By: Ned Sharpless, M.D., Acting Commissioner, Melinda K. Plaisier, Associate Commissioner for Regulatory Affairs, and Catherine A. Hermsen, Director, Office of Criminal Investigations
The American public relies on the U.S. Food and Drug Administration to help ensure the quality and safety of FDA-regulated products available to consumers, many of which are sourced or manufactured overseas. As the volume of globally produced products and suppliers expands daily, the risk of fraudulent, intentionally adulterated, and/or other illegal products shipping into the U.S. also increases.
Every day, thousands of illicit products are shipped to the United States from overseas, across the spectrum of things the FDA regulates, including unapproved opioids, counterfeit medicines, fake medical devices, bogus vaccines, imitation cosmetics, adulterated foods and components of illicit vaping products. These products can be outright forgeries of items produced for the American market, as well as “gray market” products manufactured for use in another country but shipped illegally to the U.S. These products are unsafe: they may contain contaminants or be adulterated, and are not shipped and handled under conditions designed to preserve product stability and sterility.
The importation of illegal FDA-regulated products threatens the American consumer. It undermines the integrity of the supply chain for legitimate products and is at odds with the important objective of sustaining confidence in the manufacturers and developers of domestic drugs, devices and biologics. Most importantly, illicit imported products can find their way into American households and put consumers at risk. FDA inspections, investigations, and law enforcement operations are led by the Office of Regulatory Affairs (ORA) and are essential to the FDA’s ability to help ensure the quality and safety of these medical products.
New authorities and resources provided by Congress have enabled the FDA to make significant investments to increase and strengthen its criminal law enforcement capabilities and footprint. Within ORA is the Office of Criminal Investigations (OCI), whose seasoned law enforcement special agents are critical to protecting public health through a diverse global law enforcement network responsible for investigating illegal activities involving FDA-regulated products, arresting those responsible, and presenting criminal cases for prosecution. With six field offices in the U.S., and special agents posted in The Hague, Netherlands (EUROPOL), Washington, D.C. (INTERPOL), and now London (U.S. Embassy), OCI continues to establish posts in strategic locations around the world.
Given the increasing volume of FDA-regulated products being imported into the U.S., the agency has significantly increased the number of special agents assigned to OCI’s Import Operations Program and within the Cybercrime Investigations Unit. OCI has increased its cadre of headquarters-level analysts assigned to its Intelligence Analysis Branch to provide information that supports the investigative activities at our borders and within the cybersphere. These expansions will help to stop illegal products from entering the country as well as help to increase the number of overall convictions of criminal actors.
Enhanced Ability to Respond to Emerging Threats to Public Health and Safety
FDA’s ORA, including OCI, is playing a critical role within the agency’s response to the growing number of vaping-related lung injuries and deaths across the U.S. From direct collaboration with FDA Center-level experts and ORA forensic scientists, to the targeting of inbound shipments of illegal, potentially harmful products at domestic International Mail Facilities, and identifying illicit products being sold online, FDA’s enhanced criminal investigative resources are being used to help determine where these vaping products originate, whether here or abroad, how are they being distributed, and the harmful substances they may contain. In turn, the information generated by the agency is being shared, as appropriate, internally within FDA and with other federal and state government agencies and law enforcement partners, to ensure a more coordinated and effective overall response.
It is at this convergence of public health and criminal enforcement where OCI’s unique ability to protect the health of consumers is the most apparent because it allows the agency to meaningfully engage on both fronts as health threats begin to emerge through all stages of the response.
Furthering FDA’s Role in Criminal Investigations
Earlier this month, we visited the International Mail Facilities (IMFs) in New York and New Jersey, where we saw firsthand, the sheer volume of packages examined by ORA investigators, and the efforts to prevent the importation of illegal, unapproved, counterfeit and/or potentially dangerous FDA-regulated products from entering the U.S., including illicit opioid and vaping-related products. Since the implementation of the Food and Drug Administration’s Safety and Innovation Act (FDASIA) in 2012, ORA import staff at the IMF in NY has directed the destruction of 3,753,355 capsules/tablets -- weighing 16.58 tons – of illegal and potentially dangerous drugs. Work at the IMFs occurs through a long-term and highly successful collaboration with U.S. Customs and Border Protection (CBP).
