A bill to establish a process for updating the labeling of certain drugs with outdated labeling.

H.R. 938, Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 985, Fair Access for Safe and Timely (FAST) Generics Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 986, Protecting American with Preexisting Conditions Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 987, Marketing and Outreach Restoration to Empower Health Education Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 1010, Short-Term, Limited Duration Insurance (STLDI), regarding all bio-pharmaceutical related provisions. H.R. 1323, Rural Hospital Frontier Fairness Act, regarding all bio-pharmaceutical related provisions. H.R. 1385, State Allowance for a Variety of Exchanges (SAVE) Act, regarding all bio-pharmaceutical related provisions. H.R. 1386, Expanded Navigators Resources for Outreach, Learning, and Longevity (ENROLL) Act, regarding all bio-pharmaceutical related provisions. H.R. 1409, Transparency in All Health Care Pricing Act, regarding all bio-pharmaceutical related provisions. H.R. 1425, State Health Care Premium Reduction Act, regarding all bio-pharmaceutical related provisions. H.R. 1478, Insulin importation, regarding all bio-pharmaceutical related provisions. H.R. 1503, Orange Book Transparency Act, regarding all bio-pharmaceutical related provisions. H.R. 1506, Fair and Immediate Release (FAIR) of Generics Act, regarding all bio-pharmaceutical related provisions. H.R. 1520, Purple Book Continuity Act, regarding all bio-pharmaceutical related provisions. H.R. 2011, Protecting Access to Biosimilars Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 2038, State-based , Market-Oriented, Prescription Drug Negotiations Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 2064, Product Sample reporting, regarding all bio-pharmaceutical related provisions. S. 61, Safe and Affordable Drugs from Canada Act, regarding all bio-pharmaceutical related provisions. S. 97, Affordable and Safe Drug Importation Act, regarding all bio-pharmaceutical related provisions. S. 102, Prescription Drug Price Relief Act, regarding all bio-pharmaceutical related provisions. S. 344/H.R. 990, Hatch-Waxman Integrity Act, regarding all bio-pharmaceutical related provisions. S. 366/H.R. 1188, FLAT Prices Act- Reduced exclusivity period for certain price hikes, regarding all bio-pharmaceutical related provisions. S. 418, FDA Accountability for Public Safety Act, regarding all bio-pharmaceutical related provisions. S. 419, Protecting Americans from Dangerous Opioids Act, regarding all bio-pharmaceutical related provisions. S. 637, CURE High Drug Prices Act, regarding all bio-pharmaceutical related provisions. S. 657, Drug Price Transparency Act, regarding all bio-pharmaceutical related provisions. S. 658, Accelerated Drug Approval for Prescription Therapies Act, regarding all bio-pharmaceutical related provisions. S. 659, Biologic Patent Transparency Act, regarding all bio-pharmaceutical related provisions. S. 660, Transparency in Petitions Act, regarding all bio-pharmaceutical related provisions. S. 709, Establishes public dashboard for price and utilization of drugs purchased by federal programs, regarding all bio-pharmaceutical related provisions. S. 741 /H.R. 1730, Cancer Drug Parity Act, regarding all bio-pharmaceutical related provisions. S. 844, Short Competition Act, regarding all bio-pharmaceutical related provisions. S. 977, Transparent Drug Pricing Act of 2019, regarding all bio-pharmaceutical related provisions. S. 989, STEER Act, regarding all bio-pharmaceutical related provisions. S. 1140, A bill 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 biological product license pursuant to section 7002 of the Biologics Price Competition and Innovation Act of 2009, regarding all bio-pharmaceutical related provisions. S.1169, FDA citizen petition, regarding all bio-pharmaceutical related provisions. S. 1209, A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to approval of abbreviated new drug applications, regarding all bio-pharmaceutical related provisions. H.R. 2115, Public Disclosure of Drug Discounts Act, regarding all bio-pharmaceutical related provisions H.R.2296/S.1391, FAIR Drug Pricing Act, regarding all bio-pharmaceutical related provisions H.R.2700, Lowering Prescription Drug Costs and Extending Community Health Centers and other Health Priorities Act, regarding all bio-pharmaceutical related provisions H.R. 3223, Pharmacy Benefit Manager Accountability Study Act, regarding all bio-pharmaceutical related provisions S. 1361/H.R.2584, Preventive Health Savings Act, regarding all bio-pharmaceutical related provisions S. 1437, DTC Act, regarding all bio-pharmaceutical related provisions S.1532, Pharmacy Benefit Managers Accountability Study Act, regarding all bio-pharmaceutical related provisions S.1636, Ensuring Innovation Act, regarding all bio-pharmaceutical related provisions S. 1664, Prescription Drug Price Reporting Act, regarding all bio-pharmaceutical related provisions S. 1801, Affordable Medications Act, regarding all bio-pharmaceutical related provisions S. 1895, Lowering Health Costs Act, regarding all bio-pharmaceutical related provisions S. 1897, a bill to establish a process for updating the labeling of certain drugs with outdated labeling, regarding all bio-pharmaceutical related provisions S. 1897/H.R. 3523, End Price Gouging for Medications Act, regarding all bio-pharmaceutical related provisions S. 2004, Emergency Access to Insulin Act, regarding all bio-pharmaceutical related provisions H.R. 2279/S. 2546, Safe Step Act of 2019, regarding all bio-pharmaceutical related provisions H.R 748/S. 3548, Coronavirus Aid, Relief and Economic Security Act (CARES Act), regarding all bio-pharmaceutical provisions. H.R. 1425, State Health Care Premium Reduction Act, regarding all bio-pharmaceutical related provisions H.R. 6800, Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act, regarding all bio-pharmaceutical related provisions

Client expense: $1,600,000 · 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), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)

