Duane Boise, CEO of MMJ International Holdings, expressed frustration over the contrasting approaches of federal agencies, stating, "While the FDA is facilitating medical innovation, the DEA's hindrance not only blocks scientific progress but also contradicts directives aimed at revitalizing domestic manufacturing." This situation starkly contrasts with the "Buy American" initiative endorsed by President Trump in 2020, which was intended to strengthen U.S. drug production capabilities and reduce dependence on foreign manufacturers.
WASHINGTON, DC / ACCESS Newswire / March 27, 2025 / The U.S. Food and Drug Administration (FDA) has provided critical feedback on MMJ International Holdings' Investigational New Drug (IND) application for MMJ-002, charting a clear course for the advancement of clinical trials. This development marks a significant step forward in the battle against Huntington's disease. However, the Drug Enforcement Administration (DEA) has yet to issue an API Bulk Manufacturing Registration, essential for legally producing the cannabis-derived active pharmaceutical ingredients (APIs) in the U.S., potentially forcing the drugs development offshore against President Trumps mandates.
FDA Collaboration vs. DEA Stagnation
Duane Boise, CEO of MMJ International Holdings, expressed frustration over the contrasting approaches of federal agencies, stating, "While the FDA is facilitating medical innovation, the DEA's hindrance not only blocks scientific progress but also contradicts directives aimed at revitalizing domestic manufacturing." This situation starkly contrasts with the "Buy American" initiative endorsed by President Trump in 2020, which was intended to strengthen U.S. drug production capabilities and reduce dependence on foreign manufacturers.
Global Implications and Domestic Frustrations
The DEA's reluctance to approve necessary manufacturing licenses threatens to push pioneering firms like MMJ to seek more accommodating regulatory climates abroad, potentially diminishing the U.S. position in the burgeoning global cannabis pharmaceutical market, valued at $50 billion. Countries like Canada, Germany, and Israel could become new hubs for innovation, eroding U.S. competitive edges.
Rep. Earl Carter (R-GA), an advocate for modernizing cannabis research regulations, criticized the DEA's outdated approach, "Their delays reflect a prohibition-era mindset that is directly undermining American economic and medical leadership on the global stage."
Impact on Patients and the Pharmaceutical Industry
The delay in DEA approval not only impacts companies but also the over 500,000 Americans living with Huntington's disease and multiple sclerosis, who might benefit from MMJ-002. This therapy, which aims to reduce neuroinflammation and slow disease progression, represents a groundbreaking treatment avenue. The pharmaceutical industry also warns that such federal inconsistencies could deter investment in U.S.-based cannabis research, redirecting vital resources and expertise overseas.
A Critical Juncture for U.S. Drug Policy
MMJ's ongoing struggle highlights the broader conflict between outdated federal drug policies and current medical and economic realities. As MMJ considers legal measures to force DEA compliance, its actions could establish legal precedents that may significantly alter the regulatory landscape for cannabis.
"This is more than just about one drug," Boise added. "It's about deciding if the U.S. will be a leader or a follower in the next wave of medical innovation."
As bipartisan support grows, the DEA is now at a crossroads: either align with the broader federal goals of fostering health innovation and bolstering domestic manufacturing or continue on a path that may lead to its diminished relevance in a rapidly evolving global market.
Stay Updated:
For further insights into MMJ's regulatory journey and its implications for U.S. drug policy, continue following our coverage here: FDA Awards Orphan Drug Designation to MMJ-002 for Huntington's.
MMJ is represented by attorney Megan Sheehan.
CONTACT:
Madison Hisey
media@mmjih.com
203-231-8583
SOURCE: MMJ International Holdings
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