Sentinel – Just Do It

Executive Summary

As FDA refines an approach to its Sentinel post-market drug safety surveillance project, "we will address issues of patient privacy and confidentiality [and] we will address the issues of the scientific accuracy and reliability of the data before we use it," Commissioner Andrew von Eschenbach says at a June 13 Brookings Institution conference on the issue. "On the other hand, in terms of implementing it, if we can identify the fatal flaws and address them, we should do that and must do that before we do it. But if it isn't a fatal flaw, it's just a flaw, a blemish, or a defect, it shouldn't stop us from doing it. It may impair us or prevent us from using it, but that's an important distinction." Sentinel is envisioned as a national network of electronic data systems that FDA could access to monitor the safety of drugs and medical devices (1"The Pink Sheet," May 26, 2008, p. 3)