Tomorrow, the Food and Drug Administration will publish two proposed regulations that hold the potential to improve access to and analysis of safety information provided by the medical product industry (drug, device, and biologic makers, and others in the supply chain). Both regulations will be open for comment for 90 days.

One regulation will require electronic reporting of adverse health events associated with the use of medical devices. The other would require similar electronic reporting of safety information for drugs and biologics. (In both cases, the rules cover only medical products already approved for use.)

Both rules would benefit the public, FDA says: “The principal benefit…would be the public health benefits associated with more rapid processing and analysis” of device, drug, and biologic adverse events reports. Faster processing could lead to “faster identification of safety problems.”

FDA would also benefit from the reduction in paper handling. FDA says it currently receives 100,000 medical device reports by paper. In 2006, 60 percent of the 445,000 drug and biologic reports the agency received came by paper.

The proposed rule does not include a discussion of the potential benefits of faster public access to the safety reports. The electronic reporting systems will allow FDA to more quickly upload medical device reports to the Manufacturer and User Facility Device Experience (MAUDE), a publicly accessible online database of medical device reports, and drug and biologic reports to the Adverse Events Reporting System (AERS).

Currently, FDA only updates MAUDE once per month. AERS updates quarterly. The rule does not specify whether electronic reporting will allow for more frequent updates.

I’m not a regular user of MAUDE or AERS, so I can’t speak to their usefulness. Should FDA’s proposal address other improvements to the databases? If you have any experiences or thoughts, feel free to share them in the comment section below.

Image by Flickr user vectorlyme, used under a Creative Commons license.