Why It Matters

A recent Government Accountability Office report found that the DEA lacks policies identifying roles, responsibilities, and procedures for scheduling, and FDA lacks policies or procedures specifying how its staff conducts evaluations or develops recommendations.

At DEA, the gap covers the full range of scheduling pathways: administrative scheduling, new drug application scheduling, temporary scheduling, and international treaty scheduling. At FDA, the gap is concentrated in the eight-factor evaluations that the agency's Center for Drug Evaluation and Research (CDER) staff conduct when developing scheduling recommendations for the Department of Health and Human Services (HHS) to transmit to DEA.

One of those eight factors is a substance's "potential for abuse" relative to other substances, and FDA has no written methodology specifying how its staff is to make that determination. Developing such policies and procedures could help ensure operational consistency, particularly if key personnel with longstanding subject matter expertise depart.

The Big Picture

The Controlled Substances Act (CSA) requires DEA to obtain a scientific and medical evaluation and a scheduling recommendation from HHS, based on an evaluation conducted by FDA, before taking certain scheduling actions. Of the 208 substances for which DEA took scheduling actions from 2020 through 2025, HHS evaluations and recommendations were required for 95, and DEA considered HHS input for all 95. Of those 95 substances, DEA had published a final rule for 84 as of Dec. 31, 2025, and its final scheduling decision aligned with HHS's recommendation in every case. The remaining 11 substances were still under extended temporary scheduling orders. The remaining 113 substances were scheduled through legislation, a pathway under which neither HHS nor DEA evaluations are required.

DEA and FDA have a memorandum of understanding (MOU) to share information, but GAO found gaps in the agencies' existing policies. A separate MOU between FDA and the National Institutes of Health's (NIH) National Institute on Drug Abuse (NIDA), which governs FDA's consultation with NIDA when developing scheduling recommendations, is more than 40 years old and does not reflect the current entities involved or current procedures. It also lacks a term clause to ensure regular review. Without updating and regularly reviewing that MOU, FDA and NIDA staff may not know which entities and procedures to follow to ensure NIDA's expertise on drug abuse informs scheduling recommendations, GAO found.

Members of Congress have raised questions about how the Drug Enforcement Administration considers evaluations and recommendations from the Department of Health and Human Services. According to DEA and FDA officials, scientific disagreements between the two agencies about a substance's schedule have occurred but are rare. In such cases, they typically discuss their differences, share information, and resolve them before soliciting public comments.

GAO issued three recommendations, all of which the affected agencies concurred with, though all three remain open. GAO directed the DEA administrator to develop policies and procedures covering administrative scheduling, new drug application scheduling, temporary scheduling and international treaty scheduling. It directed the FDA commissioner to develop procedures for CDER staff to complete eight-factor evaluations and develop scheduling recommendations. It directed the FDA commissioner and NIH director jointly to update their MOU to reflect current entities and procedures and add a term clause requiring regular review.

The Bottom Line

All three recommendations are currently open, meaning GAO has not yet confirmed actions that satisfy them. Although DEA and FDA have policies addressing aspects of the scheduling process, GAO found gaps in their written policies and procedures that could undermine operational consistency, particularly if experienced personnel leave. Those gaps affect a federal process that determines how controlled substances are regulated and the extent to which criminal penalties under the CSA may apply.

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