Expanding Access to Low-Cost Generics Act of 2019

H.R. 3 - Lower Drug Costs Now Act of 2019 - Pallone - drug pricing H.R. 4398 - Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 - Cicilline - drug pricing H.R. 4906 - Insulin Price Reduction Act - DeGette - insulin costs H.R. 5444 - Lower Insulin Costs Now Act - Underwood - lowering insulin costs H.R. 5749 - Affordable Insulin for All Act - Crist - insulin costs H.R. 6155 - To amend the Biologics Price Competition and Innovation Act of 2009 to make improvements with respect to the transition of biological products - Grothman - biological products H.R. 6426 - To require group health plans and health insurance issuers offering group or individual coverage to provide notices relating to prescription drug refills to individuals covered under such plans or coverage who reside in emergency areas during emergency periods - McBath - prescription drug refill notices S. 2543 - Prescription Drug Pricing Reduction Act of 2019 - Grassley - Drug pricing S. 3092 - Expanding Access to Low-Cost Generics Act of 2019 - Smith - 180-day exclusivity period S. 3166 - Prescription Drug Affordability and Access Act - Booker - prescription drug costs 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 COVID-19; 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.

Client expense: $3,630,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Office of Management & Budget (OMB), Office of the Vice President of the United States, SENATE, Treasury, Dept of, White House Office

Opioids (Epidemic, Deterrence, Treatment); CREATES Act; Drug Pricing; PBM/Prescription Drug Costs; Rx Rebates; Rx Rebates; Biosimilars; Part D Reform; Drug Patents; generic drugs; Drug approval; Civica Rx. H.R.1781 - 116th Congress (2019-2020) Payment Commission Data Act of 2019 Sponsor: Rep. Carter, Earl L. "Buddy" [R-GA-1] (Introduced 03/14/2019) H.R.938 - 116th Congress (2019-2020) BLOCKING Act of 2019 Sponsor: Rep. Schrader, Kurt [D-OR-5] (Introduced 01/31/2019) H.R.1499 - 116th Congress (2019-2020) Protecting Consumer Access to Generic Drugs Act of 2019 Sponsor: Rep. Rush, Bobby L. [D-IL-1] (Introduced 03/05/2019) H.R.1520 - 116th Congress (2019-2020) Purple Book Continuity Act of 2019 Sponsor: Rep. Eshoo, Anna G. [D-CA-18](Introduced 3/05/2019) H.R.1503 - 116th Congress (2019-2020) Orange Book Transparency Act of 2019 Sponsor: Rep. Kelly, Robin L. [D-IL-2](Introduced 3/5/2019) H.R.965 - 116th Congress (2019-2020) CREATES Act of 2019 Sponsor: Rep. Cicilline, David N. [D-RI-1] (Introduced 02/05/2019) H.R.3 - 116th Congress (2019-2020) Lower Drug Costs Now Act of 2019 Sponsor: Rep. Pallone, Frank, Jr. [D-NJ-6] (Introduced 09/19/2019) H.R.275 - 116th Congress (2019-2020) Medicare Prescription Drug Price Negotiation Act of 2019 Sponsor: Rep. Welch, Peter [D-VT-At Large] (Introduced 01/08/2019) H.R.448 - 116th Congress (2019-2020) Medicare Drug Price Negotiation Act Sponsor: Rep. Cummings, Elijah E. [D-MD-7] (Introduced 01/10/2019) H.R.1046 - 116th Congress (2019-2020) Medicare Negotiation and Competitive Licensing Act of 2019 Sponsor: Rep. Doggett, Lloyd [D-TX-35] (Introduced 02/07/2019) S.3092 - 116th Congress (2019-2020) Expanding Access to Low-Cost Generics Act of 2019 Sponsor: Sen. Tina Smith (D-MN) (Introduced 12/18/2019) S.2546 - 116th Congress (2019-2020) Safe Step Act Sen. Lisa Murkowski [R-AK] (Introduced 09/25/2019) S.3374 - 116th Congress - Second Session Protecting Jessica Grubbs Legacy Act Sen. Joe Manchin [D-WV] (Introduced 03/03/2020) H.R. 19 - 116th Congress -First Session Lower Costs, More Cures Act of 2019 Rep. Greg Walden [R-OR-02] (Introduced 12/09/2019)

