DEA Has Expanded Its Resources and Targeted Its Investigation Strategies to Respond to Rising Criminal Diversion and Growing Registrant Population

To respond to the increasing rate of criminal diversion and a growing  registrant population, DEA has expanded its resources and targeted  investigation strategies in ways to collaborate with state and local entities  and enhance the effectiveness of its Diversion Control Program. Specifically, DEA has expanded its use of Tactical Diversion Squads,  which work with DEA’s state, local, and other federal partners, to  maximize resources and improve efforts to investigate, disrupt, and  dismantle individuals or organizations involved in diversion schemes  related to controlled substances and listed chemicals. DEA has also  renewed its focus on regulatory oversight of the more than 1.3 million  DEA registrants to ensure registrants comply with the CSA and  implementing regulations. According to DEA and local officials we interviewed, the establishment of  the squads has been a means to improve communication, coordination,  and simplify information sharing as the squads have become the  clearinghouse for diversion-related investigative information. According to the Executive Assistant to the Deputy Assistant  Administrator for Diversion Control, DEA was able to increase its  regulatory investigations primarily by using the squads to free up  Diversion Investigator resources that had previously been working both  criminal and regulatory cases and DEA plans to hire additional diversion  staff in the future to conduct investigations. Furthermore, DEA has conducted other targeted outreach efforts to  specific registrant types to inform them of specific regulatory  responsibilities or help them prepare for regulatory investigations:  In 2005 DEA established an initiative to better inform wholesale  distributors of controlled substances of their responsibilities under the  CSA to report suspicious orders from pharmacies that are possibly  filling invalid prescriptions. The  presentation provided examples of Internet pharmacies and rogue  pain clinics as well as their purchase patterns and methods of  operation. To ensure that  Diversion Investigators and Special Agents have the necessary skills to  carry out their responsibilities and that DEA monitors the results of its  employee guidance and training, DEA has established internal control  activities, which are consistent with Standards for Internal Control in the  Federal Government. DEA has established performance measures to  assess and report on its progress toward meeting its performance goal of  reducing the diversion of licit drugs, but could reassess the measures to  identify ways to better capture and report on the results of DEA’s  investigations. DEA has established internal control activities related to guidance and  training such as program policy and procedures manuals and diversion  investigation courses. DEA has implemented a multilayered approach  to monitor the work of its Diversion Control Program personnel to help  ensure that they are following policies and procedures for diversion  investigations. The monitoring process includes direct supervisory review,  self-inspection/peer review, and on-site internal inspection. The Office of Inspections also conducts on-site internal inspections of  DEA’s 21 field divisions to ensure that employees are following required  program policies and procedures—in accordance with the Diversion  Investigator manual. We  found that the inspections did not identify widespread findings or issues  related to the timeliness and overall quality of the diversion investigations. DEA Could Better Identify and Report on the Results of Its Diversion Control Efforts

Given DEA’s increased focus on regulatory and criminal investigations in  response to growing prescription drug diversion, it is critical for DEA to  determine and report on the extent to which these additional efforts are  helping to reduce diversion. However, while the  performance measure is focused on the regulatory investigations and  provides a count of the number of investigations completed, this measure  does not demonstrate the results of those completed investigations or  give a sense as to the extent to which registrants were found to comply  with the CSA and thereby the extent to which DEA is achieving its stated  objective. As a result, this measure does not provide a clear  indication as to the effect DEA’s investigative efforts are having on the  problem of diversion. Recommendation for Executive Action

In order for DEA to better determine to what extent its efforts are  decreasing diversions and to inform future program decisions, we  recommend that the Administrator of DEA strengthen the agency’s  performance measurement for the Diversion Control Program by  reassessing its set of performance measures for the program to identify  ways to enhance the measures and their link to the program outcome  goal of reducing diversion.
Why GAO Did This Study

The Drug Enforcement Administration's (DEA) Diversion Control Program is responsible for enforcing the Controlled Substances Act (CSA) and ensuring the availability of prescription drugs such as pain relievers and stimulants while preventing their diversion for abuse. The CSA requires entities handling controlled substances--such as manufacturers, pharmacies, and physicians, among others-- to register with DEA, which conducts regulatory investigations of registrants, as well as criminal investigations. GAO was asked (1) how DEA manages diversion investigation efforts, and (2) how DEA ensures policies and procedures are followed for investigations and the extent to which it determines the results of its efforts. GAO reviewed DEA policies and procedures, and interviewed DEA, state, and local officials at eleven locations which were selected on the basis of volume of cases handled, geographic diversity, and other considerations. These observations are not generalizable, but provided insights on DEA operations.

What GAO Found

To respond to the increasing rate of criminal diversion of prescription drugs and a growing registrant population, DEA has expanded its resources and targeted its investigation strategies to collaborate with state and local entities and enhance the effectiveness of its diversion investigations. Specifically, the agency expanded its use of Tactical Diversion Squads (squads) of DEA personnel as well as other federal, state, and local partners investigating diversion schemes to maximize resources and improve efforts to investigate criminal diversion. DEA currently has 40 squads across the country and plans to establish more. According to squad participants and DEA officials GAO contacted, the squads have improved communication and coordination and simplified information sharing for investigations. Because of the growing registrant population and noncompliance by some with the CSA and implementing regulations, DEA renewed its focus on regulatory oversight of registrants to better ensure compliance. By using the squads to free up resources previously dedicated to both criminal and regulatory cases, DEA used those resources to increase regulatory investigations of the registrants. As a result, the number of regulatory investigations more than tripled between fiscal years 2009 and 2010. DEA also conducted outreach to specific registrant types to inform them of regulatory responsibilities and prepare them for regulatory investigations. DEA has taken steps to ensure that investigators follow policies and procedures for such investigations, but could better assess how its efforts are reducing the diversion of prescription drugs. To ensure that diversion investigators and special agents have the necessary skills to carry out their responsibilities and that DEA monitors the extent to which policies and procedures are followed during investigations, DEA has established internal controls related to guidance, training, and oversight of investigations. These controls include providing and updating guidance to investigators to follow during investigations, providing initial and on-going training to investigators, and monitoring the quality of investigations through a combination of direct supervisory reviews, self-inspections, and on-site internal inspections by DEA's Office of Inspections. Recent reports from on-site internal inspections of each of DEA's field divisions did not identify any widespread or systematic issues related to the timeliness and overall quality of diversion investigations. Given DEA's increased focus on investigations in response to growing prescription drug diversion, it is critical for DEA to determine the extent to which these additional efforts are reducing diversion. DEA has established performance measures for the Diversion Control Program, but these measures do not clearly demonstrate the effect the additional efforts are having on the diversion problem the program seeks to address. For example, for its overall performance measure of the diversion control program, DEA is tracking the development and implementation of an internal information technology project. By more closely linking performance measures to the goal of reducing diversion, DEA could better capture the results of the Diversion Control program to help inform decision makers in allocating resources.

What GAO Recommends

GAO recommends DEA reassess the program's performance measures to better link them to the goal of reducing diversion. DEA did not concur. GAO continues to believe the measures could be enhanced as discussed in this report.