U.S. FDA plans tracking of drug safety reviews
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The U.S. Food and Drug Administration needs a way to track the hundreds of internal safety reviews completed each year about drugs already on the market, an agency official said on Tuesday.
Dr. Paul Seligman said building such a system would be one of his priorities as he takes the newly created position of associate director for safety policy and communication in the FDA’s Center for Drug Evaluation and Research.
Analysts in the FDA’s Office of Drug Safety provide about 600 reports a year about potential concerns from marketed prescription drugs to officials in another office, the Office of New Drugs.
“At present, we have really no mechanism for tracking these reviews and ensuring that the conclusions and recommendations that come out of these reviews are adequately addressed,” Seligman told reporters.
By keeping a tally of the reports and their outcomes, “my hope is this will lead to greater confidence by all in the (FDA’s) ability to really stay on top of emerging safety concerns,” he said.
The effort is the latest FDA move to address criticism of its past handling of drug safety issues, including concerns about heart damage from Merck & Co. Inc.‘s arthritis pill Vioxx. The company pulled the drug from the market in September 2004.
Some staff in the FDA’s Office of Drug Safety have complained that their concerns about Vioxx and other drugs were downplayed or not fully investigated.
Seligman has directed the FDA’s Office of Pharmacoepidemiology and Statistical Science since 2001.
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