FDA Now Making Data Available from CFSAN’s Adverse Event Reporting System (CAERS)

As part of the FDA’s commitment to transparency, for the first time it has begun posting data from CFSAN’s Adverse Event Reporting System (CAERS) on FDA.gov here and through OpenFDA. It’s downloadable in ASCII format, which is amenable to automated querying.

The database contains information on adverse event and product complaint reports submitted to the FDA for Center for Food Safety and Applied Nutrition (CFSAN)-regulated products including foods, dietary supplements, and cosmetics. While the FDA uses the data to identify potential safety signals for products, or reports that may require further follow-up, the agency has not necessarily determined that the reported events were actually caused by the product in question. In other words, CAERS data does not represent conclusions by the FDA that a product caused a reported event.

Formerly only available by submitting Freedom of Information Act (FOIA) requests, the FDA is making the information more easily accessible to the public and stakeholders like manufacturers, researchers,  and health professionals. The FDA believes this increased transparency may result in more detailed and complete reports, helping them more rapidly identify red flags signaling possible safety issues with the products they regulate.

The initial data file contains data from January 2004 through March 2016. Subsequent data files will contain raw data extracted quarterly, and will be posted when available.

This new endeavor will undoubted have significant implications for manufacturers whose company name and products will appear in the database along with the reports of adverse effects suspected to be associated with product use.  Given the limited accompanying data it will be difficult to determine what, if any, role the products may have played in the reported event.  That kind of determination requires much more in-depth analysis of the events and all supporting documentation.  It remains to be seen how releasing the data in this format will impact safety surveillance for these products.