FDA: Criminals using EU hubs to ship illicit medical products into the US

Regulatory NewsRegulatory News | 02 September 2022 | By

FDA's Cathy Hermsen (left), and Ritu Nalubola (right), say criminals have been circumventing the agency's inspections and importing illegal medical products. (Source: FDA)

The US Food and Drug Administration (FDA) on Thursday said that bad actors are using shipping hubs in the European Union to get around its inspection system to transport illicit medical products to the US. Key stakeholders, including FDA and EU officials, plan to meet later this month to strategize on how to stop them.
 
In a 1 September blog post, Cathy Hermsen, FDA assistant commissioner for criminal investigations, and Ritu Nalubola, director of FDA’s Europe office, said the agency was playing “a sophisticated version of whack-a-mole” with criminal entities who have learned to circumvent the traditional inspection process. They called the spectrum of illegal products getting into the US is “staggering.”
 
“The agency has seen medications to treat cancer or chronic diseases such as high blood pressure or diabetes, prescription medical devices, and veterinary drugs,” said the officials. “Some products are mislabeled, some are counterfeit. In some cases, we know of products targeted for sale to physicians, that have then been administered to patients, who were unaware these products were being obtained from unauthorized foreign sources and being shipped and stored outside of approved conditions.”
 
FDA said that criminals have adapted to the agency’s inspection practices and have been using EU member states to smuggle their products into the country using a practice known as transshipment. Regulators say the practice has surged during the COVID-19 pandemic as its ability to inspect has been limited and its resources drained.
 
A key tactic is to ship products into the US in parts and smaller packages rather than in large batches to avoid getting caught by border inspectors.
 
“For criminal actors, using multiple small shipments instead of larger ones reduces the likelihood of detection and makes it more difficult for authorities to identify the product’s origin or its manufacturer,” said FDA.
 
FDA blames the new tactic employed by criminals on its own success.
 
The officials noted that since 2017, US and UK regulators have been working together under an initiative called Operation Lascar to stop illegal products from getting into their borders. The agency says its staff have been using new digital technologies such as handheld devices at international mail facilities in London to confiscate counterfeit drugs, and the two countries have exchanged customs declaration data to detect out criminal trends.
“Over the course of five Operation Lascar Initiatives, the FDA originated more than 80 new criminal investigations and identified more than 3,000 violative shipments of illicit medicines intended for the U.S.,” the officials said. “However, analysis of recent FDA detentions focused on shipments from the EU suggests that bad actors are now using EU member states as transshipment ‘hubs’ before final shipment to the U.S., likely due to the success of Operation Lascar.
 
“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,” they added.
 
To counter the counterfeiters, the officials said that FDA it is taking a “whole-of-government” approach that includes working with the Organization of Economic Co-Operation and Development (OECD) Task Force on Countering Illicit Trade, and other state-level partners. The agency said it met with OECD officials and representatives from 19 countries, including regulators and law enforcement in a closed meeting in May and July to discuss new strategies to stop the criminals.
 
They plan to come together again for a two-day workshop hosted by FDA’s Europe Office and the OECD in Paris starting 15 September to continue the talks. The agency said the workshop will allow public and private stakeholders to discuss regulatory and legal weaknesses and identify potential whole-of-governments solutions.

 

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