FDA Launches New & Improved Adverse Event Database for Drugs & Biologics

Last month, the FDA launched a new tool that allows users to search for data on the adverse events associated with drug or biological products, which was added as a dashboard to FDA’s Adverse Event Reporting System (FAERS).  The Agency’s goal was for the tool to be user-friendly, and it was designed to make the information more accessible for consumers, providers, and researchers.

According to a statement released by the FDA, “the new dashboard enables users to search for and organize data by criteria such as drug/biological product, age of the patient, type of adverse event, year the adverse event occurred, or within a specific timeframe.”  Furthermore, in addition to the improved search function of the database, the Agency also states that it “hopes the increased transparency will spur the submission of more detailed and complete reports from consumers, health care professionals and others, by making it easier for people to see other reports that the FDA receives, and search the database for similar observations.”

The FAERS database is also used by the FDA for surveillance purposes.  For example, the Agency may use it to:

• Look for new safety concerns that could potentially be related to a currently marketed product
• Evaluate a manufacturer’s compliance with reporting regulations
• Respond to outside requests for information regarding the adverse events reported with the use of certain drug or biological product.

In order to monitor the safety of products after they are approved, all of the reports provided in the FAERS system are evaluated by clinical reviewers within CDER and CBER.  If a potential safety concern arises during this review, further evaluation of the potential issue is completed.

FDA notes that there are still limitations associated with the data that is provided through the dashboard. Specifically, FDA states that “while FAERS contains reports on adverse events associated with a particular drug or biologic, this does not mean that the drug or biologic caused the adverse event. Importantly, the FAERS data by themselves are not an indicator of the safety profile of the drug or biologic.”  Although consumers now have access to more data and information about the side effects of drug and biologic products, the Agency still advises patients to speak with their health care providers if any questions or concerns arise regarding a medication.

In addition to the FAERS database for drugs and biologics, FDA also has adverse event reporting programs and databases for:

• Foods, dietary supplements, and cosmetics - CFSAN Adverse Event Reporting System, or “CAERS”
• Medical devices – Manufacturer and User Facility Device Experience, or “MAUDE”
• Vaccines - Vaccine Adverse Event Reporting System, or “VAERS” (co-managed by the FDA & the CDC).

“The FDA encourages health care professionals and consumers to report adverse events or quality problems experienced with the use of drug and biologic products to the FDA’s MedWatch Adverse Event Reporting program. To do so:

• Complete and submit the report online at fda.gov/medwatch/report.htm; or
• Download and complete the form, then submit it via fax at 1-800-FDA-0178.”

Are you using the FAERS database and still have questions? We can help you achieve successful interactions with the Agency and get your product approved by the FDA. Contact us today to learn more about our services and how we can be of assistance to you.