FDA Focuses on Opioids Online; Additional Action Expected

July 19, 2018

By: Libby Baney and Matthew Rubin, Faegre Baker Daniels Consulting

On June 27, 2018, US Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, convened the “Online Opioid Summit: Reducing Availability of Illicit Opioids Online,” which focused on combating the illegal advertisement and sale of prescription opioids and illicit narcotics online. In addition to Commissioner Gottlieb, senior FDA officials Dr Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), and Donald Ashley, director of the Office of Compliance (OC), made comments alongside other colleagues from FDA’s CDER and OC, the Department of Justice (DOJ), Drug Enforcement Administration (DEA), and Substance Abuse and Mental Health Services Administration. Leading global search, online marketplace, and social media companies attended at the request of the commissioner. FDA also invited NABP, the Alliance for Safe Online Pharmacies, two academic representatives, and other non-governmental organizations to participate in the Summit.

Commissioner Gottlieb stated the issue clearly: “[t]here’s no gray area here: no controlled substances, including opioids, can be lawfully sold or even offered to be sold online.” The Ryan Haight Online Pharmacy Consumer Protection Act prohibits the advertisement and sale of controlled substances (CS) unless explicit permission has been given from DEA. To date, DEA has never granted such authorization.

Speaking to internet commerce companies, Commissioner Gottlieb called for action: “We need to work together on shared solutions to address the problem of opioids being illegally sold online. And we need internet companies to be our partners in this effort as we all take on the social responsibility for implementing those solutions.”

Commissioner Gottlieb continued the focus on the advertisement and sale of prescription opioids and illicit narcotics online during a July 1 Tweetorial. In his series of 21 Tweets, Commissioner Gottlieb reviewed many of the topics covered during the summit, cited research from NABP’s Internet Outlet Identification Program Progress Report for State and Federal Regulators: February 2018, and suggested several actions internet companies could take to proactively address illegal online sales of CS.

Findings from NABP’s February 2018 report were also cited during the summit. NABP found more than half (54%) of the websites reviewed to be selling CS, which is a substantial jump from the 13% of all sites NABP has reviewed over the past nine years. With these products and others commonly adulterated with fentanyl and other synthetic products (40%) readily available on websites feigning legitimacy, it is critical to utilize resources like the .Pharmacy Verified Websites Program to ensure legitimacy when purchasing prescription drugs online from any source.

Going forward, Commissioner Gottlieb called for continued dialogue amongst summit participants, including follow-up meetings and additional working groups aimed at establishing and disseminating best practices to combat illegal online drug sellers and make a meaningful impact in reducing the availability of prescription opioids and illicit narcotics on both the surface and dark web.

Federal agency participants acknowledged ongoing efforts to take down illegal websites or warn consumers of potentially dangerous websites, but stressed the importance of proactive and ongoing efforts to promote legitimate content and ensure consumers are not directed to illegal sources. NABP’s .Pharmacy Program, for example, already serves as a guidepost for providing users with legitimate content simply by looking to the right of the dot.

While ongoing efforts have proven useful in addressing some components of the issue, meeting participants left with the understanding that continued collaboration between US government representatives, internet commerce companies, and public- and private-sector stakeholders is critical. We will continue to monitor these ongoing efforts from all those around the table with the goal of ensuring patient safety and public health online.