FDA looks to make drugs risks clearer for patients
pharmafile | June 22, 2011 | News story | Medical Communications | FDA, advertising
Potential side effects from medicines need to be presented more clearly on prescription drug advertising so patients can understand the risks better.
This is the conclusion from a new FDA study that showed the way information is conveyed and displayed in print advertising directly affects consumer understanding of prescription drugs.
The US regulator also trialed a new format that included a ‘Question and Answer’ section and a Prescription Drug Facts Box.
It found that people who saw this Drug Facts format were better able to recall risks than those who saw the traditional format, and where thus more aware of potential side effects of the drug.
The FDA will now review the study and decide whether adding these new elements to prescription drug advertising could help made safety risk clearer.
The study, designed by the FDA’s Division of Drug, Marketing, Advertising and Communications (DDMAC) in the Center for Drug Evaluation and Research, also examined ways to improve understanding of how consumers use the ‘brief summary’ section of printed prescription drug adverts.
The FDA said this brief summary should include side effects, contraindications, and effectiveness, but this is not always getting across to patients.
Thomas Abrams, director of DDMAC, said: “Some of the current approaches to fulfilling the brief summary requirement, while adequate from a regulatory perspective, are not optimal in communicating this important information to consumers.
“FDA’s research and policy development seeks to improve the presentation of this information so it is easier for consumers to read and understand.”
Ben Adams
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