MDMA and Psilocybin for Mental Health: Deconstructing the Controlled Substances Act’s Usage of “Currently Accepted Medical Use”

ABSTRACT

MDMA and psilocybin are drugs that exhibit almost never-before-seen relief—including complete remission—from debilitating mental health disorders including Post Traumatic Stress Disorder (PTSD) and Treatment-resistant depression. Doctors, however, are unable to legally prescribe them outside of tightly-controlled research trial settings because of the drugs’ categorization under Schedule I of the Controlled Substances Act (CSA)—the Act’s most restrictive schedule—by the Drug Enforcement Agency (DEA). Legal scholarship on the subject, unfortunately, is not commensurate with the pace of recent progress in both the medical and commercial fields. Further, while state and local efforts to decriminalize, regulate, and provide access to MDMA and psilocybin may offer some hope, unless the drugs are reclassified to a less restrictive schedule on the federal level under the CSA, the state-by-state patchwork approach would inevitably create inequities in patient access to these potentially life-saving drugs and expose patients to federal prosecution, notwithstanding their compliance with state or local laws.

This Note examines the federal structural legal barriers that hinder patient access to MDMA and psilocybin. It begins by providing a historical backdrop of the legal and political reasons the drugs were banished to the CSA’s most restricted category, Schedule I, over fifty years ago. It then demonstrates that the DEA, in the decades that followed, exceeded its administrative authority in interpreting the Controlled Substances Act’s undefined requirement that Schedule I be reserved for drugs and substances with “no currently accepted medical use.” Concomitantly, federal circuit courts have, by and large, upheld the DEA’s interpretations under Chevron v. Natural Resources Defense Council, a 1984 U.S. Supreme Court decision that requires federal courts to defer to permissible agency constructions of ambiguous federal statutory provisions.

This Note presents aspects of three recent U.S. Supreme Court decisions that clarify the Chevron standard, and argues that the DEA’s interpretation is no longer warranted deference under U.S. Supreme Court law. Ultimately, this Note proposes an alternative statutory interpretation of “currently accepted medical use” that comports both with current Supreme Court jurisprudence and with the CSA’s public health purpose.

Introduction

Jonathan Lubecky, a veteran, recently recovered from Post-Traumatic Stress Disorder (PTSD) that had resulted from traumas he suffered during his deployment in Iraq in 2006.[1] After returning from Iraq and for five years thereafter,[2] his daily reality centered around one goal—how to take his own life.[3] He attempted suicide five times, all near-successful.[4] “When all seemed lost,” he turned to the club drug MDMA—but legally—as part of a clinical trial.[5] After only three treatment sessions, his crippling symptoms disappeared.[6] According to Jonathan, MDMA saved his life.[7] His message to fellow veterans battling PTSD: “[MDMA] treatment is the reason my son has a father instead of a folded flag.”[8]

Jonathan is not alone.[9] Mental illness is a public health crisis that affects almost one in five Americans annually.[10] Compounding this mass human suffering is a profound economic impact: in 2010, “the global direct and indirect economic costs of mental disorders were estimated at US $2.5 trillion,[11] and that figure is “expected to double by 2030.”[12] And the approximately 15 million PTSD sufferers are among the worst off:[13] no disorder-specific drug has been developed since 2002, and those currently available have shown little, if any efficacy.[14] In fact, studies have found that the most commonly used psychiatric drugs—selective serotonin re-uptake inhibitors (SSRIs)—do not alleviate symptoms in up to fifty percent of patients with depression.[15] Prospects for new treatments are dim: pharmaceutical companies reduced research and development of new psychiatric drugs by seventy percent over the last decade.[16]

Put simply, the United States healthcare system is woefully ill-equipped to offer effective treatment for up to twenty percent of its population.[17] Yet two experimental drugs, 3,4-Methylenedioxymethamphetamine (MDMA) and psilocybin, have shown phenomenal promise.[18] In fact, the Food and Drug Administration (FDA) in 2017 granted “breakthrough therapy” status for MDMA-assisted psychotherapy[19] following several recent studies that demonstrated “significant relief” for PTSD patients.[20] One of those studies showed that 67 percent of the participants “no longer met the diagnostic criteria for PTSD” after just two months of treatment.[21] MDMA works by reducing the activity in the amygdala, the fear-processing part of the brain: when the fear is calmed, patients feel safe in processing their traumatic memories with professional therapists with a positive perspective.[22]

As for psilocybin, the FDA granted the same status twice in 2019 for the treatment of severe depression in patients who have not improved from traditional antidepressants.[23] A Johns Hopkins University study published last year found that psilocybin “was four times more effective than traditional antidepressants.”[24] Psilocybin profoundly impacts the brain and can have long-term therapeutic effects by “wiping away depressive symptoms” in many patients with major depressive disorders.[25] According to Johns Hopkins University neuropharmacologist Roland Griffiths, psilocybin is distinguishable from traditional pharmaceuticals because it produces “enduring meaning and belief changes . . . . People feel ‘reorganized’ in a way they don’t with other drugs.”[26] And because psilocybin therapy is four times as likely to be effective than SSRIs “with more enduring benefits,”[27] Newsweek’s October 2021 issue cover hailed it as possibly “the biggest advance in treating depression since Prozac.”[28]

Despite having shown promise for almost half a century,[29] MDMA and psilocybin are still not legally available to patients, largely because the federal government, decades ago, hastily categorized them under Schedule I of the Controlled Substances Act (CSA).[30] A drug’s placement on Schedule I subjects it to severe restrictions by the Drug Enforcement Administration (DEA) and, as a consequence, researchers’ access to that drug is tremendously hindered, delayed, and often cost-prohibitive.[31]

Unique to Schedule I drugs is their legal characterization of having “no currently accepted medical use.”[32] Rescheduling a drug from Schedule I to another, less restrictive schedule is a complex administrative process.[33] Essentially, rescheduling proceedings must demonstrate that a drug or substance has a “currently accepted medical use,”[34] a process which has been historically administered by the DEA.[35]

Unlike the federal government, many cities and states, seeming to recognize the “untapped resource” that psilocybin and MDMA represent, have either decriminalized the possession of these two drugs or explicitly permitted research into them.[36] The trend began in 2019 in Denver, Colorado, where voters approved a referendum decriminalizing psilocybin.[37] By 2020, Oakland and Santa Cruz, California,[38] Washington, D.C.,[39] and Oregon[40] followed suit in what has been dubbed as the “psychedelic renaissance.”[41] Chicago and Iowa are among other state and local jurisdictions considering the enactment of similar measures,[42] and California legislators are proposing further reforms.[43] On the research front, in 2021 Texas tasked its state health departments with conducting studies to evaluate the therapeutic efficacy of psilocybin and MDMA research in the treatment of PTSD, depression, anxiety, migraines, and other mental and physical health conditions,[44] following Connecticut’s enactment of a similar measure.[45] As of this writing, eleven additional states are proposing similar measures.[46]

These state and local measures are significant for two reasons that may be in tension. On one hand, they demonstrate that many American voters acknowledge the therapeutic effects of certain Schedule I drugs. However, their conflict with the CSA exposes patients who, while acting consistently with state or local law, risk prosecution and incarceration by the federal government “unless federal drug regulation is updated.”[47]

Legal scholarship on the subject, unfortunately, has not kept pace with the momentum in both the medical and commercial fronts.[48] Over the last two years, medical research papers on the subject have multiplied: 139 papers were published on psilocybin in 2020, almost twice as many as in 2019.[49] On the commercial front, companies are already seeking patents on psilocybin formulations.[50] As of this writing, three such companies are publicly listed in the United States, and in Canada, more than two dozen are listed, with an estimated collective value of more than $4.5 billion.[51] On the legal front, however, “there is no systematic research being done on psychedelics law.”[52] This Note aims to contribute in ongoing efforts to fill this gap.[53]

This Note argues that federal rescheduling is more effective than a patchwork of state laws because, by virtue of the preemption doctrine, federal rescheduling would provide immediate and nationwide relief for suffering Americans.[54] Further, rescheduling is possible under the current statutory framework because current DEA regulations are inconsistent with the plain text of the CSA.[55] Part I of this Note provides the legal and historical backdrop of the CSA and its stymying effects on MDMA and psilocybin research. It then summarizes the legal evolution of rescheduling requirements under DEA regulations that interpret the descriptive language of Schedule I drugs under the CSA. Part II demonstrates the illegality of those regulations in their current state, arguing that they are inconsistent with the plain text of the CSA. Part III in turn proposes regulatory criteria for Schedule I drugs that are consistent with the CSA and current federal jurisprudence. Part IV concludes by noting additional considerations and challenges that may nonetheless prevent broad patient access to MDMA and psilocybin.

I. Background

A. How We Got Here: The CSA and the War on Drugs

Medical experts have found that MDMA and psilocybin are both safe and effective.[56] In fact, they “appear to have fewer and less severe side effects than many FDA-approved medicines including widely prescribed psychiatric drugs.”[57] These findings are not all new: experts began researching and publishing their findings of the potential therapeutic effects of MDMA, psilocybin, and other psychedelic drugs over fifty years ago.[58] But, according to Professor Mason Marks, these drugs became mischaracterized and eventually “miscategorized” as a result of the U.S. war on drugs.[59] President Richard Nixon’s administration associated psychedelic drugs with the countercultural movements of 1960s,[60] and the CSA—including its quintessential scheduling regime—was born as a “cornerstone” of the war on drugs.[61] But decades later, one of President Nixon’s top aides and Watergate co-conspirators, John Ehrlichman, revealed that war on drugs was actually fabricated “as a political tool” against racial minorities and political dissidents.[62] Confirming, in point-blank fashion, that the CSA was “hardly based on evidence-based dialogue,”[63] Ehrlichman bluntly admitted during a 1994 interview published in a 2016 Harper’s Magazine exposé:

We knew we couldn’t make it illegal to be either against the war or black, but by getting the public to associate the hippies with marijuana and blacks with heroin, and then criminalizing both heavily, we could disrupt those communities. We could arrest their leaders, raid their homes, break up their meetings, and vilify them night after night on the evening news. Did we know we were lying about the drugs? Of course we did.[64]

President Nixon succeeded.[65] Over the last five decades, the war on drugs has devastated racial minorities “by incarcerating millions, disrupting families, and reinforcing social inequality,”[66] and raised the United States to the highest incarcerator of its citizenry among all nations worldwide on a per capita basis.[67] At the same time, MDMA and psilocybin became the collateral damage of the war on drugs.[68] The CSA was the war’s primary arsenal,[69] which Congress enacted in 1970 as Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970 to address drug abuse and to “control the legitimate and illegitimate traffic in controlled substances.”[70] The CSA was originally intended to be “sufficiently flexible” to handle the “ever-changing drug scene.”[71] However, the emphasis on control restrictions to tackle illicit drug use has come at the expense of the curtailment of legitimate medical research.[72]

