CREATES Act of 2016

- Issues related to Medicare Part D/Part B, the Affordable Care Act, Regulation of Non-Biological Complex Drugs, TRICARE, & Step Therapy/Fail First. - Issues related to HR 2841, "FAST Generic Act of 2015", regarding risk evaluation and mitigation strategy. - Issues related to HR 2739/S 1566, "Cancer Drug Coverage Parity Act". - Issues related to HR 1600, "Patients Access To Treatments Act". - Issues related to S 3056, "CREATES Act of 2016", regarding REMS.

Client expense: $1,030,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Pending health care legislation and potential impact on the biopharmaceutical industry; Ryan White Care Act reauthorization; Hepatitis C policy; PEPFAR reauthorization; HIV/AIDS research, testing, and treatment; Affordable Care Act implementation; HCV screening and linkage to care programs; H.R. 6 - 21st Century Cures Act. Funding for HCV and public health activities via appropriations. Pharmaceutical policy as it relates to payments under the 340B program; implementation of section 340B drug discount program. S. 3056 CREATES Act of 2016; S.524 - Comprehensive Addiction and Recovery Act of 2016 - HCV testing provision in bill; S. 1287 - Viral Hepatitis Act of 2015. Prison population and Hepatitis C.

Client expense: Not reported · Firm income: $14,500

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Coverage of pharmaceuticals, cost-sharing, and other access issues, H.R. 21st Century Cures Act; Implementation of Pub. L. No. 114-1448, the ACA; issues related to coverage and reimbursement of pharmaceuticals; issues related to Medicare, Medicaid, and ACA implementation; FDA issues and 340B. S. 3056: CREATES Act of 2016.

Client expense: Not reported · Firm income: $14,500

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Rare disease patient care and screening; S. 3056, Creating and Restoring Equal Access to Equivalent Samples Act of 2016 or the CREATES Act of 2016.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). Pharmaceutical Exclusivity. S.3056: CREATES Act of 2016. H.R.6043/S.3335: Fair Accountability and Innovative Research Drug Pricing Act of 2016. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Drug Importation.

Client expense: $720,000 · Firm income: Not reported

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

Creating and Restoring Equal Access to Equivalent Samples Act of 2016 (CREATES Act of 2016) (formerly S. 3056); FAST Generics Act (formerly H.R. 2841)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.3056 - CREATES Act of 2016.

Client expense: Not reported · Firm income: $40,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Legislation relating to the provision of brand drug products by brand manufacturers to generic manufacturers for development testing, including: H.R. 2841, The FAST Generics Act of 2015; S. 3056, the CREATES Act; H.R. 34, 21st Century Cures Act; and House Energy & Commerce Committee/Senate Health, Education, Labor and Pensions Committee draft legislative proposal.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Health and Human Services Appropriations - In support of increased funding for the Department of Health and Human Services including National Institutes of Health research programs and Title VII and Title VIII funding; Poison Control Centers and programs for teaching and research at academic medical centers. In support of the NIH peer review system and continued support of NIH funding.In support of full restoration of NIH funding. In support of funding for National Institute for Occupational Safety and Health. In support of funding for Agency for Healthcare Research and Quality. In support of extension for 340B Program. In support of 21st Century Cures Initiative. In support of continuation of subsidized graduate student health care. In support of Centers for Medicare and Medicaid Services working with Congress to address concerns for Hospital Compare Star Ratings; in support of delay of Ratings release. In support of merger of Penn State Health and Pinnacle Health. In support of S.3056, Creating and Restoring Equal Access to Equivalent Samples Act. In support of H.R.5273, Helping Hospitals Improve Patient Care Act. In support of H.R.6088, the Hospital Quality Rating Transparency Act. In support of Sec. 603 of the Bipartisan Budget Act of 2015 re: site neutral policy. In support of authorization of center to coordinate data collection on college mental health sciences.

Client expense: $130,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office

Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). Pharmaceutical exclusivity. S.3056: CREATES Act of 2016. H.R.6: 21st Century Cures Act.

Client expense: $950,000 · Firm income: Not reported

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

Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Drug Importation. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). S.2615: Increasing Competition in Pharmaceuticals Act. Pharmaceutical exclusivity. H.R.4931: Pharmaceutical Stewardship Act of 2016. H.R.953: Comprehensive Addiction and Recovery Act of 2015 (CARA). S.3056: CREATES Act of 2016.

