Science and Law
1st October 2012

The FDA Sentinel Initiative: Holy Grail of Safety Signal Data

This initiative could have implications for both the Plaintiff and the Defense bar in drug and device litigation. For example, defendants may be in a position to make a case that this adds another layer of oversight and product stewardship into the process.

The FDA Sentinel Initiative:  Holy Grail of Safety Signal Data

Back in 2008, FDA launched the Sentinel Initiative, the goal of which is to establish “… a national electronic system that will transform FDA’s ability to track the safety of drugs, biologics, and medical devices once they reach the market.” This fascinating initiative is designed to serve as a proactive alternative to retrospective “one-off” evaluations of safety issues that come to the fore based on new scientific studies or opportunistic observations of anecdotal adverse events.

This initiative could have implications for both the Plaintiff and the Defense bar in drug and device litigation. For example, defendants may be in a position to make a case that this adds another layer of oversight and product stewardship into the process. Therefore one could make the argument that it would be unreasonable to hold a manufacturer liable for adverse events that did slip through the cracks of the process. On the other hand, plaintiffs may be in a better position to identify targets earlier in the process and therefore cases earlier against pharmaceutical and medical device manufacturers. In any case, both sides of the bar should keep their eye on this initiative with keen interest.

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