Recent On Drugs Developments: A Note of Gratitude

Pounding the docket

Foreword

Here at On Drugs, we’re practicing lawyers, first; journalists/essayists, second. (Internet pharmacologists, distant third.)

Maybe you’ve noticed a lighter post-load over the past several weeks. That’s because for the past two months, in the drug policy arena, we’ve been primarily wearing our lawyer hats. In addition to our full-time jobs, we’ve been litigating two cases:¹

1. AIMS III: a proceeding appealing a DEA denial of a psilocybin rescheduling petition we filed in February 2022

2. FOIA Fight: a proceeding against DOJ/DEA regarding unlawful FOIA policies.

For a variety of reasons, I’ve been reticent to discuss matters I’m actively litigating where I am a lawyer for a client. That practice will likely continue going forward.

But I’m breaking that rule today. Turns out, I have a mini-platform. Since I do, I can use it. And today, I am using it to recognize individuals that pitched in on AIMS III—most of whom did so without any compensation and with no direct benefit to themselves.

As a lawyer, I understand the value of doing this work and participation. It isn’t always flashy or career advancing like a podcast, a law review article, a speaking gig, or whatnot. But in many cases, it has far greater potential to make a real difference. The legal system is where much of the sausage is made. Also, these briefs can also live beyond the case itself; for example, Lisa Pittman’s brief in our Sisley v. DEA case on cannabis use for chronic pain, which was cited in a congressional hearing on opioids.

• For the pro bono lawyers who jumped in to write briefs: It is hard for me to emphasize how thankless of a task writing and polishing briefs for no compensation can be. These amicus briefs can take hundreds of hours. Thank you.

• For the individuals and organizations that signed onto these briefs: These individuals put reputations and credentials forward to give our case a stamp of approval and give our arguments—particularly on the exigencies and science—a stronger imprimatur of legitimacy. It matters. Also, remember we are suing the DEA. Rankling a few feathers. Signing on in support of our brief wasn’t a completely costless decision. These folks are sticking their necks out, even if it only a little bit. Thank you too.

It is a special moment for us to see so many people come together to try to fix an arcane regulatory issue.² This is what Hamilton Morris meant when he said at his infamous Wonderland talk that the community needs to stop fighting each other and come together—solidarity—a principle I generally agree with. (No, Hamilton did not sign onto an amicus brief. To be fair to him, he probably wasn’t asked.)

1. AIMS III

AIMS III is the third in a series of cases brought on behalf of our clients Dr. Sunil Aggarwal and AIMS Institute. The campaign started in early 2021 when Kathryn Tucker began corresponding with DEA to get therapeutic access to psilocybin for AIMS under Right to Try Laws. DEA said it had no authority to do so. Kathryn built a legal team and we sued. The Ninth Circuit dismissed our case for lack of jurisdiction—not reaching the merits—based on the notion that DEA had not made a final appealable decision.

So, we did two things. First, we submitted a more formal request to DEA to elicit a final agency decision that we could appeal. Second, we submitted a rescheduling petition seeking a transfer of psilocybin from schedule I to II. In the Government’s AIMS I brief, it suggested that we seek rescheduling if we believed that psilocybin should be available for therapeutic use. We did just that.

The petition and lawsuit in the case leverages an argument that I first wrote about here more than a year ago, long before I became “psychedelic garbage guy.” Succinctly stated, the argument is as follows:

1. Psilocybin is a breakthrough therapy and is eligible for expanded access

2. Clinical trials provide sufficient evidence to show that psilocybin can be safely administered under medical supervisions

3. According to past remarks and actions by FDA, this suffices to show that psilocybin has a “currently accepted medical use with severe restrictions.”

4. Because psilocybin has a relatively low potential for abuse compared to schedule I and II drugs, it has a “currently accepted medical use with severe restrictions,” and has an accepted safety for use under medical supervision, the schedule I classification is improper.

5. Psilocybin should be rescheduled to schedule II.

It is worth noting that rescheduling psilocybin would not make psilocybin an FDA approved drug available for therapeutic use in interstate marketing generally. Moving psilocybin to schedule II will not unleash a mushroom bacchanal. The move in fact does remarkably little. Here’s a dirty little secret: there isn’t really a meaningful difference between a Schedule I drug and an unapproved Schedule II drug. Except barriers to research and compassionate access. Here’s my PCP essay proving the point.

