Expanding Access to Low Cost Generic Drugs Act

Genetically Engineered (GE) Animals ---Labeling ---Efficient Science-Based Review of Biotech Products ---FDA Proposed Guidance on Gene Editing ---H.R. 5961/S.2476: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 ------Amendment on GE Salmon Labeling ---The Animal Drug User Fee Reauthorization Act of 2018 One Health ---S. 2615: Advancing Emergency Preparedness Through One Health Act

Client expense: $2,480,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

Drug Importation ---S.469: Affordable and Safe Prescription Drug Importation Act Genetically Engineered (GE) Animals ---Labeling ---Efficient Science-Based Review of Biotech Products ---FDA Proposed Guidance on Gene Editing ---H.R. 5961/S.2476: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 ------Amendment on GE Salmon Labeling ---The Animal Drug User Fee Reauthorization Act of 2018 Opioid Crisis ---NIH Research ---FDA Reforms ---Coverage and Reimbursement ---Transparency ---H.R. 5590: Opioid Addiction Action Plan Act ---H.R. 5002: Advancing Cutting Edge Research Act ---H.R. 5473: Better Pain Management Through Better Data Act ---H.R. 5806: 21st Century Tools for Pain Addiction Treatment ---H.R. 6: SUPPORT for Patients and Communities Act ---S.2665: Providing Clarity in Development of Pain Treatment ---S.2669: Advancing Innovation in Alternative Pain and Addiction Therapies Act ---S.2680: Opioid Crisis Response Act ---S.2769: HEAL Act Review and Labeling of Food Derived from Biotechnology ---Implementation of Disclosure Law

Client expense: $2,480,000 · Firm income: Not reported

Stop the Importation and Trafficking of Synthetic Analogues Act of 2017 (H.R. 2851/S. 1327); The Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now Act (i.e., the "SCREEN Act")(H.R. 5228); Opioid Crisis Response Act of 2018 (S. 2680); Expanding Access to Low Cost Generic Drugs Act (S. 2476); Preserve Access to Affordable Generics Act (S. 124); Regulatory exclusivity; Improving Access To Affordable Prescription Drugs Act (S. 771/H.R. 1776); Comprehensive Addiction Resources Emergency Act (CARE Act)(S. 2700/HR 5545); SOUND Disposal and Packaging Act (HR 5687); Long-Term Opioid Efficacy Act of 2018 (HR 5811); SAFETY Act of 2018 (H.R. 5803); Drug pricing; H.R. 5752, the Stop Illicit Drug Importation Act of 2018; proposed legislation regarding tableting and encapsulating opioid products; Drug Importation; CREATES Act (HR 2212/S. 974; 340B issues; SUPPORT for Patients and Communities Act (H.R. 6), Biosimilars Competition Act of 2018 (H.R. 6478), Patient Right to Know Drug Prices Act (S. 2554/H.R. 6143), Re-Valuing Anti-Microbial Products Act of 2018 (H.R. 6294), Medicare Negotiation and Competitive Licensing Act of 2018 (H.R. 6505), Making Objective Drug Evidence Revisions for New (MODERN) Labeling Act (S. 3519), citizen petitions

Client expense: Not reported · Firm income: $270,000

H.R. 2212 & S. 974, the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act. S. 2476-Expanding Access to Low Cost Generic Drugs Act; Issues relating to generic drug pricing.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Genetically Engineered (GE) Animals ---Labeling ---Efficient Science-Based Review of Biotech Products ---FDA Proposed Guidance on Gene Editing ---H.R. 5961/S.2476: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 ------Amendment on GE Salmon Labeling ---The Animal Drug User Fee Reauthorization Act of 2018 ------Amendment on GE Salmon Labeling One Health ---S. 2615: Advancing Emergency Preparedness Through One Health Act

Client expense: $2,520,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Council of Economic Advisers (CEA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office

