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"PARALLEL TRACK" DRUG ADVERSE REACTION REPORTING SYSTEM

Executive Summary

"PARALLEL TRACK" DRUG ADVERSE REACTION REPORTING SYSTEM will be discussed at an upcoming FDA Anti-Infective Drug Products Advisory Committee meeting tentatively scheduled for Aug. 17, FDA Commissioner Young told a House subcommittee Aug. 1. Testifying at a hearing on AIDS patient care issues by the House Government Operations/Human Resources Subcommittee, Young said representatives from the National Institutes of Health, the National Cancer Institute, the community-based clinical trials program and AIDS patient groups will participate in the meeting. The advisory committee will prepare a report on unresolved issues of the parallel track approach for submission to the Health and Human Services Department by Aug. 21. Subcommittee Chairman Weiss (D-N.Y.) asked Young to elaborate on the agency's thinking on adverse drug reactions in the parallel track system. Young replied: "First, we'll have to have a system in place that will identify adverse reactions," which may be "very substantial." The agency will also "need to have the strong cooperation of the sponsor to report these [reactions] and then use the compliance staff at the FDA to verify" them. The adverse reactions will have to be assessed carefully so that the agency is not too quick to discontinue distribution of drugs available through the program, Young pointed out. He noted, for example, that patients participating in the open protocol track "may be dying or seriously affected" not solely because of an adverse drug reaction, but more as a result of the disease's progress. "We wouldn't want to prematurely stop a particular trial," Young stated. Under the "parallel track" or "expanded use" system, selected experimental AIDS drugs would be made available after Phase I testing to patients who have been excluded from efficacy trials and are unable to benefit from existing therapies. Weiss also asked Young whether data would be collected on patients getting early access to the experimental drugs and how useful such data would be to the FDA. "Data will be collected on safety. That's going to be extremely useful because individuals will be exposed to experimental therapies at an earlier stage and in larger amounts," the FDA commissioner replied. Explaining FDA's requirements for collecting the data, Young said: "We [will] follow the same regulations as [those used for] INDs; that is, unexpected deaths reported in five days, serious illness in fifteen days." He pointed out that the agency "does not feel that there will be significant efficacy data that will be gathered" from the open protocol track.
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