Fair Access for Safe and Timely Generics Act of 2014

FDA proposed rule, Supplemental Applications Proposing Labeling Changes For Approved Drugs And Biological Products, Docket Number FDA-2013-N-0500, provisions relating to generic drug labeling changes; Federal policy relating to issues affecting the generic drug industry within the House Energy and Commerce Committee's 21st Century Cures initiative; Federal policy relating to International Nonproprietary Names for Biosimilars; HR 5657, the Fair Access for Safe and Effective Generics Act, provisions relating to the provision of brand drug products by brand manufacturers to generic manufacturers for development testing; HR 5748/S 2948, the Medicaid Generic Drug Fairness Act, provisions relating to Medicaid rebates for generic pharmaceuticals; Federal policy relating to the use of generic drugs in the Medicare Part D program; Federal policy relating to the implementation of the Biologic Price Competition and Innovation Act, Title VII, Subtitle A, of Public Law 111-148, the Patient Protection and Affordable Care Act; and HR 3116, the MODDERN Cures Act, provisions relating to the exclusivity term for dormant therapies

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 3742, Antibiotic Development to Advance Patient Treatment Act: Provisions related to antibiotics and drug approval H.R. 4709, Ensuring Patient Access and Effective Drug Enforcement Act: Provisions related to the Controlled Substances Act, Drug Enforcement Agency (DEA) regulation and related issues (a reintroduced version of H.R. 4069) H.R. 4299, Improving Regulatory Transparency for New Medical Therapies Act: Provisions related to DEA scheduling H.R. 5214, To require the Secretary of Health and Human Services to provide for recommendations for the development and use of clinical data registries for the improvement of patient care H.R. 5657, Fair Access for Safe and Timely (FAST) Generics Act: Provisions related to Risk Evaluation and Mitigation Strategies (REMS) H.R. 5805, Andrea Sloan Compassionate Use Reform and Enhancement Act: Provisions related to expanded access and compassionate use S. 1723, No ObamaCare Kickbacks Act of 2013: Provisions related to application of the anti-kickback statute to qualified health plans S. 2295, Patient Safety and Generic Labeling Improvement Act: Provisions related to drug safety labeling (112th Congress) S. 2917, Adding Ebola to the FDA Priority Review Voucher Program: Provisions related to new proposed voucher program; Public Law No. 113-233 Implementation issues related to the Food and Drug Administration Safety and Innovation Act (Public Law 112-144), including user fee reauthorization and FDA reform Implementation issues related to the Drug Quality and Security Act (Public Law 113-54), including pharmacy compounding and supply chain issues Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Branded Prescription Drug Fee policy issues (79 Fed. Reg. 43631 (July 28, 2014)) 21st Century Cures legislation and policy issues R&D tax credit renewal as part of H.R. 5771, Tax Increase Prevention Act of 2014 Draft legislation relating to prescription drug coverage issues Issues related to value and cost of prescription drugs Issues related to user fee reauthorization and FDA reform Patient savings program policy issues Comparative effectiveness policy issues Academic detailing policy issues General HHS, NIH, and FDA related advocacy Biopharmaceutical innovation policy issues Prescription drug abuse policy issues FDA expedited drug approval policy issues Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products [Docket No. FDA-2013-N-0500]: Patient labeling Issues relating to communications about prescription drugs 340B program policy issues Importation policy issues Clinical trial policy issues

Public Law No. 112-144, the "Food and Drug Administration Safety and Innovation Act," specifically those sections relating to the implementation of the Prescription Drug User Fee program. Public Law No. 111-148, the "Patient Protection and Affordable Care Act," including policy and implementation issues. Public Law No. 110-85, the "Food and Drug Administration Amendments Act," including current policy issues relating to FDA's Risk Evaluation and Mitigation Strategy authority. H.R. 5657, the "Fair Access for Safe and Timely Generics Act." H.R. 3230, the "Veterans' Access to Care through Choice, Accountability and Transparency Act." H.R. 3116, the "Modernizing Our Drug and Diagnostics Evaluation and Regulatory Network Cures Act." Policy issues relating to orphan drugs and medicines for rare diseases.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

FDA proposed rule, Supplemental Applications Proposing Labeling Changes For Approved Drugs And Biological Products, Docket Number FDA-2013-N-0500, provisions relating to generic drug labeling changes; Proposed FDA rule, "Electronic Distribution of Prescribing Information for Human Prescription Drugs Including Biological Products," RIN: 0910-AG18, provisions relating to the use of electronic package inserts for human pharmaceuticals and biologics; Implementation of Biosimilars in the Affordable Care Act (ACA), Biosimilar Naming, Implementation of FDASIA and Generic Drug User Fee Act; H.R. 4437, The Generic Drug Pricing Transparency Act, Generic drug pricing issues, Medicare Part D program and Generic Drugs; H.R. 5657, the Fair Access for Safe and Timely Generics Act of 2014 (FAST Generics Act) PEPFAR program supply chain management

Client expense: $250,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues relating to prescription drugs in health care bills; orphan drug and rare disease bill; Cancer Drug Coverage Parity Act of 2013 (H.R. 1801); Patients' Access to Treatment of 2013 (H.R. 460); MODDERN Cures Act (H.R. 3116); H.R. 5657, the FAST Generics Act of 2014; tax extenders package; 21st Century Cures; H.R. 5780, the Protecting the Integrity of Medicare Act.

