The Food and Drug Administration (FDA) has made a significant change in how it shares information about adverse events related to drugs and some vaccines. Starting Friday, the FDA began to publicly report these events in real time, a move that FDA Commissioner Dr. Marty Makary describes as a step toward “radical transparency.”
The FDA’s Adverse Event Reporting System, known as FAERS, is the main database for collecting reports about medication errors, prescription drugs, and certain vaccines. While FAERS handles many reports, vaccine-related incidents are primarily tracked through a different system called VAERS. Reports come from health care professionals, manufacturers, and consumers.
Dr. Makary emphasized the importance of quick and clear reporting. He stated that people should not have to wait months for information about adverse events to become public. The new approach aims to speed up this process and improve the overall system for reporting adverse events.
The FDA has made the FAERS public dashboard available online, allowing anyone to access this information easily. In a press release, the agency noted that this change is part of a broader effort to modernize its safety monitoring systems and enhance public health protection.
This shift is just one of many steps in the FDA’s plan to improve how it handles adverse event reports. The goal is to identify safety signals more quickly and efficiently.
In related news, Robert F. Kennedy Jr., who leads the Department of Health and Human Services, has made significant changes regarding therapeutics and vaccinations. Recently, he restructured the Advisory Committee for Immunization Practices (ACIP), replacing all 17 current members with new ones, including critics of the COVID-19 vaccines. Kennedy believes the previous committee had conflicts of interest and aims to restore public trust in vaccines.
Overall, these developments reflect a broader movement towards transparency and accountability in health reporting, with the FDA taking a proactive approach to protect public health.