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FDA Expresses Interest in Increasing Impact, Reach of Safety Warnings

Posted 03 January 2014 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) has announced that it will soon convene an advisory committee to discuss whether changes are needed to its "Consumer Updates" in order to make them more impactful and useful to consumers.


At present, consumer updates are used by the agency to address important or pressing topics of public health interest. In recent weeks, FDA has issued Consumer Updates for topics including misbranded dietary supplements, the limitations of breast cancer screening tests, the use of antibiotics in food-producing animals and even important updates to its website.

They are, in other words, one of the main ways FDA interacts directly with the public, as opposed to doing so through the media or health professionals.

But therein lies a challenge for FDA: The complexity of its subject matter, which doesn't always make for quick or easy reads for consumers. It's one thing to communicate with the public if your company sells toys, but quite another if you're an agency charged with making sure people aren't subject to unnecessary harms-or worse.

Impact and Evaluation

And according to a recent posting by FDA in the Federal Register, that challenge is one it wants its Risk Communications Advisory Committee (RCAC) to confront at its next meeting in early February 2014.

There, RCAC will be charged with discussing "methods for identifying the impact and increasing the reach of communications on topics of interest to consumers."

In particular, FDA said it was interested in investigating how it can evaluate whether its Consumer Updates are actually reaching the intended audience-consumers-and if the messages are being understood and acted upon appropriately by that same audience.

But the Register notice also indicates that FDA is interested in assessing more than just Consumer Updates. The "Communications on topics of interest to consumers" could potentially include a wide swath of communications, including recall notices, targeted or specific safety warnings, and approval notices.

As with most meetings it convenes, FDA said the complete materials will be available for public consumption at least two days prior to the 3-4 February 2014 meeting date.

Federal Register Notice


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