FDA Reconvenes Stakeholders for Online Opioid Summit With Focus on Internet Intermediaries

April 26, 2019

By Beena Patel and Matthew Rubin, Faegre Baker Daniels Consulting

Food and Drug Administration (FDA) held its second Online Opioid Summit on April 2, 2019. The summit created an important opportunity for government, private sector, and nonprofit stakeholders to discuss the persistent problem of illegal online drug sales, following FDA’s initial convening in June 2018. The focus of this year’s summit was on the critical role domain name registries and registrars play as part of the internet ecosystem.

Then-FDA Commissioner Scott Gottlieb’s remarks included a call for action, “ . . . registries can remove domain names for websites that illegally offer opioids for sale online. I urge these stakeholders to take action to protect consumers and continue the efforts underway to address this public health crisis . . . ”

The internet facilitates movement of products, money, and information across global borders. Undoubtedly, the speed with which the internet allows transactions to occur in multinational drug markets poses a major challenge to law enforcement and public health. Indeed, the internet is awash with illegal prescription drug sellers claiming to be selling safe FDA- or Health Canada-approved medicines.

However, as we have previously discussed, these claims are simply not true. At any given time, there are up to 35,000 active online “pharmacy” websites operating on the surface web, of which nearly 95% are operating out of compliance with state and federal laws and relevant pharmacy practice standards. For most American patients, finding a safe online pharmacy website can be like finding a needle in a haystack – one with potentially deadly consequences.

Today, transnational organized criminal networks marketing dangerous counterfeit medications are still proliferating. Illegal actors can game search engine algorithms, dodge social media and online marketplace filters, and register domain names with impunity. This is especially dangerous during the opioid epidemic, where counterfeit medicines laced with even a flake of fentanyl can – and have – killed.

Given the magnitude of the public health crisis, Online Opioid Summit participants discussed potential voluntary measures that domain name registries and registrars, social media companies, search engines, and online marketplaces can take to substantially reduce the availability of illicit opioids and other counterfeit, falsified, substandard, or otherwise unapproved prescription drugs online. Additional interagency cooperation with the United States Department of Commerce, National Telecommunications and Information Administration, with influence over US-based domain name registries and registrars, brings new focus to efforts to address the crisis on all fronts.

Examples of these efforts include proactive detection and removal of violative content, promoting verified online pharmacies and authoritative sources of health care information, lock and suspension of domain names used to advertise or sell medications illegally, and other such efforts to improve health care provider and consumer awareness and education. Each potential pathway to improve patient safety and public health online is bolstered by existing resources and infrastructures such as NABP’s .Pharmacy Verified Websites Program that gives health care providers, patients, caregivers, and others a source of legitimate and verified medications online. At a time when nearly 95% of online pharmacy websites are illegal, ensuring access to appropriate resources is of paramount importance.