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Scientific Evidence for Cannabis Rescheduling Difficult to Challenge, Says Sklamberg

January 19, 2024

Howard Sklamberg, Life Sciences & Healthcare Regulatory partner, was quoted in Medscape and MarketWatch regarding the U.S. Department of Health and Human Services’ (HHS) recommendation to move cannabis from Schedule I to Schedule III on the controlled substances list, which was issued in August of this year and sits with the U.S. Drug Enforcement Administration (DEA).

Newly released documents of the HHS’ recommendation illustrate that the U.S. Food and Drug Administration (FDA) has determined that cannabis has a legitimate medical use and should thus be moved from Schedule I to Schedule III. Sklamberg told Medscape that although President Biden’s directive for the HHS and U.S. Attorney General to review how cannabis is scheduled under federal law “certainly made the agencies reconsider” rescheduling cannabis, rescheduling “was going to happen anyway.” Sklamberg predicted that a proposed rule would be issued by mid-summer of 2024, because “agencies generally want to get their important rulemaking done before you get too much into the political season and the potential end of a presidency.”

Discussing claims that the HHS’ recommendation is low on scientific evidence, Sklamberg told MarketWatch that “both in thoroughness of the analysis and its tone,” the HHS’ recommendation “is a very, very substantial document.” In particular, “the part of the analysis covering the science and medicine would be very hard to challenge. You would have to show the agency was acting in an arbitrary way,” which Sklamberg said he doubts would happen. “It would be hard for a judge to say ‘I am going to overturn the HHS science,’” he continued.

Read the MarketWatch article, “Opinion: These cannabis stocks and ETFs stand to benefit if the Biden administration reforms marijuana laws” (subscription required).

Read the Medscape article, “FDA Recommends DEA Move Cannabis to Schedule III.”