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NTIA, FDA Pilot Program to Curb Access to Illegal Opioids Online Delivers Promising Results

January 19, 2021 by Jaisha Wray, Associate Administrator, Office of International Affairs

NTIA and the U.S. Food and Drug Administration (FDA) have successfully concluded a “trusted notifier” pilot program to curb access to illegal online opioid sales by working with domain name registries. A trusted notifier is generally recognized by a registry or registrar for providing credible and accurate information about illegal or abusive website content to domain name registries and/or registrars.

The new working relationships created through the program led to nearly 30 domain names associated with websites that were offering misbranded and/or unapproved opioids for sale to U.S. consumers being rendered inaccessible via the Domain Name System. The pilot also yielded valuable insights into potential mechanisms to help in the fight against the opioid crisis.

The Department of Commerce and the Department of Health and Human Services (HHS) in June announced the voluntary, 120-day pilot program, conducted in cooperation with three U.S. domain name registries: Verisign, Registry Services, LLC (formerly Neustar Registry Services), and Public Interest Registry.

During the pilot, which concluded in October, the FDA referred domain names for potential technical action to the registries, which administer the .com, .net, .us, .biz, and .org top level domains.

The FDA issues warning letters to operators of websites that offer for sale misbranded and unapproved drugs to U.S. consumers. Under the pilot, the FDA notified the domain name registries when the agency sent a warning letter to a website operator and the website operator did not respond adequately within the required timeframe. The registries reviewed the FDA’s notifications and assessed whether to take further voluntary action. The pilot enhanced the effectiveness of the FDA’s existing program by engaging the registries to take action on the websites’ domain name registrations – for example by applying a hold or lock to the domain – which makes the navigation by the public to these websites using these domain names impossible.

The voluntary collaboration among NTIA, FDA and the domain name registries helped to curb access to opioids illegally being sold online, while also respecting technical safeguards for the Domain Name System. NTIA is pleased that the FDA and the registries plan to continue this relationship going forward.