01/26/2024
FRIENDLY UPDATE! Let's hope logic and sanity win the day and Cannabis legalization is just around the bend!
3 Takeaways From Health Officials' Ma*****na Proposal By Sam Reisman
Law360 (January 22, 2024, 9:15 PM EST) -- Federal health regulators have acknowledged for the first time that ma*****na has a currently accepted medical use, can be safe to use under medical supervision and has fewer associated dangers than other highly restricted drugs and even alcohol.
The U.S. Department of Health and Human Services' latest findings on the science and medical risks and uses of ma*****na concluded with a recommendation that the drug be moved from the highly restrictive Schedule I tier to the less prohibitive Schedule III status under the federal Controlled Substances Act.
In response to a Freedom of Information Act lawsuit, HHS made its findings public earlier this month. The agency in August sent its recommendation and analysis to the Drug Enforcement Administration, which will ultimately have the final say over whether federal regulations on ma*****na are loosened. Here, Law360 breaks down some of the most significant takeaways from HHS' analysis of the science surrounding ma*****na.
State-Regulated Programs Provide Evidence of Medical Use
HHS' Schedule III recommendation is largely bolstered by an analysis of data derived from state- regulated medical ma*****na programs, finding that even though cannabis is not a U.S. Food and
Drug Administration-approved medication, it does have a "currently accepted medical use." The findings represent a break from federal regulators' previous inquiries into ma*****na's Schedule I status, which often began and ended with the assertion that because there was no evidence of ma*****na's efficacy in a medical context, it could not have a currently accepted medical use that warranted rescheduling.
"Ma*****na has long been stuck in a cycle that has prevented it from rescheduling," Meghana Shah, a partner at Eversheds Sutherland who co-leads the firm's cannabis group, told Law360. "It cannot get rescheduled because there is insufficient data to show that it has an accepted medical use, and because it is a Schedule I drug there is limited access to federally legal cannabis and/or federally sanctioned studies to get data."
The last time federal agencies tasked with enforcing drug policy were asked to review ma*****na's Schedule I status, they determined in 2016 that the designation was still appropriate, following a review that stretched on for more than six years.
While the FDA is empowered to approve drugs for sale in interstate commerce, the regulation of the practice of medicine is left to the states, 38 of which have approved a medical ma*****na program. According to experts, the data supplied by states about their medical ma*****na programs have given federal health regulators the latitude to find a new definition of "currently accepted medical use," and empowered them to reach a different conclusion from previous reviews of ma*****na.
"State legalization is the main thing that was able to give [regulators] this body of knowledge," William Bogot, co-chair of the cannabis practice group at Fox Rothschild LLP, told Law360. "In the past, DEA could say, 'We don't have the evidence, we don't have the tests.' Now, with all the states having legalized it, they have the body of knowledge."
Specifically, HHS found that there are more than 30,000 healthcare professionals across the U.S. authorized to recommend the use of ma*****na, and there are more than 6 million registered patients in state-regulated medical cannabis programs. According to the findings, this constitutes "widespread clinical experience associated with various medical conditions recognized by a substantial number of jurisdictions across the United States."
A Scientific Basis for Some Therapeutic Cannabis Use
Not only are medical practitioners and patients using cannabis in a therapeutic manner, HHS determined that there was scientific data to support ma*****na's efficacy in treating at least some of the conditions for which physicians are authorized to make medical cannabis recommendations. Specifically, HHS concluded that there was "some credible scientific support for the use of ma*****na in the treatment of pain, anorexia related to a medical condition, and nausea and vomiting." In addition, the agency found no significant safety concerns where ma*****na use would worsen conditions for patients taking medical ma*****na for those indications. The findings that ma*****na has a "currently accepted medical use" and can be safe to use under medical supervision are significant because, as a Schedule I drug, ma*****na has been considered so dangerous that it cannot be used at all, even under medical supervision. Moving cannabis to Schedule III would place it in the same tier as medications like anabolic steroids, ketamine and Tylenol with codeine.
However, the HHS findings make clear multiple times that the scientific data informing this conclusion are not robust enough to suggest that ma*****na would receive FDA approval for an indication if it went through that agency's standard new drug application process.
In a response to the HHS' proposal, the anti-legalization group Smart Approaches to Ma*****na, or SAM, blasted the agency's findings as "weak and intellectually dishonest." The group specifically criticized the FDA for using a new standard to establish "currently accepted medical use" that drew heavily upon data from state-regulated programs and differed from previous reviews.
"The FDA's novel standard in recommending ma*****na's rescheduling is rooted in a logical fallacy: some people say that ma*****na is medicine, so ma*****na must be medicine," SAM wrote.
SAM said it was "unclear" why the FDA did not use the "five-part test" federal agencies have used since the 1990s to consider petitions to reschedule controlled substances — and, invariably, reject petitions to reschedule ma*****na. That test, which was recently challenged in federal appellate court, requires that a drug's chemistry be known and reproducible. As a botanical with myriad psychoactive compounds, cannabis can never clear this hurdle.
Ma*****na Is Less Dangerous Than Other Comparable Drugs
In addition to finding that ma*****na has a currently accepted medical use and can be safe to use under medical supervision, HHS determined that cannabis was not as dangerous as other drugs in Schedule I, such as he**in; in Schedule II, such as co***ne and fentanyl; or even alcohol, which is not scheduled.
In analyzing various metrics to determine different drugs' abuse potential — including death rates and emergency room visits, among many others — HHS found that ma*****na very rarely resulted in serious adverse outcomes, such as death, when compared to Schedule I and II drugs like he**in, fentanyl and benzodiazepines.
"Overall, these data demonstrate that, while ma*****na is associated with a high prevalence of abuse, the profile of and propensity for serious outcomes related to that abuse lead to a conclusion that ma*****na is most appropriately controlled in Schedule III under the CSA," the report said.
Regulators even took the additional step of comparing ma*****na's abuse potential with alcohol, a drug that is nowhere to be found on the Controlled Substances Act's list of scheduled substances, even though it is addictive and widely abused.
"While this comparison between ma*****na and alcohol contains a lot of other interesting information, significantly, we have FDA saying here that, generally speaking, ma*****na is less to blame for adverse outcomes or severe substance abuse disorder than alcohol" and several other substances, said Jonathan Havens, co-chair of the cannabis law practice at Saul Ewing LLP.
The report found that while unscheduled drugs are not typically used as points of comparison for scheduling placement, regulators opted to measure ma*****na's risks specifically against those of alcohol because both substances are widely available and widely used for nonmedical or recreational purposes.
"Although not expressly stated in the report, all of these observations appear to be an effort to address previous messaging from the war on drug days about the dangers of ma*****na," according to Emily A. Sellers, an associate who practices cannabis law at Shook Hardy & Bacon LLP.
When adjusting for the commonality of use, regulators found that alcohol and he**in were the drugs most linked to what regulators described as "adverse outcomes," including hospitalizations, emergency room visits, accidental exposures and overdose deaths.
"This suggests consistency across databases, across drugs and over time, and although abuse of ma*****na produces clear evidence of harmful consequences, these appear to be relatively less common and less severe than some other comparator drugs," regulators wrote. For some advocates in the cannabis space, the findings are further evidence that ma*****na should be descheduled altogether and removed from the ambit of the CSA, like alcohol and to***co.
"The [currently accepted medical use] evidence should push this across the finish line. Let's hope the DEA agrees," Jonathan Robbins, chair of the cannabis group at Akerman LLP, told Law360. "Of course, I'd prefer to see a complete descheduling, but baby steps."