Opioids (Epidemic, Deterrence, Economic Impact Zones); CREATES Act; Drug Pricing; PBM/Prescription Drug Costs Rx Rebates; Biosimilars; Drug approval; Drug patents, generic drugs, Part D Reform, Biosimilars, Civica Rx H.R.1781 - 116th Congress (2019-2020) Payment Commission Data Act of 2019 Sponsor: Rep. Carter, Earl L. "Buddy" [R-GA-1] H.R.938 - 116th Congress (2019-2020) BLOCKING Act of 2019 Sponsor: Rep. Schrader, Kurt [D-OR-5] H.R.1520 - 116th Congress (2019-2020) Purple Book Continuity Act of 2019 Sponsor: Rep. Eshoo, Anna G. [D-CA-18] H.R.1503 - 116th Congress (2019-2020) Orange Book Transparency Act of 2019 Sponsor: Rep. Kelly, Robin L. [D-IL-2] H.R.1499 - 116th Congress (2019-2020) Protecting Consumer Access to Generic Drugs Act of 2019 Sponsor: Rep. Rush, Bobby L. [D-IL-1] H.R.965 - 116th Congress (2019-2020) CREATES Act of 2019 Sponsor: Rep. Cicilline, David N. [D-RI-1] H.R.3 - 116th Congress (2019-2020) Lower Drug Costs Now Act of 2019 Sponsor: Rep. Pallone, Frank, Jr. [D-NJ-6] H.R.275 - 116th Congress (2019-2020) Medicare Prescription Drug Price Negotiation Act of 2019 Sponsor: Rep. Welch, Peter [D-VT-At Large] H.R.448 - 116th Congress (2019-2020) Medicare Drug Price Negotiation Act Sponsor: Rep. Cummings, Elijah E. [D-MD-7] H.R.1046 - 116th Congress (2019-2020) Medicare Negotiation and Competitive Licensing Act of 2019 Sponsor: Rep. Doggett, Lloyd [D-TX-35] S. 3092 -- 116th Congress (2019-2020) Expanding Access to Low-Cost Generics Act of 2019 Sponsor: Sen. Tina Smith (D-MN) S. 2546 - 116th Congress (2019-2020) Safe Step Act Sen. Lisa Murkowski (R-AK) S. 3374 - 116th Congress - Second Session Protecting Jessica Grubb's Legacy Act Sen. Joe Manchin (D-WV) H.R. 19 - 116th Congress - First Session Lower Costs, More Cures Act of 2019 Rep. Greg Walden (R-OR-02) H.R. 6193 - 116th Congress - Second Session Medication Access in Emergencies Act of 2020 Rep. Chris Pappas (D-NH-01) H.R. 5578 - 116th Congress - Second Session Recall Unsafe Drugs Act of 2020 Rep. Rosa DeLauro (D-CT-03) H.R. 5691 - 116th Congress - Second Session Insulin Affordability Data Collection Act H.R. 5894 - 116th Congress - Second Session Transparency in Prescription Drug Advertising Act Rep. Sharice Davids (D-KS-03) H.R. 5927 - 116th Congress - Second Session Safe Medicine Act Rep. Bill Posey (R-FL-08) H.R. 5663 - 116th Congress - Second Session Safeguarding Therapeutics Act Rep. Brett Guthrie (R-KY-02) R. 4712 - 116th Congress - First Session Fairness in Orphan Drug Exclusivity Act Rep. Madeleine Dean (D-PA-04) H.R. 2477 - 116th Congress - First Session Beneficiary Enrollment Notification and Eligibility Simplification Act of 2019 Rep. Raul Ruiz (D-CA-36)