So why do this? Three reasons.

1. Schedule I research restrictions remain cumbersome and unnecessary. Numerous bills have floated through Congress to fix them. But an easier fix is already hardcoded into the CSA: just move a drug late in development to schedule II.

2. The greatest challenge for the impending rollout of psychedelic-assisted therapy is going to be infrastructure. Psychedelic-assisted therapy defies many modern medical paradigms for mental health treatments, e.g., pill-a-day. To get things right and calibrated—to develop best practices—there must be some experimentation and trial-and-error in protocols, setups, and what not. The best way to do this is to start now, on a smaller scale, and in a controlled fashion. Think of it as a clinical trial for infrastructure. The time to do this to maximize social welfare and patient safety is not if/when MDMA gets FDA approved. By way of analogy, a prudent big tech company would not release a revolutionary software product without first beta testing it under real world conditions. Rescheduling psilocybin (or MDMA) could allow infrastructure to ramp up at a more conservative pace using limited access programs.

3. As the amici briefs make clear, folks are already turning to these medicines in desperation, often leaving the country or going underground. I’ll save my issues with the safety/efficacy standard for another day. Suffice to say, if these medicines can be delivered safely in the United States pre-approval in a circumscribed, regulated, and intelligent manner, without meaningfully increasing diversion or undermining the regulatory process, why the hell wouldn’t we do that? Seems like a no-brainer.

The rescheduling petition I drafted, DEA’s response, and our Opening Brief filed last week, lay out these arguments.

Amicus Briefs

So, if you are starved for new On Drugs material, look no further than these outstanding amicus briefs, which I summarize and link to below.

If you like these briefs, please reach out to the authors or signatories and say thanks. As an attorney who does quite a bit of this by now, I can tell you that these projects are often thankless. Even a small e-mail note of thanks can make a lawyers day. Showing gratitude, after all, is a simple way to help others boost mental health that doesn’t require a facilitator.

• The Veterans Brief. The Veteran Mental Health Leadership Coalition and Reason for Hope, Inc. submitted on behalf of dozens of organizations in the space.

  

  The brief explains how psilocybin-assisted therapy is a promising suicide prevention treatment and that rescheduling will reduce regulatory barriers to research and compassionate aspects while reducing the number of Veterans and other patients who are forced to go abroad or underground. To that end, the brief humanizes the issues spinning a few vignettes to show, not tell, the court of what this is like. Special thanks to Neil Markey and Ethan Abend for sharing their stories; Brett Waters for leading the brief from RFH; and Erica Harris from Susman Godfrey LLP, one of the best law firms in the world. You can support more RFH work like this and the Breakthrough Therapy Act by donating here.

• The NORML Brief. The NORML brief chronicles DEA’s conduct with rescheduling marijuana, which closely ties into the issues of this case. The NORML brief excels at highlighting how DEA has manipulated the administrative process. My favorite paragraph is the following:

  The DEA’s threadbare response without any FDA investigation bears many similarities to the one-page letter that the D.C. Circuit found so woefully lacking in NORML II nearly forty-five years ago. Neither response complied with the scientific and medical evaluation requirement of the CSA, neither response had any substance supporting its barefaced conclusions, and neither response provided the respective petitioners with the procedural due process required by statute.

  David Holland (Prince Lobel Tye), Joshua Bauchner and Raahool Patel (Ansell Grimm & Aaron), and Joseph Bondy wrote this great historical review brief.

• The Clinician Brief. This brief, from 29 doctors and an Osteopathic medical practice, sharpens the stakes and repeats the key reasons why there should be a public rulemaking hearing. What I like most about this brief is how it strips down the administrative-law veneer of the case to describe the stakes and the “most important message”:

  Perhaps the most important message the amici carry to this Court is: Please let us not lose sight of the human cost of the DEA’s refusal to act. Human dignity and suffering are at stake and stand to be affected by this Court’s ruling. The goal of the petitioners and amici may be wrapped, necessarily, in administrative law arguments. But at the heart of it, this is about dying patients’ physical and emotional suffering and their doctors’ efforts to get them meaningful, effective treatment.

