Rep. Andy Harris claims the FDA’s eight-factor analysis on cannabis was “flawed,” leading to a “misguided” recommendation to reschedule.
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The man responsible for keeping Washington, D.C., from launching adult-use sales is now attempting to sway the Drug Enforcement Administration (DEA) from rescheduling cannabis.
U.S. Rep. Andy Harris, R-Md., sent a letter Jan. 31 to DEA Administrator Anne Milgram urging her to keep cannabis classified as a Schedule I drug under the Controlled Substances Act (CSA), holding it in the same class as heroin, LSD and ecstasy as having the highest potential for abuse with no currently accepted medical use. The letter was first reported by Fox News Radio.
Harris, a long-time cannabis reform opponent, is also the lawmaker behind 2015 legislation that included a provision known as the “Harris Rider,” which stripped D.C.’s power to tax and regulate commercial adult-use cannabis sales despite 70% of district voters approving a legalization measure the previous year.
The congressman’s Jan. 31 letter comes on the heels of the U.S. Department of Health and Human Services (HHS) recommending to the DEA in August that cannabis be reclassified as a Schedule III substance under the CSA after conducting an eight-factor analysis on the plant’s accepted medical use and potential for abuse—a study that was directed by President Joe Biden.
But now Harris is calling that analysis “flawed” and is pushing the DEA to consider an international drug treaty from more than 50 years ago as it conducts its official rescheduling review.
The HHS conducted its eight-factor analysis in coordination with the Food and Drug Administration (FDA), an HHS agency. Harris argued in his letter that the FDA ignored “several important factors” when considering cannabis’s potential for abuse and harm, leading to a “misguided” recommendation to the DEA.
“The recommendation did not sufficiently examine the effect of daily marijuana use, a key indicator of addiction,” he wrote. “The recommendation also failed to consider the public health damage caused by traffic fatalities due to individuals driving under the influence of marijuana. Notably, FDA did not discuss the impact of marijuana use on pregnant women and children, despite a warning from SAMHSA [Substance Abuse and Mental Health Services Administration].”
SAMHSA is a branch of the HHS.
Harris did not mention that countless substances omitted from the CSA—such as alcohol and tobacco—also can impact pregnant women and their unborn children.
Additionally, Harris argued that the United States’ treaty obligations to the United Nations’ Single Convention on Narcotic Drugs of 1961 should prevent cannabis’s classification as anything but a Schedule I or II drug under the CSA. Harris specifically called attention to a 2016 rescheduling review in making this claim.
This position came two days after 12 U.S. senators penned a letter to Milgram and Attorney General Merrick Garland saying that obligations to the international drug treaty have changed since the DEA last reviewed how cannabis is scheduled under the CSA in 2016.
According to the senators, cannabis has been rescheduled under international law since 2016—a change that the U.S. and World Health Organization supported in light of “the legitimate medical use” of certain cannabis products.
Still, Harris accused the FDA of biases in that it “failed” to compare cannabis’s potential for abuse to many other Schedule I drugs, instead opting to hand-select drugs “that appear more harmful.”
“The only comparator substance in Schedule I in the recommendation was heroin—the agency could have included at least one Schedule I hallucinogen, such as LSD or ecstasy,” he wrote. “The review even compared marijuana to alcohol, a substance that is not controlled, but did not review any stimulants, such as Adderall or Ritalin in Schedule II. They reviewed nine scheduled substances, of which five were opioids, which had the effect of skewing the presentation of the data.”
Harris also said the FDA “mischaracterized” data on cannabis’s harms, calling attention to the number of emergency room visits associated with THC as compared to other substances. He also said the FDA used a new two-factor test, instead of what he deems as a more reliable five-factor test, to determine cannabis’s medicinal value and wrongly leaned on the prevalence of state-legal medical cannabis programs as evidence of “currently accepted medical use.”
Lastly, Harris suggested that the FDA misinterpreted three studies that had “inconclusive or mixed” findings to support its claim that cannabis has currently accepted medical use.
In conclusion, Harris asked Milgram to respond to six questions no later than Feb. 16, 2024:
Will the DEA abide by the legally binding treaty obligations related to drug scheduling as outlined in the Single Convention when determining marijuana’s schedule?
Does the DEA believe that our international treaty obligations can be met if marijuana is placed in Schedule III, despite the fact that NORML v. DEA (1977) ruled otherwise?
Does the DEA consider FDA’s new two-factor test an adequate method for determining a drug’s currently accepted medical use? If so, why?
Will the DEA use the five-factor test to establish “currently accepted medical use” in its own scheduling review?
Does the DEA consider it acceptable to use studies that had inconclusive and/or not statistically significant findings as justification for marijuana having currently accepted medical use?
Does the DEA consider daily marijuana use, impacts on pregnancy and children, and effects of driving under the influence of marijuana necessary elements to consider when measuring marijuana’s abuse potential? If not, why?
