Increasing Competition in Pharmaceuticals Act

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)

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)

Issues related to the CMS Part B Drugs Payment Model Demo Issues related to Zika funding Issues related to counterfeit drugs H.R. 5325 - Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2017, and Zika Response and Preparedness Act H.R. 34 - 21st Century Cures Act S. 2615 - Increasing Competition in Pharmaceuticals Act H.R. 4784 -Lower Drug Costs through Competition Act

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

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

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)

Health issues specifically related to group purchasing organizations, including matters related to supply chains in health care, including drugs and medical devices, pricing, and shortages. Protection of Medicare safe harbor and the Medicaid 340(B) programs. H.R.6 - 21st Century Cures Act/ Senate Companion Legislation Issues related to implementation of the Generic Drug User Fee Act (GDUFA) S.2615 - Increasing Competition in Pharmaceuticals Act H.R. 4784 - Lower Drug Costs through Competition Act

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

Government targets: Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Advocate for improved access to specialty drugs for patients with chronic conditions (H.R. 1600, Patients' Access to Treatments Act of 2015). Lobby members of House and Senate to write to FDA regarding the agencys draft guidance document on office-use compounding. Support S. 2615, the Increasing Competition in Pharmaceuticals Act. Support H.R. 4784, the Lower Drug Costs through Competition Act. Lobby members of Congress to join the Congressional Skin Cancer Caucus. Lobby Congress to provide oversight of implementation of Public Law 113-54, the Drug Quality and Security Act, and to protect and preserve the in-office use of compounded pharmaceuticals without a patient prescription. Lobby in support of FDAs proposed rule to restrict indoor tanning for youth under 18. Lobby Congress on issues related to telemedicine. Advocate for increased price transparency for drugs and tools to help lower costs. Advocate for increased funding and reforms to Graduate Medical Education including Ensuring Childrens Access to Specialty Care Act (H.R. 1859/S. 2782). Oppose paragraph d, Location of Care in Section 704, Enhancement of Use of Telehealth Services in Military Health System" in the Senate-passed version of S. 2943, the National Defense Authorization Act for Fiscal Year 2017. Lobby members of Congress to support H. Res. 854 to encourage proper sun safety practices for youth under care of schools and camps. Support legislation to study online learning collaboratives and the impact they have on the health care systems (H.R. 5395/S. 2873 The Expanding Capacity for Health Outcomes Act aka ECHO Act).

Client expense: $350,000 · Firm income: Not reported

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

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

Hospital Group Purchasing Organizations - Provided ongoing outreach and education efforts regarding the value delivered by group purchasing organizations for hospitals across the country. Drug Prices - (S. 2615 - the Increasing Competition in Pharmaceuticals Act) Supported passage of S. 2615. Monitored legislative proposals to slow the growth of increasing prices in prescription drugs. Tracked ongoing discussion and offered information relating to how hospital group purchasing organizations help hold down cost growth of prescription drugs. 340B Drug Discount Program - Monitored proposals to modify the 340B Drug Discount program. 21st Century Cures (H.R. 6, H.R. 34) - Supported enhancing funding and improving efficiency within the Food and Drug Administration and the National Institutes of Health in the 21st Century Cures Act. Supported inclusion of funding for programs authorized under the Comprehensive Addiction and Recovery Act to address growing challenges related to opioid abuse and addiction. Supported provisions related to combating drug resistant bacteria included in the 21st Century Cures Act. Stark Law Reform - Monitored discussions in the Senate Finance Committee around potential changes to Stark laws. Advocated for changes to the Stark laws to allow hospitals and other providers to work together to reduce costs in health care. Anti-microbial stewardship (S. 3176 - the Strategies to Address Antibiotic Resistance Act; S. 2467 - the Patient Safety Improvement Act) - Engaged in education and outreach efforts to highlight the importance of antimicrobial stewardship.

Client expense: $125,000 · Firm income: Not reported

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

Increasing Competition in Pharmaceuticals Act (S. 2615); issues related to drug shortages and prices.

