For the seventh time since 2006, law enforcement, customs, and regulatory authorities from 111 countries collaborated to identify and root out Internet-based makers and distributors of illegal drug products and medical devices.
Sponsored by Interpol, the latest sting operation, known as Operation Pangea VII, detained or seized 19,618 packages containing medicines purportedly from Australia, the UK, New Zealand and Canada from May 13 to May 20.
The packages actually contained unapproved or suspected counterfeit drugs from countries, including India, China, Singapore, Taiwan, Mexico, Laos, Malaysia, as well as Australia, New Zealand and the UK.
The US FDA and the CBP (Customs and Border Patrol) inspected packages at the mail facilities in Los Angeles, New York and Chicago, and detained or seized 583 packages. Preliminary findings show that certain drug products from abroad, such as insulin, estrogen, bimatoprost, human chorionic gonadotropin, tramadol, tadalafil and sildenafil citrate were on their way to US consumers.
The FDA also notified Internet service providers, domain name registrars and other related organizations that 1,975 websites were selling products in violation of US law. The last Pangea operation in June took down more than 1,500 illegal websites.
“When consumers buy prescription drugs from outside the legitimate supply chain, they cannot know if the medicines they receive are counterfeit or even if they contain the right active ingredient in the proper dosages,” said Douglas Stearn, director of the FDA‘s Office of Enforcement and Import Operations. “Consumers have little or no legal recourse if they experience a reaction to the unregulated medication or if they receive no therapeutic benefit at all. In addition to health risks, these pharmacies pose other risks to consumers, including credit card fraud, identity theft or computer viruses.”
Investigations and operations such as Operation Pangea VII have revealed that many American consumers order medicines from online sources believe “they will receive the same medicine as the US approved version,” according to the FDA, even though many of the drugs are unapproved, counterfeit, or from countries with less stringent manufacturing standards or regulatory controls.
“Many illegal online pharmacies use slick website templates and empty guarantees to convince U.S. consumers that the inexpensive drugs they sell are the exact same prescription drugs that are dispensed in the US,” said Philip J. Walsky, acting director of the FDA‘s Office of Criminal Investigations. “