FAST Generics Act of 2015

Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Drug Importation. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). S.2615: Increasing Competition in Pharmaceuticals Act. Pharmaceutical exclusivity. H.R.4931: Pharmaceutical Stewardship Act of 2016. H.R.953: Comprehensive Addiction and Recovery Act of 2015 (CARA). S.3056: CREATES Act of 2016.

Client expense: $570,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Drug Importation. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). S.2615: Increasing Competition in Pharmaceuticals Act. Pharmaceutical exclusivity. H.R.4931: Pharmaceutical Stewardship Act of 2016. H.R.953: Comprehensive Addiction and Recovery Act of 2015 (CARA). S.3056: CREATES Act of 2016.

Client expense: $800,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)

Implementation of FDASIA and GDUFA,Labeling of Generic Drugs, Biosimilars Naming, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products, Innovation for Healthier Americans Initiative, Prescription Drug Cost,H.R. 2841 FAST Generics Act,The Bipartisan Budget Act of 2015, Drug Importation, Risk Evaluation and Mitigation Strategies(REMS),Biologics Price Competition and Innovation Act (BPCIA), Pharmaceutical exclusivity

Client expense: $540,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

Issues related to epinephrine auto-injectors pricing Prescription drug pricing, Generic Drugs HR 6, 21st Century Cures Act; Innovation for Healthier Americans Initiative; Issues regarding market exclusivity Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, S. 3056 CREATES Act, H.R. 2841 FAST generics Act

Client expense: $455,000 · Firm income: Not reported

Government targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Program Support Center, SENATE

Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Drug Importation. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). S.2615: Increasing Competition in Pharmaceuticals Act. Pharmaceutical exclusivity. H.R.4931: Pharmaceutical Stewardship Act of 2016. H.R.953: Comprehensive Addiction and Recovery Act of 2015 (CARA). S.3056: CREATES Act of 2016.

Client expense: $569,598 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

Provisions of PL 111-148 and PL 111-152 impacting Medicare Part D such as formulary requirements, PBM disclosure provisions, implementation of the prescriber registration rules and definition of negotiated price. Regulatory design and coverage of pharmacy benefits in health reform exchanges and the commercial market (essential health benefits, grandfathering, e-prescribing, PBM disclosure requirements, specialty pharmacy, mail-service pharmacy, formulary transparency, and medical loss ratio). Regulatory and proposed legislative changes to Medicare part D including non-interference, pharmacy networks, classes of clinical concern, mail-service pharmacy, EGWP waivers, MTM expansion, long term care pharmacy, recovery audit contractors. Implementation of changes to the definition of Average Manufacturer Price in Medicaid Issues related to the management of Medicaid prescription drug benefits Legislation to promote generic drugs. Issues related to prescription drug abuse in Medicare. H.R.2: Medicare Access and CHIP Reauthorization Act of 2015 - provisions related to the expansion of availability of Medicare data H.R.244: The MAC Transparency Act H.R.793/S1190: The Ensuring Seniors Access to Local Pharmacies Act H.R.1021: The Protecting the Integrity of Medicare Act H.R.1600: The Patient Access to Treatments Act Provisions related to the 21st Century Cures Initiative (Energy and Commerce) and Innovations for Healthier Americans (HELP Committee). Issues related to the affordability of prescription drugs and competitive marketplace, including: pedigree, FDA user fees, manufacturer market and data exclusivity, REMS, biosimilars. H.R.804: The Access to Medicare Data Act H.R.2298: The Medicare Drug Abuse Prevention Act H.R.6: 21st Century Cures Act S.2700: The FDA and NIH Workforce Authorization Modernization Act - Provisions related to biologic drugs H.R.2841: The FAST Generics Act S.3056: The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2016 H.R. 4784/S.2651: The Increasing Competition in Pharmaceuticals Act H.R. 5573/S.3094 The Price Relief, Innovation, and Competition for Essential Drugs Act or the PRICED Act

Client expense: $755,506 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), General Services Administration (GSA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), SENATE

Issues related to implementation of the Generic Drug User Fee Agreement; Issues related to H.R. 6, 21st Century Cures Initiative and Innovation for Healthier Americans Initiative; Issues related to epinephrine auto injector pricing; Issues related to generic drug pricing; REMs program, H.R. 2841 FAST Generics Act and S.3056 CREATES Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: Combination Product Regulatory Fairness Act of 2016 - Provisions related to improvements in the regulation of combination drug-device products S. 1878: Advancing Hope Act of 2016 - Provisions related to pediatric cancer and other pediatric diseases S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act - Provisions related to priority review vouchers S. 2615: Increasing Competition in Pharmaceuticals Act - Provisions related to FDA review of generic drugs and study on risk evaluation and mitigation strategies (REMS) program S. 2689: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments S. 2700: FDA and NIH Workforce Modernization Act - Provisions related to FDA and NIH S. 2912: Trickett Wendler Right to Try Act of 2016 - A bill to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes - Provisions related to use of unapproved medical products by patients with a terminal illness S. 3056: CREATES Act of 2016 - Provisions related to access to samples of prescription drugs S. 3239: RACE for Children Act - Provisions related to pediatric studies S. 3335: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act - Provisions relating to transparency H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 1270 - Restoring Access to Medication and Improving Health Savings Act of 2016 - FSA and HSA use for over the counter medication H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 or FAST Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing H.R. 3012: Right to Try Act of 2015 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 3250 - DXM Abuse Prevention Act of 2015 - age requirement for purchase of OTC medication including dextromethorphan Monograph reform H.R. 4762: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments H.R. 4784: Lower Drug Costs Through Competition Act - Provisions related to generic drugs and priority review vouchers; REMS study; and tropical disease product applications H.R. 5122: A bill to prohibit further action on the proposed rule regarding testing of Medicare Part B prescription drug models H.R. 5858: The RACE for Children Act - Provisions related to pediatric studies H.R. 6043: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act of 2016 - Provisions related to transparency H.R. 6174: Closing Loopholes for Orphan Drugs Act - Provisions relating to 340B discounts on orphan drugs Kids Innovative Drugs Act (draft) - Incentives for the development of pediatric oncology drugs The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) - Incentives for the development of pediatric drugs Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation and other issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges 340B Drug Discount Program policy issues General FDA advocacy including sharing of truthful and non-misleading information about medicines with healthcare professionals Prescription Drug User Fee Act (PDUFA) reauthorization Biosimilar User Fee Act (BsUFA) reauthorization Biologics Price Competition and Innovation Act (BPCIA) implementation issues Biopharmaceutical and medical innovation policy issues Drug development ecosystem policy issues Drug cost and pricing policy issues Expedited drug approval policy issues Compassionate use policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Transparency policy issues NIH Funding policy issues Precision Medicine Initiative Biomarker policy issues Policy issues related to prescription drug abuse and secure disposal Drug compounding policy issues Prescription drug importation policy issues Cancer Moonshot Prescription drug take back policy issues Clinical trial policy issues Pediatric cancer policy issues Cancer drug vial size policy issues House Republican Health Proposal (A Better Way) Expanded access policy issues