Drug Importation ---S.469: Affordable and Safe Prescription Drug Importation Act Genetically Engineered (GE) Animals ---Labeling ---Efficient Science-Based Review of Biotech Products ---FDA Proposed Guidance on Gene Editing ---H.R. 5961/S.2476: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 ------Amendment on GE Salmon Labeling ---The Animal Drug User Fee Reauthorization Act of 2018 ------Amendment on GE Salmon Labeling Opioid Crisis ---NIH Research ---FDA Reforms ---Coverage and Reimbursement ---Transparency ---H.R. 5590: Opioid Addiction Action Plan Act ---H.R. 5002: Advancing Cutting Edge Research Act ---H.R. 5473: Better Pain Management Through Better Data Act ---H.R. 5806: 21st Century Tools for Pain Addiction Treatment ---H.R. 6: SUPPORT for Patients and Communities Act ---S.2665: Providing Clarity in Development of Pain Treatment ---S.2669: Advancing Innovation in Alternative Pain and Addiction Therapies Act ---S.2680: Opioid Crisis Response Act ---S.2769: HEAL Act Review and Labeling of Food Derived from Biotechnology ---Implementation of Disclosure Law

Client expense: $2,520,000 · Firm income: Not reported

Agricultural Education Policy Biomass Programs (Non-Funding) ---Reauthorization of Biomass Crop Assistance Program ---Reauthorization of Biomass R&D Program ---H.R. 2: Agriculture and Nutrition Act ---S. 3042: Agriculture Improvement Act EPA Regulations on Biotechnology ---H.R. 1029 Pesticide Registration Act ---Efficient Science-Based Reviews of Biotech Products Foreign Agricultural Biotechnology Laws and Regulations ---Asynchronous Approvals ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations Funding for Biomass Crop Assistance Program ---H.R. 2: Agriculture and Nutrition Act ---S. 3042: Agriculture Improvement Act ---H.R. 5961/S.2476: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 Funding for the USDA ---H.R. 5961/S.2476: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 ---Foreign Agriculture Service Funding and Authority ------H.R. 5379: Growing American Food Exports Act Genetically Engineered (GE) Animals ---Labeling ---Efficient Science-Based Review of Biotech Products ---FDA Proposed Guidance on Gene Editing ---H.R. 5961/S.2476: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 ------Amendment on GE Salmon Labeling ---The Animal Drug User Fee Reauthorization Act of 2018 ------Amendment on GE Salmon Labeling One Health ---S. 2615: Advancing Emergency Preparedness Through One Health Act Potential Regulation of New Genetic Modification Technologies Review and Labeling of Food Derived from Biotechnology ---Implementation of Disclosure Law USDA/APHIS Agricultural Biotechnology Regulations ---Efficient Science-Based Review of Biotech Products ---Potential Revisions to Part 340 Regulations ---H.R. 2: Agriculture and Nutrition Act ---S. 3042: Agriculture Improvement Act Review of the Coordinated Framework for Biotechnology Products

Stop the Importation and Trafficking of Synthetic Analogues Act of 2017 (H.R. 2851/S. 1327); The Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now Act (i.e., the "SCREEN Act")(H.R. 5228); Opioid Crisis Response Act of 2018 (S. 2680); Expanding Access to Low Cost Generic Drugs Act (S. 2476); Preserve Access to Affordable Generics Act (S. 124); Regulatory exclusivity; Improving Access To Affordable Prescription Drugs Act (S. 771/H.R. 1776); Legislation on drug labeling; Comprehensive Addiction Resources Emergency Act (CARE Act)(S. 2700/HR 5545); SOUND Disposal and Packaging Act (HR 5687); Biologics patent settlements; Long-Term Opioid Efficacy Act of 2018 (HR 5811); SAFETY Act of 2018 (H.R. 5803); Insulin pricing; H.R. 5752, the Stop Illicit Drug Importation Act of 2018; proposed legislation regarding tableting and encapsulating opioid products; Drug Importation; Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act (HR 5247/S. 204; CREATES Act (HR 2212/S. 974)

Client expense: Not reported · Firm income: $290,000

S. 974/H.R. 2212, the Creating and Restoring Equal Access to Equivalent Samples Act of 2017, provisions relating to the provision of brand drug products by brand manufacturers to generic manufacturers for development testing, and for shared Risk Evaluation and Mitigation (REMS) programs for brand and generic pharmaceuticals; S. 2476, the Expanding Access to Low Cost Generics Act, provisions relating to pharmaceutical market blockages caused by "parked" Hatch-Waxman 180 day exclusivity periods; Federal policy relating to the Trump Administration's Fiscal Year 2019 Budget proposal to address pharmaceutical market blockages caused by parked Hatch-Waxman 180 day exclusivity periods; S. 124, the Preserve Access to Affordable Generics Act, provisions relating to pharmaceutical patent settlements between generic and brand drug manufacturers; and Federal policy relating to the impact of rebates on the development of the biosimilars market.