H.R. 938, Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 985, Fair Access for Safe and Timely (FAST) Generics Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 986, Protecting American with Preexisting Conditions Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 987, Marketing and Outreach Restoration to Empower Health Education Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 1010, Short-Term, Limited Duration Insurance (STLDI), regarding all bio-pharmaceutical related provisions. H.R. 1323, Rural Hospital Frontier Fairness Act, regarding all bio-pharmaceutical related provisions. H.R. 1385, State Allowance for a Variety of Exchanges (SAVE) Act, regarding all bio-pharmaceutical related provisions. H.R. 1386, Expanded Navigators Resources for Outreach, Learning, and Longevity (ENROLL) Act, regarding all bio-pharmaceutical related provisions. H.R. 1409, Transparency in All Health Care Pricing Act, regarding all bio-pharmaceutical related provisions. H.R. 1425, State Health Care Premium Reduction Act, regarding all bio-pharmaceutical related provisions. H.R. 1478, Insulin importation, regarding all bio-pharmaceutical related provisions. H.R. 1503, Orange Book Transparency Act, regarding all bio-pharmaceutical related provisions. H.R. 1506, Fair and Immediate Release (FAIR) of Generics Act, regarding all bio-pharmaceutical related provisions. H.R. 1520, Purple Book Continuity Act, regarding all bio-pharmaceutical related provisions. H.R. 2011, Protecting Access to Biosimilars Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 2038, State-based , Market-Oriented, Prescription Drug Negotiations Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 2064, Product Sample reporting, regarding all bio-pharmaceutical related provisions. S. 61, Safe and Affordable Drugs from Canada Act, regarding all bio-pharmaceutical related provisions. S. 97, Affordable and Safe Drug Importation Act, regarding all bio-pharmaceutical related provisions. S. 102, Prescription Drug Price Relief Act, regarding all bio-pharmaceutical related provisions. S. 344/H.R. 990, Hatch-Waxman Integrity Act, regarding all bio-pharmaceutical related provisions. S. 366/H.R. 1188, FLAT Prices Act- Reduced exclusivity period for certain price hikes, regarding all bio-pharmaceutical related provisions. S. 418, FDA Accountability for Public Safety Act, regarding all bio-pharmaceutical related provisions. S. 419, Protecting Americans from Dangerous Opioids Act, regarding all bio-pharmaceutical related provisions. S. 637, CURE High Drug Prices Act, regarding all bio-pharmaceutical related provisions. S. 657, Drug Price Transparency Act, regarding all bio-pharmaceutical related provisions. S. 658, Accelerated Drug Approval for Prescription Therapies Act, regarding all bio-pharmaceutical related provisions. S. 659, Biologic Patent Transparency Act, regarding all bio-pharmaceutical related provisions. S. 660, Transparency in Petitions Act, regarding all bio-pharmaceutical related provisions. S. 709, Establishes public dashboard for price and utilization of drugs purchased by federal programs, regarding all bio-pharmaceutical related provisions. S. 741 /H.R. 1730, Cancer Drug Parity Act, regarding all bio-pharmaceutical related provisions. S. 844, Short Competition Act, regarding all bio-pharmaceutical related provisions. S. 977, Transparent Drug Pricing Act of 2019, regarding all bio-pharmaceutical related provisions. S. 989, STEER Act, regarding all bio-pharmaceutical related provisions. S. 1140, A bill 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 biological product license pursuant to section 7002 of the Biologics Price Competition and Innovation Act of 2009, regarding all bio-pharmaceutical related provisions. S.1169, FDA citizen petition, regarding all bio-pharmaceutical related provisions. S. 1209, A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to approval of abbreviated new drug applications, regarding all bio-pharmaceutical related provisions. H.R. 2115, Public Disclosure of Drug Discounts Act, regarding all bio-pharmaceutical related provisions H.R.2296/S.1391, FAIR Drug Pricing Act, regarding all bio-pharmaceutical related provisions H.R.2700, Lowering Prescription Drug Costs and Extending Community Health Centers and other Health Priorities Act, regarding all bio-pharmaceutical related provisions H.R. 3223, Pharmacy Benefit Manager Accountability Study Act, regarding all bio-pharmaceutical related provisions S. 1361/H.R.2584, Preventive Health Savings Act, regarding all bio-pharmaceutical related provisions S. 1437, DTC Act, regarding all bio-pharmaceutical related provisions S.1532, Pharmacy Benefit Managers Accountability Study Act, regarding all bio-pharmaceutical related provisions S.1636, Ensuring Innovation Act, regarding all bio-pharmaceutical related provisions S. 1664, Prescription Drug Price Reporting Act, regarding all bio-pharmaceutical related provisions S. 1801, Affordable Medications Act, regarding all bio-pharmaceutical related provisions S. 1895, Lowering Health Costs Act, regarding all bio-pharmaceutical related provisions S. 1897, a bill to establish a process for updating the labeling of certain drugs with outdated labeling, regarding all bio-pharmaceutical related provisions S. 1897/H.R. 3523, End Price Gouging for Medications Act, regarding all bio-pharmaceutical related provisions S. 2004, Emergency Access to Insulin Act, regarding all bio-pharmaceutical related provisions H.R. 2279/S. 2546, Safe Step Act of 2019, regarding all bio-pharmaceutical related provisions H.R 748/S. 3548, Coronavirus Aid, Relief and Economic Security Act (CARES Act), regarding all bio-pharmaceutical provisions. H.R. 1425, State Health Care Premium Reduction Act, regarding all bio-pharmaceutical related provisions H.R. 6800, Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act, regarding all bio-pharmaceutical related provisions

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 discount program H.R. 2296: FAIR Drug Pricing Act of 2019 / More Efficient Tools to Realize Information for Consumers Act - Provisions related to prescription drug pricing and transparency H.R. 2376: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 4812: Ensuring Compliance Against Drug Diversion Act of 2019 - Provisions related to registrations under the Controlled Substances Act H.R. 5239: Prescription Drug Price Reporting Act - Provisions related to prescription drug pricing transparency H.R. 5668: MODERN Labeling Act of 2020 - Provisions related to prescription drug labeling H.R. 6019: Cure the Coronavirus Act - Provisions related to FDA prescription drug approvals H.R. 6080: Preventing Drug Shortages Act - Provisions related to prescription drug shortage reporting requirements H.R. 6173: Covering Coronavirus Test Act of 2020 - Provisions related to medical device pricing and coverage H.R. 6213: No Cost for COVID-19 Testing Act - Provisions related to medical device pricing and coverage H.R. 6222: Ensuring Affordable COVID-19 Preventive Care Act of 2020 - Provisions related to prescription drug pricing and access H.R. 6231: Ensuring Access to COVID-19 Preventive Care Act of 2020 - Provisions related to prescription drug pricing and access H.R. 6253: To expand certain securities exemptions to respond to COVID-19, to establish an X-prize for creating an effective COVID-19 vaccine, and for other purposes - Provisions related to prescription drug research and development H.R. 6261: To provide for coverage of testing for COVID-19 at no cost sharing for Indians receiving health services through the Indian Health Service, and for other purposes - Provisions related to medical device pricing and coverage H.R. 6264: To prohibit price gouging during a state of emergency declaration, and for other purposes - Provisions related to prescription drug and medical device pricing H.R. 6351: To authorize the Secretary of Health and Human Services to administer vaccinations for COVID-19, once available, at no cost to the inoculated, in response to the COVID-19 outbreak, and for other purposes - Provisions related to prescription drug patient access and cost sharing H.R. 6390: To require the President to use authorities under the Defense Production Act of 1950 to require emergency production of medical equipment to address the COVID-19 outbreak - Provisions related to the Defense Production Act H.R. 6410: To direct the President to use authority under the Defense Production Act of 1950 to ensure an adequate supply equipment necessary for limiting the spread of COVID-19 - Provisions related to the Defense Production Act 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. 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. 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: Drug Price Transparency Act - Provisions related to prescription drug pricing transparency and commercial market rebates S. 660: Efficiency and Transparency in Petitions Act - Provisions related to the FDA citizen petition process S. 801: Payment Commission Data Act of 2019 - Provisions related to prescription drug pricing transparency S. 977: Transparent Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and foreign reference pricing S. 1089: Restoring Access to Medication Act of 2019 - Provisions related to prescription drug access S. 1227: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1384: Prescription Drug Rebate Reform Act of 2019 - Provisions related to prescription drug pricing and negotiated rebates S. 1391: FAIR Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and transparency S. 1437: Drug-price Transparency in Communications (DTC) Act - Provisions related to direct-to-consumer prescription drug advertising S. 1532: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1567: Finding Orphan-disease Remedies With Antifungal Research and Development Act of 2019 - Provisions related to rare disease research and funding S1872/HR5076 Protecting Seniors Through Immunization Act S. 1897: A bill to establish a process for updating the labeling of certain drugs with outdated labeling - Provisions related to prescription drug labeling S. 2004: Emergency Access to Insulin Act of 2019 - Provisions related to prescription drug pricing S. 2103: Affordable Insulin Approvals Now Act - Provisions related to FDA prescription drug approvals S. 2161: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 - Provisions related to reciprocity S. 2304: Strategies To Address Antibiotic Resistance Act - Provisions related to antimicrobial resistance (AMR) and other issues S. 2723: Mitigating Emergency Drug Shortages Act - Provisions related to prescription drug pricing transparency and other provisions S. 2897: Patient-Centered Outcomes Research Institute Reauthorization Act - Provisions related to PCORI reauthorization S. 3162: Affordable Drug Manufacturing Act of 2019 - Provisions related to prescription drug manufacturing S. 3166: Prescription Drug Affordability and Access Act - Provisions related to prescription drug pricing S. 3180: Responsibility in Drug Advertising Act of 2020 - Provisions related to prescription drug direct-to-consumer advertising S. 3384: Lowering Prescription Drug Prices for America's Seniors and Families Act of 2020 - Provisions related to prescription drug price negotiation, importation, and other issues S. 3439: Lower Health Insurance Deductibles Act - Provisions related to prescription drug pricing and insurance plan design S. 3432: Securing America's Medicine Cabinet Act of 2020 - Provisions related to advanced manufacturing and prescription drugs S. 3442: Care for COVID-19 Act - Provisions related to prescription drug pricing and access S. 3499: A bill to amend coverage requirements to ensure that no person incurs cost sharing when receiving a test to confirm a COVID-19 infection - Provisions related to medical device pricing and access S. 3505: A bill to require private health insurance to rapidly cover preventive services and vaccines related to the coronavirus - Provisions related to prescription drug pricing and access S. 3545: A bill to amend the Federal Food, Drug, and Cosmetic Act to provide for reciprocal marketing approval of certain drugs, biological products, and devices that are authorized to be lawfully marketed abroad, and for other purposes - Provisions related to FDA prescription drug marketing approvals S. 3564: A bill to amend title XIX of the Social Security Act to require States to provide medical assistance for COVID-19 treatment services for individuals who are diagnosed with COVID-19, and for other purposes - Provisions related to prescription drug pricing and access S. 3570: A bill to provide for the expedited procurement of equipment needed to combat COVID-19 under the Defense Production Act of 1950 - Provisions related to the Defense Production Act Transparency policy issues Drug cost and pricing policy issues Drug importation and counterfeiting policy issues HHS Safe Importation Action Plan Prescription drug take back and secure disposal policy issues Expanded access policy issues Antimicrobial resistance 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 Monograph Reform CDC Programmatic Funding Restoration of HSA/FSAs 340B drug discount program policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Patient assistance program policy issues Foreign manufacturing policy issues Biosimilar approval and reimbursement policy issues Cancer drug vial size policy issues Drug shortages policy issues Proposed Rule; Importation of Prescription Drugs (RIN 0910-AI45) Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients

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 discount program H.R. 2296: FAIR Drug Pricing Act of 2019 / More Efficient Tools to Realize Information for Consumers Act - Provisions related to prescription drug pricing and transparency H.R. 2376: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 4812: Ensuring Compliance Against Drug Diversion Act of 2019 - Provisions related to registrations under the Controlled Substances Act H.R. 5239: Prescription Drug Price Reporting Act - Provisions related to prescription drug pricing transparency H.R. 5382: To create a mechanism whereby insulin manufacturers may sell directly to consumers at current net prices. - Provisions related to prescription drug pricing H.R. 5668: MODERN Labeling Act of 2020 - Provisions related to prescription drug labeling H.R. 6019: Cure the Coronavirus Act - Provisions related to FDA prescription drug approvals H.R. 6080: Preventing Drug Shortages Act - Provisions related to prescription drug shortage reporting requirements H.R. 6173: Covering Coronavirus Test Act of 2020 - Provisions related to medical device pricing and coverage H.R. 6213: No Cost for COVID-19 Testing Act - Provisions related to medical device pricing and coverage H.R. 6222: Ensuring Affordable COVID-19 Preventive Care Act of 2020 - Provisions related to prescription drug pricing and access H.R. 6231: Ensuring Access to COVID-19 Preventive Care Act of 2020 - Provisions related to prescription drug pricing and access H.R. 6253: To expand certain securities exemptions to respond to COVID-19, to establish an X-prize for creating an effective COVID-19 vaccine, and for other purposes - Provisions related to prescription drug research and development H.R. 6261: To provide for coverage of testing for COVID-19 at no cost sharing for Indians receiving health services through the Indian Health Service, and for other purposes - Provisions related to medical device pricing and coverage H.R. 6264: To prohibit price gouging during a state of emergency declaration, and for other purposes - Provisions related to prescription drug and medical device pricing H.R. 6351: To authorize the Secretary of Health and Human Services to administer vaccinations for COVID-19, once available, at no cost to the inoculated, in response to the COVID-19 outbreak, and for other purposes - Provisions related to prescription drug patient access and cost sharing H.R. 6390: To require the President to use authorities under the Defense Production Act of 1950 to require emergency production of medical equipment to address the COVID-19 outbreak - Provisions related to the Defense Production Act H.R. 6410: To direct the President to use authority under the Defense Production Act of 1950 to ensure an adequate supply equipment necessary for limiting the spread of COVID-19 - Provisions related to the Defense Production Act 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. 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. 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: Drug Price Transparency Act - Provisions related to prescription drug pricing transparency and commercial market rebates S. 660: Efficiency and Transparency in Petitions Act - Provisions related to the FDA citizen petition process S. 801: Payment Commission Data Act of 2019 - Provisions related to prescription drug pricing transparency S. 977: Transparent Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and foreign reference pricing S. 1089: Restoring Access to Medication Act of 2019 - Provisions related to prescription drug access S. 1227: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1384: Prescription Drug Rebate Reform Act of 2019 - Provisions related to prescription drug pricing and negotiated rebates S. 1391: FAIR Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and transparency S. 1437: Drug-price Transparency in Communications (DTC) Act - Provisions related to direct-to-consumer prescription drug advertising S. 1532: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1567: Finding Orphan-disease Remedies With Antifungal Research and Development Act of 2019 - Provisions related to rare disease research and funding S. 1897: A bill to establish a process for updating the labeling of certain drugs with outdated labeling - Provisions related to prescription drug labeling S. 2004: Emergency Access to Insulin Act of 2019 - Provisions related to prescription drug pricing S. 2103: Affordable Insulin Approvals Now Act - Provisions related to FDA prescription drug approvals S. 2161: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 - Provisions related to reciprocity S. 2304: Strategies To Address Antibiotic Resistance Act - Provisions related to antimicrobial resistance (AMR) and other issues S. 2723: Mitigating Emergency Drug Shortages Act - Provisions related to prescription drug pricing transparency and other provisions S. 2897: Patient-Centered Outcomes Research Institute Reauthorization Act - Provisions related to PCORI reauthorization S. 3162: Affordable Drug Manufacturing Act of 2019 - Provisions related to prescription drug manufacturing S. 3166: Prescription Drug Affordability and Access Act - Provisions related to prescription drug pricing S. 3180: Responsibility in Drug Advertising Act of 2020 - Provisions related to prescription drug direct-to-consumer advertising S. 3384: Lowering Prescription Drug Prices for America's Seniors and Families Act of 2020 - Provisions related to prescription drug price negotiation, importation, and other issues S. 3439: Lower Health Insurance Deductibles Act - Provisions related to prescription drug pricing and insurance plan design S. 3432: Securing America's Medicine Cabinet Act of 2020 - Provisions related to advanced manufacturing and prescription drugs S. 3442: Care for COVID-19 Act - Provisions related to prescription drug pricing and access S. 3468 Preventing Essential Medical Device Shortages Act of 2020 - Provisions related to medical device shortage reporting requirements S. 3499: A bill to amend coverage requirements to ensure that no person incurs cost sharing when receiving a test to confirm a COVID-19 infection - Provisions related to medical device pricing and access S. 3505: A bill to require private health insurance to rapidly cover preventive services and vaccines related to the coronavirus - Provisions related to prescription drug pricing and access S. 3545: A bill to amend the Federal Food, Drug, and Cosmetic Act to provide for reciprocal marketing approval of certain drugs, biological products, and devices that are authorized to be lawfully marketed abroad, and for other purposes - Provisions related to FDA prescription drug marketing approvals S. 3564: A bill to amend title XIX of the Social Security Act to require States to provide medical assistance for COVID-19 treatment services for individuals who are diagnosed with COVID-19, and for other purposes - Provisions related to prescription drug pricing and access S. 3568: To require the President to use authorities under the Defense Production Act of 1950 to require emergency production of medical equipment to address the COVID-19 outbreak - Provisions related to the Defense Production Act S. 3570: A bill to provide for the expedited procurement of equipment needed to combat COVID-19 under the Defense Production Act of 1950 - Provisions related to the Defense Production Act Transparency policy issues Drug cost and pricing policy issues Drug importation and counterfeiting policy issues HHS Safe Importation Action Plan Prescription drug take back and secure disposal policy issues Policy issues related to prescription drug abuse and opioids Expanded access policy issues Antimicrobial resistance 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 Foreign manufacturing policy issues Biosimilar approval and reimbursement policy issues Cancer drug vial size policy issues Drug shortages policy issues Proposed Rule; Importation of Prescription Drugs (RIN 0910-AI45) Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients

H.R. 938, Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 985, Fair Access for Safe and Timely (FAST) Generics Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 986, Protecting American with Preexisting Conditions Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 987, Marketing and Outreach Restoration to Empower Health Education Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 1010, Short-Term, Limited Duration Insurance (STLDI), regarding all bio-pharmaceutical related provisions. H.R. 1323, Rural Hospital Frontier Fairness Act, regarding all bio-pharmaceutical related provisions. H.R. 1385, State Allowance for a Variety of Exchanges (SAVE) Act, regarding all bio-pharmaceutical related provisions. H.R. 1386, Expanded Navigators Resources for Outreach, Learning, and Longevity (ENROLL) Act, regarding all bio-pharmaceutical related provisions. H.R. 1409, Transparency in All Health Care Pricing Act, regarding all bio-pharmaceutical related provisions. H.R. 1425, State Health Care Premium Reduction Act, regarding all bio-pharmaceutical related provisions. H.R. 1478, Insulin importation, regarding all bio-pharmaceutical related provisions. H.R. 1503, Orange Book Transparency Act, regarding all bio-pharmaceutical related provisions. H.R. 1506, Fair and Immediate Release (FAIR) of Generics Act, regarding all bio-pharmaceutical related provisions. H.R. 1520, Purple Book Continuity Act, regarding all bio-pharmaceutical related provisions. H.R. 2011, Protecting Access to Biosimilars Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 2038, State-based , Market-Oriented, Prescription Drug Negotiations Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 2064, Product Sample reporting, regarding all bio-pharmaceutical related provisions. S. 61, Safe and Affordable Drugs from Canada Act, regarding all bio-pharmaceutical related provisions. S. 97, Affordable and Safe Drug Importation Act, regarding all bio-pharmaceutical related provisions. S. 102, Prescription Drug Price Relief Act, regarding all bio-pharmaceutical related provisions. S. 344/H.R. 990, Hatch-Waxman Integrity Act, regarding all bio-pharmaceutical related provisions. S. 366/H.R. 1188, FLAT Prices Act- Reduced exclusivity period for certain price hikes, regarding all bio-pharmaceutical related provisions. S. 418, FDA Accountability for Public Safety Act, regarding all bio-pharmaceutical related provisions. S. 419, Protecting Americans from Dangerous Opioids Act, regarding all bio-pharmaceutical related provisions. S. 637, CURE High Drug Prices Act, regarding all bio-pharmaceutical related provisions. S. 657, Drug Price Transparency Act, regarding all bio-pharmaceutical related provisions. S. 658, Accelerated Drug Approval for Prescription Therapies Act, regarding all bio-pharmaceutical related provisions. S. 659, Biologic Patent Transparency Act, regarding all bio-pharmaceutical related provisions. S. 660, Transparency in Petitions Act, regarding all bio-pharmaceutical related provisions. S. 709, Establishes public dashboard for price and utilization of drugs purchased by federal programs, regarding all bio-pharmaceutical related provisions. S. 741 /H.R. 1730, Cancer Drug Parity Act, regarding all bio-pharmaceutical related provisions. S. 844, Short Competition Act, regarding all bio-pharmaceutical related provisions. S. 977, Transparent Drug Pricing Act of 2019, regarding all bio-pharmaceutical related provisions. S. 989, STEER Act, regarding all bio-pharmaceutical related provisions. S. 1140, A bill 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 biological product license pursuant to section 7002 of the Biologics Price Competition and Innovation Act of 2009, regarding all bio-pharmaceutical related provisions. S.1169, FDA citizen petition, regarding all bio-pharmaceutical related provisions. S. 1209, A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to approval of abbreviated new drug applications, regarding all bio-pharmaceutical related provisions. H.R. 2115, Public Disclosure of Drug Discounts Act, regarding all bio-pharmaceutical related provisions H.R.2296/S.1391, FAIR Drug Pricing Act, regarding all bio-pharmaceutical related provisions H.R.2700, Lowering Prescription Drug Costs and Extending Community Health Centers and other Health Priorities Act, regarding all bio-pharmaceutical related provisions H.R. 3223, Pharmacy Benefit Manager Accountability Study Act, regarding all bio-pharmaceutical related provisions S. 1361/H.R.2584, Preventive Health Savings Act, regarding all bio-pharmaceutical related provisions S. 1437, DTC Act, regarding all bio-pharmaceutical related provisions S.1532, Pharmacy Benefit Managers Accountability Study Act, regarding all bio-pharmaceutical related provisions S.1636, Ensuring Innovation Act, regarding all bio-pharmaceutical related provisions S. 1664, Prescription Drug Price Reporting Act, regarding all bio-pharmaceutical related provisions S. 1801, Affordable Medications Act, regarding all bio-pharmaceutical related provisions S. 1895, Lowering Health Costs Act, regarding all bio-pharmaceutical related provisions S. 1897, a bill to establish a process for updating the labeling of certain drugs with outdated labeling, regarding all bio-pharmaceutical related provisions S. 1897/H.R. 3523, End Price Gouging for Medications Act, regarding all bio-pharmaceutical related provisions S. 2004, Emergency Access to Insulin Act, regarding all bio-pharmaceutical related provisions H.R. 2279/S. 2546, Safe Step Act of 2019, regarding all bio-pharmaceutical related provisions H.R 748/S. 3548, Coronavirus Aid, Relief and Economic Security Act (CARES Act), regarding all bio-pharmaceutical related provisions

H.R. 938, Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 985, Fair Access for Safe and Timely (FAST) Generics Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 986, Protecting American with Preexisting Conditions Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 987, Marketing and Outreach Restoration to Empower Health Education Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 1010, Short-Term, Limited Duration Insurance (STLDI), regarding all bio-pharmaceutical related provisions. H.R. 1323, Rural Hospital Frontier Fairness Act, regarding all bio-pharmaceutical related provisions. H.R. 1385, State Allowance for a Variety of Exchanges (SAVE) Act, regarding all bio-pharmaceutical related provisions. H.R. 1386, Expanded Navigators Resources for Outreach, Learning, and Longevity (ENROLL) Act, regarding all bio-pharmaceutical related provisions. H.R. 1409, Transparency in All Health Care Pricing Act, regarding all bio-pharmaceutical related provisions. H.R. 1425, State Health Care Premium Reduction Act, regarding all bio-pharmaceutical related provisions. H.R. 1478, Insulin importation, regarding all bio-pharmaceutical related provisions. H.R. 1503, Orange Book Transparency Act, regarding all bio-pharmaceutical related provisions. H.R. 1506, Fair and Immediate Release (FAIR) of Generics Act, regarding all bio-pharmaceutical related provisions. H.R. 1520, Purple Book Continuity Act, regarding all bio-pharmaceutical related provisions. H.R. 2011, Protecting Access to Biosimilars Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 2038, State-based , Market-Oriented, Prescription Drug Negotiations Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 2064, Product Sample reporting, regarding all bio-pharmaceutical related provisions. S. 61, Safe and Affordable Drugs from Canada Act, regarding all bio-pharmaceutical related provisions. S. 97, Affordable and Safe Drug Importation Act, regarding all bio-pharmaceutical related provisions. S. 102, Prescription Drug Price Relief Act, regarding all bio-pharmaceutical related provisions. S. 344/H.R. 990, Hatch-Waxman Integrity Act, regarding all bio-pharmaceutical related provisions. S. 366/H.R. 1188, FLAT Prices Act- Reduced exclusivity period for certain price hikes, regarding all bio-pharmaceutical related provisions. S. 418, FDA Accountability for Public Safety Act, regarding all bio-pharmaceutical related provisions. S. 419, Protecting Americans from Dangerous Opioids Act, regarding all bio-pharmaceutical related provisions. S. 637, CURE High Drug Prices Act, regarding all bio-pharmaceutical related provisions. S. 657, Drug Price Transparency Act, regarding all bio-pharmaceutical related provisions. S. 658, Accelerated Drug Approval for Prescription Therapies Act, regarding all bio-pharmaceutical related provisions. S. 659, Biologic Patent Transparency Act, regarding all bio-pharmaceutical related provisions. S. 660, Transparency in Petitions Act, regarding all bio-pharmaceutical related provisions. S. 709, Establishes public dashboard for price and utilization of drugs purchased by federal programs, regarding all bio-pharmaceutical related provisions. S. 741 /H.R. 1730, Cancer Drug Parity Act, regarding all bio-pharmaceutical related provisions. S. 844, Short Competition Act, regarding all bio-pharmaceutical related provisions. S. 977, Transparent Drug Pricing Act of 2019, regarding all bio-pharmaceutical related provisions. S. 989, STEER Act, regarding all bio-pharmaceutical related provisions. S. 1140, A bill 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 biological product license pursuant to section 7002 of the Biologics Price Competition and Innovation Act of 2009, regarding all bio-pharmaceutical related provisions. S.1169, FDA citizen petition, regarding all bio-pharmaceutical related provisions. S. 1209, A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to approval of abbreviated new drug applications, regarding all bio-pharmaceutical related provisions. H.R. 2115, Public Disclosure of Drug Discounts Act, regarding all bio-pharmaceutical related provisions H.R.2296/S.1391, FAIR Drug Pricing Act, regarding all bio-pharmaceutical related provisions H.R.2700, Lowering Prescription Drug Costs and Extending Community Health Centers and other Health Priorities Act, regarding all bio-pharmaceutical related provisions H.R. 3223, Pharmacy Benefit Manager Accountability Study Act, regarding all bio-pharmaceutical related provisions S. 1361/H.R.2584, Preventive Health Savings Act, regarding all bio-pharmaceutical related provisions S. 1437, DTC Act, regarding all bio-pharmaceutical related provisions S.1532, Pharmacy Benefit Managers Accountability Study Act, regarding all bio-pharmaceutical related provisions S.1636, Ensuring Innovation Act, regarding all bio-pharmaceutical related provisions S. 1664, Prescription Drug Price Reporting Act, regarding all bio-pharmaceutical related provisions S. 1801, Affordable Medications Act, regarding all bio-pharmaceutical related provisions S. 1895, Lowering Health Costs Act, regarding all bio-pharmaceutical related provisions S. 1897, a bill to establish a process for updating the labeling of certain drugs with outdated labeling, regarding all bio-pharmaceutical related provisions S. 1897/H.R. 3523, End Price Gouging for Medications Act, regarding all bio-pharmaceutical related provisions S. 2004, Emergency Access to Insulin Act, regarding all bio-pharmaceutical related provisions H.R. 2279/S. 2546, Safe Step Act of 2019, regarding all bio-pharmaceutical related provisions

