pharmacoepidemiology and drug safety 2014; 23: 109–110

Published online in Wiley Online Library (wileyonlinelibrary.com) DOI: 10.1002/pds.3525

LETTER TO THE EDITOR

RE: Drug risk assessment and data reuse To the Editor We welcome FDA’s view on this complex topic. The purpose-driven approach proposed by Hammad et al.1 is conceptually very similar to the framework delineated by the committee.2 Both note that all FDA-requested Mini-Sentinel analyses should be carried out for a reason and that Mini-Sentinel is just one of the several streams of evidence the Agency uses when making regulatory decisions. The committee adopted a classification system described by the FDA, which categorizes surveillance activities into signal generation, signal refinement, and signal evaluation.3 Hammad et al. suggest that signal generation and signal refinement may have to be grouped in certain situations; their suggestion is consistent with the committee’s recommendation that both activities may use a similar approach. The dynamic nature of evidence does not preclude the need for understanding the strength of evidence at the time of a Mini-Sentinel analysis. Although the committee does not provide operational definitions of the strength of the evidence, it recommends that the classification should be based on information from other sources available to FDA at the time of analysis. The committee deliberated at the FDA’s request on the issues around data re-use from a scientific point of view. It is obviously at the FDA’s discretion to decide whether and how to use the information provided by the committee from a regulatory point of view. The Agency should be able to operationalize the framework to the extent that it can distinguish among signal generation, signal refinement, and signal evaluation. CONFLICT OF INTEREST The authors declare no conflict of interest. ACKNOWLEDGEMENTS The Mini-Sentinel program is funded by the U.S. Food and Drug Administration through the Department of Health and Human Services Contract number HHSF223200910006I. Copyright © 2013 John Wiley & Sons, Ltd.

REFERENCES 1. Hammad T, Shoaibi A, Levenson M, et al. Drug risk assessment and data reuse. Pharmacoepidemiol Drug Saf 2013. In press. 2. Toh S, Avorn J, D’Agostino RB, Sr., et al. Re-using Mini-Sentinel data following rapid assessments of potential safety signals via modular analytic programs. Pharmacoepidemiol Drug Saf 2013. DOI: 10.1002/pds.3478 3. Robb MA, Racoosin JA, Sherman RE, et al. The US Food and Drug Administration’s Sentinel Initiative: expanding the horizons of medical product safety. Pharmacoepidemiol Drug Saf 2012; 21 Suppl 1: 9–11.

SENGWEE TOH1 JERRY AVORN2 RALPH B. D'AGOSTINO, SR.3 JERRY H. GURWITZ4,5 BRUCE M. PSATY6,7 KENNETH J. ROTHMAN2,8,9 KENNETH G. SAAG10 MIRIAM CJM STURKENBOOM11 JAN P. VANDENBROUCKE12 ALMUT G. WINTERSTEIN13,14 BRIAN L. STROM15* 1

Department of Population Medicine Harvard Medical School and Harvard Pilgrim Health Care Institute Boston, MA, USA 2 Division of Pharmacoepidemiology and Pharmacoeconomics Brigham and Women's Hospital and Harvard Medical School Boston, MA, USA 3 Department of Mathematics and Statistics Boston University Boston, MA, USA 4 Division of Geriatric Medicine University of Massachusetts Medical School Worcester, MA, USA 5 Meyers Primary Care Institute Worcester, MA, USA 6 Cardiovascular Health Research Unit, Departments of Medicine, Epidemiology, and Health Services, University of Washington Seattle, WA, USA 7 Group Health Research Institute Seattle, WA, USA 8 RTI Health Solutions, RTI International Research Triangle Park, NC, USA

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letter to the editor 9

Department of Epidemiology Boston University School of Public Health Boston, MA, USA 10 Division of Clinical Immunology and Rheumatology The University of Alabama at Birmingham Birmingham, AL, USA 11 Departments of Epidemiology and Medical Informatics Erasmus University Medical Center Rotterdam, The Netherlands 12 Department of Clinical Epidemiology Leiden University Medical School Leiden, The Netherlands 13 Department of Pharmaceutical Outcomes and Policy, College of Pharmacy University of Florida Gainesville, FL, USA

Copyright © 2013 John Wiley & Sons, Ltd.

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Department of Epidemiology, College of Public Health and Health Professions and College of Medicine University of Florida Gainesville, FL, USA 15 Center for Clinical Epidemiology and Biostatistics and Department of Biostatistics and Epidemiology, Center for Pharmacoepidemiology Research and Training, Perelman School of Medicine University of Pennsylvania Philadelphia, PA, USA *B. L. Strom, 237 John Morgan Building 3620 Hamilton Walk, Philadelphia, PA 19104, USA E-mail: [email protected]

Pharmacoepidemiology and Drug Safety, 2014; 23: 109–110 DOI: 10.1002/pds

RE: Drug risk assessment and data reuse.

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