Responsibility in Drug Advertising Act of 2019

Proposals relating to the regulation of direct-to-consumer prescription drug advertising Discussions over specific HHS/CMS proposal and proposed legislation to require televised direct-to-consumer prescription drug ads to contain list price information H.R. 4106, Responsibility in Drug Advertising Act of 2019, to prohibit direct-to-consumer prescription drug advertising for there years after FDA approval of a drug

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Postal Regulatory Commission, SENATE, U.S. Postal Service (USPS)

H.Con.Res.55: Expressing the sense of Congress on the need to inform American consumers with more balanced purchasing information for prescription drugs through the disclosure of price information in direct-to-consumer (DTC) advertisements. H.R. 4106: Responsibility in Drug Advertising Act of 2019 H.R. 5894: Transparency in Prescription Drug Advertising Act S. 73: End Taxpayer Subsidies for Drug Ads Act S. 3180: Responsibility in Drug Advertising Act of 2020

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

Government targets: Executive Office of the President (EOP), Federal Communications Commission (FCC), HOUSE OF REPRESENTATIVES, Natl Economic Council (NEC), Patent & Trademark Office (PTO), SENATE, Treasury, Dept of, U.S. Copyright Office, U.S. Trade Representative (USTR)

FTC Reauthorization Act of 2019 (Not introduced) S.73, End Taxpayer Subsidies for Drug Ads Act S.1437, Drug-price Transparency in Communications (DTC) Act H.R.4106, Responsibility in Drug Advertising Act H.R. 4711 - No Tax Breaks for Drug Ads Act S.2550 - No Tax Subsidies for E-Cigarette and Tobacco Ads Act S.1801 - Affordable Medications Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Proposals relating to the regulation of direct-to-consumer prescription drug advertising Discussions over specific HHS/CMS proposal and proposed legislation to require televised direct-to-consumer prescription drug ads to contain list price information H.R. 4106, Responsibility in Drug Advertising Act of 2019, to prohibit direct-to-consumer prescription drug advertising for there years after FDA approval of a drug

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Postal Regulatory Commission, SENATE, U.S. Postal Service (USPS)

-HR 583 - Preventing Illegal Radio Abuse Through Enforcement Act - all provisions related to cable. -HR 896 - Fairness in Political Advertising Act of 2019 - all provisions related to cable. -HR 1789 - Local and Independent Television Protection Act - all provisions related to cable. -HR 1848 - Communications Jobs Training Act of 2019 - all provisions related to cable. -HR 2135 - Preventing Adversaries Internationally from Disbursing Advertising Dollars (PAID AD) Act - all provisions related to cable. -HR 2592 - Honest Ads Act - all provisions related to cable. -HR 2682 - Agricultural News and Rural Content Act of 2019 - all provisions related to cable. -HR 3994 - Modern Television Act of 2019 - all provisions related to cable. -HR 4054 - Stand by Every Ad Act - all provisions related to cable. -HR 4106 - Responsibility in Drug Advertising Act of 2019 - all provisions related to cable. -HR 5015 - Honest Campaigns Act of 2019 - all provisions related to cable. -HR 5016 - Fair and Clear Campaign Transparency Act - all provisions related to cable. -HR 5025 - Western Expanded In-State Television Access Act of 2019 - all provisions related to cable. -HR 5035 - Television Viewer Protection Act of 2019 - all provisions related to cable. -HR 5140 - Satellite Television Community Protection and Promotion Act of 2019 - all provisions related to cable. -HR 5365 - License Transfer Modernization Act of 2019 - all provisions related to cable. -HR 5659 - Protecting Community Television Act - all provisions related to cable. -HR 5894 - Transparency in Prescription Drug Advertising Act - all provisions related to cable. -HConRes 55 - Expressing the sense of Congress on the need to inform American consumers with more balanced purchasing information for prescription drugs through the disclosure of price information in direct-to-consumer (DTC) advertisements - all provisions related to cable. -S 189 - Social Media Privacy Protection and Consumer Rights Act of 2019 - all provisions related to cable. -S 1356 - Honest Ads Act - all provisions related to cable. -S 1748 - Furthering Access and Networks for Sports Act - all provisions related to cable. -S 1962 - Preventing Adversaries Internationally from Disbursing Advertising Dollars (PAID AD) Act - all provisions related to cable. -S 2125 - Bot Disclosure and Accountability Act of 2019 - all provisions related to cable. -S 2181 - Cyber AIR Act - all provisions related to cable. -S 2182 - Security and Privacy in Your Car (SPY Car) Act of 2019 - all provisions related to cable. -S 2454 - Go Pack Go Act of 2019 - all provisions related to cable. -S 2763 - Filter Bubble Transparency Act - all provisions related to cable. -S 2789 - Satellite Television Access Reauthorization (STAR) Act - all provisions related to cable. -S 2829 - Western Expanded In-State Television Access Act of 2019 - all provisions related to cable. -S 3180 - Responsibility in Drug Advertising Act of 2020 - all provisions related to cable. -S 3218 - Protecting Community Television Act - all provisions related to cable. -S 3473 - Airline Information and Entertainment Access Act - all provisions related to cable.

H.Con.Res.55: Expressing the sense of Congress on the need to inform American consumers with more balanced purchasing information for prescription drugs through the disclosure of price information in direct-to-consumer (DTC) advertisements. H.R. 4106: Responsibility in Drug Advertising Act of 2019 H.R. 5894: Transparency in Prescription Drug Advertising Act S. 73: End Taxpayer Subsidies for Drug Ads Act S. 3180: Responsibility in Drug Advertising Act of 2020

Client expense: $1,150,000 · Firm income: Not reported

Government targets: Executive Office of the President (EOP), Federal Communications Commission (FCC), HOUSE OF REPRESENTATIVES, Natl Economic Council (NEC), Patent & Trademark Office (PTO), SENATE, Treasury, Dept of, U.S. Copyright Office, U.S. Trade Representative (USTR)

FTC Reauthorization Act of 2019 (Not introduced) S.73, End Taxpayer Subsidies for Drug Ads Act S.1437, Drug-price Transparency in Communications (DTC) Act H.R.4106, Responsibility in Drug Advertising Act H.R. 4711 - No Tax Breaks for Drug Ads Act S.2550 - No Tax Subsidies for E-Cigarette and Tobacco Ads Act S.1801 - Affordable Medications Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Proposals relating to the regulation of direct-to-consumer prescription drug advertising Discussions over specific HHS/CMS proposal and proposed legislation to require televised direct-to-consumer prescription drug ads to contain list price information H.R. 4106, Responsibility in Drug Advertising Act of 2019, to prohibit direct-to-consumer prescription drug advertising for there years after FDA approval of a drug

Client expense: $360,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Postal Regulatory Commission, SENATE, U.S. Postal Service (USPS)