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

Implementation of FDASIA and GDUFA, Drug Shortages, Labeling of Generic Drugs, Risk Evaluation and Mitigation Strategies, Biosimilars Naming, Electronic Labeling for Pharmaceuticals, Generic Drugs Savings, H.R. 5657 Fair Access for Safe and Timely Generics Act, H.R. 3116 MODDERN Cures Act, H.R. 2985 Combination Drug Development Incentive Act, H.R. 4437 Generic Drug Pricing Fairness Act, Issues Regarding Market Exclusivity

Client expense: $700,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office

H.R. 3742, Antibiotic Development to Advance Patient Treatment Act: Provisions related to antibiotics and drug approval H.R. 4709, Ensuring Patient Access and Effective Drug Enforcement Act: Provisions related to the Controlled Substances Act, Drug Enforcement Agency (DEA) regulation and related issues (a reintroduced version of H.R. 4069) H.R. 4299, Improving Regulatory Transparency for New Medical Therapies Act: Provisions related to DEA scheduling H.R. 5214, To require the Secretary of Health and Human Services to provide for recommendations for the development and use of clinical data registries for the improvement of patient care H.R. 5657, Fair Access for Safe and Timely (FAST) Generics Act: Provisions related to DEA scheduling S. 1723, No ObamaCare Kickbacks Act of 2013: Provisions related to application of the anti-kickback statute to qualified health plans S. 2295, Patient Safety and Generic Labeling Improvement Act: Provisions relating to drug safety labeling (112th Congress) Implementation issues related to the Food and Drug Administration Safety and Innovation Act (Public Law 112-144), including user fee reauthorization and FDA reform Implementation issues related to the Drug Quality and Security Act (Public Law 113-54), including pharmacy compounding and supply chain issues Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including PPACA; Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking 21st Century Cures legislation and policy issues Draft legislation relating to prescription drug coverage issues Issues related to value and cost of prescription drugs Issues related to user fee reauthorization and FDA reform Patient savings program policy issues Comparative effectiveness policy issues Academic detailing policy issues General HHS, NIH, and FDA related advocacy Biopharmaceutical innovation policy issues Prescription drug abuse policy issues FDA accelerated approval policy issues Unapproved use policy issues 340B policy issues Importation policy issues Clinical trial policy issues

REMS proposals, including Stivers-Welch (H.R. 5657); MODDERN Cures Act (H.R. 3116); oral parity (H.R. 1801); specialty tier/cost sharing (H.R. 460); proposed orphan drug policies; other issues related to dormant therapies, including proposed legislation to expand incentives

Client expense: $498,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

Implementation of Affordable Care Act as it relates to a regulatory pathway for biosimilars. Legislative efforts to help accelerate the discovery, development and delivery of promising new treatments to patients (21st Century Cures). Education about the value of innovative new medicines.H.R. 5657: Fair Access for Safe and Timely Generics Act of 2014.

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

Government targets: HOUSE OF REPRESENTATIVES

Issues relating to prescription drugs in health care bills; Issues related to coding of products; orphan drug and rare disease bill; Family Cord Blood Banking Act; Cancer Drug Coverage Parity Act of 2013 (H.R. 1801); Patients' Access to Treatment Act of 2013 (H.R. 460); MODDERN Cures Act of 2013 (H.R. 3116); Veterans access legislation (H.R. 3230/H.R. 4810); The America Invents Act; H.R. 5657, the FAST Generics Act of 2014.

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

FDA proposed rule,Supplemental Applications Proposing Labeling Changes For Approved Drugs And Biological Products, Docket Number FDA-2013-N-0500, provisions relating to generic drug labeling changes; HR 5657, the Fair Acess for Safe and Timely Generics Act of 2014, provisions relating to the provision of brand drug products by brand manufacturers to generic manufacturers for development testing; Federal policy relating to issues affecting the generic drug industry within the House Energy and Commerce Committee's 21st Century Cures initiative; Federal policy relating to International Nonroprietary Names for Biosimilars; and, Implementation of Public Law 112-144 - The Food and Drug Administration Safety and Innovation Act, federal policy relating to provisions in Title 3 regarding generic drug user fees.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Public Law No. 112-144, the "Food and Drug Administration Safety and Innovation Act," specifically those sections relating to the implementation of the Prescription Drug User Fee program. Public Law No. 111-148, the "Patient Protection and Affordable Care Act," including policy and implementation issues. Public Law No. 110-85, the "Food and Drug Administration Amendments Act," including current policy issues relating to FDA's Risk Evaluation and Mitigation Strategy authority. H.R. 5657, the "Fair Access for Safe and Timely Generics Act." H.R. 3230, the "Veterans' Access to Care through Choice, Accountability and Transparency Act." H.R. 3116, the "Modernizing Our Drug and Diagnostics Evaluation and Regulatory Network Cures Act." Policy issues relating to orphan drugs and medicines for rare diseases.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE