Ansell Grimm & Aaron Congratulates Clients for Securing Cannabis Licenses

Ansell Grimm & Aaron, PC is pleased to congratulate its latest clients to secure annual cannabis licenses from the Cannabis Regulatory Commission. The Social Leaf, LLC was awarded an Annual Class Five Retailer License, and CSDE Manufacturing, LLC was awarded an Annual Class One Cultivator License. The Commission issues licenses for medicinal and recreational cannabis business operations in New Jersey. We proudly support these developing businesses.

Our Controlled Substances and Regulatory Practice attorneys understand the complex laws related to the production, sale, use, regulation, and legalization of controlled substances, including hemp, cannabis, and psychedelics. A multifaceted area of the law with conflicting regulations from different governing bodies, we help our clients navigate all aspects of this emerging field. We are committed to helping our clients understand their rights and opportunities in this evolving area of law.

9th Circuit to Decide Whether the Federal Government Can Continue to Deprive End-of-Life Patients of Psilocybin’s Palliative Benefits

By Joshua S. Bauchner and Rahool Patel

Much ink has been spilled over the past decade about the absurdity of the federal government’s insistence on maintaining marijuana’s listing as a Schedule I drug with “no accepted medical use” under the Controlled Substances Act (CSA) despite ample evidence of and consensus about marijuana’s therapeutic and medical benefits. A similarly illogical and unjust prohibition against the therapeutic use of another drug – psilocybin – is the subject of a current challenge before the United States Court of Appeals for the 9th Circuit. The outcome of this pending litigation will determine whether the Drug Enforcement Administration (DEA) can continue to deprive countless palliative care and end-of-life patients of a therapy that can help them with unrelieved anxiety and depression in their remaining days.

The case, which has taken a long and winding path back to the appellate court, has attracted the interest and involvement of scores of clinicians, patient rights groups, and drug reform advocates. These parties have submitted amicus briefs to support the rescheduling of psilocybin so that dying patients can avail themselves of the relief the drug may provide. Among those groups is the National Organization for the Reform of Marijuana Laws (“NORML”), whose amicus brief was prepared and filed pro bono by Ansell Grimm & Aaron attorneys Joshua S. Bauchner and Rahool Patel.

“A Law Enforcement Agency Lacking Scientific and Medical Expertise Dictating the Outcomes of Drug Scheduling”

The efforts to reschedule psilocybin and the litigation that followed were commenced by Seattle-based physician Dr. Sunil Aggarwal, who asked the DEA to approve the use of the drug for his palliative care patients under the 2018 federal Right to Try (RTT) Act. That law allows certain patients access to investigational drugs outside of clinical trials.

Despite the fact that the Food and Drug Administration (FDA) had twice designated psilocybin as a “breakthrough therapy,” thus making it potentially eligible for use under the RTT, the DEA refused Aggarwal’s request. Aggarwal then asked the 9th Circuit in 2021 to order the DEA to allow him to treat his patients with psilocybin, arguing that the RTT superseded the CSA’s ban on the use of the drug. However, the court dismissed the petition on procedural grounds, as the DEA had not yet issued a final agency decision that would allow for judicial review.

After the dismissal, Aggarwal continued his fight but changed his approach. Instead of challenging the DEA’s decision under the RTT, he affirmatively petitioned the DEA in February 2022 to reschedule psilocybin as a Schedule II drug, which would allow for its therapeutic use.

The DEA was equally unmoved by this effort and summarily rejected Aggarwal’s petition in September 2022, asserting there was no scientific evidence that would justify rescheduling. The pending litigation ensued, in which Aggarwal is asking the 9th Circuit to vacate the DEA’s denial and remand the petition back to the agency on the grounds that the DEA did not follow the required procedure when denying the petition.

Specifically, Aggarwal asserts that the DEA violated the law by failing to consult the FDA to assess psilocybin’s potential uses. As noted, the FDA had previously designated it as “breakthrough therapy,” facilitating research into its potential medical applications. As Aggarwal asserts in his initial brief, “DEA disregarded procedures Congress established to cabin the agency’s authority and to prevent precisely what has happened here: a law enforcement agency lacking scientific and medical expertise dictating the outcomes of drug scheduling.”

The firm is proud to stand with Dr. Aggarwal and his efforts to make a promising and game-changing treatment available to ease the pain of patients nearing the end of their lives and others who may benefit from such therapies. The federal government’s imperviousness to scientific and medical evidence that does not align with their obsolete treatment of potentially beneficial drugs unjustly interferes with the doctor-patient relationship and deprives patients of much-needed relief.

CONTROLLED SUBSTANCES AND REGULATORY LAW DEPARTMENT UPDATE – FEBRUARY 2023

Ansell Files Amicus Curiae Brief In Support Of De-Scheduling Psilocybin

Ansell Grimm & Aaron, PC once again proudly joins the National Organization for the Reform of Marijuana Laws (“NORML”) in securing access for patients, especially veterans, to the scientifically established medicinal benefits of psilocybin. Americans waited a half-century before gaining access to medicinal cannabis while the federal government continues to pursue a racist agenda in the face of legalization in nearly 40 states. History must not repeat itself. The federal government must stop interfering in the doctor-patient relationship.

