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.
“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.
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