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  1. Inspections, Compliance, Enforcement, and Criminal Investigations

Operation Ancord

A Whole-Of-Governments Approach to Combating Illicit Medicines

 
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Operation Ancord, with the United Kingdom (U.K.), is the U.S. Food and Drug Administration’s (FDA) bilateral initiative focused on the movement of illicit FDA-regulated products. It started in 2017, recognizing that any effective attempt at halting the illicit shipment of FDA-regulated products to the United States (U.S.) from and through the U.K. would require marshalling the forces of multiple U.S. and U.K. agencies.

Since 2017, there have been seven joint Operation Ancord initiatives with the U.K. The latest initiative conducted this summer involved the following participating agencies:

  • FDA Office of Criminal Investigations (OCI)
  • United States Customs & Border Protection (CBP)
  • Medicines & Healthcare Regulatory Agency (MHRA)
  • United Kingdom Intellectual Property Office (UKIPO)
  • United Kingdom Border Force (UKBF)
  • United Kingdom HM Revenue & Customs (HMRC)
  • United Kingdom Veterinary Medicines Directorate (UK VMD)

The Road to Success

At the onset of Operation Ancord, many of the illicit medications encountered (including counterfeit products) were intended to treat serious and life-threatening conditions, such as various forms of cancer, and required strict temperature controls to be administered safely. Further, the underlying distribution model had changed from solely direct-to-consumer sales to one seeking to penetrate the FDA-regulated pharmaceutical supply chain with targeted sales to physicians. These products are subsequently administered to unsuspecting patients unaware of the risks associated with these illicit products.
Through FDA’s enhanced relationships with a range of U.K. counterpart agencies and a posting at the U.S. Embassy in London, FDA has successfully participated in and/or supported a range of criminal investigations, including: 

  • Veterinary treatments and other fraudulent COVID-19 products
  • Counterfeit Xanax
  • the distribution of DNP (an extremely dangerous industrial chemical illegally marketed to promote weight loss); and
  • Counterfeit and diverted semaglutides

In addition to the shipment of medications for chronic medical conditions (e.g., hypertension, diabetes, cholesterol), Operation Ancord also has revealed illegal transshipments of baby formula, opioid drug products, and khat. There continues to be a consistently high volume of fertility drug products and injectable anti-aging products, including dermal fillers and Botox-type products, that are normally administered by physicians in the U.S.

From 2018 to 2023, FDA-OCI initiated many cases involving food and drug crimes with a U.K. nexus, leading to 104 arrests, seven international apprehensions, five extraditions, 35 convictions, and roughly $29 million in fines, restitution, and asset forfeiture. The operation also uncovered new products, such as veterinary medicines, semaglutides, cosmetics, and intrauterine devices (IUD), indicating evolving trends in illicit shipments.

More information about Operation Ancord and Ancord VII can be found in the press release published on July 22, 2024, titled, “Operation Ancord VII: Collaboration Yields Significant Seizures of Illicit Medicines.”

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