Client expense: $570,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Drug Importation. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). S.2615: Increasing Competition in Pharmaceuticals Act. Pharmaceutical exclusivity. H.R.4931: Pharmaceutical Stewardship Act of 2016. H.R.953: Comprehensive Addiction and Recovery Act of 2015 (CARA). S.3056: CREATES Act of 2016.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)

Issues related to epinephrine auto-injectors pricing Prescription drug pricing, Generic Drugs HR 6, 21st Century Cures Act; Innovation for Healthier Americans Initiative; Issues regarding market exclusivity Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, S. 3056 CREATES Act, H.R. 2841 FAST generics Act

Client expense: $455,000 · Firm income: Not reported

Government targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Program Support Center, SENATE

P.L. 111-148 Patient Protection and Affordable Care Act: Employer responsibility requirements premium and cost sharing subsidies, treatment of excepted benefits P.L. 111-152 Health Care and Education Reconciliation Act of 2010: Employer responsibility requirements premium and cost sharing subsidies, treatment of excepted benefits H.R. 3999 FMLA 2014, FMLA Enhancement Act of 2014 H.R.2050/S. 2045 Middle Class Health Benefits Tax Repeal Act of 2015: Provisions repealing the tax on high cost health care plans H.R.2712 Commonsense Reporting and Verification Act of 2015: Provisions reducing employers' requirements to report compliance with the ACA employer responsibility requirement S. 2075: American Worker Health Care Tax Relief Act of 2015 S. 1697: Small Business Healthcare Relief Act S. 2698: Preserving Consumer Health Accounts Act of 2016: Provisions that exempt health savings accounts S. 2499/H.R. 4469: Health Savings Act of 2016: Provisions that permit expanded use of Health S. 1809, H.R. 863 (STARS Act): Provisions affecting definition of seasonal employment for purposes of ACA employer responsibility H.R. 2911, H.R. 5447: Small Business Healthcare Relief Act H.R. 5458: Veterans TRICARE Choice Act S. 3056: CREATES Act of 2016, prescription drug approvals, provisions H.R. 5445: Healthcare Security Act of 2016 H.R. 879: Ax the Tax on Middle Class Americans' health plans Act: Provisions repealing the tax on high cost health care plans H.R. 1270: Restoring access to medication and improving health savings act of 2016: provisions H.R. 210: Student worker exemption act: provisions H.R. 5573: PRICED Act: provisions H.R. 5410: Health Coverage state flexibility act of 2016: provisions H.R. 5589: Plan verification & fairness act of 2016: provisions

Client expense: $760,000 · Firm income: Not reported

Government targets: Defense, Dept of (DOD), Election Assistance Commission (EAC), Energy, Dept of, Equal Employment Opportunity Commission (EEOC), Federal Communications Commission (FCC), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Labor Relations Board (NLRB), Occupational Safety & Health Administration (OSHA), Office of Management & Budget (OMB), SENATE, Securities & Exchange Commission (SEC), Social Security Administration (SSA), State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

P.L. 111-148 Patient Protection and Affordable Care Act: Employer responsibility requirements premium and cost sharing subsidies, treatment of excepted benefits P.L. 111-152 Health Care and Education Reconciliation Act of 2010: Employer responsibility requirements premium and cost sharing subsidies, treatment of excepted benefits H.R. 3999 FMLA 2014, FMLA Enhancement Act of 2014 H.R.2050/S. 2045 Middle Class Health Benefits Tax Repeal Act of 2015: Provisions repealing the tax on high cost health care plans H.R.2712 Commonsense Reporting and Verification Act of 2015: Provisions reducing employers' requirements to report compliance with the ACA employer responsibility requirement S. 2075: American Worker Health Care Tax Relief Act of 2015 S. 1697: Small Business Healthcare Relief Act S. 2698: Preserving Consumer Health Accounts Act of 2016: Provisions that exempt health savings accounts S. 2499/H.R. 4469: Health Savings Act of 2016: Provisions that permit expanded use of Health S. 1809, H.R. 863 (STARS Act): Provisions affecting definition of seasonal employment for purposes of ACA employer responsibility H.R. 2911, H.R. 5447: Small Business Healthcare Relief Act H.R. 5458: Veterans TRICARE Choice Act S. 3056: CREATES Act of 2016, prescription drug approvals, provisions H.R. 5445: Healthcare Security Act of 2016 H.R. 879: Ax the Tax on Middle Class Americans' health plans Act: Provisions repealing the tax on high cost health care plans H.R. 1270: Restoring access to medication and improving health savings act of 2016: provisions H.R. 210: Student worker exemption act: provisions H.R. 5573: PRICED Act: provisions H.R. 5410: Health Coverage state flexibility act of 2016: provisions H.R. 5589: Plan verification & fairness act of 2016: provisions

