FDA to Ease Adverse Event Reporting

October 27, 2008
Julia Ernst, MS

The FDA has started development on a MedWatch/Plus/Portal that will aim to be a fully automated system with current data.

In an attempt to make the reporting of adverse events (AE) easier, the FDA has started development on a MedWatch/Plus/Portal that will aim to be a fully automated system with current data that allows for simple reporting of AEs for regulated products. The system will be accessible to anyone—medical personnel, manufacturing companies, and consumers—. AEs to be included on the portal include product malfunctions, food-related concerns, and medical complaints, among other things. The FDA hopes to “better enable persons to submit their information.”

According to an exhibit report from the FDA on the Health and Human Services (HHS) website, the administration receives “more than 600,000 voluntary post-marketing adverse event reports annually from manufacturers, health care professionals and consumers.”

The portal will also feature the “Rationale Questionnaire,” a form that would help users sort through information in order to better judge what should be included in the AE report. “The system will compile the user's responses into a standardized report that would be routed to the appropriate FDA organizational components for review and analysis,” according to the exhibit report.

In addition to easier accessibility, the new system will lower the cost of preparing and processing AE filings, according to the HHS exhibit. Reports will also become more consistent and be filed in a more timely fashion. These anticipated positive results, as well as several others, align with the “FDA strategic goal of improving patient and consumer safety and also with DHHS strategic objective of improving health care quality, safety, cost and value.”

The MedWatch/Plus/Portal is currently only in the developing stages. The FDA is asking for comments on how this new Web-based version of the pre-existing MedWatch system might improve the simplicity of filing reports for consumers, manufacturers, and healthcare professionals.