-HR 466 - Amateur Radio Parity Act - all provisions related to cable. -HR 583 - Preventing Illegal Radio Abuse Through Enforcement (PIRATE) Act - all provisions related to cable. -HR 896 - Fairness in Political Advertising Act of 2019 - all provisions related to cable. -HR 1789 - Local and Independent Television Protection Act - all provisions related to cable. -HR 1848 - Communications Jobs Training Act of 2019 - all provisions related to cable. -HR 2135 - Preventing Adversaries Internationally from Disbursing Advertising Dollars (PAID AD) Act - all provisions related to cable. -HR 2592 - Honest Ads Act - all provisions related to cable. -HR 2682 - Agricultural News and Rural Content Act of 2019 - all provisions related to cable. -HR 2860 - Bots Research Act - all provisions related to cable. -HR 3002 - To provide for the carriage of certain television broadcast stations - all provisions related to cable. -HR 3393 - To amend the Communications Act of 1934 to prohibit Federal funding for the Corporation for Public Broadcasting after fiscal year 2021 - all provisions related to cable. -HR 3994 - Modern Television Act of 2019 - all provisions related to cable. -HR 4054 - Stand by Every Ad Act - all provisions related to cable. -HR 4106 - Responsibility in Drug Advertising Act of 2019 - all provisions related to cable. -HR 5015 - Honest Campaigns Act of 2019 - all provisions related to cable. -HR 5016 - Fair and Clear Campaign Transparency Act - all provisions related to cable. -HR 5025 - Western Expanded In-State Television (WEST) Access Act of 2019 - all provisions related to cable. -HR 5035 - Television Viewer Protection Act of 2019 - all provisions related to cable. -HR 5140 - Satellite Television Community Protection and Promotion Act of 2019 - all provisions related to cable. -HR 5263 - Stopping Grinch Bots Act of 2019 - all provisions related to cable. -HR 5365 - License Transfer Modernization Act of 2019 - all provisions related to cable. -HR 5564 - Enhancing Broadcaster Diversity and Inclusion by Verifying and Ensuring the Reporting required by Statute is Transpiring and Yielding (DIVERSITY) Data Act - all provisions related to cable. -HR 5567 - Measuring the Economics Driving Investments and Access (MEDIA) for Diversity Act of 2020 - all provisions related to cable. -HR 5659 - Protecting Community Television Act - all provisions related to cable. -HR 5894 - Transparency in Prescription Drug Advertising Act - all provisions related to cable. -HRes 549 - Reaffirming the commitment to media diversity and pledging to work with media entities and diverse stakeholders to develop common ground solutions to eliminate barriers to media diversity - all provisions related to cable. -HConRes 20 - Supporting the Local Radio Freedom Act - all provisions related to cable. -HConRes 55 - Expressing the sense of Congress on the need to inform American consumers with more balanced purchasing information for prescription drugs through the disclosure of price information in direct-to-consumer (DTC) advertisements - all provisions related to cable. -S 189 - Social Media Privacy Protection and Consumer Rights Act of 2019 - all provisions related to cable. -S 822 - To permit the televising of Supreme Court proceedings - all provisions related to cable. -S 941 - Section 331 Obligation Clarification Act - all provisions related to cable. -S 1228 - Preventing Illegal Radio Abuse Through Enforcement (PIRATE) Act - all provisions related to cable. -S 1356 - Honest Ads Act - all provisions related to cable. -S 1748 - Furthering Access and Networks for Sports Act - all provisions related to cable. -S 1962 - Preventing Adversaries Internationally from Disbursing Advertising Dollars (PAID AD) Act - all provisions related to cable. -S 2125 - Bot Disclosure and Accountability Act of 2019 - all provisions related to cable. -S 2181 - Cyber AIR Act - all provisions related to cable. -S 2182 - Security and Privacy in Your Car (SPY Car) Act of 2019 - all provisions related to cable. -S 2454 - Go Pack Go Act of 2019 - all provisions related to cable. -S 2763 - Filter Bubble Transparency Act - all provisions related to cable. -S 2789 - Satellite Television Access Reauthorization (STAR) Act - all provisions related to cable. -S 2829 - Western Expanded In-State Television (WEST) Access Act of 2019 - all provisions related to cable. -S 2957 - Stopping Grinch Bots Act of 2019 - all provisions related to cable. -S 3180 - Responsibility in Drug Advertising Act of 2020 - all provisions related to cable. -S 3218 - Protecting Community Television Act - all provisions related to cable. -S 3473 - Airline Information and Entertainment Access Act - all provisions related to cable. -SRes 306 - Reaffirming the commitment to media diversity and pledging to work with media entities and diverse stakeholders to develop common ground solutions to eliminate barriers to media diversity - all provisions related to cable.

H.Con.Res.55: Expressing the sense of Congress on the need to inform American consumers with more balanced purchasing information for prescription drugs through the disclosure of price information in direct-to-consumer (DTC) advertisements. H.R. 4106: Responsibility in Drug Advertising Act of 2019 H.R. 5894: Transparency in Prescription Drug Advertising Act S. 73: End Taxpayer Subsidies for Drug Ads Act S. 3180: Responsibility in Drug Advertising Act of 2020

Client expense: $738,000 · Firm income: Not reported

Government targets: Executive Office of the President (EOP), Federal Bureau of Investigation (FBI), Federal Communications Commission (FCC), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Library of Congress (LOC), Natl Economic Council (NEC), Patent & Trademark Office (PTO), SENATE, Treasury, Dept of, U.S. Copyright Office, U.S. Immigration & Customs Enforcement (ICE), U.S. Trade Representative (USTR)

FTC Reauthorization Act of 2019 (Not introduced) S.73, End Taxpayer Subsidies for Drug Ads Act S.1437, Drug-price Transparency in Communications (DTC) Act H.R.4106, Responsibility in Drug Advertising Act H.R. 4711 - No Tax Breaks for Drug Ads Act S.2550 - No Tax Subsidies for E-Cigarette and Tobacco Ads Act S.1801 - Affordable Medications Act

