FDA Adverse Drug Events App for Public Health Crises Could Expand to More General Adverse Event Reporting

February 2012

The FDA recently announced plans to create an app to help it gather and provide information about adverse reactions during public health crises such as the 2009 outbreak of the H1H1 influenza virus.

According to Kaye Scholer Partner and Products Liability Co-Chair Lori Leskin, “It is interesting to see FDA’s recognition, and embrace, of the rapid expansion of new technology. This app — as described for now — is for use in public health emergencies. Smart phones clearly are the easiest technology to use; many doctors are already starting to use them in regular practice.”

On the app’s potential expansion beyond public health crises, Leskin observed, “Although FDA discusses the issue in the context of a ‘national crisis,’ FDA is recognizing the difficulties and inefficiencies in the current reporting system. These same issues are present in the non-emergency current adverse event reporting system. It is not a far leap to believe that if the app is seen as successful in ‘crisis’ situations, FDA could expand it to all adverse event reporting.”

Leskin added, “At that point, it would be interesting to see how the FDA uses it: do they make it available to the general public or only to healthcare providers? What obligations would FDA impose on companies to monitor and follow up on these adverse events? Companies have certain obligations to collect, follow up, and report on adverse event reports received — no matter what the source. Trying to keep up with the increasing number of adverse event reports would likely impose significant burdens on certain manufacturers.”

“Similar to FDA’s limited social media guidelines released in January, this new app reflects an understanding by FDA of the power of evolving technology. But unlike the recently released draft guidance documents on social media in drugs and devices — which restricts to some degree manufacturers’ use of social media to disseminate information — this app project looks to use social media affirmatively and increase and improve communications. But, as I mention, this project is likewise limited,” Leskin concluded.

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