Using a Whole-of-Government Approach to Address Illicit Health Products

By: Cathy Hermsen, Assistant Commissioner for Criminal Investigations and Ritu Nalubola, Director of the European Office of the FDA

Criminal networks are increasingly sophisticated and able to exploit regulatory, legal and other loopholes to ship and/or transship illicit and potentially harmful health products to the United States, putting patients at risk.

The variety and scope of illicit products witnessed by the United States Food and Administration entering our international mail facilities has been 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. Some products are mislabeled, others are counterfeits. In some cases, we know of products intended for sale to physicians, which were then administered to patients, who were unaware that these products came from unauthorized foreign sources and were shipped and stored outside of approved conditions.

In many of these cases, the illicit products entered the U.S. market after first being shipped to a European Union (EU) country as an intermediate destination, usually bypassing customs, a practice known as transhipment. This practice intensified during the COVID-19 pandemic when we saw an increase in fraudulent COVID-19 products – many of which were ordered online and shipped in small packages. For criminal actors, using multiple small shipments instead of larger ones reduces the likelihood of detection and makes it harder for authorities to identify the origin of the product or its manufacturer.

The E. But when criminals intend to probe for potential weaknesses, in what amounts to a sophisticated version of whack-a-mole, proceeds can slip through if no agency can fully thwart those efforts.

A series of successful investigations by the FDA’s Office of Criminal Investigations (OCI) have demonstrated that the best way to solve this problem is to cast a wide net by enlisting the help of other parts of the FDA, other agencies US governments and officials. In other countries.

For example, since 2017, the OIC and the United Kingdom (UK) have engaged in a series of initiatives they call Operation Lascar, which brings together the collective forces of the many US and UK agencies that play a role in the healthcare trade, including those involved in customs and border protection, taxation, patent and trademark protection and drug regulation.

FDA staff deployed wearable devices at international mail facilities in London that could detect counterfeit drugs. The FDA and the UK exchanged import and export customs declaration data and analyzed other current trends. During five Operation Lascar initiatives, the FDA launched more than 80 new criminal investigations and identified more than 3,000 non-compliant shipments of illicit drugs destined for the United States.

However, analysis of recent FDA detentions focused on shipments from the EU suggests that malicious actors are now using EU member states as transshipment “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 hide all previous distribution activity, effectively “restarting” the shipment of illicit products by changing carriers within the EU so that it appears the shipment originated in the EU. .

The FDA is now drawing lessons from Operation Lascar and other past investigations to promote a whole-of-government initiative for an effective regional solution. To do this, the agency has partnered with the Organization for Economic Co-operation and Development (OECD) Working Group on Combating Illicit Trade, which has been studying the problem of illicit trade for 15 years.

The FDA’s European office and the OECD hosted a non-public meeting with officials from 19 countries in May 2022 to present the whole-of-government approach. Counterparts from regulatory, law enforcement, intellectual property, customs and other relevant government agencies participated in this meeting. Operation Lascar was the first item on the agenda and was hailed as a successful model to emulate.

These government officials met again in July 2022 to discuss transshipments of illicit products and trends in the EU and to lay the groundwork for a two-day workshop on September 15-16, 2022 in Paris, again organized by the FDA Europe office and the OECD.

During this workshop, representatives from the public and private sectors will explore regulatory and legal weaknesses and identify potential whole-of-government solutions. For example, in some countries tax authorities may not be able to easily exchange information with customs or the police, and some countries may take different approaches to illicit goods, which can make more difficult to identify criminal operators. In addition, we hope to better understand the roles, responsibilities and authorities of the various multilateral organizations involved in the fight against illicit products in order to determine the best way to synergize authorities and quickly bring an end to illicit trade throughout the world. along the supply chain. Industry also has a role to play in these efforts and we look forward to their contributions.

A whole-of-government approach is the best way to protect public health from the trade in illicit health products, and FDA will advocate for this approach at the September workshop. By having so many parties working together, we hope to effectively shut down the pipeline of illicit products passing through. And with the volume of illicit products increasing every day, there is no time to waste.