Client expense: $492,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR)

S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 2615: Increasing Competition in Pharmaceuticals Act - Provisions related to FDA review of generic drugs and study on risk evaluation and mitigation strategies (REMS) program S. 2680: Mental Health Reform Act of 2016 - Provisions related to mental health issues S. 2689: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments S. 2700: FDA and NIH Workforce Modernization Act - Provisions related to FDA and NIH S. 2912: Trickett Wendler Right to Try Act of 2016 - A bill to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes - Provisions related to use of unapproved medical products by patients with a terminal illness S. 3056: CREATES Act of 2016 - Provisions related to access to samples of prescription drugs S. 3335: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act - Provisions relating to transparency H.R. 6 / H.R. 34: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2805: Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 - Provisions related to the treatment of heroin and prescription opioid abuse H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 or FAST Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing H.R. 3012: Right to Try Act of 2015 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 3381: Childhood Cancer STAR Act - Provisions related to expanded access and other issues H.R. 4762: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments H.R. 4784: Lower Drug Costs Through Competition Act - Provisions related to generic drugs and priority review vouchers; REMS study; and tropical disease product applications H.R. 5122: A bill to prohibit further action on the proposed rule regarding testing of Medicare Part B prescription drug models H.R. 5858: The RACE for Children Act - Provisions related to pediatric studies H.R. 6043: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act of 2016 - Provisions related to transparency H.R. 6174: Closing Loopholes for Orphan Drugs Act - Provisions relating to 340B discounts on orphan drugs Kids Innovative Drugs Act (draft) - Incentives for the development of pediatric oncology drugs The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) - Incentives for the development of pediatric drugs Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation and other issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges 340B Drug Discount Program policy issues General FDA advocacy including sharing of truthful and non-misleading information about medicines with healthcare professionals Prescription Drug User Fee Act (PDUFA) reauthorization Biosimilar User Fee Act (BsUFA) reauthorization Biologics Price Competition and Innovation Act (BPCIA) implementation issues Biopharmaceutical and medical innovation policy issues Drug development ecosystem policy issues Drug cost and pricing policy issues Expedited drug approval policy issues Compassionate use policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Transparency policy issues NIH Funding policy issues Precision Medicine Initiative Biomarker policy issues Policy issues related to prescription drug abuse and secure disposal Drug compounding policy issues Prescription drug importation policy issues Cancer Moonshot Prescription drug take back policy issues Clinical trial policy issues Pediatric cancer policy issues Cancer drug vial size policy issues House Republican Health Proposal (A Better Way) Expanded access policy issues

Client expense: $4,990,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

Issues related to epinephrine auto-injectors pricing Prescription drug pricing, Generic Drugs HR 6, 21st Century Cures Act; Innovation for Healthier Americans Initiative; Issues regarding market exclusivity Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, S. 3056 CREATES Act, H.R. 2841 FAST generics Act

Client expense: $315,000 · Firm income: Not reported

Government targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Program Support Center, SENATE

Policy and implementation issues relating to Public Law No. 111-148, the Patient Protection and Affordable Care Act. Policy and implementation issues relating to Public Law No. 112-144, the Food and Drug Administration Safety and Innovation Act, specifically those sections relating to the Prescription Drug User Fee program. Current policy issues relating to Public Law No. 110-85, the Food and Drug Administration Amendments Act, specifically FDA's Risk Evaluation and Mitigation Strategy authority. Policy issues relating to orphan drugs, dormant therapies and medicines for rare diseases; patient cost-sharing for specialty medicines; and step therapy. H.R. 34, the 21st Century Cures Act. H.R. 1078, the Food and Drug Administration Safety Over Sequestration Act. H.R. 2841, the Fair Access for Safe and Timely Generics Act. H.R. 1600, the Patients Access to Treatments Act. H.R. 2739, the Cancer Drug Coverage Parity Act. S. 1566, the Cancer Drug Coverage Parity Act. H.R. 3982, the Family Cord Blood Banking Act.

Client expense: Not reported · Firm income: $40,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Implementation of Food and Drug Administration Safety and Innovation Act (PL 112-144); Drug safety issues; Prescription drug abuse; H.R. 6, 21st Century Cures Act; H.R. 2841, FAST Generics Act; Senate HELP Committee's Innovation Working Group

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 2841, "FAST Generic Act of 2015", regarding risk evaluation and mitigation strategy. HR 2739/S 1566, "Cancer Drug Coverage Parity Act", regarding all provisions. HR 1600, "Patients Access To Treatments Act", regarding all provisions. S 3056, "CREATES Act of 2016", provisions regarding REMS. Issues related to Medicare Part D/Part B, the Affordable Care Act, Regulation of Non-Biological Complex Drugs, TRICARE, & Step Therapy/Fail First.