The CSA’s classification system is its “cardinal feature.”[73] Controlled drugs are categorized into five schedules[74] “based on their accepted medical uses, their potential for abuse, and their psychological and physical effects on the body.”[75] Schedule I drugs are considered “the most dangerous substances, possessing no redeeming value as medicines.”[76] Therefore, the CSA subjects them “to the most severe controls.”[77] For example, drugs in Schedule I “are the only category of drugs that doctors may never prescribe.”[78] Section 812(b) of the CSA provides the statutory criteria that set forth the findings required for each of the five schedules.[79] For a drug to be placed in Schedule I, the CSA requires that:

(A) The drug or other substance has a high potential for abuse;

(B) The drug or other substance has no currently accepted medical use in treatment in the United States;

(C) There is a lack of accepted safety for use of the drug or other substance under medical supervision.[80]

Unlike Schedule I drugs, all drugs in Schedules II to V have, inter alia, a “currently accepted medical use.”[81] Thus, a drug can be placed in Schedule I only if it has “no currently accepted medical use.”[82]

Drugs can travel between schedules.[83] Section 811(a) describes this process, empowering the Attorney General to initiate rulemaking proceedings to reschedule a drug “on his own motion,” or at the request of either of the Secretary of Health and Human Services (HHS) or “any interested party.”[84] The Attorney General has historically delegated this authority to the DEA.[85] Before initiating rulemaking proceedings, however, the Attorney General (or the DEA) must gather “the necessary data” and request a “scientific and medical evaluation” and recommendation from HHS.[86] Section 811(c) enumerates eight factors the Attorney General must consider in making a rescheduling determination for a drug:

(1) Its actual or relative potential for abuse.

(2) Scientific evidence of its pharmacological effect, if known.

(3) The state of current scientific knowledge regarding the drug or other substance.

(4) Its history and current pattern of abuse.

(5) The scope, duration, and significance of abuse.

(6) What, if any, risk there is to the public health.

(7) Its psychic or physiological dependence liability.

(8) Whether the substance is an immediate precursor of a substance already controlled under [subchapter I of 21 U.S.C.].[87]

According to the CSA’s original drafters, including former director of the Bureau of Narcotics and Dangerous Drugs (the DEA’s predecessor agency) Michael Sonnenreich, “[t]he intent of the scheduling system and its greatest value is its practicality and ability to adjust the regulatory framework.”[88] The drafters emphasized the importance of the scheduling system’s adaptability to “changing social circumstances,” and warned that using it solely for expanding drug restrictions and control would essentially defeat its purpose.[89]

Even though “Congress contemplated that the classification set forth in the [CSA] as originally passed would be subject to continuing review by the executive officials concerned,”[90] in practice, instances of drug reschedulings have been sparse. Over a forty-year period, the DEA rescheduled a drug from Schedule I to Schedule II only five times.[91] Over the same period, the DEA entirely removed a drug from Schedule I only twice.[92] In its original incarnation, the CSA may have “balanced law enforcement and public health concerns,” but subsequent amendments during the 1970s War on Drugs tipped the balance in favor of the DEA’s interests.[93] Over the next several decades, the CSA became more concerned with convicting drug offenders, largely leaving behind its original public health concerns.[94]

B. Legal Evolution of Rescheduling Under § 811

The only statutory difference between Schedule I and the other four schedules is that Schedule I substances have “no currently accepted medical use,” [95] whereas the other four do have a “currently accepted medical use.”[96] It follows that if a drug has a “currently accepted medical use,” it cannot legally be scheduled in (or remain in) Schedule I: the DEA must move the drug to Schedules II–V, or remove it entirely from the CSA.[97] However, Congress never defined the phrase “currently accepted medical use” when enacting or amending the CSA.[98]

Since 1992, the DEA has required that a drug meet a conjunctive five-part test to satisfy the “currently accepted medical use” standard (the “1992 Test”):

1) whether a drug’s chemistry is known and reproducible;

2) whether there are adequate safety studies;

3) whether there are adequate and well controlled studies proving efficacy;

4) whether the drug is accepted by qualified experts; and

5) whether the scientific evidence is widely available.[99]

The 1992 Test remains the prevailing legal standard today by virtue of the judicial deference courts have afforded DEA interpretations of “no currently accepted medical use” pursuant to the Chevron doctrine.[100] In 1984, the Supreme Court decided Chevron v. Natural Resources Defense Council, [101] ushering in an era of judicial deference to agency interpretations of civil statutes.[102] Essentially, Chevron instructs courts to follow a two-step process when reviewing an agency’s interpretation of a statute.[103] First, courts must ask “whether Congress has directly spoken to the precise question at issue.”[104] “If the intent of Congress is clear,” courts and federal agencies “must give effect to the unambiguously expressed intent of Congress.”[105] If, on the other hand, courts determine that “Congress has not directly addressed the precise question at issue,” courts must not “simply impose” their own interpretation of the statute.[106] Instead, “if the statute is silent or ambiguous,” courts should defer to the agency’s interpretation only if the agency’s interpretation is “based on a permissible construction of the statute.”[107]

Based on Chevron, federal courts, by and large, have deferred to the DEA’s interpretation of “currently accepted medical use.”[108] In that respect, three federal appellate decisions shed light on the extent to which federal courts have deferred to DEA interpretations under Chevron: Grinspoon v. DEA,[109] Alliance for Cannabis Therapeutics v. DEA,[110] and Americans for Safe Access v. DEA.[111]

1. Grinspoon v. Drug Enforcement Administration

1987 marked a significant year in federal appellate court Schedule I rescheduling disputes under the CSA.[112] In Grinspoon v. Drug Enforcement Administration, Dr. Lester Grinspoon, a Harvard University researcher, petitioned the First Circuit Court of Appeals for a review of the DEA’s issuance of a final rule classifying MDMA as a Schedule I substance.[113] The First Circuit remanded Grinspoon’s MDMA rescheduling petition to the DEA for reconsideration because the DEA had erroneously interpreted “currently accepted medical use” to mean a drug must have Food & Drug Administration (FDA) “interstate marketing approval.”[114] The court reasoned that, even though FDA interstate marketing approval was sufficient to prove that a drug had an accepted medical use, such approval was not necessary according to the CSA.[115] Under Chevron, the First Circuit found the DEA’s interpretation “contrary to congressional intent.”[116]

Regardless, the DEA on remand adopted the FDA criteria, delineating eight “characteristics” that a drug must have for it to have an “accepted medical use”:

[1] scientifically determined and accepted knowledge of its chemistry; [2] the toxicology and pharmacology of the substance in animals; [3] establishment of its effectiveness in humans through scientifically designed clinical trials; [4] general availability of the substance and information regarding the substance and its use; [5] recognition of its clinical use in generally accepted pharmacopeia, medical references, journals or textbooks; [6] specific indications for the treatment of recognized disorders; [7] recognition of the use of the substance by organizations or associations of physicians; and [8] recognition and use of the substance by a substantial segment of the medical practitioners in the United States.[117] 

These eight factors continued to constitute the DEA’s interpretation of “currently accepted medical use” under the CSA until 1991.[118]

2. Alliance for Cannabis Therapeutics v. Drug Enforcement Administration

In 1991, petitioner Alliance for Cannabis Therapeutics (ACT) challenged the eight-factor test at the U.S. Court of Appeals for the District of Columbia Circuit in an appeal from the DEA’s denial of ACT’s petition to reschedule marijuana.[119] In Alliance for Cannabis Therapeutics v. Drug Enforcement Administration, the court found unreasonable three of eight factors the DEA had relied on in denying ACT’s petition because they were “logically impossible to satisfy,”[120] but deferred to the DEA’s interpretation with respect to the remaining five because the CSA did not “precisely” define the term “currently accepted medical use.”[121] In accepting the DEA’s interpretation, the court reasoned it was “obliged” under Chevron to defer to the DEA’s interpretation because it was “reasonable.”[122]

On remand, the DEA relied on FDA standards again.[123] It used the five remaining factors in making its determination:

1) whether a drug’s chemistry is known and reproducible;

2) whether there are adequate safety studies;

3) whether there are adequate and well controlled studies proving efficacy;

4) whether the drug is not accepted by qualified experts; and

5) whether the scientific evidence is not widely available.[124]

To date, the DEA has relied on the 1992 Test in making Schedule I rescheduling determinations.[125]

3. Americans for Safe Access v. Drug Enforcement Administration

The D.C. Court of Appeals has deferred to the DEA not only for its interpretations of the CSA language governing Schedule I,[126] but also for its own interpretations of the 1992 Test.[127] With respect to the test’s third factor—determining whether a drug has “adequate and well controlled studies proving efficacy”—the DEA has required a showing of “adequate, well-controlled, well-designed, well-conducted, and well-documented studies.”[128] In Americans for Safe Access v. Drug Enforcement Administration, the D.C. Circuit upheld the DEA’s denial to reschedule marijuana as a Schedule III, IV, or V drug. The case turned on the application of the third factor of the 1992 Test: whether there were “adequate and well controlled studies proving efficacy.”[129] In its denial below, the DEA had interpreted this requirement to mean that “the effectiveness of a drug must be established in well-controlled, well-designed, well-conducted, and well-documented scientific studies.”[130] Although the court noted that the DEA had relied on the FDA’s interpretation of what constitutes an “adequate and controlled” study for that agency’s review of applications for new drugs under a different law, it did not find such an interpretation unreasonable.[131]

C. The Decline of Chevron

The Chevron doctrine has visibly waned in recent years.[132] Professor Nathan Richardson posits that it is

not the influential doctrine it once was and has not been for a long time. It has been eroded from the outside as a series of exclusions have narrowed its scope, and has been hollowed out from the inside as [Supreme Court] Justices have become ever more willing to find clear meaning in statutes, thereby denying deference to agencies.[133]

Since 2018, the Chevron doctrine has evolved in three significant respects. Justice Kennedy first signaled this in a 2018 concurring opinion in Pereira v. Sessions, where he cautioned against “reflexive deference” to agency interpretations.[134] Instead, in 2019, Justice Kagan in Kisor v. Wilkie urged federal judges to tackle “hard interpretive conundrums” before waving “the ambiguity flag.”[135] Justice Kagan clarified when and how a federal agency is allowed to interpret its own rule.[136] Justice Kagan provided courts with three “important markers” to help identify when an agency’s interpretation of its own ambiguous rule warrants deference:[137]

First, the interpretation must represent the agency’s “authoritative” or “official” position rather than an “ad hoc statement not reflecting the agency’s views.” . . . Second, the interpretation must implicate the agency’s expertise. This marker is based on the assumption that agencies have a more “nuanced understanding of the regulations they administer.” And if an agency “has no comparative expertise in resolving a regulatory ambiguity, Congress presumably would not grant it that authority.” And third, the agency’s interpretation must reflect “fair and considered judgment.”[138]