Opioids (Epidemic, Deterrence, Economic Impact Zones); CREATES Act; Drug Pricing; PBM/Prescription Drug Costs; Rx Rebates; Biosimilars; Drug Approval; Drug Patents; Generic Drugs; Part D Reform, Civica Rx HR 3 (116th Congress), Lower Drug Costs Now Act of 2019, by Rep. Frank Pallone, Jr. (D-NJ). To establish a fair price negotiation program, protect the Medicare program from excessive price increases, and establish an out-of-pocket maximum for Medicare part D enrollees, and for other purposes. HR 19 (116th Congress), Lower Costs, More Cures Act of 2019, by Rep. Greg Walden (R-OR). To provide for certain reforms with respect to the Medicare program under title XVIII of the Social Security Act, the Medicaid program under title XIX of such Act, the Food and Drug Administration, and for other purposes. HR 275 (116th Congress), Medicare Prescription Drug Price Negotiation Act of 2019, by Rep. Peter Welch (D-VT). To amend part D of title XVIII of the Social Security Act to require the Secretary of Health and Human Services to negotiate covered part D drug prices on behalf of Medicare beneficiaries. HR 448 (116th Congress), Medicare Drug Price Negotiation Act, by Rep. Elijah Cummings (D-MD). To amend title XVIII of the Social Security Act to provide for the negotiation of lower covered part D drug prices on behalf of Medicare beneficiaries and the establishment and application of a formulary by the Secretary of Health and Human Services under Medicare part D, and for other purposes. HR 938 (116th Congress), Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 (the BLOCKING Act) of 2019, by Rep. Kurt Schrader (D-OR). To amend the Federal Food, Drug, and Cosmetic Act, with respect to eligibility for approval of a subsequent generic drug, to remove the barrier to that approval posed by the 180-day exclusivity period afforded to a first generic applicant that has not yet received final approval, and for other purposes. HR 965 (116th Congress), CREATES Act of 2019, by Rep. David Cicilline (D-RI). To promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products. HR 1046 (116th Congress), Medicare Negotiation and Competitive Licensing Act of 2019, by Rep. Lloyd Doggett (D-TX). To amend title XVIII of the Social Security Act to require the Secretary of Health and Human Services to negotiate prices of prescription drugs furnished under part D of the Medicare program. HR 1499 (116th Congress), Protecting Consumer Access to Generic Drugs Act of 2019, by Rep. Bobby Rush (D-IL). To prohibit brand name drug manufacturers from compensating generic drug manufacturers to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable product manufacturers to delay entry of biosimilar and interchangeable products, and for other purposes. HR 1503 (116th Congress), Orange Book Transparency Act of 2019, by Rep. Robin Kelly (D-IL). To amend the Federal Food, Drug, and Cosmetic Act regarding the list under section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act, and for other purposes. HR 1520 (116th Congress), Purple Book Continuity Act of 2019, by Rep. Anna Eshoo (D-CA). To amend the Public Health Service Act to provide for the publication of a list of licensed biological products, and for other purposes. HR 1781 (116th Congress), Payment Commission Data Act of 2019, by Rep. Earl Carter (D-GA). To amend titles XVIII and XIX of the Social Security Act to provide the Medicare Payment Advisory Commission and the Medicaid and CHIP Payment and Access Commission with access to certain drug payment information, including certain rebate information. HR 4712 (116th Congress), Fairness in Orphan Drug Exclusivity Act, by Rep. Madeleine Dean (D-PA). To amend the Federal Food, Drug, and Cosmetic Act with respect to limitations on exclusive approval or licensure of orphan drugs, and for other purposes. HR 5578 (116th Congress), Recall Unsafe Drugs Act of 2020, by Rep. Rosa DeLauro (D-CT). To provide for the mandatory recall of drugs regulated by the Food and Drug Administration. HR 5663 (116th Congress), Safeguarding Therapeutics Act, by Rep. Brett Guthrie (R-KY). To amend the Federal Food, Drug, and Cosmetic Act to give authority to the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to destroy counterfeit devices. HR 5691 (116th Congress), Insulin Affordability Data Collection Act, by Rep. Angie Craig (D-MN). To require the Secretary to conduct a study and issue a report on the affordability of insulin. HR 5894 (116th Congress), Transparency in Prescription Drug Advertising Act, by Rep. Sharice Davids (D-KS). To direct the Secretary of Health and Human Services to issue guidance requiring the list prices of drugs to be included in advertisements for such drugs. HR 5927 (116th Congress), Safe Medicine Act, by Rep. Bill Posey (R-FL). To direct the Secretary of Health and Human Services to study American dependence on unsafe Chinese pharmaceuticals and to empower the Food and Drug Administration to mandate drug recalls in the case of critical contamination. HR 6193 (116th Congress), Medication Access in Emergencies Act of 2020, by Rep. Chris Pappas (D-NH). To amend title XXVII of the Public Health Service Act to require group health plans and health insurance issuers offering group or individual health insurance coverage to provide benefits under such plan or such coverage for a 30-day refill of prescription drugs to individuals who reside in emergency areas during emergency periods. S 2546 (116th Congress), Safe Step Act, by Sen. Lisa Murkowski (R-AK). To amend the Employee Retirement Income Security Act of 1974 to require a group health plan or health insurance coverage offered in connection with such a plan to provide an exceptions process for any medication step therapy protocol, and for other purposes. S 3092 (116th Congress), Expanding Access to Low-Cost Generics Act of 2019, by Sen. Tina Smith (D-MN). To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period, and for other purposes.

Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs and Biosimilars. Country of Manufacture Labeling. S.3537: A bill to require the Secretary of Health and Human Services to maintain a list of the country of origin of all drugs marketed in the United States, to ban the use of Federal funds for the purchase of drugs manufactured in China, and for other purposes. S.3538: A bill to require the Secretary of Defense to submit to Congress a report on the reliance by the Department of Defense on imports of certain pharmaceutical products made in part or in whole in certain countries, to establish postmarket reporting requirements for pharmaceuticals, and for other purposes. FDA Priority MAPP 5240.3 REV 5. H.R.5668: MODERN Labeling Act of 2020. Drug Shortages. S.2723: Mitigating Emergency Drug Shortages Act. Product Hopping. H.R.4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019. Biosimilars Naming. Biosimilars Insulin. H.R.4244: MAGIC Act. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. S.1140: Protecting Access to Biosimilars Act of 2019. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. H.R.5982: Safe Medicine Act. Prescription Drug Costs. Drug Pricing. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.1506: FAIR Generics Act. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. S.3092: Expanding Access to Low-Cost Generics Act of 2019. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. S.64: Preserve Access to Affordable Generics and Biosimilars Act. S.1416: Affordable Prescriptions for Patients Act of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. S.3384: Lowering Prescription Drug Prices for Americas Seniors and Families Act of 2020. H.R.3: Lower Drug Costs Now Act of 2019. S.1895: Lower Health Care Costs Act. H.R.965/S.340: CREATES Act of 2019. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. 30-Month Stays. Biologic Exclusivity. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.2214: NO BAN Act. H.R.4793: Budgeting for Opioid Addiction Treatment Act. Issues Related to COVID-19. H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act. H.R.6201: Families First Coronavirus Response Act. S. ___Facilitating Innovation to Fight Coronavirus Act. Rubio Coronavirus Plan. Commission on Americas Medical Security Act. Buy American Proposals. S.3478: A bill to require a report to assess, evaluate, and address the dependence of the United States on critical drugs and devices sourced or manufactured outside of the United States.

Opioids (Epidemic, Deterrence, Economic Impact Zones); CREATES Act; Drug Pricing; PBM/Prescription Drug Costs Rx Rebates; Rx Rebates; Biosimilars; Drug approval; Drug patents, generic drugs, Part D Reform; Civica Rx H.R.1499 - 116th Congress (2019-2020) Protecting Consumer Access to Generic Drugs Act of 2019 Sponsor: Rep. Rush, Bobby [D-IL-1](Introduced 03/08/2019) H.R.965 - 116th Congress (2019-2020) CREATES Act of 2019 Sponsor: Rep. Cicilline, David [D-RI-1](Introduced 02/05/2019) H.R.3 - 116th Congress (2019-2020) Lower Drug Costs Now Act of 2019 Sponsor: Rep. Pallone, Frank, Jr. [D-NJ-6](Introduced 09/19/2019) H.R.275 - 116th Congress (2019-2020) Medicare Prescription Drug Price Negotiation Action of 2019 Sponsor: Rep. Welch, Peter [D-VT-At Large](Introduced 01/08/2019) H.R.448 - 116th Congress (2019-2020) Medicare Drug Price Negotiation Act Sponsor: Rep. Cummings, Elijah E. [D-MD-7](Introduced 01/10/2019) H.R.1046 - 116th Congress (2019-2020) Medicare Negotiation and Competitive Licensing Act of 2019 Sponsor: Rep. Doggett, Lloyd [D-TX-35](Introduced 02/07/2019) S.3092 - 116th Congress (2019-2020) Expanding Access to Low-Cost Generics Act of 2019 Sponsor: Sen. Smith, Tina [D-MN](Introduced 12/18/2019) H.R.19 - 116th Congress (2019-2020) Lower Costs, More Cures Act of 2019 Sponsor: Rep. Walden, Gred [R-OR-2](Introduced 12/09/2019) H.R.6193 - 116th Congress (2019-2020) Medication Access in Emergencies Act of 2020 Sponsor: Rep Pappas, Chris [D-NH-1](Introduced 03/11/2020) H.R.5578 - 116th Congress (2019-2020) Recall Unsafe Drugs Act of 2020 Sponsor: Rep. Delauro, Rosa [D-CT-3](Introduced 01/10/2020) H.R.5691 - 116th Congress (2019-2020) Insulin Affordability Data Collection Act Sponsor: Rep. Craig, Angie [D-MN-2](Introduced 01/28/2020) H.R.5894 - 116th Congress (2019-2020) Transparency in Prescription Drug Advertising Act Sponsor: Rep Davids, Sharice [D-KS-3](Introduced 02/13/2020)

