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The Notice of Proposed Rulemaking (NPRM) and the Drug Enforcement Administration's (DEA) General Notice of Hearing (GNoH) state: "The purpose of a hearing would be to receive factual evidence and expert opinion regarding whether marijuana should be transferred to Schedule III of the list of controlled substances.Upon reviewing the Notice of Proposed Rulemaking (NPRM) and the Office of Legal Counsel (OLC) memorandum titled "Questions Related to the Potential Rescheduling of Marijuana," it becomes apparent that the DEA takes issue with the Department of Health and Human Services (HHS) approach to the Eight-Factor Analysis and the determination of "currently accepted medical use" (CAMU). 

In the DEA’s Prehearing Statement (PHS), they included a footnote expressing their intent to potentially add more witnesses while also highlighting HHS's refusal to participate with a seeming jab:

"DEA made a request to the Department of Health and Human Services (HHS) and its operating division, the Food and Drug Administration (FDA), to provide witnesses to testify before the Tribunal regarding the scientific and medical evaluations in the HHS Eight-Factor analysis that is the basis for the Notice of Proposed Rulemaking, including the novel two-factor test applied by HHS for determination of 'currently accepted medical use.' HHS rejected DEA's request for witnesses from HHS (or its operating divisions). In the event DEA determines it is necessary to subpoena a witness or witnesses from HHS (or its operating divisions), DEA respectfully requests to reserve the ability to add that witness in a supplemental filing."

Notably, the DEA proposed only five exhibits in their PHS. One of them is:

• Proposed Government Exhibit No. 5: HHS, Basis for Recommendation to Place Marijuana in Schedule III of the Controlled Substance Act, dated August 29, 2023 (252 pages); posted to regulations.gov in support of NPRM.

Despite the DEA's characterization of HHS and FDA as refusing to participate in these hearings, prior case law clarifies the role these agencies should play in rescheduling hearings. It is unlikely that the DEA will be granted a subpoena to compel their appearance.

Case Law Context: DEA–333 and the Placement of Carisoprodol into Schedule IV

In [Docket No. DEA–333] Schedules of Controlled Substances: Placement of Carisoprodol into Schedule IV, the procedural history provides relevant insights. Pursuant to section 811(b), in March 1996, the DEA requested from HHS a scientific and medical evaluation of carisoprodol and a recommendation on whether it should be controlled.

The Administrative Law Judge (ALJ) noted:

"The FDA's detailed administrative process for making its scientific and medical fact findings suggests that Congress did not intend the DEA to secondarily review those filings." (ALJ at 17)

Citing a 1999 Hearing Report of the Subcommittee on Oversight and Investigations of the House Committee on Commerce, the ALJ further stated:

"The scientific and medical evaluation process is a complex one which is part of the balancing of the interests of various agencies and may extend over many years, [and] is subject to review by various components of the FDA and interagency review." (Id.)

However, Congress did not bifurcate the hearing process between the DEA and HHS. Instead, it tasked the Attorney General with the responsibility for conducting the hearing. Neither the statute nor the legislative history indicates that Congress intended challenges to the Secretary's scientific and medical findings to be litigated before HHS. Moreover, both the statute and legislative history emphasize that scheduling proceedings should be conducted expeditiously. For instance, section 811(b) requires the Secretary to submit their report "to the Attorney General within a reasonable time" (21 U.S.C. § 811(b)). Additionally, the House Report expresses Congress's intent "that controls may be established expeditiously where necessary" (1970 U.S.C.C.A.N. at 4589).

ALJ's Ruling on the Binding Nature of FDA's Scientific and Medical Evaluation

The ALJ held that:

"The [Controlled Substances Act] limits the scope of the administrative hearing to those issues outside of the medical and scientific fact-findings of the FDA." (ALJ at 11)

According to the ALJ:

"The plain language and legislative history of [sections 811(a) and (b)] and federal case law indicate that Congress intended that the Secretary's scientific and medical fact-findings bind the [Agency] throughout the scheduling process."

