Congressional watchdog blasts FDA over shortcomings of postmarketing oversight IT system

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The congressional watchdog has taken the FDA to task over the IT system it uses to track the safety of approved drugs. Officials at the Government Accountability Office (GAO) told the FDA it should identify IT investments that will enable regulatory staffers to "easily and systematically" access postmarket data for oversight purposes.

As it stands, the FDA IT system is reportedly falling short of this ideal. A GAO investigation into postapproval oversight at the FDA found problems with the completeness, timeliness and accuracy of the data, as well as issues with the way information is recorded in the system. The upshot is that the GAO has doubts about whether postmarket oversight at the FDA is sufficiently advanced to enable the regulator to comply with federal government internal control standards about the timely recording of information.

"FDA lacks reliable, readily accessible data on tracked safety issues and postmarket studies needed to meet certain postmarket safety reporting responsibilities and to conduct systematic oversight," the GAO wrote in its report. Officials at the regulator told GAO the Document Archiving, Reporting, and Regulatory Tracking System (DARRTS) they use cannot provide characteristics of safety issues, such as the population or therapeutic indication affected. If staffers want to review such details, they must manually dig into electronic documents in search of the relevant pieces of information.

The GAO thinks the limitations of this approach are hindering postmarket surveillance at the FDA, something it is particular concerned about given the small data sets with which drugs can win approval under the regulator's expedited pathways. FDA is aware of the shortcomings of DARRTS. "Officials said they have … begun meeting with the Office of Business Informatics within [the Center for Drug Evaluation and Research] to discuss improvements that could be made in the FDA's new information technology platform, such as automated collection of certain types of data," the GAO wrote.

While acknowledging that this and other efforts could rectify some of the problems with the system, the GAO also made recommendations about what else the FDA can do to improve its IT. "We recommend that the Secretary of [the Department of Health and Human Services] direct the Commissioner of FDA to … work with stakeholders within FDA to identify additional improvements that could be made to FDA's current database or future information technology investments to capture information in a form that can be easily and systematically used by staff for oversight purposes," the GAO wrote.

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