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Executive Summary

FDA's COMPUTERIZED ADR TRACKING SYSTEM IS MISSING ABOUT 10,000 reports per year, according to estimates provided by the General Accounting Office in a recent report on the agency's computerized information systems. GAO concludes that the agency is not entering over a quarter of the adverse drug reaction reports it receives each year into its Adverse Drug Reaction System. The agency recieves about 40,000 ADRs per year, according to the report. In addition to problems in keeping the ADR online system up-to-date, GAO maintains that the FDA is having difficulty incorporating information from the system into the regulatory process. GAO notes that FDA upgraded the Adverse Drug Reaction (ADR) System to online capability in 1984. However, the report alleges that FDA "has not decided how reviewers should use the system's information to make informed decisions on drug safety." New drug evaluation reviewers are responsible for assessing the safety of drugs both before and after approval, but they "have little direct access to the ADR System" and cannot rely on it to determine whether the number of incoming ADR reports warrants corrective action, GAO contends. "Conversely, ADR reviewers in the Reports Evaluation Branch, who do not have the authority to approve drugs or make labeling changes, have direct terminal access to the ADR System. We are concerned that a lack of interaction between these two reviewing groups could hinder [FDA's] ability to inform the public of ADRs," the report asserts. Regarding ADR reports on marketed drugs, HHS said the report does not acknowledge FDA's three-year old policy requiring ADR review to be conducted by the Epidemiology & Surveillance Division, which communicates its information to the new drug review divisions through "safety conferences." The conferences "were initiated shortly after GAO began its audit," HHS noted. The GAO report on FDA's collection, processing, and use of drug information was commissioned by the House Government Operations/Intergovernmental Relations Subcommittee in the spring of 1984. In his letter requesting the study, subcommittee Chairman Weiss (D-N.Y.) said congressional hearings revealed that agency handling of data is deficient in ways that "weaken" its regulatory programs and result in "uninformed or misinformed decisionmaking." The committee's interest in the issue stems from its 1982-1983 hearings on the approval of Lilly's Oraflex and on the withdrawal of J&J's Zomax. FDA cleared Oraflex while Lilly was reporting adverse reaction information under the drug's IND. During investigations into the Zomax case, J&J said it submitted 900 adverse experience reports, but the agency could account for only 300 of them in its computer, according to GAO. GAO's general conclusions urged FDA to establish more effective "data input and processing controls," determine its reviewers' and managers' automation requirements, and "develop long-range automatic data processing plans." The report notes that FDA is considering greater use of additional technologies, including electronic transmission, laser disk scanners, bar coding of documents, and microfiche. "Despite some improvements since 1983, FDA's three principal drug information systems are inaccurate and one is incomplete," the report contends. Furthermore, "these systems are not useful to most of FDA's reviewers because they are not reliable and do not meet their needs in facilitating the evaluation of NDAs," GAO said, adding: "FDA's difficulties with its drug information systems continue because the agency has not effectively managed its information resources, as required by" an Office of Management & Budget directive. The report examined the three principal computer systems used for drug review and surveillance by the Center for Drugs & Biologics: the Adverse Drug Reaction System, which handles postmarketing reports on approved products; the Astro-IV Drug Information System, which monitors information on pending NDAs; and the New Drug Evaluation/Management Information System, which identifies FDA reviewers and the time consumed for each pending application. In a statistical analysis, GAO concluded that, 35% of all ADR reports on marketed drugs "contained inaccurate data", data on 17% of the pending NDAs are inaccurate, 34% of the information on pending NDA review and management contains inaccuracies. The major deficiency cited for the Astro-IV System involved omission of "at least one inactive ingredient" in descriptions of drugs subject to pending NDAs. GAO's survey of FDA drug reviewers found that 78% preferred "manual sources of information," such as the NDA itself, to the Astro-IV or other automated systems.

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