Even DIRTIER Secrets On Rescheduling

From Hunter Biden's Laptop to DEA's Orange Book to Staggered Listings

In my last post on rescheduling with a tabloid headline, I took on several myths/misunderstandings about rescheduling. I also delved into the treaty issues, which are important to understand at this juncture. Check it out here:

This next post continues the rip, picking up where I last left off.

In particular, the cannabis industry is putting a lot of faith in the (undisclosed) HHS recommendation that marijuana be moved from Schedule I to III. That article of faith rests on the notion that because DEA has never departed from an HHS recommendation in the past, it won’t do so here. The Congressional Research Service came to a similar conclusion yesterday stating it that it is “unaware of any instance where DEA has rejected an FDA recommendation to reschedule.”¹

True enough: DEA has never superseded an HHS recommendation. But as I explain below, that point isn’t quite as robust as one may think.

After that, I’ll go deeper—to the center of the regulatory earth. Though the Federal Register and DEA drug codes, I’ll pave a Schedule III possibility nobody has really discussed: a plausible doomsday scenario for the cannabis industry where, based on treaty authority, DEA doesn’t disregard the HHS recommendation, medical marijuana preparations get moved to Schedule III, and the President’s directive is largely adhered to—but 280E remains for most of what the industry currently does. It’s a scenario that isn’t too fantastical if you aren’t an industry thumb-sitter and take the time to meticulously understand the deeper precedents, laws, and regulations at play.

Scheduling Decisions are a Mixture of Science, Law—and Politics

First, let me begin by stating the obvious: this rescheduling, as opposed to others, is a deeply political process. It may seem like an obvious point, but it is a critical one—and one I will return to at the end.

This process was initiated by the President of the United States. That may seem surprising to some. After all, he doesn’t have the best track record on drug policy. But whatever one thinks of that, he does seems to have compassion on many issues, especially those that hit close to home.

Today, Joe Biden says he’s always been in favor of legalizing medical marijuana. Perhaps we should believe him, or at least over the past decade. After all, the Biden clan was all aboard the medical marijuana train as early as 2014 in relation to Beau Biden’s cancer treatment:

Yup. I’m that guy that uses eye-catching material from Hunter Biden’s Laptop to shamelessly grab your attention and lure you in so I can dupe you into reading important information. Remember, you saw it here first.

I think this President understands that the former Attorney General of Delaware, veteran, and brain cancer victim shouldn’t have had to look for a way to “do it quietly.” Nor should anyone else. If a family and their doctor agree that marijuana could ease the suffering of a dying patient, marijuana should be available to the patient—and at minimum, it should not be federal contraband under those circumstances.

If medical marijuana is legal in a state, the decision whether to use it in treatment should be a decision made by doctors and patients—not the U.S. Drug Enforcement Administration. And I hope the White House tells Anne Milgram that. As Amber Littlejohn importantly points out, this President did not initiate rescheduling process because he cares about or has been influenced by the cannabis industry. I’m as cynical as they come when it comes to agencies; but here, I think the President instructed the agencies to proceed only because he cares about doing the right thing.

If we’re looking for motivation and direction, to me, that’s it. My best read on the situation is that the President asked agencies to initiate this process because he cares about justice issues, research, and potentially alleviating suffering. And while he also cares about jobs, he probably doesn’t care too much about the industry per se and certainly not 280E, except insofar as it relates to those other primary concerns (which it does).

This is why—politics, not precedent, science, or legal authority—if I had to bet, I’d put my money on DEA sticking with the HHS recommendation and also landing on Schedule III. As we’ve explained all over On Drugs, the scheduling criteria are so amorphous so as to allow DEA and HHS to justify placing a drug in almost any schedule; the classifications as a whole don’t make any sense whatsoever. For example, to the newer subscribers, check out this early 2022 classic:

Put simply, the schedules are arbitrary at their core with some logic at the edges, not the other way around.

