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Regulatory Focus™ > News Articles > FDA Warns Specialty Pharma Company Over Adverse Event Reporting

FDA Warns Specialty Pharma Company Over Adverse Event Reporting

Posted 30 November 2016 | By Michael Mezher 

FDA Warns Specialty Pharma Company Over Adverse Event Reporting

The US Food and Drug Administration (FDA) sent a warning letter to Langhorne, Pennsylvania-based STI Pharma LLC for failing to meet the agency's requirements for adverse event reporting.

FDA sent the warning letter following an inspection on 21 July 2016, during which FDA says it found the company lacked written procedures for gathering, evaluating and reporting postmarketing adverse drug experiences (PADE), which are required under federal regulations.

"Given your reliance on contractors to carry out PADE activities, we are concerned about your firm's fundamental understanding and implementation of PADE regulations, including how they relate to your use of contractors," FDA writes.

Surveillance, Evaluation and Reporting

In the warning letter, FDA cites the company for a number of violations related to adverse event surveillance, evaluation and reporting.

"Your firm does not have any written procedures that describe the surveillance and receipt of ADE information from any source, including how you monitor, receive, identify, triage, process, reconcile, and document ADEs," FDA writes.

Specifically, FDA said the company failed to properly document some 70% (16/23) of ADEs it received. The agency also says the company did not document when it received incoming ADEs, and was unable to determine when they had been received.

"As the application holder and recipient of ADE information, you are responsible for ensuring that the initial received dates for ADEs are appropriately determined and documented," FDA writes.

Additionally, FDA says the company misreported some of the ADEs it reviewed. In one instance, FDA said the company made assumptions about aspects of a report from a patient. "Your firm subsequently made various assertions … in the report before you relayed it to your contractor. Consequently, your contractor considered these assertions to be factual when evaluating the case."

According to FDA, STI Pharma failed to properly evaluate a number of the ADEs it received. FDA also says the firm, and its contractor lacked written procedures detailing how such reports should be evaluated.

In one case, FDA says the company inappropriately evaluated a report of ischemic insult stemming from a study of one of its drugs. "You evaluated this serious, unexpected study-based ADE as unrelated, because you considered the ADE unlikely to be caused by your firm's product; however, you were unable to provide information justifying how you determined this."

Lastly, FDA says STI Pharma lacked written procedures for reporting 15-day Alert Reports and non-expedited individual case safety reports (ICSRs). "Your firm's agreement with your contractor states that they provide regulatory submission services on your behalf. However, neither you nor your contractor has any written procedures that define how you report ICSRs to FDA."

Following the inspection, FDA says STI Pharma submitted a series of draft standard operating procedures (SOPs) describing various pharmacovigilance practices. However, FDA said these were not adequate to correct the issues cited in the warning letter as the company did not provide a date for when they would be implemented, and that the company's response did not discuss any corrective actions for ensuring the issues would not happen again.

As such, FDA has ordered STI Pharma to report on the steps it has taken to correct the violations to the agency within 15 days, or if the firm is unable to make corrections within the 15-day window, to explain why they are unable to do so.


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