The U.S. Food and Drug Administration, in partnership with other federal and international agencies, took action this week against websites that sell potentially dangerous, unapproved prescription drugs to U.S. consumers. The FDA and the U.S. Customs and Border Protection (CBP) also conducted extensive examinations at U.S.-based international mail facilities, where many packages containing prescription drugs enter the U.S., and found that most of the examined packages contained illegal prescription drugs that had been ordered from online sources.
These actions took place in support of the 7th annual International Internet Week of Action (IIWA) – May 13 to May 20, 2014 – sponsored by Interpol, and also known as Operation Pangea VII. During Operation Pangea VII, law enforcement, customs, and regulatory authorities from 111 countries collaborated to identify the makers and distributors of illegal drug products and medical devices that used the Internet to sell their products and remove these products from the supply chain.
Operation Pangea VII’s coordinated efforts at mail facilities resulted in the detention or seizure of 19,618 packages containing medicines purportedly from Australia, the United Kingdom (UK), New Zealand and Canada. These packages actually contained unapproved or suspected counterfeit drugs from other countries, such as India, China, Singapore, Taiwan, Mexico, Laos, Malaysia, as well as Australia, New Zealand and the UK.
The FDA and the CBP 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 U.S. consumers. The FDA also notified Internet service providers, domain name registrars and related organizations that 1,975 websites were selling products in violation of U.S. law.
“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 believing they will receive the same medicine as the U.S. approved version. These medicines, however, are often unapproved or counterfeit and from countries with less stringent manufacturing standards or regulatory controls. Many illegal online pharmacies purport to sell drugs identical to the U.S. approved versions to attract consumers but then send them unapproved, counterfeit or substandard versions.
“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 U.S.,” said Philip J. Walsky, acting director of the FDA’s Office of Criminal Investigations. “The FDA will continue to leverage our resources and strengthen our national and international partnerships to shed light on these Internet-based fraudulent activities which target consumers.”
The IIWA is a collaborative effort between the FDA, the U.S. Department of Homeland Security, National Intellectual Property Rights Coordination Center, Interpol, the World Customs Organization, the Permanent Forum of International Pharmaceutical Crime, Heads of Medicines Agencies Working Group of Enforcement Officers, the pharmaceutical industry, and national health and law enforcement agencies from 111 participating countries.