Written by: Matthew Rubin and Libby Baney, Faegre Drinker Consulting
On June 8, 2020, Food and Drug Administration (FDA) and Department of Commerce’s National Telecommunications and Information Administration (NTIA) formally announced the formation of a 120-day pilot program targeting the illegal advertisement and sale of prescription opioids and illicit narcotics online. This announcement builds upon the April 2019 Online Opioid Summit where former FDA Commissioner Scott Gottlieb, MD, acknowledged the formation of the partnership, importance of proactive engagement needed from internet registries and registrars, and the efforts already under way to address illegal activity online.
The pilot includes representatives from FDA, NTIA, and three United States-based domain name registries: Neustar, Verisign, and Public Interest Registry. The three registries are responsible for managing the top-level domains of .us, .com/.net, and .org, respectively. FDA will serve as a “trusted notifier” for the purposes of this pilot, in which they will notify the three registries of any websites reportedly advertising or selling opioids on their platform. The agency’s role in the notification process is intended to help expedite the process of thwarting illegal activity online.
Based upon non-compliance to agency warning letters by website operators and reports provided by FDA, registries maintain several voluntary pathways to mitigate harm to consumers and the proliferation of dangerous content online through:
- locking the domain to avoid transfer of the content to an alternate URL or platform;
- deleting the domain from the registry; or
- placing a hold on the domain until a further review is completed.
Following the four-month pilot, FDA and NTIA will assess the findings of the pilot and potential effectiveness of lock-and-suspend protocol to combat illegal online drug sellers. Amid the confluence of the opioid epidemic and the COVID-19 pandemic, which has shifted much of consumer purchasing online, the results of this pilot could prove critical in reducing improper access to opioids and other controlled substances (CS) and further addressing their misuse, abuse, and diversion.
Remarks by US Department of Health and Human Services (HHS) Secretary Alex Azar and Commerce Department Secretary Wilbur Ross underscore the ongoing support and importance behind the pilot. “Cooperation between the Department of Health and Human Services and the Department of Commerce, with the addition of the pilot program, will help stop the online sale of illicit opioids and combat our country’s deadly addiction crisis,” noted Secretary Azar. Secretary Ross further commended the collaboration and the pilot’s goals, stating “[t]he Commerce Department is eager to work with our partners at HHS, FDA, and the domain name registries to remove a major channel for the sale of illicit opioids, which will help save many American lives.”
NABP’s 2019 Rogue Rx Activity Report highlights the pervasiveness of illegal online opioid sales with nearly one-third of new entries added to the Not Recommended List offering CS. Of those websites, an alarming rate did not require a valid prescription or offered products that were not FDA-approved (99% and 94%, respectively). Ultimately, the findings of the FDA and NTIA pilot coupled with consumer resources like NABP’s .Pharmacy Verified Websites Program will shine a light on illegal – and potentially deadly – activity online and ways in which we can ensure patients and consumers remain safe online.