As reported by CQ Healthbeat News, the FDA has awarded a contract to speed up the detection of product hazards. In a nutshell, the FDA awards $72 million over five years to Harvard Pilgrim Health Care Inc to develop a scaled down version of the Sentinel System. The system meets the requirements of a 2007 law intended to strengthen FDA drug safety oversight.
Forget for a moment the Orwellian program name "the Sentinel System", it's great to see the FDA moving up the timeline in their desire to learn sooner about Adverse Events. However, I find it surprising that they stopped three quarters of the way and didn't go right to the source.
With all of the technology available to be on the bleeding edge of potential Adverse Events (AEs) being discussed by e-patients, the FDA has decided to spend $72 million on examining historical data. For the historians among you, my definition of historical is anything that is not a part of today's conversation. (more...)
