For over two decades, NABP has raised concerns over the vast number of illegal online pharmacies that put Americans’ health at risk by selling medications without a prescription, operating without a license, and peddling substandard, falsified, or counterfeit prescription drugs, including illicit opioids, to patients. Government agencies, including Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), the United States Department of Justice (DOJ), and the US Department of Health and Human Services (HHS), have spent decades trying to disrupt the illegal online pharmacy marketplace. Overcome by the sheer volume of websites and the inherent challenges of investigating and prosecuting internet crimes, including the lack of reliable WHOIS data, law enforcement agencies have relied on internet stakeholders to take voluntary action. While many sectors in the online marketplace, including search engines and payment networks, have taken steps to establish and enforce policies that would prohibit illegal online pharmacies from using their services, other sectors, such as domain name registrars, have repeatedly turned a blind eye, making it virtually impossible to put a significant dent in the prevalence of illegal online pharmacies. That soon may change.
At the end of last year, a bill aimed at stopping illegal online sales of prescription drugs and controlled substances – the Domain Reform for Unlawful Drug Sellers Act (DRUGS Act) – was introduced in the US Senate by Senator Rubio (R-FL) (S 3399) and in the US House of Representatives by Representatives Rush (D-IL) and McKinley (R-WV) (HR 6352). Taking aim at one of illegal online pharmacies’ most important resources, domain names (or website URLs), the DRUGS Act requires domain registries and registrars to lock and suspend domain names when alerted by a “trusted notifier” that the domain is being used to sell drugs illegally (ie, in violation of the provisions of Section V of the Federal Food, Drug, and Cosmetic Act (FD&C Act)).
Registries manage domain extensions or Top-Level Domains (TLDs), such as .com, .gov, .org, and .pharmacy. Registrars license second-level domain names to the public (ie, the name to the left of the extension). For example, NABP is the registry that manages the “.pharmacy” TLD, and “nabp.pharmacy” is the domain name for this website. Thus, together, registries and registrars control what many consider to be one of the most essential features of a website – its common name or address. In a browser (Firefox, Chrome, Edge), typing the domain name of the website will take you to the website’s landing page. When you use a search engine, like Google or Bing, it will often render a list of domain names for websites relevant to your search terms. Advertisements also use domain names to redirect users to a merchant’s website. In short, domain names allow users to easily connect to a website. Registries and registrars often have terms and conditions that prohibit the domain names they license from being used to conduct illegal activity. However, far too many fail to exercise their contractual right to terminate services, in some cases even after receiving repeated alerts from government entities and nonprofit organizations, like FDA and NABP.
In 2020, in an effort to better facilitate coordination between registries/registrars and government agencies, FDA and the Department of Commerce’s National Telecommunications and Information Administration launched a pilot program aimed at shutting down websites illegally selling opioids. In that pilot, the three US-based domain name registries (Registry Services (formerly Neustar), Verisign, and Public Interest Registry) responsible for managing the TLDs of .us, .com/.net, and .org, respectively, agreed to allow FDA to serve as a trusted notifier and direct them to websites selling opioids illegally. Over the course of four months, this led to the takedown of nearly 30 websites, demonstrating that expanding surveillance to other trusted entities and formalizing a process by which registries must respond to illegal activity can help expedite the identification of and action against illegal online prescription sellers.
This is the premise upon which the DRUGS Act has been designed. The DRUGS Act enables trusted notifiers, which includes FDA, DOJ, HHS, state attorneys general, state boards of pharmacy, and any entities partnering with FDA or DEA to inform registries and registrars of websites that are selling prescription medications in violation of the provisions of the FD&C Act. In response, registries and registrars are required to take the following action:
- Lock the domain within 24 hours of notification
- Suspend the domain name within seven days of notification, unless the domain name registrant successfully appeals to the trusted notifier’s findings
Locking the domain name prevents the domain name licensee from updating, deleting, or transferring the domain name to another registrar. Suspending the domain name renders the website inaccessible to users. Failing to take action will be treated as a violation of the FD&C Act, and the registry and registrar will be subject to the following penalties:
- First offense: one year in jail, a $1,000 fine, or both
- Second offense: three years in jail, a $10,000 fine, or both
Registrants and website operators would have the ability to appeal the action by providing evidence of compliance with applicable laws, such as submitting a copy of their pharmacy licenses for applicable jurisdictions and/or providing the license number of the medical practitioner that issued the relevant prescription.
The bill has already garnered formal support from NABP and 27 other national associations representing health care providers, pharmacists, and law enforcement. There is a long road before the bill will be brought forth for discussion in the US Senate Committee on Health, Education, Labor, and Pensions / the US House Committee on Energy and Commerce. At the same time, the number of Americans purchasing prescription medicines online is increasing every year; so, it is unlikely that illegal online pharmacies will fall off Congress’ radar any time soon.