Client expense: $170,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE

HR976, Patient Access to Higher Quality Health Care Act of 2015 (All sections of full text) HR2513:Promoting Access, Competition and Equity Act of 2015 or the PACE Act of 2015 (All sections of full text) S.2511 Improving Health Information Technology Act - Discussions involving new HHS/OCR HIPAA guidance to providers for release of information(ROI) Discussions involving White House Cancer research task force initiative Discussions involving potential reform of health care delivery and payment systems implemented by The Affordable Care Act Monitored P.L. 114-255 To accelerate the discovery, development, and delivery of 21st century cures, and for other purposes (all sections of full text) Monitored HR 4784 Lower Drug Costs through Competition Act Monitored S.2615 Increasing Competition in Pharmaceuticals Act; discussions regarding price escalation of certain orphan or generic drugs Monitored HR776 Stark Administrative Simplification Act of 2015 Monitored Hatch white paper examining potential reforms to the Stark Law Monitored HR2300 Empowering Patients First Act of 2015 Monitored P.L. 114-198 Comprehensive Addiction and Recovery Act of 2016 Monitored H.R. 6018 Ensuring Health Care Opportunities Act Monitored S. 3320 Ensuring Health Care Opportunities Act Monitored S.3326 State Flexibility to Provide Affordable Health Options Act

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

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of the Vice President of the United States, SENATE

Group purchasing organization issues. S. 2615, Increasing Competition in Pharmaceuticals Act. Prescription drug and inpatient drug costs. H.R. 6, 21st Century Cures Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to pharmacy delivery including S. 2615, The Increasing Competition in Pharmaceuticals Act; H.R. 34, The 21st Century Cures Act; and H.R. 244, The MAC Transparency Act.

Client expense: Not reported · Firm income: $34,500

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Reducing the costs of pharmaceuticals, medical devices, and supplies for consumers and health care providers, including implementation of the Drug Quality and Security Act (P.L.113-54) and P.L.112-144; support medical device pricing transparency and prohibition on medical device price "gag clauses"; preserving access to group purchasing organizations (GPOs) and protecting the GPO safe harbor; educating policymakers on hospital drug shortages and significant drug price increases and support draft reform legislation; pharmaceutical labeling of generic drugs (FDA-2013-N-0500); legislation to create a comprehensive Medicare home infusion benefit (H.R.605/S.275) - support; support reforming the durable medical equipment competitive bidding program; supporting "any willing pharmacy" legislation; promoting access to biosimilars (labeling/interchangeability); 21st Century Cures Act (H.R.6) - general support for overall bill, support final pharmacy lock-in policy, oppose PPSA weakening of existing requirements, oppose Section 4004 treatment of infusion drugs furnished through durable medical equipment, oppose use of savings from home infusion payment reform for purposes other than creating a Medicare home infusion benefit; Ensuring Seniors Access to Local Pharmacies Act (H.R.793/S.1190) - support; Pharmacy and Medically Underserved Areas Enhancement Act (H.R.592/S.314) - support; MAC Transparency Act (H.R.244) - support; Medication Therapy Management Empowerment Act (S.776) - support; Strengthening Medicare Advantage Through Innovation and Transparency for Seniors - oppose; FDA-2014-D-1524-0002 - comments, Administration and Capitol Hill meetings on draft guidance on repackaging of certain human drug products by pharmacies and outsourcing facilities; FDA-2014-N-1459 - comments and Capitol Hill meetings on draft MOU addressing certain distributions of compounded human drug products between states and the FDA; proposed changes to the 340B prescription drug program - oppose; 21st Century Cures Act (H.R.6, now P.L.114-255) - support, but with serious concerns about the misalignment of implementation dates for two home infusion provisions - oppose implementation of Section 5004 (a) without aligning the start date of the new Medicare home infusion service benefit in Section 5012; proposed amendments to 340b program (not ultimately included in H.R.6) - oppose; provide comments on proposed 340b omnibus guidance (RIN 0906 AB08); Stopping Medication Abuse and Protecting Seniors Act of 2015 (S.1913)- support (with some concerns about pharmacy lock-in policy); submitted comments on Management Standards for Hazardous Waste Pharmaceuticals (EPA-HQ-RCRA-2007-0932); meeting with DEA on Controlled Substances Act (21 USC 802); proposed changes to regulation of Laboratory Developed Tests (FDA-2011-D-0360-Draft Guidance for Industry, Food and Drug Administration Staff and Clinical Laboratories: Framework for Regulatory Oversight of Laboratory Developed Tests) - oppose; Comprehensive Addiction and Recovery Act of 2016 ((S.524), monitoring for pharmacy lock-in policy, which includes exemption for LTC) - support; Increasing Competition in Pharmaceuticals Act (S.2615/H.R.4784) - support; CREATES Act addressing REMS abuses (S.3056) - support; submitted comments in response to HRSA proposed rule establishing an Administrative Dispute Resolution (ADR) Process for the 340B Drug Purchasing Program (81 Fed. Reg. 53,381).

