Enforcement Challenges with Fake Online Pharmacies: Special Agent Dan Burke at Interchange 2013

Dan Burke at Interchange 2013 small

FDA Special Agent Dan Burke was gracious enough to participate in an Interchange 2013 panel concerning fake online pharmacies. Special Agent Burke knows more about fake online pharmacies than most. His job is to investigate the highly organized illegal operations behind a typical fake online pharmacy. He is the senior operations manager in FDA’s Cybercrimes Investigations Unit, a special team created in March 2013 in the agency’s Office of Criminal Investigations (OCI).

SA Burke described the broad reach of the typical fake online pharmacy operation: “We’ve seen sources of supply of fake drugs from India/Pakistan/China, but then the brains of the operation were located on a yacht in Tel Aviv harbor.”

He pointed out, “It doesn’t take long to set up an online pharmacy.” Recent research by Tim Mackey & Bryan Liang bears this statement out. In their study, Global Reach Of Direct-To-Consumer Advertising Using Social Media For Illicit Online Drug Sales, they found their were “few barriers” to setting up an illicit online pharmacy operation.

He described the challenges inherent in fake online pharmacy investigations: “There are a number of features of the Internet ecosystem that obfuscates location.”

He also emphasized the need to inform patients of the dangers inherent in fake online pharmacies because, “when we look at a SQL database for an illicit online pharmacy, 80% of the customers are US-based.”

An FDA consumer update from January 15 warns that “claiming to be a Canadian pharmacy is one of the hallmarks of Internet sites that sell illegal prescription drugs which, in many cases, are not made in Canada at all, but in a number of other countries.”

SA Burke stated that sites that claimed to be Canadian in their marketing materials figured prominently in the seizure of hundreds of rogue pharmacy websites that occurred in June 2013.

Burke warned in the FDA consumer update that the drugs sold by these illicit sites are often stolen or counterfeit. Patient safety is a serious risk because consumers may be unwittingly buying medication that has no active ingredient at all, dangerous ingredients such as industrial toxins or medications banned by the FDA for health safety reasons.

As OCI Director John Roth says in the consumer update, “Consumers are able to buy prescription drugs, unap
proved drugs and potentially counterfeit drugs without a full understanding of the risks that they take when they do that. What worries me is that people naively believe that these medicines are safe.”

Inform yourself about the true nature of online pharmacies that claim to be Canadian by reviewing PSM’s Questions and Answers On Medicine Importation.

By S. Imber