Drug Enforcement Administration

The Order further explained that it was not necessary for the Attorney General to issue a scheduling order for Epidiolex through normal notice-and-comment rulemaking according to the Administrative Procedure Act (APA), because the FDA approval of Epidiolex represented an expedited scheduling action.

As we noted previously, by statute, the DEA had 90 days from the approval date (technically September 23, a Sunday or the next business day September 24) to issue a scheduling decision, even though it could have potentially opted for the full APA process scheduling process, which would have taken much longer.

Regulatory Analyses

Administrative Procedure Act

The CSA provides for an expedited scheduling action where control of a drug is required by the United States' obligations under the Single Convention. 21 U.S.C. 811(d)(1). Under such circumstances, the Attorney General must “issue an order controlling such drug under the schedule he deems most appropriate to carry out such obligations,” without regard to the findings or procedures otherwise required for scheduling actions. Id. (emphasis added). Thus, section 811(d)(1) expressly requires that this type of scheduling action not proceed through the notice-and-comment rulemaking procedures governed by the Administrative Procedure Act (APA), which generally apply to scheduling actions; it instead requires that such scheduling action occur through the issuance of an “order.”

Although the text of section 811(d)(1) thus overrides the normal APA considerations, it is notable that the APA itself contains a provision that would have a similar effect. As set forth in 21 U.S.C. 553(a)(1), the section of the APA governing rulemaking does not apply to a “foreign affairs function of the United States.” An order issued under section 811(d)(1) may be considered a foreign affairs function of the United States because it is for the express purpose of ensuring that the United States carries out its obligations under an international treaty.

Scottsdale Research Institute v. DEA, No. 19-1120 (DC Circuit)

Washington v. Barr, No. 18-859 (2nd Circuit)

Opinion and Recommended Ruling, Findings of Fact, Conclusions of Law and Decision of Administrative Law Judge (September 6, 1988)