FDA, DEA Send Warning to Illegal Opioid Distributors

October 2, 2019

Controlled substance tramadol among the illegally marketed painkillers.

FDA and DEA issued joint warning letters to several web sites for illegally marketing unapproved and misbranded versions of opioids such as tramadol.

The warning letters issued to Meds4U, Divyata, Euphoria Healthcare Pvt Ltd, and JCM Dropship, which operate a total of 10 web sites, say that they must immediately stop illegally selling the opioids, FDA and DEA say in a statement.

The agencies say the illegal sale of these opioids is particularly concerning because tramadol carries a boxed warning for significant risk of serious or even life-threatening side effects.

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“As the FDA works to forcefully tackle the opioid crisis on all fronts, 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,” said Acting FDA Commissioner Ned Sharpless, MD. “Today’s effort is also noteworthy because while the FDA partners regularly with the DEA, this is the first time we have issued joint warning letters with them. This action further strengthens the warning to the operators of these websites. We remain committed to using all available regulatory and enforcement tools to stop the illicit flow of opioids online.”

The FDA remains concerned that the easy availability of opioids online further fuels the crisis, the agency says.

The networks also violated the Controlled Substances Act (CSA) by failing to register their online pharmacies with the DEA, despite knowingly or intentionally advertising the sale of controlled substances, including opioids.

The FDA issued a similar series of warning letters earlier this year and in 2018.

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In addition, the FDA hosted internet stakeholders and thought leaders, government entities, academic researchers, and advocacy groups at its second Online Opioid Summit to discuss ways to collaboratively take stronger action in combatting the opioid crisis by reducing the illicit availability of opioids online. 

“The FDA remains committed to addressing the national crisis of opioid addiction on all fronts, with a significant focus on decreasing exposure to opioids and preventing new addiction; supporting the treatment of those with opioid use disorder; fostering the development of novel pain treatment therapies and opioids more resistant to abuse and misuse; and taking action against those who contribute to the illegal importation and sale of opioids,” the agency says.

The FDA will continue to evaluate how opioids currently on the market are used, in both medical and illicit settings, and “take regulatory action where needed.”

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