DEA is Without an ALJ. What Does that Mean for Registrants?

Last week, the Drug Enforcement Administration’s (“DEA”) last remaining administrative law judge (“ALJ”) retired, leaving DEA with no ALJ to oversee its administrative cases. As observed over its first six months, the Trump administration has not shown any meaningful interest in prioritizing the hiring of new agency officials to fill voids, so there seems to be little reason to expect the government will fill these vacancies any time soon. In the meantime, all pending administrative cases have come to an immediate halt and have been stayed indefinitely. While this unfortunately leaves defendant registrants in perpetual legal uncertainty for their cases, it may have more far-reaching implications for DEA and the rest of the registrant population because, without an ALJ, DEA is unable to obtain final agency action for cases it deems most worthy of prosecution.

*Note: While DEA’s regulations specify that the presiding officer is an ALJ, the Controlled Substances Act (“CSA”) allows the presiding officer to be an ALJ, "the agency," or "one or more members of the body which comprises the agency." Rabadi v. DEA, 122 F.4th 371 (9th Cir. 2024). Therefore, it is possible DEA could use this opportunity to dispense with its historical reliance of ALJs and deputize DEA-friendly, non-attorney employees to adjudicate cases.

Beyond it stalling all pending administrative cases, the absence of an ALJ comes with many other significant implications, including the potential of it neutralizing one of DEA's most coveted administrative enforcement tools—the order to show cause (“OTSC”). When DEA proposes to revoke an existing registration, it must issue an OTSC and give the registrant an opportunity for a hearing before an ALJ to contest the proposed action. See 21 U.S.C. § 824(c). Until a hearing is held and final agency action is taken, the registration remains active and the registrant may continue to engage in its ordinary business activities unimpeded. However, without an ALJ, DEA is now extremely limited in how it can leverage OTSCs. The DEA’s Administrator is, of course, still able to issue new OTSCs but, once issued, it has no path forward and there is no venue in which it can be adjudicated. Thus, all of the sudden, OTSCs may now offer very little substantive value to DEA’s causes until ALJs are appointed.

Notwithstanding the challenges DEA may now face with OTSCs, the absence of ALJs is not likely to disarm DEA of its most feared enforcement tool—Immediate Suspension Orders (“ISOs”). To the contrary, ISOs may only become even more menacing to the industry and become a more appealing tool for DEA to try and wield. The DEA can, in its discretion, suspend any registration where it finds that there is an imminent danger to the public health or safety. See 21 U.S.C. § 824(d). To do so, DEA must issue an ISO that establishes the danger posed by the registrant to the public's health and safety. See 21 CFR § 1301.36(e). Upon receipt of an ISO, the registrant is then entitled to an “expedited administrative hearing.” 21 CFR § 1301.36(h). Most harmful to registrants is the fact that ISOs suspend use of registrations until the conclusion of the administrative proceedings, unless it is otherwise withdrawn by DEA or dissolved by a court of competent jurisdiction. See 21 U.S.C. § 824(d). In light of this, once an ISO is issued, time is of the essence for the registrant and the urgency with seeking protection from an ALJ at an administrative hearing is especially critical. In many cases, the timeliness of the administrative hearing will eventually determine whether the registrant’s business will be able to survive and continue operations once the registration is reinstated. Without an ALJ, registrants are now unable to look to an “expedited administrative hearing” to have an ISO lifted and have its registration reinstated. With no way for the registrant to secure a hearing, DEA may be tempted to leverage ISOs in a far more aggressive way than what Congress ever intended because, in essence, DEA would be able to suspend registrations on an almost permanent basis where (1) the registrant has no administrative remedy to remove the suspension and (2) DEA is relieved of having to demonstrate to an ALJ that the requisite “imminent danger” exists and it justifies the suspension. In other words, the DEA may seek use the absence of ALJs to its advantage by letting suspensions linger on indefinitely to the point that, in practice, the registrations are revoked.

In considering this potential risk, it is worth noting that there is no statute or regulation imposing any specific timeliness requirements for DEA’s handling of ISOs. The APA requires DEA to conclude matters “within a reasonable time.” 5 U.S.C. § 555(b). In addition, DEA’s regulations require an ALJ to issue a recommended decision “as soon as practicable” after a hearing has been held and the parties have had the opportunity to submit proposed findings of fact and conclusions of law. 21 CFR § 1316.65. Similarly, DEA’s regulations require the Administrator to issue a final decision “as soon as practicable” after receiving the certified record from the ALJ. 21 CFR § 1301.46. But neither of these provisions truly prevent DEA from issuing ISOs and leaving them in place indefinitely. With that said, in 2006, DEA issued a memorandum that established timeliness standards specifically for its handling of ISOs. The memorandum was issued chiefly in response to a preliminary injunction issued by a U.S. District Court after finding DEA had violated the due process clause of the Fifth Amendment by not providing a timely hearing for a registrant that had received an ISO. Through the memorandum, DEA committed to issuing final decisions within 180 days from the issuance of an ISO. It also required ALJs to commence a hearing within 60 days of an ISO’s issuance and to submit the certified record of the hearing to the Administrator for a final decision within 150 days of the issuance of an immediate suspension order. Thus, while neither the CSA nor DEA’s regulations afford registrants protection from an overly aggressive use of ISOs, DEA’s historical approach to the timeliness of ISOs and registrants’ obvious due process rights will likely dissuade DEA from deploying its ISO authority in such a powerful way.

Further threatening DEA’s enforcement mechanisms is the fact that the Department of Justice (“DOJ”) is facing its own personnel challenges, which calls into question how much capacity AUSAs will have for CSA civil cases going forward, particularly for DEA’s referrals that are limited to recordkeeping violations. Thus, in addition to new risks to its ability to rely on OTSCs, DEA may also find itself increasingly limited in how often it will be able to lean on DOJ in order to pursue civil monetary penalties against registrants, which has historically been one of DEA’s most effective methods of forcing registrants to settlement. If nothing else, these potential strains on DEA’s historical reliance on OTSCs, ISOs and civil monetary penalties may result in registrants having new leverage when defending against less severe agency action (e.g. LOAs and MOAs).