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The Drug Enforcement Administration (DEA) is about to deschedule a cocaine-derived drug after receiving a petition for a policy change. Drug policy advocates have wanted to see the DEA take action like this for other Schedule I drugs, such as cannabis and psychedelic mushrooms. Instead, however, the agency is proposing to remove this cocaine-derived drug from Schedule II and remove all criminal penalties for it.
It’s baffling how quick the agency moves when companies from an industry like Big Pharma want a revision made to the Controlled Substances Act (CSA), one of the country’s most rigid laws. While it has not been confirmed that Big Pharma is the motivation behind the DEA’s relatively swift action, we know that this cocaine-derived drug called “[18F] FP-CIT” is “a diagnostic substance that’s used in assisting the evaluation of adult patients with suspected Parkinsonian syndromes” and is used in the “visualization of striatal dopamine transporters (DAT) using positron emission tomography (PET) imaging,” according to a notice published in the Federal Register last week, Marijuana Moment reports. This has Big Pharma written all over it.
The company that submitted the descheduling petition is Advanced Imaging Projects, a corporation that is technically a part of the “scientific research and development services industry,” according to a few business directories. But, Advanced Imaging Projects has partnered with other pharmaceutical groups in the past to apply for an orphan drug designation to receive “regulatory agency approvals of a cannabinoid pharmaceutical product for multiple medical indications with a focus on treatment of a rare pediatric disease,” according to a press release that circulated in 2016.
Advanced Imaging Projects submitted for the descheduling of [18F] FP-CIT back in 2018. Several federal agencies were also allegedly involved in processing the application before deciding the substance should be fully removed from the CSA.
What this ultimately points to, Kyle Jaeger from Mariijuana Moment points out, is the fact that the scheduling review process can result in changes, even if it takes years to complete. It’s a little, uh, surprising, considering advocates have repeatedly petitioned the DEA to reschedule and fully remove cannabis from the CSA for years without any luck. Even lawsuits challenging the DEA’s cannabis scheduling denials haven’t yielded any results.
The new notice — which is subject to a public comment period that ends on December 6 — outlines the steps that need to happen before the government amends a drug schedule.
After the DEA accepted the petition for the cocaine-derivative, the DEA spent several months collecting information before forwarding their findings and the petition to the U.S. Department of Health and Human Services (HHS) in May 2019. They sent a “request for scientific and medical evaluation and scheduling recommendation.”
HHS finally offered its recommendation in April 2021. It was made in collaboration with the Food and Drug Administration (FDA) and National Institute on Drug Abuse (NIDA), and concluded that [18F] FP-CIT (which is likely to go by the name of “Fluoroseek” on the market) “does not conform with the findings for schedule II… or in any other schedule.”
This is despite the fact HHS determined that [18F] FP-CIT “appears to be more potent than cocaine in some behavioral assessments” with respect to its affinity for dopamine transporters. [18F] FP-CIT “may potentially have abuse potential if the dose taken is high enough and if the deterrent effect of the extremely low concentration of the available radioligand is not considered,” the notice states.
“Based on FDA’s scientific and medical review…and findings related to the substance’s abuse potential, legitimate medical use, and dependence liability, HHS recommended that [18 F]FP-CIT be removed from all schedules of the CSA,” DEA said.
“The CSA requires DEA, as delegated by the Attorney General, to determine whether HHS’s scientific and medical evaluation, scheduling recommendation, and all other relevant data constitute substantial evidence that a substance should be scheduled. 21 U.S.C. 811(b). DEA reviewed the scientific and medical evaluation and scheduling recommendation provided by HHS, and all other relevant data, and completed its own eight-factor review document on [18 F]FP-CIT pursuant to 21 U.S.C. 811(c).”
The eight factors that HHS considered in its review are: 1) the drug’s actual or relative potential for abuse, 2) scientific evidence of the drug’s pharmacological effects, 3) current scientific evidence about the drug, 4) the substance’s history and current patterns of abuse, 5) the scope, duration and significance of abuse, 6) any risks to public health, 7) psychic or physiological dependence risk and 8) whether the substance is an “immediate precursor of a substance already controlled under the CSA.”
“Based on consideration of the scientific and medical evaluation and accompanying recommendation of HHS, and based on DEA’s consideration of its own eight-factor analysis, DEA finds that these facts and all relevant data demonstrate that [18 F]FP-CIT does not possess abuse or dependence potential,” the notice concludes. “DEA finds that [18 F]FP-CIT does not meet the requirements for inclusion in any schedule, and should be removed from control under the CSA.”
This all comes on the heels of a federal appeals court decision to dismiss a petition that would require the DEA to reevaluate the plant’s scheduling under the CSA. In a concurring opinion, one judge said that the agency may soon be forced to consider a policy change anyway based on a misinterpretation of the therapeutic value of marijuana. This happened in August 2021.
So there you have it, everyone. The Feds are cool with removing a coke-derived drug from the CSA even though it has potential for abuse, while keeping cannabis and psilocybin and MDMA and LSD (all of which are low on the scale of addiction) locked up in Schedule I jail. Are we surprised? No, because big pharma uses big money to get what it wants.