Client expense: Not reported · Firm income: $120,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 447: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 478: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation H.R. 965: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 985: FAST Generics Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 1093: Stop Price Gouging Act - Provisions related to prescription drug pricing H.R. 1478: Affordable Insulin Act of 2019 - Provisions related to importation H.R. 1506: Fair and Immediate Release (FAIR) of Generic Drugs Act - Provisions related to generic prescription drug approvals H.R. 1922: Restoring Access to Medication Act of 2019 - Provisions related to prescription drug access H.R. 2064: To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes - Provisions related to prescription drug samples H.R. 2069: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs H.R. 2087: Drug Price Transparency Act - Provisions related to prescription drug pricing and transparency H.R. 2113: Prescription Drug STAR Act - Provisions related to prescription drug pricing, reporting and product samples 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. 2734: Safer Prescribing of Controlled Substances Act - Provisions related to the prescribing of prescription drugs H.R. 3223: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 3327: Drug Price Transparency for Medicare Patients Act of 2019 - Provisions related to direct-to-consumer prescription drug advertising H.R. 3415: Real-Time Beneficiary Drug Cost Bill - Provisions related to drug pricing transparency H.R. 3947: Competition Prescription Act of 2019 - Provisions related to prescription drug pricing, patents, and other provisions H.R. 4106: Responsibility in Drug Advertising Act of 2019 - Provisions related to direct-to-consumer prescription drug advertising H.R. 4158: CURE High Drug Prices Act - Provisions related to prescription drug pricing and transparency H.R. 4244: MAGIC Act - Provisions related to FDA approval pathways H.R. 4439: Creating Hope Reauthorization Act - Provisions related to rare disease priority review vouchers H.R. 4538: Closing Loopholes for Orphan Drugs Act - Provisions related to 340B prescription drug exclusions H.R. 4633: Investing in Safety and Innovation Act of 2019 - Provisions related to FDA programs reauthorization H.R. 4640: Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2019 - Provisions related to prescription drug pricing and negotiation H.R. 4667: Biomedical Innovation Expansion Act of 2019 - Provisions related to NIH programs reauthorization H.R. 4710: Pharmaceutical Independence Long-Term Readiness Reform Act - Provisions related to the supply chain H.R. 4711: No Tax Breaks for Drug Ads Act - Provisions related to direct-to-consumer prescription drug advertising H.R. 4812: Ensuring Compliance Against Drug Diversion Act of 2019 - Provisions related to registrations under the Controlled Substances Act H.R. 4866: National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2019 - Provisions related to designation of universities as centers of excellence supporting manufacturing H.R. 4963: Stop the Importation and Manufacturing of Synthetic Analogues Act of 2019 - Provisions related to synthetic analogues H.R. 5031: Medical Innovation Act of 2019 - Provisions related to prescription drug manufacturer taxation and supplemental fees H.R. 5198: Patients' Right to Know Their Medication Act of 2019 - Provisions related to prescription drug labeling H.R. 5239: Prescription Drug Price Reporting Act - Provisions related to prescription drug pricing transparency H.R. 5304: PBM Transparency in Prescription Drug Costs Act - Provisions related to prescription drug pricing transparency H.R. 5381: International Pharmaceutical Transparency Act of 2019 - Provisions related to prescription drug labeling H.R. 5442: To amend title XXVII of the Public Health Service Act and title XVIII of the Social Security Act to require pharmacies to disclose any differential between the cost of a prescription drug based on whether certain individuals use prescription drug coverage to acquire such drug, and for other purposes. - Provisions related to prescription drug pricing and transparency H.R. 5497: Conditional Approval Act - Provisions related to approval pathway S. 61: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation S. 73: End Taxpayer Subsidies for Drug Ads Act - Provisions related to direct-to-consumer prescription drug advertising S. 97: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 340: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 378: Stop Price Gouging Act - Provisions related to prescription drug pricing S. 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. 658: Accelerated Drug Approval for Prescription Therapies Act - Provisions related to FDA drug approvals S. 660: Efficiency and Transparency in Petitions Act - Provisions related to the FDA citizen petition process S. 1140: Protecting Access to Biosimilars Act of 2019 - Provisions related to biological products S. 1227: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1250: American Cures Act - Provisions related to pharmaceutical research and development 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. 2004: Emergency Access to Insulin Act of 2019 - Provisions related to prescription drug pricing S. 2161: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 - Provisions related to reciprocity 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 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 Generic drug approval process policy issues High deductible health plans/HSA policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues FDA modernization policy issues PDUFA implementation policy issues 340B drug discount program policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Patient assistance program policy issues Foreign manufacturing policy issues Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Cancer drug vial size policy issues TRICARE pharmacy pilot program Drug shortages policy issues Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49) Proposed Rule; Importation of Prescription Drugs (RIN 0910-AI45) Monograph Reform, HSA/FSAs S 2740 - Over-the-Counter Monograph Safety S1872/HR5076, Protecting Seniors Through Immunization Act S1654/HR1973, Vaccine Access Improvement Act

