By Pat Anson, PNN Editor

The U.S. Food and Drug Administration is trying to put more teeth into efforts to stop the sale of unapproved or misbranded opioid medications online.

The FDA has launched a pilot program with the National Telecommunications and Information Administration (NTIA) that could result in online pharmacies being blocked or having their domain names suspended for selling illicit opioids. The NTIA is a branch of the U.S. Commerce Department that is responsible for telecommunications and information policy issues.

Under the pilot program, the FDA will notify three internet registries – Neustar, Verisign and Public Interest Registry – when the agency sends a warning letter to a website operator for selling opioids illicitly and the operator does not respond adequately within the required time frame. The internet registries could then voluntarily block or suspend the website domains, which would effectively take them offline.

“Stopping abuse of illegal opioids, including those sold online, has been one of President Trump’s top health priorities. The men and women of FDA have worked tirelessly over the years with the private sector and federal partners, like NTIA, to fight illegal online opioid sales,” Health and Human Services Secretary Alex Azar said in a statement.

For now, according to an FDA spokesperson, the pilot program will not target websites selling kratom, an herbal supplement that the agency considers an opioid.

“Websites selling kratom are not being included in this pilot at this time,” the spokesperson said in an email to PNN. “FDA continues to express concerns about kratom, which affects the same opioid brain receptors as morphine and appears to have properties that expose users to the risks of addiction, abuse, and dependence.”

In recent years, the FDA has sent hundreds of warning letters to rogue online pharmacies that sell counterfeit drugs or illegal medication. When they are caught, the websites often reappear under new domain names or move offshore.

‘Our Best Selling Product’

Sometimes the letters are simply ignored. For example, in September 2019, the FDA sent a warning letter to Euphoria Healthcare, which operates an online pharmacy called “Generic Wellness.” The letter warned Euphoria about selling the opioid tapentadol under the name “Aspadol” – a generic version of Nucynta. The FDA considers Aspadol to be an unapproved and misbranded drug, and gave Euphoria 15 days to respond to the letter or face possible civil or criminal charges.

Nine months later, Generic Wellness not only continues marketing Aspadol, it calls the drug “our best selling product” and claims the company is a “well known online pharmacy for selling FDA approved high quality generic medicines.”

The FDA had better luck with a March 2019 warning letter to the online pharmacy “The Don Rx” for selling misbranded versions of the opioid tramadol. That website has apparently been blocked or is no longer operating.  

The FDA’s new pilot program is apparently the result of meetings the agency had with internet stakeholders and registries to discuss ways to collaboratively stop sales of illicit opioids online. As a result of those meetings, Google began to de-index websites named in FDA warning letters, and social media platforms like Facebook and Instagram redirected users looking to buy opioids to a government run help line.