FDA, Medicare To Improve Drug Monitoring

The Food & Drug Administration and the Centers for Medicare & Medicaid Services have joined forces to launch the Sentinel Initiative???a national strategy to develop an electronic, early-warning system to detect problems with approved drugs and medical devices that are already on the market.

The Sentinel System will be developed through public-private partnerships. It will make use of large databases, such as Medicare's data on medical claims and prescription drug use, as well as data from other sources that agree to participate.

The long-term effort will "create a forum and an infrastructure that will enable FDA to gather information about medical products by posing targeted queries," Janet Woodcock, director of FDA's Center for Drug Evaluation & Research, said at a May 22 briefing announcing the initiative. For example, FDA could query Medicare's large database to determine whether any patients had an adverse reaction to a particular drug.

"Having access to Medicare data allows you to potentially look at large numbers of events rather quickly," Jesse Goodman, director of FDA's Center for Biologics Evaluation & Research, said at the briefing. It could also reveal risks to particularly sensitive groups of people.

A big part of the Sentinel project will be to develop best practices and validate methods "so that when we do these queries and analyses, we can all agree on what the results mean," Woodcock said.

FDA acknowledges that safeguards for protecting proprietary and personal privacy information need to be established before the Sentinel System becomes operational.