Regulatory Focus™ > News Articles > Study: FDA Recall Communication System Ineffective, Poorly Designed

Study: FDA Recall Communication System Ineffective, Poorly Designed

Posted 06 June 2012 | By Alexander Gaffney, RAC 

It can be difficult to keep up with the dizzying number of drug recall notices sent by the US Food and Drug Administration (FDA). So difficult, in fact, that the agency seems to miss a significant number of recall notices itself, says a new study.

The study, published in the Archives of Internal Medicine, finds FDA's recall information communication systems are sorely lacking, failing to disseminate information for as approximately 20% of all recalled medical products and presenting a needlessly large torrent of information which obscures important recalls.

Recalls are categorized by the magnitude of their known or perceived risk, with Class I recalls reserved for the most serious and potentially harmful product failures. Despite the potential for patient harm, FDA failed to send many recall notices to either the public or physicians through either of its electronic notification systems, known as MedWatch and its Recall Alert System.

The authors of the study, including Joshua Gagne of Brigham and Women's Hospital in Boston, were also critical of FDA's communication strategy, saying there is a high signal-to-noise ratio in recall notices sent to the public. "I think a good system would indicate all of the Class I recalls, and it wouldn't necessarily communicate recalls the FDA deems less important, such as Class II and Class III," Gagne said.

"It's very possible that these important recalls are being lost in the less important ones," Gagne added.

Between 2004 and 2011, just 91 Class I recalls were initiated, while more than 1,600 were for less serious Class II and Class III recalls. FDA sent more than 2,900 recall announcements through its Recall Alert System, but didn't send alerts for 36 of the 91 Class I recalls. Half of those unsent recalls were filed through FDA's MedWatch system, leaving 18 Class I recalls unknown to the public.

In a response to Gagne's study, FDA spokeswoman Sarah Clark-Lynn said additional reporting methods are sometimes used outside of MedWatch and the Recall Alert System, including prominent press releases, email list serves, telecommunications and social media, all of which could account for some of the missing recall notices.

FDA also put some of the blame on manufacturers, which it said can notify healthcare providers about recalls through "Dear Doctor" letters not necessarily communicated to FDA.

"The recall system depends on full and open disclosure [by manufacturers], trust and the industry's acceptance of its responsibilities to protect the public from violative products," Clark-Lynn said in an email to ABC News.

The agency is moving to make at least one improvement to its recall procedures. FDA announced on 1 June it would seek to speed up the release of some recall notices, particularly if the recalls are known to the agency but remain in the process of being classified according to their respective risk.

In an email to Pharmalot, Gagne said the agency should move beyond cosmetic changes and institute customized procedures for receiving recall notices. "A simple solution would be to allow subscribers to the Recall Archive altering system to customize the types of alerts they receive. For example, clinicians may be interested in only class 1 alerts, but can't currently sign up for only those without getting lots of other extraneous notice," Gagne explained.

Read more:

ABC News - U.S. Has Drug Recall Problem, Study Says

Reuters - U.S. drug recalls common, not well publicized: study

Pharmalot - FDA Does a Poor Job of Communicating Recalls

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