FDA Proposes Mandatory Electronic Safety Reporting
September 8, 2009 // Published as a news service by IHS
The U.S. Food and Drug Administration (FDA) proposed two rules to amend post-market safety reporting regulations, which would require the reports to be in an electronic format.
One rule applies to electronic medical device adverse event reporting and the other rule applies to electronic drug and biologic product adverse experience reporting.
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 then eliminate manual processing of paper forms by both manufacturers and the FDA.
Reports will be submitted to the FDA using either the International Conference on Harmonization (ICH) electronic standards or through an FDA safety reporting web portal that is under development.
The Center for Devices and Radiological Health (CDRH) receives most mandatory medical device adverse event reports on paper. Reports must then be manually entered into the center's adverse event database - the Manufacturer and User Facility Device Experience (MAUDE) - for further analysis.
The FDA considers this step costly and it hinders CDRH's ability to review safety data quickly to uncover potential public health problems.
The proposed regulation for medical devices would require manufacturers, importers and user facilities to submit reports to the FDA in electronic format, which will be loaded into the MAUDE database.
The electronic medical device reporting system (eMDR) provides a choice of two electronic options for reporting post-market safety information. Small manufacturers with a limited number of reports may prefer an application known as eSub, which runs on free software available from the FDA.
Large manufacturers, which can submit hundreds of reports per year, may prefer to use a batch submission protocol based on an informatics standard.
The FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) 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, CDER and CBER allowed manufacturers (through a pilot program and FDA guidance) to submit adverse event reports electronically, thereby getting them quickly entered into AERS, according to the FDA.
This pilot program enabled FDA staff to rapidly review post-marketing safety data and identify emerging safety problems.
Safety reports in electronic format can be submitted to the FDA either through the FDA's electronic submission gateway or on CD-ROM, digital tape or floppy disk. ICH standards for data elements and technical specifications are used for these electronic submissions.
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.
The proposed rule for medical devices also does not apply to reports submitted on a voluntary basis.
Manufacturers submitting reports under either rule would be required to obtain an electronic certificate to use the FDA electronic submissions gateway.
More information about eMDR is available from the FDA.
Source: U.S. Food and Drug Administration (FDA).