Client expense: $400,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Office of Management & Budget (OMB), SENATE, White House Office

S.2041/HR 5182 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs Part B Demo Regrow Act IPAB Generic Drug Labeling H.R.4784 Lower Drug Costs through Competition Act S.2615 Increasing Competition in Pharmaceuticals Act Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information

Client expense: $890,000 · 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

H.R.4784: Lower Drug Costs Through Competition Act, support increasing generic availability. S.2680: A bill to amend the Public Health Service Act to provide comprehensive mental health reform, and for other purposes. S.2615: the Increasing Competition in Pharmaceuticals Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.2615: Increasing Competition in Pharmaceuticals Act, support increasing generic availability. H.R.6/P.L. 114-252: The 21st Century Cures Act and Senate companions, ensuring no new barriers to generic and biosimilar market entry. Generic Drug User Fee Act Reauthorization, support increasing generic availability. H.R.1600: The Patients' Access to Treatment Act, educating on the importance of step therapy to ensuring optimal therapy access and cost control. H.R.2841: the FAST Generics Act. S.3056: the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act. Drug pricing in general. H.R.6043 and S.3335, "Fair Accountability and Innovative Research Drug Pricing Act of 2016".

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.976, Patient Access to Higher Quality Health Care Act of 2015 (all sections of full text) H.R. 2513: Promoting Access, Competition, and Equity Act of 2015 or the PACE Act of 2015 (all sections of full text) S. 2511 Improving Health Information Technology Act; discussions involving new HHS/OCR HIPAA guidance to providers for release of information(ROI) Discussions involving White House Cancer research task force initiative Discussions involving potential reform of health care delivery and payment systems implemented by The Affordable Care Act Monitored P.L. 114-255 To accelerate the discovery, development, and delivery of 21st century cures, and for other purposes (all sections of full text) Monitored H.R. 4784 Lower Drug Costs through Competition Act Monitored S. 2615 Increasing Competition in Pharmaceuticals Act; discussions regarding price escalation of certain orphan or generic drugs Monitored H.R. 776 Stark Administrative Simplification Act of 2015 Monitored Hatch white paper examining potential reforms to the Stark Law Monitored H.R. 2300 Empowering Patients First Act of 2015 Monitored P.L. 114-198 Comprehensive Addiction and Recovery Act of 2016 Monitored H.R. 6018 Ensuring Health Care Opportunities Act Monitored S. 3320 Ensuring Health Care Opportunities Act Monitored S. 3326 State Flexibility to Provide Affordable Health Options Act

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

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of the Vice President of the United States, SENATE

Issues affecting supply chain management including health information technology matters related to S. 2511, The Improving Health IT Act. Also, advocate for improved FDA review processes related to H.R. 4784 & S. 2615, The Increasing Competition in Pharmaceuticals Act. Monitor H.R. 34, the "21st Century Cures Act."

Client expense: Not reported · Firm income: $32,250

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 406 & S. 1767, Combination Drug Development Incentive Act of 2015; H.R. 1537 & S. 1878, Advancing Hope Act of 2015; S. 632, STRONG Patents Act of 2015; H.R. 9, Innovation Act; S. 2733, Venue Equity and Non-Uniformity Elimination Act of 2016; H.R. 3709, Protecting Consumer Access to Generic Drugs Act of 2013; H.R. 971 & S. 1421, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015; S. 2615, Increasing Competition in Pharmaceuticals Act; Proposals/Initiatives related to international intellectual property protection;

Client expense: $2,610,000 · 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), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

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

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

Government targets: Centers For Medicare and Medicaid Services (CMS), 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: $569,598 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), 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. 524: Comprehensive Addiction and Recovery Act of 2016 - Provisions related to opioids S. 1077: Advancing Breakthrough Devices for Patients Act of 2016 - Issues related to the biopharmaceutical industry S. 1597: Patient-Focused Impact Assessment Act of 2016 - Provisions related to patient-focused drug development 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.2055: Medical Countermeasure Innovation Act of 2015 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. 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. 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. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1538: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on medical research 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. 3250: DXM Abuse Prevention Act of 2015 H.R. 3299: The Strengthening Public Health Emergency Response Act of 2015 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. 5046: Comprehensive Opioid Abuse Reduction Act of 2016 - Provisions related to opioids 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 Other: - 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 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 - 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) - OTC Monograph Reform - Expanded access policy issues - Patient assistance program policy issues

Client expense: $640,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), Government Accountability Office (GAO), 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), Vice President of the U.S.