S. 61, Safe and Affordable Drugs from Canada Act (Grassley) - drug importation S. 64, Preserve Access to Affordable Generics and Biosimilars Act (Grassley-Klobuchar) - prohibiting pay-for-delay settlements S. 73, End Taxpayer Subsidies for Drug Ads Act (Shaheen) - prohibiting tax deduction for DTC advertising expenses S. 102, Prescription Drug Price Relief Act (Sanders) - reforms linked to international pricing S. 340, CREATES Act (Leahy) - removing barriers to generic drugs S. 344, Hatch-Waxman Integrity Act (Tillis) - inter partes review process S. 366, FLAT Prices Act (Durbin) - reforms for drugs with sudden price spikes S. 378, Stop Price Gouging Act (Durbin) - excise tax for drugs that have price spikes S. 440, Preserving Access to Cost-Effective Drugs Act (Cotton) - sovereign immunity and Inter Partes Review process S. 474, SPIKE Act (Wyden) - justification for drug price increases S. 476, Creating Transparency to Have Drug Rebates Unlocked Act (Wyden) - drug price transparency S. 637, CURE High Drug Prices Act (Blumenthal) - remedies for price gouging S. 657, Point of Sale Rebates (Braun) S. 659, Biologic Patent Transparency Act (Collins) - patent disclosure requirements S. 660, Efficiency and Transparency in Petitions Act (Braun) - FDA citizen petition process S. 844, Short on Competition Act (Klobuchar) - remedies for marginally competitive drug markets S. 977, Transparency Drug Pricing Act (Scott) - transparency and drug pricing reforms S. 1209, Reforming Evergreening and Manipulation that Extends Drug Years Act (Cassidy) - preventing evergreening of patent protections S. 1224, Stop STALLING Act (Klobuchar) - citizen petition process S. 1227, Prescription Pricing for the People Act (Grassley) - FTC report on role of PBMs and allegations of anticompetitive conduct by manufacturers of sole-source drugs S. 1384, Prescription Drug Rebate Reform Act (Romney-Braun) - prescription drug cost sharing S. 1416, Affordable Prescriptions for Patients Act (Cornyn) - product hopping, patent thickets S. 1664, Prescription Drug Price Reporting Act (Scott) - prescription drug price reporting S. 2247, Phair Relief Act of 2019 (Kennedy)-transparency around price concessions for drugs S. 2387, We Protect American Investment in Drugs Act (Van Hollen)-drug pricing S. 2543, Prescription Drug Pricing Reduction Act of 2019 (Grassley)-Drug pricing S. 2740, Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 (Isakson) - regulations re nonprescription drugs that are marketed without an approved new drug application S. 3052, United States-Mexico-Canada Agreement Implementation Act (Grassley) - drug pricing S. 3067, Non-Opioids Prevent Addiction In the Nation Act (Capito) - non-opioid treatments S. 3092, Expanding Access to Low-Cost Generics Act of 2019 (Smith) - exclusivity period H.R. 3, Lower Drug Costs Now Act of 2019 (Pallone)-drug pricing H.R. 465, Prescription Drug Price Relief Act (Khanna) - reforms linked to international pricing H.R. 478, Safe and Affordable Drugs from Canada Act (Pingree) - drug importation H.R. 938, BLOCKING Act (Schrader) - changes to 180-day period of market exclusivity for first generic applicant H.R. 965, CREATES Act (Cicilline) - removing barriers to generic drugs H.R. 985, FAST Generics Act (Welch) - removing barriers to generic drugs H.R. 990, Hatch-Waxman Integrity Act (Flores) - inter partes review process H.R. 1093, Stop Price Gouging Act (Pocan) - excise tax for drugs that have price spikes H.R. 1188, FLAT Prices Act (Golden) - reforms for drugs with sudden price spikes H.R. 1344, Competitive DRUGS Act (Doggett) - prohibiting pay-for-delay agreements H.R. 1419, Public Option Deficit Reduction Act (DeFazio) - public option H.R. 1499, Protecting Consumer Access to Generic Drugs Act (Rush) - prohibiting pay-for-delay agreements H.R. 1503, Orange Book Transparency Act (Kelly) - removal of invalidated patents from Orange Book H.R. 1506, FAIR Generics Act (Barragan) - changes to 180-day period of market exclusivity for first generic applicant H.R. 1520, Purple Book Continuity Act (Eshoo) - access to updated information on biologics and biosimilars H.R. 2038, State-Based, Market-Oriented Prescription Drug Negotiations Act (Meadows) - drug price negotiations H.R. 2064, Sunshine for Samples Act (Chu) - reporting requirements on drug samples H.R. 2069, SPIKE Act (Horsford) -justification for drug price increases H.R. 2087, Drug Price Transparency Act (Doggett) - reporting of drug pricing data under Medicare Part B H.R. 2113, Prescription Drug Sunshine, Transparency, Accountability and Reporting Act (Neal) - transparency in drug pricing H.R. 2115, Public Disclosure of Drug Discounts Act (Spanberger) - disclosure of negotiated Rx discounts H.R. 2279, Safe Step Act (Ruiz) - exceptions process for medication step therapy H.R. 2296, FAIR Drug Pricing Act (Schakowsky) - transparency requirements and justification for high list prices and drug price increases H.R. 2374, Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act (Jeffries) - citizen petition process H.R. 2375, Preserve Access to Affordable Generics and Biosimilars Act (Nadler) - prohibiting pay-for-delay agreements H.R. 2376, Prescription Pricing for the People Act (Collins) - FTC study on role of PBMs and competition and transparency in pharmaceutical supply chain H.R. 3379, Price Relief, Innovation, and Competition for Essential Drugs Act (Schakowsky) - exclusivity period for biological products H.R. 3805, Prescription Drug Rebate Reform Act of 2019 (Gallagher)- drug rebates H.R. 3927, PDMPs Help Patients Act of 2019 (McKinley)-integrating SUDs and behavioral health into PDMPs H.R. 3947, Competition Prescription Act of 2019 (Meadows)- drug pricing H.R. 4010, Emergency Access to Insulin Act of 2019 (Craig)- drug pricing H.R. 4106, Responsibility in Drug Advertising Act of 2019 (DeLauro)-transparency in drug pricing H.R. 4244, MAGIC Act (Kelly)-pathways for insulin approval H.R. 4398, Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 (Cicilline)-drug pricing H.R. 4455, BIOSIM Act (Schrader)-access to biosimilars H.R. 4460, Turn the Tide Act (Kuster)-Opioids H.R. 4538, Closing Loopholes for Orphan Drugs Act (Welch)-Access to drugs H.R. 4640, Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2019 (DeFazio) - direct negotiation H.R. 4712, Fairness in Orphan Drug Exclusivity Act (Dean) - limitations on exclusive approval of orphan drugs H.R. 4810, Opioid Prescription Verification Act of 2019 (David) - dispensing of controlled substances H.R. 4906, Insulin Price Reduction Act (Diana DeGette) - insulin costs H.R. 5304, PBM Transparency in Prescription Drug Costs Act (Schrader) - PBMs H.R. 5364, End Price Gouging for Insulin Act (Beatty) - annual reference price for insulin products H.R. 5430, United States-Mexico-Canada Agreement Implementation Act (Hoyer) - drug pricing H.R. 5442, Lowest Price for Patients Act (Porter) - pharmacies to disclose any differential between the cost of a prescription drug H.R. 5444, Lower Insulin Costs Now Act (Underwood) - lowering insulin costs H.Con.Res. 55, Expressing the sense of Congress on the need to inform American consumers with more balanced purchasing information for prescription drugs through the disclosure of price information in direct-to-consumer (DTC) advertisements. (Burgess)-drug pricing Regulatory Issues: Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to price of drugs and biologics and proposals to limit high prices; issues related to drug patents and market exclusivity; issues related to pharmacy benefit managers; issues related to biosimilars; issues related to approval of drugs and biologics; issues relating to opioids; issues relating to prescription drug rebates; issues relating to prescription drug price blueprint; direct-to-consumer advertising for prescription drugs; issues related to proposed changes to removal of safe harbor protection for rebates (proposed rule); issues relating to access for investigational drugs; and other issues relating to health care reform implementation.

