FDA seeks wider rollout of international illicit trade alliance

A pilot between authorities in the US and UK in the fight against illicit and potentially dangerous health products should be extended to other international partners, says the FDA.

Multiple government agencies in the two countries have been working since 2017 on the project – called Operation Lascar – which targets the movement of illicit versions of FDA-regulated products, such as medicines and nutritional supplements.

Now, the FDA says it wants to encourage wide-scale adoption of this approach, and has been meeting with government officials ahead of a workshop to be held in Paris next week (September 15-16) – co-hosted by the Organization of Economic Co-Operation and Development (OECD) – to chart a course forward.

"Criminal networks are increasingly sophisticated and capable of exploiting regulatory, legal, and other gaps to ship and/or tranship illicit and potentially dangerous health products to the US, putting patients at risk," write Cathy Hermsen, FDA's assistant commissioner for criminal investigations, and Ritu Nalubola, director of the agency's Europe office in an update on the programme.

"A series of successful investigations conducted by the FDA's Office of Criminal Investigations (OCI) have demonstrated that the best way to address this problem is to cast a wide net by soliciting the help of other parts of the FDA, other US government agencies, and officials in other countries," they continue.

The work with the UK authorities has resulted in around 80 investigations into criminal networks, revealing how they exploit regulatory, legal, and other gaps to get these products into the US market, and identified more than 3,000 illegal shipments of medicines.

However, an analysis of recent FDA detentions focused on shipments from the EU suggests that bad actors are now using EU member states as transhipment hubs before final shipment to the US, which may be in part a result of Operation Lascar making this more difficult from the UK.

"This latest practice gives criminals the ability to mask all the prior distribution activity, effectively 'restarting' the shipment of illicit products by switching carriers in the EU so that it appears the shipment originated in the EU," according to Hermsen and Naubola.

At the workshop later this month, representatives from the public and private sectors are due to discuss regulatory and legal weaknesses and identify potential whole-of-governments solutions.

For example, in some countries tax authorities may not be able to easily exchange information with customs or the police, and some nations may take different approaches to illicit goods that may make it more difficult to identify the criminal operators.