Client expense: $510,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 2841-Fair Access to Safe and Timely (FAST) Generics Act; S.3056-The CREATES Act; HR 34-21st Century Cures Act

Client expense: Not reported · Firm income: $40,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

General FDA issues; S 1566/HR 2739 Cancer Drug Coverage Parity Act; S 3056 CREATES Act; HR 2841 FAST Generics Act. 21st Century Cures legislation (HR6/HR 34)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

-Issues relating to bioequivalence and related administrative procedures. -Issues relating to prescription drug abuse. -Issues relating to the labeling of generic drugs. -House 21st Century CURES legislation (including Senate companion bill(s)) -S. 524 the Comprehensive Addiction and Recovery Act and related legislation H.R. 4641. - H.R.2841 - FAST Generics Act / S.3056 - CREATES Act of 2016 concerning REMS

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Legislation relating to the provision of brand drug products by brand manufacturers to generic manufacturers for development testing, including: H.R. 2841, The FAST Generics Act of 2015; S. 3056, the CREATES Act; H.R. 34, 21st Century Cures Act; and House Energy & Commerce Committee/Senate Health, Education, Labor and Pensions Committee draft legislative proposal.

Client expense: $380,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). Pharmaceutical exclusivity. S.3056: CREATES Act of 2016. H.R.6: 21st Century Cures Act.

Client expense: $947,004 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE

Policy matters related to generic pharmaceuticals and biosimilars including naming, labeling, access and interchangeability and changes to the Risk Evaluation and Mitigation Strategies (REMS) program, H.R.2841, FAST Generics Act of 2015 and S.3056, The CREATES Act, access to samples for generic testing, including S.3455, the Pharmaceutical Supply and Value Enhancement (SAVE) Act. The 21st Century Cures Act included in H. R. 2028, Further Continuing and Security Assistance Appropriations Act for Fiscal Year 2017. Affordability and pricing of pharmaceuticals. Issues related to drug takeback and opioid addiction. H. R. 4931, The Pharmaceutical Stewardship Act of 2016 and S.2977, The Budgeting for Opioid Addiction Treatment Act.

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

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office

General education about the pharmacy benefit manager/pharmacy industry. Issues related to H.R. 6, The 21st Century Cures Act. Affordability and pricing of pharmaceuticals. S.3455 the CREATES Act and H.R. 2841 the FAST Generics Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.__/H.R.__ (Fairness in Nursing Home Arbitration Act); draft legislation not formally introduced as of 1-01-2017; relating to the use of arbitration agreements to resolve disputes involving nursing home cases and nursing home contracts. Lobbying with regard to CMS rulemaking on mandatory pre-dispute arbitration in nursing home residency contracts. Lobbying with regard to the Consumer Financial Protection Bureau rulemaking on forced arbitration. Lobbying with regard to the Education Department Rulemaking on forced arbitration. General lobbying with regard to the Federal Communications Commission and forced arbitration. S. 1122/H.R. 2079 (Court Legal Access and Student Support (CLASS) Act of 2015); makes procedures for the enforcement of arbitration agreements inapplicable to an enrollment agreement between a student and an institution of higher education (IHE). H.R. 2087/S. 1133 (Arbitration Fairness Act); prohibits mandatory, pre-dispute arbitration in consumer contracts. General lobbying with regard to the enforceability of mandatory, pre-dispute arbitration provisions in employment and consumer contracts, including financial consumer contracts and servicemember contracts for consumer products. General lobbying with regard to the ability of consumers and injured parties to bring class actions, including limitations on the ability to bring class actions involving the securities industry. S. 3491/H.R. 6423 (Justice for Victims of Fraud Act of 2016); amends the Truth in Lending Act and the Electronic Fund Transfer Act to prohibit pre-dispute arbitration agreements with consumers (i.e., agreements to arbitrate any future disputes between parties instead of pursuing the claims in court) from being valid or enforceable in disputes related to credit card accounts or personal bank accounts that are not subject to a final judgment by a court if the credit card or bank account was not issued in response to a request or application for that account. General lobbying with regard to the regulation of pre-dispute arbitration by the Federal Communications Commission. General lobbying on consumer protection provisions related to servicemember contracts for consumer products. S.__/H.R.__ (Civil Legal Access to Strong Safeguards); draft legislation not formally introduced as of 1-01-2017; amends the Class Action Fairness Act to ensure that consumers and injured parties in a class action are treated fairly and equally. General Lobbying with regard to the preemption of states causes of action involving medical device and drug manufacturers. General lobbying with regard to asbestos exposure and related health and environmental issues. S. 357/H.R. 526 (Furthering Asbestos Claim Transparency Act); amends Title 11 of the United States Code to require the public disclosure by trusts established under Section 524(g) of such Title, of quarterly reports that contain detailed information regarding the receipt and disposition of claims for injuries based on exposure to asbestos, and the filing of such reports with the Executive Office for United States Trustees. H.R. 1199 (Innocent Sellers Fairness Act); prevents undue disruption of interstate commerce by limiting civil actions brought against persons whose only role with regard to a product in the stream of commerce is as a lawful seller of the product. General lobbying with regard to alternative litigation funding. H.R. 54 (Frank Lautenberg Memorial Secure Chemical Facilities Act)/S. 697 (Frank R. Lautenberg Chemical Safety for the 21st Century Act)/S.725 (Alan Reinstein and Trevor Schaefer Toxic Chemical Protection Act); amends the Toxic Substances Control Act to reauthorize and modernize that Act, and for other purposes. H.R. 2576 (TSCA Modernization Act); provides for the safe and efficient flow of chemicals in interstate and foreign commerce; specific interest in provisions that would preempt state-based causes of action. Lobbying with regard to draft legislation related to PCB exposure and liability. General lobbying with regard to pesticide regulations. General lobbying with regard to the ongoing development of a proposed TAFT-TTIP trade agreement, specific interest in effect the trade agreement would have on state-based causes of action. General lobbying with regard to warranties of Energy Star-rated products and ability of consumers to bring a class action against manufacturers of Energy Star-rated products. H.R. 504/S. 1038 (Energy Star Program Integrity Act); clarifies that no express or implied warranty is provided by reason of a disclosure relating to voluntary participation in the Energy Star program. H.R. 2030/S. 700 (READ Act); amends the Asbestos Information Act of 1988 to establish a public database of asbestos-containing products, to require public disclosure of information pertaining to the manufacture, processing, distribution, and use of asbestos-containing products in the United States. Lobbying with regard to updating generic drug labeling rulemaking and responsibilities. H.R. 2841 (FAST Generics Act of 2015); amends the Federal Food, Drug, and Cosmetic Act to prohibit the license holder of a Food and Drug Administration (FDA)-approved drug or biological product from restricting availability of the medication for testing by a product developer seeking to develop a drug, generic drug, or biosimilar, including restricting availability with a risk evaluation and mitigation strategy (REMS). S. 3056 (Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2016); provides for certain causes of action relating to delays of generic drugs and biosimilar biological products. Lobbying with regard to biosimilar naming and labeling. General lobbying with regard to off-label promotion of pharmaceutical products. H.R. 3304 (Foreign Manufacturers Legal Accountability Act of 2015); Requires foreign manufacturers of products imported into the US to establish registered agents in the United States who are authorized to accept service of process against such manufacturers. S. 2506 (Restoring Statutory Rights and Interests of the States Act of 2016); amends the Federal Arbitration Act to invalidate arbitration agreements between parties in certain commercial contracts or transactions if they require arbitration of a claim for damages or injunctive relief brought by an individual or small business arising from the alleged violation of a federal or state statute, the U.S. Constitution, or a state constitution, unless the written agreement to arbitrate is entered into by both parties after the claim has arisen and pertains solely to an existing claim. S. 1014 (Personal Care Products Safety Act); amends the Federal Food, Drug, and Cosmetic Act to require cosmetics companies to register their facilities with the Food and Drug Administration (FDA) and to submit to the FDA cosmetic ingredient statements that include the amounts of a cosmetic's ingredients. H.R. 4075 (Cosmetic Modernization Amendments of 2016); amends the Federal Food, Drug, and Cosmetic Act to establish new procedures and requirements for the registration of cosmetic manufacturing establishments, the submission of cosmetic and ingredient statements, and the reporting of serious cosmetic adverse events. H.R. 1195 (Bureau of Consumer Financial Protection Advisory Boards Act); amends the Consumer Financial Protection Act of 2010 to establish advisory boards. General lobbying regarding altering CFPB's operational structure and rulemaking authority. H.R. 1486 (Taking Account of Bureaucrats Spending Act of 2015 (TABS Act); amends the Consumer Financial Protection Act of 2010 to bring the Bureau of Consumer Financial Protection into the regular appropriations process. H.R. 5983 (Financial CHOICE Act of 2016); repealing provisions of the Dodd-Frank Act.

