CIOIN

Executive summary

When there seemed to be an increase in heart attacks and strokes among patients taking the arthritis pain reliever Vioxx, it appeared that FDA reviewers may have overlooked data from Merck's clinical trials pointing to potentially fatal reactions to the drug. Their legacy systems made change difficult and magnified the risk facing the 100-year-old agency.

The FDA's high-wire act requires it to balance the demands of manufacturers and patients with competing demands from the general public to make sure the products are safe-while maintaining the trust of all these constituents. In the past, the FDA has hired more scientists and other support staff to keep it in balance, but, increasingly, FDA managers are concluding that IT has a central role to play in managing the agency's enterprise risks.

Earlier, top FDA managers had not considered IT to be a central component to balancing the competing imperatives of caution and speed. IT was more of a support service, and scientists didn't question what the department delivered. Meanwhile, IT planning or buying decisions were primarily made by the IT directors in each of the eight centers. The higher profile centers, such as the CDER, which handles drug approvals, got more money and better equipment. But still, the FDA ran mostly on disparate legacy systems.

Under Rinaldi, former CIO, the agency spent the first two years of the modernization project focused on reducing costs by revamping the IT organization and its business processes. In 2003, the FDA created a central Office of Shared IT Services, consolidating 15 contracts covering such services as help desk and desktop support. And in March 2004, the IT function was completely reorganized, so that the CIOs in each center reported directly to the FDA CIO, giving the agency CIO more control over technical standards and purchasing.

Then came the hard part: Devising a workflow that could be used by every center. Rinaldi could not simply transfer the workflow system from the biologics centre to the drug evaluation center because the biologics center's workflow system could not be scaled to handle the drug center's workload. Rinaldi knew that if he tried to force the biologics center's solution onto the drug center, he risked creating a system that provided less functionality and that would not be robust enough to cut review times and provide better information to scientists.

Early in 2003, as the IT department reorganization proceeded, Rinaldi and Farmer (who was director of IT programs at the time) convened a meeting with representatives from the FDA's centers to begin defining a common workflow. The discussion led to two IT initiatives: The development of a single intranet based on enterprise technology standards and the beginnings of an FDA-wide automated workflow system.

The point of the workflow system is to give each center the components to create a workflow of its own, but still be able to integrate them. One component that Wilson is helping to develop is a standard webpage for scientific and regulatory reference information. A reviewer will be able to select the type of product the application is for, then determine how to proceed with the review. Having this functionality, Wilson says, will make it easier to train new reviewers because the workflow process will be simpler and standardized. That in itself should enable the FDA to conduct reviews and grant approvals more efficiently, thereby giving scientists more time to do their analysis instead of doing paperwork.

It's too early to measure the impact of the FDA's latest investments on its approval process. Farmer and the top managers in charge of workflow processes in the FDA's centers believe IT has the potential to shorten the approval time more, while reducing the risk that they will approve products that have dangerous side effects.