  This is about recognizing and honoring the voices that cannot be ignored in a debate of this magnitude. The DEA’s summary denial of the petition to reschedule muzzles the people who have firsthand, experiential knowledge of psilocybin therapy’s use and impact: palliative care clinicians and patients. Opening rulemaking proceedings would allow the courts, rulemaking authorities, and the American public to hear those voices and consider evidence and argument from the people whose lives are most impacted by the DEA’s refusal.

  Attorneys Karen Luong, Kimberly Chew, Natasha Sumner, and Danny Solomon at Husch Blackwell wrote this wonderful put-it-in-perspective brief.

• Professor Brief. Attorneys Whitney Hodges and Sarah Blitz penned this brief on behalf of Professors David Hoffman, Jill Simonian, and Kathy Cerminara. This brief does a great job of showing how the the federal government and states have created exceptions to regulatory norms for use of unapproved substances in end-of-life situations.

• Researcher Brief. The researcher brief poignantly makes the case for why the government should, at minimum, DEA acted improperly by shutting down debate before it could even begin. I really like this brief because it sharpens the key issues for the Court, arguing the most forceful parts of the case as well as we did—and in fewer pages. And I’m jealous of whoever came up with the phrase “infinity loop of excuses.”

  The lawyers who drafted this brief are Aaron Thompson, James Nikraftar, Jennifer Briggs Fischer, Cristina White, and Andrew Kim at Goodwin Procter LLP. I’m also particularly proud and honored to have some of the signatories on this brief, including some living OG luminaries—folks I look up to—like Roland Griffiths, Carey Turnbull, Bill Richards, Ethan Nadelmann, Bob Jesse, and the indefatigable David Nutt. And of this elite group, I want to doubly thank Roland Griffiths, who continues to have an outsized impact on this space and the world.

Of course, on our team, I want to pay special thanks to our clients and the legal team.

• Sunil Aggarwal, who is our fearless client that is sticking his neck out there to advance this case and allow us to join together in this worthy endeavor. I also want to thank Erinn Baldeschwiler and Michael Bloom who, while not the clients in this particular matter, have been central to the broader effort.

• Kathryn Tucker, who organized the legal team, spearheaded the amici co-ordination described above, and is the fighting spirit.

• The Perkins Coie team, that assisted in drafting, served as a sanity check, keeps the trains running on time, and polished the brief so it shines.

• Austin Brumbaugh, an associate at my firm, that jumped in and drafted a few portions of the brief knowing little about the case.

• Shane Pennington, my co-lead counsel in this and so many other endeavors.

“And last but not least, I wanna thank me. I wanna thank me for believing in me. I wanna thank me for doing all this hard work. I wanna thank me for having no days off. I wanna thank me for never quitting. I wanna thank me for always being a giver and trying to give more than I receive. I wanna thank me for trying do more right than wrong. I wanna thank me for just being me at all times.”

2. FOIA Fight

With far less fanfare, I’ve been burning up a second docket here in Houston with the rest of my free time. I personally sued DOJ and DEA over what I contend to be unlawful FOIA practices and policies. The most recent complaint I’ve filed with the court is here. The gist of my grievances is as follows:

• The Justice Department has an unlawful policy of disregarding FOIA’s statutory timelines by invoking a statutory exception called the “unusual circumstances” exception any time it has to search outside the FOIA office for records—which is what any FOIA Office would have to do in almost every case.

• Each agency must designate a Chief FOIA Officer having a position at the “Assistant Secretary or equivalent level.” Congress included this requirement to ensure that the FOIA buck would stop with some politically accountable government official. DEA—and a great many federal agencies—do not have lawfully designated Chief FOIA Officer. And, their disregard of this statutory requirement appears to be willful.

• The Justice Department has unpublished secret policies on how it processes FOIA requests. Under FOIA, policies and interpretations as well as staff manuals and instructions to staff that affect members of the public must be affirmatively disclosed.

• DEA’s recordkeeping processes and practices in administrative proceedings violate the First Amendment because, for all practical purposes, records from administrative proceedings are entirely inaccessible to the public.

