Drug Regulation:

FDA's Computer Systems Need To Be Better Managed

IMTEC-86-32: Published: Sep 5, 1986. Publicly Released: Oct 9, 1986.

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In response to a congressional request, GAO reviewed the Food and Drug Administration's (FDA) management and use of drug information to determine whether its primary drug information systems were: (1) accurate and complete; and (2) useful to reviewers in facilitating the evaluation of new drug applications.

GAO found that, despite some improvement since 1983: (1) the three principal FDA drug information systems are inaccurate and one is incomplete; (2) these systems are not useful to most FDA drug reviewers because they are unreliable and do not meet user needs in facilitating the evaluation of new drug applications; and (3) these systems' inadequacies and other information management deficiencies may result in delays in identifying unsafe drugs that are already on the market and in the approval and marketing of new drugs that are unsafe, ineffective, or both. GAO believes that FDA difficulties with its drug information systems will continue because the agency has not effectively managed its information resources.

Recommendations for Executive Action

  1. Status: Closed - Implemented

    Comments: Ongoing needs assessments are continuing at FDA.

    Recommendation: The Secretary of Health and Human Services, through the Assistant Secretary of Management and Budget, should direct the Commissioner, FDA, to identify and document reviewers' and managers' automation needs through a rational assessment and development process and develop systems that directly support the review and analysis of drug applications and the monitoring of approved drugs. As part of the assessment and development process, FDA should evaluate: (1) the existing systems and determine if it would be more cost-beneficial to enhance, replace, or scrap them; and (2) the use of up-to-date technology to enhance database integrity and to solve paper-volume, handling, and storage problems.

    Agency Affected: Department of Health and Human Services

  2. Status: Closed - Implemented

    Comments: Work on standardizing terminology is continuing, and plans are being implemented to integrate systems.

    Recommendation: The Secretary of Health and Human Services, through the Assistant Secretary of Management and Budget, should direct the Commissioner, FDA, to implement standard drug terminology to enhance the integration of drug information systems.

    Agency Affected: Department of Health and Human Services

  3. Status: Closed - Implemented

    Comments: Periodic testing of input and output has been initiated.

    Recommendation: The Secretary of Health and Human Services, through the Assistant Secretary of Management and Budget, should direct the Commissioner, FDA, to monitor the reliability of data in all three systems by periodically testing data input procedures and system output.

    Agency Affected: Department of Health and Human Services

  4. Status: Closed - Implemented

    Comments: FDA agreed to review the system to determine its use for drug reviewers. Further, FDA will assess the need for certain data elements in the system.

    Recommendation: The Secretary of Health and Human Services, through the Assistant Secretary of Management and Budget, should direct the Commissioner, FDA, to evaluate the Astro-IV System to determine its role in FDA, specifically to assess whether it is to be used in the drug review process or as an administrative tool supporting other programs. Only if the agency decides to use the system for drug reviews should it correct the system inaccuracies identified in this report. The agency should cease spending resources to upgrade the system's accessibility and utility for drug reviewers until this evaluation is completed.

    Agency Affected: Department of Health and Human Services

  5. Status: Closed - Implemented

    Comments: The Department of Health and Human Services (HHS) implemented criteria for the timely entry of data into the management information system.

    Recommendation: The Secretary of Health and Human Services, through the Assistant Secretary of Management and Budget, should direct the Commissioner, FDA, to develop and implement specific criteria for the timely entry of new drug application status and assignment information into the New Drug Evaluation/Management Information System.

    Agency Affected: Department of Health and Human Services

  6. Status: Closed - Not Implemented

    Comments: FDA believes that it already identified weaknesses prior to the GAO review.

    Recommendation: The Secretary of Health and Human Services, through the Assistant Secretary of Management and Budget, should direct the Commissioner, FDA, to develop and implement precise instructions for the receipt, processing, and input of adverse drug reaction (ADR) reports, particularly in the area of document control, to ensure that reports are entered into the system.

    Agency Affected: Department of Health and Human Services

  7. Status: Closed - Implemented

    Comments: The HHS response indicates that FDA will continue to use the ITS budget as its planning tool.

    Recommendation: The Secretary of Health and Human Services, through the Assistant Secretary of Management and Budget, should direct the Commissioner, FDA, to prepare long-range automatic data processing (ADP) plans to assist in: (1) identifying the automated technology and information systems the Center for Drugs and Biologics needs to carry out its mission; and (2) justifying resulting budget requests.

    Agency Affected: Department of Health and Human Services

 

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