The U.S. Food and Drug Administration (FDA) announced today that warning letters were sent to four online networks operating a total of 21 websites illegally selling potentially dangerous, unapproved, and misbranded versions of opioid medications. The warning letters stated that each of the networks must immediately cease selling these illegal products to American consumers. All four networks listed various misbranded and unapproved versions of tramadol, a Schedule IV drug. The networks that received warning letters were CoinRX, MedInc.biz, PharmacyAffiliates.org, and PharmaMedics.
FDA Commissioner Scott Gottlieb, M.D. said, “The illegal online sales 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.” This is the second time this summer that the FDA has issued letters to networks operating websites selling illicit opioids to Americans, bring the total number of websites warned to over 70 since May. Gottlieb stated that additional operations are underway and more actions are planned.
Purchasing prescription medicines, including opioids, from illegal online pharmacies poses a health risk due to the products potentially being counterfeit, contaminated, expired, or otherwise unsafe. However, physical harm is not the only kind of harm consumers may experience after they make a purchase from an illegal online pharmacy. Those other risks include credit card fraud, identity theft, and computer viruses.
Each of the four companies has ten working days to respond to the FDA. The companies must inform the FDA of specific actions they have taken to address the agency’s concerns. If the companies fail to do so, they may be subject to legal enforcement action.