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

Government targets: Consumer Financial Protection Bureau (CFPB), Education, Dept of, Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), Office of the Vice President of the United States, SENATE

H.R.5194 - 114th Congress (2015-2016)Safe Drug Disposal Tax Credit Act of 2016 H.R. 2841 the FAST Generics Act of 2015. S.3056: CREATES Act of 2016.

Client expense: $380,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

S.2041/HR 5182 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs Part B Demo Regrow Act IPAB Generic Drug Labeling H.R.4784 Lower Drug Costs through Competition Act S.2615 Increasing Competition in Pharmaceuticals Act Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information

Client expense: $890,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office

S.2615: Increasing Competition in Pharmaceuticals Act, support increasing generic availability. H.R.6/P.L. 114-252: The 21st Century Cures Act and Senate companions, ensuring no new barriers to generic and biosimilar market entry. Generic Drug User Fee Act Reauthorization, support increasing generic availability. H.R.1600: The Patients' Access to Treatment Act, educating on the importance of step therapy to ensuring optimal therapy access and cost control. H.R.2841: the FAST Generics Act. S.3056: the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act. Drug pricing in general. H.R.6043 and S.3335, "Fair Accountability and Innovative Research Drug Pricing Act of 2016".

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 2841, "FAST Generic Act of 2015", regarding risk evaluation and mitigation strategy. HR 2739/S 1566, "Cancer Drug Coverage Parity Act", regarding all provisions. HR 1600, "Patients Access To Treatments Act", regarding all provisions. S 3056, "CREATES Act of 2016", provisions regarding REMS. Issues related to Medicare Part D/Part B, the Affordable Care Act, Regulation of Non-Biological Complex Drugs, TRICARE, & Step Therapy/Fail First.

Client expense: $740,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 2841, "FAST Generic Act of 2015", regarding risk evaluation and mitigation strategy. HR 2739/S 1566, "Cancer Drug Coverage Parity Act", regarding all provisions. HR 1600, "Patients Access To Treatments Act", regarding all provisions. S 3056, "CREATES Act of 2016", provisions regarding REMS. Issues related to Medicare Part D/Part B, the Affordable Care Act, Regulation of Non-Biological Complex Drugs, TRICARE, & Step Therapy/Fail First.

Client expense: $820,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Drug Importation. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). S.2615: Increasing Competition in Pharmaceuticals Act. Pharmaceutical exclusivity. H.R.4931: Pharmaceutical Stewardship Act of 2016. H.R.953: Comprehensive Addiction and Recovery Act of 2015 (CARA). S.3056: CREATES Act of 2016.

