In a recent letter to Attorney General Merrick Garland and Department of Health and Human Services (HHS) Secretary Xavier Becerra, House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) and Subcommittee on Health Chair Brett Guthrie (R-KY) requested information regarding the rescheduling of marijuana.
"We write to express our concerns with the recent notice of proposed rulemaking titled 'Schedules of Controlled Substances: Rescheduling of Marijuana,' to transfer marijuana from Schedule I to Schedule III of the Controlled Substances Act (CSA). The circumstances surrounding this proposed rule are unusual, and we are concerned by the process that led to this determination," stated Rodgers and Guthrie in their letter.
The representatives expressed support for research into innovative therapies but raised concerns about potential political motivations behind the decision. "We support research into innovative therapies to improve patient outcomes, but we are concerned with how the normal process was circumvented to achieve a result for political purposes and we have a number of unanswered questions."
Marijuana has been classified as a Schedule I substance since the CSA was enacted in 1970, indicating it has no accepted medical use and a high potential for abuse. Federal law prohibits its manufacturing, possession, and distribution except for certain DEA-approved research. A multi-year review conducted during the Obama administration concluded that marijuana should remain a Schedule I substance due to its high potential for abuse and lack of accepted medical use.
President Biden issued pardons for all simple possession federal offenses of marijuana on October 6, 2022, urging governors to do the same at the state level. He also directed HHS and DOJ to expedite reviewing marijuana's scheduling status under federal law.
The DEA typically assesses whether a substance has medical use based on FDA approval under the Food Drug and Cosmetic Act (FDCA) and a five-part test evaluating safety studies, known chemistry, controlled studies, expert acceptance, and scientific evidence. However, HHS developed its own two-part test for determining medical use under the CSA: widespread medical use under licensed health care supervision within state-authorized programs and credible scientific evidence supporting such use.
HHS applied this new test to analyze marijuana, determined it has medical use, and recommended transferring it from Schedule I to Schedule III. The DOJ declared this new test sufficient for establishing medical use. However, most professional organizations listed in HHS’s recommendation either request more evidence or oppose using marijuana as medicine.
To date, no New Drug Application (NDA) containing botanical marijuana has been approved by the FDA for treating any medical condition(s), keeping it classified as a Schedule I drug without an accepted medical use. Additionally, THC potency in marijuana has increased significantly over time. The proposed rule notes that further data on public safety risks related to THC potency may be necessary.
"The vast majority of professional organizations did not recommend the use of marijuana in their respective specialties; however, none specifically recommended against it," except for the American Psychiatric Association which noted that "marijuana is known to worsen certain psychiatric conditions." An HHS report also highlighted that more research is needed on cannabis's therapeutic potential.
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