Six years after the Drug Enforcement Administration issued a two-year temporary order placing fentanyl-related substances (FRS) under Schedule I of the Controlled Substances Act, that order is about to expire again. It never has before, and there’s no reason it would now.
Between 2021 and 2022, Congress extended the Temporary Reauthorization and Study of the Emergency Scheduling of Fentanyl Analogues Act seven times. On December 29, 2022, two days before the Act’s previous expiration date, it was extended two more years to its current expiration date of December 31, 2024. The longer they remain scheduled, the more people the Department of Justice will be able to prosecute, and the longer those people will remain in prison.
In consideration of this deadline, on November 21 the Congressional Research Service (CRS) published a report outlining the legal landscape of scheduling FRS. The nonpartisan agency exists to find the most relevant information about a given issue and distill it for legislators; it doesn’t make recommendations for or against any policies under consideration, but does provide context about their impact and about potential alternatives. The report was written by Joanna R. Lampe, who does a lot of the agency’s coverage of the legal aspects of the CSA.
In 2018, the DEA issued a temporary scheduling order for FRS as a broad category. Temporary sheduling orders aren’t limited to FRS—the DEA has been issuing them for nitazenes, xylazine, etc.— but class-wide bans are not the norm. Usually the CSA specifies the individual substances on it by name.
In practice, the Attorney General delegates scheduling authority to the DEA.
Schedule I contains drugs that can’t be prescribed. Schedule II, which is less restrictive, contains drugs that have been approved by the Food and Drug Administration for medical purposes. Fentanyl is a Schedule II substance, due to its FDA indication for pain relief. Some FRS have already been individually placed under Schedule I, and others under Schedule II.
Also known as fentanyl analogs, FRS are substances that share certain chemical building blocks with fentanyl. However, despite being reported in the media as more potent than fentanyl, some are more potent while some are less potent. Some are similar in effect to fentanyl; some are different. The point is that we don’t know much about them.
The United States Attorney General can place a substance under Schedule I after a lengthy rulemaking process undertaken with the Health and Human Services Administration, which determines whether the substance has any currently accepted medical use. In practice, the AG delegates this authority to the DEA, even though the agency is part of the DOJ and not the HHS.
But even so, the DEA hasn’t moved to schedule FRS permanently. It could, but this would require making a case for each analog individually, which would be a lot of work given that there are thousands of them and many have not been researched at all. Which isn’t to say the DEA couldn’t just push through class-wide findings anyway, but scheduling decisions arrived at that way wouldn’t necessarily hold up in court and the whole point of this is to prosecute people.
This rulemaking process isn’t designed to be unilateral; if the Food and Drug Administration, which is part of the HHS, recommends against placing a drug under Schedule I then traditionally the DEA can’t override that recommendation. Though recently the DEA seems to have decided that, actually, it can.
In April, the Office of Legal Council backed up the DEA’s claim that the overall HHS recommendations are “not binding on DEA … the scientific and medical determinations that underlie HHS’s ‘currently acceptable medical use’ recommendations are binding, but only until the initiation of formal rulemaking proceedings.” The OLC is also part of the DOJ.
It’s been four years now since permanent scheduling was punted to Congress, which in theory is the faster route of the two.
The other route to placing a substance under Schedule I is through Congress, which needs no scientific or medical justification to do so. It’s not subject to any of the HHS rulemaking criteria. It just has to pass legislation. It’s been four years now since permanent scheduling was punted to Congress, which in theory is the faster route of the two.
The CRS report covers the various legislative pushes to schedule FRA permanently. The Save Americans from the Fentanyl Emergency (SAFE) Act, the Stopping Overdoses of Fentanyl Analogues (SOFA) Act, the Halt All Lethal Trafficking (HALT) of Fentanyl Act, the Protecting Americans from Fentanyl Trafficking Act, which apparently doesn’t use an acronym.
Though the report doesn’t mention it, in September the Senate also introduced legislation to extend the temporary scheduling order through December 31, 2025. The legislative route to permanent scheduling is pretty conducive to the DEA’s interests, but not as conducive as creating and extending temporary orders indefinitely.
Unlike permanent scheduling, the DEA can temporarily schedule anything pretty much unilaterally. This can be good for two years at a time; three, if a proposal for permanent scheduling is under consideration. Rather than the usual eight HHS rulemaking criteria, the DEA can initiate a temporary scheduling process based on just three: “history and current pattern of abuse”; “scope, duration and significance of abuse”; and “[w]hat, if any, risk there is to the public health.”
Scheduling decisions arrived at via legislation, rather than regulation, are less likely to be struck down by the federal court system. But temporary orders are beyond the purview of the courts. If Congress just creates and extends them again and again, they’ll never be subject to judicial review at all.
Image (cropped) via United States Drug Enforcement Administration
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