FDA Enhances Postmarket Drug Safety Surveillance Practices

Janet Woodcock MD, director of FDA’s Center for Drug Evaluation and Research, issued a statement on Nov. 6, 2019 detailing efforts to strengthen the agency’s postmarket drug safety surveillance practices. These efforts include new best practices, reporting of the progress of postmarketing studies, and holding companies accountable for timely completion of these studies.

As part of these efforts, FDA has published “Best Practices in Drug and Biological Product Postmarket Safety Surveillance for FDA Staff,” which outlines FDA’s approach for timely postmarket analyses of drugs and biologics and how FDA takes into consideration the product’s characteristics and use. The document includes an overview of tools, methods, and signal detection and evaluation activities.

“Our best practices document incorporates the guiding principle that postmarket safety surveillance is a dynamic and constantly evolving field. By using a risk-based approach, the FDA takes into account the nature of the drug, its potential adverse events, the intended population, and the potential for serious outcomes, as well as the impact on individuals and the overall potential impact on the health of the public. When information is uncovered that may change the benefit-risk profile of a product, we will investigate the issue and consider appropriate action, including labeling changes, issuing drug safety communications, requiring postmarketing studies or requiring a Risk Evaluation and Mitigation Strategy. Even when we do not have enough evidence to establish a causal association between a drug and adverse event, we continue monitoring the safety of the product,” Woodcock stated.

Source: FDA