Second, also in 2019, a majority of the Court in SAS Institute v. Iancu emphasized that “[e]ven under Chevron, [courts] owe an agency’s interpretation of the law no deference unless, after ‘employing traditional tools of statutory construction,’ [courts find themselves] unable to discern Congress’s meaning.”[139]

Third, the Court has cautioned against Chevron deference in the interpretation of dual-application statutes (such as the CSA), even in the application of a civil provision of such statutes.[140] Instead, “if a law has both criminal and civil applications, the rule of lenity governs its interpretation in both settings.”[141] The rule of lenity, in turn, requires courts to choose the more lenient interpretation “when there are two rational readings of a criminal statute, one harsher than the other.’”[142] The harsher application is appropriate “only when Congress has spoken in clear and definite language.”[143]

II. Analysis

A. The Impact of Iancu

As noted above, recent Supreme Court decisions continue to erode the Chevron standard.[144] Notably, in 2019 the Iancu Court clarified that even under Chevron, courts must not defer to agency interpretations unless, “after ‘employing traditional tools of statutory construction,’ [courts find themselves] unable to discern Congress’s meaning.”[145]

Applying the traditional tools of statutory construction in interpreting “currently accepted medical use” yields a result very different from the 1992 Test. This Part continues by analyzing the 1992 Test under the directive provided by Iancu.[146] As this analysis will demonstrate, the 1992 Test is incompatible with the plain meaning of sections 811 and 812 of the CSA. Ultimately, this author proposes a modified test for “currently accepted medical use” that better comports with the relevant statutory language.

Although the principal canons of statutory construction are familiar to most readers, a brief review is helpful. When interpreting a statute, federal courts first interpret words of a statute according to their plain meaning.[147] Second, “the words of a statute must be read in their context and with a view to their place in the overall statutory scheme.”[148] Finally, courts also consult legislative history when interpreting ambiguous language.[149]

1. Plain Meaning

The natural starting point in a plain meaning analysis is the ordinary-meaning rule.[150] The Supreme Court instructs that a statute should be interpreted according to “the ordinary public meaning of its terms at the time of its enactment.”[151] Accordingly, the table below illustrates the definitions of the words contained in “currently accepted medical use” according to Webster’s Third New International Dictionary’s 1969 edition:[152]

Word

Definition

“current”

“In genuine knowledge, acceptance use or practice; prevalent, accustomed, general; commonly accepted, engaged in, followed, used, or practice; in vogue; contemporary[153]

“currently”

“Fluently, readily; at present <~ engaged in scientific research <~ running at the local theater>”[154]

“accepted”

“Generally approved; widely used or found <there are three ~ types of pump>; generally agreed upon <~ interpretation of the poem>”[155]

“acceptable”

“Capable or worthy of being accepted <no compromise could ever be ~>”[156]

“medical”

“Of, relating to, or concerned with physicians or with the practice of medicine often as distinguished from surgery”[157]

“use”

“The act or practice of using something”[158]

Simply interchanging “currently accepted” with their respective definitions above indicates that the phrase means “generally agreed upon at present.” Although the temporal element is unambiguous, the phrase “generally agreed upon,” because of its passive voice, is ambiguous vis-à-vis its subject. Put differently, “generally agreed upon” by whom? Was Congress referring to private medical professionals, researchers, or the general public? The plain meaning analysis thus does not extinguish the ambiguity surrounding “accepted.”

2. Overall Statutory Scheme

The plain meaning analysis can be supplemented by reading the statutory language in its context, with a view of its place in the overall statutory structure of the CSA.[159] Section 811 authorizes the Attorney General to add, remove, and reschedule substances.[160] Subsection 811(a) also specifically identifies the HHS Secretary as a party able to request the Attorney General to adjust a drug’s scheduling status, even though “any interested party” can similarly petition the Attorney General.[161] It is noteworthy that Congress singled out the HHS Secretary, notwithstanding her legal empowerment under subsection 811(a) as a potential “interested party.”[162] Significantly, subsection 811(b) requires the Attorney General, “before initiating proceedings under subsection 811(a) to control a drug or other substance or to remove a drug or other substance entirely from the schedules,” to “gather[] the necessary data,” and to “request from the [HHS] Secretary a scientific and medical evaluation, and his recommendations, as to whether such drug or other substance should be so controlled.”[163] The subsection, in turn, requires the HHS Secretary to “consider” eight factors during the evaluation.[164] The HHS evaluation is then “binding on the Attorney General as to such scientific and medical matters, and if the [HHS] Secretary recommends that a drug or other substance not be controlled, the Attorney General shall not control the drug or other substance.”[165] The foregoing indicates that Congress granted considerable authority to HHS, requiring the Attorney General not only to seek its evaluation prior to scheduling proceedings, but also requiring the Attorney General to remove a drug from CSA control if HHS so recommends.[166]

The considerable authority and deference Congress granted to HHS in section 811 cures the ambiguity noted above: when Congress said “accepted,” they likely meant “accepted by HHS.” The fact that the word “accepted” is followed by the words “medical use” supports this interpretation because HHS is “the U.S. Government’s principal agency for protecting the health of all Americans,”[167] in stark contrast to the Attorney General’s function—the federal government’s “chief law enforcement officer.”[168]

The Supreme Court’s evaluation of the Attorney General’s powers under the CSA in Gonzales v. Oregon[169] further supports the conclusion that Congress likely did not intend the phraseology it selected—“currently accepted medical use”[170]—to be interpreted by the Attorney General. The Oregon Court emphasized the limitation on the Attorney General’s powers described above when it analyzed the CSA’s overall statutory scheme.[171] In Oregon, the Court noted that the “CSA gives the Attorney General limited powers, to be exercised in specific ways.”[172] It emphasized that the Attorney General “can promulgate rules relating only to ‘registration’ and ‘control,’ and ‘for the efficient execution of his functions’ under the statute.”[173] The Court also noted that various sections of the CSA use the words “accepted” and “legitimate” interchangeably.[174] Significantly, the Court made clear that “the statutory terms ‘public interest’ and ‘public health’ do not call on the Attorney General, or any other executive official, to make an independent assessment of the meaning of federal law.”[175]

Congress also likely intended to ensure the CSA’s schedules be harmonized with the constant variations of what constitutes “accepted” and “legitimate” in the medical community. This can be gleaned by the placement of the word “currently” immediately before “accepted medical use” in § 812(b)(1)(B) of the CSA.[176] Moreover, section 812 requires the Attorney General to update and republish the schedules at least once a year.[177] Viewed together, § 812(b)(1)(B)’s use of the word “currently”[178] is synchronous with subsection 812(a)’s updating requirements.[179] Thus, because the CSA in subsection 811(a) requires the Attorney General to update the schedules at least once a year,[180] and because the ordinary meaning of “currently” in 1969 was “at present,”[181] Congress likely intended to tether Attorney General’s evaluation of a drug’s “accepted medical use” with the medical community’s assessment of that drug on an annual basis. Simple logic supports this conclusion: a drug which may not have been known to the medical community as an accepted treatment last year may become “accepted” this year as a result of, say, a successful clinical trial. For example, between 2000 and 2008, the FDA approved twenty-three drugs per year on average.[182] This fact illustrates the continuous evolution of the medical community’s evaluation of treatments: what may not have been an “accepted” drug yesterday may become an “accepted” drug tomorrow. Congress likely recognized this reality when it qualified the phrase “accepted medical use” with the word “currently.”

This line of analysis is supported by the drafters of the CSA. In a book they co-authored following the CSA’s enactment, Robert L. Bogomolny, Michael R. Sonnenreich, and Anthony J. Roccograndi explained that “the intent of the scheduling system and its greatest value is in the practicality and ability to adjust the regulatory framework.”[183] Its “true test,” they predicted, would be in “loosening restraints when justified. A scheme that is directly only towards tighter and tighter controls will, in time, lose its most important attributes, flexibility, and the capacity to adjust to changing social circumstances.”[184]

3. Legislative History

The CSA’s legislative history buttresses the conclusion that Congress was referencing the medical community—and, more particularly, to HHS—when it used the word “accepted” in § 812(b)(1)(B).[185] Legislative history can provide an opportunity to understand a statute’s meaning across different times and contexts,[186] which is instructive in discerning Congress’s understanding of the phrase “currently accepted medical use” when it enacted the CSA. A litigant in the Ninth Circuit, as part of a marijuana rescheduling challenge to the 1992 Test, recently made persuasive arguments as to why the CSA’s legislative history supports an interpretation not dissimilar from the legislative history analysis below.[187]

The CSA’s legislative history indeed provides revealing clues. During the CSA’s debate in the Senate, Senator Harold Hughes used the words “accepted,” “recognized,” and “valid” interchangeably:

Classification in the bill depends primarily upon whether there is an accepted medical use for the drug. Because heroin and marihuana have no recognized medical use, they are classified in the same category. . . . If there is no valid use for a drug, there is a sound reason to impose the strictest manufacturing and record-keeping controls. But criminal sanctions for illegal distribution and use should be based upon the danger to society and the individual, not upon whether there is any valid medical use.[188]

Testimony from the bill’s original drafters, Michael Sonnenreich and John Ingersoll,[189] shed further light on the meaning of “accepted medical use” as used in the CSA.[190] During the CSA’s pre-enactment congressional subcommittee hearings, Sonnenreich explained that:

[S]chedule I drugs . . . are really different from . . . [Schedule] II, III, and IV drugs. It is this basic determination that is not made by any part of the Federal Government. It is made by the medical community as to whether or not the drug has medical use or doesn’t.[191]

Sonnenreich further elaborated that “currently accepted medical use”:

is a factual determination and normally where [BNDD] get[s] such information is through the [American Medical Association] or [the World Health Organization]. You don’t have to be a doctor to find out whether or not it has an accepted medical use in the United States or not. So the fact that you are asking whether it has got accepted medical use is something that a lawyer can find out as well as a doctor. I mean it is not something that you are going out to create research on.[192]

In a book he co-authored following the CSA’s enactment, Sonnenreich validated Congress’s likely understanding of the word “accepted” when he explained that Schedule I is reserved for drugs with “no legitimate medical use.”[193] During the same congressional hearings noted above, John Ingersoll endorsed Sonnenreich’s understanding of “accepted medical use.”[194] Ingersoll elucidated that Schedule I is reserved for those substances “which the medical profession has already determined have no legitimate medical use in the United States.”[195] In sum, the CSA’s legislative history reveals that Congress intended to limit Schedule I to illicit drugs for which medical community has found no legitimate or valid use.

B. DEA’s Interpretation of Its Own Rule

Even if the 1992 Test continues to pass legal muster under Iancu, it may be deficient because the DEA’s own interpretation of the 1992 Test’s third factor—whether a drug has “adequate and well controlled studies proving efficacy”[196]—is ambiguous.[197] In determining whether a drug has adequate and well controlled studies proving efficacy, the DEA has in turn required a showing of “adequate, well-controlled, well-designed, well-conducted, and well-documented studies.”[198] This requirement places an onerous burden on a petitioner because it adds three additional hurdles: an “adequate and well controlled study” must essentially also be (1) well-designed, (2) well-conducted, and (3) well-documented.[199] Not only did the DEA render one of its own factors more stringent, it also has not articulated what constitutes a well-designed, well-conducted, and well-documented study, leaving its own interpretation ambiguous.[200]

Justice Kagan’s markers in Kisor v. Wilkie are instructive in evaluating whether deference to the DEA with respect to the third factor is warranted.[201] The most significant marker of Justice Kagan’s test in this case is the second one—that “the agency’s interpretation must in some way implicate its substantive expertise.”[202] The DEA’s interpretation of the third factor of the 1992 Test does not “implicate its substantive expertise” in any cognizable way. The DEA is a law enforcement agency,[203] whereas interpretation of what constitutes “adequate and well-controlled studies” is a matter that implicates public health.[204] Indeed, federal regulations concerning “adequate and well-controlled studies” were promulgated by the Food & Drug Administration, an HHS agency.[205] HHS, in turn, requires only a “consensus of medical opinion” among “experts” for a drug to meet the “accepted by qualified experts” factor of the 1992 Test.[206] It is therefore unlikely that the DEA’s interpretation is legal under Kisors second marker.

Arguably, though, Justice Kagan’s “markers” may not be dispositive. After all, “markers” are more like guideposts, indicators, or factors of a test rather than elements of a test.[207] Indeed, Justice Kagan was clear that the “markers” were created in lieu of an “exhaustive test.”[208] However, following Kisor,[209] federal district courts began rejecting deference to agency interpretations of ambiguous regulations “based on the character and context of the interpretation.”[210] For example, In Belt v. P.F. Chang’s China Bistro, the Eastern District of Pennsylvania did not defer to the Department of Labor’s interpretation of an ambiguous regulation because the interpretation did not meet Justice Kagan’s third marker—it did not reflect the agency’s “fair and considered judgment.”[211] Thus, it is unclear whether the DEA’s interpretation of the third factor of the 1992 Test is entirely illegal, even though it is likely insufficient to meet Justice Kagan’s second “marker.” Regardless, the DEA’s interpretation is at the very least threatened because it unequivocally fails to meet the second marker.

C. Applicability (or Lack Thereof) of Chevron to Dual-Application Statutes

The fact that the CSA is a dual-application statute supports a lenient interpretation of “currently accepted medical use.”[212] Although the Supreme Court has not plainly stated that Chevron deference is unwarranted to laws that contemplate both civil and criminal enforcement,[213] it has held that “if a law has both criminal and civil applications, the rule of lenity governs its interpretation in both settings.”[214] As outlined above, the rule of lenity favors a more lenient interpretation of a statute’s provision among two rational readings of the provision. The 1992 Test, which created five distinct and unrelated barriers in the form of a five-factor conjunctive test, cannot be reasonably construed as a lenient interpretation. There is undoubtedly a countless number of possible reasonable interpretations that are more lenient than the 1992 Test. This author’s modest interpretation, proposed below, is but one of many interpretations that could arguably be reasonably characterized as more lenient than the 1992 Test.

III. “Currently Accepted Medical Use”: A Pragmatic Way Forward

Given the considerations and dimensions of the analysis above, a synthesis of the CSA’s structure, purpose, and legislative history illuminates a reasonable interpretation of “currently accepted medical use” for purposes of the Attorney General’s scheduling authority under the CSA, legal under Chevron and its progeny: A drug or substance has “no currently accepted medical use” only if HHS has made a determination within the past year that the drug or substance has no legitimate or valid use in the United States. This interpretation comports with the CSA’s plain language, structure, purpose, and intent. The DEA is warranted no deference because the traditional tools of statutory construction cure the ambiguity surrounding “currently accepted medical use.”

Further, the proposed interpretation satisfies the rule of lenity, which, as noted above, governs the interpretation of the civil provisions in a dual-application statute.[215] The rule of lenity favors a more lenient interpretation of a statute’s provision among two rational readings of the provision.[216] Between the 1992 Test, which essentially synonymizes the four words of a provision—“currently accepted medical use”—into five distinct and unrelated factors,[217] and this author’s interpretation—a drug or substance has “no currently accepted medical use” only if HHS has made a determination within the past year that the drug or substance has no legitimate or valid use in the United States—the latter is certainly more lenient. It vindicates the principles that only Congress may define federal crimes and determine punishments, and that Congress “cannot, through ambiguity, effectively leave that function to the courts—much less to [an] administrative bureaucracy”[218] such as the DEA.

Practical considerations militate in favor of the proposed interpretation. Applied here, this test compels the DEA to remove MDMA and psilocybin from Schedule I because HHS has not determined that either drug has no legitimate or valid use in the United States. This does not mean that, under the proposed interpretation, the drugs would need to be removed entirely from CSA control because the DEA could properly find them to be suitable to a less restrictive schedule.[219] For example, alprazolam (commonly known as Xanax) is a Schedule IV drug,[220] and was prescribed over twenty-five million times in 2019 for the treatment of panic and anxiety disorders.[221] Thus, under a proper interpretation of “currently accepted medical use,” the DEA would retain a suitable level of control, in tandem with wider researcher and patient access to MDMA and psilocybin. Equally, it would incentivize more communication and coordination between HHS and the DEA (since the DEA would effectively require an HHS determination before classifying a drug in Schedule I). This in turn may favor the prioritization of public health considerations going forward as opposed to predilections of bureaucrats, which in turn would promote a more rational and coherent national drug policy that better comports with the CSA’s purpose.

The only plausible alternative to a federal solution—a patchwork of discontinuous state and local laws—would unnecessarily impede safe, equitable, and urgent patient access to MDMA and psilocybin. MDMA and psilocybin were historic “causalities” of the war on drugs,[222] and the “psychedelic renaissance” demonstrates that cities and states are quickly beginning to recognize their untapped potential by taking measures to ensure those who need these types of treatments can legally access them.[223] Such a clash between federal and state law in the drug regulation context is not new:[224] the disparate regulation of marijuana between the state and federal levels illustrates this phenomenon.[225] As of 2021, forty-seven states and the District of Columbia have legalized marijuana or cannabidiol, for either medical or recreational use, or both.[226] Yet, like MDMA and psilocybin, marijuana remains on Schedule I of the CSA, and congressional efforts to change that fact are still largely falling on deaf ears.[227] Moreover, the state deregulation of marijuana occurred discontinuously over twenty years.[228] This disjointed approach lays bare the pitfalls of a federalism-based, state-led solution to drug deregulation: it can take decades and requires patients to assume the risk of federal prosecution, notwithstanding their compliance with state law.[229]

These pitfalls need not be repeated here. As Professor Marks aptly tweeted, “What might have happened if the psychedelics research of the 1950s and 60s had been allowed to continue? How many lives could have been saved?”[230] These questions underscore both the urgency and ultimate conclusion: only a federal rescheduling of MDMA and psilocybin would ensure immediate, uniform, and equitable access in all U.S. states and territories to millions of Americans living with the debilitating disorders of severe depression and PTSD, whose suffering has only been exacerbated by the COVID-19 pandemic.[231] Rescheduling would also stimulate further medical research and innovation.[232] But for that to happen, federal courts must recognize the “regulatory black hole” they enabled in their broad deference to the DEA’s interpretation of “currently accepted medical use,”[233] deference that is no longer warranted under current Supreme Court jurisprudence.

IV. Conclusion

This Note has presented the primary legal challenge that is restricting nationwide access to MDMA and psilocybin qualifying patients. It has also illustrated the limitations of a state-based approach by reviewing the drawbacks of the limited and staggered deregulation of another Schedule I substance (marijuana). The statutory interpretation analysis has demonstrated that Congressional amendments to the CSA may not be necessary because proper interpretation of “currently accepted medical use” for purposes of Schedule I classification forecloses the DEA from continuing to classify MDMA and psilocybin in Schedule I of the CSA.

There are several additional legal, social, and practical obstacles that may hinder patient access to MDMA and psilocybin, notwithstanding their Schedule I status. First, the United States is a party to the United Nations Convention of Psychotropic Substances,[234] a treaty that imposes certain control obligations on its parties relating to particular psychoactive drugs that may hinder a federal rescheduling of MDMA and psilocybin.[235] Second, the negative social stigma associated with MDMA and psilocybin among patients and medical professionals still exists, although it has waned significantly in recent years.[236] Although these are considerable challenges, they are arguably subordinate to the federal regulatory framework governing the interpretation of “currently accepted medical use” under the CSA. Resolving these obstacles would not result in any meaningful impact to struggling patients until “currently accepted medical use” is properly interpreted by the federal courts.

Nabil Al-Khaled*

  1. . Today (NBC television broadcast Nov. 5, 2021), https://www.today.com/video/new-research-shows-how-psychedelic-drug-can-help-people-with-ptsd-125464645835.

  2. . Matt Saintsing, PTSD Breakthrough, DAV (May 5, 2020), https://www.dav.org/learn-more/news/2020/ptsd-breakthrough/ [https://perma.cc/3GBM-RC7W].

  3. . See Today, supra note 1 (“Every single day, no matter how good or bad the day was, my brain was trying to figure out how to kill myself.”)

  4. . Erich Wenzel, Jonathan Lubecky on PTSD, MDMA Therapy, and Healing, Feeding Curiosity (Aug. 19, 2020), https://feedingcuriosity.net/podcast/jonathan-lubecky.

  5. . Saintsing, supra note 2.

  6. . Today, supra note 1.

  7. Id.

  8. . Id.

  9. . Will Stone, MDMA, or Ecstasy, Shows Promise as a PTSD Treatment, NPR (Aug. 14, 2019, 11:40 AM), https://www.npr.org/sections/health-shots/2019/08/14/746614170/mdma-aka-ecstasy-shows-promise-as-a-ptsd-treatment [https://perma.cc/3T2M-5W52]. Saj Razvi, a psychotherapist in one of the clinical trials, “observed hundreds of hours of these sessions” and reported “they can sometimes look tough, almost like a ‘bad trip,’ but the process leads to emotional breakthroughs that otherwise ‘may take months or years to accomplish.’” Id.

  10. . See Mason Marks, Psychedelic Medicine for Mental Illness and Substance Use Disorders: Overcoming Social and Legal Obstacles, 21 N.Y.U. J. Legis. & Pub. Pol’y 69, 71 (2018); Mental Illness, Nat’l Inst. Mental Health, https://www.nimh.nih.gov/health/statistics/mental-illness.shtml [https://perma.cc/V2GV-X8UX].

  11. . Sebastian Trautmann, Jürgen Rehm & Hans-Ulrich Wittchen, The Economic Costs of Mental Disorders, 17 EMBO Reps. 1245, 1245 (2016), https://www.embopress.org/doi/epdf/10.15252/embr.201642951.

  12. . Id. at 1246.

  13. . PTSD: National Center for PTSD, U.S. Dep’t of Veterans Affs. (Sept. 10, 2021), https://www.ptsd.va.gov/understand/common/common_adults.asp [https://perma.cc/3R9U-5NW7].

  14. . Stone, supra note 9.

  15. . Alison Little, Treatment-Resistant Depression, 80 Am. Fam. Physicians 167, 167 (2009) (reporting that up to two-thirds of patients do not benefit from a single SSRI); Natalia Olchanski et al., The Economic Burden of Treatment-Resistant Depression, 35 Clinical Therapeutics 512, 513 (2013) (reporting that approximately one in three patients with depression did not improve even after treatment with four “different vigorous and sequential” antidepressants). Richard C. Shelton, Olawale Osuntokun, Alexandra N. Heinloth & Sara A. Corya, Therapeutic Options for Treatment-Resistant Depression, 24 CNS Drugs 131, 133 (2010) (reporting “that remission is achieved in only about one-third of depressed patients in response to treatment with one antidepressant,” and that, among patients who do not respond to two antidepressants, the success rate of utilizing multiple antidepressant treatments “drops precipitously”).

  16. . Mary O’Hara & Pamela Duncan, Why ‘Big Pharma’ Stopped Searching for the Next Prozac, Guardian (May 10, 2016, 4:12 PM), https://www.theguardian.com/society/2016/jan/27/prozac-next-psychiatric-wonder-drug-research-medicine-mental-illness [https://perma.cc/5K7N-DSWU]. See also Richard A. Friedman, A Dry Pipeline for Psychiatric Drugs, N.Y. Times (Aug. 19, 2013), https://www.nytimes.com/2013/08/20/health/a-dry-pipeline-for-psychiatric-drugs.html [https://perma.cc/8RVS-74LF] (“Yet even though 25 percent of Americans suffer from a diagnosable mental illness in any year, there are few signs of innovation from the major drug makers.”). The decline in innovation is attributable to “a series of failed clinical trials” in which new treatments were largely ineffective, leading pharmaceutical companies to stop innovating in this field and to conclude that “developing new psychiatric drugs is too risky and too expensive.” Id.

  17. . Mason M. Marks, Controlled Substance Regulation for the COVID-19 Mental Health Crisis, 72 Admin. L. Rev. 649, 652 (2020).

  18. . See id. at 654; see also infra notes 20–25 and accompanying text.

  19. . Janet Burns, FDA Designates MDMA as ‘Breakthrough Therapy’ for Post-Traumatic Stress, Forbes (Aug. 28, 2017, 3:58 PM), https://www.forbes.com/sites/janetwburns/2017/08/28/fda-designates-mdma-as-breakthrough-therapy-for-post-traumatic-stress/#5724cd917460 [https://perma.cc/LP8N-EF5B]. Section 902 of the Food and Drug Administration Safety and Innovation Act defines “breakthrough therapy” as a drug that is “intended . . . to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies. . . .” 21 U.S.C. § 356.

  20. . Burns, supra note 19. See also Allison A. Feduccia et al., Breakthrough for Trauma Treatment: Safety and Efficacy of MDMA-Assisted Psychotherapy Compared to Paroxetine and Sertraline, Frontiers in Psychiatry (Sept. 12, 2019), https://www.frontiersin.org/articles/10.3389/fpsyt.2019.00650/full (presenting clinical trial evidence showing that “MDMA-assisted psychotherapy was superior . . . in terms of safety and efficacy compared to the two approved SSRIs for treatment of PTSD”); Michael C. Mithoefer et al., 3,4-methylenedioxymethamphetamine (MDMA)-Assisted Psychotherapy for Post-Traumatic Stress Disorder in Military Veterans, Firefighters, and Police Officers: A Randomized, Double-Blind, Dose-Response, Phase 2 Clinical Trial, 5 Lancet Psychiatry 486, 486 (2018) (finding MDMA-assisted psychotherapy in controlled settings “effective and well-tolerated in reducing PTSD symptoms in veterans and first responders”).

  21. . Jennifer M. Mitchell et al., MDMA-Assisted Therapy for Severe PTSD: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study, 27 Nature Med. 1025, 1026 (2021).

  22. . Today, supra note 1.

  23. . Yasemin Saplakoglu, FDA Calls Psychedelic Psilocybin a ‘Breakthrough Therapy’ for Severe Depression, Live Sci. (Nov. 25, 2019), https://www.livescience.com/psilocybin-depression-breakthrough-therapy.html [https://perma.cc/JW3N-5TAS]. Studies have shown that psilocybin is safe, and efficacious for treatment-resistant depression. Robin L. Carhart-Harris et al., Psilocybin with Psychological Support for Treatment-Resistant Depression: An Open-Label Feasibility Study, 3 Lancet Psychiatry 619, 619, 627 (2016). For example, one randomized, double-blind study demonstrated that a single dose of psilocybin “produced substantial and enduring decreases in depressed mood and anxiety along with increases in quality of life and decreases in death anxiety in patients with a life-threatening cancer diagnosis.” Roland R. Griffiths et al., Psilocybin Produces Substantial and Sustained Decreases in Depression and Anxiety in Patients with Life-Threatening Cancer: A Randomized Double-Blind Trial, 30 J. Psychopharmacology 1181, 1195 (2016).

  24. . Adam Piore, Magic Mushrooms May Be the Biggest Advance in Treating Depression Since Prozac, Newsweek (Sept. 22, 2021, 5:00 AM), https://www.newsweek.com/2021/10/01/magic-mushrooms-may-biggest-advance-treating-depression-since-prozac-1631225.html [https://perma.cc/A3U2-6XW5] (citing Alan K. Davis et al., Effects of Psilocybin-Assisted Therapy on Major Depressive Disorder A Randomized Clinical Trial, 78 JAMA Psychiatry 481 (2021)).

  25. . Saplakoglu, supra note 23; see also Carhart-Harris et al., supra note 23; Griffiths et al., supra note 23. Researchers at Imperial College London reported that, in a study of twelve patients who had been clinically depressed for an average of 17.8 years, all twelve markedly improved after one week of psilocybin treatment, and five were completely cured after three months. Zoe Cormier, Magic Mushroom Drug Lifts Depression in Human Trial: Psilocybin Shows Higher Remission Rate than SSRI Drugs in a U.K. Study, Sci. Am. (May 17, 2016), https://www.scientificamerican.com/article/magic-mushroom-drug-lifts-depression-in-human-trial1/# [https://perma.cc/2Y4G-T243]. Before the study, none of the twelve had responded to SSRIs or even electroconvulsive therapy (ECT). Id.

  26. . Zoe Cormier, Psilocybin Treatment for Mental Health Gets Legal Framework, Sci. Am. (Dec. 1, 2020), https://www.scientificamerican.com/article/psilocybin-treatment-for-mental-health-gets-legal-framework/ [https://perma.cc/Z24X-NV3F]. University of California in San Francisco neuroscientist Robin Carhart-Harris explained it this way:

    [Psilocybin can] shut down a specific constellation of brain structures known as the “default mode network.” This network is most active when our mind wanders—when we are daydreaming. It gives us that voice we hear in our heads, which is often hyperactive in depressed and anxious patients who are tormented by negative thought loops.

    Piore, supra note 24.

  27. . Alan K. Davis et al., supra note 24; Mason Marks, Opinion, A Strategy for Rescheduling Psilocybin, Sci. Am. (Oct. 11, 2021), https://www.scientificamerican.com/article/a-strategy-for-rescheduling-psilocybin/ [https://perma.cc/6&KP-XYUM].

  28. . Piore, supra note 24.

  29. . Kai Kupferschmidt, All Clear for the Decisive Trial of Ecstasy in PTSD Patients, Sci. (Aug. 26, 2017), https://www.science.org/news/2017/08/all-clear-decisive-trial-ecstasy-ptsd-patients [https://perma.cc/3FSD-BWT2]. According to David Nutt, a neuropsychopharmacologist at Imperial College London, it has “been obvious for 40 years that [certain illegal mind-altering] drugs are medicines,” but he acknowledged the FDA’s designation as “‘a huge step in acceptance.” Id.

  30. . See Jasen B. Talise, Take the Gatekeepers to Court: How Marijuana Research Under a Biased Federal Monopoly Obstructs the Science-Based Path to Legalization, 47 Sw. L. Rev. 449, 467–68 (2018); Controlled Substances, U.S. Drug Enf’t Admin., https://www.deadiversion.usdoj.gov/schedules/orangebook/c_cs_alpha.pdf [https://perma.cc/M2SL-YRNR]; see also discussion infra Section I.A.

  31. . Marks, supra note 10, at 74. Pursuant to the CSA and its implementing regulations, Schedule I drugs are subject to “strict requirements regarding registration, labeling and packaging, production quotas, drug security, and recordkeeping.” Gonzales v. Raich, 545 U.S. 1, 14 (2005) (citations omitted). The requirements can be time-consuming and onerous. Marks, supra note 10, at 89. According to DEA estimates, researchers usually have to wait nine months in order to receive a license to research Schedule I drugs. Shaunacy Ferro, Why Doctors Can’t Give You LSD (But Maybe They Should), Popular Sci. (Apr. 16, 2013, 10:00 PM), https://www.popsci.com/science/article/2013-04/new-science-lsd-therapy/ [https://perma.cc/S88Q-27RF]. In addition to the DEA’s own requirements, researchers have to navigate a maze of other federal agencies’ separate requirements, including the Food and Drug Administration (FDA) and the National Institute on Drug Abuse (NIDA). See Talise, supra note 30, at 457 (“Various administrative entities, each requiring their own individual stacks of paperwork, must give their approval.”)

  32. . 21 U.S.C. § 812(b)(1)(B).

  33. . See Marks, supra note 10, at 115.

  34. . § 812(b)(1)(B). See also § 811(a) (authorizing the Attorney General to “transfer between” schedules drugs according to each schedule’s definition as described in § 812(b)).

  35. . Marks, supra note 10, at 116.

  36. . Marks, supra note 17, at 654.

  37. . Tom Jackman, Denver Voters Approve Decriminalization of ‘Magic Mushrooms’, Wash. Post (May 8, 2019), https://www.washingtonpost.com/crime-law/2019/05/08/denver-voters-apparently-reject-decriminalization-magic-mushrooms/ [https://perma.cc/CT2C-FWGN].

  38. . Elizabeth Weise & Marco della Cavva, Oakland in California Decriminalizes Magic Mushrooms and Peyote, USA Today (June 5, 2019, 2:27 PM), https://www.usatoday.com/story/news/2019/06/05/oakland-california-legalizes-magic-mushrooms-and-peyote/1347888001/ [https://perma.cc/KS9C-H7Q6]; Harmeet Kaur, Santa Cruz Decriminalizes Magic Mushrooms and Other Natural Psychedelics, Making It the Third US City to Take Such a Step, CNN (Feb. 3, 2020, 7:50 PM), https://www.cnn.com/2020/01/30/us/santa-cruz-mushrooms-psychedelics-trnd/index.html [https://perma.cc/8NL4-EPKM].

  39. . Justin Wm. Moyer, D.C. Voters Approve Ballot Question to Decriminalize Psychedelic Mushrooms, Wash. Post (Nov. 3, 2020, 8:24 PM), https://www.washingtonpost.com%2Flocal%2Fdc-politics%2Fdc-magic-mushrooms-result%2F2020%2F11%2F03%2Fbb929e86-1abc-11eb-bb35-2dcfdab0a345_story.html&usg=AOvVaw3K97umEpj-83sHoUXXaFWB [https://perma.cc/ZG8B-ZWQX].

  40. . Joe Walsh, New Jersey Becomes Latest State to Loosen Penalties for Magic Mushrooms, Forbes (Feb. 4, 2021, 6:53 PM), https://www.forbes.com/sites/joewalsh/2021/02/04/new-jersey-becomes-latest-state-to-loosen-penalties-for-magic-mushrooms/?sh=5ef2b9059707 [https://perma.cc/7FH9-K9YX].

  41. . Will Feuer, Oregon Becomes First State to Legalize Magic Mushrooms as More States Ease Drug Laws in ‘Psychedelic Renaissance’, CNBC (Nov. 6, 2020, 6:31 AM), https://www.cnbc.com/2020/11/04/oregon-becomes-first-state-to-legalize-magic-mushrooms-as-more-states-ease-drug-laws.html [https://perma.cc/34BZ-QVDB].

  42. . Kaur, supra note 38.

  43. . Alicia Victoria Lozano, New California Bill Would Decriminalize Psychedelics, Expunge Criminal Records, NBC News (Feb. 18, 2021, 1:22 PM), https://www.nbcnews.com/news/us-news/new-california-bill-would-decriminalize-psychedelics-expunge-criminal-records-n1258261 [https://perma.cc/X8ET-ZY5H].

  44. . A Study on the Use of Alternative Therapies for Treating Post-Traumatic Stress Disorder, 2021 Tex. Sess. Law Serv. Ch. 983 (West).

  45. . Joyce E. Cutler, Texas the Latest State to Legalize Psychedelic Medical Research, Bloomberg L. (June 23, 2021, 4:40 AM), https://news.bloomberglaw.com/pharma-and-life-sciences/texas-the-latest-state-to-legalize-psychedelic-medical-research [https://perma.cc/H2KU-QV9Y].

  46. . Marisa Fernandez, States Want to Study Possible Mental Health Benefits of Psychedelics, Axios (July 2, 2021), https://www.axios.com/states-fund-psychedelic-research-mental-health-ec6a4b6b-62fd-4ff0-aecf-38d07cf00d65.html [https://perma.cc/PN8L-KZFY].

  47. . Marks, supra note 17, at 655.

  48. . See Announcing the Project on Psychedelics Law and Regulation (POPLAR) at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, Petrie-Flom Ctr. for Health Law Pol’y, Biotechnology, & Bioethics at Harv. L. Sch. (June 30, 2021), https://petrieflom.law.harvard.edu/resources/article/petrie-flom-center-launches-POPLAR [https://perma.cc/JKH9-TUKE]; Ritika Dubey, POPLAR: Harvard’s Psychedelic Law, Policy Initiative, Truffle Rep. (Aug. 10, 2021), https://www.truffle.report/poplar-harvards-psychedelic-law-policy-initiative/ [https://perma.cc/A6FR-D55V].

  49. . Dubey, supra note 48.

  50. . See, e.g., Ann Harrison, Researchers Examine Psilocybin Patent Claims, Lucid News (Apr. 23, 2020), https://www.lucid.news/researchers-examine-psilocybin-patent-claims/ [https://perma.cc/79UC-4QJ4].

  51. . Sam Dean, This Hedgefunder Took Ayahuasca. It Changed His Life—and His Perspective on Investment, L.A. Times (Sept. 30, 2021, 5:00 AM), https://www.latimes.com/business/story/2021-09-30/hedge-fund-investor-boosts-psychedelic-therapy-startups. Elon Musk predicts that “[a]s the new generation gets into political power, . . . we will see greater receptivity to the benefits of psychedelics.” Id.

  52. . Id.

  53. . A promising development on the legal front is a new research initiative, the Project on Psychedelics Law and Regulation, announced in June 2021 by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School to “promote safety, innovation, and equity in psychedelics research, commerce, and therapeutics.” Announcing the Project on Psychedelics Law and Regulation (POPLAR) at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, supra note 48.

  54. . See Gonzales v. Raich, 545 U.S. 1, 9 (2005) (holding that the CSA preempted a state law permitting marijuana cultivation for medicinal purposes); see also Sam Kamin, The Limits of Marijuana Legalization in the States, 99 Iowa L. Rev. Bull. 39 (2014) (detailing the practical consequences of the discontinuity between marijuana regimes across states). In addition to criminal liability, the conflict between federal and state drug regulation creates challenges in employment, banking, and contract law. Id. at 44–47.

  55. . See discussion infra Section I.B.

  56. . See supra note 23 and accompanying text.

  57. . Marks, supra note 17, at 659. Professor Mason Marks cites a Johns Hopkins University study which demonstrated that just one dose of psilocybin “significantly reduced depression and anxiety in people with life-threatening cancer diagnoses” with no significant side effects, and “the benefits persisted for up to six months.” Id. (citing Roland R. Griffiths et al., supra note 23, at 1195).

  58. . See, e.g., Anthony K. Busch & Warren C. Johnson, L.S.D. 25 as an Aid in Psychotherapy: Preliminary Report of a New Drug, 11 Diseases Nervous Sys. 241, 241–43 (1950); J. Carranza-Acevedo, Hallucinogens vs. Psychotherapy, 113 British J. Psychiatry 1156, 1156–57 (1967); Jonathan O. Cole & Martin M. Katz, The Psychotominetic Drugs, 187 JAMA 758, 760 (1964). In fact, a 2016 analysis of nineteen studies of psychedelics as therapeutics published between 1949 and 1974 reported that 79% of patients in those studies exhibited clinical improvement. James JH Rucker, Luke A. Jelen, Sarah Flynn, Kyle D. Frowde & Allan H. Young, Psychedelics in the Treatment of Unipolar Mood Disorders: A Systematic Review, 30 J. Psychopharmacology 1220, 1224–25 (2016).

  59. . Marks, supra note 17, at 666.

  60. . Id. at 667. See Dan Baum, Smoke and Mirrors: The War on Drugs and the Politics of Failure 10–11 (1996); Deborah Ahrens, Drug Panics in the Twenty-First Century: Ecstasy, Prescription Drugs, and the Reframing of the War on Drugs, 6 Alb. Gov’t L. Rev. 397, 402 (2013). See also Deborah Ahrens, Methademic: Drug Panic in an Age of Ambivalence, 37 Fla. St. U. L. Rev. 841, 851–52 (2010) [hereinafter Ahrens, Methademic] (positing that federal drug policy during “the 1960s and early 1970s was less about reducing the possible personal or social harms associated with drug use than it was about reinforcing the majority’s status,” and that drug policy during this period “was often a proxy for cultural contestation between competing social groups”). Another catalyst was the fact that, at the time, President Nixon was concerned with delivering on his law-and-order platform, but the federal government had almost no domestic policing authority. Baum, supra, at 13.

  61. . Marks, supra note 17, at 667.

  62. . Dan Baum, Legalize It All: How to Win the War on Drugs, Harper’s Mag. (Apr. 2016), https://harpers.org/archive/2016/04/legalize-it-all/ [https://perma.cc/SH92-LBY3].

  63. . Talise, supra note 30, at 452 (citations omitted).

  64. . Baum, supra note 62.

  65. . Marks, supra note 17, at 667.

  66. . Id. See also Ira Glasser & Loren Siegel, When Constitutional Rights Seem Too Extravagant to Endure: The Crack Scare’s Impact on Civil Rights and Liberties, in Crack in America: Demon Drugs and Social Justice 229, 242 (Craig Reinarman & Harry G. Levine eds., 1997) (citing the rise in drug arrests from less than 200,000 in 1968 to 1.2 million annually following the CSA’s enactment, and disproportionately skewed towards Black Americans).

  67. . Ahrens, Methademic, supra note 60, at 842–43 (citations omitted).

  68. . Marks, supra note 17, at 666.

  69. . Baum, supra note 62, at 67–75 (noting the increase in the federal drug-enforcement from $65 million in 1969 to $719 million in 1974).

  70. . Gonzales v. Raich, 545 U.S. 1, 12 (2005). See also Comprehensive Drug Abuse Prevention and Control Act of 1970, Pub. L. No. 91-513, 84 Stat. 1236 (codified at 12 U.S.C. §§ 801–971, 42 U.S.C. § 257a) (introducing the CSA as “[a]n Act . . . to provide increased research into, and prevention of, drug abuse and drug dependence; to provide for treatment and rehabilitation of drug abusers and drug dependent persons; and to strengthen existing law enforcement authority in the field of drug abuse”).

  71. . Robert L. Bogomolny, Michael R. Sonnenreich & Anthony J. Roccograndi, A Handbook on the 1970 Federal Drug Act 5 (1975).

  72. . Jasen B. Talise argues that the emphasis on drug control have had a “discriminate impact” on legitimate medical research. Talise, supra note 30, at 468–69. Indeed, Mr. Talise aptly quotes Heffter Research Institute founder Mark Geyer: “‘The goal wasn’t to stop scientists, the goal was to stop street use . . . but the side effect of that was that even legitimate research was curtailed.’” Id. (citing Ferro, supra note 31).

  73. . Raich, 545 U.S. at 13.

  74. . 21 U.S.C. § 812.

  75. . Raich, 545 U.S. at 13.

  76. . All. for Cannabis Therapeutics v. DEA, 930 F.2d 936, 937 (D.C. Cir. 1991).

  77. . Id.

  78. . Talise, supra note 30, at 452 n.31.

  79. . § 812(b).

  80. . § 812(b)(1) (emphasis added).

  81. . 21 U.S.C. § 812(b)(2)–(b)(5).

  82. . See § 812(b).

  83. . See § 811.

  84. . § 811(a).

  85. . See Marks, supra note 10, at 116.

  86. . § 811(b).

  87. . § 811(c).

  88. . Bogomolny, Sonnenreich & Roccograndi, supra note 71, at 28.

  89. . See id. at 75–76 (“The true test of this system will be in loosening restraints when justified. A scheme that is directed only towards tighter and tighter controls will, in time, lose its most important attributes, flexibility and the capacity to adjust to changing social circumstances.”).

  90. . Nat’l Org. for Reform of Marijuana Laws (NORML) v. Ingersoll, 497 F.2d 654, 656 (D.C. Cir. 1974).

  91. . Marks, supra note 10, at 116. For example, the DEA in 1984 moved the drug Sufentanil, a powerful opioid, from Schedule I to Schedule II, and in 1986, the DEA also moved the THC drug Marinol from Schedule I to Schedule II. Id.

  92. . Id.

  93. . Id. at 88.

  94. . See id.

  95. . See 21 U.S.C. § 812(b)(1) (emphasis added).

  96. . See § 812(b)(2)–(b)(5).

  97. . See All. for Cannabis Therapeutics v. DEA, 930 F.2d 936, 937 (D.C. Cir. 1991) (“Drugs can be ‘re-scheduled’ or ‘de-scheduled’ only if the DEA makes certain statutorily mandated findings.”).

  98. . Talise, supra note 30, at 453–54; § 812(b)(1). In fact, “the only portion of the Schedule I criteria that Congress has expressly defined in the CSA” is the term “United States.” Alex Kreit, Controlled Substances, Uncontrolled Law, 6 Alb. Gov’t L. Rev. 331, 342 (2013) (citing Grinspoon v. DEA, 828 F.2d 881, 885 (1st Cir. 1987)).

  99. . Marijuana Scheduling Petition; Denial of Petition; Remand, 57 Fed. Reg. 10,499, 10,506 (Mar. 26, 1992).

  100. . See, e.g., Grinspoon, 828 F.2d at 885; All. for Cannabis Therapeutics, 930 F.2d at 939; Ams. for Safe Access v. DEA, 706 F.3d 438, 449–50 (D.C. Cir. 2013).

  101. . Chevron U.S.A., Inc. v. Nat’l Res. Def. Council, Inc., 467 U.S. 837 (1984).

  102. . See Nicholas R. Bednar, What to Do About Chevron: Nothing, 72 Vand. L. Rev. 151, 151 (2019).

  103. . Chevron, 467 U.S. at 842–43.

  104. . Id. at 842.

  105. . Id. at 842–43.

  106. . Id. at 843.

  107. . Id.

  108. . See, e.g., Grinspoon v. DEA, 828 F.2d 881, 891 (1st Cir. 1987); All. for Cannabis Therapeutics v. DEA, 930 F.2d 936, 937 (D.C. Cir. 1991); All. for Cannabis Therapeutics v. DEA, 15 F.3d 1131, 1135 (D.C. Cir. 1994); Ams. for Safe Access v. DEA, 706 F.3d 438, 440–41 (D.C. Cir. 2013).

  109. . 828 F.2d 881 (1st Cir. 1987).

  110. . 930 F.2d. 936 (D.C. Cir. 1991).

  111. . 706 F.3d 438, 440–41 (D.C. Cir. 2013).

  112. . Grinspoon, 828 F.2d at 881.

  113. . Id.

  114. . Id. at 888–91.

  115. . Id. at 886–87.

  116. . Id. at 885.

  117. . Schedules of Controlled Substances; Scheduling of 3,4-Methylenedioxymethamphetamine (MDMA) Into Schedule I of the Controlled Substances Act; Remand, 53 Fed. Reg. 5156, 5157–58 (Feb. 22, 1988).

  118. . See All. for Cannabis Therapeutics v. DEA, 930 F.2d 936, 938 (D.C. Cir. 1991) (noting in 1991 that the DEA had reaffirmed the eight-factor test in a proceeding below that had denied a marijuana rescheduling petition).

  119. . Id. at 936.

  120. . Id. at 937.

  121. . Id. at 939.

  122. . Id.

  123. . Marijuana Scheduling Petition; Denial of Petition; Remand, 57 Fed. Reg. 10,499, 10,504–06 (Mar. 26, 1992).

  124. . Id. at 10,506.

  125. . See e.g., Denial of Petition to Initiate Proceedings To Reschedule Marijuana, 76 Fed. Reg. 40,552 (July 8, 2011); Denial of Petition to Initiate Proceedings To Reschedule Marijuana, 81 Fed. Reg. 53,767 (Aug. 12, 2016).

  126. . See All. for Cannabis Therapeutics v. DEA, 930 F.2d 936, 937 (D.C. Cir. 1991); All. for Cannabis Therapeutics v. DEA, 15 F.3d 1131, 1135 (D.C. Cir. 1994).

  127. . See Ams. for Safe Access v. DEA, 706 F.3d 438, 450 (D.C. Cir. 2013).

  128. . Marijuana Scheduling Petition; Denial of Petition; Remand, 57 Fed. Reg. 10,499, 10,505 (Mar. 26, 1992).

  129. . Ams. for Safe Access, 706 F.3d at 450.

  130. . Id. (quoting Denial of Petition to Initiate Proceedings to Reschedule Marijuana, 76 Fed. Reg. at 40,579).

  131. . Id. at 451–52.

  132. . See, e.g., King v. Burwell, 576 U.S. 473, 486 (2015) (finding Chevron inapplicable to Internal Revenue Service (IRS) rule because the subject matter was of “deep economic and political significance” and because it was inconceivable that Congress intended the IRS to craft health insurance regulations); Michigan v. EPA, 576 U.S. 743, 759 (2015) (finding environmental regulation an unreasonable construction of a statute); Perez v. Mortgage Bankers Ass’n, 575 U.S. 92, 1212 (2015) (Scalia, J., concurring in the judgement) (signaling support for Chevron to be “uprooted”).

  133. . Nathan Richardson, Deference Is Dead (Long Live Chevron), 73 Rutgers L. Rev. 441, 441 (2021).

  134. . Pereira v. Sessions, 138 S. Ct. 2105, 2120 (2018) (Kennedy, J., concurring). Indeed, Justice Kennedy went further:

    [I]t seems necessary and appropriate to reconsider . . . the premises that underlie Chevron and how courts have implemented that decision. The proper rules for interpreting statutes and determining agency jurisdiction and substantive agency powers should accord with constitutional separation-of-powers principles and the function and province of the Judiciary.

    Id. at 2121 (Kennedy, J., concurring).

  135. . Kisor v. Wilkie, 139 S. Ct. 2400, 2415 (2019).

  136. . Id.

  137. . Id. at 2406.

  138. . Lacey Ferrara, Comment, A New Auer: Overview and Analysis of the Supreme Court’s Decision in Kisor v. Wilkie, 70 Case W. Res. L. Rev. 217, 230–31 (2019) (emphasis added).

  139. . SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348, 1358 (2018).

  140. . Whitman v. United States, 574 U.S. 1003, 1005 (2014) (Scalia, J., concurring in denial of certiorari). Although Justice Scalia’s concurrence in this context does not carry mandatory precedential effect, the principle has been recognized in earlier cases and reflects the Court’s current attitude on the issue. See infra note 141 and accompanying text.

  141. . Whitman, 574 U.S. at 1005. In Whitman, Justice Scalia highlighted several cases in which the Court upheld this proposition. Id. (citing Leocal v. Ashcroft, 543 U.S. 1, 11–12 n.8 (2004); United States v. Thompson/Center Arms Co., 504 U.S. 505, 518 n.10 (1992) (plurality opinion); id. at 519, (Scalia, J., concurring in the judgment). The premise underlying applying the rule of lenity is that “only the legislature may define crimes and fix punishments.” Whitman, 574 U.S. at 1005.

  142. . McNally v. United States, 483 U.S. 350, 359 (1987).

  143. . Id. at 359–60.

  144. . See discussion supra Section I.B.

  145. . SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348, 1359 (2018).

  146. . Id.

  147. . Bostock v. Clayton Cty., 140 S. Ct. 1731, 1825 (2020) (Alito, J., dissenting).

  148. . Davis v. Michigan Dep’t of Treas., 489 U.S. 803, 809 (1989).

  149. . See, e.g., Gen. Elec. Co. v. Gilbert, 429 U.S. 125, 143 (1976) (noting the significance of the, albeit brief, legislative history of Title VII of the Civil Rights Act in the context of sex discrimination). But see Bostock, 140 S. Ct. at 1750 (noting that “legislative history can never defeat unambiguous statutory text”).

  150. . Antonin Scalia & Bryan A. Garner, Reading Law: The Interpretation of Legal Texts 69 (2012) (“The ordinary-meaning rule is the most fundamental semantic rule of interpretation.”).

  151. . Bostock, 140 S. Ct. at 173.

  152. . Webster’s Third New International Dictionary (Philip Babcock Gove et al. eds., 1969).

  153. . Id. at 557.

  154. . Id.

  155. . Id. at 11.

  156. . Id.

  157. . Id. at 1402.

  158. . Id. at 2523.

  159. . See Roberts v. Sea-Land Servs., Inc., 566 U.S. 93, 101 (2012) (“Statutory language . . . cannot be construed in a vacuum. It is a fundamental canon of statutory construction that the words of a statute must be read in their context and with a view to their place in the overall statutory scheme.”) (internal quotation marks omitted).

  160. . 21 U.S.C. § 811(a).

  161. . Id.

  162. . Id.

  163. . § 811(b).

  164. . Id. HHS is required to consider eight factors—set forth in subsection 811(c)—with respect to the drug or substance:

    (1) Its actual or relative potential for abuse.

    (2) Scientific evidence of its pharmacological effect, if known.

    (3) The state of current scientific knowledge regarding the drug or other substance.

    (4) Its history and current pattern of abuse.

    (5) The scope, duration, and significance of abuse.

    (6) What, if any, risk there is to the public health.

    (7) Its psychic or physiological dependence liability.

    (8) Whether the substance is an immediate precursor of a substance already controlled under [subchapter I of 21 U.S.C.].

    § 811(c).

  165. . § 811(b).

  166. . See id. (“[I]f the [HHS] Secretary recommends that a drug or other substance not be controlled, the Attorney General shall not control the drug or other substance.”).

  167. . Introduction: About HHS, U.S. Dep’t of Health & Human Servs. (Feb. 28, 2018), https://www.hhs.gov/about/strategic-plan/introduction/index.html [https://perma.cc/AA76-YUSA].

  168. . About the Office, U.S. Dep’t of Just. (July 17, 2018), https://www.justice.gov/ag/about-office [https://perma.cc/Y3Q5-NFAC].

  169. . 546 U.S. 243 (2006).

  170. . 21 U.S.C. § 812(b)(1)(B).

  171. . Gonzales, 546 U.S. at 259.

  172. . Id.

  173. . Id.

  174. . Id. at 257.

  175. . Id. at 263.

  176. . See 21 U.S.C. § 812(b)(1)(B).

  177. . § 812(a) (“[T]he schedules . . . be updated and republished on a semiannual basis during the two-year period beginning one year after October 27, 1970, and . . . on an annual basis thereafter.”).

  178. . § 812(b)(1)(B).

  179. . See § 812(a).

  180. . § 811(a).

  181. . Webster’s Third New International Dictionary, supra note 152, at 557.

  182. . See Angelika Batta, Bhupinder Singh Kalra & Raj Khirasaria, Trends in FDA Drug Approvals Over Last 2 Decades: An Observational Study, 9 J. Fam. Med. & Primary Care 105, 105 (2020).

  183. . Bogomolny, Sonnenreich & Roccograndi, supra note 71, at 28.

  184. . Id. at 75–76.

  185. . See 21 U.S.C. § 812(b)(1)(B).

  186. . See Bostock v. Clayton Cty., 140 S. Ct. 1731, 1750 (2020). In Bostock, The Supreme Court similarly discerned Congress’s intent when it used the words “because of” and “sex” in the Civil Rights Act of 1964 over fifty years later. Id. at 1739.

  187. . Petitioners’ Brief at 53–55, Sisley v. DEA, No. 20-71433, 2021 WL 3853049 (9th Cir. Aug. 30, 2021). As of this writing, the litigant’s rescheduling petition was denied on failure of exhaustion grounds. Sisley, 2021 WL 3853049, at *6. On the merits, however, Judge Whatford acknowledged “the strength of petitioners’ arguments that the [DEA] has misinterpreted the controlling statute by concluding that marijuana ‘has no currently accepted medical use in treatment in the United States.’” Id. (Watford, J., concurring).

  188. . 116 Cong. Rec. 36,882 (1970) (emphasis added).

  189. . Gerald Posner, Pharma: Greed, Lies, and the Poisoning of America 256–57 (2020). Michael Sonnenreich drafted the initial version of the bill that was eventually enacted. Id. At the time, he was Deputy Chief Counsel of the Bureau of Narcotics and Dangerous Drugs (BNDD), DEA’s predecessor agency, and John Ingersoll was its Director. Grinspoon v. DEA, 828 F.2d 881, 891–92 (1st Cir. 1987).

  190. . See, e.g., Bostock, 140 S. Ct. at 1750 (noting that courts sometimes consult “the understandings of the law’s drafters” as evidence to resolve “shifts in linguistic usage or subtle distinctions between literal and ordinary meaning”); Udall v. Tallman, 380 U.S. 1, 16 (1965) (giving weight to a law’s drafters’ understanding of a statute when the interpretative question involved “a contemporaneous construction of a statute by the men charged with the responsibility of setting its machinery in motion, of making the parts work efficiently and smoothly while they are yet untried and new”) (internal quotation marks ommited).

  191. . Drug Abuse Control Amendments—1970: Hearings on H.R. 11701 and HR 13743 Before the Subcomm. on Pub. Health and Welfare of the H. Comm. on Interstate and Foreign Com., 91st Cong., 718 (1970) (emphasis added) [hereinafter Drug Abuse Control Amendments].

  192. . Id. at 165.

  193. . Bogomolny, Sonnenreich & Roccograndi, supra note 71, at 27 (emphasis added).

  194. . See Grinspoon, 828 F.2d at 892 (noting that Ingersoll’s testimony limited Schedule I substances to “those drugs that ‘the medical profession has already determined to have no legitimate medical use in the United States.’”).

  195. . Drug Abuse Control Amendments, supra note 191, at 678 (statement of John E. Ingersoll, Director, Bureau of Narcotics and Dangerous Drugs) (emphasis added).

  196. . Marijuana Scheduling Petition; Denial of Petition; Remand, 57 Fed. Reg. 10,499, 10,506 (Mar. 26, 1992).

  197. . Marks, supra note 10, at 118–19.

  198. . Denial of Petition to Initiate Proceedings to Reschedule Marijuana, 76 Fed. Reg. 40,552, 40,579 (July 8, 2011).

  199. . See id.

  200. . See Marks, supra note 10, at 119.

  201. . See discussion supra Section I.B.

  202. . Kisor v. Wilkie, 139 S. Ct. 2400, 2406 (2019).

  203. . The DEA is an agency of the U.S. Department of Justice. Drug Enf’t Admin., History: The Early Years 29, https://www.dea.gov/sites/default/files/2018-07/Early%20Years%20p%2012-29%20%281%29.pdf [https://perma.cc/DPZ5-AH44].

  204. . Indeed, federal regulations concerning “adequate and well-controlled studies” were promulgated by the Food & Drug Administration, a Department of Health and Human Services agency. See 21 C.F.R. § 314.126 (2020). The regulations set forth detailed “characteristics” of an “adequate and well controlled study.” See §§ 314.126(b)(1)–(b)(7). Cf. King v. Burwell, 576 U.S. 473, 486 (2015) (setting aside an Internal Revenue Service rule and substituting it with a judicial interpretation in part because it was inconceivable that Congress intended the IRS to craft health insurance regulations).

  205. . See § 314.126.

  206. . Notice of Denial of Petition, 66 Fed. Reg. 20,038, 20,051–20,052 (Apr. 18, 2001).

  207. . See Michael R. Smith, Elements v. Factors, 39 Wyo. Law. 46, 46–47 (2016). (“A factor test in the law sets out a list of areas of inquiry a court must consider in determining whether a particular legal conclusion can be reached. . . . No single factor is dispositive of the issue.”).

  208. . Kisor v. Wilkie, 139 S. Ct. 2400, 2416 (2019).

  209. . Id.

  210. . Ferrara, supra note 138, at 236.

  211. . 401 F. Supp. 3d 512, 531 (E.D. Pa. 2019).

  212. . See Petitioner’s Brief at 68–69, Sisley v. DEA, No. 20–71433 (9th Cir. Aug. 30, 2021).

  213. . See Whitman v. United States, 574 U.S. 1003, 1004 (2014) (Scalia, J., concurring in denial of certiorari).

  214. . Id. at 1005. See also Leocal v. Ashcroft, 543 U.S. 1, 11–12 n.8 (2004) (applying the rule of lenity to the noncriminal provision of a dual-application statute); United States v. Thompson/Center Arms Co., 504 U.S. 505, 518 n.10 (1992) (plurality opinion) (same); id. at 519, (Scalia, J., concurring in the judgment)).

  215. . See Whitman, 574 U.S. at 1004 (Scalia, J., concurring in denial of certiorari).

  216. . See McNally v. United States, 483 U.S. 350, 359–60 (1987).

  217. . See Marijuana Scheduling Petition; Denial of Petition; Remand, 57 Fed. Reg. 10,499, 10,506 (Mar. 26, 1992).

  218. . Whitman, 574 U.S at 1005 (Scalia, J., concurring in denial of certiorari).

  219. . See 21 U.S.C. § 812(b)(1)–(b)(5) (setting forth the criteria for Schedules II–V).

  220. . Controlled Substances, supra note 30.

  221. . The 50 Most Commonly Prescribed Drugs in America and Their Average Price, Drug Rep. (Mar. 23, 2020), https://www.drugreport.com/50-commonly-prescribed-drugs-in-america/#sources-links [https://perma.cc/J65K-2WCA].

  222. . See Marks, supra note 17, at 666.

  223. . See discussion supra Introduction.

  224. . Joëlle Anne Moreno, Half-Baked: The Science and Politics of Legal Pot, 123 Penn St. L. Rev. 401, 406–07 (2019).

  225. . Id.

  226. . Christian Nunley, Democratic Senators Will Push to Pass Pot Reform Bill This Year, CNBC (Feb. 1, 2021, 6:58 PM), https://www.cnbc.com/2021/02/01/cannabis-reform-senators-say-they-will-push-pot-bill-in-2021.html [https://perma.cc/S7Q8-MNY5]; Michael Hartman, Cannabis Overview, Nat’l Conf. St. Legislators (July 6, 2021), https://www.ncsl.org/research/civil-and-criminal-justice/marijuana-overview.aspx [https://perma.cc/P7SE-2Z2S].

  227. . Nathalie Bougenies, Is 2021 the Year Marijuana Becomes Federally Legal? Probably Not., Above the L. (June 22, 2021, 5:01 PM), https://abovethelaw.com/2021/06/is-2021-the-year-marijuana-becomes-federally-legal-probably-not/ [https://perma.cc/5TFR-JJCV].

  228. . Moreno, supra note 224, at 406–07.

  229. . See Moreno, supra note 224, at 442 (discussing “whether, in jurisdictions where marijuana is now legal, it is physically impossible to comply with both state and federal law”).

  230. . Mason Marks (@MasonMarksMD), Twitter (Oct. 24, 2021, 4:48 PM), https://twitter.com/MasonMarksMD/status/1452391529205559296 [https://perma.cc/E8MS-SGC6].

  231. . Marks, supra note 17, at 651. See also Marks, supra note 27 (opining that the judicial path to rescheduling psilocybin (as opposed to Congressional or DEA action), is likely the “most effective” path).

  232. . See Marks, supra note 27.

  233. . See id. at 677.

  234. . The International Drug Control Conventions, Schedules of the Convention on Psychotropic Substances of 1971, U.N. Doc. ST/CND/1/Add.2/Rev.7 (Dec. 7, 2021).

  235. . The International Drug Control Conventions, Single Convention on Narcotic Drugs of 1961 as amended by the 1972 Protocol art. 2, Mar. 30, 1961, 18 U.S.T. 407, 520 U.N.T.S. 151.

  236. . Mason Marks, Drug Regulation for the COVID-19 Mental Health Crisis, Harv. L. & Pol’y Rev. Blog (May 30, 2020), https://harvardlpr.com/2020/05/30/drug-regulation-for-the-covid-19-mental-health-crisis/ [https://perma.cc/N97M-Z8MD].

    * J.D. Candidate (2022), Washington University School of Law; M.B.A. (2018), Columbia University; B.S. (2006), Northwestern University. I would like to thank my fellow editors at the Washington University Law Review for their invaluable contributions, most especially Frank Cascone, Sara Hubaishi, Maya Kieffer, Clare Martin, and Robert Neel. Equally, a special thanks to my dear brother Fahad and devoted friend Fay Al-Tukhaim for their engagement and support throughout the writing process.

Published by Nabil Al-Khaled

Washington University School of Law

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