FDA plans electronic filing for some safety reports

The rules would affect only the format in which reports are submitted and not their content for filing.

The Food and Drug Administration (FDA) today proposed rules that would require reports of adverse effects from approved drugs and medical devices to be filed electronically.


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The rules, which would affect only the format in which reports are submitted and not their content, would provide manufacturers, packagers and shippers of drugs and devices with several options for filing, including an electronic gateway, physical media and a Web portal now under development.

“This should significantly improve our ability to monitor the safety of devices already on the market,” said David Buckles, director of FDA’s Division of Postmarket Surveillance in the Office of Surveillance and Biometrics at FDA's Center for Devices and Radiological Health (CDRH).

Electronic filing would improve efficiency and accuracy of post market monitoring, enhancing the ability to quickly identify and share information about safety concerns, said Dr. Gerald Dal Pan, director of the Office of Surveillance and Epidemiology in the Center for Drug Evaluation and Research (CDER).

“It can take up to two weeks for a report to be manually entered” into the FDA’s Adverse Event Reporting System, Dal Pan said. Electronic files can be transferred directly into the database, saving time, money and eliminating transcription errors.

The proposed rules would apply to the mandatory reports of adverse events required for medical devices by CDRH, and those required for drugs by CDER and the Center for Biologics Evaluation and Research (CBER). They would not apply to safety reports filed under an investigational new drug application, annual reports submitted by manufacturers 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.

CDRH, CDER and CBER already have systems in place to receive electronic files, and for many submitters the rules would not mean much of a change.

“A lot of companies already are doing this,” said Dal Pan. He added that about 80 percent of the 500,000 reports received each year by the drug and biologics centers are submitted electronically.

“We’re not quite at the same level as drugs for electronic reporting,” Buckles said. Only about 15 percent of the 135,000 reports received by the devices center each year are filed electronically.

CDRH’s Electronic Medical Device Reporting system (eMDR), offers two options for electronic reporting. Small manufacturers with a limited number of reports can use the eSub application, which runs on free FDA software. Large manufacturers that might submit hundreds of reports per year may prefer to use a batch submission protocol, based on an international informatics standard from the International Conference on Harmonization.

Since 2000, a CDER and CBER pilot program has let manufacturers submit reports electronically, 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 gateway is expected to be used for most submissions, particularly companies with large numbers of reports. For smaller organizations with fewer reports and for consumers, a Web portal is being developed for submissions.

There will be a 90 day comment period on the proposed rules before they can be finalized and they will become effective a year after the final rules are published. Except for the Web portal, which remains under development, FDA is ready for electronic submissions.

“FDA is ready for this, and we’ve been doing it for several years,” said Dal Pan.

“Our processes are in place and we’re ready to receive reports,” said Buckles.

However, the Web portal, which could take another 18 months to be put into place, might not be available when the rules go into effect, which could leave small organizations without a convenient way to submit reports.

“We’ll just have to see how the timing of the rules goes,” said Dal Pan. “We hope to have it up and running” by the time the rules are finalized; but if it is not, FDA will work with small companies to accommodate them.

About the Author

William Jackson is a Maryland-based freelance writer.

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