Safety of the U.S. prescription drug supply

Introduction/Objective: The contamination or adulteration of medical products, whether deliberate or the result of problematic manufacturing, presents a serious risk to patient health. The deaths of Americans who received the contaminated blood thinner heparin in 2007 and 2008 focused attention on the risks of a globalized and increasingly outsourced pharmaceutical manufacturing system. The past decade has witnessed a transformation of the routes drugs travel from creation to distribution. Rapid globalization of manufacturing as well as growth in pharmaceutical trade has shifted the geography of drug production and has multiplied the players involved in their movement. The true prevalence of counterfeit or adulterated drug product is unknown. Estimates in developing countries range as high as 40%. The U.S. domestic prevalence is lower – the U.S. Food and Drug Administration (FDA) puts it at “less than 1%,” but no reliable data exist. Even a rate of one-tenth of one percent would equate to millions of counterfeit, adulterated or substandard prescriptions each year. 148 U.S. patients developed hypersensitivity reactions and died after receiving contaminated heparin. Counterfeit erythropoietin also reached US patients in several states in 2002. In 2009 and 2010, Johnson & Johnson recalled contaminated Tylenol products that reportedly caused nausea and vomiting. This paper presents an overview of the pharmaceutical manufacturing and distribution supply chain, and proposals for meaningful reforms to enhance public safety. Methodology: Research methods included review of regulatory documents, peer-reviewed and specialty publications, as well as background interviews with more than 60 supply chain experts, including regulators and representatives of the manufacturing, distribution and pharmacy industries. Results: The current regulatory framework and industry standards must be updated to address new risks associated with the globalization of pharmaceutical manufacturing and distribution. The FDA lacks the resources and authority to effectively inspect foreign manufacturing facilities or assess risk. During distribution, insufficient regulation and minimal tracking has meant that drug theft, diversion (illegal movement from designated routes), and counterfeit are inadequately addressed. Congress must institute reforms that ensure FDA oversight and industry management of overseas manufacturing are increased; drug testing standards are strengthened; drug distribution tracking and regulation are improved; and that FDA is given the resources and authorities it needs to significantly elevate its internal capacity and regulatory presence.