Remember that drug-safety database Congress required the FDA to set up? The idea was for the FDA to actively monitor drugs and possible adverse effects, rather than waiting for doctors and drug companies to report problems. Well, the agency is ready to announce its plans--and they don't include setting up a database. Instead, the FDA will contract with insurers, such as WellPoint and UnitedHealth, to scan their members' records for potential problems. The agency also plans to bring other health systems into the effort.
"We're bringing together all these different groups in a network so that we can ask them to look at the same question at the same time," Janet Woodcock (photo), CDER director, told the Wall Street Journal.
The FDA will use the databases to monitor potential problems that showed up in a less-than-statistically-significant way during clinical trials. The insurers and other network participants also will build computer models to detect signals of potential problems that weren't suspected before. To show that it could do so, WellPoint tested its 1999 data and found that it could have spotted the heart-related problems associated with Vioxx within four months of the drug's introduction.
- read the WSJ story
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