According to estimates by the United States Food and Drug Administration (FDA), 80 percent of the active and bulk chemical ingredients in U.S. drugs now originate overseas. The increasingly global and outsourced production of drugs creates vulnerabilities in the pharmaceutical supply system, which, without sufficient oversight by industry and regulators, can put patients’ lives at risk.
Once a finished drug enters distribution, it may pass through many hands before reaching a pharmacy. Stolen and counterfeit medicines have made it onto pharmacy shelves at numerous times over the past decade, yet no comprehensive national system currently exists to track drugs and ensure their authenticity.
In 2009, thieves stole a truck containing over 120,000 vials of Levemir Insulin® made by Novo Nordisk. According to an FDA affidavit, the temperature-sensitive medicine was illicitly sold back into distribution through wholesalers, eventually reaching medical centers in Texas, Georgia, and Kentucky. Diabetic patients received the stolen goods, with some reporting poor blood sugar control. Wholesaler documentation of the insulin’s origins, (what is known as the drug “pedigree”) indicated it was purchased from a national distribution company a day after the medicine was reported stolen.