FDA Makes "Mixed Progress" on IT Improvement

The US Food and Drug Administration has made “mixed progress” in information technology (IT) modernization, according to findings from the Government Accountability Office (GAO).

The GAO was asked to evaluate the agency’s overall plans for modernizing its IT systems, including the extent to which the plans address known limitations or inadequacies in the agency’s capabilities, and assess the extent to which the agency has put in place key IT management policies and processes to guide the implementation of its modernization projects.

The FDA relies heavily on information technology (IT) to carry out its responsibility for ensuring the safety and effectiveness of certain consumer products. Recognizing limitations in its IT capabilities, the agency has begun various initiatives to modernize its IT systems. The GAO interviewed agency officials, reviewed key management policies and processes, and analyzed the FDA’s plans to determine whether they followed best practices and addressed capability limitations.

In response to the report, the FDA told the GAO that it plans to assess workforce needs, develop hiring plans based on those needs, and survey staff to identify concerns about the organizational environment. The agency will issue a draft management plan by the end of the year.

The limitations of the FDA’s IT system have already been cited as contributing factors in the recent heparin contamination issues and in 2007, the FDA Science Board said that the agency’s obsolete IT system was a hindrance to the agency.