The founder of a Canadian Internet pharmacy accused of selling counterfeit drugs will be arraigned this week in federal court, putting other operators around the world on notice that the U.S. is stepping up enforcement on that loose link in the supply chain in which thousands of Internet sites sell drugs of unknown origin to people without prescriptions.
The 38-year-old Andrew Strempler, who was arrested last week, was a pioneer in this arena. In an indictment he and his former company RxNorth.com are accused of selling and shipping to U.S. consumers fake and misbranded drugs between early 2005 and the summer of 2006, The Wall Street Journal reports. Strempler sold his company to a competitor in 2006, and was believed to have hightailed it to the Caribbean after U.S. authorities accused him of selling counterfeit medications. Authorities globally have been trying to figure out how to attack the growing problem of counterfeit drugs making their way to consumers through this unregulated end-run around the legitimate supply chain.
The arrest follows an FDA warning in May that fake versions of the ADHD drug Adderall, made by Teva Pharmaceutical Industries ($TEVA) and other generics companies, is showing up on Internet pharmacy sites. At least some of the counterfeit Avastin discovered in the U.S. in February squeezed its way in through a Canadian pharmacy company that delivers discounted prescription drugs from overseas to U.S. citizens.The owner of one Canadian Internet pharmacy acknowledged shipping at least some of the fake injectables of the Roche ($RHHBY) drug into the U.S. but said he notified authorities when he learned they were counterfeit.
In a report in March 2011, the Counterfeit Pharmaceutical Inter-Agency Working Group, made up of a host of federal agencies and authorities, acknowledged the growing threat and said it was looking for ways to be proactive to a threat that is global in nature and difficult to monitor.
In a recent interview, Connie Jung with the FDA explained that illegal Internet pharmacies presented a particular challenge to federal authorities because they may sell counterfeit or other unapproved drugs. Jung is the acting associate director for policy and communications within the Office of Drug Security, Integrity and Recalls. It was established last year to focus on such problems as drug counterfeiting in an industry that now relies on a global supply chain. Part of its work is to coordinate with other agencies like Customs and the FBI to find ways to be proactive in the face of a serious threat.
"Consumers and healthcare providers can be confident that consumers are receiving safe, effective, high quality drugs from their local pharmacies," Jung says. "It is when we have entities that choose to buy outside the legitimate drug supply chain that harmful products may be introduced."
The U.S. is not alone in trying to figure out how to get on top of this new outlet for counterfeits. China Daily reports that after a 5-month investigation into counterfeiting there, the State Food and Drug Administration sent 670 cases to the police for investigation. "Many counterfeit drug cases featured online advertisements and sales, underground production workshops and transfers through postal express," Yin Li of the SFDA says.