(Slip Opinion)<\/p>\n
The approach that the Drug Enforcement Administration currently uses to determine whether a drug has a \u201ccurrently accepted medical use in treatment in the United States\u201d under the Controlled Substances Act is impermissibly narrow. An alternative, two-part inquiry proposed by the Department of Health and Human Services is sufficient to establish that a drug has a \u201ccurrently accepted medical use\u201d even if the drug would not satisfy DEA\u2019s current approach.<\/p>\n
Under 21 U.S.C. \u00a7 811(b), a recommendation by HHS that a drug has or lacks a \u201ccurrently acceptable medical use\u201d does not bind DEA. In contrast, the scientific and medical determinations that underlie HHS\u2019s \u201ccurrently acceptable medical use\u201d recommendation are binding on DEA, but only until the initiation of formal rulemaking proceedings to schedule a drug. Once DEA initiates a formal rulemaking, HHS\u2019s determinations no longer bind DEA, but DEA must continue to accord HHS\u2019s scientific and medical determinations significant deference, and the CSA does not allow DEA to undertake a de novo assessment of HHS\u2019s findings at any point in the process.<\/p>\n
Neither the Single Convention on Narcotic Drugs nor the CSA requires marijuana to be placed into Schedule I or II of the CSA. Both the Single Convention and the CSA allow DEA to satisfy the United States\u2019 international obligations by supplementing scheduling decisions with regulatory action, at least in circumstances where there is a modest gap between the Convention\u2019s requirements and the specific restrictions that follow from a drug\u2019s placement on a particular schedule. As a result, DEA may satisfy the United States\u2019 Single Convention obligations by placing marijuana in Schedule III while imposing additional restrictions pursuant to the CSA\u2019s regulatory authorities.<\/p>\n
April 11, 2024<\/p>\n
NDPA EXPLANATORY: GUIDANCE TO ASSISTANT ATTORNEY GENERAL’S FULL COMMENT:<\/p>\n
To access Mr Fonzone’s full document:<\/p>\n