Politics
Federal Watchdog Agency Says Drug Scheduling Process Has ‘Gaps’ As DEA’s Marijuana Review Continues
A new federal watchdog report is calling on agencies to improve their policies that govern the drug scheduling process—including how they evaluate substances and develop recommendations.
The new U.S. Government Accountability Office (GAO) report published on Wednesday comes as the federal government continues to consider whether to comprehensively reschedule marijuana under the Controlled Substances Act (CSA) to Schedule III as was recommended by the Department of Health and Human Services (HHS).
In general, GAO found that the Drug Enforcement Administration’s (DEA) scheduling decisions usually aligned with HHS and Food and Drug Administration (FDA) recommendations during the period of six years that it examined—but that both agencies lack important procedures for carrying out their responsibilities and to ensure consistency in the process.
“We found that DEA and FDA have some policies that address aspects of the scheduling process; however, these policies have gaps,” the report said. “For example, DEA does not have any policies or procedures regarding how its staff are to conduct evaluations or schedule substances. In addition, FDA does not have policies or procedures specifying how its staff are to conduct evaluations or develop scheduling recommendations for substances.”
“DEA does not have policies that assign roles and responsibilities related to scheduling substances, and neither DEA nor FDA have policies that describe the specific procedures staff should follow for fulfilling their responsibilities related to preparing scheduling evaluations and recommendations.”
GAO said DEA specifically is lacking policies that identify roles, responsibilities and procedures for
- collecting and analyzing data prior to initiating administrative rulemaking;
- carrying out responsibilities related to new drug application scheduling;
- conducting a three-factor analysis and making findings to issue a temporary scheduling order;
- conducting an eight-factor analysis and making findings to determine schedule placement; or
- considering HHS scientific and medical evaluations and scheduling recommendations and making final scheduling decisions.
FDA, for its part, does not have policies or procedures that:
- outline how its staff are to conduct an eight-factor analysis or make scheduling recommendations; or
- clearly define the criteria and process for determining a substance’s “potential for abuse,” including its abuse potential relative to other substances.
“These policies have gaps that may pose a risk to the consistency of DEA’s and FDA’s future operations in the event of staff turnover or any other disruption that could lead to a loss of institutional knowledge,” the report said.
GAO noted that an FDA memorandum of understanding with the National Institutes of Health’s (NIH) National Institute on Drug Abuse (NIDA) that describes procedures for consulting on scheduling recommendations is over 40 years old and, as such, is “outdated because it does not reflect the current entities involved or procedures.”
GAO is making three recommendations to improve the drug scheduling process:
- The Administrator of DEA should develop policies and procedures that identify DEA’s roles, responsibilities, and procedures for evaluating and scheduling substances through administrative scheduling, new drug application scheduling, temporary scheduling, and international treaty scheduling under relevant statutes (including collecting and evaluating data, conducting three-factor and eight-factor analyses, and determining scheduling decisions).
- The Commissioner of FDA should develop policies and procedures that Center for Drug Evaluation and Research staff are to use to when completing eight-factor evaluations and developing scheduling recommendations, including the criteria and process for determining a substance’s “potential for abuse,” including abuse potential relative to other substances.
- The Commissioner of FDA and the Director of NIH should update their memorandum of understanding (MOU) concerning developing drug scheduling recommendations. The updated MOU should reflect the current entities involved and procedures and include a term clause to ensure the MOU is regularly reviewed.
The watchdog said that the Department of Justice, DEA, HHS, FDA and NIH have all agreed with the recommendations.
Depending on the process through which a drug is being scheduled—via administrative scheduling, new drug application scheduling, temporary scheduling, international treaty scheduling through domestic scheduling orders or legislation—DEA is sometimes required to consider recommendations and medical and scientific evaluations from HHS.
During the period GAO examined—2020 through 2025—DEA was required to do so for 95 of the 208 substances for which the agency took scheduling actions, and it did so 100 percent of the time. The agency’s final scheduling decision aligned with HHS recommendations for all 84 substances for which it published a final scheduling decision, while the remaining 11 were still subject to extended temporary scheduling orders.
DEA and FDA officials told GAO that “differences of scientific opinion between the two agencies about a substance’s schedule are rare, but they have occurred,” the report said. “In such cases, they typically discuss their differences, share data and other information, and resolve any differences before DEA solicits public comments.”
GAO said that it conducted the new evaluation because “members of Congress have raised questions and concerns about how DEA considers scientific and medical evaluations and scheduling recommendations from HHS when making its decisions.”
“A substance’s schedule and quantity control the extent to which criminal penalties under the Controlled Substances Act may be levied regarding its illegal manufacturing, distribution, or possession. In recent years, members of the public, interest groups, and elected officials have raised questions about how certain substances are scheduled under the act.”
“For example, substances such as marijuana have been legalized in some states for medical use,” the report said, noting that Attorney General Todd Blanche in April issued an order immediately moving marijuana products regulated by a state medical cannabis license from Schedule I of the CSA to Schedule III, along with marijuana products that are approved by the Food and Drug Administration (FDA).
A DEA hearing that recently concluded testimony is considering broader marijuana rescheduling.
The GAO report included an appendix focused on the ongoing cannabis rescheduling process, and noted that it involved a new two-part test to evaluate marijuana’s medical value was sanctioned by the Department of Justice Office of Legal Counsel.
“In April 2024, the Department of Justice Office of Legal Counsel issued an opinion related to questions on the potential rescheduling of marijuana. One issue addressed by the Office of Legal Counsel was whether a substance that satisfies HHS’s two-part inquiry was sufficient to establish a currently accepted medical use under the statute, even if the substance has not been approved by the FDA and does not satisfy DEA’s five-part test. According to the Office of Legal Counsel, DEA’s approach to determining whether a substance had a currently accepted medical use was an impermissibly narrow interpretation of the Controlled Substances Act and that satisfying HHS’s two-part inquiry was sufficient to establish a substance had a currently accepted medical use. This was still the case, even if the substance had not been approved by the FDA and did not satisfy DEA’s test.”
That office, it noted, also determined that moving cannabis to Schedule III would not violate the U.S.’s international treaty obligations.
A DEA administrative law judge is currently considering testimony in the marijuana rescheduling hearing. After he issues a recommendation, DEA Administrator Terrance Cole will make the final determination on whether cannabis is comprehensively moved to Schedule III.
That said, the marijuana rescheduling process is being challenged with several lawsuits that have been consolidated by a federal appeals court. Those pieces of litigation against the cannabis reform have been filed by state attorneys general, marijuana legalization opponents and a cannabis-focused biopharmaceutical corporation.
The U.S. Court of Appeals for the District of Columbia Circuit recently rejected a drug testing industry association and a pharmaceutical company’s request to block the Trump administration from moving forward with cannabis rescheduling while the litigation is considered.
