Top FDA Official Says Marijuana Scheduling Review Is 'A Very High Priority,' But Who Has Final Say?

Department of Health and Human Services (HHS) Secretary Xavier Becerra said earlier this month that the agency plans to review the status of cannabis as a Schedule I drug following President Joe Biden's historic announcement that he will pardon federal cannabis possession convictions, "as quickly as we can."

On Thursday, the Food and Drug Administration's (FDA) principal deputy commissioner Janet Woodcock called the federal government's marijuana scheduling review a "very high priority" during a webinar organized by the Council for Federal Cannabis Regulation (CFCR) and Thompson Coburn LLP, reported Marijuana Moment.

Woodcock provided some insights into the FDA's next steps. "We are working diligently on looking at the scheduling of marijuana under the Controlled Substance Act and what flexibilities we might have here," she said.

She highlighted, however, that the DEA would have "the final word" on any further action, while the FDA would mainly focus on the scientific and medical evaluation of marijuana and give its recommendation based on insights from the National Institute on Drug Abuse (NIDA).

While she didn't specify either the outcome or timeframe of the agency's assessment process, which is based on eight factors, Woodcock said that the FDA is "agnostic" regarding marijuana.

Interestingly, in a scenario where the FDA determines that cannabis is medically valuable, its recommendation would conflict with its Schedule I drug status under the Controlled Substance Act (CSA).

Despite the passage of the 2018 Farm Bill that descheduled hemp and gave the FDA authority to oversee hemp-derived products, the agency has been searching for additional safety data, which is why it has prohibited CBD in foods and dietary supplements.

A Significant Step Forward

Meanwhile, the FDA recently hired a cannabis research and regulation advisor for the first time ever.

Norman Birenbaum, who agreed to fill the newly-created role, is the former New York State cannabis program director. His extensive experience in policy analysis and legislative outreach to the center would help the FDA expand its relationship with the healthcare community as well as patients and patient advocacy groups, FDA deputy director for Regulatory Programs, Dr. Douglas Throckmorton said.

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