By: Howard Sklamberg, J.D., George Karavetsos, J.D., and Cynthia Schnedar, J.D.
Unfolding earlier this month was a global cooperative effort, which included the Food and Drug Administration, to combat the online sale and distribution of potentially counterfeit and illegal medical products. Operation Pangea VIII was a project of massive scope, a lightning move by 115 countries that resulted in more than 2,400 websites being taken offline and the seizure of $81 million worth of potential dangerous illegal medicines and medical devices worldwide.
Howard Sklamberg, FDA’s Deputy Commissioner for Global Regulatory Operations and Policy
It’s a sad and cruel fact that drug and device counterfeiting and adulteration pose serious threats to public health. Unapproved and misbranded prescription drug products and unapproved/uncleared medical devices offered for sale on the Internet are potentially dangerous. The illegal sale of these medicines and devices bypasses both the existing safety controls required by the FDA and the protections provided when these products are used under a licensed practitioner’s supervision.
FDA is dedicated to sustaining and expanding the fight against counterfeits as part of our global strategy that leverages resources and expertise, engages the private and public sectors, and is data-driven and risk-based.
We have developed a Global Strategic Framework for counterfeit and substandard medical products (sometimes known by the acronym SSFFC, for Substandard, Spurious, Falsely-Labeled, Falsified, Counterfeit) to help protect consumers by reducing their exposure to counterfeit and substandard medical products.
The framework is focused on three pillars: Prevention, Detection, and Response.
What’s needed is better prevention of market entry of counterfeit and substandard products. Better detection of these products. And, more efficient response when counterfeit and substandard products are found.
FDA developed this framework in order to lay out a strategic vision of what is needed and how these needs can be met globally. There are areas where our expertise can and does contribute to prevention, detection, and response, but there are other areas where other U.S. federal and local government agencies, foreign counterparts, industry, healthcare professionals, consumer and patients, non-governmental organizations, procurement and donor organizations, standards bodies, and others have a role.
George Karavetsos, J.D., FDA’s Director, Office of Criminal Investigations
It is important for all players fighting to combat counterfeit and substandard drugs and devices to understand exactly how to best use our resources, knowledge, and experience, and leverage the work of others. This framework helps shape what roles we can play, minimize duplication of effort, and strengthen our global might in this fight against the criminals.
FDA has many ongoing activities and initiatives that support the framework goals. To better prevent counterfeit and substandard products from entering the market, we are working on improving the transparency, accountability, and integrity of the supply chain. Specifically, we are focusing on good manufacturing, distribution, and pharmacy practices, and we’re working for a convergence of global standards to create a more level playing field for the legitimate supply chain.
We are also implementing the new track and trace law (the Drug Supply Chain Security Act), which outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States, no matter where they originate. This is a collaborative effort whereby FDA is working with drug manufacturers, wholesale drug distributors, repackagers and dispensers (primarily pharmacies) to implement the law and develop the new system over the next eight years. Some of the key goals of this system will be to trace the path of drugs at the package-level through the drug supply chain, help ensure they are legitimate products, and enhance the detection of illegitimate drugs.
Cynthia Schnedar, J.D., Director of the Office of Compliance at FDA’s Center for Drug Evaluation and Research
To better detect potentially harmful products before they enter the supply chain on their way to patients, we are focusing on improving information-sharing and communication. Also, as part of our effort for better detection, we are improving our surveillance through more efficient investigations of suspect incidents, and more quickly confirming that products are counterfeit. To this end, we have developed new detection technologies, specifically the handheld device, CD3, which uses wavelength detection to detect counterfeit drugs and packaging at our ports of entry.
Lastly, to better respond to incidents in the most efficient manner, FDA’s Center for Drug Evaluation and Research is developing more effective ways to notify the public of confirmed incidents and quicker removal of counterfeit products from the marketplace.
As for enforcement, we will continue to rely on our skilled professionals in FDA’s Office of Criminal Investigations (OCI) to lead domestic and global investigations to combat counterfeits. For example, OCI’s involvement in the past seven years of Operation Pangea has resulted in the seizure of more than $172 million in unlawful medical products — a real testament to effective international partnership.
We fully recognize that there are sophisticated, global criminal networks engaged in money laundering and the preparation and transportation of illegal products around the world. Importantly, we are meeting this global threat with international collaboration. FDA’s Office of International Programs has engaged with the World Health Organization’s Global Surveillance and Monitoring System, the World Bank, and the U.S. Agency for International Development in securing drug supply chains, reducing the threat of substandard drugs and strengthening regulatory systems.
We also collaborate with many foreign law enforcement organizations. For example, we have an OCI agent permanently assigned to Europol, based in The Hague, Netherlands. We also have a longstanding and solid partnership with the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA). More recently, OCI signed with the French National Gendarmerie a Letter of Intent to increase law enforcement collaboration.
Moreover, the stakes have grown higher in the U.S. as judges around the country recognize the risks of unapproved drugs in the U.S. marketplace. In January 2015, for example, a Turkish exporter of illegal drugs was sentenced to 30 months in federal prison for his part in the scheme.
As underscored by Operation Pangea last week, our actions to protect the health of Americans from the online sale of potentially dangerous illegal medical products will continue. In the longer term, our focus will be prevention, detection and response. We will need a more coordinated, domestic and global approach that leverages resources, expertise, tools, and trainings, and engages stakeholders, other regulators, and law enforcement.
Through our framework for strategically safeguarding supply chain security and integrity and combatting counterfeit and substandard drugs and devices, we know we are on the right path with the right goal: Protecting public health by helping to ensure that the prescription medications and devices used by health care professionals and patients are safe, effective and of high quality.
Howard Sklamberg, J.D., is FDA’s Deputy Commissioner for Global Regulatory Operations and Policy
George Karavetsos, J.D., is FDA’s Director, Office of Criminal Investigations
Cynthia Schnedar, J.D., is FDA’s Director, Office of Compliance, Center for Drug Evaluation and Research