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 Antibiotic & Diagnostic Tax Credit ---H.R. 3539: Antibiotic & Diagnostic Innovation Act Biodefense Research, Development and Procurement Issues (Nonfunding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2967: National Biodefense Strategy Act Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorizaton and Implementation ---Interchangeability and Pharmacy Substitution ---Naming ---S.3056: Creating and Restoring Equal Access to Equivalent Samples Act of 2016 Drug Evaluation and Review ---ADAPT Act (House Discussion Draft) ---Compassionate Use/Expanded Access ---FDA Proposed Rule on Changes to Drug Labeling ---H.R. 2029: The Patient Choice Act ---H.R. 4475: Compassionate Freedom of Choice Act ---Implementation of the FDA Safety and Innovation Act ---Reauthorization of the Prescription Drug User Fee Act ---S. 2912: Trickett Wendler Right to Try Act of 2016 ---Special Medical Use/Limited Population Drugs 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 ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---Implementation of H.R. 3204: The Drug Quality and Security Act ---Pharmacy Compounding & Oversight ---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 FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for 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 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---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 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 FY 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 ---S. 2615: Increasing Competition in Pharmaceuticals Act ---S.3056: Creating and Restoring Equal Access to Equivalent Samples Act of 2016 Government Price Reporting ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Medicaid Pricing and Rebates ---Average Manufacturer Price Calculations ---Implementation of Affordable Care Act Reimbursement for Innovative Products ---CMMI Medicare Part B Proposed Demonstration Project ---H.R. 5122: To prohibit further action on the proposed rule regarding testing of Medicare Part B Prescription Drug Models ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Value-based Contracting and Communications Senate Innovation for Healthier Americans ---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 ---H.R. 4762: Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW) Act ---Innovation Incentives ---Longitudinal Study of Chronic Diseases ---Patient Access to Approved Drugs ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---S. 195: PATH Act ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2912: Trickett Wendler Right to Try Act of 2016 ---S.524: Comprehensive Addiction and Recovery Act of 2016 ---The KIDS Act ---Use of Real-World Evidence ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---S. 1878: Advancing Hope Act of 2015 ---S.2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act Transatlantic Trade and Investment Partnership ---Intellectual Property Issues ---Regulatory Harmonization TransPacific Partnership ---Data and Intellectual Property Protection for Pharmaceuticals Vaccine Access/Financing ---Adult Immunization (Senate Discussion Draft) ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Senate Chronic Care Working Group Proposals Vaccines and Infectious Diseases - General ---S.2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---H.R. 5325: Continuing appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Orphan Drug Tax Credit Independent Payment Advisory Board UN High Level Commission on Access to Medicines ---Intellectual Property Provisions Sunshine Act Implementation Precision Medicine Initiative Affordable Care Act Implementation ---Third Party Support of Patient Premiums and Cost-Sharing Obligations

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), Health Resources & Services Administration (HRSA), Natl Economic Council (NEC), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Office of Technology Policy (OTP), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), Vice President of the U.S.

Issues related to generic drug pricing. Increasing Competition in Pharmaceuticals Act (S. 2615); issues related to drug shortages and prices.

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

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

Biosimilar Naming, Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Act (GDUFA), PL 112-144 Prescription drug pricing, Medicare Part D program and 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 S. 1972 Airline Access to Emergency Epinephrine Act of 2015, Anaphylaxis awareness, access to epinephrine auto injector; federal building anaphylaxis policy S. 2615 Increasing Competition in Pharmaceuticals Act, H.R. 4784 Lower Drug Costs through Competition Act, generic medicines pricing issues The Comprehensive Addiction and Recovery Act (CARA) S.524/H.R.953, the Addiction Prevention and Responsible Opioid Practices Act S.3075, Budgeting for CARA

Client expense: $285,000 · Firm income: Not reported

Government targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Program Support Center, SENATE, U.S. Trade Representative (USTR), White House Office

Issues related to epinephrine auto-injectors pricing Biosimilar Naming, Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Act (GDUFA), PL 112-144 Prescription drug pricing, Medicare Part D program and 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 S. 2615 Increasing Competition in Pharmaceuticals Act, H.R. 4784 Lower Drug Costs through Competition Act, generic medicines pricing issues The Comprehensive Addiction and Recovery Act (CARA) S.524/H.R.953, the Addiction Prevention and Responsible Opioid Practices Act S.3075, Budgeting for CARA

Client expense: $345,000 · Firm income: Not reported

Government targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Program Support Center, SENATE, 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: $1,710,000 · Firm income: Not reported

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

Health issues specifically related to group purchasing organizations, including matters related to supply chains in health care, including drugs and medical devices, pricing, and shortages. Protection of Medicare safe harbor and the Medicaid 340(B) programs. H.R.6 - 21st Century Cures Act/ Senate Companion Legislation Issues related to implementation of the Generic Drug User Fee Act (GDUFA) S.2615 - Increasing Competition in Pharmaceuticals Act H.R. 4784 - Lower Drug Costs through Competition Act

