US: A Whole-Of-Governments Approach to Combating Illicit Medicines

Operation Lascar

Operation Lascar, with the United Kingdom (U.K.), is the U.S. Food and Drug Administration’s (FDA) first 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.

Five FDA criminal investigations — Canada Drugs, TC Medical, Gallant Pharma, Ozay Pharmaceuticals, and Medical Device King — revealed how increasingly sophisticated criminal networks were exploiting regulatory, legal, and other gaps to ship and transship these products. As a result, Operation Lascar was initiated to collectively combat this shared threat to public health by leveraging the resources of those involved with customs and border protection, taxation, policy, patent and trademarks, and drug regulation to combat the threat of this illegal activity.

Since 2017, there have been five joint Operation Lascar initiatives with the U.K. The latest initiative involved the U.S. FDA’s Office of Criminal Investigations (OCI is a component of the Office of Regulatory Affairs), U.S. Customs and Border Protection, the U.S. Patent and Trademark Office, the U.S. Embassy in London, and the United Kingdom’s Revenue and Customs, Border Force, and Intellectual Property Office to execute Operation Lascar V. Participating agencies:

• analyzed current trends;
• identified opportunities to leverage best practices and capabilities, free trade zones, and potential regulatory enhancements; and
• began to discuss the need for legislative and/or regulatory enhancements to address illicit exported and transshipped products.

The Road to Success

At the onset of Operation Lascar, 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
• anabolic steroids, including testosterone and selective androgen receptor modulators (SARMs).

In addition to the shipment of medications for chronic medical conditions (e.g., hypertension, diabetes, cholesterol), Operation Lascar 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.

Over the last 5 years, Operation Lascar has been responsible for the initiation of more than 80 new FDA criminal investigations and identified more than 3,000 violative shipments of illicit medicines intended for the U.S.

On the Horizon

Operation Lascar has achieved notable successes, as well as provided a model for how to combat these increasingly sophisticated criminal networks. While quantification is difficult, the Organisation of Economic Co-Operation and Development (OECD) on Countering Illicit Trade (TF-ICT), which has been studying illicit trade of all product types for more than 15 years, estimates that illicit goods account for $460 billion in global trade every year.

The FDA increased its engagement in this effort by partnering with the OECD TF-CIT to launch an initiative aimed at encouraging the wide-scale adoption of a “whole of governments” approach to combat illicit medical products. The OCI and international policy experts from FDA’s Europe Office are working with the OECD TF-CIT to increase coordination of efforts by multiple countries and their arsenals of authorities that crosscut multiple sectors of government. In initial meetings hosted by FDA’s Europe Office and the OECD, in May and July 2022, with government officials from across the world, OCI and U.K. officials presented Operation Lascar as a case study for how to move forward.

A two-day public symposium on the whole-of-governments approach to combat illicit FDA-regulated products is scheduled for September 15-16, 2022, at the OECD in Paris, France. This symposium will bring together leaders from industry, government, and the international community to explore regulatory and legal weaknesses and identify multinational and whole-of-governments solutions. For example, some systems used between countries or sectors of government may not be interoperable, and criminal actors will often change transshipment points and carriers to avoid detection. Potential gaps in the legal framework and how that framework applies or is effectively enforced with respect to shipments of illicit products destined for third countries are also top priorities.

To date, this crosscutting initiative has drawn the support from:

• numerous European Union-level organizations and members states;
• multinational organizations including the World Health Organization, World Customs Organization, Interpol, Europol, and Universal Postal Union; and
• more than 20 countries throughout the world.

For more information on the September 2022 meeting, see https://oe.cd/wgpExternal Link Disclaimer.

To register for the meeting, please contact Chiara.Ruggeri@oecd.org