The U.S. Food and Drug Administration warned the operators of 53 websites to stop selling illicit opioids, such as tramadol and oxycodone, or face seizure or an injunction to shut them down.
"The internet is virtually awash in illegal narcotics and we're going to be taking new steps to work with legitimate internet firms to voluntarily crack down on these sales," FDA Commissioner Scott Gottlieb said.
The commissioner sent warning letters to the nine online networks — AnonShop, Eassybuyonline, Instabill ECS-Rx, Medstore.biz, One Stop Pharma, RemedyMart, RxCash.Biz, TramadolHub and XLPharmacy — that run the targeted sites to let them know that their illegal activity would "not go unchallenged."
The action comes ahead of the FDA's June 27 summit with internet stakeholders to discuss ways to collaboratively take stronger action to combat the U.S. opioid crisis by reducing the availability of the drugs sold illicitly online.
Gottlieb alerted Americans that opioids bought online may be counterfeit and could contain other dangerous substances.
"Consumers who use these products take significant risk with their lives," the commissioner said. "Patients who buy prescription medicines from illegal online pharmacies may be putting their health at risk because the products, while being marketed as authentic, may be counterfeit, contaminated, expired or otherwise unsafe."
The FDA said the online sales of tramadol and oxycodone were particularly concerning because the U.S.-approved versions of those products carry black-box warnings in their labeling — the agency's strongest safety alert — telling doctors and patients the drugs are associated with significant risks of serious or even life-threatening adverse effects.
People who use the medicines are also at risk of addiction, abuse, misuse and life-threatening respiratory depression.
Taking opioids with other central nervous system depressants, including alcohol, could result in a coma or even death, the FDA warned.
Babies whose mothers took opioids while pregnant also are at risk of developing neonatal withdrawal syndrome, the agency added.
In addition to health risks, illegal online pharmacies can pose other risks to consumers, including credit card fraud, identity theft and computer viruses, regulators warned.
Broader campaign
Gottlieb said the new warning letters are part of the FDA's comprehensive campaign to target illegal sales of unapproved opioids.
"We'll be following these actions with additional steps in coming months to crack down on the flow of illegal, unapproved opioids sold online and shipped through the mail," he said.
"We're also taking new steps to evaluate the flow of opioids and counterfeits coming through international mail, working closely with our outstanding partners," Gottlieb said in a June 5 tweet. He warned that consumers buying opioids online are often getting pressed fentanyl products advertised as brand-name opioids such as Vicodin, Percocet or OxyContin.
As part of the FDA's strategy, Gottlieb has invited a number of senior executives from major internet search engines, social media platforms, domain name registries and online marketplaces to join him and academic researchers and leaders from government entities and advocacy groups at the June 27 summit. They are expected to participate in a roundtable discussion to identify gaps and new solutions.
In April, Gottlieb told social media sites, such as Twitter Inc. and Facebook Inc., that they must do more to halt ads and illicit offers on their platforms for fentanyl and other opioids.
In advance of the internet summit, which will be webcast, the FDA commissioner asked his invited guests to provide his agency with any steps their organizations have implemented to prevent opioids from being offered online.
The FDA chief plans to ask the internet organizations to commit to the agency's pledge to reduce the availability of illicit opioids online, according to the invitation.
The summit comes as a number of bills are making their way through Congress aimed at addressing the opioid crisis — an epidemic in which about 115 Americans are dying every day — with expectations for the House and Senate to act on their respective packages over the summer.