H.R. 987-Strengthening Health Care and Lowering Prescription Drug Costs (Section 101);S. 3092-Expanding Access to Low-Cost Generics Act of 2019; S.1895-Lower Health Care Costs Act (Section 205).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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.

Opioids (Epidemic, Deterrence, Economic Impact Zones); CREATES Act; Drug Pricing; PBM/Prescription Drug Costs Rx Rebates; Direct-to-Consumer Rx Advertising;Biosimilars; Drug approval; Drug patents, generic drugs, Part D Reform, Biosimilars H.R.1781 - 116th Congress (2019-2020) Payment Commission Data Act of 2019 Sponsor: Rep. Carter, Earl L. "Buddy" [R-GA-1] H.R.938 - 116th Congress (2019-2020) BLOCKING Act of 2019 Sponsor: Rep. Schrader, Kurt [D-OR-5] H.R.1520 - 116th Congress (2019-2020) Purple Book Continuity Act of 2019 Sponsor: Rep. Eshoo, Anna G. [D-CA-18] H.R.1503 - 116th Congress (2019-2020) Orange Book Transparency Act of 2019 Sponsor: Rep. Kelly, Robin L. [D-IL-2] H.R.1499 - 116th Congress (2019-2020) Protecting Consumer Access to Generic Drugs Act of 2019 Sponsor: Rep. Rush, Bobby L. [D-IL-1] H.R.965 - 116th Congress (2019-2020) CREATES Act of 2019 Sponsor: Rep. Cicilline, David N. [D-RI-1] H.R.3 - 116th Congress (2019-2020) Lower Drug Costs Now Act of 2019 Sponsor: Rep. Pallone, Frank, Jr. [D-NJ-6] H.R.275 - 116th Congress (2019-2020) Medicare Prescription Drug Price Negotiation Act of 2019 Sponsor: Rep. Welch, Peter [D-VT-At Large] H.R.448 - 116th Congress (2019-2020) Medicare Drug Price Negotiation Act Sponsor: Rep. Cummings, Elijah E. [D-MD-7] H.R.1046 - 116th Congress (2019-2020) Medicare Negotiation and Competitive Licensing Act of 2019 Sponsor: Rep. Doggett, Lloyd [D-TX-35] S. 3092 -- 116th Congress (2019-2020) Expanding Access to Low-Cost Generics Act of 2019 Sponsor: Sen. Tina Smith (D-MN) S. 2546 - 116th Congress (2019-2020) Safe Step Act Sen. Lisa Murkowski (R-AK)

Client expense: $1,840,000 · Firm income: Not reported

Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs and Biosimilars. Country of Manufacture Labeling. H.R.5381: International Pharmaceutical Transparency Act of 2019. Drug Compounding. Drug Shortages. Product Hopping. H.R.4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019. Biosimilars Naming. Biosimilars Insulin. Pass Through Payments for Biosimilars. S.1140: Protecting Access to Biosimilars Act of 2019. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. Prescription Drug Costs. Drug Pricing. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. FDA Citizen Petitions. H.R.2387: STOP GAMES Act of 2019. H.R.1506: FAIR Generics Act. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. S.475: RxCAP Act of 2019. 180-Day Exclusivity. H.R.2455/S.1169: Ensuring Timely Access to Generics Act of 2019. S.3092: Expanding Access to Low-Cost Generics Act of 2019. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. S.64: Preserve Access to Affordable Generics and Biosimilars Act. S.1416: Affordable Prescriptions for Patients Act of 2019. H.R.2376: Prescription Pricing for the People Act of 2019. H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. S.1895: Lower Health Care Costs Act. S.1805: Better Tools for Healthy Living Act. H.R.965/S.340: CREATES Act of 2019. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. 30-Month Stays. Biologic Exclusivity. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA).

