Washington, D.C. — In a new 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 related to rescheduling of marijuana. 

KEY LETTER EXCERPTS: 

“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.” 

[...] 

“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.” 

BACKGROUND: 

History: 

• Marijuana is a psychoactive substance that has been listed in Schedule I since the CSA was enacted in 1970. 
• All substances in Schedule I are classified as having no accepted medical use and a high potential for abuse. 
• This means that the manufacturing, possession, and distribution of marijuana is illegal at the federal level, except for certain research approved by the Drug Enforcement Administration (DEA). 
• During the Obama administration in 2016, the DEA and HHS, acting through the Food and Drug Administration (FDA), conducted a multi-year review of whether to transfer marijuana from Schedule I to a lesser schedule. Both the DEA and HHS agreed that marijuana continued to meet the criteria to be considered a Schedule I substance. 
• HHS concluded that “[…] marijuana has a high potential for abuse, has no accepted medical use in the United States, and lacks an acceptable level of safety for use even under medical supervision.” 
• President Biden made a public statement on October 6, 2022, issuing pardons for all simple possession federal offenses of marijuana, requesting all Governors do the same with state level offenses, and requiring HHS and DOJ to begin the administrative process to quickly review how marijuana is scheduled under federal law. 
• While the administration has the authority to alter a substance’s scheduling status, it is bound by the CSA to consider factors, including whether a substance has a medical use and to determine its potential for abuse and dependence, prior to changing its scheduling status. 

Process: 

• The DEA typically determines whether a substance has a medical use if it has been approved for marketing under the Food Drug and Cosmetic Act (FDCA) and by conducting a five-part test, which considers the following: 
• (1) there were adequate safety studies, 
• (2) the drug’s chemistry is known and reproducible, 
• (3) there are adequate and controlled studies, 
• (4) the drug is accepted by qualified experts, and 
• (5) there is widely available scientific evidence. 
• However, this proposed rule indicates that HHS notified the DEA that HHS disagreed with the existing process and decided to develop its own test to determine whether a substance has medical use under the CSA. 
• This test is comprised of two considerations: 
• (1) if there is widespread medical use of such a substance under the supervision of a licensed health care practitioner operating within a State-authorized program and, 
• (2) if so, there is credible scientific evidence to support medical use of such substance. 
• HHS analyzed marijuana by utilizing its own two-part test, determined it has a medical use, and therefore recommended to transfer marijuana from Schedule I to Schedule III of the CSA. 
• DOJ received HHS’s recommendation and declared that this new two-part test is sufficient to establish medical use, which is an unusual deviation from the typical process. 
• It is notable that the proposed rule states, “DEA has not yet made a determination as to its views of the appropriate schedule for marijuana,” seeming to indicate that the DEA is not yet convinced of the merits of this review. 
• Additionally, most of the professional organizations listed in the HHS “Basis for the Recommendation to Reschedule Marijuana into Schedule III of the Controlled Substances Act” have released position statements that either request more evidence or oppose using marijuana as medicine for their specialties. 

Further Considerations: 

• To date, the FDA has not approved a New Drug Application (NDA) necessary to have satisfied the criteria required under the previous five-factor analysis, such as adequate and well-controlled studies proving safety and efficacy, for a drug product containing botanical marijuana to treat any medical condition(s); thus, it has remained a Schedule I drug without a currently accepted medical use. 
• This is misaligned from typical practice, as the presence of a marketing application approved to treat a certain condition or disease has been central to the FDA's determinations. 
• The Delta-9-tetrahydrocannabinol (THC) potency in marijuana is also continuing to increase. 
• According to the proposed rule, THC potency has spiked from about three percent in 1991 to 17 percent in 2017 and it notes, “[…] DEA anticipates that additional data on public safety risks, risks from acute and chronic marijuana use via oral and inhaled administration routes, and the impact of THC potency may be appropriate for consideration.” 
• The proposed rule also states, “the vast majority of professional organizations did not recommend the use of marijuana in their respective specialties; however, none specifically recommended against it, with the exception of the American Psychiatric Association, which states that marijuana is known to worsen certain psychiatric conditions.” 
• Further, HHS’s own report to Congress titled “Health Effects of Cannabis and Cannabinoids and Barriers to Research” states that “[m]ore research is needed to evaluate the therapeutic potential of cannabis and cannabinoids as a means of safely and effectively treating various indications […] it is also worth noting that the U.S. jurisdictions that have legalized the use of cannabis products for medicinal purposes have often done so with inadequate scientific research to support all allowable uses.” 

CLICK HERE to read the letter.