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IND SAFETY REPORTS: PROMPT REPORTING IS MORE IMPORTANT

Executive Summary

IND SAFETY REPORTS: PROMPT REPORTING IS MORE IMPORTANT than a definitive determination of the cause of an adverse event, FDA Office of Drug Research and Review Acting Deputy Director Paula Botstein, MD, told a Sept. 10 meeting of the Drug Information Association (DIA) in Rockville, MD. In making the initial safety report, "the idea is prompt reporting as a trigger, a signaling mechanism," Botstein explained. "You report what information you have about the adverse experience itself. There is no requirement for a definitive determination of any causality on those safety reports." While "it certainly is in everybody's interest to try and pursue that question to find out if the hypothesis is correct," FDA Office of Drug Research and Review Director John Temple, MD, added, "you report it first and then work it up later." Reporting on an informal survey among PMA companies, Merrell Dow Regulatory Affairs V. P. George Ohye, noted that 70% of respondants viewed the safety report section as the most challenging part of the new IND regs to interpret. By contrast, Ohye told the DIA meeting, the sections of the regs dealing with IND format and IND methods were "listed by only 24% and 6% of the respondants, respectively, as troublesome." Ohye said that the informal survey was designed to take a sounding of initial reactions to the new IND regulations, and that 22 companies had responded to date. Temple explained at the meeting that FDA's emphasis in the new safety reporting requirements is on rapid communication of problems serious enough to change or interrupt the investigations that are taking place. "What we want to know about is anything that is crucial to the patient's safety, that suggests that the studies need to be modified, or in the worst case terminated. We want to know about them very quickly, and we want to participate in the judgement of what is important." The new regulations call for sponsors to make some determination that the reaction is both serious and reasonably likely to be associated with the drug before filing a report, Temple noted. However, he advised sponsors "to be careful not to dismiss reactions as due to the underlying disease. All too often they turn out not to be." Serious and unexpected reactions should be reported, Temple maintained, where it remains unclear that the drug is responsible. Citing as an example the difficulty that can arise in interpreting arrhythmias, Temple advised that "when you are not reasonably sure, then you consider [the reaction] as possibly related to the drug and report it, get it into the brochure as a possibility that is under evaluation, and then do a controlled trial to find out." FDA Division of Biological Investigational New Drugs Director Bruce Burlington, MD, noted that overreporting of adverse events can also be a problem for the agency. In Biologics, Burlington said, "people tend to overreport adverse experiences. Where they have made an assessment and in their opinion there is no possibility that the adverse event is related to the use of the drug, they report it anyway just for the sake of completeness or corporate concern that they would subsequently be challenged on it." Such inappropriate reporting, Burlington noted, "is a burden on the agency and a problem."
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