Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at email@example.com if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
The highly-anticipated fifth edition is here! Get the must-have resource for achieving compliance with medical device regulations.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Posted 20 March 2013 | By Alexander Gaffney, RAC,
US regulators plan to hold a meeting in the coming weeks to address how it communicates risk about regulated products, including how best to communicate adverse event information it receives from its reporting systems.
In recent months, FDA's Risk Communications Advisory Committee (RCAC) has frequently brought up the notion of "message fatigue"-the way consumers of information behave when they are repeatedly subjected to the same or similar information over a relatively short period of time.
For example, if FDA were to send out a warning to doctors regarding a speculative but likely association between a drug and a serious risk to a patient, the doctors are likely to listen if that is a relatively uncommon warning. If similar warnings were sent out on a weekly basis, doctors might be less likely to treat it as a serious risk, and some might even ignore it. Were that frequency to increase to multiple times per day, many doctors might choose to ignore all warnings rather than attempt to seek out ones relevant to their patients.
At previous meetings, such as one held in October, the RCAC said it wanted to focus on the topic, as well as the topic of "inaccurate risk perception," both of which are related to a larger question: What are the best practices for communicating risk to a diverse and public audience?
Prior studies have shown that FDA's attempts to communicate risk with the public are inconsistent in their effects.
"While some FDA drug risk communications had immediate, strong impact, many had either delayed or no impact on health care utilization or health behaviors," the authors of a meta-analysis of FDA's communications wrote in the July 2012 issue of Medical Care. For instance, FDA missives asking for healthcare providers to monitor the use of a drug led to decreased utilization, but often minimal long-term monitoring of symptoms. Warnings against co-prescribing drugs "often took months or years to show an effect," explain the authors, while still other warnings spilled over into the prescribing utilization of other drugs.
"Risk communication is a complex science and understanding the intended and unintended outcomes from prior FDA advisories, and label warnings may help to guide future risk communication," the authors wrote. "This demonstrates the challenge that policy-makers face to design risk messages that are maximally effective, specific, and that don't become risks themse
The complexity of those interactions can become compounded further when consumers face multiple risks at the same time, RCAC explained at a June 2011 meeting.
The subject of discussion for the RCAC's upcoming 29 April 2013 meeting appears to fall along similar lines as the above topics, but with a greater emphasis on adverse event reporting systems and message fatigue.
"The Committee will discuss general factors in risk communication about FDA-regulated products, including how to communicate effectively about FDA's adverse event reporting systems, and messaging in the context of competing communicators," it said in a Federal Register statement.
Further details will be available at least two days before the start of the meeting, FDA added.