David Mangone headshot by Jared Wolfe
Key topics in this article:
- The process and timeframe to review the 43,564 comments
- Insights from comparative rescheduling (hydrocodone)
- Administrative priority: comparing another proposed rule (Student Debt Relief)
- Hearing requirements and timing
- Possible litigation after the final rule and what litigation would have to prove
After the public comment period closed on July 22 on the Department of Justice’s (DOJ) proposed rule to reschedule cannabis from a Schedule I to a Schedule III drug under the Controlled Substances Act (CSA), the cannabis industry seems to be holding its collective breath as it awaits the Drug Enforcement Administration’s (DEA) determination for a final rule.
And questions abound. How will the DEA even get through the more than 43,000 public comments that were submitted? How long will that take? Is this number of comments typical for a proposed rule and, more specifically, a proposed rescheduling or scheduling rule? How will the comments factor into the review process? What about any requested hearings? (As part of the rulemaking process, people can request a hearing or to participate in a hearing. It is then up to the DEA administrator to decide which, if any, hearings to grant.) Would hearings have been granted by now? Will litigation follow? And what is the likelihood rescheduling could be blocked? What kind of timeframe are we looking at overall for a final rule?
To get answers to these and other important questions regarding the fate of rescheduling through this rulemaking process, Cannabis Business Times turned to David Mangone, J.D., vice president of federal cannabis advocacy firm Liaison Group and policy director for National Cannabis Roundtable, an alliance of cannabis companies and related businesses working to push cannabis reform forward. Mangone has worked for nearly a decade influencing federal and state cannabis policy through authoring legislation and advising lawmakers at all levels of government. With a deep understanding of cannabis policy in the context of political affairs, the legislative process, administrative law, and executive actions, he previously served as the director of government affairs and counsel for Americans for Safe Access, the nation’s largest nonprofit representing medical cannabis patients, as a legislative fellow for a senior Democratic member of Congress on the House Committee on Ways and Means, and as a private practice attorney.
Here’s what he shared with CBT:
Noelle Skodzinski: Do you know how long it might take the DEA to review the 43,000-plus public comments that were submitted? Is that a typical number of comments to receive on a proposed rule?
David Mangone: The DEA doesn't have to review and respond to every single comment that's submitted. They only have to look at the ones that, in their language, “materially affect the rule.” So, what that basically means is that your one- or two-sentence comments that are in support or against rescheduling—or a lot of these comments that I reviewed call for full legalization instead [which isn’t necessarily relevant to this proposed rule]—those are likely not going to be viewed in the DEA’s mind as material comments.
There is also a mechanism used within many agencies of the executive branch—and I haven't seen anything to indicate that DEA does not use this process—to filter out duplicate comments during these rulemaking processes. So, if there are form letters that are being submitted for national activism or advocacy groups, those duplicate comments will be filtered out. For example, NORML had an action letter form that their membership could submit as a comment to the DEA. The members could change this template letter, add how it directly impacts them. There is a pretty large membership at NORML, and I think it’s a safe presumption that not everyone who clicked on that link changed that form letter in a way that was different enough to survive getting past this filter of duplicates. (Editor’s note: Thousands of comments included language from the sample public comment drafted by NORML.)
But you do look at the interest in rescheduling. Typically, when the DEA goes through this process, HHS and DEA agree on their eight-factor analysis, and drugs are moved from one schedule to another, or emergency scheduled for a year without too much controversy or public interest.
I think the most comparable example of rescheduling the DEA has done in recent years has been for hydrocodone. But, even still, that comment period only generated a few thousand comments rather than the 40,000-plus that we're seeing in this rulemaking process.
With that in mind, predicting the timing is difficult because you have this process that was initiated by the president, which is unusual for the rescheduling process. Often, a manufacturer of a particular pharmaceutical will initiate an outside petition, or, in a lot of cases, HHS will go through the rulemaking and rescheduling process in response to something happening on the international stage—perhaps a new drug or a new analogue coming up in conversation at the U.N. or another international body that requires the U.S. to follow suit based on our treaty obligations.
But it being initiated by the president indicates that this is a presidential priority.
If you look at another major rulemaking that's happening right now, around student loan relief, that proposed rule [which came out in April] had a 30-day comment period and generated over 100,000 comments. The White House is already putting out statements that they are nearing the stages of publishing that final rule. Presumably, they’re going to be finalizing it in the next week or so. That turnaround for that level of comments shows that these agencies can get through a massive amount of comments in a relatively short amount of time when something is an agency or administrative priority.
