FDA’s ‘Whole-of-Government’ Approach to Illicit Products

FDA says it is expanding its “whole-of-governments” approach to combating the entry of illicit health products into the U.S. An FDA Voices post by FDA assistant commissioner for criminal investigations Cathy Hermsen and FDA Europe Office director Ritu Nalubola says “the variety and scope of the illicit products that FDA is witnessing entering our international mail facilities has been staggering.” They say there have been medicines to treat cancer or chronic diseases, prescription medical devices, and veterinary drugs, all that have been mislabeled or counterfeit.

A series of successful investigations by the agency’s Office of Criminal Investigations has determined, the two write, that the best way to address the problem is to “cast a wide net by soliciting the help of other parts of FDA, other U.S. government agencies, and officials in other countries.”

Hermsen and Nalubola describe Operation Lascar efforts conducted since 2017 with the UK, joining the collective forces of the many U.S. and UK agencies that play a role in healthcare trade, including those involved with customs and border protection, taxation, patent and trademark protection, and drug regulation.

“Over the course of five Operation Lascar initiatives,” they say, “FDA originated more than 80 new criminal investigations and identified more than 3,000 violative shipments of illicit medicines intended for the U.S.”

They report that bad actors have changed their method of operation, possibly due to the success of Operation Lascar, and are now using European Union member states as transshipment “hubs” before final shipment to the U.S.

Hermsen and Nalubola say FDA is taking lessons learned from Operation Lascar and other investigations to promote a whole-of-government initiative for an effective regional solution, partnering with an Organization of Economic Cooperation and Development task force on countering illicit trade, which has been studying the issue of illicit trade for 15 years.

“A whole-of-government approach is the best way to protect the public health from the trade of illicit products and FDA will advocate for that approach …,” the post concludes. “By having so many parties working together, we hope to effectively close the pipeline of illicit products that are getting through. And with the volume of illicit products growing daily, there’s no time to delay.”