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FDA cracks down on rogue online pharmacies

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The FDA took action against over 500 websites deemed as illegal sellers of prescription drugs.

SILVER SPRINGS, Md. — The Food and Drug Administration has clamped down on hundreds of websites engaged in illegal sales of prescription drugs.

The FDA said Monday that, in tandem with international regulatory and law enforcement agencies, actions were taken against more than 500 websites selling potentially dangerous, unapproved versions of prescription medicines — including opioids, antibiotics and injectable epinephrine products — to Americans.

The effort was part of a global sting operation targeting drugs illegally marketed online, shipped and distributed through the nation’s postal system to consumers.

“These rogue online pharmacies are often run by sophisticated criminal networks that knowingly and unlawfully distribute illicit drugs, including counterfeit medicines and controlled substances,” FDA Commissioner Scott Gottlieb said in a statement. “Consumers go to these websites believing that they are buying safe and effective medications, but they are being deceived and put at risk by individuals who put financial gains above patient safety.”

The FDA’s effort was part of Operation Pangea X, a global operation led by Interpol to combat the unlawful sale and distribution of illegal and potentially counterfeit or substandard medical products on the Internet. At the center of the initiative were identification of the makers and distributors of illegal prescription drugs and removal of those products from the supply chain.

During Operation Pangea X, the FDA sent 13 warning letters to the operators of 401 websites considered illegal online pharmacies. The agency also seized nearly 100 website domain names, such as buyhydrocodoneonline.com, canadian-pharmacy24x7.com and buyklonopin.com.

FDA inspectors, in collaboration with other federal agencies, screened packages suspected of containing illegal drug products at international mail facilities in Chicago, Miami and New York. The screenings resulted in nearly 500 parcels being detained for FDA compliance follow-up. Parcels found in violation of the Federal Food, Drug and Cosmetic Act will are refused entry into the country.

The operation was part of Interpol’s 10th annual International Internet Week of Action (IIWA) effort earlier this month to crack down on illicit online drug sales. Gottlieb joined efforts to kick off the operation with a visit he made to the international mail facility in New York in late August.

“The ease with which consumers can purchase opioid products online is especially concerning to me, given the immense public health crisis of addiction facing our country,” Gottlieb stated. “Some of the websites sold unapproved versions of multiple prescription opioids directly to U.S. consumers. This easy and illegal availability of these controlled substances fuels the misuse and abuse of opioids. As part of a broader effort to target this illegal activity, in addition to the operation that we are announcing today, the FDA is also working on a comprehensive Enforcement Operations Work Plan that’s focused on combating the sale of foreign unapproved drugs to U.S. consumers and aimed at increasing the scope of our operations related to these risks.”

Along with health hazards, illegal online pharmacies can pose other risks to consumers, including credit card fraud, identity theft and computer viruses, the FDA reported.


ECRM_06-01-22


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