9th Circuit Court of Appeals Orders DEA to Respond to MMJ’s Writ of Mandamus Within 30 Days
WASHINGTON D.C. / ACCESSWIRE / October 3, 2023 / Attorney Megan Sheehan (HEADER IMAGE) representing MMJ BioPharma Cultivation last month filed suit against the DEA for “dragging their heels” for the approval of MMJ’s API Bulk Manufacturing Registration to grow pharmaceutical marijuana needed to produce its medicine. Today the 9th Circuit Court of Appeals ordered the DEA (Drug Enforcement Agency) to respond within 30 days.
MMJ BioPharma Cultivation, MMJ Biopharma Labs , MMJ International Holdings, are the leading Pharma cannabis companies that have FDA Investigational New Drug (IND) filings to conduct clinical trials in Multiple Sclerosis and Huntington’s disease. MMJ has completed manufacturing of its proprietary dose form, THC and CBD non-synthetic soft gelatin capsule developed from marijuana plant extracts. MMJ has submitted its proprietary formulation to the FDA for approval to utilize its medicine in human clinical trials. To date MMJ is the only company with a final dose THC, CBD formulation ready for clinical trials. Duane Boise the companies President stated ” while there has been significant DEA delays on processing MMJ’s application to grow strain specific cannabis for development of its pharmaceutical, the court has not turned a blind eye on the patients suffering from Multiple Sclerosis and Huntington’s disease. MMJ has been strictly following the current federal laws to obtain the FDA and DEA approvals necessary to preform clinical trials to prove efficacy of MMJ’s drug. ”
Last October President Joe Biden asked the Secretary of the Department of Health and Human Services (“HHS”) and the Attorney General to “initiate the administrative process to review expeditiously how marijuana is scheduled under federal law.
Bloomberg News reports that the National Institute on Drug Abuse agreed with the recommendation and he Health Human Services Secretary recommended that the DEA reschedule cannabis to a schedule III. By doing so the HHS Secretary has made a determination that cannabis does have medical value.