How does the Food and Drug Administration find out about adverse events or side effects?
The Food and Drug Administration finds out about adverse side effects primarily through its collected voluntarily reported cases of an adverse event. The vast majority of these come to the manufacturer or sponsor of the pharmaceutical agent. Ninety percent of the reports that we receive at the FDA come through that route — from a physician, pharmacist, health care institution, or other provider who reports to the manufacturer, who follows up on that case and then reports to the FDA. If an adverse event is serious — which means it could cause death, it resulted in hospitalization, or was potentially life-threatening or prolonged the hospitalization — the manufacturer has a legal responsibility to report that case to the FDA within 15 days of receipt. For all other adverse events that are reported to the FDA, the manufacturer, again, has a responsibility to report those to us on a quarterly basis for the first three years after a drug is approved, and then annually thereafter. The oth
