Prescription Drug Control

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.

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. 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.

Recommendations

Our recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.

Director: Eileen Larence Team: Government Accountability Office: Homeland Security and Justice Phone: (202) 512-6510