars.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

ACA Pharmaceutical Industry Fee Exclusions R&D Tax Credit Anti-Inversion Tax H.R.3618 - Orphan Drug Fairness Act S.1906 - Orphan Drug Fairness Act Medical Device Tax Repeal

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office

H.R.3618, Orphan Drug Fairness Act; issues related to the orphan drug tax.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Monitor Orphan Drug Fairness Act (S. 1906, H.R. 3618); Prescription drug pricing; Prescription drug importation; Support delay of new Medicare reimbursement policy for biosimilars; Monitor H.R. 2029 for Medicare Part B offsets

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Monitor Orphan Drug Fairness Act (S. 1906, H.R. 3618); Prescription drug pricing; Prescription drug importation; Support delay of new Medicare reimbursement policy for biosimilars; Monitor H.R. 2029 for Medicare Part B offsets

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.3618, Orphan Drug Fairness Act; P.L.114-113, Protecting Americans from Tax Hikes Act of 2015 and Consolidated Appropriations Act, 2016; issues related to the Orphan Drug Tax.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

Monitor Orphan Drug Fairness Act (S. 1906, H.R. 3618)

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, Orphan Drugs), no specific bill FDA Reform, H.R. 6, 21st Century Cures Innovation for Healthier Americans Act, no specific bill S. 1906 Orphan Drug Fairness Act H.R. 3618 Orphan Drug Fairness Act

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

H.R.6, 21st Century Cures Act. S.2041, Promoting Life-Saving New Therapies for Neonates Act of 2015. H.R.3618, Orphan Drug Fairness Act. Healthcare issues affecting pharmaceuticals, biologics, medical devices, and biosimilars.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

ACA Pharmaceutical Industry Fee Exclusions R&D Tax Credit Anti-Inversion Tax H.R.3618 - Orphan Drug Fairness Act S.1906 - Orphan Drug Fairness Act

Client expense: $1,430,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office

H.R.3618, Orphan Drug Fairness Act; issues related to the orphan drug tax.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.3618, Orphan Drug Fairness Act; issues related to the Orphan Drug Tax.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE