How does the FDA monitor post-marketing drug safety?

The FDA monitors post-marketing drug safety primarily through the Adverse Event Reporting System (AERS). This system allows healthcare professionals, consumers, and manufacturers to report any adverse effects or problems associated with drugs once they are on the market. The data collected in AERS is crucial for identifying potential safety concerns that may not have been evident during clinical trials, as it reflects real-world usage of medications across diverse populations.

The information gathered by AERS helps the FDA to assess the risk-benefit profile of marketed drugs, determines if regulatory action is necessary, and informs healthcare providers and the public about safety issues. This ongoing surveillance is vital because it ensures that any emerging safety concerns can be addressed promptly, thereby protecting public health.

While inspections of pharmacies, annual reports from drug manufacturers, and media reports may play a role in the overall monitoring framework, they do not specifically focus on tracking adverse drug events in the way that AERS does.