On July 27, 2015, the Government Accountability Office (GAO) released a report titled, Prescription Drugs: More DEA Information about Registrants’ Controlled Substances Roles Could Improve Their Understanding and Help Ensure Access.  GAO’s report examined, (1) to what extent registrants interact with DEA about their CSA responsibilities, and registrants’ perspectives on those interactions, (2) how state agencies and national associations interact with DEA, and their perspectives on those interactions, and (3) stakeholders’ perspectives on how DEA enforcement actions have affected prescription drug abuse and diversion and access to those drugs for legitimate needs.

GAO’s survey results concluded, among other things the following:

  • Registrants vary in the extent of their interaction with DEA and awareness of DEA resources, and while generally satisfied, some want additional information and guidance.
  • State agencies and national associations interact with DEA through joint task forces or meetings, and while generally satisfied, some associations want improved communication.
  • Many registrants have changed certain business practices as a result of DEA enforcement actions and reported these changes have limited legitimate access.
  • While providing additional guidance to registrants about their CSA roles and responsibilities cannot ensure that registrants are meeting them, by doing so DEA will have a greater assurance that registrants understand their CSA responsibilities.

GAO’s report recommended that DEA take the following three actions:

  • Identify and implement means of cost-effective, regular communication with distributor, pharmacy, and practitioner registrants, such as through listservs or web-based training.
  • Solicit input from distributors, or associations representing distributors, and develop additional guidance for distributors regarding their roles and responsibilities for suspicious orders monitoring and reporting.
  • Solicit input from pharmacists, or associations representing pharmacies and pharmacists, about updates and additions needed to existing guidance for pharmacists, and revise or issue guidance accordingly.

In response to this report, DEA described the actions that it plans to take to implement the three recommendations, although in some instances the agency asserts that the survey results are based on anecdotal data.  DEA officials also indicated that they do not believe there is a need for more registrant guidance or communication.  However, DEA has stated that its goal is bringing registrants into compliance rather than taking enforcement actions, and DEA can move closer towards this goal by improving its communications and information sharing with registrants, consistent with federal internal controls standards.


Amanda Klopt, Legal Intern, Washington, D.C. Office