An ounce of prevention: Dealing with the threat of counterfeit pharmaceuticals

Abstract

Unlike counterfeit handbags, watches, or movies that one can buy from a street vendor, counterfeit pharmaceuticals present a real and imminent public health risk. How to prevent counterfeit pharmaceuticals from entering the consumer supply chain has challenged the United States Food and Drug Administration (FDA) and other regulators since the late 1980s. FDA has not yet successfully implemented final regulatory safeguards in this arena, leading some drug manufacturers to delay implementation of anti-counterfeiting measures. Drug manufacturers are taking a considerable risk, however, by waiting for FDA to overcomethe complexities of broad-based regulation. First, when FDA issues final regulations, manufacturers must be ready to comply. Second, and more important, companies need safeguards against counterfeits in order to protect their businesses from profit loss, serious erosion of consumer confidence, and possible legal exposure. As regulators and courts delay, company exposure to each of these threats increases. Prudent manufacturers should make anti-counterfeit measures a current priority to prevent threats to their business from materializing into potentially irreparable harms. This article outlines the regulatory landscape, identifies threats that counterfeit pharmaceuticals pose to the industry, and highlights proactive steps that drug manufacturers can, and should, take to protect themselves.