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

Government targets: Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Issues related to the CMS Part B Drugs Payment Model Demo Issues related to Zika funding H.R. 5325 - Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2017, and Zika Response and Preparedness Act H.R. 6 - 21st Century Cures Act S. 2615 - Increasing Competition in Pharmaceuticals Act H.R. 4784 -Lower Drug Costs through Competition Act

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

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

Advocate for improved access to specialty drugs for patients with chronic conditions (H.R. 1600, Patients' Access to Treatments Act of 2015). Lobby members of House and Senate to write to FDA regarding the agencys draft guidance document on office-use compounding. Support S. 2615, the Increasing Competition in Pharmaceuticals Act. Support H.R. 4784, the Lower Drug Costs through Competition Act. Lobby members of Congress to join the Congressional Skin Cancer Caucus. Lobby Congress to provide oversight of implementation of Public Law 113-54, the Drug Quality and Security Act, and to protect and preserve the in-office use of compounded pharmaceuticals without a patient prescription. Lobby in support of FDA proposed rule to restrict indoor tanning for youth under 18. Lobby Congress on issues related to telemedicine. Support legislation to establish a federal standard for the provision of telemedicine (H.R. 691, the Telehealth Modernization Act). Support the review of online learning collaboratives and their integration into health care systems (H.R. 5395/S. 2873 The Expanding Capacity for Health Outcomes Act) Oppose S.2175, Department of Veterans Affairs Provider Equity Act. Advocate for increased price transparency for drugs and tools to help lower costs. Advocate for increased funding and reforms to Graduate Medical Education including Ensuring Childrens Access to Specialty Care Act (H.R. 1859/S. 2782). Oppose paragraph d, Location of Care, in Section 705, "Enhancement of Use of Telehealth Services in Military Health System," in S. 2943, the National Defense Authorization Act for Fiscal Year 2017. Lobby members of Congress to support H. Res 854 to encourage proper sun safety practices for youth under care of schools and camps.

Client expense: $470,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), 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. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2016 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 524: Comprehensive Addiction and Recovery Act of 2016 - Provisions related to opioids S. 800: Enhancing the Stature and Visibility of Medical Rehabilitation Research at the NIH Act - Issues related to the biopharmaceutical industry S. 849: Advancing Research for Neurological Diseases Act of 2016 - Provisions related to research on neurological diseases S. 1077: Advancing Breakthrough Devices for Patients Act of 2016 - Issues related to the biopharmaceutical industry S. 1101: Medical Electronic Data Technology Enhancement for Consumers' Health Act - Provisions related to regulation of software S. 1455: Recovery Enhancement for Addiction Treatment Act - Provisions related to opioids S. 1597: Patient-Focused Impact Assessment Act of 2016 - Provisions related to patient-focused drug development S. 1622: FDA Device Accountability Act of 2016 - Issues related to the biopharmaceutical industry 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. 2014: Next Generation Researchers Act - Provisions related to NIH promoting new research. S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2016 - Provisions related to rare disease treatment S. 2055: Medical Countermeasure Innovation Act of 2016 - Provisions related to priority review vouchers S. 2256: Co-Prescribing Saves Lives Act of 2015 - Provisions related to co-prescribing of opioids and reversal agents S. 2388: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2015 - Provisions related to reciprocity of drug approvals S. 2511: Improving Health Information Technology Act - Provisions related to health information technology (HIT) 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. 2624: National Biomedical Research Act - Provisions related to mandatory funding for NIH and FDA 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. 2713: Advancing Precision Medicine Act of 2016 - Provisions related to data sharing and security S. 2742: Promoting Biomedical Research and Public Health for Patients Act - Issues related to the biopharmaceutical industry S. 2912: 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 H.R. 6: 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. 1538: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on medical research 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 - 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 - Issues related to prescription drug abuse 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. 5046: Comprehensive Opioid Abuse Reduction Act of 2016 - Provisions related to opioids H.R. 5127: Curb Opioid Abuse By Advancing Technology Act of 2016 - Provisions related to opioids Kids Innovative Drugs Act (draft) 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 ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Drug Supply Chain Security Act policy issues Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) 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 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) negotiation and 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 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)

Client expense: $4,550,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Natl Security Council (NSC), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