Here, the boss instructed the agencies to follow the science. And now, the agency that does science came up with Schedule III. Whether that determination is in fact rooted in a change in the science can obviously be debated. But against a backdrop of the agency charged with evaluating medicine and science landed on Schedule III, with the President instructing both agencies to follow the science, it is politically difficult for DEA to depart from HHS and the implicit instructions of the boss.

Once one clears the hurdle of concluding that marijuana has a “currently accepted medical use in treatment in the United States” based on state markets—ruling out Schedule I—the next question centers on relative potential for abuse to determine where on the schedules marijuana should go. On the surface, that’s an easy call. Beyond Schedule I, when one looks at the schedules, Schedule III recommendation is the highest possible recommendation that makes any semblance of sense.

Unless, of course…

…you are brohibitionist™-in-chief, Kevin Sabet. In that case, Schedule III is “one of the lowest schedules available.”

Two days ago, he wrote an op-ed on Newsweek, pleading his case to the DEA Administrator not to heed the HHS recommendation, sprinkling in a reference to “Cheech and Chong,” and chiding HHS for recommending Schedule III and made this ridiculous assertion among others:

Of course, this is false. Schedule III is the dead middle. There are two schedules above and below it. Schedule III is one schedule higher than the second-lowest-schedule which houses the far more addictive benzodiazepine class. But, I guess when you are a brohibitionist™, anything other than Schedule I or II is one of the “lowest schedules available.” It’s like making a million dollars a year and blurting out at a party that a salary of $100,000/year is one of the lowest salaries available.

And yet, within his op-ed, Sabet recognizes that Schedule III is “the category for drugs that have less abuse potential than Schedule I and II drugs” like heroin, methamphetamine, or fentanyl. That makes sense for marijuana, right? If marijuana has an accepted medical use in treatment—and it appears HHS has so concluded—then Schedule III is the highest schedule one could rationally justify. Does anyone seriously think marijuana has an abuse potential comparably to fentanyl? (Other than former DEA Administrator Michelle Leonhart.)

The point Sabet seems to miss is that Schedule III doesn’t mean a drug has no abuse potential or is not dangerous. Indeed, ketamine, a Schedule III drug, clearly has abuse potential. Rather, it is for drugs that have “a potential for abuse less than the drugs or other substances in schedules I and II.” You can take all of Sabet’s substantive points about THC potency at face value. Still, you don’t need to own a white lab coat to know that marijuana has a potential for abuse less than dopaminergic drugs like fentanyl and methamphetamine.

Sabet also incorrectly claims “Schedule III drugs are all individually approved products traced by the government and tracked by pharmacies.” Nonsense. To be clear, Sabet’s bottom line conclusions are often right. Often, I appreciate his commentary. We agree on a wide variety of issues. But in the details, he gets sloppy and often just makes shit up. Such as here. Ergine is a Schedule III drug. It isn’t approved. When is the last time you walked into a pharmacy and saw ergine? Ever heard of sulfonmethane, another obscure Schedule III drug? Also, there appear to be all sorts of steroids in Schedule III; I’m fairly sure some are not “approved products” that are “tracked by pharmacies.” Nor is Schedule III merely a collection of “prescription steroids” and “depressants not preferred by those with a drug use disorder.”

If we had to broadly and accurately describe the Schedule III classification, the best way to describe it is that it includes a hodge-podge of drugs that are supposed to be more dangerous or addictive than Schedule IV drugs, but less addictive or dangerous than Schedule II drugs. That’s it.

The only legally defensible path to a schedule above that, Schedule II, runs through the treaty. Again, I don’t think that’s a probable outcome because (1) as discussed in my last essay, there is an established way around the obstacle and (2) the President’s instructions. The Attorney General and DEA Administrator work for the President. Employees do the boss’s work. While agencies often disagree with each other on a matter, they don’t often go out on a limb to thumb the nose at the President.

But just because it isn’t likely, doesn’t mean it is impossible.

Is the HHS Recommendation Legally Binding?

