FDA's collaboration with Europol bears first fruit

The FDA's closer ties with Europol - with an agent now seconded to the EU agency - has generated rapid results.

Just last week, a joint operation between the FDA and Europol led to two Turkish nationals being charged with smuggling counterfeit cancer treatment prescription drugs from Turkey and other countries into US.

The two men - from Istanbul - were arrested in Puerto Rico on January 17 and subsequently charged with one felony count of conspiracy to smuggle merchandise into US and three counts of smuggling. If convicted, each count of smuggling carries a maximum penalty of 20 years in prison and/or fines up to $250,000.

"The posting of a permanent liaison officer to Europol headquarters from FDA's Office of Criminal Investigations has been key to establishing a closer relationship with European law enforcement authorities to attack problems such as counterfeit drugs at source," said Europol in a statement.

In a recent blog post, Special Agent Daniel Burke - senior operations manager in the FDA's Cybercrimes Investigations Unit (CIU) which was set up as part of the OCI last March - revealed that the agent started the secondment this year.

The move is the latest in a series of measures undertaken by the FDA and its international partners as it tries to crack down on the counterfeit medicines trade.

Last June, for example, the FDA seized and shut down 1,677 illegal pharmacy websites as part of the international Pangea VI operation, which took down around 9,000 sites in total and also resulted in the seizure of almost 10 million illicit drugs worth an estimated $41m.

Some of the rogue pharmacy websites taken down by the FDA during the action included examples that would be hard to spot by consumers such as walgreens-store.com and c-v-s-pharmacy.com. The CIU logo is displayed on seized sites to identify them as illegal.

Aside from the health risks associated with buying counterfeit drugs from rogue online pharmacies, consumers who use them also risk identity theft, computer viruses or credit card fraud, according to Burke.

He estimates that there are 40,000 to 60,000 domain names that could be tied to illegal online pharmacies at any given time, and that this number is in a constant state of flux. The drugs that these rogue pharmacies sell typically come from Southeast Asia, the Middle East, North Africa and South and Central America, although the websites often claim to be from Canada.

Meanwhile, in March 2013, the FDA sent out a request for information to try to gain an understanding of industry best practices and technical solutions for monitoring sales of medicines on the Internet, and has also set up a programme - called BeSafeRx - to help consumers identify legitimate online pharmacies.

The agency convened an advisory committee last summer to discuss how to communicate the health risks posed by counterfeits. A transcript of that meeting is available here.