MMJ International Holdings Facilitates FDA Clinical Trials for Cannabis Research
ST PETERSBURG, FL / ACCESSWIRE / January 16, 2020 / MMJ International Holdings:
The House Energy and Commerce Subcommittee on Health held a hearing on cannabis with much of the focus on research, with the Drug Enforcement Administration revealing that it has a cultivation licensing proposal pending before the White House Office of Management and Budget.
MMJ International holdings, the premier medical research company, who filed Investigational New Drug (IND) applications with the FDA was pleased to learn at a congressional hearing aired on C-SPAN on Wednesday, that federal regulators recognized that valuable research into marijuana is needed. For decades researchers have been inhibited by cannabis's current legal status. The FDA, DEA and NIDA described how they are taking steps to resolve the issue.
DEA, FDA and NIDA witnesses all agreed under questioning that the current supply of cannabis for study purposes is inadequate and that researchers should be able to access a wider range of federally approved marijuana products that have followed the FDA drug guidance for further clinical research.
The US Federal Government has only authorized one facility to cultivate cannabis for researchers. Nora Volkow, Director of NIDA, acknowledged that the current situation "limits the diversity of products and formulations available to researchers and slows the development of cannabis-based medications…Although the University of Mississippi supplies cannabis for clinical trials, it does not have the capacity to manufacture a broad array of cannabis-derived formulations for research or to supply these cannabis products for commercial development," she said. The consensus of the hearing is that more federally approved research is needed and further development of products and should be grounded in science to protect the public health interest.
MMJ International Holdings (MMJ) will be initiating its clinical trials in Multiple Sclerosis (MS) and Huntington's Disease (HD) to prove safety and efficacy for patients. MMJ has accomplished several major milestones, including the DEA's most recent approval for its THC and CBD international shipment to the United States for further development of its plant-derived cannabinoid drug. Also, MMJ has recently been awarded FDA "Orphan Drug Designation" for its proprietary drug formulation.
In further response to MMJ Biopharma Cultivation's application for bulk manufacturing license, DEA Senior Policy Advisor, Matthew Strait, said the agency is aware of the issue and is actively developing regulations to address the problem by licensing additional growers.
"We actually have a draft regulation in place," he said, adding that it is currently being reviewed by the White House Office of Management and Budget (OMB) and that regulators have a call scheduled for today to discuss the proposed rule.
"That regulation is in draft form. I can't talk too much about it, but rest assured, we have submitted to the White House OMB, it's been drafted and tomorrow some of us will be getting on a call to talk through it."
Matthew Strait, DEA Senior Policy Advisor, wrote that his agency remains committed to expanding the number of federally authorized cannabis manufacturers for research purposes. He noted that DEA is reviewing the situation but that "adjustments to DEA's policies and procedures may be necessary under applicable U.S. law to be consistent with certain treaty functions."
"In the near future, DEA intends to propose regulations that would govern persons seeking to become registered with DEA to grow marijuana as bulk manufacturers, consistent with applicable law, taking into account recent changes in the Controlled Substances Act," Strait said. "At present, a notice of proposed rulemaking is under review by the White House Office of Management and Budget."
The reason why the federal Government is opposed to the state to state federally illegal products is because "There is a significant gap in our understanding of their impact on health," Nora Volkow, Director of NIDA said. Furthermore, "The recent outbreaks of e-cigarette or vaping product use associated lung injury (EVALI), which has been linked to informally-sourced THC-containing vape products, underscores the critical importance of facilitating researcher access to different product sources."
Duane Boise, CEO of MMJ, stated that "MMJ International Holdings research is essential to understand how its drug will affect patient's health by advancing therapeutics in MS and HD. We want to provide safe and effective options for patients suffering from these chronic diseases.
Contact: Michael Sharpe
SOURCE: MMJ International Holdings