BioCentury
ARTICLE | Politics & Policy

EMA officials say regulators may be too risk averse

November 20, 2013 3:18 AM UTC

Drug regulators including EMA may be too risk averse and should consider patients' willingness to accept risk along with the opportunity costs of not approving a drug when evaluating the risk/benefit profile of a product, according to a perspective published in Nature Reviews Drug Discovery. In the perspective, current and former officials at EMA and the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) said regulators can be too risk averse to "avoid (highly publicized) drug-related adverse events," and that "good drug regulation" is about "maximizing gains in public health" and not just minimizing risk. The authors said regulators also do not consider opportunity costs when they evaluate a product, noting that a regulatory agency's request for more data to reduce uncertainty also has the "indirect and unintended consequence that the resources required are no longer available for R&D into another medicine that might yield more public health gain."

The authors said regulatory agencies should include patient perspectives on levels of acceptable risk in the drug review process. The authors also said regulators should be allowed to explicitly consider opportunity costs when evaluating the risk/benefit of a drug. Additionally, the authors noted that "rapid learning systems based on electronic medical records" now enable faster decision-making based on risk post-approval. ...