The US Drug Enforcement Administration (DEA) has formally requested that the Food and Drug Administration be ‘compelled’ by the court to give evidence at the upcoming cannabis rescheduling hearings.
In a document sent to the case’s Administrative Law Judge (ALJ) John Mulrooney on Friday (December 13), which marked the deadline for any additional evidential materials to be submitted, the DEA requested subpoenas of four FDA officials to testify at the hearing.
Earlier this month, Business of Cannabis reported that the US Department of Health and Human Services (HHS), which first recommended cannabis be rescheduled and set the whole process in motion, had rejected an invitation to attend the hearing on December 02.
Given the reluctance of the HHS, which the FDA is part of, to provide evidence, the DEA is now calling for legal action to force four experts to give evidence.
The four individuals it sees as critical witnesses are:
- Douglas C. Throckmorton, M.D. – An expert in regulating controlled substances, their benefits, and associated risks.
- Marta Sokolowska, Ph.D. – Specializing in drug abuse liability and scheduling strategies.
- Dominic Chiapperino, Ph.D. – An expert in organic chemistry.
- Patrizia Cavazzoni, M.D. – An authority in psychiatry and neuropsychopharmacology.
These officials are expected to provide testimony on the scientific and medical evaluations conducted by the Department of Health and Human Services (HHS) in its eight-factor analysis, which forms the foundation of the DEA’s Notice of Proposed Rulemaking for cannabis rescheduling.
The HHS Eight Factor Analysis evaluates substances for scheduling under the Controlled Substances Act by examining their abuse potential, pharmacological effects, and current scientific knowledge.
It also considers the history and patterns of use, the scope and significance of abuse, and risks to public health, such as addiction and safety concerns like impaired driving. Additionally, it assesses a substance’s dependence liability and whether it serves as a precursor to other controlled substances, providing a comprehensive framework for evidence-based scheduling decisions.
The DEA’s request emphasizes the FDA officials’ ability to clarify the scientific and regulatory basis for HHS’s recommendation to reschedule cannabis.
Another key and controversial inclusion in the document was a notice that the DEA plans to submit tens of thousands of public comments as evidence.
During the public comment phase of the rescheduling process, which took place between May and July this year, the DEA received over 30,000 from interested parties, including the general public, stakeholders in the medical and scientific community, legal and regulatory experts, industry representatives, advocacy groups, and government agencies.
Previously, Judge Mulroony had stated that such submissions were ‘not evidence’, and could not serve as a basis for regulatory decisions.
During the preliminary hearing on December 02, he went on to acknowledge the importance of hearing public feedback, noting the 42,000 submitted comments, but said it was impractical to review them all individually.
In its filing, the DEA justified the inclusion of public comments by referencing the Notice of Proposed Rulemaking (NPRM), which stated that public input would play a role in the decision-making process. The agency argued that the volume and diversity of opinions captured in the comments reflect significant public interest and provide context for the proposed changes.
“The Government is offering the public comments to the NPRM as evidence in this hearing… Due to the importance of having the public comments to the NPRM be admitted into evidence for consideration by the decision-makers, the government seeks leave to file electronic copies of the comments into evidence, rather than paper hard copies,” it stated.
Judge Mulrooney expressed skepticism about the DEA’s attempt to include such a large volume of public comments, calling it a ‘gargantuan mass of inadmissible comments’ in earlier rulings.
Some stakeholders have accused the DEA of attempting to overwhelm the hearing process, slowing deliberations and potentially drawing criticism from stakeholders who question the efficiency of the proceedings.