S.607/H.R. 1847, Electronic Communications Privacy Act Amendments Act, H.R. 1852, Email Privacy Act; S.1897/H.R. 3990. Personal Data Privacy and Security Act; issues related to student data protection

Client expense: Not reported · Firm income: $80,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

___ H.R. 3: Lower Drug Costs Now Act of 2019 - Provisions related to prescription drug pricing, foreign reference pricing, Part D, manufacturer rebates, and other provisions ___ 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. 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. 1839: Medicaid Services Investment and Accountability Act - Provisions related to Medicaid drug rebates and drug classification ___ H.R. 2000: Medicare-X Choice Act of 2019 - Provisions related to Part D and drug pricing negotiation ___ H.R. 2452: Medicare for America Act of 2019 - Provisions related to Part D and drug pricing negotiation ___ H.R. 2463: Choose Medicare Act - Provisions related to Part D and drug pricing negotiation ___ H.R. 2757: Creating Lower cost Alternative for Your prescription drugs Act - Provisions related to Part D and patient cost-sharing ___ H.R. 3029: Improving Low-Income Access to Prescription Drugs Act of 2019 - Provisions related to Part D prescription drug plans ___ H.R. 3523: End Price Gouging for Medications Act - Provisions related to prescription drug pricing and foreign reference pricing ___ H.R. 3910: Equality in Medicare and Medicaid Treatment Act of 2019 - Provisions related to CMMI models ___ 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. 475: Reducing Existing Costs Associated with Pharmaceuticals for Seniors (RxCap) Act of 2019 - Provisions related to Part D and patient cost-sharing ___ S. 470: Medicare at 50 Act - Provisions related to Part D and drug pricing negotiation ___ 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. 640: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates ___ S. 691: Medicare Extra Rx Higher Eligibility Limits in Part D Act of 2019 - Provisions related to Part D and patient out-of-pocket costs ___ S. 801: Payment Commission Data Act - Provisions related to prescription drug pricing transparency and reporting ___ S. 981: Medicare-X Choice Act of 2019 - Provisions related to Part D and drug pricing negotiation ___ S. 1129: Medicare for All Act of 2019 - Provisions related to Part D and drug pricing negotiation ___ S. 1261: Choose Medicare Act - Provisions related to Part D and drug pricing negotiation ___ S. 1497: Health Care Price Check Act of 2019 - Provisions related to Medicare pricing transparency ___ S. 1785: Fair AMP Act - Provisions related to Medicaid drug rebates ___ S. 1801: Affordable Medications Act - Provisions relate to Part D drug pricing negotiation, importation, IP issues and pricing transparency ___ S. 1895: Lowering Health Care Costs Act - Provisions related to prescription drug pricing, transparency and patent issues ___ S. 1897: A bill to establish a process for updating the labeling of certain drugs with outdated labeling - Provisions related to prescription drug labeling ___ S. 1987: End Price Gouging for Medications Act - Provisions related to prescription drug pricing and foreign reference pricing ___ S. 1999: Improving Low-Income Access to Prescription Drugs Act of 2019 - Provisions related to Part D prescription drug plans ___ S. 2051: Strengthening Average Sales Price Reporting Act - Provisions related to Medicare pricing transparency and rebates ___ S. 2081: Stop Drug Companies from Overcharging Seniors in Medicare Part B Act of 2019 - Provisions related to prescription drug pricing and manufacturer rebates ___ S. 2247: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates ___ S. 2252: Empowering States to Address Drug Costs Act - Provisions related to prescription drug pricing transparency ___ S. 2543: Prescription Drug Pricing Reduction Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other 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 ___ 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; 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) Monograph Reform and HSA/FSAs

H.R. 3: Lower Drug Costs Now Act of 2019 - Provisions related to prescription drug pricing, foreign reference pricing, Part D, manufacturer rebates, and other provisions 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. 1839: Medicaid Services Investment and Accountability Act - Provisions related to Medicaid drug rebates and drug classification H.R. 2000: Medicare-X Choice Act of 2019 - Provisions related to Part D and drug pricing negotiation H.R. 2452: Medicare for America Act of 2019 - Provisions related to Part D and drug pricing negotiation H.R. 2463: Choose Medicare Act - Provisions related to Part D and drug pricing negotiation H.R. 2757: Creating Lower cost Alternative for Your prescription drugs Act - Provisions related to Part D and patient cost-sharing H.R. 3029: Improving Low-Income Access to Prescription Drugs Act of 2019 - Provisions related to Part D prescription drug plans H.R. 3523: End Price Gouging for Medications Act - Provisions related to prescription drug pricing and foreign reference pricing H.R. 3910: Equality in Medicare and Medicaid Treatment Act of 2019 - Provisions related to CMMI models 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. 475: Reducing Existing Costs Associated with Pharmaceuticals for Seniors (RxCap) Act of 2019 - Provisions related to Part D and patient cost-sharing S. 470: Medicare at 50 Act - Provisions related to Part D and drug pricing negotiation 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. 691: Medicare Extra Rx Higher Eligibility Limits in Part D Act of 2019 - Provisions related to Part D and patient out-of-pocket costs S. 801: Payment Commission Data Act - Provisions related to prescription drug pricing transparency and reporting S. 981: Medicare-X Choice Act of 2019 - Provisions related to Part D and drug pricing negotiation S. 1129: Medicare for All Act of 2019 - Provisions related to Part D and drug pricing negotiation S. 1261: Choose Medicare Act - Provisions related to Part D and drug pricing negotiation S. 1497: Health Care Price Check Act of 2019 - Provisions related to Medicare pricing transparency S. 1785: Fair AMP Act - Provisions related to Medicaid drug rebates S. 1801: Affordable Medications Act - Provisions related to Part D drug pricing negotiation, importation, IP issues and pricing transparency S. 1895: Lowering Health Care Costs Act - Provisions related to prescription drug pricing, transparency and patent issues S. 1897: A bill to establish a process for updating the labeling of certain drugs with outdated labeling - Provisions related to prescription drug labeling S. 1987: End Price Gouging for Medications Act - Provisions related to prescription drug pricing and foreign reference pricing S. 1999: Improving Low-Income Access to Prescription Drugs Act of 2019 - Provisions related to Part D prescription drug plans S. 2051: Strengthening Average Sales Price Reporting Act - Provisions related to Medicare pricing transparency and rebates S. 2081: Stop Drug Companies from Overcharging Seniors in Medicare Part B Act of 2019 - Provisions related to prescription drug pricing and manufacturer rebates S. 2247: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates S. 2252: Empowering States to Address Drug Costs Act - Provisions related to prescription drug pricing transparency S. 2543: Prescription Drug Pricing Reduction Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other 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 Policy issues related to patient medication information 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; 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)