Client expense: $160,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 2051-Fair Access for Safe and Timely Generics Act of 2017; H.R. 2212 & S. 974, the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act. S. 2476-Expanding Access to Low Cost Generic Drugs Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Federal policy related to Section 603, Applying the Medicaid additional rebate requirement to generics, of Public Law No 114-67, the Bipartisan Budget Act of 2015; and S. 2476, the Expanding Access to Low Cost Generics Act, provisions relating to pharmaceutical market blockages caused by "parked" Hatch-Waxman 180 day exclusivity periods.

Client expense: $500,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Federal policy related to Section 603, Applying the Medicaid additional rebate requirement to generics, of Public Law No 114-67, the Bipartisan Budget Act of 2015; and S. 2476, the Expanding Access to Low Cost Generics Act, provisions relating to pharmaceutical market blockages caused by "parked" Hatch-Waxman 180 day exclusivity periods.

Client expense: $160,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 2051-Fair Access for Safe and Timely Generics Act of 2017; H.R. 2212 & S. 974, the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act. S. 2476-Expanding Access to Low Cost Generic Drugs Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018 (H.R. 5247); Stop the Importation and Trafficking of Synthetic Analogues Act of 2017 (H.R. 2851/S. 1327); Fair Access for Safe and Timely (FAST) Generics Act (H.R. 2051) and CREATES Act (H.R. 2212/S. 974); Synthetic Drug Control Act of 2017 (H.R. 1732); Modernizing Drug Enforcement Act of 2018 (H.R. 5298) The Ensuring Patient Access to Substance Use Disorder Treatments Act of 2018 (H.R. 5202); The Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now Act (i.e., the "SCREEN Act")(H.R. 5228); Opioid Crisis Response Act of 2018; House opioids legislation discussion drafts on FDA Long-term Efficacy, FDA Misuse/Abuse, FDA Packaging and Disposal, FDA Accelerated Approval and Breakthrough Therapy Status, and FDA and International Mail; Drug importation; Expanding Access to Low Cost Generic Drugs Act (S. 2476); Preserve Access to Affordable Generics Act (S. 124); 180-day exclusivity; Over-the-Counter Drug Safety, Innovation, and Reform Act (S. 2315); Improving Access To Affordable Prescription Drugs Act (S. 771/H.R. 1776); Legislation on drug labeling.

Client expense: Not reported · Firm income: $310,000

S. 771/HR 1776-Improving access to affordable Prescription Drugs act, S 2157-Drug Price transparency in Communications Act, S 2011/HR 4138-Medicare drug price negotiation act of 2017, S 1688-Empowering medicare seniors to negotiate drug prices of 2017, S 252-Medicare drug savings act of 2017, S 1369/HR 2974-Stop Price gouging act, S 124-Preserve access to affordable generics act, S 974/HR 2212-CREATES Act of 2017, S 495-Medical Innovation and Prize Fund Act, S 1131/HR 2439-FAIR drug pricing act, Over-the-counter Monograph Safety, Innovation, and Reform Act of 2018, HR 4117-Competitive DRUGS Act of 2017), HR 2051- FAST Generics Act of 2017), Prescription drug pricing, PACED Act, S 771/HR 1776 (Improving access to affordable prescription drugs act, S 1509/HR 1223 OPEN Act), S 1309-Stronger patents act, HR 5150 Protecting Medicare from excessive price increases act, S 2476-Expanding access to low cost generics act, S 637 (c-thru act), S 1348-SPIKE act,

Client expense: $60,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Labor, Dept of (DOL), SENATE, Securities & Exchange Commission (SEC), U.S. Trade Representative (USTR)