Operation Lascar with Assistant Commissioner for Criminal Investigations, Catherine Hermsen

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Host Ulysses Garrett: 
Welcome to ORA speaks: Voices from the Field Podcast, a podcast created to highlight and inform on great work done by the Office of Regulatory Affairs here in the US and abroad when it comes to protecting the public health. My name is Ulysses Garrett, multimedia manager for the Office of Regulatory Affairs and the Office of Communications and Project Management, and your host.

Today, my guest is Catherine Hermsen, Assistant Commissioner for Criminal Investigations, who just recently returned from attending a very important international meeting in Paris, France. Where more than forty countries came together to discuss a whole-of-government approach to combating illicit health products. Cathy, thank you for joining me today. I'm very excited to hear about your trip and curious to learn more about the meeting purpose, outcomes and next steps. So let's start with the obvious. You just returned from a workshop in Paris where more than nineteen countries convened to discuss, and all of government approach to stopping illicit drugs coming into the US. Can you talk to us about the meeting and what were some of the top takeaways for you?

Catherine Hermsen, Assistant Commissioner for Criminal Investigations: 
Thank you, Ulysses, and thank you for having me here today and allowing me to highlight this important topic. The Organization for Economic Cooperation and Development, which I'll refer to from here on out, is the OECD. They played a critical role in bringing together the many unique national agencies at last week's meeting. We thank them for their leadership in the fight against illicit medicines. At the workshop we were first impressed by the excellent work being done in each country to protect their own people. Second, we are impressed by the varied and complex strategies of each country 's protection structure. Those structures grew out of their own experiences in history, just as ours did. Third, and very importantly, there's a tremendous amount of work that's already being done by entities such as the World Health Organization, World 's Customs Organization, Interpol, Europol, and others. Given the transnational nature of the crime, we view these partnerships and contributions as critical in identifying and implementing solutions towards a very complex problem. Finally, we were pleased that we laid the groundwork for working towards solutions. As you know that the Internet changed the world of criminal activity. More than anything else, it made crime more international and even more difficult to hold bad actors accountable. We are now in the early stages of building a network of international cooperation that will lead to stronger collaboration and solutions in the US and elsewhere.

Mr. Garrett: 
Thank you for that answer. My next question is, what doesn't all of government's approach look like for you?

Ms. Hermsen:
Well, I'm gonna borrow from the OECS definition of that. They've been at this longer than either OCI or FDA. So for a direct quote for the OECS,  "a whole-of-government approach emphasizes the importance of consultation, coordination, communication and cooperation to address the challenges posed by the interconnectedness of sectors and economics." In simpler language, a whole-of-government approach recognizes that our world is growing smaller and more connected. And we must grow, and we must grow in that direction too. So we must broaden our horizons and work more closely with other countries, multinational organizations, and private industry to address the challenges of international Internet-based crime, a very important public health issue.

Mr. Garrett:
Wow. Very interesting. Thank you. Now this is a major question here. What is Operation LASCAR?

Ms. Hermsen:
Thank you, Ulysses. Operation LASCAR was a series of joint law enforcement operations with the UK that began back in 2017. ORA's Office of Criminal Investigations worked with the UK agencies that had similar responsibilities to OCI's. Our goal was to look at closer at the pipeline of illegal drugs coming into the US and to draw lessons from what we had learned in the UK. I'll just mention that we see a lot of products being transshipped through the UK. We worked with the UK through five joint operations of LASCAR and we also held one joint operation with India known as Operation Broadsword. From those very informative operations, we noted that other countries had very different structures for protecting their people from the harms of illegal medical products. We learned that to cooperate more fully in protecting US consumers, we needed to take a broader approach, not just law enforcement, but also include other involved national agencies like international trade, border operations, tax and revenue structures and a host of other agencies that each country had designed to protect its own citizens, and that led us to what is known as a whole-of-government viewpoint and approach to addressing international challenges.

Mr. Garrett:
Very interesting. Now to date, what are some of the key accomplishments of Operation LASCAR?

Ms. Hermsen:
Well, OCI's international cooperation activities are, of course, expanding as a direct result of Operation LASCAR. These operations bolstered our justification for a senior operation's position in the US Embassy in London. We've done parallel initiatives with the Government of India and most recently our workshop with the OECD. As a result of these operations, OCI opened dozens of criminal investigations targeting individuals and organizations identified during LASCAR. Using the data from the investigations and detentions, we can work with foreign government counterparts to better understand and combat what has previously been an unrecognized threat to public health. Operation LASCAR is definitely a collaboration between agencies in the UK and the US, centered around protecting the public health.

Mr. Garrett:
Thank you. Now I know for myself, and I'm sure for all of our listeners out there, we would like to know what kind of illicit health products are we talking about?

Ms. Hermsen:
Great question. Operation LASCAR was initiated primarily in response to illicit medicines, including counterfeit and tampered products being shipped to the US from and through the UK, also known as transshipment. Through several investigations being worked by OCI, we identified that these included direct sales to physicians who are in turn in this administering these medicines to unsuspecting patients. These include drugs to treat very serious diseases such as HIV, malaria and various forms of cancer. In the latest operation related to LASCAR, we saw an increase in veterinary products, steroids and fertility drugs.

Mr. Garrett:
Very interesting. Thank you. What's next for operation LASCAR?

Ms. Hermsen:
So, we are in the process of forming a bilateral work group with the US and UK agencies focused on the movement of illicit medicines between our countries. The group will also look at the underlying gaps in the legal and regulatory framework related to these issues. In addition, because of LASCAR, we're establishing direct communications with counterpart individuals and agencies in other countries. We will build on these connections to work toward a more connected approach to stopping international shipments of prescription drugs before they can reach US consumers.

Mr. Garrett:
Now, have you all identified next steps following your workshop in Paris?

Ms. Hermsen:
We haven't yet finalized the plan moving forward, but it's very apparent that there is a tremendous support from the global community to tackle the issue of illicit medicines. Outreach, capacity building, data sharing were among some of the next steps that we shared during the workshop.

Mr. Garrett:
Cathy, we have come to the end of our episode, but before we go, is there anything that you would like to add?

Ms. Hermsen:
Yes, thank you Ulysses. I would certainly be remiss if I didn't thank our ORA colleagues that we work side by side with every day from the Office of Regulatory Science and the Office of Enforcement and Import Operations. We work with them daily to stop violative FDA regulated products from entering the US. Finally, I also want to recognize the critical support that the FDA Europe office, which is part of the Office of Global Policy and Strategy, that they provided to us in support of this initiative with OECD. Having just spent a week with them in Europe, I could not have been more impressed with their depth of expertise and commitment to the FDA's public health mission.

Mr. Garrett:
You've been listening to ORA Speaks Voices from the Field podcast. Once again, our guest today is Miss Catherine Hermsen, the Assistant Commissioner of Criminal Investigations. And Cathy, I thank you again for your time. Thank you for your information. I look forward to speaking with you again and finding out more as Operation LASCAR progresses.

Ms. Hermsen:
Thank you so much, Ulysses.