Preserve Access to Affordable Generics Act (S. 64); Regulatory exclusivity; Drug pricing; Medicare Part B international reference pricing; Protecting Consumer Access to Generic Drugs Act of 2019 (H.R. 1499); BLOCKING Act of 2019 (H.R. 938); Orange Book Transparency Act of 2019 (H.R. 1503); Purple Book Continuity Act of 2019 (H.R. 1520); CREATES Act of 2019 (HR 965/S. 340); Biologic Patent Transparency Act (S. 659); Generic drug competition; Drug patent issues; Proposed rule on rebate safe Harbor (84 Fed. Reg. 2340); Lower Health Care Costs Act of 2019 (S. 1895); STOP Stalling Act (S. 1224); Affordable Prescriptions for Patients Act of 2019 (S. 1416); Preserve Access to Affordable Generics and Biosimilars Act (H.R.2375); A bill to establish a process for updating the labeling of certain drugs with outdated labeling (S.1897); Protecting Access to Biosimilars Act of 2019 (H.R.2011/S. 1140); TERM Act. (H.R. 3199); Drug importation; State-Based, Market-Oriented, Prescription Drug Negotiations Act of 2019 (H.R. 2038); Transparent Drug Pricing Act of 2019 (S.977); Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 (S. 2161); Medicare Negotiation and Competitive Licensing Act of 2019 (H.R. 1046); Preserving Access to Cost Effective Drugs Act (S. 440); Affordable Insulin Approvals Now Act (S. 2103); Direct to consumer advertising; Medicare Prescription Drug Price Negotiation Act of 2019 (H.R. 275); Medicare Drug Price Negotiation Act (H.R. 448); Lower Drug Costs Now Act of 2019 (H.R. 3); Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2019 (S.476); Fair Care Act of 2019 (H.R.1332); Prescription Drug Pricing Reduction Act of 2019 (S. 2543); Competition Prescription Act of 2019 (H.R. 3947); Fixing Global Freeloading Act (H.R. 2209); National Defense Authorization Act for Fiscal Year 2020 (S.1790); Patient drug labeling.

H.R. 938, Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 985, Fair Access for Safe and Timely (FAST) Generics Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 986, Protecting American with Preexisting Conditions Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 987, Marketing and Outreach Restoration to Empower Health Education Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 1010, Short-Term, Limited Duration Insurance (STLDI), regarding all bio-pharmaceutical related provisions. H.R. 1323, Rural Hospital Frontier Fairness Act, regarding all bio-pharmaceutical related provisions. H.R. 1385, State Allowance for a Variety of Exchanges (SAVE) Act, regarding all bio-pharmaceutical related provisions. H.R. 1386, Expanded Navigators Resources for Outreach, Learning, and Longevity (ENROLL) Act, regarding all bio-pharmaceutical related provisions. H.R. 1409, Transparency in All Health Care Pricing Act, regarding all bio-pharmaceutical related provisions. H.R. 1425, State Health Care Premium Reduction Act, regarding all bio-pharmaceutical related provisions. H.R. 1478, Insulin importation, regarding all bio-pharmaceutical related provisions. H.R. 1503, Orange Book Transparency Act, regarding all bio-pharmaceutical related provisions. H.R. 1506, Fair and Immediate Release (FAIR) of Generics Act, regarding all bio-pharmaceutical related provisions. H.R. 1520, Purple Book Continuity Act, regarding all bio-pharmaceutical related provisions. H.R. 2011, Protecting Access to Biosimilars Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 2038, State-based , Market-Oriented, Prescription Drug Negotiations Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 2064, Product Sample reporting, regarding all bio-pharmaceutical related provisions. S. 61, Safe and Affordable Drugs from Canada Act, regarding all bio-pharmaceutical related provisions. S. 97, Affordable and Safe Drug Importation Act, regarding all bio-pharmaceutical related provisions. S. 102, Prescription Drug Price Relief Act, regarding all bio-pharmaceutical related provisions. S. 344/H.R. 990, Hatch-Waxman Integrity Act, regarding all bio-pharmaceutical related provisions. S. 366/H.R. 1188, FLAT Prices Act- Reduced exclusivity period for certain price hikes, regarding all bio-pharmaceutical related provisions. S. 418, FDA Accountability for Public Safety Act, regarding all bio-pharmaceutical related provisions. S. 419, Protecting Americans from Dangerous Opioids Act, regarding all bio-pharmaceutical related provisions. S. 637, CURE High Drug Prices Act, regarding all bio-pharmaceutical related provisions. S. 657, Drug Price Transparency Act, regarding all bio-pharmaceutical related provisions. S. 658, Accelerated Drug Approval for Prescription Therapies Act, regarding all bio-pharmaceutical related provisions. S. 659, Biologic Patent Transparency Act, regarding all bio-pharmaceutical related provisions. S. 660, Transparency in Petitions Act, regarding all bio-pharmaceutical related provisions. S. 709, Establishes public dashboard for price and utilization of drugs purchased by federal programs, regarding all bio-pharmaceutical related provisions. S. 741 /H.R. 1730, Cancer Drug Parity Act, regarding all bio-pharmaceutical related provisions. S. 844, Short Competition Act, regarding all bio-pharmaceutical related provisions. S. 977, Transparent Drug Pricing Act of 2019, regarding all bio-pharmaceutical related provisions. S. 989, STEER Act, regarding all bio-pharmaceutical related provisions. S. 1140, A bill 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 biological product license pursuant to section 7002 of the Biologics Price Competition and Innovation Act of 2009, regarding all bio-pharmaceutical related provisions. S.1169, FDA citizen petition, regarding all bio-pharmaceutical related provisions. S. 1209, A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to approval of abbreviated new drug applications, regarding all bio-pharmaceutical related provisions. H.R. 2115, Public Disclosure of Drug Discounts Act, regarding all bio-pharmaceutical related provisions H.R.2296/S.1391, FAIR Drug Pricing Act, regarding all bio-pharmaceutical related provisions H.R.2700, Lowering Prescription Drug Costs and Extending Community Health Centers and other Health Priorities Act, regarding all bio-pharmaceutical related provisions H.R. 3223, Pharmacy Benefit Manager Accountability Study Act, regarding all bio-pharmaceutical related provisions S. 1361/H.R.2584, Preventive Health Savings Act, regarding all bio-pharmaceutical related provisions S. 1437, DTC Act, regarding all bio-pharmaceutical related provisions S.1532, Pharmacy Benefit Managers Accountability Study Act, regarding all bio-pharmaceutical related provisions S.1636, Ensuring Innovation Act, regarding all bio-pharmaceutical related provisions S. 1664, Prescription Drug Price Reporting Act, regarding all bio-pharmaceutical related provisions S. 1801, Affordable Medications Act, regarding all bio-pharmaceutical related provisions S. 1895, Lowering Health Costs Act, regarding all bio-pharmaceutical related provisions S. 1897, a bill to establish a process for updating the labeling of certain drugs with outdated labeling, regarding all bio-pharmaceutical related provisions S. 1897/H.R. 3523, End Price Gouging for Medications Act, regarding all bio-pharmaceutical related provisions S. 2004, Emergency Access to Insulin Act, regarding all bio-pharmaceutical related provisions

