How does the FDA find out about adverse events?
Doctors and health care professionals generally report adverse events to drug companies, which are then required by law to relay serious reports to the FDA within 15 days. Health care providers should report an adverse event if it results in death, disability, hospitalization, is life-threatening, causes a congenital anomaly, or requires treatment to prevent permanent damage. For the first three years after a drug is approved, the drug manufacturer must also report all of its adverse event information to the FDA quarterly, and after three years, these reports must be submitted annually.