In furtherance of this objective, Firm attorneys Joshua S. Bauchner, head of the Controlled Substances and Regulatory Law Practice Group, and Rahool Patel served as the principal authors of a pro-bono amicus curiae brief on behalf of NORML in support of Petitioners in Dr. Sunil Aggarwal, MD, PhD; Advanced Integrative Medical Science Institute, PLLC v. U.S. Drug Enforcement Administration; Anne Milgram in Her Official Capacity as Administrator of the U.S. Drug Enforcement Administration; and Merrick Garland in His Official Capacity as Attorney General, No. 22-178, in the United States Court of Appeals for the Ninth Circuit.  A copy of the brief may be found here.

In summary, the brief cautions the federal government against allowing history to repeat itself, providing an historical account of NORML’s efforts to decriminalize cannabis for medicinal purposes for the past half-century and the never-ending efforts of the federal government to delay, resist, and obstruct the progress of science and medicine.  While the federal government is unlikely to learn any lessons from the past, NORML hopes that the Court will acknowledge and heed the legal and procedural lessons learned from those past administrative petition litigations so that innocent dying patients – who are the true victims of the government’s misbehavior – are not denied readily available medicine.

NORML’s mission is to move public opinion sufficiently to legalize the responsible use of marijuana by adults, and to serve as an advocate for consumers to assure they have access to high quality marijuana that is safe, convenient and affordable.

The Firm previously filed a pro-bono amicus brief in the United States Supreme Court in the matter of Washington v. Barr, on behalf of several non-profit organizations representing former national and international professional athletes in support of a constitutional challenge to the federal government’s continued refusal to remove marijuana from Schedule I of the Controlled Substances Act, even though millions of Americans use marijuana on a regular basis to manage debilitating health conditions in accordance with State, territorial, and local laws. Unfortunately, with the passing of Justice Ginsberg, petitioners were unable to secure the four votes necessary to secure review.

Ansell Celebrates Five-Year Anniversary of the New Jersey Cannabis Symposium

In honor of the first-ever New Jersey Cannabis Symposium, which was held on January 26, 2018, which recently celebrated its fifth anniversary, Ansell Grimm & Arron, PC is proud to acknowledge the many milestones of success and rapid growth and development, particularly with respect to licensure, since that fateful night. Many have since held meetings and events promoting cannabis decriminalization and legalization in the State, but none have replicated the energy and enthusiasm on display that night.

Nearly 1,000 people interested in taking a role in the legal adult use cannabis industry attended the NJ Cannabis Symposium at the New Jersey Performing Arts Center that night.  Media coverage of the event was extensive with reports appearing on New York’s NBC and ABC affiliates, on FIOS1 News, in NJBiz.com, and on NPR and Good Morning America.

As Ansell Partner Joshua S. Bauchner then told the Asbury Park Press, “The time is now. If you’re starting today or tomorrow, you need to ramp up. There’s a tremendous amount of work to be done before we get to the actual filing of the licenses – getting your team together, getting your capital, finding your space, figuring out your banking.” Bauchner, a featured speaker at the Symposium, leads Ansell’s Controlled Substances and Regulatory Law Practice Group which also co-hosted the Symposium alongside the BSC Group, Longview Strategic, Marcum LLP, and the New Jersey Cannabusiness Association.

Since that time, including the passage of the New Jersey Cannabis Regulatory, Enforcement Assistance, and Marketplace Modernization Act (“CREAMMA”), the Firm continues to provide guidance to prospective business owners hoping to traverse the ever-changing landscape of recreational cannabis in areas including licensing, intellectual property, employment rights and municipal zoning and approval. Indeed, nearly 1,100 dispensary, manufacturing and cultivation licenses have been awarded to date.

About Ansell Grimm & Aaron, PC

Ansell Grimm & Aaron, PC was founded in 1929 and has a long history of delivering for clients who come to us to resolve legal matters that are often urgent, stressful, and of great importance. A general practice law firm, Ansell Grimm & Aaron is powered by experienced attorneys who understand that the best outcome is the one that serves the needs of each client.

Ansell’s dedicated Controlled Substances & Regulatory Law Practice Group has an in-depth understanding of the laws related to the production, sale, use, regulation and legalization of controlled substances, including:  hemp, cannabis, and psychedelics. Controlled substances law remains a multifaceted and complex field with, at times, conflicting regulations from different governing bodies.  Our attorneys are prepared to assist in all aspects of this emerging field and are committed to helping our clients understand their rights and the opportunities in this complex and evolving area of law.  For additional information, please contact Joshua S. Bauchner at (973) 247-9000 or jb@ansellgrimm.com.

The above is for informational purposes only and does not constitute legal advice. Transmission of the materials and information contained herein is not intended to create, and receipt thereof does not constitute the formation of, an attorney-client relationship. Attorney advertising.