H.R. 447: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 478: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation H.R. 965: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 985: FAST Generics Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 1093: Stop Price Gouging Act - Provisions related to prescription drug pricing H.R. 1478: Affordable Insulin Act of 2019 - Provisions related to importation H.R. 1506: Fair and Immediate Release (FAIR) of Generic Drugs Act - Provisions related to generic prescription drug approvals H.R. 1922: Restoring Access to Medication Act of 2019 - Provisions related to prescription drug access H.R. 2064: To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes - Provisions related to prescription drug samples H.R. 2069: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs H.R. 2087: Drug Price Transparency Act - Provisions related to prescription drug pricing and transparency H.R. 2113: Prescription Drug STAR Act - Provisions related to prescription drug pricing, reporting and product samples 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. 2569: Comprehensive Addiction Resources Emergency Act of 2019 - Provisions related to opioid crisis response funding H.R. 2732: Lessening Addiction By Enhancing Labeling Opioids Act of 2019 - Provisions related to labeling of prescription drugs H.R. 2734: Safer Prescribing of Controlled Substances Act - Provisions related to the prescribing of prescription drugs H.R. 2917: Opioid Crisis Accountability Act of 2019 - Provisions related to prescription drug marketing H.R. 3223: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 3327: Drug Price Transparency for Medicare Patients Act of 2019 - Provisions related to direct-to-consumer prescription drug advertising H.R. 3415: Real-Time Beneficiary Drug Cost Bill - Provisions related to drug pricing transparency H.R. 3947: Competition Prescription Act of 2019 - Provisions related to prescription drug pricing, patents, and other provisions H.R. 4010: Emergency Access to Insulin Act of 2019 - Provisions related to prescription drug access programs H.R. 4106: Responsibility in Drug Advertising Act of 2019 - Provisions related to direct-to-consumer prescription drug advertising H.R. 4158: CURE High Drug Prices Act - Provisions related to prescription drug pricing and transparency H.R. 4439: Creating Hope Reauthorization Act - Provisions related to rare disease priority review vouchers H.R. 4538: Closing Loopholes for Orphan Drugs Act - Provisions related to 340B prescription drug exclusions H.R. 4633: Investing in Safety and Innovation Act of 2019 - Provisions related to FDA programs reauthorization H.R. 4640: Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2019 - Provisions related to prescription drug pricing and negotiation H.R. 4667: Biomedical Innovation Expansion Act of 2019 - Provisions related to NIH programs reauthorization H.R. 4710: Pharmaceutical Independence Long-Term Readiness Reform Act - Provisions related to the supply chain H.R. 4711: No Tax Breaks for Drug Ads Act - Provisions related to direct-to-consumer prescription drug advertising H.R. 4812: Ensuring Compliance Against Drug Diversion Act of 2019 - Provisions related to registrations under the Controlled Substances Act H.R. 4814: Suspicious Order Identification Act of 2019 - Provisions related to reporting on distribution of controlled substances H.R. 4906: Insulin Price Reduction Act - Provisions related to prescription drug pricing and transparency H.R. 4963: Stop the Importation and Manufacturing of Synthetic Analogues Act of 2019 - Provisions related to synthetic analogues H.R. 5031: Medical Innovation Act of 2019 - Provisions related to prescription drug manufacturer taxation and supplemental fees H.R. 5198: Patients' Right to Know Their Medication Act of 2019 - Provisions related to prescription drug labeling H.R. 5239: Prescription Drug Price Reporting Act - Provisions related to prescription drug pricing transparency H.R. 5304: PBM Transparency in Prescription Drug Costs Act - Provisions related to prescription drug pricing transparency H.R. 5381: International Pharmaceutical Transparency Act of 2019 - Provisions related to prescription drug labeling 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. 5442: To amend title XXVII of the Public Health Service Act and title XVIII of the Social Security Act to require pharmacies to disclose any differential between the cost of a prescription drug based on whether certain individuals use prescription drug coverage to acquire such drug, and for other purposes - Provisions related to prescription drug pricing and transparency H.R. 5497: Conditional Approval Act - Provisions related to approval pathway S. 61: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation S. 73: End Taxpayer Subsidies for Drug Ads Act - Provisions related to direct-to-consumer prescription drug advertising S. 97: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 340: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 378: Stop Price Gouging Act - Provisions related to prescription drug pricing S. 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. 1140: Protecting Access to Biosimilars Act of 2019 - Provisions related to biological products S. 1227: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1250: American Cures Act - Provisions related to pharmaceutical research and development 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. 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. 2199: Insulin Price Reduction Act - Provisions related to prescription drug pricing and transparency 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 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 Generic drug approval process policy issues High deductible health plans/HSA policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues FDA modernization policy issues PDUFA implementation policy issues 340B drug discount program policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Patient assistance program policy issues Foreign manufacturing policy issues Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Cancer drug vial size policy issues TRICARE pharmacy pilot program Drug shortages policy issues Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49) Proposed Rule; Importation of Prescription Drugs (RIN 0910-AI45)

-HR 466 - Amateur Radio Parity Act - all provisions related to cable. -HR 583 - Preventing Illegal Radio Abuse Through Enforcement (PIRATE) Act - all provisions related to cable. -HR 896 - Fairness in Political Advertising Act of 2019 - all provisions related to cable. -HR 1789 - Local and Independent Television Protection Act - all provisions related to cable. -HR 1848 - Communications Jobs Training Act of 2019 - all provisions related to cable. -HR 2135 - Preventing Adversaries Internationally from Disbursing Advertising Dollars (PAID AD) Act - all provisions related to cable. -HR 2592 - Honest Ads Act - all provisions related to cable. -HR 2682 - Agricultural News and Rural Content Act of 2019 - all provisions related to cable. -HR 2860 - Bots Research Act - all provisions related to cable. -HR 3002 - To provide for the carriage of certain television broadcast stations - all provisions related to cable. -HR 3393 - To amend the Communications Act of 1934 to prohibit Federal funding for the Corporation for Public Broadcasting after fiscal year 2021 - all provisions related to cable. -HR 3994 - Modern Television Act of 2019 - all provisions related to cable. -HR 4054 - Stand by Every Ad Act - all provisions related to cable. -HR 4106 - Responsibility in Drug Advertising Act of 2019 - all provisions related to cable. -HR 5015 - Honest Campaigns Act of 2019 - all provisions related to cable. -HR 5016 - Fair and Clear Campaign Transparency Act - all provisions related to cable. -HR 5025 - Western Expanded In-State Television (WEST) Access Act of 2019 - all provisions related to cable. -HR 5035 - Television Viewer Protection Act of 2019 - all provisions related to cable. -HR 5140 - Satellite Television Community Protection and Promotion Act of 2019 - all provisions related to cable. -HR 5263 - Stopping Grinch Bots Act of 2019 - all provisions related to cable. -HR 5365 - License Transfer Modernization Act of 2019 - all provisions related to cable. -HRes 549 - Reaffirming the commitment to media diversity and pledging to work with media entities and diverse stakeholders to develop common ground solutions to eliminate barriers to media diversity - all provisions related to cable. -HConRes 20 - Supporting the Local Radio Freedom Act - all provisions related to cable. -HConRes 55 - Expressing the sense of Congress on the need to inform American consumers with more balanced purchasing information for prescription drugs through the disclosure of price information in direct-to-consumer (DTC) advertisements - all provisions related to cable. -S 189 - Social Media Privacy Protection and Consumer Rights Act of 2019 - all provisions related to cable. -S 822 - To permit the televising of Supreme Court proceedings - all provisions related to cable. -S 941 - Section 331 Obligation Clarification Act - all provisions related to cable. -S 1228 - Preventing Illegal Radio Abuse Through Enforcement (PIRATE) Act - all provisions related to cable. -S 1356 - Honest Ads Act - all provisions related to cable. -S 1748 - Furthering Access and Networks for Sports Act - all provisions related to cable. -S 1962 - Preventing Adversaries Internationally from Disbursing Advertising Dollars (PAID AD) Act - all provisions related to cable. -S 2125 - Bot Disclosure and Accountability Act of 2019 - all provisions related to cable. -S 2181 - Cyber AIR Act - all provisions related to cable. -S 2182 - Security and Privacy in Your Car (SPY Car) Act of 2019 - all provisions related to cable. -S 2454 - Go Pack Go Act of 2019 - all provisions related to cable. -S 2763 - Filter Bubble Transparency Act - all provisions related to cable. -S 2789 - Satellite Television Access Reauthorization (STAR) Act - all provisions related to cable. -S 2829 - Western Expanded In-State Television (WEST) Access Act of 2019 - all provisions related to cable. -S 2957 - Stopping Grinch Bots Act of 2019 - all provisions related to cable. -SRes 306 - Reaffirming the commitment to media diversity and pledging to work with media entities and diverse stakeholders to develop common ground solutions to eliminate barriers to media diversity - all provisions related to cable.

