Doctors Ask US Appellate Court for Redo in DEA’s Selections for Cannabis Rescheduling Participants

A nonprofit organization of medical professions in support of evidence-based cannabis regulation filed a brief on Feb. 17 in the U.S. Court of Appeals for the D.C. Circuit related to its exclusion from the rescheduling hearing process.

Doctors for Drug Policy Reform (D4DPR) and its president, Bryon Adinoff, M.D., argue in the 56-page brief that the Drug Enforcement Administration (DEA) and former DEA Administrator Anne Milgram violated bedrock administrative law principles when they gave no reason why they limited the hearing to 25 participants. They also argue the selection process itself was arbitrary and capricious and must be redone.

Adinoff is a board-certified addiction psychiatrist and clinical professor at the University of Colorado School of Medicine. D4DPR has more than 400 doctors as members.

While 163 organizations/individuals requested to participate in the formal rulemaking hearing—to debate the Department of Justice’s (DOJ) proposed rule to reclassify cannabis to a Schedule III drug under the Controlled Substances Act (CSA)—D4DPR was among the majority that received rejection letters from the DEA.

“The agency denied all but 25 applications,” Monday’s appellate brief states. “It sent all other applicants, including [D4DPR], identical denial letters contending the applicants were not ‘interested persons’ and had identified no relevant evidence they intended to present.”

Monday’s appellate brief was complemented with an appendix that includes all the requests to participate as well as the DEA’s rejection letters to the unsuccessful requestors on Oct. 28. All 138 rejected applicants received an identical letter signed by Milgram, according to the appellate brief.

“Upon review and careful consideration, DEA has determined that the request did not sufficiently establish that you are an ‘interested person’ under DEA regulations and/or the request did not sufficiently state with particularity the relevant evidence on a material issue of fact that you intended to present during the hearing,” Milgram wrote in each rejection letter. “Therefore, DEA has decided not to grant your request. However, the materials (including any comments) you have submitted will be offered as evidence at the hearing as provided for in the NPRM.”

The appendix also included the DEA’s “cure letters” sent to several anti-rescheduling entities, providing them the opportunity to submit supplemental information showing that they met the “interested person” status under the Administrative Procedure Act (APA).

“To determine whether you are an ‘interested person,’ as that term is defined in DEA’s regulations, DEA is requesting that you provide additional information establishing that you are a ‘person adversely affected or aggrieved by’ the proposed rule,” DEA Deputy Assistant Administrator Matthew Strait wrote in a September cure letter to the Tennessee Bureau of Investigation. He sent the same letter to 11 others.

“Further, because the purpose of the hearing is to receive factual evidence and expert opinion regarding whether marijuana should be transferred to schedule III of the list of controlled substances … DEA is also requesting that you provide additional information describing the relevant evidence on a material issue of fact you intend to present during the hearing,” Strait wrote.

The DEA did not send D4DPR nor many other pro-rescheduling entities similar cure letters before rejecting their applications, according to Monday’s appellate brief.

Among the 12 cure letters included in the appendix, nine were sent to those who “strongly opposed” the Schedule III proposal, two had unclear positions, and one supported the proposed rule: the University of California San Diego Center for Medical Cannabis Research, according to the D4DPR’s brief.  

The two entities whose positions were unclear included the Minority Cannabis Business Association (MCBA) and Darwin Richardson, according to D4DPR.

However, the DEA rejected the San Diego Center, MCBA and Richardson for participation.

Meanwhile, the DEA approved three of the nine anti-rescheduling entities that received cure letters: the Tennessee Bureau of Investigation, the Drug Enforcement Association of Federal Narcotics Agents, and Phillip Drum, a pharmacist.

The D4DPR, as well as other pro-rescheduling parties, view the cure letters as ex parte communications between the DEA and the anti-rescheduling entities it selected for participation in the hearing.

“The agency’s silence, facially arbitrary participant selections, and ex parte assistance almost entirely to anti-rule applicants are strong evidence that the agency acted with an impermissible purpose of creating an evidentiary record supporting its preferred outcome—rejection of the proposed rule,” the D4DPR brief states. “The fundamental unfairness caused by the ex parte communications in particular cannot be cured by mere explanation.”

D4DPR, represented by Austin T. Brumbaugh, an associate at Houston-based Yetter Coleman LLP, also argued in Monday’s brief that the DEA’s rejection of 138 participant requests was arbitrary and capricious, and that former U.S. Attorney General Merrick Garland never delegated his authority to the DEA to select participants for the hearing in the first place.

“The agency’s selection of 25 participants and exclusion of petitioners does not withstand arbitrary and capricious review,” according to the brief. “The agency gave no reasons for selecting only 25 participants or why it selected particular applicants. The agency cannot be presumed to have used permissible selection criteria, and there is substantial evidence that it was motivated by the impermissible goal of creating an evidentiary record that would allow it to reject the proposed rule to reschedule marijuana.”

D4DPR argued that the DEA’s failure to explain its selections “warrants vacatur and remand” with instructions to redo the selection process.

John J. Mulrooney, the DEA’s chief administrative law judge overseeing the hearing, ordered a stay in the current hearing process when he granted an interlocutory appeal on Jan. 13 amid allegations that the DEA participated in ex parte communications with anti-rescheduling participants.

While that order has delayed the hearing process indefinitely as the DEA transitions to new leadership under President Donald Trump, the latest filing by D4DPR in the U.S. Court of Appeals could force Mulrooney to sit idle for even longer—and potentially start the rulemaking hearing from square one depending on the outcome.

Matthew Zorn, a partner at Yetter Coleman who previously represented a consolidated group of three pro-rescheduling designated participants, put this possibility on Mulrooney’s radar during preliminary proceedings held Dec. 2 in Arlington, Va.

“We may seek a stay in these proceedings in light of the administrator’s 25-person list,” Zorn said about his colleague, Brumbaugh, representing D4DPR. “Nobody really knows how that list was compiled. I could talk about the facts of how the decision first went out on the day before Thanksgiving, informing parties that they weren’t attending, as if they didn’t already know. But I think, for your honor, it’s possible that we seek a stay.”

Previously, Mulrooney denied a motion from D4DPR to intervene in the rescheduling hearing, indicating that he lacked the jurisdiction to “review, modify or reverse” Milgram’s inclusion/exclusion decisions for participation.

On Dec. 4, two days after the preliminary proceedings, D4DPR filed a motion with Mulrooney seeking an indefinite stay of the rescheduling hearing so that it could pursue relief in the D.C. Circuit. Mulrooney denied that motion but said any order from the circuit court “will be expeditiously and scrupulously adhered to by this tribunal.”

After Zorn told Mulrooney in person of D4DPR’s intentions during the in-person proceedings on Dec. 2, the judge told him he must understand the consequences of seeking appellate relief.

“Remember that you’re going to be delaying these proceedings till God only knows when,” Mulrooney said. “Now, I’ve got ways to occupy my time, I’m sure, but understand that when you go back to your seat after you get your stay, marijuana [rescheduling] just stops for as long as the … court of appeals takes.”

From D4DPR’s perspective, the stay is warranted as a result of the DEA “offhandedly and unreasonably concluding” that 138 of 163 participant requestors were not “interested persons” while failing to offer relevant evidence for that conclusion, according to Monday’s appellate brief.

“The result is that only 20 voices will be heard on whether marijuana should be rescheduled,” the brief states. “How and why those voices were chosen is a secret the agency has not explained. The agency’s secrecy prevents the court from reviewing whether the decision is based on relevant and permissible criteria, and whether the agency considered reasonable alternatives.”

Editor’s note: While the DEA selected 25 designated participants, some individuals voluntarily withdrew their requests, while Mulrooney ruled that others lacked independent standing.

The DEA’s “secretive” process violates administrative law principles because a federal government agency must disclose the basis of its actions to permit meaningful judicial review, D4DPR argued in the brief. Also, limiting the number of participants without explanation was a “quintessential arbitrary action,” the brief states.

“For example, the agency could have judged that, although many of the over 160 applicants were ‘interested persons’ with relevant evidence to present, a long, drawn-out process would upset the summer travel plans of agency staff,” D4DPR argues. “The record silence prevents the court from ruling out this impermissible basis, and the agency is not entitled to any presumption that its unexpressed reasons are permissible or rational.”

In addition, D4DPR points out that the applicant pool of 163 requestors included a broad array of entities, from individuals, educational institutions, states, corporations, trade associations, nonprofit organizations, political parties, veterans’ groups, law enforcement associations, and doctors and scientists.

However, D4DPR argues that the DEA offered no transparency about how it exercised impartiality to ensure it did not favor pro-rule or anti-rule applicants.

“For instance, the agency inexplicably selected the state of Nebraska to offer evidence against the rule but rejected other states’ detailed requests to present pro-rule evidence, including New York’s Office of Cannabis Management and the state of Colorado,” the brief states. “The rejection of Colorado is particularly puzzling because Colorado had offered to contextualize data about traffic fatalities in the state that the Attorney General specifically discussed in the notice of proposed rulemaking.”

D4DPR contends that its organization “plainly” qualifies as an interested person because its membership includes more than “400 physicians and licensed medical practitioners” who recommend cannabis for treatment, and cannabis’s schedule status affects “how medical cannabis is recommended/prescribed or dispensed.”

Meanwhile, the DEA selected another doctors’ group to participate, the International Academy on the Science and Impact of Cannabis, which D4DPR describes as the anti-rescheduling counterpart to its nonprofit organization.

D4DPR also listed several other medical professionals/groups whom it contends the DEA treated differently, especially those who received cure letters.

“The most undeniable instance of differential treatment in the record is the agency’s ‘cure letters,’ sent almost exclusively to applicants who intended to offer evidence against the proposed rule,” the appellate brief states. “These cure letters invited anti-rule applicants another bite at the apple to show they were ‘interested persons’ who intended to present relevant evidence. [D4DPR] received no similar assistance from the agency. This is a quintessential case of treating similarly situated applicants differently without just cause.”

In conclusion, D4DPR asked the court to vacate the DEA’s participant selections and remand with instructions for the agency to redo the selections.