The public now has insight into why the U.S. Department of Health and Human Services has recommended that the federal government loosen its restrictions on cannabis.
HHS released more than 250 pages of documents late Friday in response to a suit filed by Matthew Zorn, a lawyer, who then published the documents on his blog. Cannabis Wire independently confirmed the authenticity of the documents.
Since the passage of the Controlled Substance Act of 1970, cannabis has been in Schedule I, a designation for substances deemed to have no medical value and a high potential for misuse. HHS recommended in August that cannabis be moved to Schedule III, which marks the first time that the agency has acknowledged that cannabis has medical use.
The Drug Enforcement Administration, which has the final say, is currently reviewing the recommendation. If they agree, the public will have a chance to weigh in. HHS and DEA have previously received petitions to reschedule cannabis, most often from reform advocates, but have rejected them. The last petition was rejected in 2016.
President Joe Biden put wheels in motion for a federal review of cannabis in October 2022 when he called on his administration to explore rescheduling. He declared that “it makes no sense” that cannabis is in the same category as heroin.
In August 2023, Bloomberg first reported on the Schedule III recommendation, though no documents detailing HHS’s decision were released until today.
The United States sits at a tipping point, with cannabis legal for adults in 24 states and D.C., and legal medical cannabis in more than half the country.
As the documents make clear, it is these state medical cannabis programs, and the data emerging from them, that played a critical role in the HHS recommendation. So, too, did the field of cannabis-focused research, which has been booming in recent years.
Schedule III would not legalize cannabis, but it would lead to several significant changes. On research, for example, it would remove hurdles, as there are many more hoops for researchers to jump through when dealing with a Schedule I substance. For the industry, it would bring tax relief. Revenue Code Section 280E, which only applies to Schedules I and II, has prevented cannabis businesses from making the same deductions as other businesses, leading to hefty tax bills.
An overview of the documents
The 252 pages of released documents begin with a letter dated August 29, 2023 from Rachel Levine, Assistant Secretary for Health at HHS, to DEA Administrator Anne Milgram. In it, Levine passes along her recommendation that “marijuana, referring to botanical cannabis (Cannabis sativa L.) that is within the definition ‘marihuana’ or ‘marijuana’ in the CSA, be controlled in Schedule III of the CSA.”
Levine conveys that her recommendation is “based” on her “review of the evidence and [U.S. Food and Drug Administration] recommendation,” and that the National Institute on Drug Abuse “concurs” with the FDA, too.
Attached to Levine’s letter is a 77-page “Eight Factor Analysis.” This analysis served as the foundation for HHS’s recommendation that cannabis be moved from Schedule I to Schedule III.
“In considering the scheduling of marijuana in response to President Biden’s request, the Secretary of HHS is required to consider in a scientific and medical evaluation eight factors determinative of control under the CSA,” HHS wrote.
These factors range from a substance’s “potential for abuse” to “what, if any, risk there is to the public health,” though a critical piece of the puzzle is an assessment of its “currently accepted medical use,” or “CAMU.”
In fact, the remaining 150+ pages of documents focus on the two-part analysis that HHS conducted to determine CAMU.
These two steps aim to asses “whether there is (1) widespread current experience with medical use of the substance in the United States by licensed health care practitioners (HCPs) operating in accordance with implemented state-authorized programs, where the medical use is recognized by entities that regulate the practice of medicine” and “(2) whether there is scientific support for at least one of these medical uses of a substance.”
The Office of the Assistant Secretary of Health (OASH) took on Part 1. Among the documents is a 20-page letter (including tables and figures) dated July 17, 2023 from OASH to the FDA outlining the Office’s work on Part 1, and handing the baton over to FDA for Part 2. The final item in the batch of documents is a 143-page report dated August 28, 2023 — one day before Levine’s letter to Milgram — comprising the work that the FDA’s Center for Drug Evaluation and Research completed for Part 2.
For Part 1, OASH found that “more than” 30,000 healthcare practitioners are “authorized” to recommend medical cannabis for the more than six million registered patients, “constituting widespread clinical experience associated with various medical conditions recognized by a substantial number of jurisdictions across the United States.”
“For several jurisdictions, these programs have been in place for several years, and include features that actively monitor medical use and product quality characteristics of marijuana dispensed,” OASH found.
The conclusion of Part 1, therefore, “warranted” an assessment by the FDA on whether there “exists credible scientific support for the use of marijuana for at least one of the medical conditions.”
For Part 2, the FDA looked at “systematic reviews of studies investigating the safety and effectiveness of marijuana, relevant professional societies’ position statements, data from state medical marijuana programs and United States national surveys, and the labeling of FDA-approved products relevant to the analysis.”
In assessing a range of “medical conditions,” they found that the “largest evidence base for effectiveness exists for marijuana use within the pain indication (in particular, neuropathic pain).”
Further, in assessing potential harms, they found that “none of the evidence from the systematic reviews included in our CAMU Part 2 analysis identified any safety concerns that would preclude the use of marijuana in the indications for which there exists some credible scientific support for its therapeutic benefit.”
Among the many insights detailed in the FDA’s report on Part 2 is how it considered existing FDA-approved drugs containing THC. While the only FDA-approved pharmaceuticals containing THC to-date have been made of synthetic THC, one of the most well-known, Marinol, has been on Schedule III since 1999.
“Therefore,” FDA concluded after providing a list of these drugs, “if the above approved formulations of THC were considered to have proven benefit for various indications, it is logical to conclude that a similar dose administered through a marijuana preparation would be relevant to informing potential therapeutic uses of marijuana for drug scheduling purposes.”
