FDA Seizes Counterfeit Medicine in an International Operation

First Posted: May 23, 2014 02:32 PM EDT
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The Medicines and Healthcare Products Regulatory Agency (MHRA) of Britain was responsible for seizing millions of dollars in counterfeit medicine. Now, it turns out that the U.S. FDA made some busts as well in the international operation.

The INTERPOL-led Operation Pangea VII made some significant strides this past week. The MHRA of Britain seized over $31 million in counterfeit medicines and arrested 237 people involved in such illegal sales while also shutting down or suspending over 10,000 websites involving the sale of fake medication.

The U.S. Food and Drug Administration reported similar busts, seizing 19,618 packages of counterfeit medicine from Australia, the UK, New Zealand, and Canada. The FDA and U.S. Customs and Border Protection (CBP) inspected and detained or seized 583 packages at mail facilities in Los Angeles, New York, and Chicago. They've identified nearly 2,000 U.S. websites that could be responsible for the illegal transports.

The seizures included drugs such as insulin, estrogen, bimatoprost, human chorionic gonadotropin, tramadol, tadalafil, and sildenafil citrate. All of the packages were heading to consumers within the United States. The FDA and CBP operations took place between May 13 and May 20, in support of the 7th annual International Internet Week of Action. The FDA warned of the purchase of counterfeit medicines.

"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, in a news release. "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."

The seized medicines were either unapproved or counterfeit and were from countries with loose manufacturing standards and/or regulatory controls. Those who purchased them did so online, which has grown to become an issue as of late. Operation Pangea VII as a whole consisted of 111 countries with 196 agencies and resulted in over $36 million in seizures, 239 arrests, 1,235 launched investigations, and over 10,000 shutdowns of websites.

You can read more about the FDA seizures and investigations in this news release.

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