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 - Provisions related to prescription drug pricing transparency and reporting H.R. 1788: Medicare Part B Fairness Act - Provisions related to Part B enrollment H.R. 1839: Medicaid Services Investment and Accountability Act - Provisions related to Medicaid drug rebates and drug classification H.R. 2000: Medicare-X Choice Act of 2019 - Provisions related to Part D and drug pricing negotiation H.R. 2452: Medicare for America Act of 2019 - Provisions related to Part D and drug pricing negotiation H.R. 2463: Choose Medicare Act - Provisions related to Part D and drug pricing negotiation H.R. 2757: Creating Lower cost Alternative for Your prescription drugs Act - Provisions related to Part D and patient cost-sharing H.R. 3029: Improving Low-Income Access to Prescription Drugs Act of 2019 - Provisions related to Part D prescription drug plans H.R. 3107: Improving Seniors' Timely Access to Care Act of 2019 - Provisions related to Medicare Advantage insurance plans H.R. 3276: Fair AMP Act - Provisions related to Medicaid drug rebates 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. 475: Reducing Existing Costs Associated with Pharmaceuticals for Seniors (RxCap) Act of 2019 - Provisions related to Part D and patient cost-sharing S. 470: Medicare at 50 Act - Provisions related to Part D and drug pricing negotiation 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. 691: Medicare Extra Rx Higher Eligibility Limits in Part D Act of 2019 - Provisions related to Part D and patient out-of-pocket costs S. 801: Payment Commission Data Act - Provisions related to prescription drug pricing transparency and reporting S. 1129: Medicare for All Act of 2019 - Provisions related to Part D and drug pricing negotiation S. 1261: Choose Medicare Act - Provisions related to Part D and drug pricing negotiation S. 1785: Fair AMP Act - Provisions related to Medicaid drug rebates S. 1801: Affordable Medications Act - Provisions relate to Part D drug pricing negotiation, importation, IP issues and pricing transparency S. 1895: Lower Health Care Costs Act - Provisions related to prescription drug pricing, transparency and patent issues S. 1897: A bill to establish a process for updating the labeling of certain drugs with outdated labeling - Provisions related to prescription drug labeling S. 1926: PrEP Access and Coverage Act - PrEP insurance coverage requirement and grant program for uninsured S. __: Patient Affordability Value and Efficiency Act - Value-based arrangements 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 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; 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)

Preserve Access to Affordable Generics Act (S. 64); Regulatory exclusivity; Drug pricing; Medicare Part B international reference pricing; Protecting Consumer Access to Generic Drugs Act of 2019 (H.R. 1499); BLOCKING Act of 2019 (H.R. 938); Orange Book Transparency Act of 2019 (H.R. 1503); Purple Book Continuity Act of 2019 (H.R. 1520); CREATES Act of 2019 (HR 965/S. 340); Biologic Patent Transparency Act (S. 659); Generic drug competition; Drug patent issues; Proposed rule on rebate safe Harbor (84 Fed. Reg. 2340); Lower Health Care Costs Act of 2019 (S. 1895); STOP Stalling Act (S. 1224); Affordable Prescriptions for Patients Act of 2019 (S. 1416); Reforming Evergreening and Manipulation that Extends Drug Years Act (S. 1209); Preserve Access to Affordable Generics and Biosimilars Act (H.R.2375); A bill to establish a process for updating the labeling of certain drugs with outdated labeling (S.1897); Protecting Access to Biosimilars Act of 2019 (H.R.2011/S. 1140); Second Look at Drug Patents Act of 2019 (S.1617); TERM Act. (H.R. 3199); Drug importation; State-Based, Market-Oriented, Prescription Drug Negotiations Act of 2019 (H.R. 2038); Transparent Drug Pricing Act of 2019 (S.977); Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2017 (S. 2022); Medicare Negotiation and Competitive Licensing Act of 2019 (H.R. 1046).

Client expense: Not reported · Firm income: $520,000

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 - Provisions related to prescription drug pricing transparency and reporting H.R. 1788: Medicare Part B Fairness Act - Provisions related to Part B enrollment H.R. 1839: Medicaid Services Investment and Accountability Act - Provisions related to Medicaid drug rebates and drug classification H.R. 2000: Medicare-X Choice Act of 2019 - Provisions related to Part D and drug pricing negotiation H.R. 2452: Medicare for America Act of 2019 - Provisions related to Part D and drug pricing negotiation H.R. 2463: Choose Medicare Act - Provisions related to Part D and drug pricing negotiation H.R. 2757: Creating Lower cost Alternative for Your prescription drugs Act - Provisions related to Part D and patient cost-sharing H.R. 3029: Improving Low-Income Access to Prescription Drugs Act of 2019 - Provisions related to Part D prescription drug plans H.R. 3107: Improving Seniors' Timely Access to Care Act of 2019 - Provisions related to Medicare Advantage insurance plans H.R. 3276: Fair AMP Act - Provisions related to Medicaid drug rebates 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. 475: Reducing Existing Costs Associated with Pharmaceuticals for Seniors (RxCap) Act of 2019 - Provisions related to Part D and patient cost-sharing S. 470: Medicare at 50 Act - Provisions related to Part D and drug pricing negotiation 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. 691: Medicare Extra Rx Higher Eligibility Limits in Part D Act of 2019 - Provisions related to Part D and patient out-of-pocket costs S. 801: Payment Commission Data Act - Provisions related to prescription drug pricing transparency and reporting S. 1129: Medicare for All Act of 2019 - Provisions related to Part D and drug pricing negotiation S. 1261: Choose Medicare Act - Provisions related to Part D and drug pricing negotiation S. 1785: Fair AMP Act - Provisions related to Medicaid drug rebates S. 1801: Affordable Medications Act - Provisions relate to Part D drug pricing negotiation, importation, IP issues and pricing transparency S. 1895: Lower Health Care Costs Act - Provisions related to prescription drug pricing, transparency and patent issues S. 1897: A bill to establish a process for updating the labeling of certain drugs with outdated labeling - Provisions related to prescription drug labeling S. 1926: PrEP Access and Coverage Act - PrEP insurance coverage requirement and grant program for uninsured S. __: Patient Affordability Value and Efficiency Act - Value-based arrangements 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 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; 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)

S.607/H.R. 1847, Electronic Communications Privacy Act Amendments Act, H.R. 1852, Email Privacy Act; S.1897/H.R. 3990. Personal Data Privacy and Security Act; issues related to student data protection

Client expense: Not reported · Firm income: $80,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Preserve Access to Affordable Generics Act (S. 64); Regulatory exclusivity; Drug pricing; Medicare Part B international reference pricing; Protecting Consumer Access to Generic Drugs Act of 2019 (H.R. 1499); BLOCKING Act of 2019 (H.R. 938); Orange Book Transparency Act of 2019 (H.R. 1503); Purple Book Continuity Act of 2019 (H.R. 1520); CREATES Act of 2019 (HR 965/S. 340); Biologic Patent Transparency Act (S. 659); Generic drug competition; Drug patent issues; Proposed rule on rebate safe Harbor (84 Fed. Reg. 2340); Lower Health Care Costs Act of 2019 (S. 1895); STOP Stalling Act (S. 1224); Affordable Prescriptions for Patients Act of 2019 (S. 1416); Reforming Evergreening and Manipulation that Extends Drug Years Act (S. 1209); Preserve Access to Affordable Generics and Biosimilars Act (H.R.2375); A bill to establish a process for updating the labeling of certain drugs with outdated labeling (S.1897); Protecting Access to Biosimilars Act of 2019 (H.R.2011/S. 1140); Second Look at Drug Patents Act of 2019 (S.1617); TERM Act. (H.R. 3199); Drug importation; State-Based, Market-Oriented, Prescription Drug Negotiations Act of 2019 (H.R. 2038); Transparent Drug Pricing Act of 2019 (S.977); Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2017 (S. 2022); Medicare Negotiation and Competitive Licensing Act of 2019 (H.R. 1046).

