Sentinel Role in Drug Safety Defended

Responding to critics who say the FDA Sentinel System lacks important data and has not identified any safety issues, CDER Office of Surveillance and Epidemiology deputy director Robert Ball says Sentinel has been useful in evaluating drug safety and can also contribute important information for labeling actions, responses to citizen petitions or advisory committees, and many other actions that are not easily quantified or visible to the public. In an online conversation about Sentinel, he also notes that it has only been fully operational for about 18 months.

“Prior to 2016,” he writes, “the focus of the mini-Sentinel pilot was on developing the infrastructure and methods that would allow FDA to take full advantage of the Sentinel distributed database. All of the benefits of this important new source of safety information will not be evident for several years.”

The post gives a history of Sentinel development and describes the ways in which it differs from other systems. A major difference, he writes, is that Sentinel uses a distributed data approach in which data partners maintain physical and operational control over electronic data in their existing environments.

During a drug safety evaluation, Ball says, reviewers identify significant safety concerns and develop an action plan for safety monitoring after approval. If there is a need for post-approval monitoring, the agency determines whether the Sentinel System’s Active Risk Identification and Analysis (ARIA) system can meet the safety monitoring need. If so, the agency begins to plan for a future ARIA study. If FDA finds that ARIA cannot meet the need, he says, it can require a sponsor to conduct a post-marketing study. “In this way,” Ball says, “Sentinel’s ARIA system is an integral and strategic part of the regulatory planning process to monitor serious safety concerns identified in the review of new drug applications.”