As shown in figure 1, after 8 years and three software development contractors, FDA still does not have a fully functional automated import system. FDA decided to maintain and refine OASIS in the Seattle District. The results of this study are expected in February 1996. In addition, FDA has made little progress in implementing basic systems development procedures, including conducting user acceptance testing and a risk assessment. Recent developments include the completion of a system design review which concluded that OASIS was not ready for national implementation and recommended an immediate reengineering effort. Cost and Performance Information Are Needed

We found that FDA has not been effective in controlling costs or monitoring the progress of OASIS. In February 1995, the current contractor was tasked with conducting a cost-benefit analysis, which was completed in June 1995. Recommendations

We recommend that the Secretary of Health and Human Services direct the Assistant Secretary for Management and Budget and the Commissioner of the Food and Drug Administration to ensure that continuous top management oversight and systems expertise are provided to FDA as it proceeds with its import automation effort;
FDA develops and maintains reliable cost and performance information;
FDA follows sound systems development practices, including validating systems software, conducting user acceptance testing, developing a security plan, and conducting a cost-benefit analysis that includes an assessment of alternative systems.
Why GAO Did This Study

Pursuant to a congressional request, GAO reviewed the Food and Drug Administration's (FDA) progress in implementing its Operational and Administrative System for Import Support (OASIS), focusing on systems development areas that need improvement.

What GAO Found

GAO found that: (1) although some improvements have been made to import operations, FDA has not completed OASIS after 8 years and about $14 million in system development costs, mainly due to inadequate management oversight; (2) in 1994, FDA determined that OASIS was at a high risk for failure and it should suspend development until it completed a comprehensive system review; (3) FDA has taken an inadequate approach in developing OASIS, resulting in the potential for unsafe products entering the country; (4) FDA completed the comprehensive review of OASIS in June 1995 and determined that OASIS was not ready for national implementation and recommended an immediate reengineering effort; and (5) FDA success in improving OASIS depends on better planning and top management involvement in system design, development, and deployment.