Recently, the Justice Department Office of Inspector General (“OIG”) released a report criticizing the regulatory activities and enforcement efforts of the Drug Enforcement Administration (“DEA”) for it is response to the opioid epidemic, finding that the DEA was “slow to respond” to the increasing use and diversion of opioids. The report also noted that the DEA failed to use effectively its enforcement tools, and instead actually authorized an increase in opioid output.
The report noted five specific areas of regulatory and enforcement efforts that “could have been more effective” in combating opioid.
The OIG found that the DEA’s preregistration process did not adequately investigate new applications before DEA registration was granted.
The report noted that DEA regulations fail to assess the suitability of potential new registrants, which may prevent the identification of registrants whose applications merit heightened scrutiny.
The report found that, while electronic prescriptions can frequently prevent prescription fraud, the DEA has not taken steps to revise its regulations to require all prescribers to submit prescriptions electronically.
The OIG noted that “stringent” DEA headquarters requirements for field divisions to complete Diversion Control work plans left little room for targeting registrants suspected of diversion.
Finally, the report noted that, beginning in 2013, the DEA rarely used its strongest enforcement tool, the Immediate Suspension Order, which allows it to order stop shipments, to stop registrants from diverting prescription drugs. To the contrary, the DEA actually authorized a 400% increase in oxycodone production between 2002 and 2013, and did not significantly reduce the production of oxycodone until 2017. Further, the DEA struggles to render timely final decisions in administrative actions against registrants for diversion and other alleged violations.
The report also examined that DEA’s data collection and analysis efforts, and found that those are also lacking. Specifically, the OIG concludes that the DEA does not capture sufficient data to detect timely opioid diversion or emerging drug trends, and the DEA does not track the diversion of all pharmaceuticals. In addition, a DEA suspicious order database is “incomplete,” as suspicious order reports are initially sent to DEA field divisions, but those reports are never uploaded to the database at DEA headquarters. As a result of these deficiencies, the DEA is “ill-equipped” to monitor ordering patterns for all pharmaceutical opioids, and that could compromise public safety.
The OIG also provides a number of recommendations for remedying this issues, including developing a national prescription opioid enforcement strategy that encompasses the work of all DEA field divisions, requiring criminal background investigation of all new registrant applicants, requiring electronic prescribing for all controlled substance prescriptions, and requiring that all suspicious orders reports be sent to DEA headquarters.
The report concluded by acknowledging that the DEA has “taken steps” to address the epidemic, including increasing intelligence sharing with local law enforcement agencies, and launching “community outreach efforts” to raise awareness of the dangers of opioids. However, more progress is needed. In response to the statement, the DEA noted that “it appreciated [the] assessment and that it has made improvements intended to control the diversion of opioids.”