Proposals relating to the regulation of direct-to-consumer prescription drug advertising Discussions over specific HHS/CMS proposal and proposed legislation to require televised direct-to-consumer prescription drug ads to contain list price information H.R. 4106, Responsibility in Drug Advertising Act of 2019, to prohibit direct-to-consumer prescription drug advertising for there years after FDA approval of a drug

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

H.R.2135,"Preventing Adversaries Internationally from Disbursing Advertising Dollars Act or the PAID AD Act," all provisions H.R.2592, Honest Ads Act, all provisions H.R.3327, Drug Price Transparency for Medicare Patients Act of 2019, all provisions H.R.4054,Stand By Every Ad Act, all provisions HR 4106, Responsibility in Drug Advertising Act of 2019, all provisions H.Con.Res.55, Expressing the sense of Congress on the need to inform American consumers with more balanced purchasing information for prescription drugs through the disclosure of price information in direct-to-consumer (DTC) advertisements, all provisions S.73, "End Taxpayer Subsidies for Drug Ads Act, all provisions related to advertising S.474, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019," all provisions related to advertising S.1356, Honest Ads Act, all provisions S.1437, Drug-price Transparency in Communications (DTC) Act, all provisions

Client expense: $900,000 · Firm income: Not reported

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

FTC Reauthorization Act of 2019 (Not introduced) S.73, End Taxpayer Subsidies for Drug Ads Act S.1437, Drug-price Transparency in Communications (DTC) Act H.R.4106, Responsibility in Drug Advertising Act H.R. 4711 - No Tax Breaks for Drug Ads Act S.2550 - No Tax Subsidies for E-Cigarette and Tobacco Ads Act S.1801 - Affordable Medications Act

Client expense: Not reported · Firm income: $140,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 447: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation ___ H.R. 478: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation ___ H.R. 965: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems ___ H.R. 985: FAST Generics Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 1922/S. 1089 _ Restoring Access to Medicine Act ___ H.R. 1093: Stop Price Gouging Act - Provisions related to prescription drug pricing ___ H.R. 1332: Fair Care Act of 2019 - Provisions related to prescription drug pricing, patent issues, Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems ___ H.R. 1409: Transparency in All Health Care Pricing Act of 2019 - Provisions related to prescription drug pricing transparency ___ H.R. 1506: Fair and Immediate Release of (FAIR) Generic Drugs Act - Provisions related to generic prescription drug approvals H.R. 1973: Vaccine Access Improvement Act ___ H.R. 2011: Protecting Access to Biosimilars Act of 2019 - Provisions related to biological products ___ H.R. 2038: State-Based, Market-Oriented, Prescription Drug Negotiations Act of 2019 - Provisions related to prescription drug pricing ___ H.R. 2064: To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes - Provisions related to prescription drug samples ___ H.R. 2069: Stopping the Pharmaceutical Industry from Keeping Drug Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs ___ H.R. 2087: Drug Price Transparency Act - Provisions related to prescription drug pricing and transparency ___ H.R. 2113: Prescription Drug STAR Act - Provisions related to prescription drug pricing, reporting and product samples ___ H.R. 2115: Public Disclosure of Drug Discounts Act - Provisions related to prescription drug pricing transparency and pharmacy benefit managers ___ 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. 2401: American Cures Act - Provisions related to pharmaceutical research and development ___ H.R. 3223: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers ___ H.R. 3327: Drug Price Transparency for Medicare Patients Act of 2019 - Provisions related to direct-to-consumer prescription drug advertising ___ H.R. 3415: Real-Time Beneficiary Drug Cost Bill - Provisions related to drug pricing transparency ___ H.R. 3443: Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 - Provisions related to FDA over-the-counter drug approvals ___ H.R. 3947: Competition Prescription Act of 2019 - Provisions related to prescription drug pricing, patents, and other provisions ___ H.R. 4106: Responsibility in Drug Advertising Act of 2019 - Provisions related to direct-to-consumer prescription drug advertising ___ H.R. 4158: CURE High Drug Prices Act - Provisions related to prescription drug pricing and transparency ___ H.R. 4538: To amend title III of the Public Health Service Act to limit the orphan drug exclusion under the drug discount program under section 340B of such title. - Provisions related to 340B prescription drug exclusions ___ S. 61: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation ___ S. 73: End Taxpayer Subsidies for Drug Ads Act - Provisions related to direct-to-consumer prescription drug advertising ___ S. 97: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation ___ S. 340: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems ___ S. 378: Stop Price Gouging Act - Provisions related to prescription drug pricing ___ S. 440: PACED Act - Provisions related to use of sovereign immunity in patent disputes ___ S. 474: Stopping the Pharmaceutical Industry from Keeping Drug 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. 658: Accelerated Drug Approval for Prescription Therapies Act - Provisions related to FDA drug approvals ___ S. 660: Efficiency and Transparency in Petitions Act - Provisions related to the FDA citizen petition process ___ S. 844: Short on Competition Act - Provisions related to generic prescription drug approvals and importation ___ S. 977: Transparent Drug Pricing Act of 2019 - Provisions related to pharmaceutical drug pricing ___ S. 1140: Protecting Access to Biosimilars Act of 2019 - Provisions related to biological products ___ 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 commercial 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. 1664: Prescription Drug Price Reporting Act - Provisions related to prescription drug pricing transparency S.1872 _ Protecting Seniors through Immunizations Act of 2019 ___ S. 2387: We Protect American Investment in Drugs Act - Provisions related to prescription drug pricing ___ 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 ___ Generic drug approval process policy issues ___ High deductible health plans/HSA policy issues ___ Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors ___ Risk Evaluation and Mitigation Strategy (REMS) policy issues ___ FDA modernization policy issues ___ PDUFA implementation policy issues ___ 340B drug discount program policy issues ___ Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions ___ Patient assistance program policy issues ___ Biosimilar approval and reimbursement policy issues ___ Cancer drug vial size policy issues ___ TRICARE pharmacy pilot program ___ Drug shortages policy issues ___ Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49)

