Incidents Review Support and Records Management

The CDER's Office of Compounding Quality and Compliance (OCQC) is requesting contractor support with triaging incidents report information. There is also a critical need for support for incidents to help with daily triaging. We would like to continue current contractor support that is essential for recording and cataloging information that is reviewed by the point of contact on the incidents team daily. The contractor helps to triage and address the materials that come from FAERS, including MedWatch reports and reports submitted by firms. Contracted support staff assist with incident triaging by contacting reporters or firms who submit reports to FAERS to gather information about whether the incident was related to a compounded drug and the information about the compounder of that drug. There is an unprecedented volume of adverse event/incident reports. In the past, OCQC has struggled to keep up with triaging these reports until we were able to obtain contractor support beginning in FY24. Review of incidents is one way the OCQC helps to protect the public health from potentially serious adverse events that may be related to compounded drug products such as the 2012 fungal meningitis outbreak associated with contaminated compounded drugs shipped by the New England Compounding Center to patients and healthcare providers nationwide, causing over 60 deaths and 750 cases of infection. This incident was the most significant of a long history of serious adverse events resulting from compounded drug products. Both before and since this outbreak, FDA has investigated many serious adverse events and serious product quality issues, such as contamination or potency failures, associated with sterile and non-sterile compounded drug products. It is critical the OCQC maintain this additional support needed to keep up with the increased rate of adverse event reports to help prevent large scale serious adverse events.