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A Proactive Pharmacovigilance Program (RADAR) vs Safety Activities Conducted by the Food and Drug Administration and Pharmaceutical Manufacturers

Charles L. Bennett, MD, PhD, MPP; Jonathan R. Nebeker, MD, MS; Paul R. Yarnold, PhD; Cara C. Tigue, BA; David A. Dorr, MD, MS; June M. McKoy, MD, MPH, JD; Beatrice J. Edwards, MD; John F. Hurdle, MD, PhD; Dennis P. West, PhD; Denys T. Lau, PhD; Cara Angelotta, BA; Sigmund A. Weitzman, MD; Steven M. Belknap, MD; Benjamin Djulbegovic, MD, PhD; Martin S. Tallman, MD; Timothy M. Kuzel, MD; Al B. Benson, MD; Andrew Evens, DO; Steven M. Trifilio, RPh; D. Mark Courtney, MD; Dennis W. Raisch, RPh, PhD

Arch Intern Med. 2007;167(10):1041-1049.

Background  The Food and Drug Administration (FDA) and pharmaceutical manufacturers conduct most postmarketing pharmaceutical safety investigations. These efforts are frequently based on data mining of databases. In 1998, investigators initiated the Research on Adverse Drug events And Reports (RADAR) project to investigate reports of serious adverse drug reactions (ADRs) and prospectively obtain information on these cases. We compare safety efforts for evaluating serious ADRs conducted by the FDA and pharmaceutical manufacturers vs the RADAR project.

Methods  We evaluated the completeness of serious ADR descriptions in the FDA and RADAR databases and the comprehensiveness of notifications disseminated by pharmaceutical manufacturers and the RADAR investigators. A serious ADR was defined as an event that led to death or required intensive therapies to reverse.

Results  The RADAR investigators evaluated 16 serious ADRs. Compared with descriptions of these ADRs in FDA databases (2296 reports), reports in RADAR databases (472 reports) had a 2-fold higher rate of including information on history and physical examination (92% vs 45%; P<.001) and a 9-fold higher rate of including basic science findings (34% vs 4%; P = .08). Safety notifications were disseminated earlier by pharmaceutical suppliers (2 vs 4 years after approval, respectively), although notifications were less likely to include information on incidence (46% vs 93%; P = .02), outcomes (8% vs 100%; P<.001), treatment or prophylaxis (25% vs 93%; P<.001), or references (8% vs 80%; P<.001).

Conclusion  Proactive safety efforts conducted by the RADAR investigators are more comprehensive than those conducted by the FDA and pharmaceutical manufacturers, but dissemination of related safety notifications is less timely.

Author Affiliations: Division of Hematology/Oncology (Drs Bennett, Weitzman, Tallman, Kuzel, Benson, and Evens, Mss Tigue and Angelotta, and Mr Trifilio), Department of Dermatology (Dr West), Buehler Center on Aging (Dr Lau), Division of General Internal Medicine (Dr Belknap), Division of Geriatrics (Drs McKoy and Edwards), and Department of Emergency Medicine (Drs Yarnold and Courtney), Northwestern University Feinberg School of Medicine, and the Robert H. Lurie Comprehensive Cancer Center (Drs Bennett, McKoy, Belknap, and Benson), Chicago, Ill; the Jesse Brown Veterans Affairs Medical Center and the Veterans Affairs Center for Management of Complex Chronic Care, Chicago (Dr Bennett and Mss Tigue and Angelotta); Veterans Affairs Salt Lake City Geriatric Research, Education and Clinical Center and Informatics Decision Enhancement and Surveillance Center (Dr Nebeker), and University of Utah School of Medicine, Salt Lake City (Drs Nebeker and Hurdle); Department of Medical Informatics and Clinical Epidemiology, Oregon Health and Science University, Portland (Dr Dorr); H. Lee Moffitt Cancer Center and Research Institute at the University of South Florida, Tampa (Dr Djulbegovic); and Veterans Affairs Cooperative Studies Program, Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (Dr Raisch).

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