FDA access to public health databases imperative, report says

FDA must tap into various public health databases to identify adverse events and product risks, according to a Nov. 29 report from the Subcommittee on Science and Technology, an ad hoc panel of the FDA Science Board. "Similarly, by leveraging standards and access to growing health information exchanges, the FDA should catalyze and participate in the development of efficient premarket and postmarket data exchange networks required to ensure the quality, safety and efficacy of medical and consumer products," the report notes. The report also charges that the agency's information technology (IT) infrastructure is inadequate and prevents FDA from fulfilling its regulatory mandates. Further, the subcommittee recommended that FDA adopt advanced data mining and analytical methodologies to beef up its adverse event and signal detection, as well as develop risk-based models for selecting which manufacturers to inspect. "The IT situation at FDA is problematic at best - and at worst it is dangerous," the report states. "Reports of product dangers are not rapidly compared and analyzed, [and] inspectors' reports are still handwritten and slow to work their way through the compliance system.