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

Copyright/Patent/Trademark CPT

H.R. 465: Prescription Drug Price Relief Act of 2019 - Provisions related to foreign reference pricing and patents H.R. 938: BLOCKING Act of 2019 - Provisions related to 180 day generic prescription drug exclusivity H.R. 990: Hatch-Waxman Integrity Act of 2019 - Provisions related to PTAB proceedings and other patent system reforms H.R. 1188: FLAT Prices Act - Provisions related to prescription drug exclusivity periods and pricing H.R. 1344: Competitive Deals Resulting in Unleashed Generics and Savings Act of 2019 - Provisions related to patent settlements H.R. 1499: Protecting Consumer Access to Generic Drugs Act of 2019 - Provisions related to patent settlements H.R. 1503: Orange Book Transparency Act of 2019 - Provisions related to patent listings H.R. 1506: Fair and Immediate Release of (FAIR) Generic Drugs Act - Provisions related to 180 day exclusivity and patent litigation H.R. 1520: Purple Book Continuity Act of 2019 - Provisions related to biologics patent listings H.R. 2011: To amend the Public Health Service Act with respect to the treatment under section 351(k)(7) of such Act (relating to exclusivity for reference products) of certain products deemed to have a biologics license pursuant to section 7002 of the Biologics Price Competition and Innovation Act of 2009 S. 64: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 102: Prescription Drug Price Relief Act of 2019 - Provisions related to foreign reference pricing and patents S. 344: Hatch-Waxman Integrity Act of 2019 - Provisions related to PTAB proceedings and other patent system reforms S. 366: FLAT Prices Act - Provisions related to prescription drug exclusivity periods and pricing S. 659: Biologic Patent Transparency Act - Provisions related to biologic patent disclosures 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: Natl Economic Council (NEC); SENATE; Executive Office of the President (EOP); HOUSE OF REPRESENTATIVES; Congressional Budget Office (CBO); Centers For Medicare and Medicaid Services (CMS); Health & Human Services, Dept of (HHS); U.S. Trade Representative (USTR); Patent & Trademark Office (PTO)

Bills named: H.R. 1503 (116th), H.R. 1520 (116th), S. 102 (116th), H.R. 1344 (116th), H.R. 938 (116th), S. 659 (116th), S. 366 (116th), H.R. 465 (116th), H.R. 1188 (116th), H.R. 1499 (116th), H.R. 990 (116th), S. 344 (116th), H.R. 1506 (116th), S. 64 (116th), H.R. 2011 (116th)

Medicare/Medicaid MMM

H.R. 107: 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 - Provisions related to Medicaid drug rebates H.R. 275: Medicare Prescription Drug Price Negotiation Act of 2019 - Provisions related to Part D and drug pricing negotiation H.R. 366: Insulin Access for All Act of 2019 - Provisions related to insulin cost-sharing H.R. 448: Medicare Drug Price Negotiation Act - Provisions related to Part D and drug pricing negotiation H.R. 937: Right Rebate Act of 2019 - Provisions related to Medicaid drug rebates and drug classification H.R. 1034: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates H.R. 1035: Prescription Drug Price Transparency Act - Provisions related to drug pricing transparency and pharmacy benefit managers H.R. 1046: Medicare Negotiation and Competitive Licensing Act of 2019 - Provisions related to Part D, drug pricing negotiation and compulsory licensing H.R. 1346: Medicare Buy-In and Health Care Stabilization Act of 2019 - Provisions related to Part D and drug pricing negotiation H.R. 1384: Medicare for All Act of 2019 - Provisions related to Part D, drug pricing negotiation and march-in rights H.R. 1781: Payment Commission Data Act of 2019 - Provisions related to prescription drug pricing transparency and reporting H.R. 1839: Medicaid Services Investment and Accountability Act of 2019 - Provisions related to Medicaid drug rebates and drug classification S. 62: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019 - Provisions related to Part D and drug pricing negotiation S. 99: Medicare Drug Price Negotiation Act - Provisions related to Part D and drug pricing negotiation S. 205: Right Rebate Act of 2019 - Provisions related to Medicaid drug rebates and drug classification S. 377: Medicare Negotiation and Competitive Licensing Act of 2019 - Provisions related to Part D, drug pricing negotiation and compulsory licensing S. 470: Medicare at 50 Act - Provisions related to Part D and drug pricing negotiation S. 475: Reducing Existing Costs Associated with Pharmaceuticals for Seniors (RxCap) Act of 2019 - Provisions related to Part D and patient cost-sharing S. 476: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2019 - Provisions related to transparency of prescription drug pricing and pharmacy benefit managers S. 551: Recovering Excessive Funds for Unused and Needless Drugs Act of 2019 - Provisions related to prescription drug vial sizes and rebates S. 640: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates S. 801: To amend titles XVIII and XIX of the Social Security Act to provide the Medicare Payment Advisory Commission and the Medicaid and CHIP Payment and Access Commission with access to certain drug payment information, including certain rebate information 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 Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues 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 (RIN 0936-AA10) Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Services Fees (RIN 0936-AA08)

Contacted: U.S. Trade Representative (USTR); Congressional Budget Office (CBO); SENATE; HOUSE OF REPRESENTATIVES; Centers For Medicare and Medicaid Services (CMS); Health & Human Services, Dept of (HHS); Natl Economic Council (NEC); Patent & Trademark Office (PTO); Executive Office of the President (EOP)

