FDA’s global law enforcement footprint is expanding. A recent FDA Voices article showcases impressive efforts within the agency to protect consumers from illegally-imported products, like unapproved opioids, counterfeit medicines, fake medical devices, bogus vaccines, imitation cosmetics, adulterated foods and components of illicit vaping products. According to the agency, “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.”
FDA’s Office of Criminal Investigations (OCI) is the tip of the agency’s criminal enforcement operations spear and has agents posted at Europol in the Netherlands and the U.S. Embassy in London, with plans to expand beyond that. Further, to help stem the flow of illegal FDA-regulated imports and secure more criminal convictions, FDA has significantly bolstered staffing for OCI’s Import Operations Program and its Cybercrimes Investigations Unit.
These strategic shifts are reportedly paying dividends for the agency and consumers alike. For instance, FDA’s article reported that, “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.”
But the opportunity cost associated with FDA’s increasingly global law enforcement approach must also be considered. As I posted more than two years ago, “Problems will surely arise if FDA’s domestic and global supply chain strategies are not properly aligned. The counterfeit Avastin and Altuzan incidents, mammoth prescription drug diversion cases, and numerous instances of supply chain abuses involving independent pharmacies must not be ignored. FDA’s presence on the global stage is noble, but must not distract from its crucial mission to ensure the integrity of our nation’s drug distribution process and to protect vulnerable patients from the ever-increasing diverted and counterfeit drug threat.”
Over the last month I highlighted two multimillion-dollar prescription drug diversion cases involving our nation’s legitimate drug distribution supply chain. But this type of criminal activity seems to be getting much less attention from FDA. To highlight this point, there’s no sign of these two cases anywhere on FDA’s web site and OCI was involved in both of the investigations. Why is the agency not also trumpeting these successes and likewise pledging to increase its law enforcement response as a result?
I would like to hear from FDA about its law enforcement strategy to protect vulnerable patients from domestic drug supply chain crimes. Patients suffering from HIV, cancer, and other diseases who are continually victimized by these crimes would likely agree. If FDA is not taking a leadership role in rooting out criminal networks within our domestic drug supply, who is?