Advisory Committee Recommends Better Use of Electronic Databases

June 1, 2005

The FDA intends to listen carefully to recent recommendations made by its drug-safety advisers, particularly to suggestions that the agency begin tapping emerging electronic databases to improve its oversight of marketed drugs, the FDA's top drug-safety officer said.

Using new electronic databases to identify drug-safety signals was one of the key recommendations to emerge from a two-day meeting of the FDA's Drug Safety and Risk Management Advisory Committee meeting, said Paul Seligman, director of the FDA's Office of Pharmacoepidemiology and Statistical Science.

"The take home message from the advisory committee is that we need to take advantage of many of the changes occurring out there in the healthcare world, particularly in the utilization of various kinds of databases that are created from electronic medical records," Seligman said during a webcast sponsored by the Drug Information Association and the Center for Drug Evaluation and Research.

"Clearly, the federal government is going to be more closely monitoring drug payments for the elderly when Medicare Part D takes effect," Seligman said, referring to the new Medicare Rx drug benefit that starts in January 2006. "There will be databases associated with that program that the FDA should utilize, as well as increasing opportunities to link different kinds of data sets."

Because of the new possibilities for studying drug-safety problems using these kinds of databases, this "is something we should be focusing our attention on and trying to take advantage of," Seligman said of the committee's recommendation. One of the FDA advisers, in fact, suggested the FDA consider focusing its resources on enhancing active database surveillance rather than on trying to improve the agency's existing passive adverse-event reporting system.