Client expense: $569,598 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 524: Comprehensive Addiction and Recovery Act of 2016 - Provisions related to opioids S. 1077: Advancing Breakthrough Devices for Patients Act of 2016 - Issues related to the biopharmaceutical industry S. 1597: Patient-Focused Impact Assessment Act of 2016 - Provisions related to patient-focused drug development S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: Combination Product Regulatory Fairness Act of 2016 - Provisions related to improvements in the regulation of combination drug-device products S. 1878: Advancing Hope Act of 2016 - Provisions related to pediatric cancer and other pediatric diseases S.2055: Medical Countermeasure Innovation Act of 2015 S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act - Provisions related to priority review vouchers S. 2615: Increasing Competition in Pharmaceuticals Act - Provisions related to FDA review of generic drugs and study on risk evaluation and mitigation strategies (REMS) program S. 2680: Mental Health Reform Act of 2016 - Provisions related to mental health issues S. 2689: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments S. 2700: FDA and NIH Workforce Modernization Act - Provisions related to FDA and NIH S. 2912: Trickett Wendler Right to Try Act of 2016 - A bill to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes - Provisions related to use of unapproved medical products by patients with a terminal illness S. 3056: CREATES Act of 2016 - Provisions related to access to samples of prescription drugs S. 3239: RACE for Children Act - Provisions related to pediatric studies S. 3335: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act - Provisions relating to transparency H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1538: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on medical research H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2805: Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 - Provisions related to the treatment of heroin and prescription opioid abuse H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 or FAST Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing H.R. 3012: Right to Try Act of 2015 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 3250: DXM Abuse Prevention Act of 2015 H.R. 3299: The Strengthening Public Health Emergency Response Act of 2015 H.R. 3381: Childhood Cancer STAR Act - Provisions related to expanded access and other issues H.R. 4762: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments H.R. 4784: Lower Drug Costs Through Competition Act - Provisions related to generic drugs and priority review vouchers; REMS study; and tropical disease product applications H.R. 5046: Comprehensive Opioid Abuse Reduction Act of 2016 - Provisions related to opioids H.R. 5122: A bill to prohibit further action on the proposed rule regarding testing of Medicare Part B prescription drug models H.R. 5858: The RACE for Children Act - Provisions related to pediatric studies H.R. 6043: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act of 2016 - Provisions related to transparency H.R. 6174: Closing Loopholes for Orphan Drugs Act - Provisions relating to 340B discounts on orphan drugs Other: - Kids Innovative Drugs Act (draft) - Incentives for the development of pediatric oncology drugs - The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments - Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development - Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) - Incentives for the development of pediatric drugs - Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues - Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures - Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy - Proposed HRSA 340B program mega-guidance - Provisions related to 340B program - Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges - 340B Drug Discount Program policy issues - General FDA advocacy including sharing of truthful and non-misleading information about medicines with healthcare professionals - Prescription Drug User Fee Act (PDUFA) reauthorization - Biosimilar User Fee Act (BsUFA) reauthorization - Biologics Price Competition and Innovation Act (BPCIA) implementation issues - Biopharmaceutical and medical innovation policy issues - Drug development ecosystem policy issues - Drug cost and pricing policy issues - Expedited drug approval policy issues - Compassionate use policy issues - Biosimilar approval and reimbursement policy issues - Transparency policy issues - NIH Funding policy issues - Precision Medicine Initiative - Biomarker policy issues - Policy issues related to prescription drug abuse and secure disposal - Drug compounding policy issues - Prescription drug importation policy issues - Cancer Moonshot - Prescription drug take back policy issues - Clinical trial policy issues - Pediatric cancer policy issues - Cancer drug vial size policy issues - House Republican Health Proposal (A Better Way) - OTC Monograph Reform - Expanded access policy issues - Patient assistance program policy issues

Client expense: $640,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), Vice President of the U.S.

-Issues relating to bioequivalence and related administrative procedures. -Issues relating to prescription drug abuse. -Issues relating to the labeling of generic drugs. -House 21st Century CURES legislation (including Senate companion bill(s)) -S. 524 the Comprehensive Addiction and Recovery Act and related legislation H.R. 4641. - H.R.2841 - FAST Generics Act / S.3056 - CREATES Act of 2016 concerning REMS

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Biosimilar Naming, Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Act (GDUFA), PL 112-144 Prescription drug pricing, Medicare Part D program and Generic Drugs HR 6, 21st Century Cures Act; Innovation for Healthier Americans Initiative; Issues regarding market exclusivity Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, S. 3056 CREATES Act, H.R. 2841 FAST generics Act S. 1972 Airline Access to Emergency Epinephrine Act of 2015, Anaphylaxis awareness, access to epinephrine auto injector; federal building anaphylaxis policy S. 2615 Increasing Competition in Pharmaceuticals Act, H.R. 4784 Lower Drug Costs through Competition Act, generic medicines pricing issues The Comprehensive Addiction and Recovery Act (CARA) S.524/H.R.953, the Addiction Prevention and Responsible Opioid Practices Act S.3075, Budgeting for CARA

Client expense: $285,000 · Firm income: Not reported

Government targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Program Support Center, SENATE, U.S. Trade Representative (USTR), White House Office

Issues related to epinephrine auto-injectors pricing Biosimilar Naming, Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Act (GDUFA), PL 112-144 Prescription drug pricing, Medicare Part D program and Generic Drugs HR 6, 21st Century Cures Act; Innovation for Healthier Americans Initiative; Issues regarding market exclusivity Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, S. 3056 CREATES Act, H.R. 2841 FAST generics Act S. 2615 Increasing Competition in Pharmaceuticals Act, H.R. 4784 Lower Drug Costs through Competition Act, generic medicines pricing issues The Comprehensive Addiction and Recovery Act (CARA) S.524/H.R.953, the Addiction Prevention and Responsible Opioid Practices Act S.3075, Budgeting for CARA

Client expense: $345,000 · Firm income: Not reported

Government targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Program Support Center, SENATE, U.S. Trade Representative (USTR), White House Office

