Catch-22 for regulators: risk aversion may be harmful
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Catch-22 for regulators: risk aversion may be harmful Regulatory agencies have in the recent past been accused of a lack of balance in their approach towards assessing whether to be overly tolerant of the risks of a new drug versus being excessively risk-averse, according to a recent opinion by the EMA.1 The opinion suggests that denying marketing authorisation of a drug, or withdrawing or restricting its use for reasons such as risk aversion could lead to greater harm than benefit for the public.1,2 In addition, the EMA point out that there are ‘opportunity costs’ associated with an unwillingness to allow a degree of uncertainty when it comes to marketing approval and drug risk, as resources intended for the research and development of another drug may have to be diverted in order to fulfil a regulators request for additional data.1,2 The EMA made some suggestions to attain more appropriate approval of risk and uncertainty by regulatory agencies, including a greater focus on the patients’ values and views of acceptable risk, an introduction of ‘tolerability of risk’ thresholds, and a greater emphasis on safety and effectiveness on real world scenarios.1,2 1. Eichler H-G, et al. The risks of risk aversion in drug regulation. Nature Reviews Drug Discovery : [10 pages], 15 Nov 2013. Available from: URL: http:// dx.doi.org/10.1038/nrd4129. 2. EMA. Mitigating risk aversion in medicines regulation in the interest of public health. Internet Document : 15 Nov 2013. Available from: URL: http:// www.ema.europa.eu. 803096192
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Reactions 7 Dec 2013 No. 1481
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