The DEA Games Continue To Delay Legitimate Marijuana Clinical Trials and Research
PROVIDENCE, RI / ACCESSWIRE / September 1, 2022 / Megan Sheehan and Associates, lawyers representing MMJ Companies, fired back at the DEA recently with a reply in Federal Court. The reply specifically citing where the DEA Investigators errored, citing Federal Law on how Congress governs the Drug Enforcement Agency on the MMJ's drug development and clinical trials application process. MMJ BioPharma Cultivation has filed in December of 2018 and has been patiently waiting approval.
"823 (i) Registration to manufacture certain controlled substances for use only in a clinical trial
1. For purposes of registration to manufacture a controlled substance under subsection (d) for use only in a clinical trial, the Attorney General shall register the applicant, or serve an order to show cause upon the applicant in accordance with section 824(c) of this title, not later than 180 days after the date on which the application is accepted for filing.
2. For purposes of registration to manufacture a controlled substance under subsection (a) for use only in a clinical trial, the Attorney General shall, in accordance with the regulations issued by the Attorney General, issue a notice of application not later than 90 days after the application is accepted for filing. Not later than 90 days after the date on which the period for comment pursuant to such notice ends, the Attorney General shall register the applicant, or serve an order to show cause upon the applicant in accordance with section 824(c) of this title, unless the Attorney General has granted a hearing on the application under section 958(i) of this title."
MMJ BioPharma Labs, one of the triad of companies, received its DEA schedule 1 Analytical Lab Registration. This was admission by the DEA that MMJ meet the security and divergence requirements for the schedule 1 award. This DEA award allows for the international importation of cannabis for research and API development. However, MMJ BioPharma Cultivation continues to be delayed in receiving its DEA cultivation registration.
"The DEA games continue to delay legitimate marijuana clinical trials and research," company President Duane Boise stated.
WHY HAS THE DEA FAILED ITS MANDATE?
As stated on the DEA website, "A Diversion Investigators mission is to enforce the Controlled Substances Act and the Chemical Diversion and Trafficking Act regarding the manufacture, distribution and dispensing of legally produced controlled substances and listed chemicals in order to prevent diversion of controlled substances and listed chemicals into the illicit market, while ensuring an adequate uninterrupted supply of pharmaceutical controlled substances and listed chemicals to meet the legitimate medical, commercial and scientific needs of the public.
In addition, MMJ BioPharma has been awarded FDA "Orphan Designation" for its clinical trial in Huntington's Disease. The company also has an investigational new drug (IND) application filed with the FDA to begin clinical trials in Multiple Sclerosis. Meanwhile, MMJ is awaiting the DEA to issue its bulk manufacturing registration.
"MMJ has filed suit against the DEA for dragging their feet on the matter of not issuing the registration in a timely manner. Currently, MMJ BioPharma is nearing completion of its state-of-the-art, marijuana center of excellence," stated the firm in a recent press release.
"As MMJ International Holdings continues to advance to its clinical trials, these DEA delays are unprecedented, we will get to the bottom of this," stated Elio Mariani, Ph.D., of MMJ. "The statutory mandate of the DEA is security and divergence and to facilitate the manufacturing of pharmaceuticals to help patients suffering from chronic disease."
WHY IS THE DEA USING DIFFERENT STANDARDS FOR APPROVAL ACROSS THE COUNTRY?
Duane Boise, President MMJ
MMJ company officials have recently learned of further DEA inappropriate registration actions.
- Issuance of a registration to one company to grow marijuana in a residential area garage, and
- Recently a company sought to list on the NASDAQ without the company having meet the security and document requirements as directed by 21 Code of Regulations 1301 etal https://contracts.justia.com/companies/bright-green-corp-14810/contract/239232/
- Other company DEA registrants do not or can not meet the DEA definition of chemical reproducibility.
For a number of ongoing years, DEA states "full support in expanding research into the potential medical utility of marijuana and its chemical constituents." Noting, increased public interest in medical marijuana drug development and potential treatments for certain medical conditions. Yet, they continue to delay MMJ's registration to proceed with human clinical trials.
"As MMJ International Holdings continues to advance to its clinical trials, a specialty pharmaceutical solutions company has supported MMJ with the FDA required development for its specialized liquid encapsulation manufacturing," said Elio Mariani, Ph.D., in charge of research & development. "Patients will benefit from quality therapies in an accessible and efficient format. We firmly believe that our MMJ oral gel cap medication, containing the marijuana plant's unique pharmacological properties, will be FDA-approved as a safe and effective drug," he further stated.
Tim Moynahan, MMJIH chairman, mentioned, "There is significant public interest in cannabis-derived compounds. However, it is an egregious dereliction of duty that the DEA continues with this delay. We are working with the NIH and FDA to fill in the knowledge gaps about the science safety and quality of MMJ's products. We are committed to advancing our product development through an approach that is in line with our mission to prioritizes public health, fosters innovation, and promotes consumer confidence."
MMJ International Holdings continues its process of scientific drug development and discovery by following the NIH and FDA development processes and the DEA regulatory manufacturing guidelines.
Media Contact:
Sara Parker
media@mmjih.com
203-231-8583
SOURCE: MMJ International Holdings
View source version on accesswire.com:
https://www.accesswire.com/705021/DEA-a-Rogue-Agency-Not-Following-Its-Legislative-Mandate-for-MMJs-Marijuana-Pharmaceutical-Development-and-Clinical-Trials
