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FDA Targets Thousands of Illegal Online Pharmacies


 

The Food and Drug Administration took action this week against 4,100 Internet pharmacies selling counterfeit and illegal medicines, part of a coordinated international crackdown on the $75 billion counterfeit drug market.

The larger worldwide initiative, known as Operation Pangea V, shut down more than 18,000 illegal pharmacy websites and seized $10.5 million in pharmaceuticals worldwide during the week of Sept. 25-Oct. 2.

"Because these criminals do not respect international borders, the international coordinated law enforcement response represented by Operation Pangea demonstrates that international cooperation is the best way to protect the American public from the risk of unsafe drugs," said John Roth, director of the FDA’s Office of Criminal Investigations, in a statement.

Counterfeit drug sales hit $75 billion worldwide in 2010, a 90% increase from the previous year, according to the Center for Safe Internet Pharmacies (CSIP).

INTERPOL, the World Customs Organization, the Permanent Forum of International Pharmaceutical Crime, the Heads of Medicines Agencies Working Group of Enforcement Officers, Pharmaceutical Security Institute, and Europol directed the Pangea V, with participation from more than 100 countries.

The operation also received support from CSIP, as well as a group of Internet and e-commerce companies that includes Visa, American Express, MasterCard, Yahoo, Facebook, and PayPal.

The FDA said it targeted websites selling "unapproved and potentially dangerous medicines." The agency sent warning letters to the operators of more than 4,100 identified websites and then notified registries, Internet service providers, and domain name registrars that these websites were selling products in violation of U.S. law.

During the week-long crackdown, the FDA screened all drug products received through the international mail facilities. The screenings found antibiotics, antidepressants, and other drugs for high cholesterol, diabetes, and high blood pressure headed for American consumers. Many of those drugs could be risky to take without the supervision of a physician, the agency warned.

Some of the drugs intercepted also had been removed from the U.S. market, including domperidone, which was taken off the U.S. market in 1998 because of its potential to cause severe cardiac effects, including sudden death.

Also found in the mail were the acne drug isotretinoin, which is available in the United States only through a risk management distribution program; sildenafil citrate (Viagra); and the antiviral oseltamivir (Tamiflu), which is often sold as a "generic," though there is no such approved U.S. generic. Tests by the FDA have shown that fraudulent generic versions of Tamiflu contained the wrong active ingredient, which would not be effective in treating flu.

Seventy-nine people have been arrested or are under investigation, according to INTERPOL.

The FDA launched a consumer-oriented campaign in late September, called BeSafeRx–Know Your Online Pharmacy. The website gives consumers tips on how to understand who they are buying from and when it might not be a good idea to purchase through a website.

The agency said one-quarter of consumers buy prescription drugs online, according to a survey it conducted, but that one-third of respondents said they did not have confidence in how to make safe online purchases.

"Fraudulent and illegal online pharmacies often offer deeply discounted products," said FDA Commissioner Margaret Hamburg in a statement. "If the low prices seem too good to be true, they probably are," she said.

The FDA urged patients to only buy online through pharmacies that require a valid prescription from a doctor or other health care professional; are located in the United States; have a licensed pharmacist available for consultation; and are licensed by the patient’s state board of pharmacy.

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