Electronic Safety Reporting May Soon Be Mandatory, says FDA

August 27, 2009
Angie Drakulich

Angie Drakulich was editorial director of Pharmaceutical Technology.

ePT--the Electronic Newsletter of Pharmaceutical Technology

The US Food and Drug Administration announced in an Aug. 20, 2009 release that it would like to amend postmarket safety reporting regulations "to require that manufacturers and other facilities subject to current reporting requirements submit their reports in an electronic format."

The US Food and Drug Administration announced in an Aug. 20, 2009 release that it would like to amend postmarket safety reporting regulations “to require that manufacturers and other facilities subject to current reporting requirements submit their reports in an electronic format.”

One of two new proposed rules affecting drugs and biologics asks companies to submit adverse experience reports electronically so that the agency can process, review, archive, and retrieve critical information in a more efficient and effective way. The types of adverse events that must be reported remain the same. The second proposed rule applies to adverse events for medical devices.

Currently, reports are submitted on paper and entered into the FDA system manually. “Both proposed rules will improve the agency’s ability to obtain safety information more quickly, which will help lead to faster identification of potential safety problems. Information obtained from these reports may be critical to future action that improves patient safety,” said David Buckles, Ph.D., director of the Division of Postmarket Surveillance at the FDA’s Center for Devices and Radiological Health (CDRH), in the release.

The agency’s Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research began a pilot program in 2000 to allow manufacturers to submit electronic adverse event reports through FDA’s Electronic Submission Gateway or on CD-ROM, digital tape, or floppy disk. The International Conference on Harmonization (ICH M4) defines standards for these submissions. Under the proposed rule for drugs and biologics, firms will be able to submit electronic reports using ICH standards or through a new safety reporting Web portal that FDA is developing. Firms that wish to use the gateway will need to obtain an electronic certificate from the agency first.

Not covered in the proposed rule for drugs and biologics are: “safety reports filed under an investigational new drug application, annual reports that manufacturers submit to FDA on approved drugs and biologics, biologic product deviation reports, reports of complications of blood transfusion and collection confirmed to be fatal, and certain reports on human cells, tissues and cellular and tissue-based products.”