Progress Report: A Comprehensive Evaluation of the FDA's Battle against Counterfeit Drugs

Abstract

Although drug counterfeiting is a major issue in many regions of the world, the U.S. drug supply is generally safe due to extensive federal and state oversight and steps taken by drug manufactures, distributors, and pharmacies to prevent drug counterfeiting. The U.S., however, now faces an increasing counterfeit drug threat due to advances in counterfeiting technology and increased financial incentives for criminals to introduce counterfeit drugs into the U.S. drug supply. The first half of this paper describes the threat posed by counterfeit drugs, discusses the scope of the counterfeit drug problem, explains how counterfeit drugs may be introduced into the U.S. drug supply, and discusses past efforts taken by U.S. authorities to secure the drug supply. The second half of this paper analyzes the FDA’s 2004 recommendations on how to best fight the counterfeit drug threat, addressing the merits of the FDA’s recommendations as well as the FDA’s success in implementing such recommendations thus far.