Bills named: H.R. 1035 (116th), H.R. 448 (116th), H.R. 366 (116th), S. 470 (116th), H.R. 107 (116th), S. 475 (116th), H.R. 1046 (116th), H.R. 1346 (116th), S. 801 (116th), S. 476 (116th), S. 99 (116th), S. 377 (116th), S. 205 (116th), H.R. 1781 (116th), H.R. 937 (116th), H.R. 1034 (116th), H.R. 1839 (116th), H.R. 1384 (116th), S. 62 (116th), S. 551 (116th), H.R. 275 (116th), S. 640 (116th)

Budget/Appropriations BUD

H.R. 21: Consolidated Appropriations Act, 2019 - FDA provisions related to prescription drugs H.R. 265: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2019 - FDA provisions related to prescription drugs House H.R. 648: Consolidated Appropriations Act, 2019 - FDA provisions related to prescription drugs H. J. Res. 31: Consolidated Appropriations Act, 2019 - FDA funding H. Res. 293: Providing for budget enforcement for fiscal year 2020 S. Con. Res. 12: An original concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2020 and setting forth the appropriate budgetary levels for fiscal years 2021 through 2024 - Provisions related to prescription drugs Presidents FY 2020 Budget Request - Provisions related to prescription drugs FY 2020 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations FY 2020 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations

Contacted: SENATE; Natl Economic Council (NEC); Centers For Medicare and Medicaid Services (CMS); Health & Human Services, Dept of (HHS); U.S. Trade Representative (USTR); Congressional Budget Office (CBO); HOUSE OF REPRESENTATIVES; Patent & Trademark Office (PTO); Executive Office of the President (EOP)

Bills named: H.Res. 293 (116th), S.Con.Res. 12 (116th), H.R. 648 (116th), H.R. 21 (116th), H.R. 265 (116th), H.J.Res. 31 (116th)

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); Congressional Budget Office (CBO); U.S. Trade Representative (USTR); Patent & Trademark Office (PTO); Centers For Medicare and Medicaid Services (CMS); HOUSE OF REPRESENTATIVES; SENATE; Natl Economic Council (NEC); Executive Office of the President (EOP)

Health Issues HCR

H.R. 447: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 478: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation H.R. 965: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 985: FAST Generics Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 1093: Stop Price Gouging Act - Provisions related to prescription drug pricing H.R. 1323: Rural Hospital Frontier Fairness Act - Provisions related to the 340B drug pricing program H.R. 1332: Fair Care Act of 2019 - Provisions related to prescription drug pricing, patent issues, Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 1409: Transparency in All Health Care Pricing Act of 2019 - Provisions related to prescription drug pricing transparency H.R. 1478: Affordable Insulin Act of 2019 - Provisions related to importation H.R. 1506: Fair and Immediate Release of (FAIR) Generic Drugs Act - Provisions related to generic prescription drug approvals H.R. 1730: Cancer Drug Parity Act of 2019 - Provisions related to prescription drug patient cost-sharing H.R. 2064: To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes H.R. 2069: To amend title XI of the Social Security Act to provide for drug manufacturer price transparency H.R. 2113: Prescription Drug Sunshine, Transparency, Accountability and Reporting Act - Price transparency S. 61: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation S. 73: End Taxpayer Subsidies for Drug Ads Act - Provisions related to direct-to-consumer prescription drug advertising S. 97: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 340: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 378: Stop Price Gouging Act - Provisions related to prescription drug pricing S. 418: FDA Accountability for Public Safety Act - Provisions related to FDA drug approvals S. 419: Protecting Americans from Dangerous Opioids Act - Provisions related to FDA drug approvals S. 474: Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs S. 637: Combatting Unreasonable Rises and Excessively (CURE) High Drug Prices Act - Provisions related to prescription drug pricing and transparency S. 657: To amend title XXVII of the Public Health Service Act to establish requirements with respect to prescription drug benefits - Provisions related to prescription drug pricing transparency and commercial market rebates S. 658: Accelerated Drug Approval for Prescription Therapies Act - Provisions related to FDA drug approvals S. 660: Efficiency and Transparency in Petitions Act - Provisions related to the FDA citizen petition process S. 741: Cancer Drug Parity Act of 2019 - Provisions related to prescription drug patient cost-sharing S. __: Transparent Drug Pricing Act - Provisions related to transparency and drug pricing S. __: Patient Affordability Value and Efficiency Act - To amend titles XI, XVIII, and XIX of the Social Security Act to promote value-based arrangements Transparency policy issues Drug cost and pricing 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 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 FDA modernization policy issues PDUFA implementation policy issues 340B drug discount program policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Patient assistance program policy issues 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 Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49)

Contacted: U.S. Trade Representative (USTR); Congressional Budget Office (CBO); Executive Office of the President (EOP); HOUSE OF REPRESENTATIVES; Natl Economic Council (NEC); Centers For Medicare and Medicaid Services (CMS); Patent & Trademark Office (PTO); SENATE; Health & Human Services, Dept of (HHS)

Bills named: S. 657 (116th), S. 378 (116th), S. 97 (116th), H.R. 985 (116th), S. 474 (116th), S. 658 (116th), H.R. 2113 (116th), S. 637 (116th), H.R. 478 (116th), H.R. 1506 (116th), H.R. 1332 (116th), S. 73 (116th), H.R. 1409 (116th), H.R. 1093 (116th), H.R. 447 (116th), S. 660 (116th), S. 340 (116th), S. 418 (116th), S. 419 (116th), H.R. 965 (116th), H.R. 2064 (116th), H.R. 1730 (116th), H.R. 1478 (116th), S. 61 (116th), H.R. 2069 (116th), S. 741 (116th), H.R. 1323 (116th)