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MARIJUANA MOMENT

NEW FDA REPORT HIGHLIGHTS HOW MARIJUANA RESCHEDULING REVIEW ANALYZED CANNABIS
USERS’ SOCIAL MEDIA POSTS


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POLITICS


NEW FDA REPORT HIGHLIGHTS HOW MARIJUANA RESCHEDULING REVIEW ANALYZED CANNABIS
USERS’ SOCIAL MEDIA POSTS

Published

4 hours ago

on

February 19, 2024

By

Kyle Jaeger

The Food and Drug Administration (FDA) is highlighting its scientific review
into marijuana that led the agency to recommend rescheduling—a process that
involved a comprehensive analysis of research, as well looking at hundreds of
posts on social media platforms to see how consumers described cannabis’s
therapeutic impact.

In its 2023 fiscal year Drug Safety Priorities report that was published on
Thursday, FDA’s Center for Drug Evaluation and Research (CDER) discussed various
initiatives that it says illustrate “the depth and versatility of drug safety
initiatives across the Center and FDA.” That includes the cannabis analysis it
conducted under a 2022 directive from President Joe Biden.

CDER said its staff “conducted an expansive review of numerous data sources to
inform a scientific and medical assessment called an Eight Factor analysis
(8FA),” and the results “informed FDA’s recommendation to the Drug Enforcement
Administration (DEA) to down-schedule marijuana to Schedule III” from Schedule I
under the Controlled Substances Act.

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Maria Mercedes Galuppo has the story.
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“As part of CDER’s cross-center evaluation of marijuana, the CDER Office of
Surveillance and Epidemiology (OSE) completed a review of epidemiologic and
pharmacovigilance data sources to inform the 8FA provided to DEA,” it said.

After the conclusion of the FDA review, the U.S. Department of Health and Human
Services (HHS) submitted a letter with hundreds of pages of research material to
DEA with the Schedule III recommendation. DEA is now carrying out its own review
before making a final determination. There were rumors that the decision would
be announced two weeks ago, but a Biden administration official told Marijuana
Moment said they’d “wave off” that speculation.



FDA’s work to reach a scheduling conclusion also involved a team of social
scientists who spent six months conducting a “detailed qualitative analysis of
online and social media conversations occurring about marijuana,” the report
says.

“This six-month study involved manually analyzing hundreds of posts on publicly
available online/social media platforms to provide context directly from users
regarding marijuana, including its effectiveness for several therapeutic
purposes such as anorexia, anxiety, nausea, and pain; nonmedical purposes;
benefits and negative effects, experiences with access,” it says.



Separately, the new FDA report said the agency “completed an assessment of the
capabilities and usefulness of a variety of epidemiologic, pharmacovigilance,
and drug utilization data sources for monitoring the safety of unapproved
cannabis-derived products.”

It’s been nearly six months since FDA provided DEA with is marijuana
rescheduling recommendation, but the timing of a final decision is uncertain. In
the interim, Congressional Cannabis Caucus founder Rep. Earl Blumenauer (D-OR)
recently urged the agency to release more information about its ongoing
review—including what its “planned deadline” is for finishing and whether it
will take into account the fact that many states have already legalized
cannabis.

The correspondence came in response to a recent assertion from DEA that it has
“final authority” on the rescheduling decision—which itself was a reply to
a separate letter from Blumenauer and 30 other bipartisan lawmakers.

On the other side of the issue, a Republican congressman who has long opposed
marijuana reform claimed in a letter to DEA that FDA came to a “misguided
conclusion” to recommend rescheduling cannabis, challenging the health agency’s
scientific standards and imploring DEA to dismiss them as it prepares to make a
final determination.



A separate letter sent to DEA Administrator Anne Milgram this month—led by Sens.
Elizabeth Warren (D-MA) and John Fetterman (D-PA), along with Senate Majority
Leader Chuck Schumer (D-NY) and other champions of marijuana reform—urged DEA to
go further than rescheduling by fully removing cannabis from the CSA.

Meanwhile, HHS Secretary Xavier Becerra said last month that his agency
has “communicated” its “position” on marijuana rescheduling to DEA and has
continued to offer additional information to assist with the final
determination.

Prior to HHS releasing a trove of documents concerning its cannabis
recommendation, a coalition of 12 Democratic state attorneys general implored
DEA to move forward with federal marijuana rescheduling, calling the policy
change a “public safety imperative.”



In another letter in December, 29 former U.S. attorneys called on the Biden
administration to leave cannabis in Schedule I.

Also that month, the governors of six U.S. states—Colorado, Illinois, New York,
New Jersey, Maryland and Louisiana—sent a letter to Biden calling on the
administration to reschedule marijuana by the end of last year.

Meanwhile, six former DEA heads and five former White House drug czars sent a
letter to the attorney general and current DEA administrator voicing opposition
to the top federal health agency’s recommendation to reschedule marijuana. They
also made a questionable claim about the relationship between drug schedules and
criminal penalties in a way that could exaggerate the potential impact of the
incremental reform.



Signatories include DEA and Office of National Drug Control Policy heads under
multiple administrations led by presidents of both major parties.

A coalition of 14 Republican congressional lawmakers, meanwhile,
separately urged DEA to “reject” the top federal health agency’s recommendation
to reschedule marijuana and instead keep it in the most restrictive category
under the CSA.

A recent poll found that about one-third of marijuana consumers say they would
go back to the illicit market if cannabis was rescheduled and only made legally
available as an FDA-approved prescription drug.



Another recent survey found that President Joe Biden stands to make significant
political gains if marijuana is rescheduled under his administrative directive.
Of course, Biden doesn’t directly control the final outcome.

The president has routinely touted his 2022 scheduling directive, as well as a
mass pardon he granted for people who’ve committed federal marijuana possession
offenses. He followed up on that action in December with a renewed and expanded
pardon proclamation. The Justice Department has already begun issuing
certifications for people who applied under the second round.

Vice President Kamala Harris’s office has been reaching out to people who’ve
received a cannabis pardon—seeking assurance that the Justice Department
certification process is going smoothly and engaging in broader discussions
about cannabis policy reform, according to a pardon recipient who was contacted.

> FDA Officials Join Experts To Discuss Psychedelics Research Challenges And
> Promises





Marijuana Moment is made possible with support from readers. If you rely on our
cannabis advocacy journalism to stay informed, please consider a monthly Patreon
pledge.
Related Topics:featured

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Kyle Jaeger


Kyle Jaeger is Marijuana Moment's Sacramento-based managing editor. His work has
also appeared in High Times, VICE and attn.



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