US FDA proposes mandatory electronic safety reporting

Proposals to amend post-market safety reporting regulations for three of its centers to require that manufacturers and other facilities subject to current reporting requirements submit their reports in an electronic format have been issued by the US Food and Drug Administration.

The agency issued two proposed rules on August 20 - one that applies to electronic medical device adverse event reporting and for drug and biologic product adverse experience reporting. These would not change what types of incidents are required to be reported to the FDA;  it would require that the incidents be reported in an electronic format that the FDA can process, review and archive.

'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,' said David Buckles, director of the Division of Postmarket Surveillance at the FDA's Center for Devices and Radiological Health. 'Information obtained from these reports may be critical to future action that improves patient safety,' he added.

Currently, the CDRH receives most mandatory medical device adverse event reports on paper, which requires that reports are manually entered into the center's adverse event database, called the Manufacturer and User Facility Device Experience (MAUDE) database, for further analysis. Not only is this step costly, but it hinders the CDRH's ability to review safety data quickly to uncover potential public health problems, says the FDA.

The FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) currently also receive adverse event reports on paper forms or electronically. Safety reporting data submitted on paper forms must be manually entered into the FDA's Adverse Event Reporting System (AERS) before these data can be evaluated. Since 2000, the CDER and CBER have allowed manufacturers (through a pilot program and FDA guidance) to submit adverse event reports electronically, which get quickly entered into AERS. This pilot program has enabled FDA staff to more rapidly review post-marketing safety data and identify emerging safety problems. Safety reports in electronic format can currently be submitted to the FDA either through the FDA's Electronic Submission Gateway or on CD-ROM, digital tape, or floppy disk. International Conference on Harmonization (ICH) standards for data elements and technical specifications are used for these electronic submissions.