Study Finds Few FDA Post-Market Regulatory Actions Backed by Research, Public Assessments

A new study has found that the majority of post-marketing regulatory actions by the US Food and Drug Administration are not corroborated by published research findings or public assessments. The findings, appearing in The BMJ this week, suggest that the that either the agency is taking regulatory actions based on evidence not made publicly available or that more comprehensive safety evaluations might be needed when potential safety signals are identified. Given the importance of monitoring the safety of drugs after they have been approved and introduced to the market, the FDA maintains a database of spontaneous adverse event reports from drug manufacturers, healthcare staff, and consumers called the FDA Adverse Event Reporting System (FAERS). However, concerns about limitations of the FAERS have been raised including ones related to underreporting, redundancies, selection bias, and incomplete data, as well as single-source bias since more than 90 percent of adverse events in the system are reported by drugmakers. To help evaluate the performance of the FAERS, a group led by scientists from Yale University examined all safety signals identified from the FAERS that were published by the FDA from 2008 to 2019 and evaluated how often a safety signal resulted in regulatory action by the agency. For a subset of signals reported in 2014 to 2015, they also determined whether relevant published research or public assessments existed that might have corroborated or refuted the FDA's regulatory actions. The investigators find that only a third of the FDA's regulatory actions were corroborated by published research and none by public assessments in the Sentinel Initiative. The findings, the authors write, "highlight the continued need for rigorous post-market safety studies to strengthen the quality of evidence available at the time of regulatory action, as well as the importance of ongoing efforts to leverage real world data sources to evaluate and resolve signals identified from the FAERS and support FDA regulatory decisions.