The threshold question to whether DEA will depart from the HHS recommendation and choose a higher schedule is whether it can. Phrased differently, is the HHS recommendation legally binding? If it is, our inquiry ends there.

We start with the text of the CSA, specifically, Section 811(b). Section 811(b) states that HHS recommendations as to “scientific and medical matters” are binding on DEA:

The Attorney General shall, before initiating proceedings under subsection (a) to control a drug or other substance or to remove a drug or other substance entirely from the schedules, and after gathering the necessary data, request from the Secretary a scientific and medical evaluation, and his recommendations, as to whether such drug or other substance should be so controlled or removed as a controlled substance. In making such evaluation and recommendations, the Secretary shall consider the factors listed in paragraphs (2), (3), (6), (7), and (8) of subsection (c) and any scientific or medical considerations involved in paragraphs (1), (4), and (5) of such subsection. The recommendations of the Secretary shall include recommendations with respect to the appropriate schedule, if any, under which such drug or other substance should be listed. The evaluation and the recommendations of the Secretary shall be made in writing and submitted to the Attorney General within a reasonable time. The recommendations of the Secretary to the Attorney General shall be binding on the Attorney General as to such scientific and medical matters, and if the Secretary recommends that a drug or other substance not be controlled, the Attorney General shall not control the drug or other substance. If the Attorney General determines that these facts and all other relevant data constitute substantial evidence of potential for abuse such as to warrant control or substantial evidence that the drug or other substance should be removed entirely from the schedules, he shall initiate proceedings for control or removal, as the case may be, under subsection (a).

What this phrase means hasn’t been vigorously litigated. But it did tangentially arise in an obscure 1980s case called Reckitt & Colman v. DEA and the drug buprenorphine.

The case addresses DEA’s classification of buprenorphine as a narcotic under the CSA and the meaning of the word “derivative.”² Reckitt claimed that DEA had improperly determined that buprenorphine was a derivative of an opiate thebaine. I’ll move the details of the case for a footnote.³ Although they may be highly relevant to hemp-derived cannabinoids and the hemp-o-sphere, vis-à-vis rescheduling, it isn’t of much import. Rather, it is what the D.C. Circuit stated in a footnote that concerns us:

The intervenor's brief contends, and the Department of Justice agreed at oral argument, that the Administrator's conclusion that buprenorphine is a thebaine derivative can be upheld on an alternative ground. According to these parties, HHS’s initial communication to DEA stated that buprenorphine is a thebaine derivative, and the Act makes HHS's recommendations as to “scientific and medical matters” binding on the DEA. See 21 U.S.C. § 811(b) (1982). If that were so, it is difficult to see what purpose the agency's on-the-record hearing served in this case. Certainly the Administrator did not appear to regard his independent findings on “scientific and medical matters” as superfluous. While we entertain doubts about the soundness of the Justice Department's interpretation of the Act-Section 811(b) could be read to indicate only that the DEA must follow HHS's recommendations on the specified matters in deciding whether to initiate scheduling actions-our disposition of this case renders it unnecessary for us to decide the point.

Since 1986, other courts have cited Reckitt & Colman just 7 times—and never for any proposition of consequence. The DEA has cited it a handful of times. In one of those cases involving a substance called carisoprodol, DEA pointed to this footnote.

In March 1996, DEA requested a scientific/medical recommendation and evaluation for carisoprodol. One year later, FDA concluded that then-available data did not support rescheduling. A decade later, the agencies collected more data. And, in 2009, HHS recommended carisoprodol be placed in Schedule IV.

