FDA Announces Online Opioid Summit, Targets Illegal Internet Sales of Controlled Substances

May 24, 2018

By: Matthew Rubin, Faegre Baker Daniels Consulting

During his remarks at the National Rx Drug Abuse and Heroin Summit in Atlanta, GA, United States Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, announced the agency’s focus on the illegal advertisement and sale of prescription drugs and illicit narcotics online. Dr Gottlieb’s recognition of illegal online pharmacy websites and their role in facilitating the misuse, abuse, and diversion of controlled substances (CS) and sale of deadly products, such as the synthetic opioid fentanyl, was a significant step in combating these bad actors.

In wrapping up his remarks, the commissioner announced that FDA would be convening internet commerce stakeholders, social media platforms, and search engines – including Facebook, Twitter, Instagram, Google, Yahoo!, and Bing – to reduce the availability of opioids online and to “[take] on more social responsibility for implementing those solutions.”

On May 23, 2018, FDA formally announced that it would hold the Online Opioids Summit on Wednesday, June 27 from 9 am to 3:30 pm. The meeting, which will be held at FDA’s White Oak Campus and available for public webcast, will include representatives from several major social media platforms, search engines, domain name registries and registrars, and online marketplaces. At this time, the companies and individual attendees have not yet been announced. During Session II, these organizations will be asked to present on their current activities aimed at reducing the advertisement and sale of opioids online.

During Session I, which follows introductory remarks from FDA Center for Drug Evaluation and Research Director Janet Woodcock, MD, a panel of five is set to frame the issues and provide an overview of current research. Donald Ashley, director of the Office of Compliance, will review the opioid crisis with four stakeholders outlining the process for which individuals can purchase CS online. Participants in this session, and consistent allies in the fight against illegal online drug sellers, include:

  • Libby Baney, JD, Alliance for Safe Online Pharmacies;
  • Tim Mackey, MAS, PhD, University of California San Diego;
  • Garth Bruen, Fisher College; and
  • John Horton, LegitScript.

Commissioner Gottlieb is expected to provide remarks to the group at 1:30 pm with a closed roundtable discussion with all Summit participants.

Following the Online Opioid Summit on June 27, FDA will work with stakeholders to develop proactive responses to reduce the advertisement and sale of prescription opioids and illicit narcotics on these platforms. As NABP notes in its Internet Drug Outlet Identification Program Progress Report for State and Federal Regulators: February 2018, 54% of surveyed websites offered at least one CS and nearly all (98%) would allow consumers to do so without a valid prescription. These discussions will prove critical in combating illegal online drug sellers and ensuring that all content available to consumers on these websites is legitimate and in compliance with the law. Addressing the US’ opioid epidemic will require stakeholder engagement throughout the public and private sectors, for which reducing the advertisement and sale of these deadly products online will serve as a step in the right direction.