H.R. 3 Lower Drug Costs Now Act of 2019 -allowing Medicare to negotiate prescription drug prices, limiting the ability of drug companies to spike their prices overnight, ensuring that actions to address egregious prices apply to coverage beyond Medicare S. 2543 Prescription Drug Pricing Reduction Act of 2019 - comprehensive legislation to lower prescription drug prices in the Medicare and Medicaid programs, to improve transparency related to pharmaceutical prices and transactions, to lower patients' out-of-pocket costs, and to ensure accountability to taxpayers H.AR. 4663 Freedom from Price Gouging Act - require drug manufacturers to pay a Medicare part B rebate for certain drugs if the price of such drugs increases faster than inflation. S. 64 Preserve Access to Affordable Generics and Biosimilars Act - prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products S.3092 Expanding Access to Low Cost Generics Act - Subjecting insulin to the new pathway to bring low-cost, generic insulin products to market S.2628 - Equity in Pretrial Medicaid Coverage Act of 2019 - remove a limitation on an individual's eligibility for medical assistance under the State Medicaid plan while the individual is in custody pending disposition of charges. H.R. 913 - CLINICAL TREAMENT Act - requires state Medicaid programs to cover routine patient costs for items and services that are provided in connection with a qualifying clinical trial regarding cancer or other life-threatening conditions Legislation to restore Medicaid eligibility to people from the Freely Associated States who are living in the U.S. under the terms of the Compacts of Free Association (COFA). H.R.1393 Medicare Dental, Vision, and Hearing Benefit Act of 2019 - provide for coverage of dental, vision, and hearing care under the Medicare program. H.R.576 Seniors Have Eyes, Ears, and Teeth Act - expands Medicare coverage to include eyeglasses, hearing aids, and dental care. S.22/H.R.2951 Medicare Dental Benefit Act of 2019 - coverage of dental services under Medicare Part B H.R.1342 EMPOWER Care Act - reauthorize the Money Follows the Person Demonstration Program H.R. 1343 - Protecting Married Seniors Act - provisions regarding Medicaid eligibility that protect against spousal impoverishment for recipients of home and community-based services. S.99 / H.R.448 - The Medicare Drug Price Negotiation Act - negotiation of lower covered part D drug prices on behalf of Medicare beneficiaries and the establishment and application of a formulary by the Secretary of Health and Human Services under Medicare part D H.R.1046 / S.377 Medicare Negotiation and Competitive Licensing Act of 2019 - requiring Secretary of Health and Human Services to negotiate prices of prescription drugs furnished under part D of the Medicare program H.R.4671 Helping Seniors Afford Health Care Act of 2019 - reduce cost-sharing, align income and resource eligibility tests, simplify enrollment, and provide for other program improvements for low-income Medicare beneficiaries. H.R. 4996 Helping Medicaid Offer Maternity Services Act of 2019 - MOMs Act - provide for a State option under the Medicaid program to provide for and extend continuous coverage for certain individual H.R.1329 Medicaid Reentry Act - allows Medicaid payment for medical services furnished to an incarcerated individual during the 30-day period preceding the individual's release H.R.1354 Territories Health Equity Act - make improvements to the treatment of the United States territories under the Medicare and Medicaid programs H.R.1384, S.1129 Medicare for All Act - establishes a national health insurance program Medicare Prescription Drug Savings and Choice Act - public option for drug coverage within Medicare Part D HEAL for Immigrant Women and Families Act of 2019 - Removes the five year waiting period for immigrants to become eligible for Medicaid and CHIP S.1423Medicare and Medicaid Dental, Vision, and Hearing Benefit Act of 2019 - provide for coverage of dental, vision, and hearing care under the Medicare and Medicaid programs S.1280BENES Act - establish a system to notify individuals approaching Medicare eligibility, to simplify and modernize the eligibility enrollment process

