FDA Reports Progress in International Effort Against Counterfeit Drugs

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 05-22-2014 14:23


FDA, in partnership with other federal and international agencies, reported on recent action made against websites that sell unapproved drugs to US consumers.The FDA and the US Customs and Border Protection (CBP) also conducted examinations at US-based international mail facilities, where many packages containing prescription drugs enter the United States 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 collaborated to identify the makers and distributors of illegal drug products and medical devices that used the Internet to sell their products and to remove these products from the supply chain. The IIWA is a collaborative effort between the FDA, the US 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.

Operation Pangea VII‘s 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 contained unapproved or suspected counterfeit drugs from other countries, such as India, China, Singapore, Taiwan, Mexico, Laos, Malaysia, Australia, and New Zealand. 

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 targeted for the US. The FDA also notified Internet service providers, domain name registrars, and related organizations that 1,975 websites were selling products in violation of US law.

Source: FDA



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