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.

The proposed rule for drugs and biologics reporting would require manufacturers, packers and distributors to submit reports to the FDA in electronic format, which will eliminate manual processing of paper forms by both manufacturers and the FDA. Reports will be submitted to the FDA using either the ICH electronic standards or through an FDA safety reporting Web portal that is currently under development.

'Electronic reporting of serious and unexpected adverse experiences will reduce industry costs and encourage better communication with the FDA and other regulators,' said Gerald Dal Pan, director of the CDER's Office of Surveillance and Epidemiology.

The proposed rule for drugs and biologics reporting does not apply to safety reports filed under an investigational new drug application, annual reports that manufacturers submit to the 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.

Manufacturers submitting reports under either rule would be required to obtain an electronic certificate to use the FDA Electronic Submissions Gateway. Information on how to prepare and send post-market safety reports for devices and for drugs and biologics is contained in draft guidance documents. Draft guidance for device reports is available from August 20, but draft guidance for drug and biological product reports has been available since June 2008, the agency noted.