Adverse Event Reporting Delay Is Most Common Cause Of FDA Postmarketing Citations
This article was originally published in The Pink Sheet Daily
Executive Summary
Failure to develop written procedures and issues of non-reporting are also frequently cited by FDA’s Postmarketing Adverse Drug Experience Reporting Compliance Program.
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Late reporting of adverse drug events by sponsors accounts for the largest number of citations from FDA's Postmarketing Adverse Drug Experience Reporting Compliance Program. "Late reporting, failure to develop written procedures and non-reporting issues...[were] the top three issues in 2004, as you look forward in 2005 and 2006 you see that these are the same issues that we're finding," Consumer Safety Officer Kristi Hampton-Thurston said at a Food & Drug Law Institute conference on drug safety May 11. FDA's compliance program is charged with identifying and alleviating potential risks in industry pharmacovigilance activities and evaluating whether adverse event reporting processes comply with regulatory requirements. According to Hampton-Thurston, reporting errors may arise from inadequate resources, impaired information flow, inadequate monitoring and non-standardized operations. Such errors may be reduced by modifying the reporting process or enacting a risk management plan when warranted. Since 2002, instances of voluntary action taken by industry to address issues of non-compliance have steadily increased from 22 in 2002 to 45 in 2005, according to Hampton-Thurston. Cases requiring official action - often resulting in a regulatory letter or meeting - increased from two in 2002 to 11 in 2004 before declining to five in 2005. -Mary Bruce |