The Food and Drug Administration is touting its scientific review of marijuana, which led to the FDA recommending rescheduling. This process involved a thorough analysis of research as well as looking at hundreds and hundreds of social media posts to see how users described cannabis’ therapeutic impact.
The FDA’s Center for Drug Evaluation and Research published its Drug Safety Priorities Report for 2023 on Thursday. It discussed a number of initiatives, including the cannabis analysis conducted in 2022 under a directive from President Joe Biden.
CDER stated that its staff had “conducted a comprehensive review of many data sources in order to inform a medical and scientific assessment known as an Eight Factor Analysis (8FA)” and the FDA recommended to the Drug Enforcement Administration to move marijuana from Schedule I to Schedule III under the Controlled Substances Act.
The report stated that “as part of CDER’s cross-center marijuana evaluation, the CDER Office of Surveillance and Epidemiology completed a review of the epidemiologic and pharmacovigilance sources of data to inform the 8FA submitted to DEA.”
The U.S. Department of Health and Human Services, after the FDA review was completed, sent a letter to DEA containing hundreds of pages of research materials with the Schedule III recommendations. DEA will now conduct its own review and make a final decision. There were reports that the decision was to be announced two week ago. However, a Biden Administration official told Marijuana Moment that they would “wave off” this speculation.
The FDA also worked with a team social scientists to come up with a conclusion on marijuana’s scheduling. They spent six months doing a “detailed analysis qualitative of online and social media discussions occurring about marijuana”, the report states.
This six-month study involved manual analysis of hundreds of posts from publicly available online/social platforms in order to gain context directly from users about marijuana, such as its effectiveness for therapeutic purposes, such as anorexia and anxiety, or pain, nonmedical uses, benefits and negative side effects, and experiences with access, it states.
Separately the new FDA report stated that the agency “completed a comprehensive assessment of the capabilities of various epidemiologic, drug utilization, and pharmacovigilance data sources to monitor the safety of cannabis-derived products not approved.”
The timing of a decision on marijuana rescheduling is still uncertain. It has been almost six months since FDA gave DEA its recommendation. Earl Blumenauer, founder of the Congressional Cannabis Caucus (D-OR), recently urged DEA to provide more information on its ongoing review. This included what the “planned deadline” for completion is and whether the agency will take into consideration the fact that several states have already legalized marijuana.
The correspondence was in response to a recent statement from DEA stating that it had “final authority” over the rescheduling of flights–which, itself, was a response to a letter sent by Blumenauer and other bipartisan legislators.
A Republican congressman, who has been a long-time opponent of marijuana reform, claimed in a letter sent to DEA, that FDA reached a “misguided” conclusion to recommend rescheduling Cannabis. He challenged the scientific standards used by the health agency and pleaded with DEA to disregard them when it comes to making a final decision.
The letter was sent by Sens. Elizabeth Warren (D) and John Fetterman(D) along with Senate Majority leader Chuck Schumer (D) and other advocates of marijuana reform- urged DEA go beyond rescheduling and fully remove cannabis from the CSA.
HHS Secretary Xavier Becerra stated last month that his department has “communicated its position” to DEA on marijuana rescheduling and continues to provide additional information in order to help with the final decision.
Before HHS released a trove documents regarding its cannabis recommendation, a group of Democratic state attorneys general urged DEA to proceed with federal marijuana rescheduling. They called the policy change a ‘public safety imperative.
In a second letter, sent in December, 29 former U.S. Attorneys urged the Biden administration not to include cannabis on Schedule I.
In the same month, six U.S. governors–Colorado. Illinois, New York. New Jersey, Maryland, and Louisiana-sent a message to Biden , urging the administration to reschedule cannabis by the end last year.
Six former DEA directors and five former White House Drug Czars have sent a letter to the Attorney General and current DEA Administrator expressing their opposition to the recommendation of the federal health agency to reschedule cannabis . The letter also included a questionable statement about the relationship between criminal penalties and drug schedules, which could have exaggerated the impact of incremental reform.
The DEA and Office of National Drug Control Policy directors under both major parties’ presidents are among the signatories.
A coalition of Republican lawmakers separately urged DEA, meanwhile to “reject”, the top federal agency’s recommendation to reschedule cannabis , and instead keep it the most restrictive category in the CSA.
According to a recent survey, about 13 of marijuana users said they would return to the illegal market in case cannabis was rescheduled as a prescription-only drug and made available legally.
A recent survey revealed that Joe Biden could gain significant political benefits if marijuana were rescheduled as per his administrative directive. Biden does not directly control the outcome.
He has regularly praised his 2022 scheduling order, as well as the mass pardons he granted to people who had committed federal marijuana possession crimes. In December , he issued a new and expanded pardon declaration. The Justice Department has begun issuing certificates for those who applied in the second round.
According to one pardoned person, the Vice President Kamala Harris’s office has been reaching out to those who have received a cannabis-pardon to ensure that the certification process at Justice Department is proceeding smoothly. They also engage in broader conversations about cannabis policy reform.
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