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Focus on Regulation

FDA Launches New Tool For Accessing Drug Adverse Event Information

FDA recently launched a public dashboard within the FDA’s Adverse Event Reporting System (FAERS) to improve access to data on adverse events related to drug and biological products.  FDA Commissioner Scott Gottlieb, M.D. stated, “Tools like [FAERS] are critical to the FDA’s ability to help ensure the greatest level of transparency and help patients and providers make safe use of drug and biologic products after they are approved by the FDA.”

The search tool is designed to make it easier for consumers, providers, and researchers to access this information – without having to submit a request under the Freedom of Information Act (FOIA).  While manufacturers are required to submit adverse event reports concerning their products, it is voluntary for healthcare providers and consumers.  The agency hopes increased transparency will encourage all stakeholders to submit more detailed and complete reports.  The FAERS database contains approximately 14 million adverse event reports submitted by various stakeholders.

CDER Director, Janet Woodcock, M.D., reaffirmed that the agency’s focus on safety extends beyond approval.  “In fact, our staff spends a lot of time looking at FAERS reports received regarding approved drug and biologic products and these reports can be very valuable components of our safety assessments.  By giving people a better understanding of these data, and the associated limitations, we hope the new interface will encourage people to submit more complete reports.”