“The public needs to know that no one is authorized to sell or distribute opioids via the Internet in the U.S., with or without a prescription,” said Donald D. Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research.
The FDA issued letters to nine online networks representing 53 websites this week after finding they were selling unapproved opioid-based products in the United States — where it is illegal to sell opioids online. Photo by JESHOOTScom/Pixabay
June 6 (UPI) — The Food and Drug Administration has sent warning letters to nine online networks that represent 53 websites to stop selling unapproved versions of opioid medications.
The FDA in a release Tuesday said companies who fail to stop selling the products may be subject to enforcement action, including product seizure or injunction. The FDA requested responses from them within 10 working days.
The companies receiving letters from the agency were AnonShop, Eassybuyonline, Instabill ECS-Rx, Medstore.biz, One Stop Pharma, RemedyMart, RxCash.Biz, TramadolHub and XLPharmacy.
Dr. Scott Gottlieb, the FDA’s commissioner, said in a statement that “the Internet is virtually awash in illegal narcotics” and the agency plans to work with legitimate Internet firms to crack down on these sales.
“This illegal online marketing of unapproved opioids is contributing to the nation’s opioid crisis,” Gottlieb said. “Warning letters go right to the source of this illegal activity to let online network operators know that marketing illegal and unapproved opioids directly to U.S. consumers will not go unchallenged by the FDA.”
Gottlieb said unapproved tramadol and oxycodone carry risk of serious or life-threatening side effects. Although the products are marketed as authentic, the FDA said they may be counterfeit, contaminated, expired or unsafe.
“Consumers who use these products take significant risk with their lives,” Gottlieb said.
In addition, the agency said illegal online pharmacies might be engaging in credit card fraud, identity theft and computer viruses. The agency is encouraging consumers to report suspected criminal activity to the FDA’s Office of Criminal Investigation.
“The public needs to know that no one is authorized to sell or distribute opioids via the Internet in the U.S., with or without a prescription,” said Donald D. Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “Drug dealers and rogue website operators are using the Internet to fuel the opioid crisis, heartlessly targeting millions of Americans struggling with opioid use disorder.”
Gottlieb has invited representatives from leading Internet companies and government entities, as well as academic researchers and advocacy groups, to an Online Opioid Summit on June 27 to examine ways to “collaboratively take stronger action in combating the opioid crisis by reducing the availability of illicit opioids online.”
Gottlieb has warned social media and search websites aren’t cracking down on ads for illegal opioids, saying in April, “we haven’t seen meaningful, voluntary actions.”
In January, U.S. Senate investigators posing as opioid-seeking drug users demonstrated how easy it is for Americans to obtain fentanyl from China over the Internet and have it delivered through regular mail service.
“This investigation has uncovered how incredibly easy it is to buy these deadly drugs online and have them shipped here through the mail,” said U.S. Sen. Tom Carper, D-Delaware, a member of the Senate Homeland Security and Governmental Affairs Committee.
Investigators conducted Internet searches with the phrase “fentanyl for sale.” They posed as first-time online buyers, and found just how easy the drug is to buy.
They identified more than 500 transactions by more than 300 people in the U.S. totaling $230,000 with a street value of about $766 million.
June 6, 2018