On January 20, 2020, the Government Accountability Office (GAO) released its report Drug Control: Actions Needed to Ensure Usefulness of Data on Suspicious Opioid Orders. The report, mandated by Congress in the SUPPORT Act, focuses almost exclusively on the need for the Drug Enforcement Administration (DEA) to beef up its capabilities for analyzing the vast amount of data provided to DEA by registrants. GAO’s investigation revealed, among other things, that DEA conducted “limited proactive and robust analysis of industry reported data” and that DEA did not have the appropriate data governance structure in place to manage drug transaction data.
GAO made four specific recommendations regarding the need to implement more sophisticated ways to analyze industry data; establish a data governance structure; consult and collaborate with industry to improve the ARCOS Enhanced Lookup Buyer Statistic Tool; and to establish “measurable performance targets related to opioid diversion activities.”
This is not the first time that GAO supported greater collaboration between DEA and the regulated industry. GAO reminds us that in its June 2015 report the GAO “found that additional guidance from and additional communication with DEA was needed about registrants’ roles and responsibilities under the CSA” and recommended that “DEA develop additional guidance for distributors for suspicious order monitoring and reporting.” At that time, DEA reiterated its long held (and arguably appropriate) position that “it cannot provide more guidance because the variables that indicate a suspicious order differ among distributors and their customers.”
When questioned in the course of this investigation about the need for greater collaboration, DEA informed GAO that
the agency had refocused its efforts on revising draft regulations in line with the SUPPORT Act, and that the revised draft was undergoing internal DEA and DOJ review. The agency noted that it expected the rule to codify existing legal obligations related to due diligence and suspicious order reporting and provide additional guidance regarding the nature and timing of the suspicious order reporting requirement, but also indicated that it was not possible to be certain of the precise nature of the draft rule.
Noticeably absent is the prospect of substantive guidance on what DEA considers to be a suspicious order. Reading between the lines (and consistent with what I have been saying), I believe DEA is signaling that the new regulations will specifically require the registrant to suspend any shipment it deems to be suspicious, will make mandatory the reporting of suspicious orders to DEA’s central database, and will require a greater level of detail as to why an order is being reported as suspicious. I will refrain from shouting “I told you so” from the rooftops until the regulations are published.
Despite DEA’s responses to GAO investigators, the “congressional watchdog” remains steadfast in its belief that DEA needs to collaborate more with industry. To that end, GAO ominously warned that the “2015 recommendation remains relevant and important, and while DEA has reported taking some actions to address [the need for greater collaboration with industry], DEA has not taken all the necessary steps to address the recommendation. We will continue to monitor DEA’s progress in addressing our recommendation.“
To that I say, me too.