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

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 - Provisions related to prescription drug pricing transparency and reporting H.R. 1788: Medicare Part B Fairness Act - Provisions related to Part B enrollment H.R. 1839: Medicaid Services Investment and Accountability Act - Provisions related to Medicaid drug rebates and drug classification H.R. 2000: Medicare-X Choice Act of 2019 - Provisions related to Part D and drug pricing negotiation H.R. 2452: Medicare for America Act of 2019 - Provisions related to Part D and drug pricing negotiation H.R. 2463: Choose Medicare Act - Provisions related to Part D and drug pricing negotiation H.R. 2757: Creating Lower cost Alternative for Your prescription drugs Act - Provisions related to Part D and patient cost-sharing H.R. 3029: Improving Low-Income Access to Prescription Drugs Act of 2019 - Provisions related to Part D prescription drug plans H.R. 3107: Improving Seniors' Timely Access to Care Act of 2019 - Provisions related to Medicare Advantage insurance plans H.R. 3276: Fair AMP Act - Provisions related to Medicaid drug rebates 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. 475: Reducing Existing Costs Associated with Pharmaceuticals for Seniors (RxCap) Act of 2019 - Provisions related to Part D and patient cost-sharing S. 470: Medicare at 50 Act - Provisions related to Part D and drug pricing negotiation 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. 691: Medicare Extra Rx Higher Eligibility Limits in Part D Act of 2019 - Provisions related to Part D and patient out-of-pocket costs S. 801: Payment Commission Data Act - Provisions related to prescription drug pricing transparency and reporting S. 1129: Medicare for All Act of 2019 - Provisions related to Part D and drug pricing negotiation S. 1261: Choose Medicare Act - Provisions related to Part D and drug pricing negotiation S. 1785: Fair AMP Act - Provisions related to Medicaid drug rebates S. 1801: Affordable Medications Act - Provisions relate to Part D drug pricing negotiation, importation, IP issues and pricing transparency S. 1895: Lower Health Care Costs Act - Provisions related to prescription drug pricing, transparency and patent issues S. 1897: A bill to establish a process for updating the labeling of certain drugs with outdated labeling - Provisions related to prescription drug labeling S. 1926: PrEP Access and Coverage Act - PrEP insurance coverage requirement and grant program for uninsured S. __: Patient Affordability Value and Efficiency Act - Value-based arrangements 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 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; 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)

H.R. 938, Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 985, Fair Access for Safe and Timely (FAST) Generics Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 986, Protecting American with Preexisting Conditions Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 987, Marketing and Outreach Restoration to Empower Health Education Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 1010, Short-Term, Limited Duration Insurance (STLDI), regarding all bio-pharmaceutical related provisions. H.R. 1323, Rural Hospital Frontier Fairness Act, regarding all bio-pharmaceutical related provisions. H.R. 1385, State Allowance for a Variety of Exchanges (SAVE) Act, regarding all bio-pharmaceutical related provisions. H.R. 1386, Expanded Navigators Resources for Outreach, Learning, and Longevity (ENROLL) Act, regarding all bio-pharmaceutical related provisions. H.R. 1409, Transparency in All Health Care Pricing Act, regarding all bio-pharmaceutical related provisions. H.R. 1425, State Health Care Premium Reduction Act, regarding all bio-pharmaceutical related provisions. H.R. 1478, Insulin importation, regarding all bio-pharmaceutical related provisions. H.R. 1503, Orange Book Transparency Act, regarding all bio-pharmaceutical related provisions. H.R. 1506, Fair and Immediate Release (FAIR) of Generics Act, regarding all bio-pharmaceutical related provisions. H.R. 1520, Purple Book Continuity Act, regarding all bio-pharmaceutical related provisions. H.R. 2011, Protecting Access to Biosimilars Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 2038, State-based , Market-Oriented, Prescription Drug Negotiations Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 2064, Product Sample reporting, regarding all bio-pharmaceutical related provisions. S. 61, Safe and Affordable Drugs from Canada Act, regarding all bio-pharmaceutical related provisions. S. 97, Affordable and Safe Drug Importation Act, regarding all bio-pharmaceutical related provisions. S. 102, Prescription Drug Price Relief Act, regarding all bio-pharmaceutical related provisions. S. 344/H.R. 990, Hatch-Waxman Integrity Act, regarding all bio-pharmaceutical related provisions. S. 366/H.R. 1188, FLAT Prices Act- Reduced exclusivity period for certain price hikes, regarding all bio-pharmaceutical related provisions. S. 418, FDA Accountability for Public Safety Act, regarding all bio-pharmaceutical related provisions. S. 419, Protecting Americans from Dangerous Opioids Act, regarding all bio-pharmaceutical related provisions. S. 637, CURE High Drug Prices Act, regarding all bio-pharmaceutical related provisions. S. 657, Drug Price Transparency Act, regarding all bio-pharmaceutical related provisions. S. 658, Accelerated Drug Approval for Prescription Therapies Act, regarding all bio-pharmaceutical related provisions. S. 659, Biologic Patent Transparency Act, regarding all bio-pharmaceutical related provisions. S. 660, Transparency in Petitions Act, regarding all bio-pharmaceutical related provisions. S. 709, Establishes public dashboard for price and utilization of drugs purchased by federal programs, regarding all bio-pharmaceutical related provisions. S. 741 /H.R. 1730, Cancer Drug Parity Act, regarding all bio-pharmaceutical related provisions. S. 844, Short Competition Act, regarding all bio-pharmaceutical related provisions. S. 977, Transparent Drug Pricing Act of 2019, regarding all bio-pharmaceutical related provisions. S. 989, STEER Act, regarding all bio-pharmaceutical related provisions. S. 1140, A bill 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 biological product license pursuant to section 7002 of the Biologics Price Competition and Innovation Act of 2009, regarding all bio-pharmaceutical related provisions. S.1169, FDA citizen petition, regarding all bio-pharmaceutical related provisions. S. 1209, A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to approval of abbreviated new drug applications, regarding all bio-pharmaceutical related provisions. H.R. 2115, Public Disclosure of Drug Discounts Act, regarding all bio-pharmaceutical related provisions H.R.2296/S.1391, FAIR Drug Pricing Act, regarding all bio-pharmaceutical related provisions H.R.2700, Lowering Prescription Drug Costs and Extending Community Health Centers and other Health Priorities Act, regarding all bio-pharmaceutical related provisions H.R. 3223, Pharmacy Benefit Manager Accountability Study Act, regarding all bio-pharmaceutical related provisions S. 1361/H.R.2584, Preventive Health Savings Act, regarding all bio-pharmaceutical related provisions S. 1437, DTC Act, regarding all bio-pharmaceutical related provisions S.1532, Pharmacy Benefit Managers Accountability Study Act, regarding all bio-pharmaceutical related provisions S.1636, Ensuring Innovation Act, regarding all bio-pharmaceutical related provisions S. 1664, Prescription Drug Price Reporting Act, regarding all bio-pharmaceutical related provisions S. 1801, Affordable Medications Act, regarding all bio-pharmaceutical related provisions S. 1895, Lowering Health Costs Act, regarding all bio-pharmaceutical related provisions S. 1897, a bill to establish a process for updating the labeling of certain drugs with outdated labeling, regarding all bio-pharmaceutical related provisions S. 1897/H.R. 3523, End Price Gouging for Medications Act, regarding all bio-pharmaceutical related provisions S. 2004, Emergency Access to Insulin Act, regarding all bio-pharmaceutical related provisions

S.607/H.R. 1847, Electronic Communications Privacy Act Amendments Act, H.R. 1852, Email Privacy Act; S.1897/H.R. 3990. Personal Data Privacy and Security Act; issues related to student data protection

Client expense: Not reported · Firm income: $80,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE