How can we better execute postmarket drug surveillance? A recent study proposes formation of a detailed, publicly available database that could be continually updated and aggregated with new information as new clinical study results are published. This essentially real-time balance sheet of a drug’s risks and benefits would be open to external review. Using the Vioxx litigation data as an example, study results suggest that cardiovascular risk could have been identified earlier using this type of sequential cumulative analysis, although this finding is disputed by Merck.
A historical overview of FDA’s postmarket drug safety surveillance system was detailed in a previous post. Since Vioxx was pulled from the market, the FDA has instituted several postmarket surveillance initiatives: additional staff members in all divisions to monitor drug safety, strengthening of the Office of Surveillance and Epidemiology, and formation of a new postmarket safety tracking system for new drugs. Dr. Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research, stated that when a potential health concern is noted, that the Agency conducts its own meta-analyses of the data. Following a Congressional amendment in 2007, the FDA can require: risk management programs for certain drugs, postmarket safety studies, drug label updates, and the publication of clinical trial results.
Source: The New York Times