HR976, Patient Access to Higher Quality Health Care Act of 2015 (All sections of full text) HR2513:Promoting Access, Competition and Equity Act of 2015 or the PACE Act of 2015 (All sections of full text) S.2511 Improving Health Information Technology Act - Discussions involving new HHS/OCR HIPAA guidance to providers for release of information(ROI) Discussions involving nominations to federally authorized commissions Monitored S.2615 Increasing Competition in Pharmaceuticals Act; discussions regarding price escalation of certain orphan or generic drugs Monitored discussions that would result in additional federal regulation of Group Purchasing Organizations Monitored HR776 Stark Administrative Simplification Act of 2015 Monitored Hatch white paper examining potential reforms to the Stark Law Monitored HR2300 Empowering Patients First Act of 2015 Monitored P.L. 114-198 Comprehensive Addiction and Recovery Act of 2016 Monitored HR 4784 Lower Drug Costs through Competition Act Monitored H.R.6 21st Century Cures Act; discussions pertaining to hospital reimbursement reductions

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.2041/HR 5182 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs Part B Demo Regrow Act IPAB Generic Drug Labeling H.R.4784 Lower Drug Costs through Competition Act S.2615 Increasing Competition in Pharmaceuticals Act Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information

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

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

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

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. 524: Comprehensive Addiction and Recovery Act of 2016 - Provisions related to opioids S. 1077: Advancing Breakthrough Devices for Patients Act of 2016 - Issues related to the biopharmaceutical industry S. 1597: Patient-Focused Impact Assessment Act of 2016 - Provisions related to patient-focused drug development 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. 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. 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. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1538: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on medical research 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. 5046: Comprehensive Opioid Abuse Reduction Act of 2016 - Provisions related to opioids 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 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: $4,130,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

Group purchasing organization issues. S. 2615, Increasing Competition in Pharmaceuticals Act. Prescription drug and inpatient drug costs.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.524: Comprehensive Addiction and Recovery Act, focused on Prescription Drug Management Plans (PDMPs), Medicare lock-ins, partial fills and co-prescribing. S.480/H.R.1725: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015, educating on the importance of PDMPs and the need for federal funding. HR.4981: The Opioid Use Disorder Treatment Expansion and Modernization Act. H.R.4599/S.2578: Reducing Unused Medications Act of 2016. H.R.3680: Co-Prescribing to Reduce Overdoses Act of 2016. S.2256: Co-Prescribing Saves Lives Act of 2016. S.1945: Senate HELP mental health reform package, Mental Health Reform Act of 2016, mental health parity treatment of step therapy and prior-authorization. S.2615: Increasing Competition in Pharmaceuticals Act, support increasing generic availability. H.R.6: The 21st Century Cures Act and Senate companions, ensuring no new barriers to generic and biosimilar market entry. Generic Drug User Fee Act Reauthorization, support increasing generic availability. H.R.1600: The Patients' Access to Treatment Act, educating on the importance of step therapy to ensuring optimal therapy access and cost control. H.R.2841: the FAST Generics Act. S.3056: the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act. S.2700: Workforce Authorities Modernization Act, Section 11, Biological Product Innovation - treatment of USP compendia in approving biologics and biosimilars. Role of PBMs in Mylan pricing before Congressional hearings/investigation of Mylan. Drug pricing in general. H.R.6043 and S.3335, "Fair Accountability and Innovative Research Drug Pricing Act of 2016".

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.524: Comprehensive Addiction and Recovery Act, focused on Prescription Drug Management Plans (PDMPs), Medicare lock-in, partial fills and co-prescribing. S.480/H.R.1725: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015, educating on the importance of PDMPs and the need for federal funding. H.R.4981: The Opioid Use Disorder Treatment Expansion and Modernization Act. H.R.4599/S.2578: Reducing Unused Medications Act of 2016. H.R.3680: Co-Prescribing to Reduce Overdoses Act of 2016. S.2256: Co-Prescribing Saves Lives Act of 2016. H.R.4784: Lower Drug Costs Through Competition Act, support increasing generic availability. S.2680: A bill to amend the Public Health Service Act to provide comprehensive mental health reform, and for other purposes. S.2615: the Increasing Competition in Pharmaceuticals Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to pharmacy delivery including S. 2615, The Increasing Competition in Pharmaceuticals Act. Also monitor matters related to H.R. 244, The MAC Transparency Act.

Client expense: Not reported · Firm income: $34,500

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues affecting supply chain management including health information technology matters related to S. 2511, The Improving Health IT Act. Also, advocate for improved FDA review processes including matters related to H.R. 4784 & S. 2615, The Increasing Competition in Pharmaceuticals Act.

