The FDA has issued four more warnings to online networks—CoinRX, MedInc.biz, PharmacyAffiliates.org, and PharmaMedics—operating a total of 21 illegal websites marketing potentially generous, unapproved, and misbranded versions of opioid medications.
“The illegal online sale of opioids represents a serious risk to Americans and is helping to fuel the opioid crisis. Cutting off this flow of illicit internet traffic in opioids is critical, and we’ll continue to pursue all means of enforcement to hinder online drug dealers and curb this dangerous practice,” said FDA Commissioner Scott Gottlieb, M.D. “Today’s effort builds on previous actions against the illegal online sale of opioids, for a total of 13 warning letters to more than 70 websites just this summer. The FDA remains resolute in our promise to continue cracking down on these networks to protect the public health. We have more operations underway, and additional actions planned. We are also working closely with legitimate Internet stakeholders, including leading social media sites, in these public health efforts.”
An unapproved version of Tramadol is one of the drugs illegally marketed on the websites, which the FDA finds particularly concerning because Tramadol carries a boxed warning, the FDA’s most prominent warning. The warning indicates the significant risks associated with adverse effects of the drug.
The warning letters state that the sale of these products must stop immediately, and that the networks are expected to respond within 10 business days detailing the specific actions taken to address the FDA’s concerns. If the networks fail to respond in the allotted time, the FDA says it may take legal enforcement action.
(Source: The U.S. Food and Drug Administration)