Enhancing postmarketing surveillance: continuing challenges.

Abstract

In this issue, Zeitoun and colleagues 1 examined whether any relationship existed between the speed of European Medicines Agency (EMA) regulatory review of 161 medicines between 2001 and 2010 and reported postmarket safety events; they found no relevant correlation. Neither rapid EMA regulatory review nor approval near the deadline was associated with more reports of adverse events. The findings are reassuring, given the pressure that regulatory agencies face to achieve timely reviews and ensure public safety. There is evidence, however, that the rush to approve new medicines may compromise safety, at least in the United States. Since the approval process at the Food and Drug Administration (FDA) was accelerated through a legislative cost-shifting strategy known as the Prescription Drug User Fee Act in 1992, the numbers of both postmarketing black-box warning and market withdrawals have significantly increased 2. But the tensions affecting one regulatory system may not be applicable to another. The process of premarket approval should also be viewed as just one facet of pharmaceutical safety. While the findings of Zeitoun et al. 1 are encouraging, neither regulatory agencies nor the public should become complacent. Belated discovery of serious adverse drug events is not always the result of poorly conducted clinical trials, nefarious drug companies or weak regulatory oversight; some drug-related complications reflect the complexities of human biology. The most meticulous regulatory review will never guarantee the detection of all adverse drug effects. Maintaining a robust system of postmarketing surveillance must complement a thorough drug approval process. However, these processes too are often thwarted by limitations of health record data and corresponding decision support tools (e.g. dashboards, data cubes, etc.), and the practice of off-label prescribing.