Robert Califf, who previously served a short stint as the FDA head under the Obama administration, hasn’t been especially vocal about marijuana issues.
“We understand that people have identified a number of possible uses of marijuana and marijuana-derived products.
“What this means is that no one has demonstrated to FDA that any such product is safe or effective for the treatment of any disease or condition.
The approval of these substances “supports the point I made earlier that our decisions on the approval of any medicine relies on the science to determine the safety and effectiveness of new medicines.
Overall, the remarks suggest that, if confirmed, it doesn’t seem that Califf wouldn’t be hostile toward attempts to explore the therapeutic potential of cannabis.
For example, industry stakeholders are eagerly awaiting action by the FDA to allow CBD to be marketed as a food item or dietary supplement.
With respect to broader marijuana policy, FDA would play a critical role in any moves to reschedule or deschedule cannabis.
It’s a potentially massive expansion of eligibility for patients after years of piecemeal additions to the list of qualifying conditions.
He notes the Department of Pharmacy will still manage a database of prescriptions through the Ohio Automated Rx Reporting System, or OARRS, but most oversight will fall under the purview of a new Division of Marijuana Control housed in the Commerce Department.
Huffman and Yuko both draw a distinction between medical and recreational cannabis, insisting that their measure and the other ideas are completely different conversations.
The ballot measure would allow home grown marijuana as well, capping the amount at six plants per person and no more than 12 per residence.
The agency took that feedback into consideration and assessed scientific demands before landing on the final quotas, which are even higher than the figures from two months ago.
For 2021, the agency now says in a notice set to be published in the Federal Register on Monday that it wants 6,000 grams of psilocybin manufactured by the end of the year, which is quadruple the figure it last put forward.
The agency also wants to see 2 million grams of marijuana produced this year, or about 4,400 pounds.
All told, the final quotas represent welcome news for researchers and advocates.
A federal appeals court recently dismissed a petition to require the DEA to reevaluate cannabis’s scheduling under the Controlled Substances Act.
It’s the kind of action that drug policy reform advocates have hoped to see from the agency for Schedule I drugs like marijuana and psilocybin.
But that process so far hasn’t served advocates who’ve repeatedly petitioned DEA to fully remove cannabis from the Controlled Substances Act or to merely reschedule it on the basis that it has medical value and low abuse potential.
After that point, DEA spent several months collecting information before forwarding their findings and the petition to the U.S.
That’s in spite of the fact that HHS determined that the derivative “appears to be more potent than cocaine in some behavioral assessments” with respect to its affinity for dopamine transporters.
“The CSA requires DEA, as delegated by the Attorney General, to determine whether HHS’s scientific and medical evaluation, scheduling recommendation, and all other relevant data constitute substantial evidence that a substance should be scheduled.
With respect to marijuana, a federal appeals court in August dismissed a petition to require the DEA to reevaluate the plant’s scheduling under the CSA.
In 2020, DEA followed up by clarifying that the drug was no longer considered a federal controlled substance.