Regulatory Focus™ > News Articles > FDA Advisory Committee to Assess 'Warning Fatigue'

FDA Advisory Committee to Assess 'Warning Fatigue'

Posted 11 October 2012 | By Alexander Gaffney, RAC 

An advisory committee meeting convened on behalf of the US Food and Drug Administration (FDA) is set to discuss factors influencing the communication concerning regulated healthcare products, including pharmaceuticals, medical devices and biologics, FDA announced in the Federal Register.

FDA's Risk Communication Advisory Committee (RCAC) is set to meet on 2 November 2012 to discuss the topic of message fatigue, warning fatigue and "inaccurate risk perception," all of which can result from improper communication strategies.

Warning fatigue occurs when a patient or healthcare provider is exposed to an excess of information-either a surge of it at once or a steady drumbeat of it over time-causing them to disregard warnings or discount certain aspects of them.

Even beyond individual products, fatigue can extend to more general warnings and recall notices sent out by FDA. When sent out too frequently or involving too much information, patients can become overwhelmed and simply assume either everything is too risky to use or decide the risks are overblown and not worth paying attention to. In 2005, for instance, FDA issued 127 safety alerts and market recalls-a rate of nearly one every three days for the entire year.

FDA's meeting seems aimed at addressing multiple ways of bringing down what it referred to as "communication barriers" between regulators and the public, prescribers and pharmacists.

Meeting materials will be available before the meeting on FDA's advisory committee calendar webpage.

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