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Executive Summary

NDA REWRITE AMENDMENT FOR ADVERSE DRUG REPORTING REQUIREMENTS is likely to be issued in final form before the end of 1987, FDA Office of Epidemiology/Biostatistics Director Gerald Faich, MD, predicted at the 11th annual meeting of the Regulatory Affairs Professional Society held Sept. 15 in Alexandria, Virgina. Noting that FDA proposed modifying the adverse drug reaction (ADR) reporting rules in December 1986, Faich said: "We are long overdue in getting the finalization, and I think we're getting close." Faich reiterated FDA's intention to incorporate two changes to loosen up reporting requirements: (1) a change in the definition of serious ADRs so that events requiring prescription drug therapy no longer trigger 15-day reporting requirements; (2) the addition of a causal assessment for serious adverse events obtained from foreign experience and post marketing studies. Both changes were endorsed by the agency in its proposed rule. Faich noted that the final rule will retain the term "life-threatening" as part of the definition of serious adverse events. Following publication of the proposed rule, Lilly and J&J submitted comments to FDA requesting that the agency delete the life-threatening portion of the definition. Both firms argued that term was ambiguous and unnecessary. Faich explained that the ADR reporting rules were being modified to eliminate unnecessary reporting. The FDAer observed that the agency "has had considerable trouble dealing" with serious reports for a marketed drug, seen in postmarketing studies or in foreign data, where events that are not associated with the drug are reported to FDA. For example, he said, suppose "you're treating metastatic cancer with an oncolytic agent and the patient dies of cancer. Now, is that reportable? or isn't it? If you use the IND preapproval mentality, of course that is reportable, but if you are using postmarketing reporting, that just clutters up the system." Faich said, "the FDA is now in the process of adding a causality assessment for studies which says, 'only if there's a reasonable possibility that the drug caused the reaction.'" ADR reporting under the NDA Rewrite, implemented in August 1985, has resulted in increased reporting. In 1986, Faich said, "we received some 53,000 reports, excluding follow-up reports. That's a five-fold increase over five of the six years before, and I fully expect that this will go over 100,000 in the next couple of years." Domestic ADR reports in 1985 numbered approximately 26,000. Of the 53,000 reports submitted in 1986, "about 51% represent manufacturers' spontaneous domestic reports from health professionals; 5% represent direct reports to FDA; 5% are for overdose [or] lack of effectiveness, which is of some interest to those of you following the generic issues; 10% are consumer reports; 2% are literature reports; 11% are study reports; and 16% are foreign reports," Faich said. Foreign and study reports combined, representing 27%, "is the wedge that is growing most quickly and causing us some difficulty . . . and "that is one of the reasons we sought to change the regs," he added.

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