FDA Targets Online Pharmacies for Selling Opioids
/By Pat Anson, PNN Editor
The Food and Drug Administration is once again playing whack-a-mole with illegal online pharmacies, warning 17 website operators to stop selling unapproved or misbranded opioid medications to U.S. consumers, including some drugs offered for sale without a prescription.
In recent years, the FDA has sent hundreds of warning letters to online pharmacies for illegally selling opioids and other controlled substances. Many of the websites are located overseas and outside U.S. jurisdiction or they shut down and soon reappear under new domain names.
According to the Alliance for Safe Online Pharmacies, there are over 30,000 online pharmacies operating worldwide, with 20 new illegal pharmacy websites being launched every day.
“Those who illegally sell opioids online put consumers at risk and undermine the significant strides we have made to combat the opioid crisis,” said Donald Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “We remain committed to using all available tools to stop the illegal sale of opioids online to help protect consumers from these potentially dangerous products.”
The 17 warning letters were issued late last month. Most of the online pharmacies appear to have been shut down or blocked, although some are still operating.
RxEasyMeds, for example, continues to sell an opioid medication called “Nalbin” that is “used to treat moderate to severe pain associated with acute and chronic medical disorders.”
Nalbin is produced by a drug company based in Islamabad, Pakistan called Global Pharmaceuticals.
The FDA warning letter to RxEasyMeds – which is located in China -- says Nalbin is not approved for sale in the U.S. and does not have an adequate warning label.
“Unapproved new drugs do not have the same assurance of safety and effectiveness as those drugs subject to FDA oversight, and drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether,” the FDA letter warns. “Accordingly, FDA requests that you immediately cease offering violative drugs for sale to U.S. consumers. This is critical to shielding the American public from harm.”
In addition to Nalbin, RxEasyMeds advertises codeine, morphine, tramadol, oxycodone and other controlled substances, which are all apparently available without a prescription.
In June, the FDA launched a pilot program to put more teeth into efforts to stop the illegal sale of opioids online. Under the program, the FDA will notify three internet registries when a warning letter is sent to an online pharmacy. The registries could then block or suspend the website domains, which would effectively take them offline.
