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Executive Summary

ADVERSE REACTIONS OF COMPETITOR PRODUCTS FOUND DURING CONTROLLED STUDIES may be reported instead of to the mfr. if the reaction is a serious one requiring reporting within 15 days, FDA Center for Drugs and Biologics Director Harry Meyer, MD, said in a recently issued Q&A document on the agency's guidelines for postmarketing reporting of adverse drug reactions. The Q&A states that "when adverse events (reactions) are found for a competitor's drug during a controlled study. . . 15-day type reports (serious, unlabeled events or increased frequency of serious labeled events) associated with a competitor's products may be made directly to FDA." However, the guideline clarifications note, "generally, reactions to a competitor's drug should be reported to the manufacturer of the drug." In the case of a controlled study the FDA is making an "allowed exception. . .in order to protect competitive information." In a cover letter to the Q&A, Meyer stated that the postmarketing adverse drug reaction (ADR) reporting guidelines would be redrafted in January 1986. The Q&As, Meyer said, "are bridging statements that are intended to provide interim guidance to applicants." Commenting on the 15-day clock for reporting ADRs, the document states that it starts when the applicant receives information indicating that a reported reaction fulfills the criteria for filing a 15-day report, i.e., that a serious, unlabeled reaction has been received or that a serious, labeled reaction has been reported at increased frequency." If the outcome of an adverse event is unknown "and therefore whether the reaction is serious cannot be determined, the report should be submitted in the periodic report," the document states. "If the reaction is later found to be both serious and unlabeled, the 15-day time period begins with receipt of this follow-up information." If the event(s) occur during a blinded study, the agency continued, "reports should be made only when the code is broken; i.e., within 15-days after the code is broken and serious unlabeled reactions are found." Defining what constitutes a "life-threatening" reaction, the document states that the term "refers to a reaction (event) associated with. . .death, new hospitalization, ]or[ prolonged hospitalization." Thus, a serious reaction "is one that is associated with one or more of the following: death, new hospitalization, prolonged hospitalization, permanent or severe disability, prescription drug therapy, congenital anomaly, cancer, or overdose." Only "overdoses which are associated with adverse reactions (events) need to be reported," the document explains. "If no adverse event occurs, the fact alone of overdose need not be reported. If the resultant or associated reaction is unlabeled, then a 15-day report must be filed; if labeled, then the report is filed within the periodic report."

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