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FDA Conducts Preliminary Review of Supply Chain Vulnerabilities Related to Diversion, Counterfeits, and Substandard Products
As part of FDA’s proactive approach to preventing diverted, counterfeit, and substandard products from entering the legitimate US drug supply chain, the agency has analyzed information from judicial diversion and counterfeiting cases to help prioritize the agency’s risk management activities. A preliminary report of the analysis, based on cases investigated by the FDA Office of Criminal Investigations (OCI), describes potential threats to drug quality and integrity and identifies risks and vulnerabilities in the drug supply chain. For example, the “review revealed various schemes and examples of the types of players in the supply chain, how different products enter the supply chain, and how fraudulent or diverted products were discovered. Having a better understanding of these characteristics will help [FDA] to identify potential vulnerabilities.” The report describes a counterfeit drug scheme in which the products were stopped at the border; a diversion scheme illustrating vulnerabilities to the supply chain when unscrupulous wholesale distributors are involved; and a diversion scheme involving a pharmacy and a pharmacist who sold diverted drug samples. FDA notes that the report is based on an initial review of “OCI case information and does not contain statistical inferences, future trend predictions or opinions. FDA expects to conduct further analysis and report as appropriate.” The “Preliminary Review of Agency’s Diversion and Counterfeit Criminal Case Information” (PDF) may be downloaded from the FDA Web site.