A manufacturer of carisoprodol (Meda) appealed and requested a hearing. The presiding administrative law judge adopted the Government’s argument that the Controlled Substances Act “limits the scope of the administrative hearing to those issues outside of the medical and scientific fact-findings of the FDA,” and concluded that “the plain language and legislative history of § 811(b), federal case law, and [HHS's] process for conducting its administrative review, make clear that Congress intended that the Secretary's scientific and medical fact-findings bind the DEA during the hearing and the subsequent scheduling determination.” Meda objected to this and appealed to the DEA Administrator. Citing the Reckitt footnote, the DEA Administrator agreed with Meda. She concluded that FDA’'s scientific and medical findings did not bind DEA in the proceedings:

Were it the case that the Secretary's findings as to medical and scientific matters are not subject to litigation in the subsequent rulemaking hearing, the only issues left to be litigated would be the drug's “actual” abuse, its “history and current pattern of abuse” and the “scope, duration, and significance of abuse.” 21 U.S.C. 811(b). However, an on-the-record hearing (as opposed to notice and comment rulemaking) would hardly be necessary to determine whether the data proffered by the Agency is adequate to support the findings necessary to control a drug. As the DC Circuit explained in Reckitt,[FN4] if HHS's medical and scientific findings are binding throughout a proceeding, “it is difficult to see what purpose the agency's on-the-record hearing [would] serve[.]”

In short, according to the agency, the medical and scientific findings of FDA are not binding and can be “secondarily review[ed]” in a rulemaking. An HHS recommendation may bind DEA on scientific and medical matters as to the initiation or rulemaking, but that does not necessarily bind DEA throughout the rulemaking.

And of course, as to cannabis, we’ve always got to juggle Single Convention problem, which is discussed here.

Past Downscheduling Actions

Okay, let’s assume DEA can depart from the HHS recommendation and choose a higher schedule as a matter of law and discretion. The next question becomes whether it has ever done so and under what circumstances. In other words, is there precedent for that?

As discussed above, aside from cases involving treaty issues, it does not appear like DEA has never departed with an HHS recommendation. But that notion doesn’t have the force one would think because it arises out of inductive reasoning—a general proposition derived from a body of observations. And here, the body of observations supporting the notion is remarkably poor. For example, when is the last time HHS recommended downscheduling of a Schedule I substance that hasn’t been approved for FDA use?

Because of on my Muskian obsession with controlled substances law—and by virtue of my work on the Five Tryptamines matter—I may be the only person on the planet to have gone through every line of the source code, DEA’s Orange Book, which lists all scheduling actions since the beginning of the CSA.

Want to come to my room and read about controlled substances?

I’ve laid eyes on every Federal Register notice for every rescheduling and every case related to those rescheduling proceedings. In addition, I’ve read dozens of eight-factor analyses underlying scheduling and rescheduling decisions. This is how I know, for example, that bifurcated rescheduling didn’t really become an accepted practice until the 21st century after GHB.

Based on my review of these decisions, disregarding treaty cases, I can confirm that DEA has never defied an HHS recommendation in a downscheduling or upscheduling proceeding—i.e., rescheduling short of descheduling or placing a drug in Schedule I. But I can also confirm that this isn’t a robust data set.

Aside from Epidiolex:

1. Over the past 50 years, how many times has DEA rescheduled a drug, as opposed to descheduling? Answer: It depends how you count—some reschedulings occur in groups. But by my count, 25 or fewer under any method.

2. How many of these took place in the 21st century? Answer: Less than 5.

3. How many rescheduling proceedings involved Schedule II recommendations? Answer: 18.

4. How many times has DEA downscheduled a drug? Answer: 10.

5. How many of these followed FDA approval? Answer: 8.

6. How many of these downschedulings involved unapproved drugs? Answer: 0.

Setting treaties to the side, while DEA has never superseded an HHS evaluation and imposed stricter scheduling, all of these prior precedents are distinguishable for one reason or another. Once you winnow out distinguishable cases, few if any data points are left. And if none of the data points is similar, then the precedent isn’t very strong and the talking point is quite weak.

So, as I state above, if I were a betting man, I’ve still got my money on Schedule III. But that isn’t because past precedent adds anything of value to the discussion. Rather, it is because of politics and the President.

Let’s take a closer look at the data—and in particular, Staggered Listings.

Staggered Listings