Opioids (Epidemic, Deterrence, Treatment); CREATES Act; Drug Pricing; PBM/Prescription Drug Costs Rx Rebates; Direct-to-Consumer Rx Advertising; Rx Rebates; Biosimilars H.R.1781 - 116th Congress (2019-2020) Payment Commission Data Act of 2019 Sponsor: Rep. Carter, Earl L. "Buddy" [R-GA-1] (Introduced 03/14/2019) H.R.938 - 116th Congress (2019-2020) BLOCKING Act of 2019 Sponsor: Rep. Schrader, Kurt [D-OR-5] (Introduced 01/31/2019) H.R.1499 - 116th Congress (2019-2020) Protecting Consumer Access to Generic Drugs Act of 2019 Sponsor: Rep. Rush, Bobby L. [D-IL-1] (Introduced 03/05/2019) H.R.1520 - 116th Congress (2019-2020) Purple Book Continuity Act of 2019 Sponsor: Rep. Eshoo, Anna G. [D-CA-18](Introduced 3/05/2019) H.R.1503 - 116th Congress (2019-2020) Orange Book Transparency Act of 2019 Sponsor: Rep. Kelly, Robin L. [D-IL-2](Introduced 3/5/2019) H.R.965 - 116th Congress (2019-2020) CREATES Act of 2019 Sponsor: Rep. Cicilline, David N. [D-RI-1] (Introduced 02/05/2019) H.R.3 - 116th Congress (2019-2020) Lower Drug Costs Now Act of 2019 Sponsor: Rep. Pallone, Frank, Jr. [D-NJ-6] (Introduced 09/19/2019) H.R.275 - 116th Congress (2019-2020) Medicare Prescription Drug Price Negotiation Act of 2019 Sponsor: Rep. Welch, Peter [D-VT-At Large] (Introduced 01/08/2019) H.R.448 - 116th Congress (2019-2020) Medicare Drug Price Negotiation Act Sponsor: Rep. Cummings, Elijah E. [D-MD-7] (Introduced 01/10/2019) H.R.1046 - 116th Congress (2019-2020) Medicare Negotiation and Competitive Licensing Act of 2019 Sponsor: Rep. Doggett, Lloyd [D-TX-35] (Introduced 02/07/2019) S.3092- 116th Congress (2019-2020) Expanding Access to Low-Cost Generics Act of 2019 Sponsor: Sen. Tina Smith (D-MN) (Introduced 12/18/2019)

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

HR 987, the Strengthening Health Care and Lowering Prescription Drug Costs Act, Title I, Subtitle A, Section 101, provisions relating to the Hatch-Waxman Acts 180-day exclusivity framework; S. 1895, the Lower Health Care Costs Act, Title II, Section 205, Preventing Blocking of Generic Drugs, provisions relating to the Hatch-Waxman Acts 180-day exclusivity framework; Federal policy relating to pharmaceutical market blockages caused by parked Hatch-Waxman 180-day exclusivity periods; HR 1865, the Further Consolidated Appropriations Act, Subtitle F, Section 605, provisions relating to the definition of chemically synthesized biologic products; and S. 3092, the Expanding Access to Low-Cost Generics Act, provisions relating to the amendment of the Hatch-Waxman Act to prevent parked 180-day exclusivity periods from blocking timely competition in the pharmaceutical marketplace

Client expense: $480,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Opioids (Epidemic, Deterrence, Economic Impact Zones); CREATES Act; Drug Pricing; PBM/Prescription Drug Costs Rx Rebates; Rx Rebates; Biosimilars; Drug approval; Drug patents, generic drugs, Part D Reform H.R.1781 -- 116th Congress (2019-2020) Payment Commission Data Act of 2019 Sponsor: Rep. Carter, Earl L. "Buddy" [R-GA-1] H.R.938 - 116th Congress (2019-2020) BLOCKING Act of 2019 Sponsor: Rep. Schrader, Kurt [D-OR-5] H.R.1520 - 116th Congress (2019-2020) Purple Book Continuity Act of 2019 Sponsor: Rep. Eshoo, Anna G. [D-CA-18] H.R.1503 - 116th Congress (2019-2020) Orange Book Transparency Act of 2019 Sponsor: Rep. Kelly, Robin L. [D-IL-2] H.R.1499 - 116th Congress (2019-2020) Protecting Consumer Access to Generic Drugs Act of 2019 Sponsor: Rep. Rush, Bobby L. [D-IL-1] H.R.965 - 116th Congress (2019-2020) CREATES Act of 2019 Sponsor: Rep. Cicilline, David N. [D-RI-1] H.R.3 - 116th Congress (2019-2020) Lower Drug Costs Now Act of 2019 Sponsor: Rep. Pallone, Frank, Jr. [D-NJ-6] H.R.275 - 116th Congress (2019-2020) Medicare Prescription Drug Price Negotiation Action of 2019 Sponsor: Rep. Welch, Peter [D-VT-At Large] H.R.448 - 116th Congress (2019-2020) Medicare Drug Price Negotiation Act Sponsor: Rep. Cummings, Elijah E. [D-MD-7] H.R.1046 - 116th Congress (2019-2020) Medicare Negotiation and Competitive licensing Act of 2019 Sponsor: Rep. Doggett, Lloyd [D-TX-35] S.3092 - 116th Congress (2019-2020) Expanding Access to Low-Cost Generics Act of 2019 Sponsor: Sen. Tina Smith (D-MN)

