Serious counterfeit drugs, like fakes of cancer treatment Avastin, have made their way into the legitimate U.S. drug supply, putting patients at high-level risk. But most fakes that consumers will encounter are obtained over the Internet. The FDA has tried a variety of ways to counter this threat, and now the FDA's Office of Criminal Investigations (OCI) is establishing a closer relationship with the Europol law enforcement agency to attack the problem at its source.
According to a recent post by the FDA, first reported by Regulatory Focus, "In 2014, the first permanent OCI agent overseas will begin an assignment at Europol--the European Union's law enforcement agency--in The Netherlands." Special Agent Daniel Burke, senior operations manager in the FDA's Cybercrimes Investigations Unit, said he and other agents have already gone undercover overseas to track down some of the rings that make or buy the fakes and sell them online. These online sites often claim to be legit Canadian Internet pharmacies, when in fact they are based in places like Asia.
The FDA is trying a number of avenues to attack the problem. In 2012, it launched BeSafeRx, aimed at educating consumers about the dangers of buying drugs online. It learned from a survey that while 25% of Internet shoppers have already bought drugs online, 30% said they didn't know how to buy drugs safely online.
While counterfeits sold online used to be limited to erectile dysfunction drugs, the problem now involves many different kinds of drugs. In 2012, the FDA sent out a warning about counterfeits of Teva Pharmaceutical Industries' ($TEVA) version of Shire's ($SHPG) ADHD drug, Adderall. The FDA said instead of the real active ingredient, at least some of the fakes contained painkillers, including the potentially habit-forming tramadol. Counterfeits of Roche's ($RHHBY) Avastin have also been found in the U.S., sold through companies tied to an Internet pharmacy owner.
The FDA, of course, has already been working with other countries to face down the problem. It was part of the sixth annual International Internet Week of Action (IIWA) in June that resulted in the seizure of more than $41 million worth of illegal drugs and actions against more than 9,600 websites. That included sending out regulatory warnings and taking some of the sites down. Many of those, the agency said, looked to be part of an "organized criminal network" that claimed to be Canadian pharmacies but were not. These sites also falsely claimed to have affiliations with some well-known retailers in an effort "to trick U.S. consumers," the FDA said.
But the problem is not going to go away. The FDA estimates that 40,000 to 60,000 domain names could be tied to illegal online pharmacies at any given time, and that this number is in a constant state of flux.