WASHINGTON -- The Food and Drug Administration should have the power to require that drug makers conduct studies on the safety of prescription medications already on the market, congressional investigators recommend.
Drug makers often promise timely follow-up studies, but they often delay going ahead, the agency said. As a result, the FDA can lack useful data in determining whether an approved drug really is safe, according to a report being released Monday by the Government Accountability Office.
Investigators also are urging Congress to change how the FDA tracks potential concerns about drug safety, makes major decisions and settles internal disputes, especially between the two offices that now assess drug safety.
"FDA lacks clear and effective processes for making decisions about and providing management oversight of, post-market safety issues," the report says.
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