FDA and DOJ Continue Focus on Illegal Online Sale of Controlled Substances

March 28, 2019

By: Libby Baney and Matthew Rubin, Faegre Baker Daniels

The resignation of Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, from his role has not changed the agency’s focus on combating the opioid epidemic, including efforts to halt the illegal advertisement and sale of prescription opioids and illicit narcotics online. Over the last several weeks, FDA has published several documents and issued statements that demonstrate the prioritization of this issue throughout the agency’s agenda:

  • On February 26, Gottlieb announced FDA’s 2019 policy and regulatory agenda focused on the opioid epidemic and efforts to further improve oversight at international mail facilities. Within these statements are references to the role of the internet in facilitating the advertisement and sale of controlled substances (CS) and illicit narcotics with proposed strategies to combat the influx of these products into the United States.
  • On March 13, the US Attorney for the Eastern District of Wisconsin announced the indictment of five Argentine men for their role in an international online pharmacy conspiracy that included the distribution of CS such as oxycodone. Through collaboration between the Department of Justice (DOJ), Drug Enforcement Administration, US Postal Inspection Service, and other national and international partners, the defendants now face potential sentences of 20 years and $1 million fines for each count. This was just one of several cases prosecuted by a US Attorney within the last several weeks related to the sale of medicine via the internet.

Looking forward, on Tuesday, April 2, FDA will also reconvene stakeholders for the second Online Opioid Summit. This follows the June 2018 FDA Summit which called for increased action from search engines and social media to address illegal opioid sales online. The 2019 Summit will focus on the role of domain name registries and registrars in stopping illegal online drug sales. This stakeholder session is a promising development as it shows the US Government is pushing for solutions to the issue of illegal online drug sales and recognizes the critical role internet companies play in the online supply chain.

Another part of thwarting illegal online drug sellers is to better educate health care providers, patients, and caregivers about risks online and to provide them with ways to stay safe. That is where NABP’s .Pharmacy Verified Websites Program comes in. The .Pharmacy Program helps consumers find safe online pharmacies. By “looking to the right of the dot,” consumers can avoid the estimated nearly 95% illegal online drug sellers and help create a safer, more trustworthy internet in the process.