Client expense: $760,000 · Firm income: Not reported

Government targets: Defense, Dept of (DOD), Election Assistance Commission (EAC), Energy, Dept of, Equal Employment Opportunity Commission (EEOC), Federal Communications Commission (FCC), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Labor Relations Board (NLRB), Occupational Safety & Health Administration (OSHA), Office of Management & Budget (OMB), SENATE, Securities & Exchange Commission (SEC), Social Security Administration (SSA), State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Drug Importation. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). S.2615: Increasing Competition in Pharmaceuticals Act. Pharmaceutical exclusivity. H.R.4931: Pharmaceutical Stewardship Act of 2016. H.R.953: Comprehensive Addiction and Recovery Act of 2015 (CARA). S.3056: CREATES Act of 2016.

Client expense: $569,598 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

1. Support The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act (S.3056). The bill would provide a clear solution to abusive, anti-competitive business practices that increase costs to the American health care system by impeding patient access to generic medicines. 2. Support the Centers for Medicare & Medicaid Services (CMS) Part B Drug Payment Model. 3. General support for a legislative response to projected increases in Medicare Part B premiums and the Part B deductible in 2017.

Client expense: Not reported · Firm income: Not reported

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

1. Support The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act (S.3056). The bill would provide a clear solution to abusive, anti-competitive business practices that increase costs to the American health care system by impeding patient access to generic medicines. 2. Support the Centers for Medicare & Medicaid Services (CMS) Part B Drug Payment Model. 3. General support for a legislative response to projected increases in Medicare Part B premiums and the Part B deductible in 2017.

Client expense: Not reported · Firm income: Not reported

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

Provisions of PL 111-148 and PL 111-152 impacting Medicare Part D such as formulary requirements, PBM disclosure provisions, implementation of the prescriber registration rules and definition of negotiated price. Regulatory design and coverage of pharmacy benefits in health reform exchanges and the commercial market (essential health benefits, grandfathering, e-prescribing, PBM disclosure requirements, specialty pharmacy, mail-service pharmacy, formulary transparency, and medical loss ratio). Regulatory and proposed legislative changes to Medicare part D including non-interference, pharmacy networks, classes of clinical concern, mail-service pharmacy, EGWP waivers, MTM expansion, long term care pharmacy, recovery audit contractors. Implementation of changes to the definition of Average Manufacturer Price in Medicaid Issues related to the management of Medicaid prescription drug benefits Legislation to promote generic drugs. Issues related to prescription drug abuse in Medicare. H.R.2: Medicare Access and CHIP Reauthorization Act of 2015 - provisions related to the expansion of availability of Medicare data H.R.244: The MAC Transparency Act H.R.793/S1190: The Ensuring Seniors Access to Local Pharmacies Act H.R.1021: The Protecting the Integrity of Medicare Act H.R.1600: The Patient Access to Treatments Act Provisions related to the 21st Century Cures Initiative (Energy and Commerce) and Innovations for Healthier Americans (HELP Committee). Issues related to the affordability of prescription drugs and competitive marketplace, including: pedigree, FDA user fees, manufacturer market and data exclusivity, REMS, biosimilars. H.R.804: The Access to Medicare Data Act H.R.2298: The Medicare Drug Abuse Prevention Act H.R.6: 21st Century Cures Act S.2700: The FDA and NIH Workforce Authorization Modernization Act - Provisions related to biologic drugs H.R.2841: The FAST Generics Act S.3056: The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2016 H.R. 4784/S.2651: The Increasing Competition in Pharmaceuticals Act H.R. 5573/S.3094 The Price Relief, Innovation, and Competition for Essential Drugs Act or the PRICED Act

Client expense: $755,506 · 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), General Services Administration (GSA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), SENATE

S.3056 - CREATES Act of 2016.

