Enhancing Regulatory Decision Making for Postmarket Drug Safety

References

• Ahuja V, Chou CH (2016) Novel therapeutics for diabetes: Uptake, usage trends, and comparative effectiveness. Current Diabetes Rep. 16(6):47.Crossref, Google Scholar
• Ahuja V, Sohn MW, Birge JR, Syverson C, Budiman-Mak E, Emanuele N, Cooper JM, Huang ES (2015) Geographic variation in rosiglitazone use surrounding FDA warnings in the Department of Veterans Affairs. J. Managed Care Specialty Pharmacy 21(12):1214–1234.Crossref, Google Scholar
• Alagoz O, Maillart LM, Schaefer AJ, Roberts MS (2007) Determining the acceptance of cadaveric livers using an implicit model of the waiting list. Oper. Res. 55(1):24–36.Link, Google Scholar
• Appleby J, Krantz M (2004) Merck estimates $2.5B impact from pulling Vioxx plug. USA Today (September 30), http://usatoday30.usatoday.com/money/industries/health/drugs/2004-09-30-merck-cover_x.htm.Google Scholar
• Austin PC (2011) An introduction to propensity score methods for reducing the effects of confounding in observational studies. Multivariate Behav. Res. 46(3):399–424.Crossref, Google Scholar
• Ball G, Siemsen E, Shah R (2017) Do plant inspections predict future quality? The role of investigator experience. Manufacturing Service Oper. Management 19(4):534–550.Link, Google Scholar
• Beach JE, Faich GA, Bormel FG, Sasinowski FJ (1998) Black box warnings in prescription drug labeling: Results of a survey of 206 drugs. Food Drug Law J. 53(3):403–411.Google Scholar
• Bjarnadóttir MV, Czerwinski D (2013) Active vaccine and drug surveillance. Operations Research and Healthcare Policy (Springer, New York), 251–279.Crossref, Google Scholar
• Bolen S, Feldman L, Vassy J, Wilson L, Yeh HC, Marinopoulos S, Wiley C, et al. (2007) Systematic review: Comparative effectiveness and safety of oral medications for type 2 diabetes mellitus. Ann. Internal Medicine 147(6):386–399.Crossref, Google Scholar
• Brass EP (2013) Assessing the benefit-risk for new drugs: Are the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee and the Division of Metabolism and Endocrinology Products in sync? Diabetes Care 36(7):1823–1826.Crossref, Google Scholar
• Centers for Disease Control and Prevention (2013) Diabetes state burden toolkit. https://nccd.cdc.gov/Toolkit/DiabetesBurden/YLL/QALY.Google Scholar
• Dahabreh IJ (2008) Meta-analysis of rare events: An update and sensitivity analysis of cardiovascular events in randomized trials of rosiglitazone. Clinical Trials 5(2):116–120.Crossref, Google Scholar
• Deyo RA, Cherkin DC, Ciol MA (1992) Adapting a clinical comorbidity index for use with ICD-9-CM administrative databases. J. Clinical Epidemiology 45(6):613–619.Crossref, Google Scholar
• Diamond GA, Bax L, Kaul S (2007) Uncertain effects of rosiglitazone on the risk for myocardial infarction and cardiovascular death. Ann. Internal Medicine 147(8):578–581.Crossref, Google Scholar
• Edwards RI, Lindquist M (2016) Pharmacovigilance: Critique and Ways Forward (Springer, Cham, Switzerland).Google Scholar
• Fihn SD, Francis J, Clancy C, Nielson C, Nelson K, Rumsfeld J, Cullen T, Bates J, Graham GL (2014) Insights from advanced analytics at the Veterans Health Administration. Health Affairs 33(7):1203–1211.Crossref, Google Scholar
• Frank C, Himmelstein DU, Woolhandler S, Bor DH, Wolfe SM, Heymann O, Zallman L, Lasser KE (2014) Era of faster FDA drug approval has also seen increased black-box warnings and market withdrawals. Health Affairs 33(8):1453–1459.Crossref, Google Scholar
• Gatwood J, Chisholm-Burns M, Davis R, Thomas F, Potukuchi P, Hung A, Kovesdy CP (2018) Evidence of chronic kidney disease in veterans with incident diabetes mellitus. PLoS One 13(2):e0192712.Crossref, Google Scholar
• Goh J, Bjarnadóttir MV, Bayati M, Zenios SA (2015) Active postmarketing drug surveillance for multiple adverse events. Oper. Res. 63(6):1528–1546.Link, Google Scholar
• Gottlieb S, Dal Pan G (2019) The future of FDA’s electronic safety surveillance. Accessed January 9, 2019, https://www.fda.gov/NewsEvents/Newsroom/FDAVoices/ucm629326.htm.Google Scholar
• Hazell L, Shakir SAW (2006) Under-reporting of adverse drug reactions. Drug Safety 29(5):385–396.Crossref, Google Scholar
• Heckman JJ, Ichimura H, Todd P (1998) Matching as an econometric evaluation estimator. Rev. Econom. Stud. 65(2):261–294.Crossref, Google Scholar
• Ho DE, Imai K, King G, Stuart EA (2007) Matching as nonparametric preprocessing for reducing model dependence in parametric causal inference. Political Anal. 15(3):199–236.Crossref, Google Scholar
• Home PD, Pocock SJ, Beck-Nielsen H, Gomis R, Hanefeld M, Jones NP, Komajda M, McMurray JJV (2007) Rosiglitazone evaluated for cardiovascular outcomes—An interim analysis. New England J. Medicine 357(1):28–38.Crossref, Google Scholar
• Imai K, Kim IS, Wang E (2020) Matching methods for causal inference with time-series cross-section data. Working paper, Harvard University, Cambridge, MA.Google Scholar
• Kalaignanam K, Kushwaha T, Eilert M (2013) The impact of product recalls on future product reliability and future accidents: Evidence from the automobile industry. J. Marketing 77(2):41–57.Crossref, Google Scholar
• Kent DM, Hayward RA (2007) Limitations of applying summary results of clinical trials to individual patients: The need for risk stratification. JAMA 298(10):1209–1212.Crossref, Google Scholar
• Klein DF (2006) The flawed basis for FDA post-marketing safety decisions: The example of anti-depressants and children. Neuropsychopharmacology 31(4):689–699.Crossref, Google Scholar
• Klimberg R, Revelle C, Cohon J (1992) Improving the effectiveness of FDA drug inspection. Oper. Res. 40(5):845–855.Link, Google Scholar
• Kulldorff M, Davis RL, Kolczak M, Lewis E, Lieu T, Platt R (2011) A maximized sequential probability ratio test for drug and vaccine safety surveillance. Sequential Anal. 30(1):58–78.Crossref, Google Scholar
• Loke YK, Kwok CS, Singh S (2011) Comparative cardiovascular effects of thiazolidinediones: systematic review and meta-analysis of observational studies. British Medical J. 342:d1309.Crossref, Google Scholar
• Lu CY, Zhang F, Lakoma MD, Madden JM, Rusinak D, Penfold RB, Simon G, et al.. (2014) Changes in antidepressant use by young people and suicidal behavior after FDA warnings and media coverage: Quasi-experimental study. British Medical J. 348:g3596.Crossref, Google Scholar
• Mannucci E, Monami M, Di Bari M, Lamanna C, Gori F, Gensini GF, Marchionni N (2010) Cardiac safety profile of rosiglitazone: A comprehensive meta-analysis of randomized clinical trials. Internat. J. Cardiology 143(2):135–140.Crossref, Google Scholar
• Mukherjee UK, Sinha KK (2018) Product recall decisions in medical device supply chains: A big data analytic approach to evaluating judgment bias. Production Oper. Management 27(10):1816–1833.Crossref, Google Scholar
• Murphy S, Roberts R (2006) “Black box” 101: How the Food and Drug Administration evaluates, communicates, and manages drug benefit/risk. J. Allergy Clinical Immunology 117(1):34–39.Crossref, Google Scholar
• Rosenbaum PR (1987) Sensitivity analysis for certain permutation inferences in matched observational studies. Biometrika 74(1):13–26.Crossref, Google Scholar
• Rosenbaum PR, Rubin DB (1983) The central role of the propensity score in observational studies for causal effects. Biometrika 70(1):41–55.Crossref, Google Scholar
• Rosenbaum PR, Rubin DB (1985) Constructing a control group using multivariate matched sampling methods that incorporate the propensity score. Amer. Statist. 39(1):33–38.Crossref, Google Scholar
• Rosenstock J, Rood J, Cobitz A, Huang C, Garber A (2006) Improvement in glycaemic control with rosiglitazone/metformin fixed-dose combination therapy in patients with type 2 diabetes with very poor glycaemic control. Diabetes Obesity Metabolism 8(6):643–649.Crossref, Google Scholar
• Roumie CL, Greevy RA, Grijalva CG, Hung AM, Liu X, Murff HJ, Elasy TA, Griffin MR (2014) Association between intensification of metformin treatment with insulin vs sulfonylureas and cardiovascular events and all-cause mortality among patients with diabetes. JAMA 311(22):2288–2296.Crossref, Google Scholar
• Roumie CL, Hung AM, Greevy RA, Grijalva CG, Liu X, Murff HJ, Elasy TA, Griffin MR (2012) Comparative effectiveness of sulfonylurea and metformin monotherapy on cardiovascular events in type 2 diabetes mellitus: A cohort study. Ann. Internal Medicine 157(9):601–610.Crossref, Google Scholar
• Rubin DB (2005) Causal inference using potential outcomes: Design, modeling, decisions. J. Amer. Statist. Assoc. 100(469):322–331.Crossref, Google Scholar
• Schneeweiss S, Avorn J (2005) A review of uses of healthcare utilization databases for epidemiologic research on therapeutics. J. Clinical Epidemiology 58(4):323–337.Crossref, Google Scholar
• Shah R, Ball GP, Netessine S (2016) Plant operations and product recalls in the automotive industry: An empirical investigation. Management Sci. 63(8):2439–2459.Google Scholar
• Singh S, Loke YK (2012) Drug safety assessment in clinical trials: Methodological challenges and opportunities. Trials 13:138.Google Scholar
• Singh S, Loke YK, Furberg CD (2007) Long-term risk of cardiovascular events with rosiglitazone. JAMA 298(10):1189–1195.Crossref, Google Scholar
• Staats BR, Kc DS, Gino F (2017) Maintaining beliefs in the face of negative news: The moderating role of experience. Management Sci. 64(2):804–824.Link, Google Scholar
• Staton T (2015) GSK’s Avandia is free and clear at the FDA, 8 years after heart-safety controversy began. Fierce Pharma (December 27), https://www.fiercepharma.com/pharma/gsk-s-avandia-free-and-clear-at-fda-8-years-after-heart-safety-controversy-began.Google Scholar
• Stoto MA (2015) Drug safety meta-analysis: Promises and pitfalls. Drug Safety 38(3):233–243.Crossref, Google Scholar
• Terwiesch C, Olivares M, StaatsBR, Gaur V (2019) OM forum—A review of empirical operations management over the last two decades. Manufacturing Service Oper. Management 22(4):656–668.Link, Google Scholar
• Thirumalai S, Sinha KK (2011) Product recalls in the medical device industry: An empirical exploration of the sources and financial consequences. Management Sci. 57(2):376–392.Link, Google Scholar
• Tuttle KR, Bakris GL, Bilous RW, Chiang JL, De Boer IH, Goldstein-Fuchs J, Hirsch IB, et al.. (2014) Diabetic kidney disease: A report from an ADA consensus conference. Amer. J. Kidney Diseases 64(4):510–533.Crossref, Google Scholar
• U.S. Congress (2016) 21st Century Cures Act, H.R. 34, 114th Congress. Accessed July 17, 2020, https://www.congress.gov/bill/114th-congress/house-bill/34/text.Google Scholar
• U.S. Department of Veterans Affairs (2006) Adverse drug events, adverse drug reactions and medication errors. Accessed February 19, 2019, https://www.pbm.va.gov/PBM/vacenterformedicationsafety/tools/AdverseDrugReaction.pdf.Google Scholar
• U.S. Department of Veterans Affairs (2015) VA research on diabetes. Office of Research and Development, accessed December 18, 2020, https://www.research.va.gov/topics/diabetes.cfm.Google Scholar
• U.S. Department of Veterans Affairs (2016) VHA formulary management process. Accessed December 18, 2020, https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3291.Google Scholar
• U.S. Department of Veterans Affairs (2018) About Veterans Health Administration. Accessed September 28, 2018, http://www.va.gov/health/aboutVHA.asp.Google Scholar
• U.S. Food and Drug Administration (2005) Guidance for industry: Good pharmacovigilance practices and pharmacoepidemiologic assessment. Accessed July 14, 2019, https://www.fda.gov/media/71546/download.Google Scholar
