WASHINGTON, D.C. / ACCESSWIRE / August 21, 2024 /

DEA Administrator Under Fire: Hypocrisy and Hindrance in Marijuana and Psychedelic Research

The government's prosecution of MMJ BioPharma Cultivation highlights significant ambiguities in the Controlled Substances Act (CSA), President Biden's Medical Marijuana and Cannabidiol Research Expansion Act, and the DEA's own regulatory standards. A critical point of contention is the legislation's requirement that the U.S. Attorney General must approve or deny a marijuana research or manufacturing application within 60 days or request additional information. Critics argue that the DEA has deviated from the original intent of the CSA designed to target drug trafficking and promote pharmaceutical development by prosecuting physicians, applicants for bulk manufacturing registrations and researchers based on increasingly vague and shifting standards for marijuana cultivation for pharmaceutical research and clinical trials.

DEA's Contradictory Actions and Public Statements

In a recent appearance on 60 Minutes, DEA Administrator compared ketamine to the opioid epidemic, all while her agency blocks several companies from advancing legitimate pharmaceutical research. Milgram's public statements stand in stark contrast to the DEA's behind-the-scenes actions, which many argue are hindering the development of drugs aimed at assisting patients in need.

MMJ BioPharma Cultivation's Legal Challenges

Duane Boise, MMJ BioPharma Cultivation President, alongside MMJ Biopharma Labs and MMJ International Holdings, stated the companies are at the forefront of pharmaceutical cannabis research. These companies have made significant strides in developing treatments for debilitating conditions such as Multiple Sclerosis (MS) and Huntington's Disease (HD). They have filed FDA Investigational New Drug (IND) applications to conduct clinical trials and have even received an orphan designation from the FDA for their work. However, despite these advancements, the DEA's prolonged delays in processing their application to cultivate strain-specific cannabis have severely hindered their progress, delaying the potential delivery of innovative treatments to patients.

BIDEN-HARRIS DEA's Shifting Standards

The case of MMJ BioPharma underscores a troubling trend in the government's shifting standards for what constitutes acceptable activities under the CSA. Historically, the CSA targeted drug traffickers-those who prescribed controlled substances without medical justification. However, in recent years, the government has broadened its interpretation of the CSA, prosecuting entities like MMJ based on vague and evolving standards that exceed what state laws require. This evolving application of standards creates uncertainty and imposes a chilling effect on pharmaceutical research and the practice of pain management, as entities must now navigate not only state laws but also unpredictable federal expectations.

DEA's Resistance to Psilocybin Use in End-of-Life Care

The DEA is also facing a legal challenge over its denial of psilocybin use for terminally ill patients under Right to Try (RTT) laws. These laws allow terminally ill patients to test investigational drugs that have not yet received full approval. The DEA argues that RTT laws do not grant it the authority to waive requirements for Schedule I substances like psilocybin. However, this stance has been met with skepticism from judges who question whether the DEA has fully explored its ability to accommodate such requests. The outcome of this case could have significant implications for the use of psilocybin in palliative care and potentially open the door for broader access to Schedule I substances for therapeutic use.

Legal Dispute Over DEA's Scheduling Actions

In another case, the DEA faced a legal challenge from Panacea Plant Sciences (PPS) over its process for scheduling psychedelic compounds. Although the case was dismissed due to procedural issues, it underscores the ongoing disputes over the DEA's reliance on administrative law judges to settle such matters. PPS CEO David Heldreth plans to appeal the decision, continuing the battle over the DEA's controversial approach to drug scheduling.

DEA DOUBLE TALK-ANTI RESEARCH PSYCHEDELICS

The Biden-Harris administration's DEA faces mounting criticism for its inconsistent policies and actions, which are seen as hindering vital research into new treatments for conditions like MS, HD, and mental health disorders. The shifting standards and lack of clear guidelines have led to legal battles that could reshape the regulatory landscape for pharmaceutical research in the United States. As these cases unfold, they will likely have far-reaching implications, potentially leading to significant reforms that ensure a more transparent and constitutionally sound process for drug development and enforcement.

Milgram's public statements, juxtaposed with the DEA's restrictive actions, paint a picture of an agency at odds with itself-one that claims to prioritize public health while simultaneously obstructing access to innovative treatments that could save lives. As the legal and public pressure mounts, the DEA may be forced to reconsider its approach, leading to a new era of drug policy in America.