Why is this important? Or, stated differently, why is Matt, partner at a Band 1 Texas litigation boutique and 2022 American Lawyer finalist for Young Lawyer of the Year, devoting time to fight these policies for free, pro se, as opposed to, say, spending time doing a more gainful activity like surfing in El Salvador or dissecting psychedelic patent garbage? Let me try to answer the question indirectly.

My FOIA issues with DEA start with the rescheduling petition. We did not hear back from the agency within “a reasonable period of time” as to whether the petition had been accepted, as DEA’s regulations require. So, I wrote to the Administrator asking for the agency to confirm receipt of the petition pointing out the regulation. Still, nothing. There is little doubt in my mind that had I or anyone else on the team been a big firm lawyer representing a pharmaceutical company (perhaps with revolving-door personal connections inside the agency) that we could have picked up the phone and figured out what was up.³ But that wasn't us, so we submitted fairly targeted FOIA requests with the aim of confirming that DEA got the FOIA petitions and that they had been circulated to the relevant persons in the agency. Under FOIA, we were entitled to this information in a timely fashion.

At the same time, in the Five Tryptamines case, I submitted FOIA requests on behalf of clients, Mindstate and Tactogen, for documents relevant to that proceeding. The main legal issue in that case turned on whether DEA could rely on a 10+ year old medical and scientific evaluation from HHS when the statute requires a “current” assessment. Rulemaking proceedings do not provide for discovery of agency files. So, I turned to FOIA.

I kept most of my requests narrow. But in response to each request, the agency informed me that the request raised “unusual circumstances,” so they could not respond to my request within the time limits provided by FOIA (a month). And I ended up narrowing my FOIA requests down to a nub: a single poster in the office of an employee who I expressly named in the request. That too raised “unusual circumstances.”

So we’re clear, the “unusual circumstances” exception isn’t some made up thing. It applies, per the statute, when there is a “need to search for and collect the requested records from field facilities or other establishments that are separate from the office processing the request” but “only to the extent reasonably necessary to the proper processing of the particular requests.” But I was batting 100%. As far as I could tell, the unusual circumstances were the only circumstances.

Once that point became clear, I picked up the phone and called the FOIA Office. I couldn’t fathom how a request for a single document in a specific location could raise unusual circumstances. Turns out, I was about to step through the FOIA looking glass. A career government employee was about to rock my world.

Matt calls. Agency employee picked up the phone. A little back-and-forth ensues. Agency employee tells me it was agency “policy” to mark any record that is not in the FOIA Office as raising “unusual circumstances,” which under the statute (5 U.S.C. § 552(a)(6)(B)), allows the agency to defer responding to the request into oblivion. This describes nearly all FOIA requests because the FOIA Office doesn’t keep records. Under this policy, nearly all FOIA requests raise “unusual circumstances,” obliterating any time limits Congress required agencies to operate under.

This is important. Information is one of those things whose value goes to zero as time wears on. Think of information that shows an executive official is not doing their job or is disregarding the law. Now, does it help if that information is disclosed 3 years from now, into the next administration, when that official is already gone? Not really. As to my case, the issue was even more acute. We had a hearing scheduled in August. I’m being told the agency can’t get a single poster within 30 days and produce to me just because it wasn’t in the FOIA Office.

This whole thing seemed beyond preposterous. And it not only harmed my clients. It harms the interests of those I represent before the agency, my interests as someone that writes on drug policy, and the public generally. So, I sued. And, believe it or not, I persuaded a judge to order a deposition of the Justice Department and DEA about FOIA. DOJ/DEA objected to many of my topics to limit the scope of the deposition. The judge overruled the objections.

The deposition I took uncovered more violations and nonsense. One particularly powerful exchange is shown in the video below:⁴

Among other crazy things, the employee I had spoken to was right. A document that is physically 10-feet outside the FOIA office raises “unusual circumstances” according to this Justice Department policy. Bogus.

Another thing I learned over the course of the deposition is that sometimes we think we know more than we actually do. In taking the deposition, I wasn’t just trying to win a lawsuit. Once I stepped through the looking glass, I was legitimately curious about how FOIA works in the real world. I wanted to learn.

And while it is true that DOJ is violating the law, I learned that DEA’s Chief FOIA Officer and DEA’s FOIA’s office generally are hard-working and very professional.

At this juncture, the most shocking aspect of the case is not that DOJ or DEA is twisting FOIA or that FOIA is in disrepair. That’s par for the course. Rather, what rankles me is the media’s disinterest in this case or FOIA more generally.

FOIA used to be a lifeblood of journalism about government. And because of the deposition and the fact that DOJ—the agency that sets FOIA policy—is the deponent, this case is about as deep of a dive into contemporary internal government FOIA operations as I’ve seen. We’ve shopped it to some reporters at mainstream news outlets that cover the DOJ beat, hoping they would cover this story. There was some initial interest. But, to my amazement, none is interested.

I can’t speak to why they don’t care. Maybe it’s on us. Maybe we didn’t shop it enough. Maybe I’m high on my own kool-aid. Or maybe, government journalism functions a bit like how I perceive many regulatory lawyers/law-firms operate: afraid to take a stance because, while correct and maybe in the best interest of a client, would upset the government and soil the relationship in the future. Who knows?

In any event, here’s why you should care. Successfully persuading a judge to order the deposition of the Justice Department is unusual. Then, getting it to say some of the stuff it admitted is more unusual. I got admissions in this deposition that I’d dream of obtaining in cases for my paying clients. DOJ has publicly stated that FOIA and transparency is a priority. That it has now made admissions in under-oath testimony that call much of that into question—that’s news. An endless barrage of stories about whether President Biden or President Trump improperly handled classified documents? Honestly, I could not care less.

In the hands of those who know how to use it, FOIA is a powerful tool. For example, Ethan Nadelmann noted on his Twitter the retirement of Alex Norcia, a tobacco harm reduction journalist, and linked to Norcia’s farewell article. There, Norcia notes that his FOIA requests revealed that FDA had adopted a “Fatal Flaw” standard for evaluating applications to market vape products (PMTA). That document has become the centerpiece of legal challenges and others Norcia unearthed with FOIA provide additional insights into the FDA’s Vape Authorization plans.

Shane and I used FOIA a couple years ago to force DOJ to release a secret OLC Opinion that explained in great detail that the notorious NIDA Monopoly violated international law and had caused the U.S. to be in continuous violation of its international treaty obligations for over half a century.

Here is the real bottom line as to why I continue: for many—particularly those without relationships to regulators—FOIA is the only tool that allows us to see how and why an agency acts the way it does. Sunshine is often the only tool the public has to hold agencies accountable, to ensure agencies are following the law, and to make sure agencies give fair treatment to the different constituencies that go before it.

If (or when) psychedelic assisted therapy goes online, DEA is not going anywhere. That’s true whether or not you believe in “net zero trauma” utopia and psilocybin vending machines. Post-approval, psychedelics will remain scheduled substances. DEA will be a regulator. And I suspect it will have a strong hand in regulating the administration of psychedelics. Everyone in the space focuses on REMS but forgets that DEA may have independent authority to regulate how controlled substances are used.

Put simply, if you want to do business with the agency and don’t want this area to become a giant black box or complete regulatory capture, having a functioning FOIA is going to be essential.

1. We’ve got some essays on-tap, including one on the Adderall shortage.

2. As opposed to, say, one publicly supporting the abolition of Schedule I on Twitter while at the same time, telling DEA in a regulatory filing that substances the person knows are being used in research by other companies to develop lifesaving medicine should be placed in Schedule I.

3. To be clear, I’m not knocking lawyers or agency officials that leverage personal relationships to get business done. This isn’t a criticism of the revolving-door. In many cases, it is far more efficient. My frustrations have to do with the disregard of FOIA, which sets an absolute floor for how agencies must interface with the public. My view is that if an agency wants to exceed the courtesies of FOIA and disclose more information or do so faster because of a personal relationship or agency priorities or what not, that’s totally fine. But FOIA substantively and procedurally sets an impenetrable floor.

4. I’m going to make the whole deposition video available in a follow-on post tomorrow for subscribers. Again, thanks for your support, which helps cover our overhead for matters like this.