PSM Board Member Jim Dahl Interviews FDA-OCI Director George M. Karavetsos

In January 2015, George M. Karavetsos was appointed the new head of the U.S. Food and Drug Administration’s Office of Criminal Investigations (FDA-OCI). Previous to his appointment as Director of FDA-OCI, Mr. Karavetsos served as the executive assistant U.S. Attorney for the Southern District of Florida, Assistant General Counsel in the FDA’s Office of the Chief Counsel (OCC), and Assistant District Attorney in Massachusetts. In his 12 years at the U.S. Attorney’s Office in the Southern District of Florida, Mr. Karavetsos also held the positions of deputy chief in the major crimes and narcotics sections, and chief of the narcotics section.

Director Karavetsos takes over the FDA-OCI at a time when breaches to the secure U.S. drug supply chain are becoming more and more commonplace.

Recently, PSM board member Jim Dahl had the opportunity to speak with Director Karavetsos about his goals as head of the FDA-OCI.

Jim Dahl: You have prosecuted fake online pharmacy cases, what do you see as the FDA-OCI’s role in counteracting the sea of fake online pharmacy websites aimed at U.S. consumers?

Director Karavetsos: Identifying and dismantling fake online pharmacy websites is a top investigative priority for FDA-OCI. Criminals that inject counterfeit drugs into the global supply chain do so with such callous disregard for human life that it truly shocks the conscience. Our special agents will continue to be relentless in their pursuit of these counterfeit drug peddlers who use the internet to prey on and profit from some of the most vulnerable in our society. These criminals will be brought to justice.

Jim Dahl: Since drug counterfeiting is a globe-spanning crime, how will the FDA-OCI partner with inspectors and investigators from other countries to try and stop fakes from reaching U.S. consumers?

Director Karavetsos: FDA-OCI continues to expand its global presence through strong partnerships with our international law enforcement and regulatory partners. Currently, FDA-OCI has a special agent assigned to Europol, The Hague, Netherlands and in the near future, we will assign a special agent to INTERPOL in Southeast Asia. FDA-OCI overseas postings such as these enhance the real-time exchange of technical and operational information between United States and foreign law enforcement agencies and lead to more efficient and effective criminal investigations against transnational criminal organizations.

At the same time, the United States government and our foreign partners continue to pledge resources for a coordinated global law enforcement response to transnational criminal organizations that engage in illegal trafficking, counterfeiting, and large-scale fraud affecting public health. For example, in December 2014, the United States and French governments signed a Letter of Intent reinforcing law enforcement cooperation to fight against public health offenses. This agreement will enhance law enforcement cooperation to prevent and fight against public health offenses by drawing on the expertise of both the FDA’s Office of Criminal Investigations and France’s Central Office to Combat Damage to the Environment and Public Health of the Directorate General of the French National Gendarmerie.

Jim Dahl: The Internet has made the distribution of fake drugs both simple and extremely lucrative. What tools will the FDA-OCI use to combat the sophisticated web of affiliate networks behind the typical fake online pharmacy?

Director Karavetsos: To meet this growing problem, in 2013, FDA-OCI created a Cybercrime Investigations Unit staffed with some of our most experienced special agents. With the number of websites purporting to be “pharmacies” growing daily due to the ease with which anyone, anywhere in the world can establish a professional-looking website, our Cybercrime Investigations Unit has focused on the criminal networks that pose the greatest threat to the U.S. and global community. The investigative goal is to arrest and prosecute the people responsible for operating these transnational organized crime enterprises, no matter where they are in the world.

Next, we focus our investigative efforts on the infrastructure supporting the illegal sale of FDA-regulated products on the internet. In other words, the crime enablers. FDA-OCI’s investigation of advertising through Google's AdWords program is a good example http://www.fda.gov/iceci/criminalinvestigations/ucm276002.htm. We simply cannot allow companies that make up the internet infrastructure to increase their profit margins while at the same time putting the health and safety of the American public at serious risk.

FDA-OCI is also a member of INTERPOL’s organizing committee for Operation Pangea. Operation Pangea is a global cooperative effort in partnership with international regulatory and law enforcement agencies, to combat the online sale and distribution of potentially counterfeit and illegal medical products.

Jim Dahl: What do you think is the best method for keeping counterfeit medication out of doctors’ offices? What will FDA-OCI be doing in the coming year to combat the growing trend of fake drugs in clinics and hospitals?

Director Karavetsos: One very important method is to educate health care professionals about the dangers associated with intentionally ordering and administering unapproved medications from foreign sources to their patients. Unfortunately, time and time again, our investigations have revealed that doctors and other health care professionals who seek to profit by purchasing unapproved medications at a discount, put their patients in jeopardy of receiving counterfeit medications.

In addition to an aggressive public awareness campaign, the best defense to combat counterfeit drugs from reaching clinics and hospitals is a well-devised proactive enforcement plan. Along with FDA’s ongoing regulatory efforts, FDA-OCI currently has several enforcement initiatives underway to prevent counterfeit drugs from reaching consumers and health care facilities.

Jim Dahl: What goals do you have for improving the security of the U.S. drug supply chain?

Director Karavetsos: To protect the American public, law enforcement must take the fight to these criminal organizations wherever they may be operating around the globe. When we encounter counterfeit drugs that have entered the supply chain, consumers’ health and safety have already been put at serious risk. My goal, through meaningful collaborative and coordinated efforts with our international law enforcement partners, is to enhance FDA-OCI’s ability to proactively identify, investigate, and dismantle U.S. and international criminal organizations before they can put the health and safety of our citizenry at jeopardy.

In fact, in April 2015, at the INTERPOL World 2015 event in Singapore, I participated on a panel and spoke to international law enforcement and regulatory agencies and private industry about some of the challenges of protecting a global supply chain, the successful law enforcement actions that FDA-OCI has recently engaged in with international partners, and the continued need for global collaboration, coordination, and commitment to ensure the supply chain’s security.

In the upcoming months, I plan to continue to meet with other international law enforcement and regulatory agencies and private industry representatives to discuss how to best leverage resources to achieve our common goal of securing the supply chain.

Jim Dahl: Do you have any advice for consumers on protecting themselves from fake medications?

Director Karavetsos: Consumers should continue to ask their health care providers questions and educate themselves about the medications that they are being administered. For those consumers who order prescription drugs online, FDA has a robust public awareness program called BeSafeRx – Know Your Online Pharmacy. BeSafeRx provides resources for consumers who might purchase prescription drugs online. BeSafeRx provides information about the dangers of purchasing drugs from fraudulent Internet pharmacies, as well as how to identify such pharmacies and how to find legitimate Internet pharmacies.