The Drug Enforcement Administration (DEA) has recently endorsed a new, simplified two-part test to determine a substance's accepted medical use, marking a significant shift in drug policy evaluation. This development, which emerged in a recent notice regarding synthetic opioid scheduling, could have far-reaching legal and political ramifications, particularly in the context of marijuana rescheduling and the broader drug policy debate.
Historically, the DEA relied on a rigorous five-part test to establish if a drug had a “currently accepted medical use.” This traditional framework required detailed analysis, covering aspects like the drug's chemistry, comprehensive safety studies, efficacy, expert acceptance, and the availability of scientific evidence. However, the Department of Health and Human Services (HHS) proposed a streamlined two-part test earlier this year, which significantly simplifies the process.
The new test narrows down the evaluation to two crucial questions:
Do licensed healthcare providers currently use the substance in medical treatment within legally authorized jurisdictions?
Is there credible scientific support for at least one medical condition for which the substance is used?
This more focused approach is a departure from the DEA’s previous methodology and has been instrumental in the HHS’s recommendation to reschedule cannabis from Schedule I to Schedule III under the Controlled Substances Act.
Legal experts like Shane Pennington, a federal administrative law attorney, regard the DEA's acceptance of the two-part test as a monumental shift. According to Pennington, the DEA is "bound by the Office of Legal Counsel (OLC) on legal issues," mandating the agency to comply with this new standard. This compliance indicates that, despite any internal pushback within the DEA, the two-part analysis must be applied during the cannabis rescheduling process.
The acceptance of the two-part test could also extend beyond marijuana. If substances like psilocybin or other psychedelics come under review, the DEA will likely be required to use the same simplified analysis, potentially leading to a broader reevaluation of drug scheduling criteria.
Despite the DEA's acknowledgment, not everyone is on board with this change. Advocacy groups opposing marijuana reform, such as Smart Approaches to Marijuana, have criticized the two-part test as politically motivated and unjustified. They argue that the revision opens the door to an overly lenient evaluation process that could set a precedent for future drug policy decisions.
These groups suggest that the new analysis could become a focal point of legal disputes, particularly as the rescheduling process progresses. With the DEA scheduled to hold an administrative hearing in December 2024 to gather additional input before potentially finalizing the rule, opponents are gearing up for a fight. This contention could lead to significant legal battles, potentially reaching federal courts if opponents argue that the new test does not meet statutory requirements or fails to consider crucial aspects of drug safety and efficacy.
The timing of the DEA's decision could have substantial political consequences. The outcome of the cannabis rescheduling process is expected to extend into January 2025, potentially allowing the next presidential administration to influence the final decision. Given the politically charged nature of drug policy, a change in administration could result in a shift in priorities, either reinforcing the new standard or pushing back against it.
Furthermore, this shift could set a precedent for future drug scheduling decisions, influencing how substances like psychedelics are evaluated. If the two-part test is upheld, it could signal a move toward a more science-based approach to drug policy, emphasizing current medical use and credible scientific support over the more stringent criteria of the past.
Do you think the DEA's new two-part test for determining medical use is a step toward a more science-based drug policy, or does it open the door for more legal
Yes, it's a step towards a more science-based approach.
No, it invites more legal and political complications.
Not sure, need more information.
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