Former Top FDA Official Predicts Agency Will Make Schedule III Marijuana Recommendation With ‘Election Cycle’ In Mind

August 28, 2023 ·

A former top Food and Drug Administration (FDA) official believes it’s most likely that marijuana will be put in Schedule III of the Controlled Substances Act (CSA) following an ongoing administrative review ordered by President Biden last year. FDA is mindful of political factors such as the 2024 election, the official said, so a policy change may come sooner rather than later.

Howard Sklamberg, who previously served as chair of FDA’s Marijuana Working Group from 2014 to 2017, spoke about the possible outcomes of the review, the impact of rescheduling and the agency’s timeline on a Mindset Capital podcast released on Thursday.

There are two things that “certainly won’t happen” with FDA’s scheduling review, Sklamberg predicted: a recommendation to keep cannabis in Schedule I or guidance to deschedule it altogether.

The agency has more flexibility since it last looked into marijuana scheduling, in 2016, so maintaining the status quo is unlikely, he said. On the other hand, descheduling “would be extremely difficult for FDA” given regulatory restraints.

“As far as the Goldilocks position, if I were a betting man, I think the most likely outcome will be Schedule III,” said Sklamberg, now an attorney at the firm Arnold & Porter. He added that while Schedule II is still a possibility, it wouldn’t have the same practical impact on issues such as allowing cannabis businesses to take federal tax deductions. FDA isn’t supposed to be “results-oriented,” he said, but the context does matter.

The former official also discussed the government’s rescheduling timeline, pushing back against the notion that the review process will take years as it has in the past.

“This is not on the normal timetable. They are aware of the importance of the issue, the interest of the issue, the White House’s interest in the issue—and they’re frankly aware of the election cycle and the administration’s term coming to an end at the end of 2024,” he said. “I think all those things come together.”

The administration hasn’t set a deadline for the review to be completed, but U.S. Health and Human Services (HHS) Secretary Xavier Becerra, who oversees FDA, told Marijuana Moment in June that agencies were aiming to finish their work by the end of the year.

FDA’s role is just one half of the review process. Once it completes its scientific review into marijuana, it will share its findings and recommendations with the Drug Enforcement Administration (DEA), which then carries out its own eight-step review before making a final call.

Sklamberg stressed in his podcast comments that while a scheduling change would be a “gigantic” step, regulations would likely continue to evolve over a period of years—and as younger voters more supportive of legalization gain representation in politics, new policies will likely reflect that.

“I think this will be an important step in a longer process,” he said.

Sklamberg also strongly dismissed concerns that placing marijuana in Schedule III would lead to a crackdown on state markets. Acknowledging that many industry stakeholders and advocates would rather see complete descheduling, he pointed out that FDA and the Justice Department have taken a hands-off approach to the legalization movement while cannabis is considered a Schedule I drug. It “defies logic” to think the agencies would suddenly enforce criminalization if it’s moved to a less restrictive category, he argued.

Sklamberg contributed to a report on scheduling considerations that was released by the recently formed Coalition for Cannabis Scheduling Reform in June. And in February, he discussed the issue in a memorandum he authored on behalf of the cannabis company Columbia Care.

In all likelihood, he said, FDA will not change its approach to marijuana if it’s rescheduled, in part because increasing enforcement would strain the agency’s resources, potentially forcing them to compromise other food safety responsibilities such as preventing E. coli and monitoring interstate dairy commerce.

If FDA attempted to single out certain marijuana or hemp companies for violating its rules related to introducing unapproved additives into the food supply or as dietary supplements, he continued, it would be breaking with a mandate against “arbitrary” action and could find itself in legal trouble under administrative law.

The conversation closed on a separate federal marijuana topic: the possibility of the U.S. attorney general reissuing a memo to federal prosecutors with explicit guidance on cannabis enforcement priorities. An Obama-era memo on that issue, known as the Cole memo, was rescinded under the Trump administration, and some advocates have pushed for an updated version to provide some clarity and assurance to the industry and consumers.

Sklamberg minimized the practical impact of such a memo, noting that the Justice Department has not meaningfully changed its approach to marijuana policy in the more than two years since the last version was rescinded under the Trump administration in 2018.

“I think its effect would be more reassuring and psychological than real,” he said. “I don’t think a Garland memo is necessary for the administration to maintain the posture it has now. As far as any change, we’d have to see what’s in the memo—but it hasn’t gone after cannabis in a big way and don’t think it will.”

Meanwhile, last week, Rep. Matt Gaetz (R-FL) pressed DEA Administrator Anne Milgram to expand on her recent remarks about the origin and timeline of President Joe Biden’s marijuana scheduling review directive. Specifically, he’s asking for a copy of a letter that Milgram said the president sent to the attorney general and HHS secretary last year directing the review. He also wants an update on whether the administrator asked HHS about the timetable for their work, as she told him she’d do during a recent House Judiciary subcommittee hearing.

As far as the alleged rescheduling letter from Biden is concerned, an attorney filed a Freedom of Information Act (FOIA) request with HHS in an effort to obtain a copy of the letter. But earlier this month, the department said it had “no records” of such a document.

Marijuana Moment separately asked the Justice Department for clarification on the letter, but a spokesperson referred the question to the White House. The White House, in turn, pointed to the president’s public statement about the directive but did not comment on the letter itself.

Meanwhile, the White House drug czar said in separate congressional testimony recently that the president’s marijuana pardons and scheduling directive are part of an effort to create cohesive cannabis policy within a patchwork of state legalization models.

Some lawmakers are growing frustrated with the administration’s approach. Congressional Cannabis Caucus co-chair Rep. Earl Blumenauer (D-OR) led a letter to Becerra and Attorney General Merrick Garland in March, alongside 15 other bipartisan members of Congress, demanding transparency in the cannabis scheduling review. (Full Story)

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