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Opportunities for enhancing the FDA guidance on pharmacovigilance.

THE FOOD AND DRUG ADMINISTRATION (FDA) HAS PROduced a large number of extremely useful guidances for industry. These guidances include recommendations about the development, review, and approval of various disease-specific drugs, as well as general matters related to drug metabolism/drug interactions, premarketing risk assessment, pharmacogenetics, and pharmacovigilance. In May 2008, the FDA held a public workshop to aid in the development of a draft guidance about how to use large electronic health care databases for drug safety studies. The draft guidance, which will be completed in fiscal year 2010 and finalized in 2011, aims ambitiously at being a major part of a national strategy to monitor medical product safety. Several textbooks and journals are devoted to pharmacoepidemiology, a highly complex field rooted in pharmacology and observational epidemiology. The effort to create a single guidance about so large a subject is therefore formidable. Most of the research experience with large electronic health care data sets has occurred in the setting of specific health care delivery systems such as health maintenance organizations or the Veterans Administration. The recent appearance of alternative models, based on personalized health records, will provide new challenges for the conduct of high-quality studies. With the development and implementation of this guidance, the FDA has an opportunity to improve public health and public trust.