S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2016 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 524: Comprehensive Addiction and Recovery Act of 2016 - Provisions related to opioids S. 800: Enhancing the Stature and Visibility of Medical Rehabilitation Research at the NIH Act - Issues related to the biopharmaceutical industry S. 849: Advancing Research for Neurological Diseases Act of 2016 - Provisions related to research on neurological diseases S. 1077: Advancing Breakthrough Devices for Patients Act of 2016 - Issues related to the biopharmaceutical industry S. 1101: Medical Electronic Data Technology Enhancement for Consumers' Health Act - Provisions related to regulation of software S. 1455: Recovery Enhancement for Addiction Treatment Act - Provisions related to opioids S. 1597: Patient-Focused Impact Assessment Act of 2016 - Provisions related to patient-focused drug development S. 1622: FDA Device Accountability Act of 2016 - Issues related to the biopharmaceutical industry S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: Combination Product Regulatory Fairness Act of 2016 - Provisions related to improvements in the regulation of combination drug-device products S. 1878: Advancing Hope Act of 2016 - Provisions related to pediatric cancer and other pediatric diseases S. 2014: Next Generation Researchers Act - Provisions related to NIH promoting new research. S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2016 - Provisions related to rare disease treatment S. 2055: Medical Countermeasure Innovation Act of 2016 - Provisions related to priority review vouchers S. 2256: Co-Prescribing Saves Lives Act of 2015 - Provisions related to co-prescribing of opioids and reversal agents S. 2388: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2015 - Provisions related to reciprocity of drug approvals S. 2511: Improving Health Information Technology Act - Provisions related to health information technology (HIT) S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act - Provisions related to priority review vouchers S. 2615: Increasing Competition in Pharmaceuticals Act - Provisions related to FDA review of generic drugs and study on risk evaluation and mitigation strategies (REMS) program S. 2624: National Biomedical Research Act - Provisions related to mandatory funding for NIH and FDA S. 2680: Mental Health Reform Act of 2016 - Provisions related to mental health issues S. 2689: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments S. 2700: FDA and NIH Workforce Modernization Act - Provisions related to FDA and NIH S. 2713: Advancing Precision Medicine Act of 2016 - Provisions related to data sharing and security S. 2742: Promoting Biomedical Research and Public Health for Patients Act - Issues related to the biopharmaceutical industry S. 2912: A bill to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes - Provisions related to use of unapproved medical products by patients with a terminal illness S. 3056: CREATES Act of 2016 - Provisions related to access to samples of prescription drugs H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1538: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on medical research H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2805: Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 - Provisions related to the treatment of heroin and prescription opioid abuse H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing H.R. 3012: Right to Try Act of 2015 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 3250: DXM Abuse Prevention Act of 2015 - Issues related to prescription drug abuse H.R. 3381: Childhood Cancer STAR Act - Provisions related to expanded access and other issues H.R. 4762: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments H.R. 4784: Lower Drug Costs Through Competition Act - Provisions related to generic drugs and priority review vouchers; REMS study; and tropical disease product applications H.R. 5046: Comprehensive Opioid Abuse Reduction Act of 2016 - Provisions related to opioids H.R. 5127: Curb Opioid Abuse By Advancing Technology Act of 2016 - Provisions related to opioids Kids Innovative Drugs Act (draft) The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Drug Supply Chain Security Act policy issues Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges 340B Drug Discount Program policy issues General FDA advocacy including sharing of truthful and non-misleading information about medicines with healthcare professionals Prescription Drug User Fee Act (PDUFA) negotiation and reauthorization Biologics Price Competition and Innovation Act (BPCIA) implementation issues Biopharmaceutical and medical innovation policy issues Drug development ecosystem policy issues Drug cost and pricing policy issues Expedited drug approval policy issues Compassionate use policy issues Biosimilar approval and reimbursement policy issues Transparency policy issues NIH Funding policy issues Precision Medicine Initiative Biomarker policy issues Policy issues related to prescription drug abuse and secure disposal Drug compounding policy issues Prescription drug importation policy issues Cancer Moonshot Prescription drug take back policy issues Clinical trial policy issues Pediatric cancer policy issues Cancer drug vial size policy issues House Republican Health Proposal (A Better Way)

Client expense: $4,550,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Natl Security Council (NSC), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

Implementation of Food and Drug Administration Safety and Innovation Act (PL 112-144); Drug safety issues; Prescription drug abuse; H.R. 6, 21st Century Cures Act; H.R. 2841, FAST Generics Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