Client expense: Not reported · Firm income: $32,250

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Hospital Group Purchasing Organizations - Provided ongoing outreach and education efforts regarding the value delivered by group purchasing organizations for hospitals across the country. Drug Prices - (S. 2615 - the Increasing Competition in Pharmaceuticals Act) Supported passage of S. 2615. Monitored legislative proposals to slow the growth of increasing prices in prescription drugs. Tracked ongoing discussion and offered information relating to how hospital group purchasing organizations help hold down cost growth of prescription drugs. 340B Drug Discount Program - Monitored proposals to modify the 340B Drug Discount program. 21st Century Cures (H.R. 6) - Tracked the development of Senate counterpart to the House-passed 21st Century Cures legislation and raised concerns about potential offsets that could impact hospital payments. Opioid legislation (S. 524, the Comprehensive Addiction and Recovery Act) - Supported passage of legislation to address growing challenges related to opioid abuse and addiction. Zika Virus (H.R. 5325 -Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2017, and Zika Response and Preparedness Act) - Monitored ongoing debate around legislative packages to provide funding to combat the spread of the Zika Virus. Stark Law Reform - Monitored discussions in the Senate Finance Committee around potential changes to Stark laws. Advocated for reasonable changes to the Stark laws to allow hospitals and other providers to work together to reduce costs in healthcare. Anti-microbial stewardship (S. 3176 - the Strategies to Address Antibiotic Resistance Act; S. 2467 - the Patient Safety Improvement Act) - Engaged in education efforts to highlight the work Vizient is doing to combat antibiotic resistance.

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

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

Reducing the costs of pharmaceuticals, medical devices, and supplies for consumers and health care providers, including implementation of the Drug Quality and Security Act (P.L.113-54) and P.L.112-144; support medical device pricing transparency and prohibition on medical device price "gag clauses"; preserving access to group purchasing organizations (GPOs) and protecting the GPO safe harbor; educating policymakers on hospital drug shortages and significant drug price increases and support draft reform legislation; pharmaceutical labeling of generic drugs (FDA-2013-N-0500); legislation to create a comprehensive Medicare home infusion benefit (H.R.605/S.275) - support; support reforming the durable medical equipment competitive bidding program; supporting "any willing pharmacy" legislation; promoting access to biosimilars (labeling/interchangeability); 21st Century Cures Act (H.R.6) - general support for overall bill, support final pharmacy lock-in policy, oppose PPSA weakening of existing requirements, oppose Section 4004 treatment of infusion drugs furnished through durable medical equipment, oppose use of savings from home infusion payment reform for purposes other than creating a Medicare home infusion benefit; Ensuring Seniors Access to Local Pharmacies Act (H.R.793/S.1190) - support; Pharmacy and Medically Underserved Areas Enhancement Act (H.R.592/S.314) - support; MAC Transparency Act (H.R.244) - support; Medication Therapy Management Empowerment Act (S.776) - support; Strengthening Medicare Advantage Through Innovation and Transparency for Seniors - oppose; FDA-2014-D-1524-0002 - comments, Administration and Capitol Hill meetings on draft guidance on repackaging of certain human drug products by pharmacies and outsourcing facilities; FDA-2014-N-1459 - comments and Capitol Hill meetings on draft MOU addressing certain distributions of compounded human drug products between states and the FDA; proposed changes to the 340B prescription drug program - oppose; 21st Century Cures Act (H.R.6) - support; proposed amendments to 340b program (not ultimately included in H.R.6) - oppose; provide comments on proposed 340b omnibus guidance (RIN 0906 AB08); Stopping Medication Abuse and Protecting Seniors Act of 2015 (S.1913)- support (with some concerns about pharmacy lock-in policy); submitted comments on Management Standards for Hazardous Waste Pharmaceuticals (EPA-HQ-RCRA-2007-0932); meeting with DEA on Controlled Substances Act (21 USC 802); proposed changes to regulation of Laboratory Developed Tests (FDA-2011-D-0360-Draft Guidance for Industry, Food and Drug Administration Staff and Clinical Laboratories: Framework for Regulatory Oversight of Laboratory Developed Tests) - oppose; Comprehensive Addiction and Recovery Act of 2016 ((S.524), monitoring for pharmacy lock-in policy, which includes exemption for LTC) - support; Increasing Competition in Pharmaceuticals Act (S.2615/H.R.4784) - support; CREATES Act addressing REMS abuses (S.3056) - support.