RELATED: White House Moves to Reschedule Cannabis in ‘Monumental’ Decision, Biden Says
That said, I don’t think it’s a secret to say that there are probably a lot of individuals at the DEA who have a long-standing opposition to cannabis rescheduling. You saw this come to light with some former DEA administrators requesting a hearing and criticizing the move to reschedule. You’ve seen less of this from current DEA employees, but that’s likely because they understand they’re part of the process and they can’t really opine one way or another while it is still ongoing.
And the DEA’s history is certainly an indication that the agency itself has been reluctant to a scheduling change. You’ve seen several petitions come before the DEA to reschedule cannabis as recently as 2016, and all those petitions have been denied for various reasons.
Skodzinski: Do you think it weighs on the outcome if the majority of the comments are in support of rescheduling?
Mangone: The comment process is not a popularity contest. It is comments that raise the issue of things that require material changes to the rule. So that can be the actual legislative text itself—of moving cannabis in the statutory reference from Schedule I to Schedule III, or it can be something in the body of the supporting rule.
In this case, we have 70, 80 pages that detail the HHS analysis, walks through the decision to go before the Office of Legal Counsel on some things like [Single Convention on Narcotic Drugs] treaty issues and details the analysis that DEA has done on its own, looking more specifically at abuse potential.
So, things that might address material changes to the rule might, for example, be studies that have come out since HHS concluded its analysis, or research or studies that were not included in the original analysis for whatever reason. Another example of material change would deal with some of the executive orders that you see at the end of the rulemaking that deal with things like federalism, tribal law and sovereignty, economic impact and a few other discrete areas.
There may be an issue that would require a material change if someone was able to present a compelling case or argument as to why one of those executive orders was appropriately or inappropriately applied.
So those are the kinds of things that are really going to be flagged by the DEA in this rulemaking process: Is it related to a material change to the rule as drafted?
Looking at a lot of these comments, even though they are in support—and a lot of them do call for taking a step further to descheduling or full legalization [which, again, isn’t necessarily relevant in this process]—that doesn't necessarily mean that the DEA is going to be compelled by those arguments.
RELATED: Cannabis Rescheduling Reactions Mixed: While Some Applaud Potential, Others Push For More
I think from a political messaging standpoint with all the comments in favor, though, it's very easy for the Biden-Harris administration to say, “Look how popular this issue is among voters and would-be voters. The overwhelming majority of these commenters are saying that this was the right move.” On the political messaging side that gives them a lot of support—they can talk about this winning campaign issue, they can use it to energize voters.
But as far as the actual technical DEA process, the volume of comments in support or against isn’t supposed to be deeply considered in how the rule is ultimately decided.
Skodzinski: Were there any comments that you thought were of particular significance to the final decision?
Mangone: I'd be remiss if I didn't plug the comments that my organization, the National Cannabis Roundtable, worked very hard on. We provided a lot of those studies that have come out that supported the conclusion of Schedule III since HHS’ analysis, and reviewed some of the clinical trials are that are being undertaken for cannabis and cannabinoids that were not necessarily included in the original swaths of research. And then we provided some data about the size and scale of the economic impact of the removal of 280E.
I think you saw a lot of the weightier comments come in in the last few weeks of the comment period. That’s when ours were submitted, the well-known cannabis law firm Vincente submitted theirs, the Coalition for Cannabis Scheduling Reform, all of these came in the final weeks. And these all support the rescheduling decision.
Certainly, on the other side, there have been a few comments that have looked to raise issues as it relates to abuse potential and how that was considered and calculated under the original analysis. Former Attorney General Barr partnered with Smart Approaches to Marijuana, and they submitted a set of pretty robust comments. We come to different conclusions, but as far as substance, they are doing the same thing that we are doing in terms of presenting a record as to why this rulemaking should go through or not.
You had some former and current state attorneys general submit comments as well, and some governors.
But the actual commenters themselves are less relevant to this process for the DEA’s purpose. It doesn't particularly matter, unless, of course, it's someone actually in the administration who is their direct superior.
Skodzinski: A number of hearing requests were made in the comments, including one from 18 state attorneys general. What can you tell us about the typical process and timeframe for the DEA administrator to review hearing requests?
Mangone: No one except for the administrator knows how many hearing requests have come in. Some individuals and organizations requested hearings in the actual public comment forum. I believe the Tennessee Bureau of Investigation requested one and, as you alluded to, the Republican attorneys general. But the actual requirements to request a hearing are that you have to send in an old-school snail mail request by June 20th, detailing your legal arguments or facts you're going to raise to the administrator.
We can glean a few groups who requested hearings in the public forum process, but we have no way of knowing if all those groups actually followed the particular instructions to request a hearing [via mail]. Nor do we know if more individuals or groups requested a hearing without submitting a public comment.