Client expense: $10,000 · Firm income: Not reported

H.R. 987-Strengthening Health Care and Lowering Prescription Drug Costs (Section 101);S. 3092-Expanding Access to Low-Cost Generics Act of 2019; S.1895-Lower Health Care Costs Act (Section 205).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Opioids (Epidemic, Deterrence, Economic Impact Zones); CREATES Act; Drug Pricing; PBM/Prescription Drug Costs; Rx Rebates; Direct to Consumer Rx Advertising; Biosimilars; Drug Approval; Drug Patents; Generic Drugs; Part D Reform HR 3 (116th Congress), Lower Drug Costs Now Act of 2019, by Rep. Frank Pallone, Jr. (D-NJ). To establish a fair price negotiation program, protect the Medicare program from excessive price increases, and establish an out-of-pocket maximum for Medicare part D enrollees, and for other purposes. HR 275 (116th Congress), Medicare Prescription Drug Price Negotiation Act of 2019, by Rep. Peter Welch (D-VT). To amend part D of title XVIII of the Social Security Act to require the Secretary of Health and Human Services to negotiate covered part D drug prices on behalf of Medicare beneficiaries. HR 448 (116th Congress), Medicare Drug Price Negotiation Act, by Rep. Elijah Cummings (D-MD). To amend title XVIII of the Social Security Act to provide for the negotiation of lower covered part D drug prices on behalf of Medicare beneficiaries and the establishment and application of a formulary by the Secretary of Health and Human Services under Medicare part D, and for other purposes. HR 938 (116th Congress), Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 (the BLOCKING Act) of 2019, by Rep. Kurt Schrader (D-OR). To amend the Federal Food, Drug, and Cosmetic Act, with respect to eligibility for approval of a subsequent generic drug, to remove the barrier to that approval posed by the 180-day exclusivity period afforded to a first generic applicant that has not yet received final approval, and for other purposes. HR 965 (116th Congress), CREATES Act of 2019, by Rep. David Cicilline (D-RI). To promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products. HR 1046 (116th Congress), Medicare Negotiation and Competitive Licensing Act of 2019, by Rep. Lloyd Doggett (D-TX). To amend title XVIII of the Social Security Act to require the Secretary of Health and Human Services to negotiate prices of prescription drugs furnished under part D of the Medicare program. HR 1499 (116th Congress), Protecting Consumer Access to Generic Drugs Act of 2019, by Rep. Bobby Rush (D-IL). To prohibit brand name drug manufacturers from compensating generic drug manufacturers to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable product manufacturers to delay entry of biosimilar and interchangeable products, and for other purposes. HR 1503 (116th Congress), Orange Book Transparency Act of 2019, by Rep. Robin Kelly (D-IL). To amend the Federal Food, Drug, and Cosmetic Act regarding the list under section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act, and for other purposes. HR 1520 (116th Congress), Purple Book Continuity Act of 2019, by Rep. Anna Eshoo (D-CA). To amend the Public Health Service Act to provide for the publication of a list of licensed biological products, and for other purposes. HR 1781 (116th Congress), Payment Commission Data Act of 2019, by Rep. Earl Carter (D-GA). To amend titles XVIII and XIX of the Social Security Act to provide the Medicare Payment Advisory Commission and the Medicaid and CHIP Payment and Access Commission with access to certain drug payment information, including certain rebate information. S 2546 (116th Congress), Safe Step Act, by Sen. Lisa Murkowski (R-AK). To amend the Employee Retirement Income Security Act of 1974 to require a group health plan or health insurance coverage offered in connection with such a plan to provide an exceptions process for any medication step therapy protocol, and for other purposes. S 3092 (116th Congress), Expanding Access to Low-Cost Generics Act of 2019, by Sen. Tina Smith (D-MN). To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period, and for other purposes.