FDA Proposes New Rules for Reporting of Medical Device and Drug Problems

The Food and Drug Administration is considering requiring makers of drugs, biologics, and medical devices to report problems with the products once they are available to patients to the FDA in electronic form rather than on paper.

Doing so would improve the agency’s ability to efficiently manage and respond to reports of problems with medications, heart stents, replacement joints, and other types of medical devices, the agency said.

In a posting today on the FDA website, safety officials said requiring medical device and drug manufacturers to submit postmarket safety reports to the agency electronically would “help lead to faster identification of potential safety problems.”

Under the current rules, manufacturers most often file adverse event reports the old fashioned way: on paper. That requires the FDA to manually transfer the paper filings into a computer database, which is time-consuming, costly, and prevents the FDA from quickly reviewing safety data and uncovering potential threats to public health, the agency said.

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

Welcome to the 21st Century, FDA

In this Internet-friendly day and age filled with on-line transactions, instant messaging, and “tweets,” the FDA’s continued reliance on paper filings of medical device defect reports makes about as much sense as taking a horse and buggy to work. It’s about time the FDA got up to speed and forced medical device and drug makers to file adverse event reports electronically.

Medical device and drug manufacturers have since 2000 had the option of submitting adverse event reports electronically through a pilot program. The FDA is now considering making the electronic filings mandatory.

The FDA’s electronic medical device reporting system, called eMDR, allows manufacturers to report postmarket events in one of two ways. Small manufacturers who file a limited number of reports can use software provided by the FDA to report problems. Larger manufacturers who may submit hundreds of reports to the FDA each year, can file the reports in batches, the FDA said.

New Reporting Rule for Drugs and Biologics

Under the proposed new rules, makers, packers, and distributors of drugs and biologics also would be required to submit some adverse event reports to the FDA electronically. However, the new reporting requirements would 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.

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