The U.S. Food and Drug Administration (FDA) has just announced a proposal to amend postmarket safety reporting regulations for three of its centers. This amendment would require that manufacturers, importers, and user facilities be subject to current reporting requirements and submit reports to the FDA in an electronic format.

According to a press release on the FDA's website, the agency has issued two proposed rules. One applies to electronic medical device adverse event reporting, and one applies to electronic drug and biologic product adverse experience reporting. The rules would not change the type of incident reported, but that the incidents should be reported in electronic format. The FDA can then process and review the reporting.

"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, Ph.D., director of the Division of Postmarket Surveillance at the FDA's Center for Devices and Radiological Health (CDRH). "Information obtained from these reports may be critical to future action that improves patient safety."

The CDRH now receives mandatory medical device adverse events on paper. The paper reports are then manually entered into MAUDE, the Manufacturer and User Facility Device Experience. The FDA says this method is both costly and impedes ability to review safety data in a timely manner. The proposal would have those subject to reporting requirements use the electronic medical device reporting system known as eMDR. eMDR has two electronic options for reporting postmarket safety information. Small manufacturers with a limited number of reports can use an application known as eSub, which runs on free software available from the FDA. Larger manufacturers with potentially hundreds of reports per year may use a batch submission protocol, which the FDA says is based on a widely recognized informatics standard. Those reports would then be loaded into the MAUDE database.

The proposed rule for medical devices does not apply to reports submitted on a voluntary basis.

For drugs and biologics reporting, the proposed rule would require manufacturers, packers and distributors to submit reports to the FDA in electronic format using ICH electronic standards or through an FDA safety reporting Web portal now under development. 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 that would submit under either rule (drugs or devices) will be required to obtain an electronic certificate in order to use the FDA Electronic Submissions Gateway. The FDA has draft guidances for devices and for drugs and biologics.

The FDA has been allowing submission of adverse event reports through a pilot program since 2000, which the FDA says has allowed staff to swiftly review postmarketing safety data and identify emerging safety problems. The 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.

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

Adapted from a press release by the FDA.

Link: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm179596.htm

More Industry Headlines