Drug Regulation: FDA's Computer Systems Need To Be Better Managed

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Report Type	Reports and Testimonies
Report Date	Sept. 5, 1986
Report No.	IMTEC-86-32
Subject	Food and drug law Health care services Information resources management Information systems Pharmaceutical industry Pharmacological research Information management FDA Adverse Drug Reaction Reporting System FDA Astro-IV Drug Information System FDA New Drug Evaluation/Management Information System Drugs Computer systems

Summary:

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.

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Drug Regulation: FDA's Computer Systems Need To Be Better Managed