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Regulatory Focus™ > News Articles > FDA Links up With EU Law Enforcement Agency Europol to Combat Fake Pharmaceuticals

FDA Links up With EU Law Enforcement Agency Europol to Combat Fake Pharmaceuticals

Posted 15 January 2014 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) is stepping up its attempts to go after online pharmacies peddling counterfeit and fake medicines to US consumers, announcing that it is embedding one of its agents with EU's law enforcement agency, Europol.

Background: Counterfeiting

US regulators have been seeing an influx of counterfeit products in recent years, testing both the limits of the security of the pharmaceutical supply chain and the ability of regulators to stop products before they reach consumers.

A recent report by the US Customs and Border Protection (CBP) agency, for example, showed nearly $82.9 million in pharmaceutical goods seized in the year preceding the report. While that number was down significantly from the prior year's report, 2012 was marked with some significant lapses in the US supply chain.

Foremost among those lapses was the early 2012 discovery of counterfeit Avastin, which regulators said had been smuggled into the country and sold by an unauthorized supplier to doctors who were trying to cut down on their costs. At the time, FDA sent out a number of warnings, including notices that products should be, "Retained and securely stored until further notice."

Then, in May 2012, FDA warned consumers that counterfeit copies of Teva Pharmaceutical's Adderall had been obtained by consumers through an online pharmacy. At the time, the drug was experiencing widespread shortages, leading many consumers to look to less-reputable sources to obtain the drug.

But those episodes were by and large the outliers of counterfeiting, and were notable because they infiltrated the official supply channels trusted by doctors.

Online Pharmacies: A Common Problem

A far more common avenue for counterfeit drugs to enter the country has been through consumers, who sometimes look for cheaper versions of their drugs at online pharmacies.

As FDA explained in a recent posting, many of these pharmacies falsely claim to be from Canada, offering assurances of safety and the implicit reputation of regulation by Canadian Health officials.

In actuality, many are based in Southeast Asia, the Middle East, North Africa and South and Central America, and their products are either fake, counterfeit, contain no active ingredient, or are unapproved for use in the US. FDA said it estimates between 40,000 and 60,000 of these pharmacies exist at any one time.

FDA has increased its enforcement of this area in recent years, and has taken a number of steps to protect consumers. For example, it maintains a suite of materials on its website explaining the dangers of ordering medicines from online pharmacies. In June 2013, it worked with international authorities to shut down nearly 1,700 illegal online pharmacies.

FDA Working with Europol

And now, according to FDA, it's going one step further by permanently embedding one of its employees within its Office of Criminal Investigations (OCI) with Europol, the EU's law enforcement agency.

The new cooperation will allow FDA to expand its law enforcement presence overseas, it said, helping it to continue to work with foreign law enforcement agencies to conduct undercover operations to "lure out the suppliers of these illegal medicines and to track down the site operators."

Some of those caught by FDA and Europol will be tried in their countries of origin, while others will be extradited to the US for prosecution, FDA said.

FDA said consumers should report suspected criminal activity at www.fda.gov/oci.

FDA Statement

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