,
Despite optimism from advocates, the reclassification of weed isn’t a sure thing. Federal drug officials have yet to approve the move, and some Republican leaders are still trying to keep it from happening.
The Drug Enforcement Administration (DEA) is currently evaluating public comments about its proposal to reschedule cannabis under the Controlled Substances Act (CSA). But two Republican lawmakers, Reps. Cathy McMorris Rodgers (R-WA) and Brett Guthrie (R-KY), wrote a letter in late July addressed to Attorney General Merrick Garland and Health Secretary Xavier Becerra, expressing concern that Health and Human Services (HHS) failed to follow the usual procedure of rescheduling a drug.
“We are concerned with how the normal process was circumvented to achieve a result for political purposes and we have a number of unanswered questions,” the lawmakers wrote.
The letter notes that the DEA usually doesn’t approve a new drug for medical use unless the FDA has already approved a marketing application to treat a certain condition — which hasn’t happened for marijuana.
The letter also notes that the DEA has a five-part test that’s usually used to determine whether a drug has medical value. The five prerequisites are: adequate safety studies, the drug’s chemistry is known and reproducible, there are adequate and controlled studies, the drug is accepted by qualified experts and there is widely available scientific evidence of the drug’s therapeutic qualities.
The HHS reportedly eschewed the five-factor analysis in favor of a two-factor analysis of its own devising to come to the conclusion that marijuana has medical value. The two-factor analysis used by the HHS determined whether doctors and health care professionals are recommending cannabis to patients and if there is credible scientific evidence supporting at least one therapeutic effect of weed.
HHS officials confirmed that more than 30,000 health care practitioners in the U.S. have recommended weed as a health treatment. And the agency included its own evaluation based on a number of scientific studies.
However, the lawmakers’ letter quotes the HHS report as proof that the standard method for rescheduling was ignored. The HHS report says, “More research is needed to evaluate the therapeutic potential of cannabis and cannabinoids as a means of safely and effectively treating various indications….It is also worth noting that the U.S. jurisdictions that have legalized the use of cannabis products for medicinal purposes have often done so with inadequate scientific research to support all allowable uses.”
The lawmakers say the DEA has reservations.
“It is notable that the proposed rule states, ‘DEA has not yet made a determination as to its views of the appropriate schedule for marijuana,’ seeming to indicate that the DEA is not yet convinced of the merits of this review,” wrote the lawmakers.
The letter asked Garland and Becerra to clarify if a president has ever instructed federal agencies to expedite the review of a Schedule I substance in a public statement before President Joe Biden did. It also asked the HHS to provide a previous example of when it used its two-factor analysis instead of the DEA’s five-factor analysis in a scheduling evaluation and asked whether the HHS would be dropping the five-factor test in favor of the new two-factor one.
It isn’t clear if either Garland or Becerra responded to the letter.
Meanwhile, as the public comment period for the proposed rescheduling came to an end, 11 Republican state attorneys general submitted a 42-page letter arguing that rescheduling marijuana would “represent a significant step toward ‘normalizing’ marijuana enterprises”—presumably a bad thing.
This letter also argued the move to reschedule is being done without following standard procedures. The attorneys general noted that the administrator of the DEA never signed the proposed rule, that rescheduling weed would violate international drug treaties, that the proposal unlawfully states that the DEA has to give the HHS’ determinations “significant deference” and that the DEA has refused prior requests to reschedule based on the same evidence that the HHS provided and that the rescheduling request did not meet qualifications set by the CSA.