Article preview reprinted from "The Gray Sheet" - October 05, 2009
Under a plan unveiled Sept. 30, FDA aims to increase its understanding of appropriate ways to communicate with the public about product risks and to streamline its product risk communication processes. Read more...
Article preview reprinted from "The Gray Sheet" - October 05, 2009
Under a plan unveiled Sept. 30, FDA aims to increase its understanding of appropriate ways to communicate with the public about product risks and to streamline its product risk communication processes.
The agency's Strategic Plan for Risk Communication lays out dozens of planned actions intended to improve FDA communication strategies, with a focus on 14 over the next year (The Gray Sheet' Sept. 28, 2009).
Among FDA's goals for the next 12 months: publish an agenda for researching the best modes of public communication; design surveys to assess public understanding of, and satisfaction with, FDA communications; and create an internal database of relevant risk communication research. The agency also says it will develop template press releases to announce regularly occurring events like recalls and will start posting pictures of products affected by higher-risk recalls on the Web.
More fundamentally, FDA says it will take strides in the short term to design better measures of how effectively it is communicating risks.
The plan draws from six meetings convened by FDA's Risk Communication Advisory Committee in 2008 and 2009. The panel was formed in 2007 to help FDA improve, among other things, how it tells consumers, patients and medical practitioners about newly identified health risks from agency-regulated products (The Gray Sheet' June 11, 2007).
Recent criticism of FDA's risk communication abilities has been especially sharp in the field of food contamination. But serious communication challenges also have cropped up in the device space.
One of the biggest device-related conundrums has been how FDA and manufacturers should announce a recall for an implanted device without causing patients to seek unwarranted explants that might cause more harm than good.
- David Filmore
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