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Key Excerpts from IG Review of the DEA's Efforts to Control the Diversion of Opioids

October 1, 2019

The following are excerpts from the recent report by the Office of the Inspector General, U.S. Department of Justice on the Drug Enforcement Administration’s (DEA) regulatory and enforcement efforts to control the diversion of opioids.

“We found that DEA was slow to respond to the significant increase in the use and diversion of opioids since 2000. We also found that DEA did not use its available resources, including its data systems and strongest administrative enforcement tools, to detect and regulate diversion effectively.” (Page i)

DEA Increased Production Quotas During the Height of the Opioid Epidemic 

  • “From 2003 to 2013, DEA authorized manufacturers to produce substantial amounts of opioids. For example, the Aggregate Production Quota (APQ) of oxycodone in the United States increased over 400 percent, from 34,482 kilograms in 2002 to a high of 153,750 kilograms in 2013…However, it was not until 2017 that then acting DEA Administrator Chuck Rosenberg reduced the APQ for most controlled substances, including oxycodone, by 25 percent.” (Page 13)

Suspicious Order Reports Could Have Helped Detect and Target Diversion 

  • “We found that the SORS [Suspicious Order Reporting] database did not include all suspicious reports provided to DEA, thereby significantly impacting its usefulness. This was due largely to the fact that most DEA registrants are not required to report suspicious orders to DEA headquarters. Instead, consistent with federal regulation, nearly all such information is sent to DEA field division offices and DEA has not created a mechanism whereby reports sent to its field divisions are uploaded into the SORS database.” (Page 31)
  • “As of August 2017, approximately 1,400 DEA registrants were manufacturers and distributors of controlled substances and ARCOS contained ordering information from about 1,100 of these registrants. Yet, we found that the SORS database contained suspicious order reports from only eight registrants.” (Page 31)
  • “During interviews, we asked DEA headquarters officials where the remaining suspicious order reports were located for the roughly 1,400 registered manufacturers and distributors of controlled substances; we were informed that DEA requires field divisions to maintain custody of the suspicious order reports. However, when we asked DEA field division staff to locate these reports at multiple sites throughout the country, staff were unaware of the requirement to maintain the reports and could not locate them. One Diversion Program Manager (DPM) described the SORS database as a 'joke,' noting that DEA field division staff did not receive access to the SORS database until 2017, nearly 10 years after it was created. We believe that the lack of consistent procedures for reporting suspicious orders, and uploading those reports into the SORS database, hampers DEA’s ability to detect and target the diversion of controlled substances, including pharmaceutical opioids.” (Page 31)

Clarity Around What Constitutes a Suspicious Order Is Needed 

  • “We … believe that DEA should establish regulations, policies, and procedures that specifically define what constitutes a suspicious order, as well as what information should be included in a suspicious order report. This is important because most of the major enforcement actions taken against manufacturers and distributors of controlled substances heavily relied on suspicious order reports, or a lack thereof, as evidence that led to administrative actions and settlements that prevented future diversion.” (Page 32)

Use of Immediate Suspension Orders Declined Beginning in 2013 

  • “Beginning in 2013, DEA rarely used its strongest enforcement tool, the Immediate Suspension Order (ISO), to stop registrants from diverting prescription drugs, and DEA continues to experience challenges in rendering final decisions on administrative actions in a timely manner.” (Page 15)
  • “We found that DEA reduced its use of ISOs by over 80 percent (38 to 6) between FYs 2010 and 2017, including by nearly 70 percent (45 to 14) in FY 2013 alone. Even prior to our review period, there was a 42 percent decrease (24 to 14) in ISOs issued between FYs 2008 and 2013. In fact, DEA issued more ISOs in FY 2012 than FYs 2013–2017 combined. By comparison, since FY 2014 the number of OTSCs issued by DEA has generally increased.” (Page 21)

The Ensuring Patient Access and Effective Drug Enforcement Act Did Not Impact Enforcement 

  • “During the course of our review, we also considered the passage of the Ensuring Patient Access and Effective Drug Enforcement Act of 2016 (Act) and its effect on DEA’s use of ISOs. The Act’s definition of imminent danger to the public health or safety required DEA to meet a higher standard of proof before issuing an ISO. While we were told that the new proof standard could negatively affect DEA’s future ability to use ISOs effectively, we found, as shown in Figure 4, that DEA’s use of ISOs had already decreased sharply in the years prior to the bill’s passage. Given that the bill did not become law until April 2016, there was not yet sufficient data available during our fieldwork to assess the legislation’s actual impact on DEA’s ability to use ISOs.” (Page 24)
  • “Former acting DEA Administrator Patterson told us that he believed the only challenge the Act presented to DEA was that it required Diversion Investigators to be diligent about providing evidence to CCD attorneys as soon as they received it in order to satisfy the bill’s imminent threat standard. Patterson stated that, if an alleged harm occurred a year before the investigator presented the case to the Chief Counsel, the imminent threat standard could not be met and the investigator would have to pursue another course of action, such as an OTSC.” (Page 24)

Click here to view the full report

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