Date: November 30, 2023Attorney: Joshua S. Bauchner

In the ever-evolving landscape of medical innovation, the journey to bring breakthrough therapies to those in need is often fraught with obstacles and red tape. For many patients grappling with life-threatening conditions, the clock is ticking, and the standard procedures of rescheduling controlled substances are causing unnecessary delays. In a remarkable legal battle, advocacy groups like NORML (National Organization for the Reform of Marijuana Laws) are challenging the status quo, advocating for quicker access to groundbreaking treatments like psilocybin and cannabis.

A History of Delay and Obstruction

The road to rescheduling controlled substances, such as cannabis and psilocybin, has been marred by decades of bureaucratic hurdles and delays. NORML’s mission to reform marijuana laws has exposed a concerning pattern of inaction and resistance by federal agencies, primarily the Drug Enforcement Administration (DEA). The saga dates back to the 1970s when NORML first petitioned for cannabis rescheduling.

Remarkably, the DEA did not respond to NORML’s petition for nearly nine years, only to deny it based on the assertion that marijuana had “no accepted medical use in the United States.” This decision was challenged in the D.C. Circuit, where the court upheld the denial under the “arbitrary and capricious” standard. The pattern of delay and resistance continued, stifling the progress of cannabis rescheduling efforts.

Similarly, the quest to reschedule psilocybin has faced frustrating delays and inaction. When Dr. Sunil Aggarwal, and his organization, Advanced Integrative Medical Science Institute, PLLC, filed a petition for psilocybin rescheduling, the DEA responded with a pro forma four-sentence rejection letter that echoed outdated conclusions without any new scientific evaluation. The situation is reminiscent of requests for cannabis rescheduling, highlighting the lack of progress and a consistent pattern of resistance. 

The Procedural Due Process Right

One of the core issues at play in these cases is the violation of procedural due process rights. The Controlled Substances Act (CSA) provides individuals with the right to challenge the designation of controlled substances. Under the Fifth Amendment of the U.S. Constitution, no person shall be deprived of life, liberty, or property without due process of law. This fundamental principle ensures that individuals have the opportunity to be heard at a meaningful time and in a meaningful manner.

In the cases of cannabis and psilocybin, due process requires the DEA to gather data and forward it to the Food and Drug Administration (FDA) for a thorough medical and scientific evaluation. This evaluation should form the basis for recommendations on the appropriate schedule, if any, for the substance in question. However, this process has been anything but efficient.

The DEA’s responses to rescheduling petitions for cannabis and psilocybin have been inadequate, lacking the necessary scientific and medical evaluations. Instead, these responses have relied on outdated recommendations that were not reevaluated in light of the pending petitions. This disregard for due process undermines the very principles upon which the CSA was built.

Life on the Line: The Urgency of Change

The delays in rescheduling controlled substances are not merely administrative inconveniences; they are a matter of life and death for countless patients. Many of these individuals, often with limited lifespans remaining, have exhausted all conventional treatment options. For them, delay is not an option, as time is an increasingly precious commodity.

The federal courts have long recognized the concept of cases “capable of repetition, yet evading review.” This principle acknowledges that certain controversies, due to their unique nature, may continue to occur but not receive timely judicial review. In the context of rescheduling petitions, this concept is alarmingly relevant. Patients in dire need of breakthrough therapies cannot afford the consistent delays caused by bureaucratic inaction.

Redefining the Future of Medical Rescheduling

Advocacy groups are challenging the status quo and fighting for faster access to breakthrough therapies. Their mission is not just about marijuana or psilocybin; it’s about redefining the future of medical rescheduling. The consistent pattern of delays and inaction by federal agencies should not be tolerated when patients’ lives hang in the balance.

The ongoing legal battles being waged are not just about specific substances; they are about the broader principles of due process, fairness, and the urgent need for reform. As medical science advances, it’s crucial for the regulatory framework to keep pace, ensuring that those in need can access life-changing treatments without unnecessary delays.

In conclusion, the fight for faster access to breakthrough therapies is a battle worth fighting. Patients and advocacy groups are leading the charge, demanding a more efficient and compassionate approach to rescheduling controlled substances. The past may be marred by delays, but the future holds the promise of a more accessible and responsive healthcare system without government intrusion and delay denying medicine to those most in need.