Congress Asks GAO to Examine Deficiencies in FDA IT Systems

By Daniel R. Matlis

Yesterday, Representative Henry A. Waxman and Senator Edward Kennedy issued a letter asking the General Accounting Office (GAO) to conduct an examination FDA’s staffing, information technology, and other resources necessary for the agency to successfully carry out its oversight of foods, drugs, biologics, and medical devices.

A stated goal of the GAO assessment is to “fully understand the extent to which deficiencies in FDA’s IT systems impair the agency’s ability to execute its mission, and the actions and resources necessary to correct those deficiencies.”

According to a report issued by the FDA’s own Subcommittee on Science and Technology “FDA’s resource shortfalls have resulted in a plethora of inadequacies that threaten our society – including, but not limited to, inadequate inspections of manufacturers, a dearth of scientists who understand emerging new technologies, inability to speed the development of new therapies, an import system that is badly broken, a food supply that grows riskier each year, and an information infrastructure that was identified as a source of risk in every Center and program reviewed by the Subcommittee.”

The Subcommittee’s report states that:

  • The FDA lacks the information science capability and information infrastructure to fulfill its regulatory mandate
  • The FDA cannot provide the information infrastructure support to regulate products based on new science
  • The FDA IT infrastructure is obsolete, unstable, and lacks sufficient controls to ensure continuity of operations or to provide effective disaster recovery services
  • The IT workforce is insufficient and suboptimally organized

The letter request that GAO conduct a review of FDA’s IT systems, and provide information on the following issues:

  1. What are the mission-critical IT systems and infrastructure that FDA centers rely on to conduct their missions?
  2. What studies or other efforts have been made to identify shortcomings, such as data limitations and inadequacies in the agency’s IT infrastructure, in FDA’s IT systems?
  3. What IT system modernizations efforts are underway and planned by FDA and to what extent do they address identified shortcomings? What is the status of these efforts?
  4. Does FDA have established processes to guide the implementation and management of its planned and ongoing IT modernization projects, and what challenges, including funding shortfalls, does it face in ensuring the success of these projects?

Although I am a strong advocate of Information Technology, and the pivotal role it can play enabling organizational transformation, I can also bear witness to the fact that Information Technology alone cannot get the job done.

The Healthcare and Life-Sciences industries are being transformed by unprecedented internal and external forces, from healthcare economics to globalization and outsourcing to patient centric healthcare. To provide fulfill it’s mission this new environment, FDA must put in place a Culture, Organizational Structure, and Information Technology (in that order) to not only support, but expedite the availability of  safe, innovative and new therapies  and treatments aimed at treating each individual’s needs.

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