I. Introduction
Happiness is not the result of a simple choice, but rather is dependent on various external forces. Depression is one of those forces. The advancement of depression treatment requires a thorough exploration of all possible treatment options, not just those traditionally accepted. Depression is a current crisis among U.S. citizens. As such, mental health should be a paramount concern to the federal government.
While the government is under-engaged with its efforts to improve mental health policy, it is overzealous on its drug enforcement policy. The federal government strictly regulates controlled substances in the United States via the Controlled Substances Act of 1970. Two substances—psilocybin and LSD—are present on Schedule I of the government’s list of controlled substances and are thus subject to the highest level of federal regulation. This inclusion has occurred despite emerging evidence that both psilocybin and LSD have the potential to treat depression and other forms of divergent mental health. The federal government’s interest in fostering positive mental health among citizens conflicts with its hyper-regulation of substances deemed capable of helping those with depression.
The tension between promoting mental health and adequately regulating drugs can be resolved. The federal government operates a Drug Supply Program (DSP) through the National Institute on Drug Abuse (NIDA). Researchers can access Schedule I substances from the NIDA DSP for study purposes. However, the NIDA’s DSP is not ideal for facilitating the investigation of progressive drug treatments. The NIDA is an executive agency focused primarily on drug abuse—not on mental health research. For that reason, among others, research concerning mental health is not optimal when it is done in the NIDA.
The National Institute of Mental Health (NIMH) is an executive agency that focuses on mental health of U.S. citizens. The NIMH runs a similar DSP, but neither psilocybin nor LSD are present on the NIMH’s DSP ordering catalog. This is the problem; if psilocybin and LSD were added to the NIMH DSP, access to each substance would be available from an executive agency for those researching mental health, but not for those researching drug abuse. Once present on the NIMH DSP, the NIMH could procure psilocybin and LSD, solicit contracts to catalog each substance, and then offer them to researchers upon request. The overall amount of research performed would likely increase, leading to an increased exploration of these substances. Methods of procuring controlled substances exist for the NIDA’s DSP and would not require alteration; transferring these substances from the NIDA to the NIMH will appropriately allocate the access point of progressive drug treatment research. Rather than the NIDA procuring psilocybin and LSD to research “problems of drug abuse and drug dependence,” the NIMH could procure the same goods, through the same contract mechanisms, but do so for the purposes of progressive mental health treatment.
Part II of this Note will explain the depression crisis in the United States, the current medications that are prescribed for depression, and the shortcomings of those medications, and describe the nation’s current drug regulations. Part III of this Note will address the implications of those regulations on controlled substance procurements and will address the NIDA’s procurement-based role as a controlled substances access point. Finally, Part IV will explain the implications of adding psilocybin and LSD to the NIMH DSP, and is accompanied by numerous policy justifications. These justifications include the presence of ample production quotas to meet increased demand triggered by addition to the NIMH DSP; bypass of the DEA’s expensive manufacturing license through the use of a research-only license; the incongruity between the NIDA’s mission and the expectation of it operating a progressive drug research forum; and the overall expansion of access to psychedelic research.
II. Background
This section will introduce the prevalence of depression in the United States. The antidepressant medications that occupy the pharmaceutical market will be briefly discussed, with a summary of their shortcomings. The description of these traditional antidepressants will be followed by an introduction of the non-traditional psychedelic treatment options that remain unexplored: psilocybin and LSD. Finally, the federal government’s regulatory scheme will be introduced to describe the current procurement-based method by which researchers can obtain psilocybin or LSD for research purposes.
A. Pervasive Depression Plagues the United States
In 2020, an estimated twenty-one million adults in the United States suffered at least one major depressive episode (about 8.4% of all U.S. adults). Depression has various causes. For example, individuals diagnosed with terminal illnesses—just one subgroup in which depression can be analyzed—display depressive symptoms in approximately 25% to 77% of their demographic. Further, awareness of death and its inevitability is one of the four main causes that can lead to existential depression. Some people spend their final years suffering from depression in addition to the physical suffering associated with a terminal diagnosis. The consequences of depression are exacerbated by the failure of many people to seek treatment for their symptoms, which is as much of a problem as the incidence of depression itself, as forgoing treatment often causes depressive symptoms to worsen. In 2020, approximately 57.2% of adults and 59% of youth suffering from mental illness received no treatment.
Together, the high incidence of depression and the failure of depressed individuals to seek treatment produce grave consequences. Depression and suicide are frequently comorbid. In one study of suicide risk among psychiatric patients, researchers found that approximately 75% of suicide attempts took place during major depressive episodes. It concluded that, among other factors, the overall time an individual spent depressed was the strongest factor indicative of long-term suicide risk. This correlation emphasizes the need to investigate depression treatments promptly and thoroughly. The longer that one suffers from lingering depression, the more likely that one is to attempt suicide. Thus, time is indisputably of the essence.
B. Traditional and Non-Traditional Depression Treatments
Treatment options are available for those who decide to seek professional help. Medications are available by prescription from psychiatrists, who can also provide psychotherapy. Medications are available in different forms, the most common being selective serotonin reuptake inhibitors (SSRIs). SSRIs block the reuptake of serotonin in the synapses between neurons, which increases the amount of serotonin available for neurotransmission in the brain. Studies show correlations between depression and decreased levels of serotonin; increasing the amount of serotonin that is available for neurotransmission increases otherwise deficient levels of serotonin commonly found in depressed individuals. Common commercial SSRIs include Celexa, Lexapro, Prozac, and Zoloft. SSRIs make up a 57% share of a $13.5 billion antidepressant industry. Prescription antidepressant medications other than SSRIs are available as well. Individuals prescribed antidepressants may need to try several medications before they find one that effectively treats their depression without also causing undesirable side effects.
Even if the proper medication has been prescribed to a particular patient, it can take weeks for depressive symptoms to improve. Only about half of patients taking a particular antidepressant will be symptom-free after their first prescription. Although traditional antidepressants offer benefits to patients, their collective success rates are discouraging. These “trial and error” treatment methods are inadequate considering the relationship between the time spent with depression symptoms and the increased risk of suicide.
Potential depression treatments remain untapped. Traditional medications may not be the only clinical option for treating depression—psilocybin (the active compound in “magic mushrooms”) and lysergic acid diethylamide (“LSD,” colloquially referred to as “acid”) are Schedule I controlled substances that, similar to widely used SSRIs, act on serotonin receptors in the brain. Preliminary evidence suggests that both psilocybin and LSD offer therapeutic benefits to depressed individuals. Some researchers hesitate to engage with these substances—they consider them unviable research candidates due to their effects on sensory perception and thought processes, which are inherent to their hallucinogenic properties.
The skepticism afforded to hallucinogens is not just unfortunate, but is also prejudicial. Current antidepressants are not void of side effects, which range from mild dizziness, weight gain, and agitation to more severe symptoms such as sexual dysfunction, psychosis, disorientation, seizures, and suicidal thoughts. These side effects must, at some point,have been weighed against these medications’ therapeutic potential in order to be placed on the market. Weighing the pros and cons of psilocybin and LSD requireinvestigation into the properties of these substances, notwithstanding their hallucinogenic effects. The preliminary results also advise against premature dismissal thereof simply because they are unconventional and produce hallucinations when used in certain quantities. Psilocybin and LSD deserve a similarly comprehensive benefit and burden weighing as SSRIs, which can only be achieved if each is thoroughly researched. Hence, uninformed rejection of potential treatments is ill-advised.
Ideally, researchers would have uninhibited access to psilocybin and LSD to explore their therapeutic potential. There would be no concern about diversion of drugs into illicit markets, and no concern about unprescribed and unsupervised use among U.S. citizens. Stigma around mind-altering substances would be nonexistent. But this stigma persists, originating in large part from previous executive policies that declared war on these and other chemicals. Perhaps psilocybin and LSD would be standard prescriptions by now if history had developed differently. The ideal world and the real world are at odds, and researchers must navigate the current prohibition of psilocybin and LSD imposed by the highest level of federal regulation: presence on Schedule I on the Drug Enforcement Administration’s (DEA’s) controlled substances list.
C. Consequences of Schedule I Classification on Research Productivity
The federal government regulates drugs by classifying each as a “controlled substance” and placing that substance on one of five “schedules.” Schedule I indicates the highest level of regulation, reserved for substances with a high potential for abuse, no currently accepted medical use in the United States, and no accepted safety for use even under medical supervision. Schedule I classifications mirror, in large part, two international drug treaties that the United States joined in 1960 and 1971. Inclusion of psilocybin and LSD on Schedule I makes it difficult for research entities to obtain either substance, which inhibits advancements in research. Research originating in procurement is critical in this light—through procurement, the government can legally provide otherwise illicit substances to researchers, who can be certain they are not violating domestic drug laws. Government collaboration in research also cuts costs, ensures standardized methods and results, and increases access to a wider field of interested researchers.
The Attorney General of the United States (or the Secretary of the DEA, to whom the AG delegated their controlled substances statutory authority) could de-schedule psilocybin and LSD. This possibility would remove the barriers imposed by the Controlled Substances Act. When presented with requests to de-schedule cannabis, the DEA has indicated that it will only de-schedule a substance if given sufficiently reliable research to support such action. This is true despite the DEA’s scheduling regime and associated regulations that make it inherently difficult to produce any such research. If thorough, credible, and uniform research of Schedule I substances was more accessible, researchers would be better poised to advise the DEA of the misguided nature of its scheduling practices. This Note does not advocate for outright de-scheduling or legalization, but rather for a meaningful and standardized research investigation of these two substances. As it stands, obtaining Schedule I substances is difficult due to federal regulations, but it is not impossible. Researchers must work within the following framework.
D. Permissible Method of Obtaining Schedule I Substances Through Government Procurement
Due to the difficulty obtaining Schedule I substances, and the potential to violate federal law in doing so, researchers require a legal method of obtaining substances to use in their studies. Balancing the status quo, which completely prohibits psilocybin and LSD as Schedule I substances, against a new era in which increasingly more researchers are interested in these substances despite their illegality, poses significant challenges that the current regulatory framework is unprepared to face.
Researchers may apply and pay to become licensed manufacturers of Schedule I substances, which allows them to produce and research those substances subject to certain control mechanisms. Researchers may also apply for a far less expensive license that allows applicants to research controlled substances, but does not allow them to manufacture those substances. The NIDA has proposed a framework in which those with research licenses can conduct manufacturing that is “coincident to research” if the manufacturing quantities are small, but this quantity restriction is limiting—researchers need an uninhibited supply of substances for their studies. In any event, not all researchers are prepared to manufacture their own supplies, and many are uninterested in doing so.
After obtaining a DEA-issued research license, researchers can request Schedule I substances (including psilocybin and LSD) from the NIDA’s Drug Supply Program (DSP). The history of cannabis procurements (also a Schedule I controlled substance) should be viewed as the predecessor to psilocybin and LSD procurements, and serves as a guide for what works well when procuring controlled substances, and more importantly, what does not.
The NIH openly recognizes difficulties surrounding access to psychedelic research. On June 15, 2022, the NIMH and NIDA co-authored a letter to Senator Brian Schatz that cited DEA requirements and “several statutes and regulations” that govern controlled substance research. In responding to an inquiry about collaboration with the private sector, and in discussing potential funding opportunities, NIH officials made no mention of the NIDA’s DSP. The letter expressed the NIH’s support for “an experimental therapeutics approach for the development and testing of therapeutic inventions, including psychedelic drugs. . . .” The NIH should be receptive to the actions identified in this analysis if it wishes to promote psychedelic research, and it should consider the procurement-based approach described in this Note.
III. Criticism of the NIDA’s Effectiveness as a Drug Supply Forum
This section will focus on the deficiencies in the NIDA’s role of operating a DSP. Following the analysis of the NIDA’s DSP, the focus will shift to the introduction of a different and more promising depression research forum: the NIMH, which operates its own DSP. The NIMH is concerned with overall mental health of U.S. citizens, while the NIDA focuses primarily on drug abuse. Currently, the NIMH DSP does not offer psilocybin or LSD. If the NIMH adds psilocybin and LSD to its DSP, procures each substance in bulk, and catalogs those substances before providing them to researchers, researchers will then have an additional forum to access high-quality controlled substances, and one within a more suitable executive agency. Procurements of psilocybin and LSD already occur, but they are solicited by the NIDA instead of the NIMH—these proposals are understandably riddled with language that emphasizes these drugs’ purported abusive properties.
Once added to the NIMH DSP, the NIMH can procure substances from entities that are already licensed DEA manufacturers, of which there are increasingly many. After procurement from manufacturers, the NIMH can solicit contracts to catalog these substances and gain an understanding of “the mechanisms underlying” their intervention response (as opposed to an understanding of only these substances’ clinical effect), as per the NIH’s stated goal. This undertaking will occur before actual clinical research. Once cataloged by the NIMH DSP, researchers can request these substances from the NIMH and proceed to research their treatment efficacy. The NIMH can condition receipt of these substances on compliance with standardized protocols and reporting mechanisms.
The DEA already signaled a willingness to acknowledge psilocybin and LSD as research candidates; production quotas were dramatically increased in 2021 for licensed manufacturers. It is not unduly distrustful, and indeed perhaps prudent, to take this messaging with skepticism given the DEA’s previous failure to deliver on its cannabis policy commitments. The DEA and NIDA’s failures in this regard will be described in this section. Arguably, the DEA only acted on cannabis reform because it was served with a writ of mandamus to force compliance with statutory obligations.
Waiting to see if the current procurement framework functions properly to meet the needs of novel treatment options is inadvisable given the DEA and NIDA’s inability to operate a DSP properly in the past, and given the crucial need to avoid prolonged periods without depression-oriented research. As this section proceeds, references to cannabis procurement woes should be consciously associated with the potential for these difficulties to recur within psychedelic procurements.
A. The Importance of Analyzing Psilocybin and LSD Procurements Through the Lens of Cannabis Procurements
The DEA’s role in cannabis procurements can be summarized by unexplained and unreasonable administrative delays, perpetuation of a bilateral monopoly, and production of grossly inadequate products to researchers. State-level cannabis legalization movements have significantly outpaced the federal government’s procurement and legalization efforts, and the federal government is lagging behind in cannabis policy reform. This situation is developing in the psychedelic space, as individual states are beginning to pull back on regulations before the federal government seems poised to do the same. This section emphasizes the federal government’s need to get ahead of state legalization movements before the United States experiences another farce in which a substance is federally prohibited yet legally obtainable in more than half of the fifty states, as is currently the case with cannabis.
Cannabis was designated as a Schedule I controlled substance in the Controlled Substances Act of 1970 (CSA). It has a lengthy history of fumbled procurement efforts. Cannabis procurement for research purposes (i.e., the federal government procuring cannabis, placing it in the NIDA DSP, and supplying it to researchers upon request), which should have informed arguments for and against legalization, was outpaced by state legalization initiatives. It will likely be outpaced by future federal legalization. In effect, the cannabis procurement scheme took too long to optimize, and legalization will moot ongoing efforts because procurements will not be subject to stringent Schedule I controls. Research of government procured cannabis was historically difficult because of a dysfunctional procurement framework. This complexity has occurred throughout the NIDA’s assumption of drug procurement responsibilities.
B. The Origin of NIDA Procurement Issues
Federal regulations for cannabis procurement date back to the United States’ obligations under an international treaty called the Single Convention on Narcotic Drugs of 1961. The Single Convention authorized government procurement of cannabis subject to questionable control mechanisms, including a provision that directly equated cannabis to opium poppy.
Article 23 of the Single Convention mandates that cultivators of opium poppy shall be required to deliver their total crops of opium “to the Agency.” The Agency, then, “shall purchase and take physical possession of such [opium] crops as soon as possible . . . ,” and those functions “shall be discharged by a single government agency . . . .” Further, Article 28 of the Single Convention—the origin of cannabis procurement failures—simply states that regulations for cannabis “shall apply [to] the systems of controls as provided in article 23 respecting the control of opium poppy.” As a result, cannabis regulations were required to be identical to and dependent on those that regulated opium poppy.
Opium poppy is used to create extremely addictive opiate-based drugs that have plagued our country for decades, producing “the opioid epidemic.” The consequences of the opioid epidemic are felt nationwide: in December of 2021, a Kansas police department announced that fentanyl overdoses surpassed suicide as the leading cause of death for Americans aged eighteen to forty-five. Cannabis and opium cannot reasonably be regulated as equivalents; cannabis is used legally as a recreational drug across the nation, while opioids are ravaging our country through cycles of addiction and death. There is no such thing as “the cannabis epidemic.” Opioids, though available legally by prescription, killed an average of forty-four people each day in 2020. Cannabis and opioids are different drugs with different effects on the body, and relying on this regulatory scheme created in 1961 defies logic. Nonetheless, the Department of Justice (DOJ) still cites to the Single Convention as a binding authority on procurement matters in times as recent as 2018 and urges the DEA to continue compliance with the provisions of this treaty.
C. The Single Convention Highlights the DEA’s Outdated Scheduling Practices
The Single Convention equates cannabis to opium poppy. Fentanyl is spreading across the country at an alarming rate. Opioids issued by prescription are no less lethal. Oxycontin is a highly addictive opioid drug that, despite being legally prescribed, frequently enters illicit drug markets and contributes to the opioid epidemic’s toll on Americans. Under the Controlled Substances Act, many opium-based drugs are Schedule II substances, while cannabis is a Schedule I substance.
Schedule I substances supposedly differ from Schedule II substances in one critical respect: Schedule II substances, though offering a high potential for abuse similar to Schedule I substances, possess “currently accepted medical use in treatment in the United States.” Several highly addictive opioids are Schedule II substances because of their recognized medical uses. Psilocybin, cannabis, and LSD are Schedule I substances, which means that the federal government believes that they have no accepted medical uses—even under medical supervision. The validity of this scheduling scheme is questionable because thirty-seven states, the District of Columbia, Puerto Rico, and the U.S. Virgin Islands all operate programs for citizens to obtain medicinal cannabis. Research studies indicate support for psychedelic use to treat, not only depression, but substance abuse disorders as well. The Controlled Substances Act unsurprisingly makes it difficult to research Schedule I substances as medicinal treatment options since they are statutorily defined as not possessing the potential for any therapeutic use. Procurement for medicinal research purposes is understandably complicated.
The DEA has not rescheduled cannabis, psilocybin, or LSD, despite the inconsistencies behind their classifications, and their presence on Schedule I continues to perpetuate the procurement issues identified in this analysis. When faced with pleas from terminal cancer patients to permit limited psilocybin use in a therapeutic setting, the DEA flatly denied the requests, citing to its main objective of “conquer[ing] drug abuse and [controlling] the legitimate and illegitimate traffic” of controlled substances. Terminally ill cancer patients seeking relief are not a threat to the United States. This rhetoric is consistent with the DEA’s April 2020 “Drug Fact Sheet” for psilocybin, featuring prejudicial headings such as “How Is It Abused?” to describe the method of ingestion; similarly, the same “fact” sheet describes effects such as the inability to discern fantasy from reality, psychotic-like episodes, nausea, and vomiting, but does not mention any potential therapeutic uses for this substance. This is ill-informed adherence to outdated laws in a manner contrary to public welfare.
D. NIDA Procurements That Comply with the Single Convention (In Theory)
The United States expressly acknowledges its obligations under the Single Convention in the United States Code. The Single Convention mandates that one government agency must exercise complete control over the opioid/cannabis procurement process described above, and the DOJ continues to urge this strict interpretation of the treaty. The “Agency” was identified as the DOJ by reference to the Attorney General (AG), and so the AG is charged with implementing controlled substance statutes.
The AG’s authority was delegated to the Secretary of the DEA. The DEA exercises some of this authority through collaboration with the NIDA, which operates a Drug Supply Program (DSP). In operating the DSP, the NIDA procures controlled substances and holds them in reserve for researchers who can request to use them in research studies (which is the intended effect of the DSP). The NIDA also provides substances to contractors for cataloging and compound identification. This framework was criticized by the DOJ in 2018 for failing to abide by the Single Convention’s “single agency” mandate because of the NIDA’s involvement, but this practice remains unchanged.
The NIDA operates its DSP in pursuit of promoting research on “drug abuse, addiction, prevention, and treatment.” The NIDA posted a notice of “Sources Sought” on December 13, 2021, that summarizes the process by which the DSP procures drugs:
[Substances] are generally procured by chemical synthesis through contract mechanism. In order to continue to supply authentic and pure drugs and research chemicals, NIDA intends to maintain the drug supply inventory, periodically check chemical purity and supply to research investigators according to the NIDA drug supply guidelines.
Specifically, NIDA plans to continue to: (1) acquire, synthesize, and maintainseveral . . . drugs of abuse and other chemical substances in its drug supply inventory and distribute them to research investigators upon approval. . . .
“NIDA drug supply guidelines” refers to a twelve-step checklist that researchers must satisfy when ordering substances from the NIDA DSP. Steps five and six address the DEA registration and DEA order form that must be included in a request for controlled substances. After review of the application by either a NIH Program Officer or a Scientific Expert Panel, a recommendation is submitted to the NIDA DSP Director, who either approves the request and authorizes shipment of the substances, or denies the request and notifies the applicant accordingly.
On paper, the NIDA DSP seems like a research-friendly program that promotes access to controlled substances. Critical analysis of cannabis procurements through the NIDA DSP suggests otherwise.
E. NIDA Procurements That Comply with the Single Convention (In Practice)
Scottsdale Research Institute (SRI) is one of approximately thirty-eight entities that, at one point, had pending applications with the DEA for a license to cultivate cannabis. If any of those thirty-eight entities intended to sell their cannabis after receiving a DEA license, it must have been sold to the DEA (who places the cannabis into the NIDA DSP) pursuant to the Single Convention mandate. The cannabis is placed in the DSP when the NIDA procures cannabis from authorized manufacturers and the manufacturers deliver cannabis to the NIDA’s reserve for storage. Despite a ninety-day statutory requirement to process these applications, the DEA has taken yearsto respond to some applications. As a result of the DEA’s inaction on unprocessed applications, only one entity was licensed to cultivate cannabis for decades, which meant that only one entity capable of supplying the NIDA DSP with cannabis. That entity was the University of Mississippi (UMiss). UMiss, unsurprisingly, was awarded NIDA contracts to supply cannabis to the DSP on a sole-source basis.
SRI, eager to commence research, but compelled to wait for its application to be processed, attempted to utilize UMiss cannabis from the NIDA DSP. When SRI received the cannabis, it “arrived in powdered form, tainted with extraneous material like sticks and seeds, and many samples were moldy.” This cannabis significantly hindered research and induced side effects such as bronchial irritation due to the cannabis’s egregious quality. SRI had no choice but to use the cannabis from the NIDA DSP if it wished to comply with federal law. No alternative forum was available for SRI to acquire cannabis, and SRI was not yet permitted to grow its own. SRI filed a writ of mandamus against the DEA, who processed several pending applications just short of the writ’s response deadline.
Even before SRI filed suit against the DEA, the DEA publicly committed to increasing the number of cannabis cultivators to address supply issues. The DEA did not follow through on this commitment, for if it had, SRI (and others) would have become licensed cannabis cultivators, and more than one single entity would have been licensed to supply the DSP with cannabis between 1960 and 2021. Hindsight bias aside, it remains uncertain if anyone should reasonably have expected the DEA or the NIDA—entities concerned with, as their names suggest, drug enforcement and drug abuse—to have been the ideal forums entrusted with promoting exploration of research into the same drugs that it had deemed highly addictive and void of medicinal qualities. For the same reason, they should not be expected to properly operate a DSP for psilocybin and LSD in the future.
SRI, throughout its battle with the DEA and NIDA, pursued research focused on veterans who suffered from treatment-resistant post-traumatic stress disorder (PTSD). SRI’s research was notconcerned with drug abuse, addiction, prevention, or treatment—focus areas that represent the mission statement of the NIDA’s DSP. Regardless, SRI had no choice but to turn to the NIDA for cannabis. SRI serves as a case study for a broader point: the NIDA, admirably focused on researching drug abuse, is not the appropriate forum to exercise a drug supply program for researchers whose focus does not touch the outer edges of drug abuse policy, except as their focus relates to pushing the rhetoric surrounding certain substances away from categorical classifications as “drugs of abuse.” Prohibited substances that have long been labeled highly addictive and easily abused can now be applied in a therapeutic setting to treat mental health. Progressive treatment investigations do not necessarily involve drug abuse.
IV. The Psychedelic Procurement Framework Is Not Bound by the Single Convention’s Mandates, and the NIMH May Participate in Psilocybin and LSD Procurements.
The issues identified in the NIDA’s DSP are amendable. In recognizing the NIDA as an inappropriate forum for certain areas of research, the federal government would not be helpless. On the contrary, it is in a position to greatly improve the state of procurement-based research drug access. A better forum already operates a DSP of its own: the National Institute of Mental Health (NIMH). If researchers are interested in investigating psilocybin or LSD’s effect on tobacco, alcohol, opioid, or other forms of addiction, then the NIDA would be an appropriate forum. In reality, not all psychedelic research falls within that scope, and other researchers require an alternative executive agency to adequately meet and understand their needs. If SRI had an alternative forum available when searching for a reliable and high-quality cannabis supply, SRI might not have needed to sue the DEA for the mere opportunity to conduct research, and SRI’s research aimed at veterans suffering from treatment-resistant PTSD could have begun sooner. SRI filed the writ of mandamus on June 11, 2019 (already thirty months after submitting their application to the DEA); it was not licensed to cultivate its own cannabis until May 2021.
Although reflection on its past involvement in drug research policy is not encouraging, the federal government can still promote effective psilocybin and LSD procurements before the current framework’s inadequacies are replicated. This section describes the international treaty that governs psilocybin and LSD among the United States and other treaty members. It also revisits the history of cannabis policy in order to anticipate issues that may arise after increased access to psilocybin and LSD, the most important of which being standardization in potency and research protocols, which is resolved by a single point of access for controlled substances within the NIMH.
Finally, this section advocates for adding psilocybin and LSD to the NIMH DSP and discusses the implications of this action. Adding psilocybin and LSD to the NIMH DSP will allow the NIMH to solicit DSP supply contracts, followed by compound identification contracts that provide an increased understanding of these substances’ underlying mechanisms before providing these cataloged substances to researchers who are awarded grants. Standardization of research supplies and protocols will foster credible results, and the responsibility of progressive drug treatment research will properly reside in the NIMH. This outcome will be compounded by the inherently beneficial nature of federally centralized research.
A. The Psychotropic Convention Governs Psilocybin and LSD, and the Single Convention Is Not Implicated in These Procurements
Psilocybin and LSD are governed by the Convention on Psychotropic Substances of 1971 (Psychotropic Convention). Unlike the Single Convention, which provides separate articles for individual substances, the Psychotropic Convention regulates all Schedule I substances within a single article: Article 7. Psilocybin and LSD are classified as Schedule I substances under the Psychotropic Convention, and so they are governed by Article 7’s special provisions.
The Psychotropic Convention does not contain a mandate that the duties described in Article 7 are to be discharged by a “single government agency,” as is the case with the Single Convention’s mandate for Articles 23 and 28 that govern cannabis. This difference is crucial because, under the Psychotropic Convention, control over psilocybin and LSD procurements do not need to be conducted solely by the DEA, the NIDA, or by any other singleagency. The door is open for the NIMH’s participation in these procurements.
Article 7 of the Psychotropic Convention, in addition to omitting the “single agency” mandate, is more lenient compared to the Single Convention’s controls placed upon cannabis. For example, the Single Convention requires that cannabis manufacturers deliver their entire crop of cannabis yield to the DEA within four months of harvest. No such mandate is contained in the Psychotropic Convention after cultivation of psilocybin or the synthetization of LSD. Instead of taking complete control over the substances that are produced, the Psychotropic Convention allows a more hands-off approach and simply requires “close supervision” of the activities that are permitted for Schedule I substances. Manufacturers may contract with the NIMH to supply psilocybin and LSD, but are not required to deliver all of their yield to the NIMH.
Article 7 of the Psychotropic Convention also calls for licensing requirements that the DEA already enforces, and requires that scientific and limited medical activities be performed by duly authorized persons who are either directly under the control of the government, or specifically approved by them. Neither of these requirements would prohibit the procurement framework proposed within this analysis. In summary, the Single Convention is not involved in these procurements, and the Psychotropic Convention is more permissive regarding the level of control exerted over manufacturer and researcher activity.
B. Few Research Studies of Psychedelics Are Centralized, Leadingto Standardization Concerns
Entities “directly under the control of the government” who perform scientific and limited medical activities with psilocybin and LSD are scarce in the United States. In 2021, Johns Hopkins Medicine was awarded the first NIH grant to research psilocybin in over fifty years. Only three active research projects investigating psilocybin are listed on the NIH Research Reporter page. The NIMH funds only one of those studies and does so with a research grant totaling $390,000—just shy of 0.05% of its total research budget. The projected end date of the study is April 30, 2027. Only six active studies relate to LSD, four of which are funded by the NIDA grants, and none of which is funded by the NIMH. Two of these four NIDA studies are researching non-psychedelic forms of LSD that are structurally and fundamentally different from LSD. The third study is researching a “frequently abused psychotomimetic agent”—namely, LSD. The final study is researching “potential risks when psychedelics are explored as novel therapies for drug addiction and mental disorders.”
This group of studies is insufficient to fully investigate LSD and psilocybin; if any of these studies produce results—promising or otherwise—they are too few in number to possess the credibility associated with data replication. If the NIMH had a reserve of psilocybin or LSD, more researchers could seek government collaboration through the NIMH instead of the NIDA, and they would not need to manufacture their own Schedule I substances after obtaining the required and expensive DEA manufacturing license. Costs of substances could be regulated through a single access point to avoid outrageous price requests from privately licensed manufacturers.
The shortage of studies conducted directly under the government’s control is concerning. Analyzing cannabis research as the predecessor to psilocybin and LSD research emphasizes the need to avoid the disadvantages of “patchwork,” i.e., decentralized, research. For example, decentralized cannabis testing facilities in some states have reported invalid potency reports, likely due in part to a lack of standardized oversight. In addition to standardization concerns, some critics have recognized the intellectual property potential surrounding psychedelics, and so there is a profit motive in private research endeavors that may threaten the credibility of research results. Collaboration with the federal government for strictly research investigation, as opposed to investigation into marketable materials in the course of research, removes this conflict of interest.
Standardized testing of cannabis is emerging in states such as California and is intended to address inconsistencies in testing results across different labs. Cannabis reform is simply predating psilocybin and LSD policy, and the current cannabis issues lend support to arguments in favor of centralized psilocybin and LSD research before decentralized related inconsistencies arise. In practice, researchers who operate directly under the government’s control via grant requirements could obtain DSP-supplied (and catalogued) psilocybin and LSD in exchange for the promise to abide by standardized research practices; this process, paired with research using government provided substances with consistent and verifiable levels of potency, will enhance research quality. The federal government already solicits contracts to procure and analyze psilocybin and LSD in other contexts, so expanding this practice to the NIMH DSP is not unprecedented.
In 2018, the DOJ issued a written opinion that criticized the DEA and the NIDA’s joint operation of the NIDA DSP. The basis for its criticism was a failure to abide by the United States’ obligations under the Single Convention, specifically the mandate that the functions described in the treaty must be discharged by a single government agency. The DOJ cannot object to the NIMH procuring psilocybin or LSD because, under the Psychotropic Convention, there is no “single agency” mandate. Further, it cannot object under the Single Convention because the Single Convention does not govern psilocybin or LSD. Article 7 of the Psychotropic Convention calls for close government supervision of research authorized under that section. The DOJ should agree with this Note’s suggested action since NIMH research grants using NIMH-supplied substances provides direct oversight and involvement in research activity. This framework fully honors the treaty’s obligations, and objection to this action can be grounded only in general prejudice to psychedelics.
C. Federally Funded Research Is Inherently Beneficial
Federally centralized psychedelic access for progressive research is not novel: Canada has already pursued this course of action. Regarding Canada’s decision to add psilocybin to its version of a federal DSP in 2021, a team of researchers considered it “[an] achievement [that would] allow for the wide-scale production of naturally occurring psilocybin and standardization of cultivation, extraction and testing methodologies—and innovation in said technologies. . . .” Canadian researchers seem to anticipate that a central psilocybin access point will mitigate inconsistencies in psilocybin supplies, the same type of inconsistencies that arose after expanded cannabis access in the United States. Canada is wise to centralize drug access before different provinces develop standards and results that conflict with one another.
Data collected from a single point of access can be pooled to increase its statistical persuasiveness and examined reliably for consistency. When data is collected in this way, future researchers can interpret that data and attempt to replicate or disprove results with less preparation time. It is estimated that almost two-thirds of the most impactful technologies from the past fifty years has been the product of federally funded research and development. The federal government is in a unique position of control over the country. Setting the standards for psilocybin and LSD research by providing federally sourced substances will bestow these benefits upon this emerging medicine before the private sector develops alternative variations of best-practices and potency reporting discrepancies.
D. Implications of Transferring Psilocybin and LSD to the NIMH DSP, and the Incongruity of Entrusting Progressive Drug Research Access Within the NIDA
The NIMH DSP operates similar to the NIDA DSP, but with important differences. The NIMH describes who is eligible to participate in the DSP: “[i]nvestigators involved in basic or clinical research relevant to mental health.” The mission of the program is to
support fundamental research on the mechanisms underlying and influencing brain development, neuronal signaling, synaptic plasticity, signal transduction pathways, and the biochemical and behavioral actions of therapeutic agents in animals and humans. The goals . . . include . . . characterization of the behavioral effects of psychoactive agents. . . .
This definition, far more inclusive than that of the NIDA’s DSP mission statement, includes researchers investigating depression, but does not confine them to research that involves drug abuse or addiction. A large portion of psilocybin and LSD research falls under the NIMH’s mission statement, but falls outside of the NIDA’s.
It is unclear whether psilocybin and LSD are on the NIDA’s DSP due to their potential to treat addiction to certain substances, or because they themselves are considered to be drugs with high abuse potential under federal regulation. Their classifications as Schedule I substances at least suggest the latter. If that is the case, then it is inappropriate to expect researchers to collaborate with a forum that explicitly considers certain substances to be highly addictive and generally dangerous if it fundamentally conflicts with the researchers’ goals. The research potential under the DEA and NIDA’s control is strained compared to the research potential within the NIMH.
The incongruity between the NIDA’s mission and the goal of advancing research of Schedule I substances is why the federal government must place psilocybin and LSD on the NIMH DSP. This action will appropriately allocate the responsibility of evaluating medicinal efficacy to an agency that is designed to explore, generally, mental health and its effects on U.S. citizens. This action will also help to remove stigma brought by the NIDA that necessarily categorizes these substances as drugs of abuse. The NIDA’s information page about psychedelics features unappealing descriptions of substances and their potential negative effects, and is found on a website called drugabuse.gov. DMT, a Schedule I hallucinogenic substance that has effects on the brain similar to LSD and psilocybin, is currently present on the NIMH DSP. DMT’s presence on the NIMH DSP illustrates the possibility of adding other Schedule I substances thereto.
Once added to the NIMH DSP, the NIMH can solicit contracts to supply the DSP—the same way that the NIDA supplies its DSP. Entities that are already licensed to manufacture psilocybin and LSD can compete for these supply contracts, and procurement can commence. Once the NIMH procures a sufficient reserve of each substance (supplies of which made possible by the DEA’s increase in psilocybin and LSD production quotas), government research grants can provide federally supplied psilocybin and LSD after it has been cataloged by contractors, which adds a layer of potency standardization and verification. This will prove itself to be beneficial beforeinconsistencies arise as they have with cannabis studies during its steady trend towards legalization.
Placing psilocybin and LSD on the NIMH DSP would offer an additional benefit. Increased access to these substances will attract researchers who are not personally licensed to manufacture either psilocybin or LSD. Applications for a manufacturing license cost $3,699. Research licenses cost $296. The NIMH can attract a wider scope of researchers who may be uninterested in operating manufacturing facilities themselves and thus unwilling to pay $3,699. Approximately 300,000 investigators rely on NIH funding to participate in research, and, if the NIH engages with psychedelic research moving forward, some of these entities can partner with the NIH to explore these potential treatment options in a cost-effective manner. This partnership, as opposed to research license holders purchasing psilocybin directly from private manufacturing license holders, will evade the hesitation (and financial struggles) felt by some academics in the course of collaborating with licensed for-profit private biotech manufacturers.
By not requiring otherwise competent researchers to pay an additional $3,403 to participate in research, this proposed action will invite a larger breadth of interested researchers who may have smaller budgets. Not only will costs be lower in the application phase, but researchers will not pay costs associated with maintaining manufacturing facilities. Additionally, some researchers may be unwilling to manufacture substances, and lacking a reliable supply of substances may prevent them from contributing to psychedelic research. In 2018, reports indicated that some researchers were paying over thirteen times the price of psilocybin’s street prices. Centralizing the access point of psilocybin can control these extreme cost barriers.
Once present on the NIMH DSP and subsequently procured in adequate amounts, the NIMH can solicit compound identification contracts that aim to achieve a deeper understanding of the underlying mechanisms of both psilocybin and LSD. These contracts will call for analysis of substances that were procured and placed in the NIMH DSP. The NIDA already contracts for cataloging and compound identification of psilocybin and LSD. Instead of seeking storage, compound identification, and analysis from NIDA contractors, the NIMH can procure these substances from licensed manufactures and then provide them to contractors to catalog and assess these substances’ properties. Instead of “Synthesis and Distribution of Drugs of Abuse,” the NIMH can seek researchers for the “Investigation of Potential Treatment Options.” The latter is more appropriate for uncovering potentially fruitful treatment options while avoiding unnecessary stigmatization.
Researchers who obtain a DEA research license for less than $300 will be incentivized to compete for NIH research grants to investigate psilocybin and LSD using NIMH-supplied substances, and the benefits of government-funded research, explained above, will follow. The NIDA already provides these substances to NIDA contractors for analysis and reporting purposes, and engaging in the same practice for other research purposes is no different. Standardization in research protocols and supplies will be ensured, and the complications found within cannabis procurements will not be repeated.
E. The Defense Authorization Act?
The House of Representatives recently approved an Amendment to “H.R.7900—National Defense Authorization Act for Fiscal Year 2023” that authorizes the Secretary of Defense, in coordination with the Secretary of Veterans Affairs and the Secretary of State, to collaborate with U.S. and Israeli institutions in a grant program aimed at PTSD research. The grants must be carried out in accordance with the “Agreement Between the Government of the United States of America and the Government of Israel on the United States-Israel Binational Science Foundation.” To receive an award, eligible entities must carry out a research project that addresses a requirement in the area of PTSD that “the Secretary [of Defense] determines appropriate to research using such grant.” This broad authorization has been interpreted to permit research of psychedelic treatment for PTSD.
This is a step in the right direction for progressive drug treatment research. The amendment must first survive the Senate’s review of H.R. 7900 to become effective, but, even if the amendment survives, the fact remains that this bill provides the Department of Defense and the Secretary of State with progressive drug research responsibilities. This bill does not resolve the issues raised in this Note. Progressive drug treatment responsibilities should reside in the NIH and, more specifically, in the NIMH. It is encouraging to see the federal government engaging with research initiatives, but it is essential that it engages with those initiatives properly. H.R. 7900 does not address the NIDA or NIMH DSP, but, then again, it is a Defense Authorization Bill, so it has no business driving drug research reform.
V. Conclusion
The ultimate goal of progressive drug treatment advocates is for the DEA to remove psilocybin and LSD from Schedule I of the government’s list of controlled substances. This Note does not advocate for outright legalization or de-scheduling of psilocybin or LSD, because it is unlikely to occur before a reliable body of research supports such action. The DEA will not alter its scheduling practices until a comprehensive body of research indicates that re-scheduling, de-scheduling, or legalizing a particular substance is the proper choice. This result can only be achieved after volumes of persuasive research results are produced.
Any individual “groundbreaking” study is unlikely to be sufficiently persuasive; several studies that reproduce those results are more credible. These studies can be conducted most effectively by increasing the quantity of researchers that have meaningful access to controlled substances and by ensuring adequate and verifiable quality of substances that are used in those studies. By adding psilocybin and LSD to the NIMH’s DSP, soliciting contracts to procure these substances, soliciting contracts to catalog these substances, and then soliciting research grants that provide those same substances to researchers, the NIMH will stimulate psychedelic literature with a degree of control that ensures high quality research. This effort will allocate progressive drug research responsibilities within an appropriate executive agency and will contribute to the body of research required to drive progressive drug reform. To call the issues raised in this note “time-sensitive” would be an understatement—the federal government must act promptly on this matter.
