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By Malorye A. Branca

July 15, 2003 | Responding to public concerns in the wake of high-profile drug withdrawals, the FDA has announced the launch of a Cooperative Research and Development Agreement (CRADA) that should improve the agency’s ability to do advanced data mining for drug safety monitoring.

In a “cash-free deal,” Lincoln Technologies’ proprietary data-mining software will be implemented and fine-tuned at the FDA. Lincoln already has several pharmaceutical clients for the software and some users at the FDA.

Chan Russell, president of Lincoln Technologies, views the two-year CRADA as a “production installation and refinement,” project. Lincoln Technologies will benefit, he says, by “getting it widely deployed there (FDA) and better understanding the issues at the receiving end of safety data.”

According to Paul J. Seligman, FDA’s principal investigator for the CRADA, the agency receives 300,000 adverse event reports about approved drugs and vaccines every year and has more than 2 million such reports, going back 20 years. This information is stored in the agency’s Adverse Event Reporting System (AERS) Oracle database (

Safety evaluators regularly analyze new reports, most of which come from manufacturers, which are required by law to report serious and unanticipated side effects from their products. Physicians also submit such reports.

“Our hope is that this data-mining software will allow us to pick things up earlier,” Seligman says. “It should also let us find novel and innovative ways to apply the data.” For example, adverse events particular to a small ethnic group should be detectable.

Once the agency confirms that a drug has an unanticipated serious side effect, physicians are warned which types of patients are at risk. If deemed necessary, the drug may be withdrawn.

The deal is timely. “The FDA has been under tremendous pressure to improve drug safety monitoring,” says Kenneth I Kaitin, director of the Tufts Center for the Study of Drug Development. “Drugs are getting reviewed and approved more quickly, and some people believe the agency has gone too far in speeding this process.”

That perception is not held up by the Tufts Center’s data, which indicate that the number of products withdrawn for safety reasons has been stable for the past 30 years. The reason for most withdrawals, Kaitin says, is “rare effects that could not have been detected.” Still, he says, “Public concern has been raised on this issue, and Congress, in response, has been voicing its concern.”

The project has been endorsed from the highest level at the FDA. “By making greater use of state-of-the-art statistical tools, coupled with 21st-century medical information systems, we can act more quickly and effectively to prevent adverse events,” said Mark B. McClellan, FDA commissioner, in a press release announcing the CRADA.


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