Client expense: Not reported · Firm income: $40,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues relating to generic drug competition, generic drug labeling, drug pricing, Risk Evaluation and Mitigation Strategies (REMS), S. 2615-Increasing Competition in Pharmaceuticals Act, S. 3056-CREATES Act of 2016, H.R. 5054-Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017, H.R. 34- 21st Century Cures Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to implementation of the Generic Drug User Fee Agreement; Issues related to H.R. 6, 21st Century Cures Initiative and Innovation for Healthier Americans Initiative; Issues related to epinephrine auto injector pricing; Issues related to generic drug pricing; REMs program, H.R. 2841 FAST Generics Act and S.3056 CREATES Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Patent settlement legislation, including HR 9, Innovation Act of 2015, S. 632, STRONG Patents Act of 2015, and S.1137, PATENT Act S.2019, Preserve Access to Affordable Generics Act S. 3056, Creating and Restoring Equal Access to Equivalent Samples Act of 2016

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

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

S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: Combination Product Regulatory Fairness Act of 2016 - Provisions related to improvements in the regulation of combination drug-device products S. 1878: Advancing Hope Act of 2016 - Provisions related to pediatric cancer and other pediatric diseases S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act - Provisions related to priority review vouchers S. 2615: Increasing Competition in Pharmaceuticals Act - Provisions related to FDA review of generic drugs and study on risk evaluation and mitigation strategies (REMS) program S. 2689: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments S. 2700: FDA and NIH Workforce Modernization Act - Provisions related to FDA and NIH S. 2912: Trickett Wendler Right to Try Act of 2016 - A bill to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes - Provisions related to use of unapproved medical products by patients with a terminal illness S. 3056: CREATES Act of 2016 - Provisions related to access to samples of prescription drugs S. 3239: RACE for Children Act - Provisions related to pediatric studies S. 3335: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act - Provisions relating to transparency H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 1270 - Restoring Access to Medication and Improving Health Savings Act of 2016 - FSA and HSA use for over the counter medication H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 or FAST Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing H.R. 3012: Right to Try Act of 2015 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 3250 - DXM Abuse Prevention Act of 2015 - age requirement for purchase of OTC medication including dextromethorphan Monograph reform H.R. 4762: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments H.R. 4784: Lower Drug Costs Through Competition Act - Provisions related to generic drugs and priority review vouchers; REMS study; and tropical disease product applications H.R. 5122: A bill to prohibit further action on the proposed rule regarding testing of Medicare Part B prescription drug models H.R. 5858: The RACE for Children Act - Provisions related to pediatric studies H.R. 6043: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act of 2016 - Provisions related to transparency H.R. 6174: Closing Loopholes for Orphan Drugs Act - Provisions relating to 340B discounts on orphan drugs Kids Innovative Drugs Act (draft) - Incentives for the development of pediatric oncology drugs The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) - Incentives for the development of pediatric drugs Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation and other issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges 340B Drug Discount Program policy issues General FDA advocacy including sharing of truthful and non-misleading information about medicines with healthcare professionals Prescription Drug User Fee Act (PDUFA) reauthorization Biosimilar User Fee Act (BsUFA) reauthorization Biologics Price Competition and Innovation Act (BPCIA) implementation issues Biopharmaceutical and medical innovation policy issues Drug development ecosystem policy issues Drug cost and pricing policy issues Expedited drug approval policy issues Compassionate use policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Transparency policy issues NIH Funding policy issues Precision Medicine Initiative Biomarker policy issues Policy issues related to prescription drug abuse and secure disposal Drug compounding policy issues Prescription drug importation policy issues Cancer Moonshot Prescription drug take back policy issues Clinical trial policy issues Pediatric cancer policy issues Cancer drug vial size policy issues House Republican Health Proposal (A Better Way) Expanded access policy issues

Client expense: $492,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR)

Issues related to transparency and competition in the prescription drug market; FDA appropriations; S. 3056 - CREATES Act, S. 3335 Fair Drug Pricing Act; 21st century cures

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to transparency and competition in the prescription drug market; FDA appropriations; S. 3056 - CREATES Act, S. 3335 Fair Drug Pricing Act; 21st century cures