Client expense: $410,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Office of Management & Budget (OMB), SENATE, White House Office

H.R.976, Patient Access to Higher Quality Health Care Act of 2015 (all sections of full text) H.R. 2513: Promoting Access, Competition, and Equity Act of 2015 or the PACE Act of 2015 (All sections of full text) S. 2511 Improving Health Information Technology Act; discussions involving new HHS/OCR HIPAA guidance to providers for release of information(ROI) Discussions involving nominations to federally authorized commissions Monitored H.R. 6 21st Century Cures Act; discussions pertaining to hospital reimbursement reductions Monitored H.R. 4784 Lower Drug Costs through Competition Act Monitored S. 2615 Increasing Competition in Pharmaceuticals Act; discussions regarding price escalation of certain orphan or generic drugs Monitored discussions that would result in additional federal regulation of Group Purchasing Organizations Monitored H.R. 776 Stark Administrative Simplification Act of 2015 Monitored Hatch white paper examining potential reforms to the Stark Law Monitored H.R. 2300 Empowering Patients First Act of 2015 Monitored P.L. 114-198 Comprehensive Addiction and Recovery Act of 2016

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

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) 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

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

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

340B Drug Pricing Program ----Implementation of Affordable Care Act ---Program Implementation & Oversight ---H.R.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Biodefense Research, Development and Procurement Issues (Nonfunding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act Biosimilars ---Biosimilar User Fee Act Reauthorization and Implementation ---Colombia Biologics Regulations ---Implementation of Affordable Care Act ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---Access to Samples for Testing ---S.3056: Creating and Restoring Equal Access to Equivalent Samples Act of 2016 Drug Evaluation and Review ---ADAPT Act (House Discussion Draft) ---Compassionate Use/Expanded Access ---FDA Proposed Rule on Changes to Drug Labeling ---Implementation of the FDA Safety and Innovation Act ---Reauthorization of the Prescription Drug User Fee Act Drug Importation ---H.R.5054 - S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325-S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Supplemental Funding for Combating Zika ---H.R. 2577: The Zika Response Appropriations Act of 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs ---H.R.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Supplemental Funding for Combating Zika ---H.R. 2577: The Zika Response Appropriations Act of 2016 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.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Supplemental Funding for Combating Zika ---H.R. 2577: The Zika Response Appropriations Act of 2016 Medicaid Pricing and Rebates ---Average Manufacturer Price Calculations ---Implementation of Affordable Care Act Orphan Drug Act Tax Credit Precision Medicine Initiative Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products -- --CMMI Medicare Part B Proposed Demonstration Project ---Medicare Part D Prescription Drug Program ---Value-based Contracting and Communications Senate Innovation for Healthier Americans ---Biomarkers and Regulatory Science Improvements ---Communication with Healthcare Professionals and Payors ---Expanded Access to Investigational Drugs ---Expedited Pathways ---FDA Hiring Flexibility ---Innovation Incentives ---Longitudinal Study of Chronic Diseases ---Patient Access to Approved Drugs ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---- S. 195: PATH Act ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act ---H.R. 4762: Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW) Act ---S. 1878: Advancing Hope Act of 2015 ---S. 2912: Trickett Wendler Right to Try Act of 2016 ---S.2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---S.524: Comprehensive Addiction and Recovery Act of 2016 ---The KIDS Act UN High Level Commission on Access to Medicines Vaccine Access/Financing ---Adult Immunization (Senate Discussion Draft) ---Senate Chronic Care Working Group Proposals ---Vaccine Injury Compensation Program ---H.R.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Vaccines and Infectious Diseases - General ---H.R. 3299: Strengthening Public Health Emergency Response Act ---S.2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---Supplemental Funding for Combating Zika ---H.R. 2577: The Zika Response Appropriations Act of 2016 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Combating Antibiotic-Resistant Bacteria (CARB) Initiative Drug Manufacturing, Quality & Distribution ---Pharmacy Compounding & Oversight ---Vial and Dose Size Gene Editing Technologies ---S.3040-H.R.5325: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Generic Drug Entry ---S. 2615: Increasing Competition in Pharmaceuticals Act ---S.3056: Creating and Restoring Equal Access to Equivalent Samples Act of 2016 Government Price Reporting ---H.R.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Antibiotic & Diagnostic Tax Credit ---H.R. 3539: Antibiotic & Diagnostic Innovation Act TransPacific Partnership ---Data and Intellectual Property Protection for Pharmaceuticals Transatlantic Trade and Investment Partnership ---Intellectual Property Issues ---Regulatory Harmonization

Client expense: $2,310,000 · 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), Health Resources & Services Administration (HRSA), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Science & Technology Policy (OSTP), SENATE, U.S. Trade Representative (USTR), White House Office