Who Is Really in Charge of Drug Scheduling?

Scholar argues that HHS and the DEA should balance each other’s federal drug scheduling authority.

The U.S. Congress divided drug scheduling power—the authority to restrict use and penalize abuse of drugs—between the U.S. Drug Enforcement Administration (DEA) and the U.S. Department of Health and Human Services (HHS). The agencies’ understanding of their responsibilities, however, conflicted so much that the U.S. Department of Justice’s office that resolves interagency disputes, known as the Office of Legal Counsel (OLC), had to intervene last year. It resolved the dispute in favor of the DEA.

In a recent article, Mason Marks, a professor at the Florida State University College of Law, argues that the DEA has assumed a greater role in drug scheduling than Congress intended, resulting in more restrictive scheduling that threatens public health.

According to Marks, the DEA places drugs in highly restrictive schedules more often than the agency deschedules drugs or moves drugs to less restrictive schedules. Under the Controlled Substances Act, doctors cannot prescribe drugs in the most restrictive schedule, and the federal government imposes higher penalties for their use, possession, and distribution. The most restrictive drug schedule includes heroin and marijuana, and the least restrictive schedule includes cough syrups.

Marks explains that Congress granted HHS, as an agency with scientific and medical expertise, the power to influence drug scheduling and “balance law enforcement perspectives.” HHS possesses a “scheduling veto” that dictates which schedule the DEA can place a drug into, Marks notes. In addition, he observes that HHS possesses a “control veto” that prevents the DEA from scheduling a drug entirely.

HHS’s drug scheduling authority yields public health benefits, Marks argues. For example, HHS used its “control veto” in 2018 to prevent the DEA from scheduling kratom, a pain reliever used as an opioid substitute. HHS explained that removing kratom from the legal drug market would likely stigmatize people using the drug for pain relief, encourage people to switch to more dangerous drugs such as heroin, and increase fatal overdoses.

Despite the agency’s power to influence drug scheduling, HHS sometimes abdicates its scheduling responsibilities, Marks contends. As an example, he explains that HHS failed to produce independent scientific evidence or consult expert panels when the DEA sought to place MDMA, a stimulant and hallucinogen, in the most restrictive schedule. Instead, HHS “merely repeated” the DEA’s conclusions about the drug, which medical experts disagreed with, Marks notes.

Marks argues that HHS and the DEA acted contrary to Congress’s intent by failing to provide scientific recommendations and scheduling MDMA without relying on scientific recommendations. Such “unbalanced scheduling actions” produce harmful public health consequences, Marks maintains. He observes that after the DEA succeeded in placing MDMA on the strictest level of federal control, research on the drug halted for 20 years because it was expensive and highly regulated.

Recently, the DEA and HHS disagreed over their drug scheduling authority during deliberations about marijuana scheduling. In support of its recommendation to move marijuana to a less restrictive schedule, HHS provided scientific support for marijuana’s medical uses. HHS contended that its recommendations legally bound the DEA throughout the entire drug scheduling process. The DEA argued that it only had to follow HHS’s medical recommendations before the DEA published a notice of proposed rulemaking to schedule a drug, but could consider other evidence submitted to the DEA once the scheduling process began, Marks explains.

The U.S. Attorney General asked OLC to resolve this dispute, and OLC agreed with the DEA and concluded that HHS’s marijuana scheduling recommendations were not binding. Marks argues that OLC’s interpretation of the agencies’ drug scheduling authority was incorrect and contrary to Congress’s intent.

According to Marks, the DEA must follow HHS’s scientific and medical recommendations throughout the entire scheduling process. The misinterpretation of the DEA’s authority results in the unscientific scheduling of drugs with “therapeutic potential” and harms scientific research and public health, Marks argues.

Marks explains that all three branches of the federal government can help restore the balance between the DEA’s and HHS’s drug scheduling authority.

Congress could amend the Controlled Substances Act to clarify the agencies’ respective drug scheduling authority, Marks argues. He suggests that Congress could increase HHS’s authority or require the agencies to provide more evidence before scheduling drugs. Marks contends that congressional action “could have the greatest impact” on repairing the DEA’s and HHS’s power imbalance.

The DEA and HHS could also clarify their own drug scheduling authorities by drafting an agreement “that clearly defines their roles,” Marks suggests. He predicts that because OLC agreed with the DEA’s interpretation of its authority, the DEA may not be willing to draft an agreement. In that case, “HHS could use its control veto more frequently to balance DEA influence” on drug scheduling, Marks argues.

Marks proposes that if Congress, the DEA, and HHS cannot clarify drug scheduling authority, the President could issue an executive order explaining the DEA’s and HHS’s drug scheduling responsibilities.

Finally, Marks argues that the federal courts could prevent the DEA from overreaching its statutory authority. Federal courts previously deferred to the DEA’s interpretation of its drug scheduling authority, Marks explains. He predicts that courts may now “feel less constrained by DEA statutory interpretations” under the U.S. Supreme Court’s 2024 decision in Loper Bright Enterprises v. Raimondo, which requires courts to determine the meaning of statutes without deferring to an agency’s interpretation.

According to Marks, restoring the balance between the DEA and HHS will allow “public health experts to resume their guiding role in drug scheduling.”