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Preventive Health Savings Act (H.R. 3660/S. 3126) House FY17 Labor, Health and Human Services, and Education and Related Agencies (Labor-HHS) Appropriations Bill Comprehensive Addiction and Recovery Act of 2016 (H.R. 953/S. 524) Helping Hospitals Improve Patient Care Act of 2016 (H.R. 5273) Hospital outpatient department reimbursement legislation (no specific bill number) Hospital Quality Rating Transparency Act of 2016 (H.R. 6088) 21st Century Cures Act (H.R. 6, H.R. 34) Senate Health Innovations Package Improving Health Information Technology Act (S. 2511) Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act (S. 3056) The ACO Improvement Act (H.R. 6101)

Client expense: $370,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 2615: Increasing Competition in Pharmaceuticals Act - Provisions related to FDA review of generic drugs and study on risk evaluation and mitigation strategies (REMS) program S. 2680: Mental Health Reform Act of 2016 - Provisions related to mental health issues S. 2689: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments S. 2700: FDA and NIH Workforce Modernization Act - Provisions related to FDA and NIH S. 2912: Trickett Wendler Right to Try Act of 2016 - A bill to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes - Provisions related to use of unapproved medical products by patients with a terminal illness S. 3056: CREATES Act of 2016 - Provisions related to access to samples of prescription drugs S. 3335: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act - Provisions relating to transparency H.R. 6 / H.R. 34: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2805: Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 - Provisions related to the treatment of heroin and prescription opioid abuse H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 or FAST Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing H.R. 3012: Right to Try Act of 2015 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 3381: Childhood Cancer STAR Act - Provisions related to expanded access and other issues H.R. 4762: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments H.R. 4784: Lower Drug Costs Through Competition Act - Provisions related to generic drugs and priority review vouchers; REMS study; and tropical disease product applications H.R. 5122: A bill to prohibit further action on the proposed rule regarding testing of Medicare Part B prescription drug models H.R. 5858: The RACE for Children Act - Provisions related to pediatric studies H.R. 6043: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act of 2016 - Provisions related to transparency H.R. 6174: Closing Loopholes for Orphan Drugs Act - Provisions relating to 340B discounts on orphan drugs Kids Innovative Drugs Act (draft) - Incentives for the development of pediatric oncology drugs The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) - Incentives for the development of pediatric drugs Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation and other issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges 340B Drug Discount Program policy issues General FDA advocacy including sharing of truthful and non-misleading information about medicines with healthcare professionals Prescription Drug User Fee Act (PDUFA) reauthorization Biosimilar User Fee Act (BsUFA) reauthorization Biologics Price Competition and Innovation Act (BPCIA) implementation issues Biopharmaceutical and medical innovation policy issues Drug development ecosystem policy issues Drug cost and pricing policy issues Expedited drug approval policy issues Compassionate use policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Transparency policy issues NIH Funding policy issues Precision Medicine Initiative Biomarker policy issues Policy issues related to prescription drug abuse and secure disposal Drug compounding policy issues Prescription drug importation policy issues Cancer Moonshot Prescription drug take back policy issues Clinical trial policy issues Pediatric cancer policy issues Cancer drug vial size policy issues House Republican Health Proposal (A Better Way) Expanded access policy issues

Client expense: $4,990,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

21st Century Cures/ Senate Innovation for Healthier Americans ---H.R.34: 21st Century Cures Act ---Biomarkers and Regulatory Science Improvements ---Communication with Healthcare Professionals and Payors ---Expanded Access to Investigational Drugs ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Innovation Incentives ---Longitudinal Study of Chronic Diseases ---Patient Access to Approved Drugs ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Use of Real-World Evidence ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---S. 1878: Advancing Hope Act of 2015 ---S. 195: PATH Act ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---S. 524: Comprehensive Addiction and Recovery Act of 2016 ---H.R. 4762: Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW) Act ---S. 3239/H.R. 5858: RACE for Children Act 340B Drug Pricing Program ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Brazil Biologics Regulations ---Coding ---Colombia Biologics Regulations ---Implementation of Affordable Care Act ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---S.3056: Creating and Restoring Equal Access to Equivalent Samples Act of 2016 ---CREATES Act (House Energy & Commerce Committee Discussion Draft) Drug Evaluation and Review ---Implementation of the FDA Safety and Innovation Act ---Reauthorization of the Prescription Drug User Fee Act ---ADAPT Act (House Discussion Draft) ---Compassionate Use/Expanded Access ---H.R. 2029: The Patient Choice Act ---H.R. 4475: Compassionate Freedom of Choice Act ---S. 2912: Trickett Wendler Right to Try Act of 2016 Drug Importation ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Drug Manufacturing, Quality & Distribution ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Vial and Dose Size Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for FDA ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Gene Editing Technologies ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Generic Drug Entry ---CREATES Act (House Energy & Commerce Committee Discussion Draft) ---S. 2615: Increasing Competition in Pharmaceuticals Act ---S.3056: Creating and Restoring Equal Access to Equivalent Samples Act of 2016 Independent Payment Advisory Board Orphan Drug Act Tax Credit Precision Medicine Initiative Reimbursement for Innovative Products ---CMMI Medicare Part B Proposed Demonstration Project ---Medicare Part B Physician-Administered Products ---Value-based Contracting and Communications TransPacific Partnership ---Data and Intellectual Property Protection for Pharmaceuticals UN High Level Commission on Access to Medicines Vaccines and Infectious Diseases ---H.R. 3299: Strengthening Public Health Emergency Response Act ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---Supplemental Funding for Combating Zika ---Vaccine Injury Compensation Program ---Vaccine Safety

