FDA, DEA clamp down on ‘rogue’ opioid website operators
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The FDA announced that it and the Drug Enforcement Administration sent warning letters to four online networks that operate 10 websites for illegally marketing “unapproved and misbranded” versions of opioid medicines, including tramadol.
The online networks are also accused of violating the Controlled Substances Act by failing to register their online pharmacies with the DEA despite “knowingly or intentionally advertising the sale of controlled substances, including opioids,” according to a press release.
Opioids sold online are potentially contaminated, counterfeit, expired or otherwise unsafe, according to the FDA. Buying them also poses financial risks such as credit card fraud, identity theft and computer viruses, the agency added.
The warning letters state that the online networks — Divyata, Euphoria Healthcare Pvt Ltd., JCM Dropship and Meds4U — must “immediately stop” illegally selling opioids. The networks have 15 working days to comply, and failure to do so could result in legal actions, the FDA said.
“We cannot allow rogue online pharmacies to continue to fuel the crisis by illegally offering opioids for sale and circumventing the important safeguards that have been put in place for opioids to help protect the public health,” Ned Sharpless, MD, acting FDA commissioner, said in the press release. “We remain committed to using all available regulatory and enforcement tools to stop the illicit flow of opioids online.”
These warning letters are not the first the FDA has sent out to online networks regarding the sale of opioids.
In June 2018, the FDA sent warning letters to 53 websites, ordering them to stop illegally marketing “potentially dangerous, unapproved and misbranded versions of opioid medications, including tramadol and oxycodone. Another 21 more websites were warned in August 2018 and two more were warned in April.
Today’s announcement marked the first time the FDA and DEA issued warning letters together, Sharpless said, adding that this move bolsters the seriousness of the letters’ message.
Disclosure: Sharpless reports no relevant financial disclosures.