The US Senate held a confirmation hearing on April 30, 2025 for Terrance C. Cole, the president’s nominee for the administrator of the Drug Enforcement Administration. Although Administrator-nominee Cole’s policy priorities for the agency remain unclear, once confirmed and sworn in, he will find several pending regulatory matters waiting for him that could significantly affect industry stakeholders with controlled substance and/or listed chemical operations.
Cole was previously with the US Department of Justice’s Drug Enforcement Administration (DEA) for more than 22 years before retiring in 2019. Most recently, he served as the secretary of public safety and homeland security of the Commonwealth of Virginia.
This LawFlash discusses key issues to watch as Cole awaits confirmation.
As we described in a prior LawFlash, under the Biden administration, DEA issued a notice of proposed rulemaking on May 21, 2024 to reschedule marijuana from Schedule I to Schedule III. DEA subsequently announced and initiated a hearing process for this rescheduling action, and a preliminary hearing was held on December 2, 2024, after which the presiding administrative law judge issued a schedule for hearing proceedings to begin on January 21, 2025. However, the hearing has since been postposed pending resolution of an appeal filed by a party challenging DEA’s role as a proponent of the proposed rescheduling action.
The current administration has not yet taken a formal stance on the proposed rescheduling, nor has Cole. Other officials in the administration, such as the secretary of the US Department of Health and Human Services, have previously expressed support for rescheduling marijuana. It remains to be seen whether DEA under the new administrator and new US attorney general will continue efforts to move this rescheduling forward.
Additionally, it is yet to be seen how the current patchwork of state laws relating to marijuana legalization and decriminalization will interact (or not interact) with federal laws. This may, in part, depend on the US attorney for the particular district.
As discussed in our prior LawFlash, DEA issued a proposed rule on January 17, 2025 for a special registration process under the Ryan Haight Act for prescribers of controlled substances who treat patients via telemedicine without first having an in-person exam. The January 2025 notice of proposed rulemaking was the latest rulemaking attempt by DEA for the use of telemedicine to prescribe controlled substances after facing significant industry criticism for prior efforts. DEA received more than 40,000 comments on the January 2025 proposed rule before the comment period closed on March 18, 2025.
Although DEA has taken some steps to reschedule marijuana, the next area that some are looking to may be psychedelics. Presently, a small number of states have taken actions with respect to use of certain psychedelic substances for medical purposes, and more states have proposed legislation. Psychedelics are also increasingly being looked at by the pharmaceutical industry as possible treatments for a range of psychiatric diseases, though development of such drugs has proven challenging, as we previously discussed in our As Prescribed blog post. As it currently stands, psychedelics, such as psilocybin and MDMA, are Schedule I controlled substances. There are also additional psychedelic substances that may not be scheduled by DEA but are scheduled by state authorities.
Added on top of this landscape is the grey area of DEA and state statutes for controlled substance analogues. This all creates an uncertain regulatory environment for the development of US Food and Drug Administration (FDA)-approved psychedelic drug products and the implementation of and compliance with what is likely to become a growing number of state laws and programs. Exactly what this means for federal psychedelic policy in the next four years is unclear. However, what is clear is that psychedelics are likely to be a growing area with which the new DEA administrator will need to grapple.
In December 2024, DEA introduced significant enhancements to the Controlled Substances Ordering System (CSOS), the secure electronic ordering system for controlled substances. These enhancements included changes to allow registrants to submit CSOS enrollment applications and perform certificate management activities (e.g., renewals and revocations) online through a secure network application.
DEA previously issued a proposed rule in February 2023 to update the regulations at 21 C.F.R. Part 1311 to require online submission of all CSOS enrollment applications and supporting materials through a secure portal and eliminate the ability of registrants to file paper CSOS enrollment applications. While DEA has not yet finalized the 2023 proposed changes to Part 1311, DEA appears to be moving forward with implementation, as the December 2024 enhancements now allow for online submission of enrollment applications and DEA stopped accepting paper applications after January 10, 2025.
Once confirmed, the new administrator will be tasked with overseeing the ongoing implementation of these CSOS updates, as well as deciding when and whether to make corresponding changes to update the regulations. With these recent efforts to modernize the electronic ordering processes, there may be an increase in the number of registrants utilizing CSOS. Additionally, as companies obtain increasing data sources and information on controlled substance ordering patterns through CSOS or otherwise, DEA’s expectations on how registrants assess the legitimacy of incoming and outgoing orders may also evolve.
Under the Biden administration, DEA kept up a hefty pace for controlled substance scheduling, issuing more than 30 proposed and 50 final scheduling rules, the vast majority of which were to add new substances (e.g., new synthetic compounds, newly identified fentanyl-related substances, and new drug compounds with pending FDA approvals) to DEA’s controlled substance schedules. DEA also issued five proposed and five final actions to add new listed chemicals.
Given the new US administration’s deregulatory priorities, including the “10-for-1” executive order discussed below, it remains to be seen whether DEA will maintain this pace under the current administration. If, however, the 10-for-1 executive order impacts the pace of new DEA scheduling actions, this could have a very real impact on the launch of new FDA-approved drug products that require DEA controlled substance scheduling.
On January 31, 2025, the president signed Executive Order 14192, Unleashing Prosperity Through Deregulation, which requires agencies, including DEA, to identify and repeal at least 10 existing regulations for each new regulation issued. The executive order defines the term “regulation” broadly to include not only rules and regulations but also guidance documents, policy statements, interagency agreements, and memoranda.
This executive order could significantly affect the ability of the new DEA administrator (once confirmed) and US attorney general to implement their regulatory priorities for controlled substances and listed chemicals, particularly if the administration is interested in further tightening controls.
As Cole moves closer to confirmation, there remains significant uncertainty on whether—and to what extent—DEA’s regulatory priorities may shift under the new US administration. How DEA will handle the ongoing regulatory matters described above also remains to be seen.
Our lawyers stand ready to assist companies handling controlled substances and listed chemicals to navigate the complex and evolving DEA requirements and related state laws and regulations. Our deep familiarity with both the federal DEA and state regulatory requirements helps us provide clients with strategic and practical solutions.
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