FDA Launches Adverse Event Reporting System Public Dashboard

The FDA’s Adverse Event Reporting System (FAERS) Public Dashboard, a new, user-friendly tool available to search the FDA’s adverse event (AE) database for drugs and biologics, has been launched. FAERS contains 14 million AE reports submitted by healthcare providers, consumers, manufacturers of drugs and biologics, and other stakeholders. The accessible database is designed to improve transparency and accessibility to AE data by allowing users to search it more easily.

"The FDA is committed to fully informing patients and providers of adverse events reported with medical products, and this enhanced portal now provides patients, doctors, and others with easier access to the data they are interested in," said FDA Commissioner Scott Gottlieb, MD. The improvements made to FAERS are important steps forward in making the database a more effective tool for postmarketing pharmacovigilance as well as efforts to track and ultimately reduce the number of AEs associated with medications.

Users of FAERS can now run searches based on criteria including product, patient age, type of AE, or time frame in which the AE occurred. The FDA hopes the increased transparency will spur the submission of more detailed and complete reports of AEs from consumers, healthcare providers, and others by making it easier for people to see other reports that the FDA receives and search the database for similar observations.

FDA uses FAERS for surveillance by looking for new safety concerns that might be related to a marketed product, evaluating manufacturers’ compliance with reporting regulations, and responding to outside requests for information. Reviewers from the agency’s Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research evaluate reports on FAERS and monitor the safety of products after they are marketed. If a potential safety concern is identified in the FAERS database, further evaluation is performed. The FAERS data will be updated quarterly by the FDA. FAERS does not include reports about vaccines or medical devices, which are found in different databases.

The FDA notes that that there are limitations to the data FAERS provides. Although FAERS contains reports on AEs associated with a particular drug or biologic, this does not mean that the drug or biologic caused the AE, and FAERS data alone are not an indicator of the safety profile of the drug or biologic. Other limitations include the following:

• Duplicate and incomplete reports are present in the system
• Some reports do not contain all necessary information
• Submission of a report does not mean that the information included has been medically confirmed, nor is it an admission from the reporter that the drug caused or contributed to the event
• Rates of occurrence cannot be established with the reports found on FAERS

Early signs suggest that some investors are concerned by the launch of the FAERS Public Dashboard; CNBC reports that 1 day after the launch of the tool, biotech stocks fell because investors found AE reports on their drugs.