The Institute for Safe Medication Practices has issued a scathing report on the Food and Drug Administration’s adverse event reporting system.
This computerized database collects information on drug side effects from patients, physicians, pharmacists and drug companies. The vast majority of the reports are submitted by manufacturers, but they are often incomplete. Only about half of those examined contained crucial basic information.
An FDA spokesman admitted that collecting accurate adverse event data is challenging and that reports are often subpar.
Out of Date?
Unfortunately, the FDA has not updated its adverse event reporting system in more than a decade. Without better data, it will be hard for the Food and Drug Administration to accurately assess the safety of our medications.
