President Biden's Scheduling Directive Is a Game Changer

for all controlled substances, not just cannabis

Most commentary I’ve seen on President Biden’s recently announced “three steps to end [the federal government’s] failed approach” to cannabis focuses primarily (often nearly entirely) on his decision to pardon all federal convictions for simple possession. Comparatively little attention has been paid to his directing “the Secretary of Health and Human Services and the Attorney General to initiate the administrative process to review expeditiously how marijuana is scheduled under federal law.” And what little attention his scheduling directive has received has treated it as a non-event because many assume it will not result in descheduling or the sort of “comprehensive reform” that advocates seek through legislation.

As is so often the case in this area, however, these takes are badly misinformed. President Biden’s scheduling directive is enormously important. In fact, if permitted to run its course, it could revolutionize federal drug control law to a far greater degree than any of the many pending cannabis legalization bills. Don’t believe me? Keep reading.

Unlike pending legislative proposals, which target cannabis specifically, President Biden has directed the Executive Branch to initiate an administrative process that can only remove cannabis from schedule I by reinterpreting the statutory requirements that have kept it in schedule I for years. And whatever new interpretations the Administration announces in this cannabis proceeding will apply with equal force to all substances under the Controlled Substances Act.

An example will make the point clear. Imagine that President Biden’s scheduling directive results in cannabis being moved to schedule II. For that to happen, DEA and FDA would have to abandon their long-held interpretation of 21 U.S.C. 812(b)(1)(B)—the provision of the Controlled Substances Act that requires DEA to place substances with high abuse potential and “no currently accepted medical use in treatment in the United States” in schedule I. For decades, DEA and FDA have insisted that a substance has a “currently accepted medical use” only if it is approved by FDA for interstate marketing as a drug or meets DEA’s five-part test designed to mirror that test. Under that standard, state laws recognizing cannabis’s medical utility and the real-world evidence of physicians across the country recommending cannabis to patients “in treatment in the United States” is categorically irrelevant to cannabis’s schedule I status under the Controlled Substances Act.

If DEA and FDA were to announce a change to that standard through the scheduling review President Biden has set in motion—one recognizing that widespread state acceptance of a substance’s medical utility as proof of “currently accepted medical use,” for example—that new standard would apply not just to cannabis, but to every other substance subject to the Controlled Substances Act, as well. That includes substances like psilocybin, MDMA, peyote, mescaline, etc. In short, virtually any adminsitrative process that permits cannabis to escape schedule I will permit—or at least open the door for—other substances to escape schedule I as well.

More fundamentally, reinterpreting federal drug control laws to prioritize state authority over medical judgments like currently accepted medical use would mark a significant shift in the balance of power over the practice of medicine in the United States. That shift would have important and immediate implications for several ongoing policy debates about who should control healthcare and the practice of medicine in the United States. A big deal? You better believe it.

Notice, also, that the dramatic implications I’ve described above would all arise from the sort of administrative decision necessary merely to reschedule cannabis to schedule II. Descheduling wouldn’t necessarily require a reinterpretation of currently accepted medical use (because the “no currently accepted medical use” requirement applies only when DEA seeks to place a substance in schedule I), but it would still require similarly dramatic changes to other generally applicable agency policies. Removing cannabis from the schedules entirely would most likely require DEA either (1) to abandon its longstanding interpretation of “potential for abuse” under 21 U.S.C. 811(a) and 812(b) or (2) to reimagine the Controlled Substances Act’s scheduling requirements as a flexible balancing test rather than a rigid brightline standard. Either way, the change DEA announced for cannabis would apply across the board to all substances subject to the Controlled Substances Act now and in the future.

The bottom line here is that regardless of whether this administrative process ultimately results in rescheduling or descheduling, if permitted to run its course, its impact on federal drug policy could be historic. For that reason, critics who characterize the President’s initiative as a “baby step” that won’t make much of a difference couldn’t be more wrong. And because rescheduling and descheduling would both have dramatic implications far beyond the cannabis context, I see no reason to assume that the President is secretly urging DEA and FDA to favor rescheduling as a prefferred “let’s not rock the boat too much” outcome here.

One more thing before I sign off: I’ve seen many arguing that rescheduling to schedule II would be “bad” beause it would invite FDA regulation. Nonsense. It's not like schedule I substances are somehow exempt from the FDCA. Nor would they be free and clear of the FDCA if Congress or DEA rescheduled cannabis to schedule II or removed it from the schedules altogether. After all, the FDCA applies to non-controlled substances just as surely as it applies to controlled substances. The real question is whether and to what extent federal enforcement would increase as a result of a rescheduling/descheduling. That’s a more complicated question and one that far fewer people are engaging at the moment.

I’m working on another post that will dig deeper into these issues and provide an overview of what the impending adminsitrative process will look like. I was actually planning to include that information with this post, but it was just getting too long. In any case, stay tuned, and don’t believe everything you read out there.