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  • Book
    Charles Bennett, Courtney Lubaczewski, Bartlett Witherspoon, editors.
    Summary: This book offers a wide-ranging description and analysis of recent developments and current trends in health policy with regard to cancer drug safety. The book opens with an overview of pharmacovigilance for cancer blockbuster drugs, covering both general considerations and efforts to develop a structured framework for the identification and reporting of adverse drug reactions (ADRs). A number of important examples of serious ADRs to hematology and oncology drugs are then reviewed, with evaluation of the lessons learned and the policy implications of the ensuing legal cases and their settlements. Further, the difficulty of reporting such blockbuster side effects in the medical literature is explored in an empirical study. Significant advances have been achieved in analytic methods for the identification of ADRs, and here there is a particular focus on the value of optimal discriminant analysis. Finally, the impacts on pharmacovigilance and drug safety of the huge fines paid under the U.S. False Claims Act relating to the defrauding of governmental programs also receive careful attention these fines are playing an important role in changing the landscape for pharmaceutical safety.

    Editors and Contributors
    1 Fluoroquinolone-Associated Disability and Other Fluoroquinolone-Associated Serious Adverse Events: Unexpected Toxicities Have Emerged in Recent Years
    1.1 Introduction
    1.1.1 FQ Adverse Event Drug Label Warnings
    1.1.2 FQ Drug Label Changes (See Table 1.1 for Levofloxacin Label Changes)
    1.1.3 FDA Reports of FQ Adverse Events
    1.1.4 November 5, 2015, FDA Advisory Committee Meeting Identifies FQAD
    1.1.5 November 5, 2015, FDA Advisory Committee Votes
    1.1.6 Boxwell FDA FQ Data Compared with Social Media FQ Reports 1.1.7 Gender
    1.1.8 Specific FQs
    1.1.9 Duration of FQAD
    1.1.10 FQAD: Reasons for Which FQ was Prescribed
    1.1.11 FQAD Specific Events
    1.1.12 Possible Mechanism of FQ Toxicities
    1.1.13 Another Possible Pathophysiologic Mechanism: Matrix Metalloproteinase Toxicity
    1.1.14 FQ-Associated Peripheral Neuropathy
    1.1.15 Levaquin Clinical Trials Completed Prior to FDA Approval in 1997
    1.1.16 2001 FDA FQ Review
    1.1.17 2003 FDA FQ Review
    1.1.18 2008 FDA Pediatric Levofloxacin Review
    1.1.19 2010 Pfizer Report
    1.1.20 2011 Levaquin Postmarketing Review 1.1.21 2013 FDA Review
    1.1.22 2014-Present Media Reports Regarding FQs
    1.1.23 2014 FDA Advisory Committee Comments
    1.1.24 2014 FDA Dear Healthcare Professional Letters
    1.1.25 2014 Citizen Petition
    1.1.26 2014 Meeting with U.S. Senate Health Committee
    1.1.27 2015 Meeting with FDA
    1.1.28 2015 FQ Case Studies
    1.1.29 2015 FDA Advisory Committee Meeting
    1.1.30 2015 FDA Listening Session
    1.1.31 2016 FQ Neuropsychiatric Study
    1.1.32 2016 FQ Label Updates
    1.1.33 2016 FDA Response to Citizen Petition
    1.1.34 2018 FQ Nature Article
    1.1.35 2019 Citizen Petition 1.1.36 2019 FQ Neuropsychiatric Toxicity Study
    1.2 Discussion
    1.3 Conclusions
    1.3.1 Recommendations
    1.3.2 Significance of This FQ Study
    1.4 REMS Request
    2 Biosimilar Epoetin in the United States: A View from the Southern Network on Adverse Reactions
    2.1 Introduction
    2.1.1 Regulatory Approval for Epoetin Biosimilar in the United States
    2.1.2 Chemistry, Manufacturing, and Controls
    2.1.3 Biological Activity
    2.1.4 Pharmacology/Toxicology
    2.1.5 Immunogenicity
    2.1.6 Clinical Pharmacology
    2.1.7 Clinical Efficacy and Safety 2.1.8 Risk Evaluation and Mitigations Strategy (REMS)
    2.1.9 Extrapolation
    2.1.10 Findings of the Oncology Drug Advisory Committee (ODAC) of the FDA
    2.1.11 Patents and Litigation
    2.1.12 Naming and Labeling
    2.1.13 Interchangeability
    2.1.14 Substitution
    2.1.15 Pharmacovigilance and Immunogenicity
    2.1.16 Lessons from the European Union (EU) Countries
    2.1.17 Lessons from Japan
    2.2 Conclusions
    3 Policing of Drug Safety Information Dissemination Under the False Claims Act
    3.1 Introduction
    3.1.1 The Settlement
    Digital Access Springer 2022