PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA for PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA

Copyright/Patent/Trademark CPT

H.R. 5340: The Support Technology & Research for Our Nations Growth and Economic Resilience (STRONGER) Patents Act of 2018 - Provisions related to reforms of Patent Trial and Appeal Board (PTAB) proceedings and other patent system reforms H.R. 7251: Hatch-Waxman Integrity Act of 2018 - Provisions related to PTAB proceedings S. 124: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 3738: Hatch-Waxman Integrity Act of 2018 - Provisions related to PTAB proceedings Biopharmaceutical innovation and patent policy issues Patent litigation reform issues and issues related to post-grant proceeding at the PTO Bayh-Dole march-in rights policy issues

Contacted: HOUSE OF REPRESENTATIVES; Office of Management & Budget (OMB); SENATE; Health & Human Services, Dept of (HHS); Executive Office of the President (EOP); Food & Drug Administration (FDA); Centers For Medicare and Medicaid Services (CMS); U.S. Trade Representative (USTR); Patent & Trademark Office (PTO)

Bills named: S. 3738 (115th), H.R. 5340 (115th), S. 124 (115th), H.R. 7251 (115th)

Budget/Appropriations BUD

H.R. 5961: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2019 - FDA provisions related to prescription drugs S. 2976: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2019 - FDA provisions related to prescription drugs

Contacted: SENATE; Centers For Medicare and Medicaid Services (CMS); U.S. Trade Representative (USTR); HOUSE OF REPRESENTATIVES; Office of Management & Budget (OMB); Health & Human Services, Dept of (HHS); Patent & Trademark Office (PTO); Food & Drug Administration (FDA); Executive Office of the President (EOP)

Bills named: S. 2976 (115th), H.R. 5961 (115th)

Health Issues HCR

H.R. 6: SUPPORT for Patients and Communities Act - To provide for opioid use disorder prevention, recovery, and treatment, and for other purposes H.R. 449: Synthetic Drug Awareness Act: Provisions related to synthetic drug report H.R. 749: Lower Drug Costs through Competition Act - Provisions related to generic drug approvals H.R. 1245: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 1480: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation H.R. 1628: American Health Care Act of 2017 - Provisions related to the biopharmaceutical industry including repeal of brand pharmaceutical manufacturer fee and individual and employer mandates, insurance affordability provisions, and Medicaid reforms H.R. 1776: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing H.R. 2051: FAST Generics Act of 2017 - Provisions related to REMS and limited distribution systems H.R. 2063: Opioid Preventing Abuse through Continuing Education (PACE) Act of 2017 - Provisions related to prescriber training H.R. 2212: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 4710: 340B Protecting Access for the Underserved and Safety-net Entities Act or PAUSE Act - Provisions related to the 340B program H.R. 5041: The Safe Disposal of Unused Medication Act - Provisions related to drug disposal H.R. 5228: SCREEN Act - Provisions related to drug recall authority H.R. 5311: CARA 2.0 Act of 2018 - Provisions to reauthorize and expand the Comprehensive Addiction and Recovery Act H.R. 5598: 340B Optimization Act - Provisions related to transparency in the 340B program H.R. 6574: Medicare Fair Drug Pricing Act of 2018 - Provisions related to drug pricing S. 64: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 92: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 469: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 771: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing S. 974: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017 - Provisions related to drug pricing S. 2312: HELP Act - Provisions related to 340B program S. 2453: Ensuring the Value of the 340B Program Act of 2018 - Provisions to increase transparency in the 340B program S. 2553: Know the Lowest Price Act of 2018 - Provisions related to drug pricing S. 2554: Patient Right to Know Drug Prices Act - To ensure that health insurance issuers and group health plans do not prohibit pharmacy providers from providing certain information to enrollees S. 2665: A bill to require guidance on how the Food and Drug Administration will consider claims of opioid sparing and on the conditions under which the Food and Drug Administration will consider misuse and abuse of drugs in making certain determinations of safety S. 2680: Opioid Crisis Response Act of 2018 - Provisions related to opioids S. 3519: A bill to establish a process for the Food and Drug Administration to determine whether to modify the labeling of drugs whose labeling may be outdated, including drugs with accepted uses that are not reflected in the approved labeling S. 3775: Affordable Drug Manufacturing Act of 2018 Drug cost and pricing policy issues Transparency policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues Policy issues related to prescription drug abuse and opioids Expanded access policy issues Generic drug approval process policy issues High deductible health plans/HSA policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues Compulsory licensing policy issues Foreign reference pricing policy issues 340B drug discount program policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Cancer drug vial size policy issues TRICARE pharmacy pilot program Drug shortages policy issues Reauthorization of the Pandemic and All-Hazards Preparedness Act Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49)

Contacted: U.S. Trade Representative (USTR); Food & Drug Administration (FDA); Health & Human Services, Dept of (HHS); SENATE; Office of Management & Budget (OMB); HOUSE OF REPRESENTATIVES; Executive Office of the President (EOP); Centers For Medicare and Medicaid Services (CMS); Patent & Trademark Office (PTO)

Bills named: H.R. 6 (115th), S. 64 (115th), H.R. 6574 (115th), S. 2680 (115th), H.R. 449 (115th), S. 3775 (115th), H.R. 1776 (115th), S. 92 (115th), H.R. 2212 (115th), S. 974 (115th), S. 2665 (115th), S. 1131 (115th), S. 2553 (115th), S. 771 (115th), H.R. 1480 (115th), H.R. 5228 (115th), H.R. 1245 (115th), H.R. 2063 (115th), H.R. 4710 (115th), S. 2453 (115th), H.R. 5311 (115th), S. 3519 (115th), S. 469 (115th), H.R. 2051 (115th), H.R. 1628 (115th), H.R. 5041 (115th), H.R. 749 (115th), S. 2554 (115th), H.R. 5598 (115th), S. 2312 (115th)

Medicare/Medicaid MMM

H.R. 242: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation H.R. 1316: Prescription Drug Price Transparency Act - Provisions related to transparency of payment methodologies H.R. 3192: CHIP Mental Health Parity Act H.R. 4005: Medicaid Reentry Act H.R. 5150: Protecting Medicare from Excessive Price Increases Act of 2018 - To require drug manufacturers to pay a Medicare part B rebate for certain drugs H.R. 5590: Opioid Addiction Action Plan Act H.R. 5605: Advancing High Quality Treatment for Opioid Use Disorders in Medicare Act H.R. 5675: To amend title XVIII of the Social Security Act to require prescription drug plan sponsors under the Medicare program to establish drug management programs for at-risk beneficiaries. H.R. 5797: Individuals in Medicaid Deserve Care that is Appropriate and Responsible in its Executive Act H.R. 5799: Medicaid Drug Review, Utilization, Good Governance Improvement Act H.R. 5801: Medicaid PARTNERSHIP Act H.R. 5808: Medicaid Pharmaceutical Home Act of 2018 H.R. 5810: Medicaid Health Homes for Opioid-Use-Disorder Medicaid Enrollees Encouraged Act H.R. 6505: Medicare Negotiation and Competitive Licensing Act of 2018 - Drug pricing H.R. 6642: To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs H.R. 7217: Improving Medicaid Programs and Opportunities for Eligible Beneficiaries Act or IMPROVE Act S. 41: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation S. 348: Prescription Drug and Health Improvement Act of 2017 - Provisions related to Part D S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017 - Provisions related to transparency of prescription drug pricing and pharmacy benefit managers S. 870: CHRONIC Care Act of 2017 - Provisions related to Medicare and chronic care S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 - Provisions related to increases in the wholesale acquisition costs of prescription drugs S. 1688: Empowering Medicare Seniors to Negotiate Drugs Prices Act of 2017 - Part D and non-interference provisions Medicare Access and Childrens Health Insurance Program (CHIP) reauthorization policy issues Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D policy issues including non-interference and rebates policy issues Part B reform including MedPAC recommendations and other policy issues and local coverage decisions Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues False Claims Act policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Changes to the Medicare Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs Prescription drug abuse policy issues ANPRM; Medicare Program; International Pricing Index Model for Medicare Part B Drugs (CMS-5528-ANPRM) Proposed Rule; Medicare and Medicaid Programs; Regulation To Require Drug Pricing Transparency (CMS-4187-P) Proposed Rule; Contract Year (CY) 2020 Medicare Advantage and Part D Drug Pricing (CMS-4180-P) Request for Information: Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Anti-Kickback Statute and Beneficiary Inducements CMP; 83 Fed. Reg. 43607 (Aug. 27, 2018) Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection (RIN 0936-AA08)

Contacted: U.S. Trade Representative (USTR); Patent & Trademark Office (PTO); Office of Management & Budget (OMB); Health & Human Services, Dept of (HHS); Centers For Medicare and Medicaid Services (CMS); SENATE; Executive Office of the President (EOP); HOUSE OF REPRESENTATIVES; Food & Drug Administration (FDA)

Bills named: H.R. 5808 (115th), H.R. 6505 (115th), H.R. 5150 (115th), S. 41 (115th), H.R. 5590 (115th), S. 637 (115th), H.R. 242 (115th), H.R. 1316 (115th), H.R. 7217 (115th), S. 870 (115th), H.R. 5675 (115th), H.R. 5810 (115th), S. 348 (115th), H.R. 6642 (115th), H.R. 5605 (115th), S. 1348 (115th), H.R. 4005 (115th), H.R. 3192 (115th), S. 1688 (115th), H.R. 5801 (115th), H.R. 5797 (115th), H.R. 5799 (115th)

Trade (domestic/foreign) TRD

Trade Agreements including NAFTA, USMCA and related policy issues Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues

Contacted: Health & Human Services, Dept of (HHS); Executive Office of the President (EOP); SENATE; Patent & Trademark Office (PTO); Office of Management & Budget (OMB); Centers For Medicare and Medicaid Services (CMS); Food & Drug Administration (FDA); HOUSE OF REPRESENTATIVES; U.S. Trade Representative (USTR)