General FDA issues; S 1566/HR 2739 Cancer Drug Coverage Parity Act; S 3056 CREATES Act; HR 2841 FAST Generics Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.__/H.R.__ (Fairness in Nursing Home Arbitration Act); draft legislation not formally introduced as of 10-01-2016; relating to the use of arbitration agreements to resolve disputes involving nursing home cases and nursing home contracts. Lobbying with regard to CMS rulemaking on mandatory pre-dispute arbitration in nursing home residency contracts. Lobbying with regard to the Consumer Financial Protection Bureau rulemaking on forced arbitration. Lobbying with regard to the Education Department Rulemaking on forced arbitration. General lobbying with regard to the Federal Communications Commission and forced arbitration. S. 1122/H.R. 2079 (Court Legal Access and Student Support (CLASS) Act of 2015); makes procedures for the enforcement of arbitration agreements inapplicable to an enrollment agreement between a student and an institution of higher education (IHE). H.R. 2087/S. 1133 (Arbitration Fairness Act); prohibits mandatory, pre-dispute arbitration in consumer contracts. General lobbying with regard to the enforceability of mandatory, pre-dispute arbitration provisions in employment and consumer contracts, including financial consumer contracts and servicemember contracts for consumer products. General lobbying with regard to the ability of consumers and injured parties to bring class actions, including limitations on the ability to bring class actions involving the securities industry. General lobbying on consumer protection provisions related to servicemember contracts for consumer products. S.__/H.R.__ (Civil Legal Access to Strong Safeguards); draft legislation not formally introduced as of 10-01-2016; amends the Class Action Fairness Act to ensure that consumers and injured parties in a class action are treated fairly and equally. General Lobbying with regard to the preemption of states causes of action involving medical device and drug manufacturers. General lobbying with regard to asbestos exposure and related health and environmental issues. S. 357/H.R. 526 (Furthering Asbestos Claim Transparency Act); amends Title 11 of the United States Code to require the public disclosure by trusts established under Section 524(g) of such Title, of quarterly reports that contain detailed information regarding the receipt and disposition of claims for injuries based on exposure to asbestos, and the filing of such reports with the Executive Office for United States Trustees. H.R. 1199 (Innocent Sellers Fairness Act); prevents undue disruption of interstate commerce by limiting civil actions brought against persons whose only role with regard to a product in the stream of commerce is as a lawful seller of the product. General lobbying with regard to alternative litigation funding. H.R. 54 (Frank Lautenberg Memorial Secure Chemical Facilities Act)/S. 697 (Frank R. Lautenberg Chemical Safety for the 21st Century Act)/S.725 (Alan Reinstein and Trevor Schaefer Toxic Chemical Protection Act); amends the Toxic Substances Control Act to reauthorize and modernize that Act, and for other purposes. H.R. 2576 (TSCA Modernization Act); provides for the safe and efficient flow of chemicals in interstate and foreign commerce; specific interest in provisions that would preempt state-based causes of action. Lobbying with regard to draft legislation related to PCB exposure and liability. General lobbying with regard to pesticide regulations. General lobbying with regard to the ongoing development of a proposed TAFT-TTIP trade agreement, specific interest in effect the trade agreement would have on state-based causes of action. General lobbying with regard to warranties of Energy Star-rated products and ability of consumers to bring a class action against manufacturers of Energy Star-rated products. H.R. 504/S. 1038 (Energy Star Program Integrity Act); clarifies that no express or implied warranty is provided by reason of a disclosure relating to voluntary participation in the Energy Star program. H.R. 2030/S. 700 (READ Act); amends the Asbestos Information Act of 1988 to establish a public database of asbestos-containing products, to require public disclosure of information pertaining to the manufacture, processing, distribution, and use of asbestos-containing products in the United States. Lobbying with regard to updating generic drug labeling rulemaking and responsibilities. H.R. 2841 (FAST Generics Act of 2015); amends the Federal Food, Drug, and Cosmetic Act to prohibit the license holder of a Food and Drug Administration (FDA)-approved drug or biological product from restricting availability of the medication for testing by a product developer seeking to develop a drug, generic drug, or biosimilar, including restricting availability with a risk evaluation and mitigation strategy (REMS). S. 3056 (Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2016); provides for certain causes of action relating to delays of generic drugs and biosimilar biological products. Lobbying with regard to biosimilar naming and labeling. H.R. 3304 (Foreign Manufacturers Legal Accountability Act of 2015); Requires foreign manufacturers of products imported into the US to establish registered agents in the United States who are authorized to accept service of process against such manufacturers. S. 2506 (Restoring Statutory Rights and Interests of the States Act of 2016); amends the Federal Arbitration Act to invalidate arbitration agreements between parties in certain commercial contracts or transactions if they require arbitration of a claim for damages or injunctive relief brought by an individual or small business arising from the alleged violation of a federal or state statute, the U.S. Constitution, or a state constitution, unless the written agreement to arbitrate is entered into by both parties after the claim has arisen and pertains solely to an existing claim. S. 1014 (Personal Care Products Safety Act); amends the Federal Food, Drug, and Cosmetic Act to require cosmetics companies to register their facilities with the Food and Drug Administration (FDA) and to submit to the FDA cosmetic ingredient statements that include the amounts of a cosmetic's ingredients. H.R. 4075 (Cosmetic Modernization Amendments of 2016); amends the Federal Food, Drug, and Cosmetic Act to establish new procedures and requirements for the registration of cosmetic manufacturing establishments, the submission of cosmetic and ingredient statements, and the reporting of serious cosmetic adverse events. H.R. 1195 (Bureau of Consumer Financial Protection Advisory Boards Act); amends the Consumer Financial Protection Act of 2010 to establish advisory boards. General lobbying regarding altering CFPB's operational structure and rulemaking authority. H.R. 1486 (Taking Account of Bureaucrats Spending Act of 2015 (TABS Act); amends the Consumer Financial Protection Act of 2010 to bring the Bureau of Consumer Financial Protection into the regular appropriations process. H.R. 5983 (Financial CHOICE Act of 2016); repealing provisions of the Dodd-Frank Act.

Client expense: $1,750,000 · Firm income: Not reported

Government targets: Education, Dept of, Executive Office of the President (EOP), Federal Communications Commission (FCC), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), Office of the Vice President of the United States, SENATE

Policy and implementation issues relating to Public Law No. 111-148, the Patient Protection and Affordable Care Act. Policy and implementation issues relating to Public Law No. 112-144, the Food and Drug Administration Safety and Innovation Act, specifically those sections relating to the Prescription Drug User Fee program. Current policy issues relating to Public Law No. 110-85, the Food and Drug Administration Amendments Act, specifically FDA's Risk Evaluation and Mitigation Strategy authority. Policy issues relating to orphan drugs, dormant therapies and medicines for rare diseases; patient cost-sharing for specialty medicines; and step therapy. H.R. 6, the 21st Century Cures Act. H.R. 1078, the Food and Drug Administration Safety Over Sequestration Act. H.R. 2841, the Fair Access for Safe and Timely Generics Act. H.R. 1600, the Patients Access to Treatments Act. H.R. 2739, the Cancer Drug Coverage Parity Act. S. 1566, the Cancer Drug Coverage Parity Act. H.R. 3982, the Family Cord Blood Banking Act.

Client expense: Not reported · Firm income: $40,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.2041/HR 5182 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs Part B Demo Regrow Act IPAB Generic Drug Labeling H.R.4784 Lower Drug Costs through Competition Act S.2615 Increasing Competition in Pharmaceuticals Act Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information

Client expense: $1,460,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office