Upon receiving the Secretary's evaluation and recommendation, the Attorney General must:

"Determine that these facts and all other relevant data constitute substantial evidence of potential for abuse such as to warrant control." (21 U.S.C. § 811(b), emphasis added)

If the Secretary's evaluation and other relevant data provide substantial evidence warranting control, the Attorney General may initiate proceedings to control the drug. Congress further stipulated that:

"Rules of the Attorney General [to control a drug] shall be made on the record after opportunity for a hearing pursuant to the rulemaking procedures prescribed by" the Administrative Procedure Act (APA). (21 U.S.C. § 811(a))

Under the APA, a rule may not be issued except on consideration of the whole record or those parts cited by a party and supported by reliable, probative, and substantial evidence (5 U.S.C. § 556(d)). If the Secretary's findings on medical and scientific matters are not subject to litigation in the subsequent rulemaking hearing, the only issues left to litigate would be the drug's "actual" abuse, its "history and current pattern of abuse," and the "scope, duration, and significance of abuse" (21 U.S.C. § 811(b)).

OLC Memorandum on Potential Rescheduling of Marijuana

The OLC memorandum titled "Questions Related to the Potential Rescheduling of Marijuana" provides further clarity on this matter:

• DEA's Current Approach: The DEA's method for determining whether a drug has a "currently accepted medical use in treatment in the United States" under the Controlled Substances Act is impermissibly narrow.
• Alternative Proposed by HHS: An alternative, two-part inquiry proposed by HHS is sufficient to establish that a drug has a "currently accepted medical use," even if it does not satisfy the DEA's current criteria.

Under 21 U.S.C. § 811(b):

• HHS Recommendations: A recommendation by HHS that a drug has or lacks a "currently acceptable medical use" does not bind the DEA.
• Binding Determinations: The scientific and medical determinations underlying HHS's recommendation are binding on the DEA until the initiation of formal rulemaking proceedings.
• Post-Rulemaking Deference: Once formal rulemaking begins, HHS's determinations no longer bind the DEA. However, the DEA must continue to accord significant deference to HHS's scientific and medical findings.
• No De Novo Assessment: The Controlled Substances Act does not permit the DEA to undertake a de novo (fresh) assessment of HHS's findings at any point in the process.

The legislative history supports this perspective. The House report on the CSA states that Congress intended "all scientific and medical determinations" to be "made by the Secretary," rather than the Attorney General (H.R. Rep. No. 91-1444, at 22–23). Nothing suggests that the Attorney General could make independent scientific and medical judgments once formal rulemaking is underway.

Furthermore, the House report emphasized that section 811 was:

"Not intended to authorize the Attorney General to undertake or support medical and scientific research" for the purpose of scheduling, as that research "is within the competence of [HHS]." (Id. at 33)

The Supreme Court, in Gonzales v. Oregon, noted that the CSA places "medical judgments" made under the Act in the "hands of the Secretary" (546 U.S. at 265).

The OLC concluded:

"To give proper effect to HHS's scientific and medical determinations, DEA must continue to accord significant deference to those determinations even once formal rulemaking has commenced and may not undertake a de novo assessment of HHS's findings at any point in the rulemaking process." (OLC Memorandum, p. 26)

Given the legal framework and historical context, it appears unlikely that the DEA will succeed in compelling HHS or FDA officials to testify in the rescheduling hearings. The Controlled Substances Act and relevant case law suggest that while the DEA is not strictly bound by HHS's recommendations on whether a drug has a "currently accepted medical use," it must give significant deference to HHS's scientific and medical findings throughout the rulemaking process.

The DEA's expressed intent to potentially subpoena HHS witnesses indicates tension between the agencies regarding the rescheduling of marijuana. However, established legal precedent underscores that the DEA cannot undertake a de novo assessment of HHS's findings and must rely on the substantial evidence provided by HHS in making its determinations.

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