• U.S. Food and Drug Administration (2012a) Tenoretic. Accessed February 11, 2019, https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018760s029lbl.pdf.Google Scholar
• U.S. Food and Drug Administration (2012b) FDA Drug Safety Communication: Important safety label changes to cholesterol-lowering statin drugs. Accessed February 11, 2019, https://www.fda.gov/Drugs/DrugSafety/ucm293101.htm.Google Scholar
• U.S. Food and Drug Administration (2012c) Guidance: Classifying significant postmarketing drug safety issues. Accessed December 18, 2020, https://www.fda.gov/media/83097/download.Google Scholar
• U.S. Food and Drug Administration (2013) FDA Drug Safety Communication: FDA requires removal of some prescribing and dispensing restrictions for rosiglitazone-containing diabetes medicines. Accessed July 14, 2018, https://www.fda.gov/Drugs/DrugSafety/ucm376389.htm.Google Scholar
• U.S. Food and Drug Administration (2017) FDA Center for Drug Evaluation and Research (CDER) strategic plan 2013–2017. Accessed February 15, 2019, https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM376545.pdf.Google Scholar
• U.S. Food and Drug Administration (2018a) MedWatch: The FDA Safety Information and Adverse Event Reporting Program. Accessed on July 14, 2018, https://www.fda.gov/Safety/MedWatch/default.htm.Google Scholar
• U.S. Food and Drug Administration (2018b) FDA Adverse Event Reporting System (FAERS) Public Dashboard. Accessed July 10, 2018, https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers-public-dashboard.Google Scholar
• U.S. Food and Drug Administration (2018c) Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA's new strategic framework to advance use of real-world evidence to support development of drugs and biologics. Accessed December 18, 2020, https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-fdas-new-strategic-framework-advance-use-real-world.Google Scholar
• U.S. Food and Drug Administration (2018d) Meta-analyses of randomized controlled clinical trials to evaluate the safety of human drugs or biological products guidance for industry. Accessed July 14, 2019, https://www.fda.gov/media/117976/download.Google Scholar
• U.S. Food and Drug Administration (2019) Risk evaluation and mitigation strategies |REMS. Accessed November 28, 2019, https://www.fda.gov/drugs/drugsafety-and-availability/risk-evaluation-and-mitigation-strategies-rems.Google Scholar
• U.S. Food and Drug Administration (2020) Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving Glycemic Control Guidance for Industry. Accessed December 18, 2020, https://www.fda.gov/regulatory-information/search-fda-guidance-documents/type-2-diabetes-mellitus-evaluating-safety-new-drugs-improving-glycemic-control-guidance-industry.Google Scholar
• Viscusi WK, Zeckhauser RJ (2015)Regulating ambiguous risks: The less than rational regulation of pharmaceuticals. J. Legal Stud. 44(S2):S387–S422.Crossref, Google Scholar
• Woodcock J (2004) The concept of pharmaceutical quality. Amer. Pharm. Rev. 7(6):10–15.Google Scholar
• Woodcock J, Behrman RE, Dal Pan GJ (2011) Role of postmarketing surveillance in contemporary medicine. Annual Rev. Medicine 62:1–10.Crossref, Google Scholar
• Yang CC, Yang H, Jiang L (2014) Postmarketing drug safety surveillance using publicly available health-consumer-contributed content in social media. ACM Trans. Management Inform. Systems 5(1):2.Crossref, Google Scholar
• Yeh JS, Sarpatwari A, Kesselheim AS (2016) Ethical and practical considerations in removing black box warnings from drug labels. Drug Safety 39(8):709–714.Crossref, Google Scholar
• Young BA, Maynard C, Boyko EJ (2003) Racial differences in diabetic nephropathy, cardiovascular disease, and mortality in a national population of veterans. Diabetes Care 26(8):2392–2399.Crossref, Google Scholar