FDA Requests Information for New AERS

In the wake of mounting concerns over drug safety, the FDA has started reviewing the possibility of building a new adverse event reporting system (AERS).

The agency has posted a formal request seeking input from information technology vendors on strategies for developing a new AERS.

"The FDA is requesting information to identify potential approaches to building a new version of the FDA's Adverse Event Reporting System, which will be known as AERSII," the request stated. "The current AERS system is a complex software application that is used by FDA's safety evaluators to monitor and manage the safety of prescription drugs. Through this announcement the FDA will also determine the availability of small businesses to compete for this requirement if a solicitation is issued in the future."

Although the request didn't provide any details about AERSII, the agency has been forthcoming in recent months about the need to improve the system. The current AERS receives approximately 350,000 reports annually, and critics contend the system is fraught with opportunities for human error because there is so much information flooding the system.

Responses to the information request are due from industry by March 3. To view the request, go to http://www.eps.gov/spg/HHS/FDA/DCASC/Reference%2DNumber%2DFDA2005%2D001/SynopsisR.html (http://www.eps.gov/spg/HHS/FDA/DCASC/Reference%2DNumber%2DFDA2005%2D001/SynopsisR.html).