[The public] will know when a hearing will take place. The notices you see for other rescheduling decisions are pretty straightforward—they say what date the hearing is going to take place, who the presiding judge is, which parties are going to be heard and how the parties can submit anything additional for the record in terms of pleadings or information. It's a very short document that actually just notices the hearing itself.
That is a fairly easy work product for the DEA to put out because they don't have to make any policy determinations upon scheduling the hearing. All they have to say is, “Here is the docket, here is the calendar.”
We're now a month and a half, give or take, past that initial deadline to request a hearing. So, I think it is interesting, but not necessarily noteworthy, that a hearing hasn't been noticed yet. There are certainly instances with scheduling and rescheduling orders where a hearing had not yet been noticed even after the comment period closed. And I've certainly seen other instances where a hearing is noticed while the comment period is still going on.
It's not unusual that we haven't heard whether there's a hearing yet. But I think the longer we bypass the end of the comment period, it becomes odder and odder that that simple notice doesn't get published.
There is no set time though, like after a certain number of weeks or months, where the DEA is required to put out a notice for hearing.
I think the interpretation that's most reasonable is that if we're several months removed from the closing of the comment period that you haven't received that simple, basically a calendar invite, then that, at least in my mind, decreases the likelihood that a hearing will be scheduled.
Skodzinski: The DEA administrator is not obligated to grant any hearings, correct?
Mangone: Correct. But if a hearing request is denied, it does perhaps open up the chance for litigation. After a final rule is issued, an individual or group could sue the DEA under the Administrative Procedures Act, saying that the comment and hearing process was deficient. … Knowing this is not the first time that arguments around cannabis have been heard because there have been other petitions [to reschedule], I don't know how successful that challenge would be, but if you remove something that is viewed as part of the process [such as granting a hearing], it allows someone to say the process was deficient.
Skodzinski: If someone filed litigation to stop the rescheduling, does it matter where they file?
Mangone: There are circuits where you are probably going to find a more friendly judge to arguments related to undoing, sort of, the administrative state, generally. That doesn't necessarily mean there is one court or one circuit that I think people are eyeing in terms of filing challenges. Because even if you find a friendly judge on the idea that maybe this rulemaking went too far or was concluded incorrectly, you still have to get an individual or group of individuals to prove the standing that the rule itself is what's going to cause them some sort of injury.
And if you're seeking a national stay or national injunction, you have to prove a national injury.
It's a really high burden to show that you have that injury across the country. Getting to the point where you can say from a policy standpoint rather than a process standpoint that this rule is deficient, and you have the requisite legal elements to file the claim—it’s challenging.
And state courts are interesting because the actual change of Schedule I to Schedule III doesn't impact a state's ability to maintain their own prohibition and criminal penalties as it relates to cannabis.
Skodzinski: Is there anything I did not ask about that you think is important to note?
Mangone: I would just want to highlight again that this is an unprecedented process, both because the president asked for it and just because of the public interest in the outcome. Those two things really can't be ignored when we have discussions about what it means on timing and what it means on considerations of having an ALJ [administrative law judge] hearing or not.
There's a very defined process in the Controlled Substances Act about how this is supposed to go. There's a very defined process about the actual notice and comment period within the Administrative Procedures Act, but it has become pretty clear that this has been an issue that's of political interest to the current administration. And I think that interest and that willingness to get something done can't be understated on how it impacts the overall process of things compared to those that may take much longer, where an administration is not involved.
Skodzinski: Do you think this rescheduling process is also accelerated because of the timing of the election?
Mangone: It sure seems that way. The review that HHS did was markedly quick compared to other reviews of cannabis. The review that the DEA did was also spectacularly quick, even bringing in a third agency that's not normally involved in process—the Office of Legal Counsel. All of that has happened since October of 2022.
When you look at some of the previous petitions to deal with the reclassification of cannabis that took over five years, over 10 years, over 15 years to review, this scheduling process is moving at lightning speed. I haven't seen any reason why that would slow down at this point.
Skodzinski: You mentioned the Office of Legal Counsel was asked to weigh in. Can you talk about what it was brought in for?
Mangone: They looked at primarily the issue of treaty obligations as it relates to the U.N. Single Convention [on Narcotic Drugs, 1961].
And they also gave a green light to HHS switching from a five-factor test for currently accepted medical use that they had previously used to a two-factor test that is I think more reflective of the modern landscape for cannabis. They said that shift from the previous test passed legal muster, and that HHS was permitted to do it within the confines of the CSA.
So those are the two main issues.
