Post-Marketing Surveillance Requirements

By federal law, generic drug manufacturers are required to assure the safety of their products through post-marketing surveillance and reporting.

Generic manufacturers must file quarterly adverse drug experience reports for the first three years after their product has been approved, and annually thereafter. In addition, serious and unexpected events must be reported to FDA within 15 days.

It must be noted that given that the brand drug has been on the market for years, there is a great deal of first-hand knowledge already gathered about human experience with the drug.  Therefore, FDA typically requires additional studies only when there are new molecules with limited human experience. Since a generic MUST contain the same amount of active ingredient as the brand, typically the types of adverse events reported are similar.

In situations where questions have been raised about any prescription medicine—brand or generic—it is always a good idea to ask your doctor or pharmacist for advice.