Client expense: $2,330,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), SENATE, U.S. Trade Representative (USTR)

Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Brazil Biologics Regulations ---Coding ---Colombia Biologics Regulations ---Implementation of Affordable Care Act ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---S.3056: Creating and Restoring Equal Access to Equivalent Samples Act of 2016 ---CREATES Act (House Energy & Commerce Committee Discussion Draft) Drug Importation ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Genetically Engineered (GE) Animals ---Amendment on GE Salmon Labeling ---Efficient Science-Based Review of Biotech Products ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---Labeling ---S. 2634: The One Health Act Review and Labeling of Food Derived from Biotechnology ---Implementation of Disclosure Law USDA/APHIS Agricultural Biotechnology Regulations ---Efficient Science-Based Review of Biotech Products ---Potential Revisions to Part 340 Regulations

Client expense: $2,330,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), SENATE, U.S. Trade Representative (USTR)

S. 3056 - Creating and Restoring Equal Access to Equivalent Samples Act S. 1878 - Advancing Hope Act S. 2912 - Trickett Wender Right to Try Act H.R. 5122 CMMI Medicare Part B proposed demonstration Medicare Part D prescription drug program Medicare Part B payment and coding issues Senate HELP biomedical innovation/H.R. 6 - 21st Century Cures Act Value-based contracting and communications

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues relating to the Biologics Price Competition and Innovation Act, S. 3056- CREATES Act of 2016, H.R. 34- 21st Century Cures Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to prescription drug abuse, preferred pharmacy networks, medication adherence, and drug pricing. HR 592 - Pharmacy and Medically Underserved Areas Enhancement Act S 314 - Pharmacy and Medically Underserved Areas Enhancement Act HR 244 - MAC Transparency Act S.3056-the Creating and Restoring Equal Access to Equivalent Samples Act (CREATES)

Client expense: $2,080,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA)

Issues related to epinephrine auto-injectors pricing Prescription drug pricing, Generic Drugs HR 6, 21st Century Cures Act; Innovation for Healthier Americans Initiative; Issues regarding market exclusivity Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, S. 3056 CREATES Act, H.R. 2841 FAST generics Act

Client expense: $315,000 · Firm income: Not reported

Government targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Program Support Center, SENATE

H.R.6 - Discussed the House Energy and Commerce Committee 21st Century Cures Initiative and Senate HELP Committee efforts focused on drug and medical device innovation issues. S. 31, H.R. 3061 - Discussed the importance of potential savings to both consumers and the federal government of granting Secretarial negotiating authority to the HHS Secretary under Medicare Part D. S. 2019 - Discussed legislation to address pay-for-delay agreements used by drug manufacturers to block lower cost drugs from entering the market. S. 3094, H.R. 5573 - Discussed legislation to reduce the market exclusivity period for biologic drugs. Discussed biologic drug issues including implementation of the new approval pathway for biosimilar drugs. S. 3335, H.R. 6043 - Discussed the need for price transparency on prescription drug prices and comparativeness effectiveness research. Discussed legislation to address the opioid abuse epidemic including fraud and abuse provisions. Discussed opioid issues generally. S. 3056 - Discussed legislation to address abuse of Risk-Evaluation and Mitigation Strategies (REMS) by brand name drug companies to block lower-cost generic drugs from entering the market. S. 3455 - Discussed legislation to allow temporary importation authority in cases of drug shortages and non-competitive markets. S. 2956, H.R. 5054, H.R. 5325, H.R. 2028, Agriculture Appropriations, FY2017 - Lobbied in support of FDA funding. H.R. 6043, FAIR Drug Pricing Act - Supported bill to require manufactures of certain drugs and biological products to report to HHS price increases that result in a 10% or more increase in the price of a drug over a 12 month period.

