In a notable shift, the Drug Enforcement Administration (DEA) has acknowledged the legitimacy of a new two-part test to determine a substance’s accepted medical use, particularly in relation to marijuana. As reported by Marijuana Moment, this development, embedded in a recent notice about synthetic opioid scheduling, could have significant implications for the ongoing cannabis rescheduling process.
Traditionally, the DEA relied on a five-part test to evaluate whether a drug had a “currently accepted medical use”, but earlier this year, the Department of Health and Human Services (HHS) introduced a simplified two-part analysis. This analysis played a key role in the HHS recommendation to reschedule cannabis from Schedule I to Schedule III under the Controlled Substances Act.
The New Two-Part Test
The revised test focuses on two key questions: whether licensed healthcare providers currently use the substance in medical treatment within legally authorized jurisdictions and whether there is credible scientific support for at least one medical condition for which the substance is used.
This streamlined approach contrasts with the previous five-part test, which required detailed evaluations of the drug’s chemistry, safety studies, efficacy, expert acceptance and the availability of scientific evidence.
In a footnote, the DEA acknowledged that the Department of Justice’s Office of Legal Counsel (OLC) found the five-part test to be “impermissibly narrow” and concluded that the two-part analysis was sufficient to determine a drug’s medical use—even if it hadn’t been approved by the FDA. The OLC further emphasized that the DEA must defer to HHS’s scientific and medical determinations during the rescheduling process.
Resistance And Criticism
Despite the DEA’s acknowledgment of the new test, opponents of marijuana reform, such as the group Smart Approaches to Marijuana, argue that the two-part standard is unjustified and politically motivated. Some suggest that the revised analysis could be a point of contention in potential legal challenges to the rescheduling decision.
Legal experts like Shane Pennington, an attorney specializing in federal administrative law, view the DEA’s acceptance as significant. Pennington explained that the DEA is “bound by OLC on legal issues,” meaning that the agency must adhere to the two-part review, despite any internal resistance.
Implications For Future Drug Scheduling
The DEA’s recognition of this new standard may not only impact marijuana’s rescheduling but could also set a precedent for future drug scheduling decisions, such as those concerning psychedelics like psilocybin. If those substances are up for review, the DEA would likely apply the same two-part analysis.
The rescheduling of marijuana remains pending, with the DEA scheduling an administrative hearing in December 2024 to gather additional input before potentially finalizing the rule. The outcome could extend into January 2025, allowing the next presidential administration to influence the process.
H/T: www.benzinga.com