H.R. 447: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 478: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation H.R. 965: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 985: FAST Generics Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 1093: Stop Price Gouging Act - Provisions related to prescription drug pricing H.R. 1332: Fair Care Act of 2019 - Provisions related to prescription drug pricing, patent issues, Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 1409: Transparency in All Health Care Pricing Act of 2019 - Provisions related to prescription drug pricing transparency H.R. 1478: Affordable Insulin Act of 2019 - Provisions related to importation H.R. 1506: Fair and Immediate Release (FAIR) of Generic Drugs Act - Provisions related to generic prescription drug approvals H.R. 1603: Alan Reinstein Ban Asbestos Now Act of 2019 - Provisions related to use of asbestos in manufacturing H.R. 2038: State-Based, Market-Oriented, Prescription Drug Negotiations Act of 2019 - Provisions related to prescription drug pricing H.R. 2064: To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes - Provisions related to prescription drug samples H.R. 2069: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs H.R. 2087: Drug Price Transparency Act - Provisions related to prescription drug pricing and transparency H.R. 2113: Prescription Drug STAR Act - Provisions related to prescription drug pricing, reporting and product samples H.R. 2115: Public Disclosure of Drug Discounts Act - Provisions related to prescription drug pricing transparency and pharmacy benefit managers 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. 2401: American Cures Act - Provisions related to pharmaceutical research and development H.R. 2569: Comprehensive Addiction Resources Emergency Act of 2019 - Provisions related to opioid crisis response funding H.R. 2734: Safer Prescribing of Controlled Substances Act - Provisions related to the prescribing of prescription drugs H.R. 2917: Opioid Crisis Accountability Act of 2019 - Provisions related to prescription drug marketing H.R. 3223: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 3327: Drug Price Transparency for Medicare Patients Act of 2019 - Provisions related to direct-to-consumer prescription drug advertising H.R. 3415: Real-Time Beneficiary Drug Cost Bill - Provisions related to drug pricing transparency H.R. 3443: Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 - Provisions related to FDA over-the-counter drug approvals H.R. 3947: Competition Prescription Act of 2019 - Provisions related to prescription drug pricing, patents, and other provisions H.R. 4106: Responsibility in Drug Advertising Act of 2019 - Provisions related to direct-to-consumer prescription drug advertising H.R. 4158: CURE High Drug Prices Act - Provisions related to prescription drug pricing and transparency H.R. 4538: To amend title III of the Public Health Service Act to limit the orphan drug exclusion under the drug discount program under section 340B of such title. - Provisions related to 340B prescription drug exclusions S. 61: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation S. 73: End Taxpayer Subsidies for Drug Ads Act - Provisions related to direct-to-consumer prescription drug advertising S. 97: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 340: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 378: Stop Price Gouging Act - Provisions related to prescription drug pricing S. 440: PACED Act - Provisions related to use of sovereign immunity in patent disputes 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. 844: Short on Competition Act - Provisions related to generic prescription drug approvals and importation S. 977: Transparent Drug Pricing Act of 2019 - Provisions related to pharmaceutical drug pricing S. 1140: Protecting Access to Biosimilars Act of 2019 - Provisions related to biological products 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 commercial 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. 1664: Prescription Drug Price Reporting Act - Provisions related to prescription drug pricing transparency 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. 2199: Insulin Price Reduction Act - Provisions related to prescription drug pricing and transparency S. 2387: We Protect American Investment in Drugs Act - Provisions related to prescription drug pricing 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 Generic drug approval process policy issues High deductible health plans/HSA policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues FDA modernization policy issues PDUFA implementation policy issues 340B drug discount program policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Cancer drug vial size policy issues TRICARE pharmacy pilot program Drug shortages policy issues Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49)

S. 61, Safe and Affordable Drugs from Canada Act (Grassley) - drug importation S. 64, Preserve Access to Affordable Generics and Biosimilars Act (Grassley-Klobuchar) - prohibiting pay-for-delay settlements S. 73, End Taxpayer Subsidies for Drug Ads Act (Shaheen) - prohibiting tax deduction for DTC advertising expenses S. 102, Prescription Drug Price Relief Act (Sanders) - reforms linked to international pricing S. 340, CREATES Act (Leahy) - removing barriers to generic drugs S. 344, Hatch-Waxman Integrity Act (Tillis) - inter partes review process S. 366, FLAT Prices Act (Durbin) - reforms for drugs with sudden price spikes S. 378, Stop Price Gouging Act (Durbin) - excise tax for drugs that have price spikes S. 440, Preserving Access to Cost-Effective Drugs Act (Cotton) - sovereign immunity and Inter Partes Review process S. 474, SPIKE Act (Wyden) - justification for drug price increases S. 476, Creating Transparency to Have Drug Rebates Unlocked Act (Wyden) - drug price transparency S. 637, CURE High Drug Prices Act (Blumenthal) - remedies for price gouging S. 657, Point of Sale Rebates (Braun) S. 659, Biologic Patent Transparency Act (Collins) - patent disclosure requirements S. 660, Efficiency and Transparency in Petitions Act (Braun) - FDA citizen petition process S. 844, Short on Competition Act (Klobuchar) - remedies for marginally competitive drug markets S. 977, Transparency Drug Pricing Act (Scott) - transparency and drug pricing reforms S. 1209, Reforming Evergreening and Manipulation that Extends Drug Years Act (Cassidy) - preventing evergreening of patent protections S. 1224, Stop STALLING Act (Klobuchar) - citizen petition process S. 1227, Prescription Pricing for the People Act (Grassley) - FTC report on role of PBMs and allegations of anticompetitive conduct by manufacturers of sole-source drugs S. 1384, Prescription Drug Rebate Reform Act (Romney-Braun) - prescription drug cost sharing S. 1416, Affordable Prescriptions for Patients Act (Cornyn) - product hopping, patent thickets S. 1664, Prescription Drug Price Reporting Act (Scott) - prescription drug price reporting S. 2247, Phair Relief Act of 2019 (Kennedy)-transparency around price concessions for drugs S. 2387, We Protect American Investment in Drugs Act (Van Hollen)-drug pricing S. 2543, Prescription Drug Pricing Reduction Act of 2019 (Grassley)-Drug pricing H.R. 3, Lower Drug Costs Now Act of 2019 (Pallone)-drug pricing H.R. 465, Prescription Drug Price Relief Act (Khanna) - reforms linked to international pricing H.R. 478, Safe and Affordable Drugs from Canada Act (Pingree) - drug importation H.R. 938, BLOCKING Act (Schrader) - changes to 180-day period of market exclusivity for first generic applicant H.R. 965, CREATES Act (Cicilline) - removing barriers to generic drugs H.R. 985, FAST Generics Act (Welch) - removing barriers to generic drugs H.R. 990, Hatch-Waxman Integrity Act (Flores) - inter partes review process H.R. 1093, Stop Price Gouging Act (Pocan) - excise tax for drugs that have price spikes H.R. 1188, FLAT Prices Act (Golden) - reforms for drugs with sudden price spikes H.R. 1344, Competitive DRUGS Act (Doggett) - prohibiting pay-for-delay agreements H.R. 1419, Public Option Deficit Reduction Act (DeFazio) - public option H.R. 1499, Protecting Consumer Access to Generic Drugs Act (Rush) - prohibiting pay-for-delay agreements H.R. 1503, Orange Book Transparency Act (Kelly) - removal of invalidated patents from Orange Book H.R. 1506, FAIR Generics Act (Barragan) - changes to 180-day period of market exclusivity for first generic applicant H.R. 1520, Purple Book Continuity Act (Eshoo) - access to updated information on biologics and biosimilars H.R. 2038, State-Based, Market-Oriented Prescription Drug Negotiations Act (Meadows) - drug price negotiations H.R. 2064, Sunshine for Samples Act (Chu) - reporting requirements on drug samples H.R. 2069, SPIKE Act (Horsford) -justification for drug price increases H.R. 2087, Drug Price Transparency Act (Doggett) - reporting of drug pricing data under Medicare Part B H.R. 2113, Prescription Drug Sunshine, Transparency, Accountability and Reporting Act (Neal) - transparency in drug pricing H.R. 2115, Public Disclosure of Drug Discounts Act (Spanberger) - disclosure of negotiated Rx discounts H.R. 2279, Safe Step Act (Ruiz) - exceptions process for medication step therapy H.R. 2296, FAIR Drug Pricing Act (Schakowsky) - transparency requirements and justification for high list prices and drug price increases H.R. 2374, Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act (Jeffries) - citizen petition process H.R. 2375, Preserve Access to Affordable Generics and Biosimilars Act (Nadler) - prohibiting pay-for-delay agreements H.R. 2376, Prescription Pricing for the People Act (Collins) - FTC study on role of PBMs and competition and transparency in pharmaceutical supply chain H.R. 3379, Price Relief, Innovation, and Competition for Essential Drugs Act (Schakowsky) - exclusivity period for biological products H.R. 3805, Prescription Drug Rebate Reform Act of 2019 (Gallagher)- drug rebates H.R. 3927, PDMPs Help Patients Act of 2019 (McKinley)-integrating SUDs and behavioral health into PDMPs H.R. 3947, Competition Prescription Act of 2019 (Meadows)- drug pricing H.R. 4010, Emergency Access to Insulin Act of 2019 (Craig)- drug pricing H.R. 4106, Responsibility in Drug Advertising Act of 2019 (DeLauro)-transparency in drug pricing H.R. 4244, MAGIC Act (Kelly)-pathways for insulin approval H.R. 4398, Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 (Cicilline)-drug pricing H.R. 4455, BIOSIM Act (Schrader)-access to biosimilars H.R. 4460, Turn the Tide Act (Kuster)-Opioids H.R. 4538, Closing Loopholes for Orphan Drugs Act (Welch)-Access to drugs H.Con.Res. 55, Expressing the sense of Congress on the need to inform American consumers with more balanced purchasing information for prescription drugs through the disclosure of price information in direct-to-consumer (DTC) advertisements. (Burgess)-drug pricing Regulatory Issues: Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to price of drugs and biologics and proposals to limit high prices; issues related to drug patents and market exclusivity; issues related to pharmacy benefit managers; issues related to biosimilars; issues related to approval of drugs and biologics; issues relating to opioids; issues relating to prescription drug rebates; issues relating to prescription drug price blueprint; direct-to-consumer advertising for prescription drugs; issues related to proposed changes to removal of safe harbor protection for rebates (proposed rule); issues relating to access for investigational drugs; and other issues relating to health care reform implementation.

