FDA: Criminals use EU hubs to ship illicit medical products to US
| September 02, 2022 | By
The U.S. Food and Drug Administration (FDA) said Thursday that malicious actors are using shipping hubs in the European Union to circumvent its inspection system to transport illicit medical products to the United States. Key stakeholders, including FDA and EU officials, plan to meet later this month to strategize on how to stop them.
In a September 1 blog post, Cathy Hermsen, the FDA’s assistant commissioner for criminal investigations, and Ritu Nalubola, director of the FDA’s European office, said the agency was playing “a sophisticated version of whack-a-mole ” with criminal entities that have learned to circumvent the traditional inspection process. They called the specter of illegal products entering the United States “staggering”.
“The agency has seen drugs to treat cancer or chronic conditions such as high blood pressure or diabetes, prescription medical devices, and veterinary drugs,” the officials said. “Some products are mislabeled, others are counterfeit. In some cases, we know of products intended for sale to doctors, which were then administered to patients, who were unaware that these products were obtained from unauthorized foreign sources. and shipped and stored outside of approved conditions.
The FDA said the criminals adapted to the agency’s inspection practices and used EU member states to smuggle their products into the country using a practice known as transshipment. Regulators say the practice has increased during the COVID-19 pandemic as its inspection capacity has been limited and its resources depleted.
A key tactic is to ship products to the United States in loose pieces and small 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 origin of the product or its manufacturer,” the FDA said.
The FDA attributes the new tactic employed by the criminals to its own success.
Officials noted that since 2017, US and UK regulators have been working together in an initiative called Operation Lascar to prevent illegal products from entering their borders. The agency says its staff are using new digital technologies such as handheld devices at London’s international mail facilities to confiscate counterfeit drugs, and that the two countries have exchanged customs declaration data to detect criminal trends.
“During five Operation Lascar initiatives, the FDA launched more than 80 new criminal investigations and identified more than 3,000 illicit shipments of illicit drugs destined for the United States,” the officials said. “However, analysis of recent FDA detentions focused on shipments from the EU suggests that malicious actors are now using EU member states as trans-shipment ‘hubs’ prior to final shipment to the states. States, probably due to the success of Operation Lascar.
“This latest practice gives criminals the ability to mask all prior distribution activity, effectively ‘rebooting’ the shipment of illicit products by switching carriers within the EU so that it appears the shipment originated in the EU. EU,” they added.
To counter counterfeiters, officials said the FDA is taking a “whole-of-government” approach that includes working with the Organization for Economic Co-operation and Development (OECD) Task Force on Combating Illicit Trade and other states. the partners. The agency said it met with OECD officials and representatives from 19 countries, including regulators and law enforcement in a closed-door meeting in May and July to discuss new strategies to stop the criminals.
They plan to meet again for a two-day workshop organized by the European office of the FDA and the OECD in Paris from September 15 to continue the discussions. The agency said the workshop will allow public and private stakeholders to discuss regulatory and legal weaknesses and identify potential whole-of-government solutions.
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