Postmarketing surveillance—lack of vigilance, lack of trust

Abstract

The current approval process for drugs and biological agents in the United States has come under intense scrutiny. The major problem with the current system for ensuring the safety of newly approved medications is that drug manufacturers are largely responsible for collecting, evaluating, and reporting data from postmarketing studies of their own products. Serious adverse drug events are quite uncommon, and detecting them accurately and using them to determine incidence rates can be difficult with the current passive system for voluntary reporting of adverse drug events.