Client expense: $2,530,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Equal Employment Opportunity Commission (EEOC), Federal Transit Administration (FTA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

H.R. 9, Innovation Act (Goodlatte) - changes to inter partes review process H.R. 1600, Patients' Access to Treatments Act (McKinley-Capps) - specialty drug tiers H.R. 4599, Reducing Unused Medications Act (Clark) - partial fillings of prescriptions H.R. 4784, Lower Drug Costs Through Competition Act (Schrader-Bilirakis) - prescription drug issues H.R. 5122, Medicare Part B Prescription Drug Demonstration (Bucshon) H.R. 5951, Improving Transparency and Accuracy in Medicare Part D Spending Act (Griffith) - Medicare Part D pharmacy payments H.R. 6043, Fair Accountability and Innovative Research Drug Pricing Act (Schakowsky) - reporting requirements for prescription drug price increases S. 1137, PATENT Act (Grassley) - changes to inter partes review process S. 2019, Preserve Access to Affordable Generics Act (Klobuchar-Grassley) - pay-for-delay settlements S. 2023, Prescription Drug Affordability Act (Sanders) - pharmaceutical issues S. 2578, Reducing Unused Medications Act (Warren) - partial fillings of prescriptions S. 2615, Increasing Competition in Pharmaceuticals Act (Collins-McCaskill) - prescription drug issues S. 2689, REGROW Act (Kirk) - stem cell /regenerative medicines S. 3056, CREATES Act (Leahy) - challenging anti-competitive practices of brand name drug manufacturers S. 3308, Improving Transparency and Accuracy in Medicare Part D Spending Act (Capito) - Medicare Part D pharmacy payments S. 3335, Fair Accountability and Innovative Research Drug Pricing Act (Baldwin) - reporting requirements for prescription drug price increases 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; issues relating to price of drugs and biologics; issues relating to access for investigational drugs; and other issues relating to health care reform implementation.

Client expense: $1,330,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Office of Personnel Management (OPM), SENATE, Treasury, Dept of, White House Office

S. 3056, Creating and Restoring Equal Access to Equivalent Samples Act of 2016 (CREATES Act of 2016)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Co-Op Consumer Protection Act of 2016; H.R. 1270 Restoring Access to Medication Act; H.R. 4262 Transparency and Accountability of Failed Exchanges Act; H.R. 5324/S. 2980 Health Savings Account Expansion Act of 2016; H.R.5344 OrganDonation Clarification Act of 2016; S.2777 Contact Lens Consumer Health Protection Act; S. 3056 CREATES Act; H.R. 3421stCentury Cures Act

Client expense: $100,000 · Firm income: Not reported

Government targets: Federal Communications Commission (FCC), HOUSE OF REPRESENTATIVES, SENATE

H.R. 6, 21st Century Cures Act; S. 3056, Creating and Restoring Equal Access to Equivalent Samples Act of 2016 or the CREATES Act of 2016.

Client expense: Not reported · Firm income: $40,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 6, 21st Century Cures Act; S. 3056, Creating and Restoring Equal Access to Equivalent Samples Act of 2016 or the CREATES Act of 2016.

Client expense: Not reported · Firm income: $40,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 6, 21st Century Cures Act; S. 3056, Creating and Restoring Equal Access to Equivalent Samples Act of 2016 or the CREATES Act of 2016.

Client expense: Not reported · Firm income: $40,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 6, 21st Century Cures Act; S. 3056, Creating and Restoring Equal Access to Equivalent Samples Act of 2016 or the CREATES Act of 2016.

Client expense: Not reported · Firm income: $40,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to transparency and competition in the prescription drug market; the FDA Appropriations Act; S. 3056, Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2016; S. 3335 Fair Accountability and Innovative Research Drug Pricing (FAIR)Act of 2016

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to transparency and competition in the prescription drug market; the FDA Appropriations Act; S. 3056, Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2016; S. 3335 Fair Accountability and Innovative Research Drug Pricing (FAIR)Act of 2016

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE