Separation of Drug Scheduling Powers

HHS Secretary RFK Jr. has substantial power to block or constrain DEA proposals to schedule drugs, including psychedelics

Who controls drug scheduling? Law enforcement or public health officials?

In a new paper, Separation of Drug Scheduling Powers, forthcoming in the Yale Law Journal Forum, I analyze the roles of federal agencies in drug scheduling. This complex administrative process determines which drugs are dangerous or addictive enough to require strict regulation. The Controlled Substances Act (CSA) of 1970 provides criteria for determining which drugs should be controlled, and which of five tiers or schedules they should fall into (where Schedule I substances are the most strictly regulated and Schedule V the least).

It is commonly believed that the Drug Enforcement Administration (DEA) is responsible for drug scheduling determinations, while the Department of Health and Human Services (HHS) plays only an advisory role. However, my analysis of the CSA text, structure, purpose, and history suggests otherwise. The Secretary of HHS, currently Robert F. Kennedy Jr., has more scheduling power than is commonly acknowledged. The Secretary can block and constrain DEA scheduling proposals. However, since 1970, HHS has frequently minimized its drug scheduling role, and DEA has effectively assumed scientific decision-making authority meant for public health officials.

President Nixon submitted the first CSA draft to Congress in 1969. In a series of hearings held then and the following year, Congress debated Nixon’s version and subsequent Senate and House drafts. Nixon wanted the U.S. Attorney General in charge of drug control. But that choice concerned physicians, medical researchers, public health officials, and members of Congress. They worried that placing the nation’s highest law enforcement official in charge of drug scheduling would prevent researchers from studying controlled drugs and block doctors from prescribing them.

Health experts from leading hospitals, medical schools, and healthcare associations urged Congress to place scheduling power in the Secretary’s hands. Congress heard and addressed their concerns. According to Representative Rogers speaking on the House Floor, “[T]he scientific community and medical community of this Nation were greatly upset over the fact that scientific and medical decisions in the Senate bill were entered in the [DOJ], with the [AG] having the responsibility to make scientific and medical determinations which were not in the competency of that Department. Rogers said Congress had changed that, so that the Secretary “will determine scientific and medical decisions. This is a most important change.”

Congress effectively reached a compromise, dividing scheduling authority between the law enforcement and public health officials. The Secretary would make scientific and medical judgements regarding drug scheduling, and the Attorney General would make non-scientific, law enforcement decisions (today, the Attorney General delegates drug scheduling authority to DEA, and HHS delegates many responsibilities to the FDA).

In 1970, Representative Springer highlighted this division of scheduling authority. “Let us also make a definite point of the fact that purely enforcement responsibilities are placed with [DOJ],” he said, whereas “medical and scientific judgments necessary to drug control are left where they properly should lie [with the Secretary].”

Federal officials acknowledged this division of labor for at least ten years. But by 1984, when DEA proposed classifying MDMA as a Schedule I drug, the separation of drug scheduling powers created by Congress was largely overlooked.

In Grinspoon v. DEA, decided by the U.S. Court of Appeals for the First Circuit in 1986, Harvard Medical School professor Lester Grinspoon challenged the DEA proposal to schedule MDMA. He and other medical experts argued that categorizing MDMA as Schedule I was unwarranted and would impede scientific research. Judges of the First Circuit were not persuaded. And the DEA successfully placed MDMA in Schedule I, an outcome that impeded scientific research on MDMA for decades.

Notably, in Grinspoon, the court underestimated HHS’s role in drug scheduling, but the agency did as well. Instead of performing a scientific and medical evaluation and developing scheduling recommendations, HHS “simply rubber-stamped” DEA’s analysis, according to the court. Furthermore, FDA failed to send HHS information that might have undermined DEA’s proposal. Nevertheless, the court concluded that these failures amounted to nothing more than harmless error because DEA need not follow the Secretary’s recommendations. But Congress, the CSA, and the U.S. Supreme Court say otherwise.

The CSA requires HHS to draft scientific and medical recommendations that include whether a drug should be controlled, and if so, the appropriate schedule to which it should be added. Importantly, the CSA binds DEA to those recommendations, which is consistent with numerous statements made during 1970 congressional hearings. As health experts and members of Congress repeatedly said, it would be inappropriate for law enforcement officials to make scientific or medical judgements. Accordingly, those decisions are the exclusive domain of the Secretary. And consequently, DEA should be bound to them, as required by the CSA. Justice Kennedy seemingly agreed in the only U.S. Supreme Court opinion to address this statutory division of power, Gonzales v. Oregon (2006).

Gonzales was not about drug scheduling. But the Court considered whether the U.S. Attorney General could make scientific or medical decisions. After Oregon legalized physician-assisted suicide, the Attorney General threatened to revoke the DEA licenses of doctors who prescribed drugs for this purpose. Although FDA had approved the drugs for other uses, prescribing them for euthanasia was an unapproved, off label use.

Justice Kennedy analyzed the text and structure of the CSA, as well as its legislative history. He concluded that “the Attorney General does not have the sole delegated authority under the CSA. He must instead share it with, and in some respects defer to, the Secretary, whose functions are likewise delineated and confined by the statute.”

Kennedy quoted the Congressional Record of 1974. “All decisions of a medical nature are to be made by the Secretary.” In contrast, the Attorney General makes law enforcement decisions, for instance, judgments regarding the security of stocks of controlled drugs and the maintenance of required records. Furthermore, the CSA’s structure “conveys unwillingness to cede medical judgments to an executive official who lacks medical expertise.”

What does all this legal history mean for drug scheduling today? In Separation of Drug Scheduling Powers, I explain how the Secretary of HHS has the power to overrule and constrain DEA when the agency makes drug scheduling proposals. That means RFK Jr. could potentially deschedule controlled substances, removing them from Schedule I and federal control under the CSA.

I argue that the Secretary has two distinct but interrelated powers, which are defined by 21 U.S.C. 811(b). This CSA provision binds DEA to the Secretary’s scientific and medical recommendations. One sentence defines both a powerful drug control veto and a more subtle scheduling veto. The control veto empowers HHS to overrule drug scheduling proposals if it believes a drug should not be controlled. Dr. Brett Giroir, Assistant Secretary for Health during President Trump’s first term, used the control veto to prevent DEA from controlling kratom, a psychoactive plant native to Southeast Asia. Although used infrequently, the control veto is universally accepted. Even DEA and the Grinspoon court would acknowledge its legitimacy.

Rather than overriding DEA, the HHS scheduling veto can constrain DEA’s scheduling options. For instance, if HHS believes that a drug should be controlled rather than removed from all schedules, the Secretary’s recommendation could limit which schedules DEA can select for a substance—DEA lacks statutory authority to select any schedule it likes.

In 1970, Representative Satterfield described the control and scheduling vetoes. First, he referenced the control veto, stating, “I point specifically to the provision which will give the Secretary the power and the authority to prohibit control of a drug which he determines from a medical or scientific standpoint should not be controlled.” Satterfield then described the scheduling veto, claiming, “by the same token,” the Secretary can “prohibit transfer of a drug from one category to another.”

Notice that preventing the transfer a drug from one schedule to another is not something the control veto can achieve. It’s too blunt an instrument for that. If limited to the control veto, the Secretary could only recommend that a substance be removed entirely from federal control to block its transfer to another schedule.

The scheduling veto provides a more nuanced alternative. Because the Secretary’s scientific recommendations must include the appropriate schedule for each drug, and they bind DEA, the recommendations should limit the schedules into which DEA can place a drug. If instead of recommending that kratom remain uncontrolled, HHS had recommended that it be classified as a Schedule III drug, that recommendation should limit DEA to scheduling kratom no higher than Schedule III. In fact, for at least a decade, that appears to have been the custom. In 1980, Frank Vocci, Chief of Drug Abuse at FDA, wrote that DEA can select a lower schedule than recommended by the Secretary but DEA “will not opt to control in a higher schedule.”

Despite Satterfield’s remarks and prior custom, the scheduling veto is more controversial than the control veto. Last year, when Biden’s plan to reschedule marijuana was advancing, HHS and DEA clashed over the portion of CSA text that describes the Secretary’s scientific and medical recommendations. Consistent with the Gonzales opinion, and the CSA text and legislative history, HHS argued that the Secretary’s recommendations bind DEA throughout the scheduling process. In contrast, DEA claimed that once it announced a proposed scheduling rule, such as the proposal to reschedule marijuana, DEA was no longer bound by the Secretary’s recommendations.

The Office of Legal Counsel (OLC) within the Department of Justice sided with DEA. OLC concluded that the Secretary’s recommendations could not bind DEA once it started the rulemaking process. In the forthcoming paper, I explain why OLC’s interpretation is incorrect.

Interestingly, OLC acknowledged that Congress had placed all scientific and medical decisions solely in the Secretary’s hands. Nevertheless, OLC concluded that the Administrative Procedure Act precluded limiting DEA’s scheduling choices once rulemaking started. Specifically, constraining DEA to the Secretary’s conclusions would deprive interested stakeholders of the opportunity to present evidence that might contradict the Secretary’s conclusions (when DEA proposes a scheduling change, it holds a hearing where stakeholders can testify).

DEA has made similar arguments in the past. For instance, in a hearing to schedule the drug carisoprodol, an administrative law judge stated that DEA could not second guess or re-litigate the Secretary’s scientific or medical recommendations. The DEA Administrator overruled the administrative law judge. In doing so, she cited the Administrative Procedure Act, making claims comparable to OLC’s marijuana rescheduling opinion. But DEA and OLC got it wrong.

Concluding that the Secretary’s scientific and medical recommendations do not bind DEA once rulemaking begins contradicts the CSA text, purpose, and history. 21 U.S.C. 811(b) binds DEA to the Secretary’s recommendations without limitation, and the history of the CSA contains substantial evidence that Congress meant for medical judgements to be made by the Secretary alone, as concluded by Justice Kennedy concluded in Gonzales. Allowing law enforcement officials to make scientific judgments undermines the text of the CSA, its purpose, and the intent of Congress.

Numerous unscientific scheduling decisions illustrate what happens when the separation of drug scheduling powers is disrupted. Instead of maintaining access to controlled substances for scientists and medical professionals, the fears expressed by public health experts in 1970 have largely materialized.

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*The views expressed on Psychedelic Week do not represent the views of Harvard University, POPLAR at the Petrie-Flom Center at Harvard Law School, Florida State University or its College of Law, or Yale University. Psychedelic Week is an independent project unaffiliated with these and other programs and institutions.

Mason Marks, MD, JD is the Florida Bar Health Law Section Professor at Florida State University. He is the senior fellow and project lead of the Project on Psychedelics Law and Regulation (POPLAR) at the Petrie-Flom Center at Harvard Law School, and a visiting fellowat the Information Society Project at Yale Law School. Professor Marks teaches drug law, psychedelic law, constitutional law, and administrative law. His forthcoming book on psychedelic law and politics will be published by Yale University Press. He tweets at @MasonMarksMD and @PsychedelicWeek. Follow him on LinkedIn and Bluesky.