We also visited the FDA’s Forensic Chemistry Center, a critical component of ORA, which serves as the agency’s premier national forensic laboratory for analyses related to criminal, regulatory, and counterterrorism investigations. Based in Cincinnati, Ohio, the Forensic Chemistry Center is one of ORA’s 13 laboratories, and is leading the FDA’s efforts in the investigation of nationwide vaping illnesses, working closely with the U.S. Centers for Disease Control and Prevention (CDC) and federal and state partners to identify the products or substances that may be causing the illnesses and deaths associated with the use of vaping products. The Forensic Chemistry Center’s work is paramount to the agency’s overall investigation to identify the products that are making people ill and follow these products to find the original source and suppliers.
Netting Results through Strengthened Enforcement
From October 2017 to June 2019, OCI’s work related to the online sale of illicit products and/or other illegal online activities involving FDA-regulated products yielded 94 arrests, 88 convictions, and fines and restitution totaling more than $45 million. In this same period, the agency’s efforts led to the forfeiture of assets valued at more than $41 million. This includes court ordered seizures of 4,229 Internet domain names selling misbranded, adulterated and/or counterfeit devices and drugs, including illicit opioids.
OCI has also engaged in numerous efforts with our global law enforcement partners to help protect American consumers from illegal products. For example, Operation Lascar in 2017 was the FDA’s first bilateral enforcement operation with the United Kingdom (U.K.), to disrupt the flow of illegal drugs being imported into the U.S. This operation is an example of an effective international, whole-of-governments, approach to a globally shared criminal threat. In 2018, the FDA along with counterparts in the U.K., led a series of coordinated activities at two U.K. International Mail Facilities and an international airport. This work identified a significant volume of mail shipments containing illicit medicines intended for the U.S.
Operation Lascar is a model for, and now drives, further multilateral international cooperation. This includes a recent review of incoming packages from the U.K. at the IMF in NY, in which FDA officials were joined by officials from CBP, the U.S. Patent and Trademark Office, and British counterparts, including the U.K. Border Force and Her Majesty’s Revenue and Customs.
The FDA also led an investigation into the practices of the U.S.-based global consumer goods conglomerate Reckitt Benckiser Group (RBG). In July 2019, the company agreed to pay $1.4 billion to resolve criminal and civil liabilities related to an illicit nationwide scheme to increase prescriptions of its opioid addiction treatment drug Suboxone (buprenorphine hydrochloride, naloxone hydrochloride). This was the largest recovery involving an opioid drug in U.S. history. The company’s subsidiary had promoted Suboxone to physicians, pharmacists, Medicaid administrators, and others across the country, knowing that the product’s safety claims had never been established.
Cracking Down on Cybercrime Through the Dark Web
In addition, FDA’s Cybercrime Investigations Unit, within OCI, conducts investigations on the surface Internet as well as the dark web marketplaces, where website operators attempt to hide online illegal activity. Over the past year, the FDA conducted Operation CyberPharma, which disrupted and dismantled dark web marketplaces and vendors manufacturing and selling counterfeit opioids (including fentanyl) through arrests and seizures of assets.
In July 2019, an investigation conducted under Operation CyberPharma resulted in a guilty plea by a San Diego resident known as “the Drug Llama” on a dark web marketplace. The defendant admitted to causing the shipment of over 50,000 counterfeit oxycodone tablets laced with fentanyl throughout the U.S. via the dark web marketplace Dream Market.
Protecting the Public from Counterfeit, Harmful Products
Likewise, in June 2019, a federal indictment charged a Massachusetts man, self-named “KillWill,” with distributing counterfeit oxycodone pills containing the powerful synthetic opioid fentanyl. He was charged with five counts of distributing fentanyl and five counts of selling counterfeit drugs. The indictment alleges the selling of 114 tablets with counterfeit identifying marks belonging to Mallinckrodt Pharmaceuticals. The tablets contained more than 14.6 grams of fentanyl. If convicted, he faces a penalty of up to 20 years in federal prison, a $1 million fine on the fentanyl charge, and up to 10 years and a fine up to $250,000 on the counterfeit drug charges.
The FDA, through ORA and its enforcement arm, OCI, is at the forefront of building a public health safety net for today’s complex, global regulatory environment. As criminals continue to commit offenses like these, whether on land or online, the FDA’s global enforcement operations are working to protect the health, safety and security of the American public from criminal actors – both home and abroad.
The FDA is committed to protecting Americans from illegal - and potentially dangerous - products that might otherwise end up on the streets, at stores and in homes across this country.