The Food and Drug Administration (FDA) and National Institute on Drug Abuse (NIDA) are drafting a new agreement governing how the agencies coordinate on federal drug scheduling evaluations, with officials hoping to finalize the agreement before the end of 2026.
The development was disclosed in a September response from the Department of Health and Human Services (HHS) included in a September 23 report from the Government Accountability Office (GAO). The report examined federal drug scheduling procedures as the Drug Enforcement Administration (DEA) continues proceedings concerning the broader rescheduling of marijuana.
According to GAO, the existing agreement between FDA and NIDA is more than 40 years old and no longer accurately reflects how the agencies operate. The agreement establishes procedures for FDA to consult NIDA when preparing scientific and medical evaluations that inform federal drug scheduling recommendations.
Investigators found that the document references organizational units that no longer exist, including FDA’s former Center for Drugs and Biologics and Division of Neuropharmacological Drug Products. It also contains outdated procedures and lacks a provision requiring periodic review.
In its formal response, HHS acknowledged the deficiencies and confirmed that work on a replacement is underway.
“FDA and NIH have been working since late 2023 to develop a revised and updated MOU that we hope to finalize within the current calendar year”, the department stated.
The updated agreement is expected to identify the agencies and personnel responsible for coordinating drug evaluations, establish procedures reflecting current practices, and include a provision requiring regular review to prevent it from becoming outdated again.
GAO said the revisions would help ensure that NIDA’s scientific expertise concerning drug abuse is properly incorporated into scheduling recommendations developed by FDA and submitted through HHS to DEA.
The report also identified a separate issue involving FDA’s internal procedures for evaluating controlled substances. Investigators found that the agency lacks comprehensive written guidance explaining how staff should conduct the eight-factor analyses used to assess substances under the Controlled Substances Act.
In response, HHS said FDA’s Center for Drug Evaluation and Research will begin developing a new internal policy describing how those evaluations are conducted, including staff responsibilities, processes and potential sources of scientific data.
Both developments are relevant to the federal marijuana scheduling process. In August 2023, HHS recommended moving marijuana from Schedule I to Schedule III following a scientific and medical evaluation conducted by FDA. The federal government subsequently moved certain medical marijuana covered by state licenses and FDA-approved marijuana products to Schedule III in April 2026, while continuing separate proceedings concerning the broader rescheduling of marijuana.
Neither GAO nor HHS indicated that the proposed procedural changes require marijuana’s existing scientific evaluation to be repeated or that the updated FDA-NIDA agreement must be completed before the broader rescheduling proceeding can conclude.
