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IND REWRITE: INVESTIGATOR ADVERSE EVENT REPORTING PROVISIONS

Executive Summary

IND REWRITE: INVESTIGATOR ADVERSE EVENT REPORTING PROVISIONS should be changed to more closely parallel the new requirements for reporting by sponsors to FDA, Office of Drug Research and Review Director Robert Temple, MD, suggested at a Drug Information Association (DIA) meeting in Rockville, Md. Sept. 9. Temple noted that the present wording of the regs has led to confusion regarding the new procedures for investigator ADR reports to sponsors. FDA is "aware of the problem created by this section," Temple said, "and I think we are going to have to fix that part -- making it track better with the requirements for safety reports from the sponsor." The new IND regs call for an investigator to "promptly report . . . any adverse effect that may be regarded as caused by, or probably caused by, the drug. If the adverse effect is alarming, the investigator shall report the adverse effect immediately." Temple noted that this provision could lead to an unnecessary reporting burden on investigators. Temple told DIA, "we don't imagine that sponsors want every dry mouth report promptly, and we don't see any interest in that either." In order to better clarify FDA expectations, Temple said that the agency intends to revise the regulations on investigator reporting to emphasize "serious reactions and the need to devote special efforts if those reactions are fatal or life threatening -- using much the same language" as the sponsor/FDA reporting requirements. Office of Drug Research and Review Acting Deputy Director Paula Botstein, MD, noted that the investigator is responsible for making the first determination of whether an adverse event should be reported to FDA. If the investigator reports to the sponsor that the event is associated with the drug under evaluation and meets the "serious and unexpected" reporting criteria, the company should forward those reports to FDA, Botstein said. "The company may, in addition, want to agree or disagree with the investigator, but I think it has an obligation to notify the FDA," she said. Several industry reps at the DIA meeting pointed to a need for the agency to better clarify its requirements regarding the overall relationship of clinical investigators to sponsors in light of the new regulations. Wallace Labs Regulatory Affairs VP James Taylor, PhD, maintained that, in the process of defining the new IND regulations, sponsor/monitor relations "have been grossly overlooked." Taylor pointed to a lack of "how to" information in the final regs. He noted, for example, that FDA has proposed regulations that discuss laboratory standards and accreditation for laboratory use. However, "this is not in the current regs," Taylor noted. He also cited a need for a compliance policy guide to better inform FDA inspectors on the current requirements regarding sponsor/monitor obligations. According to FDAer Temple, the proposal for revised clinical monitoring regulations has been placed on hold at the agency. Division of Metabolism and Endocrine Drug Products Director Solomon Sobel, MD, discussed procedures for reporting by contractors of adverse preclinical findings. The FDAer advised sponsors to clearly define the procedures with the contractor early in the relationship. "Built into the system will be the ability to handle the issues of how to interpret preclinical reporting," Sobel said.

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