H.R.2135,"Preventing Adversaries Internationally from Disbursing Advertising Dollars Act or the PAID AD Act," all provisions H.R.2592, Honest Ads Act, all provisions H.R.3327, Drug Price Transparency for Medicare Patients Act of 2019, all provisions H.R.4054,Stand By Every Ad Act, all provisions HR 4106, Responsibility in Drug Advertising Act of 2019, all provisions H.Con.Res.55, Expressing the sense of Congress on the need to inform American consumers with more balanced purchasing information for prescription drugs through the disclosure of price information in direct-to-consumer (DTC) advertisements, all provisions S.73, "End Taxpayer Subsidies for Drug Ads Act, all provisions related to advertising S.474, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019," all provisions related to advertising S.1356, Honest Ads Act, all provisions S.1437, Drug-price Transparency in Communications (DTC) Act, all provisions

Client expense: $900,000 · Firm income: Not reported

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

-HR 466 - Amateur Radio Parity Act - all provisions related to cable. -HR 583 - Preventing Illegal Radio Abuse Through Enforcement (PIRATE) Act - all provisions related to cable. -HR 896 - Fairness in Political Advertising Act of 2019 - all provisions related to cable. -HR 1789 - Local and Independent Television Protection Act - all provisions related to cable. -HR 1848 - Communications Jobs Training Act of 2019 - all provisions related to cable. -HR 2135 - Preventing Adversaries Internationally from Disbursing Advertising Dollars (PAID AD) Act - all provisions related to cable. -HR 2592 - Honest Ads Act - all provisions related to cable. -HR 2860 - Bots Research Act - all provisions related to cable. -HR 3002 - To provide for the carriage of certain television broadcast stations - all provisions related to cable. -HR 2682 - Agricultural News and Rural Content Act of 2019 - all provisions related to cable. -HR 3327 - Drug Price Transparency for Medicare Patients Act of 2019 - all provisions related to cable. -HR 3393 - To amend the Communications Act of 1934 to prohibit Federal funding for the Corporation for Public Broadcasting after fiscal year 2021 - all provisions related to cable. -HR 3994 - Modern Television Act of 2019 - all provisions related to cable. -HR 4054 - Stand by Every Ad Act - all provisions related to cable. -HR 4106 - Responsibility in Drug Advertising Act of 2019 - all provisions related to cable. -HRes 549 - Reaffirming the commitment to media diversity and pledging to work with media entities and diverse stakeholders to develop common ground solutions to eliminate barriers to media diversity - all provisions related to cable. -HConRes 20 - Supporting the Local Radio Freedom Act - all provisions related to cable. -HConRes 55 - Expressing the sense of Congress on the need to inform American consumers with more balanced purchasing information for prescription drugs through the disclosure of price information in direct-to-consumer (DTC) advertisements - all provisions related to cable. -S 822 - To permit the televising of Supreme Court proceedings - all provisions related to cable. -S 941 - Section 331 Obligation Clarification Act - all provisions related to cable. -S 1228 - Preventing Illegal Radio Abuse Through Enforcement (PIRATE) Act - all provisions related to cable. -S 1356 - Honest Ads Act - all provisions related to cable. -S 1748 - Furthering Access and Networks for Sports Act - all provisions related to cable. -S 1962 - Preventing Adversaries Internationally from Disbursing Advertising Dollars (PAID AD) Act - all provisions related to cable. -S 2125 - Bot Disclosure and Accountability Act of 2019 - all provisions related to cable. -S 2181 - Cyber AIR Act - all provisions related to cable. -S 2182 - Security and Privacy in Your Car (SPY Car) Act of 2019 - all provisions related to cable. -S 2454 - Go Pack Go Act of 2019 - all provisions related to cable. -SRes 306 - Reaffirming the commitment to media diversity and pledging to work with media entities and diverse stakeholders to develop common ground solutions to eliminate barriers to media diversity - all provisions related to cable.

Proposals relating to the regulation of direct-to-consumer prescription drug advertising Discussions over specific HHS/CMS proposal to require televised direct-to-consumer prescription drug ads to contain list price information H.R. 4106, Responsibility in Drug Advertising Act of 2019, to prohibit direct-to-consumer prescription drug advertising for there years after FDA approval of a drug

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

FTC Reauthorization Act of 2019 (Not introduced) S.73, End Taxpayer Subsidies for Drug Ads Act S.1437, Drug-price Transparency in Communications (DTC) Act H.R. 4106, Responsibility in Drug Advertising Act

Client expense: Not reported · Firm income: $140,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE