US initiatives in post-marketing drug surveillance

Abstract

The starting point for my overview of some of the changes that have occurred in post-marketing surveillance at the Food and Drug Administration (FDA) during the past 3 years, is the recognition that industry, the medical community and regulators share the responsibility for ensuring that drugs are used in safe and appropriate ways. The jobs of the regulator and the drug developer are not completed when a drug is approved. We must monitor real-world drug use, through post-marketing surveillance, to gain new safety information not available when a drug is first marketed. The FDA’s activities in post-marketing surveillance can be divided into two segments: monitoring adverse drug reaction (ADR) reports and the conduct of pharmacoepidemiology.

The opinions expressed here are those of the author and do not necessarily represent those of the Food and Drug Administration.