S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 524: Comprehensive Addiction and Recovery Act of 2016 - Provisions related to opioids S. 1077: Advancing Breakthrough Devices for Patients Act of 2016 - Issues related to the biopharmaceutical industry S. 1597: Patient-Focused Impact Assessment Act of 2016 - Provisions related to patient-focused drug development S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: Combination Product Regulatory Fairness Act of 2016 - Provisions related to improvements in the regulation of combination drug-device products S. 1878: Advancing Hope Act of 2016 - Provisions related to pediatric cancer and other pediatric diseases S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act - Provisions related to priority review vouchers S. 2615: Increasing Competition in Pharmaceuticals Act - Provisions related to FDA review of generic drugs and study on risk evaluation and mitigation strategies (REMS) program S. 2680: Mental Health Reform Act of 2016 - Provisions related to mental health issues S. 2689: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments S. 2700: FDA and NIH Workforce Modernization Act - Provisions related to FDA and NIH S. 2912: Trickett Wendler Right to Try Act of 2016 - A bill to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes - Provisions related to use of unapproved medical products by patients with a terminal illness S. 3056: CREATES Act of 2016 - Provisions related to access to samples of prescription drugs S. 3239: RACE for Children Act - Provisions related to pediatric studies S. 3335: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act - Provisions relating to transparency H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1538: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on medical research H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2805: Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 - Provisions related to the treatment of heroin and prescription opioid abuse H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 or FAST Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing H.R. 3012: Right to Try Act of 2015 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 3381: Childhood Cancer STAR Act - Provisions related to expanded access and other issues H.R. 4762: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments H.R. 4784: Lower Drug Costs Through Competition Act - Provisions related to generic drugs and priority review vouchers; REMS study; and tropical disease product applications H.R. 5046: Comprehensive Opioid Abuse Reduction Act of 2016 - Provisions related to opioids H.R. 5122: A bill to prohibit further action on the proposed rule regarding testing of Medicare Part B prescription drug models H.R. 5858: The RACE for Children Act - Provisions related to pediatric studies H.R. 6043: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act of 2016 - Provisions related to transparency H.R. 6174: Closing Loopholes for Orphan Drugs Act - Provisions relating to 340B discounts on orphan drugs Kids Innovative Drugs Act (draft) - Incentives for the development of pediatric oncology drugs The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) - Incentives for the development of pediatric drugs Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges 340B Drug Discount Program policy issues General FDA advocacy including sharing of truthful and non-misleading information about medicines with healthcare professionals Prescription Drug User Fee Act (PDUFA) reauthorization Biosimilar User Fee Act (BsUFA) reauthorization Biologics Price Competition and Innovation Act (BPCIA) implementation issues Biopharmaceutical and medical innovation policy issues Drug development ecosystem policy issues Drug cost and pricing policy issues Expedited drug approval policy issues Compassionate use policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Transparency policy issues NIH Funding policy issues Precision Medicine Initiative Biomarker policy issues Policy issues related to prescription drug abuse and secure disposal Drug compounding policy issues Prescription drug importation policy issues Cancer Moonshot Prescription drug take back policy issues Clinical trial policy issues Pediatric cancer policy issues Cancer drug vial size policy issues House Republican Health Proposal (A Better Way) Expanded access policy issues

Client expense: $4,130,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

H.R. 2841-Fair Access to Safe and Timely (FAST) Generics Act; S.3056-The CREATES Act

Client expense: Not reported · Firm income: $40,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 2841, "FAST Generic Act of 2015", regarding risk evaluation and mitigation strategy. HR 2739/S 1566, "Cancer Drug Coverage Parity Act", regarding all provisions. HR 1600, "Patients Access To Treatments Act", regarding all provisions. S 3056, "CREATES Act of 2016", provisions regarding REMS. Issues related to Medicare Part D/Part B, the Affordable Care Act, Regulation of Non-Biological Complex Drugs, TRICARE, & Step Therapy/Fail First.

Client expense: $570,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to implementation of the Generic Drug User Fee Agreement; Issues related to H.R. 6, 21st Century Cures Initiative and Senate HELP Innovation Initiative; Issues related to epinephrine auto injectors; FDA proposed rule, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products; FDA proposed rule, Electronic Distribution of Prescribing Information for Human Prescription Drugs Including Biological Products; Issues related to generic drug pricing; Access to epinephrine auto injectors on air carriers, H.R. 4441, Aviation Innovation, Reform, and Reauthorization Act of 2016, and S. 2658, Federal Aviation Administration Reauthorization Act of 2016; REMs program, H.R. 2841 FAST Generics Act and S.3056 CREATES Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Policy matters related to generic pharmaceuticals and biosimilars including naming, labeling, access and interchangeability and changes to the Risk Evaluation and Mitigation Strategies (REMS) program, H.R.2841, FAST Generics Act of 2015 and S.3056, The CREATES Act, access to samples for generic testing, including S.3455, the Pharmaceutical Supply and Value Enhancement (SAVE) Act. H. R. 6, 21st Century Cures Act and the Senate Health, Education, Labor and Pensions Committee Initiative for Healthier Americans. Affordability and pricing of pharmaceuticals. Issues related to drug takeback and opioid addiction, including S.524 and H.R. 953, The Comprehensive Addiction and Recovery Act of 2016. H. R. 4931, The Pharmaceutical Stewardship Act of 2016 and S.2977, The Budgeting for Opioid Addiction Treatment Act.

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

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

H.R. 2841, The FAST Generics Act of 2015, provisions relating to the provision of brand drug products by brand manufacturers to generic manufacturers for development testing; S. 3056, the CREATES Act, provisions relating to the provision of brand drug products by brand manufacturers to generic manufacturers for development testing; and Federal policy relating to the approval of pending abbreviated new drug applications for generic versions of Crestor

Client expense: $220,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.524: Comprehensive Addiction and Recovery Act, focused on Prescription Drug Management Plans (PDMPs), Medicare lock-ins, partial fills and co-prescribing. S.480/H.R.1725: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015, educating on the importance of PDMPs and the need for federal funding. HR.4981: The Opioid Use Disorder Treatment Expansion and Modernization Act. H.R.4599/S.2578: Reducing Unused Medications Act of 2016. H.R.3680: Co-Prescribing to Reduce Overdoses Act of 2016. S.2256: Co-Prescribing Saves Lives Act of 2016. S.1945: Senate HELP mental health reform package, Mental Health Reform Act of 2016, mental health parity treatment of step therapy and prior-authorization. S.2615: Increasing Competition in Pharmaceuticals Act, support increasing generic availability. H.R.6: The 21st Century Cures Act and Senate companions, ensuring no new barriers to generic and biosimilar market entry. Generic Drug User Fee Act Reauthorization, support increasing generic availability. H.R.1600: The Patients' Access to Treatment Act, educating on the importance of step therapy to ensuring optimal therapy access and cost control. H.R.2841: the FAST Generics Act. S.3056: the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act. S.2700: Workforce Authorities Modernization Act, Section 11, Biological Product Innovation - treatment of USP compendia in approving biologics and biosimilars. Role of PBMs in Mylan pricing before Congressional hearings/investigation of Mylan. Drug pricing in general. H.R.6043 and S.3335, "Fair Accountability and Innovative Research Drug Pricing Act of 2016".

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE