- The Food and Drug Administration announced Tuesday it issued warning letters to nine online networks it said are illegally marketing unapproved and misbranded opioids such as oxycodone and tramadol. The networks reportedly operate 53 websites.
- FDA Commissioner Scott Gottlieb said the effort is one piece of a broader effort to crack down on illegal opioids sold online and shipped by mail that will ramp up over the upcoming months.
- The agency is set to hold an "Online Opioid Summit" on June 27 to encourage major search engines, social media platforms, domain name registries and online marketplaces to play a more proactive role to combat illegal online opioid sales.
The action comes amid a push by both chambers in Congress to pass a package of opioid bills before the end of the summer. Gottlieb has asked Congress for more authority for FDA inspectors in international mail facilities to be able to screen more packages
FDA boosted the number of investigators in the facilities from 8 to 22 full time employees last year but can only physically inspect fewer than 0.06% of packages suspected to contain drug products, according to senior FDA officials.
The nine networks receiving warning letters are:
- Instabill ECS-Rx
- One Stop Pharma
The agency said it will continue to target similar players, and asked for responses to the respective warning letters within 10 working days. If the companies fail to address FDA's concerns, the agency says that it may take additional steps such as product seizures or seeking an injunction.
"The public needs to know that no one is authorized to sell or distribute opioids via the internet in the U.S., with or without a prescription," said Donald Ashley, director of the Office of Compliance in FDA's Center for Drug Evaluation and Research. "Drug dealers and rogue website operators are using the internet to fuel the opioid crisis, heartlessly targeting millions of Americans struggling with opioid use disorder."
The opioid summit will discuss findings on which illicit opioids can be easily purchased online and current industry approaches to handling such opioids being sold online.
"The internet is virtually awash in illegal narcotics and we're going to be taking new steps to work with legitimate internet firms to voluntarily crack down on these sales," Gottlieb said in a statement.