DEA Legalizes Cocaine Derivative While Pushing Back Against Critics Who Say Marijuana Should Receive Similar Treatment

The Drug Enforcement Administration (DEA) is moving forward with a plan to legalize a cocaine derivative. And even as the agency participates in a review of marijuana’s scheduling status directed by the president, it is dismissing public comments arguing that cannabis should be removed from federal control alongside the cocaine-derived substance it is now rescheduling.

DEA first proposed descheduling the compound, [18 F]FP-CIT, last year and opened a public comment period for people to weigh in. Advocates picked up on the action, seeking similar treatment of marijuana given the plant’s established medical value.

In a Federal Register filing on Monday, DEA didn’t put much stock in public feedback comparing the cocaine-derived substance’s treatment to that of cannabis.

“One commenter opposed decontrol of [18F]FP-CIT, suggesting rescheduling cocaine, or any cocaine derivative, is a safety concern and such rescheduling would wrongly signal that cocaine is less harmful than cannabis,” DEA said. “DEA does not agree with the commenter’s concern about harm. [18F]FP-CIT is derived from cocaine, a schedule II substance, via ecgonine, a schedule II substance.”

The agency didn’t explicitly address marijuana scheduling any further in the new notice, despite having received numerous petitions seeking the full removal cannabis from the Controlled Substances Act (CSA) or simple rescheduling on the basis that it has medical value and low abuse potential over several decades. Those petitions have been summarily denied over the years.

That said, President Joe Biden issued a mass marijuana pardon last month, while at the same time directing federal agencies to carry out a scientific review into cannabis scheduling that could return with a recommendation to place it in a lower classification or remove it from control altogether.

The Justice Department has said that it would move expeditiously to complete that review, and advocates are hopeful that the president’s influence in the process will lead to a meaningful change.

In the interim, however, DEA says that the cocaine derivative [18F]FP-CIT—which is a “diagnostic substance that is used in assisting the evaluation of adult patients with suspected Parkinsonian syndromes”— doesn’t meet the requirements “for inclusion in any schedule” and so it is being removed “from control under the CSA.”

DEA first accepted a petition on the cocaine derivative’s scheduling status in November 2018. After that point, the agency 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 with a “request for scientific and medical evaluation and scheduling recommendation.”

HHS finally offered its recommendation, which was made in concert with the Food and Drug Administration (FDA) and National Institute on Drug Abuse (NIDA) in April 2021, concluding that the substance “does not conform with the findings for schedule II…or in any other schedule.”

That’s in spite of the fact that HHS determined that the derivative “appears to be more potent than cocaine in some behavioral assessments” with respect to its affinity for dopamine transporters. 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,” an earlier DEA filing stated.

Separately, in another new Federal Register notice about a decision to place the cough suppressant zipeprol in Schedule I of the CSA, DEA pushed back against a public comment from one person who argued that neither that substance nor cannabis should be so strictly controlled.

“Regarding the comment about reclassifying marijuana, this current rulemaking pertains only to the scheduling of zipeprol,” the agency said. “Therefore, this comment is outside the scope of this rule.”

A top Food and Drug Administration (FDA) official said late last month that the agency is exploring “what flexibilities we might have” when it comes the federal government’s marijuana scheduling review directed by Biden, which she described as a “very high priority.”

But she said that while FDA will lead the scientific and medical evaluation of cannabis, it is the DEA that “has the final word” on any potential scheduling decision. And she pointed out that even doing scientific research into marijuana is “very, very difficult” because of it current restrictive Schedule I status.

HHS Secretary Xavier Bacerra said shortly after Biden’s announcement last month that he’d already spoken to FDA Commissioner Robert Califf about the marijuana scheduling review, which he said would be completed “as quickly as we can.”

Other federal officials have similarly committed to quickly proceeding with the review and following up with responsive action, including representatives of the Justice Department and Labor Department.

Rahul Gupta, director of the White House Office of National Drug Control Policy (ONDCP), said last month that Biden took “historic” action by issuing a mass cannabis pardon and directing the administrative review. And he again said that there’s “clearly” evidence that marijuana has medical value.

Meanwhile, DEA wants to more than double the amount of marijuana that can be legally manufactured for research in 2023—and it’s also seeking to significantly increase the quota for the production of psychedelics like psilocyn, LSD and mescaline.

The agency has touted its Schedule I drug production quotas as evidence that is supports rigorous research into the substances, but it’s faced criticism from advocates and scientists over actions that are viewed as antithetical to promoting studies.

Following pushback, DEA recently retreated on a proposed ban on psychedelic compounds that scientists say have research value.

That marked another win for scientific community, coming just one month after DEA abandoned separate plans to place five tryptamine psychedelics in Schedule I.

In more recent news, Biden intends to sign a bipartisan marijuana research bill that was passed by Congress last week, a White House spokesperson confirmed to Marijuana Moment.

The legislation would give the U.S. attorney general 60 days to either approve a given application or request supplemental information from the marijuana research applicant. It would also create a more efficient pathway for researchers who request larger quantities of cannabis.

Separately, large-scale infrastructure legislation that was signed by Biden last year contains provisions aimed at allowing researchers to study the actual marijuana that consumers are purchasing from state-legal businesses instead of having to use only government-grown cannabis.

Sen. John Hickenlooper (D-CO) sought an update last week on the status of a federal report into research barriers that are inhibiting the development of a standardized test for marijuana impairment on the roads, as required under that infrastructure legislation.

NIDA Director Nora Volkow told Marijuana Moment last year that scientists have been unnecessarily limited in the source of cannabis they’re permitted to study—and it makes sense to enact a policy change that expands their access to products available in state-legal markets.

Also last week, congressional lawmakers held a hearing to discuss federal marijuana legalization and state cannabis developments, hearing testimony from a panel of broadly pro-reform advocates.

Colombian Senators Approve Marijuana Legalization Bill

Image element courtesy of Dominic Milton Trott.