GAO finds DEA scheduling aligns with HHS recommendations, calls for policy overhaul

The Government Accountability Office examined DEA scheduling actions from 2020 through 2025. Of the 208 substances for which DEA took scheduling actions, DEA considered HHS evaluations and recommendations for all 95 substances for which they were required. For the 84 substances for which DEA had published a final rule as of December 31, 2025, the agency's final scheduling decision aligned with HHS's recommendation; the remaining 11 substances were still under extended temporary scheduling orders.

GAO identified policy gaps in both agencies. DEA does not have policies that identify roles, responsibilities, and procedures related to scheduling. FDA does not have policies or procedures specifying how its staff are to conduct evaluations or develop recommendations. The memorandum of understanding between FDA and NIH's National Institute on Drug Abuse, which guides FDA's consultation with NIDA, is more than 40 years old and does not reflect current entities or procedures.

GAO issued three recommendations: (1) the DEA Administrator should develop policies and procedures that identify DEA's roles, responsibilities, and procedures for evaluating and scheduling substances through administrative, new drug application, temporary, and international treaty scheduling; (2) the FDA Commissioner should develop policies and procedures for Center for Drug Evaluation and Research staff to use when completing eight-factor evaluations and developing scheduling recommendations, including criteria for determining a substance's potential for abuse; and (3) the FDA Commissioner and the NIH Director should update their memorandum of understanding to reflect current entities, procedures, and a term clause for regular review. All three agencies concurred with the recommendations.