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At DEA’s Door: The Battle to Open Access to Psilocybin Therapy for Peace and Comfort at the End of Life

By Kathryn Tucker, JD[1]

On Mother’s Day 2022, my client Erinn Baldeschwiler, a young mother of two with Stage IV terminal cancer travelled from Seattle to Washington D.C. instead of spending the day with her children, even thought it was likely her last Mother’s Day given the inexorable advance of her illness.  Accompanied by her palliative care nurse, Erinn made the trip to the door of the headquarters of the Drug Enforcement Administration (DEA), a federal law enforcement agency which for more than 16 months has blocked her from access to psilocybin, an investigational drug shown in clinical trials to be enormously effective in relieving anxiety and depression in dying patients.  Provisions of state and federal right to try (RTT) laws intend for investigational drugs shown to have promise in early clinical trials to be accessible to patients with advanced illness. Patients like Erinn. But DEA has steadfastly refused Erinn access.

On the Monday following Mothers’ Day, bright, breezy and sunny, Erinn stood at a podium in front of the DEA high-rise building and told DEA employees shuttered inside: “I am running out of time.” The crowd, Americans from all across the United States who had also traveled to DEA’s door in solidarity with Erinn and the multitude of Americans confronted by advanced illness, chanted: “DEA stop the delay, DEA get out of the way”. Signs and posters held by demonstrators proclaimed what clinical trials show: “Immediate, Substantial and Sustained Relief.” Psilocybin provides relief from debilitating anxiety and depression in the face of imminent death and the loss the patient faces. For Erinn that loss includes missing out on seeing her children grow up. The unspeakably sad loss of not being able to be here for them. As her counsel, I spoke from the podium just before Erinn, to explain the efforts her legal team had made, what the RTT law provides, and how the DEA was thwarting the law and exceeding its scope of authority.

Erinn and her palliative care physician Dr. Sunil Aggarwal, Co-Founder and Director of Seattle’s Advanced Medical Science Institute, came to me in October of 2020 with the hope of gaining access to psilocybin, a drug currently sited on Schedule I of the Controlled Substances Act. This designation means no distributor would supply the drug without permission from the DEA. Our request for such permission detailed that the drug was an ‘eligible investigational drug’ under the terms of RTT laws. Nonetheless, our request was flatly denied:  DEA would permit no access for therapeutic use. I assembled a team of attorneys with special expertise to develop a lawsuit to be filed in federal court to compel the DEA to comply with the RTT laws.[2]  A multitude of amicus briefs were filed in support of our case, including by 8 States, leading psilocybin researchers, prominent palliative care physicians, and progressive and conservative think tanks alike.  DEA sought to avoid review by arguing its decision to deny access had not been “final”. In a ruling which did not reach the merits the court accepted that argument in a ruling issued on January 31, 2022 dismissing the case.

We immediately asked the DEA for a final determination, so that either access could be had or we could return to court.  Despite the fact that a year of legal briefing detailed the Agency’s clear obligation to accommodate RTT, several months later the Agency has yet to respond. The dynamic reality  of terminal illness means that the Agency’s delay means relief will be forever denied. This is what brought Erinn to the nation’s capital on May 9, 2022.

The idea of holding a public demonstration to shine a bright light of public scrutiny on the DEA’s failure to accommodate the law of the land was David Bronner’s. David is the CEO of Dr. Bronner’s Magic Soaps. David (for whom the CEO title stands for Cosmic Engagement Officer) is a well-known champion of opening access to psychedelics. David professes that the catalyst for him to get his team involved to  organize and host the demonstration was hearing me speak about Erinn’s case on the Psychedelics Today podcast.[3]

Hours into the demonstration, police arrived, arresting and handcuffing Erinn, arms behind her back, placing her in a police van. She, along with 16 other demonstrators (including David Bronner) engaging in peaceful protest of the DEA’s obstruction of the law of the land, was taken to jail. All the demonstrators were released that night, with summons for a future court appearance.

Next morning, notwithstanding the exhausting previous day, Erinn met me at the Dirksen Senate Office Building for a meeting with Senator Patty Murray’s staff. The meeting lasted more than an hour. This was our first in person meeting; we had met over Zoom several times, seeking Senator Murray’s involvement in ensuring that the DEA respect state and federal RTT laws and allow access to promising investigational drugs, in this case psilocybin.  Senator Murray, a 30 year Senate veteran, is Chair of the U.S. Senate Committee on Health, Education, Labor, and Pensions (HELP).

We urged that Senator Murray intercede urgently: Laws intended to benefit Erinn and others similarly situated are being thwarted by the DEA, leaving multitudes of patients to endure suffering which could be relieved with access to this drug. Having been one of the attorneys who successfully sued the Justice Department when then U.S. Attorney General John Ashcroft (and then his successor Alberto Gonzales)  attempted to thwart operation of Oregon’s pioneering Death with Dignity Act by invoking application of the federal Controlled Substances Act to override Oregon’s law, I felt particularly well suited to educate Murray’s staff that binding federal precedent of the Supreme Court of the United States forbids a federal agency from intruding into the regulation of the practice of medicine, a matter reserved largely to the sovereignty of the states.[4]  Washington State, Senator Murray’s home state, had enacted its RTT law in 2017 by unanimous vote. The US Congress had amplified that enactment in adopting the federal RTT a year later. It is incumbent on Senator Murray, I urged, for her to stand up for Erinn and other patients, and for the sovereignty of her home state; federal elected officials have the duty to oversee a federal agency overreaching the bounds of its authority. Especially when that overreach denies much needed relief to dying patients. Erinn, I told the Senator’s staff, was running out of time.

A short film about Erinn and  the demonstration at the DEA can be viewed at this link:  https://vimeo.com/713486783/8b7f4b4eda

For those interested in following Erinn’s case, and the continuing effort to open access to psilocybin therapy for peace and comfort at the end of life, visit:  https://righttotrypsilocybin.com/.  Join the petition and contact your federal elected officials to enourage them to ensure that RTT laws are respected and that dying patients are able to access this palliative care investigational medicine

The legal team leading the effort to forge a path to access pursuant to RTT laws will continue to press the DEA to issue a waiver allowing access, and/or to reschedule psilocybin from Schedule I to Schedule II of the Controlled Substances Act. Other strategies to ensure access are also being explored;  We will continue to move this advocacy forward until access is ensured.

[1] Special Counsel at Emerge Law Group, Co-Chair Psychedelic Practice Group. Founding board member of the Psychedelic Bar Association, Co-Chair, Litigation and Advocacy Committee.  Liaison to the American Bar Association. Founding Advisory Board Member, the Initiative on Psychedelics and Healing, Global Wellness Institute.

[2] Counsel joining me in representing Erinn and the other plaintiffs include Matt Zorn, Yetter Coleman LLP;  Shane Pennington, Vicente Sederberg LLP; and James Williams, Andrew Kline, Thomas Tobin and Holly Martinez, Perkins Coie LLP.

[3] Psychedelics Today webinar/podcast, “The Right to Try Act and the Battle for Psilocybin Access”, https://psychedelicstoday.com/2022/04/05/pt307/(4/5/22)

[4] Gonzales v. Oregon, 546 U.S. 243(2006)(landmark decision of the US Supreme Court which ruled that the United States Attorney General cannot enforce the federal Controlled Substances Act against physicians participating in Oregon’s Death with Dignity Act.)

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FREE Virtual Event Series – Deep Dive Into the Oregon Psilocybin Services Act: Federal Law Issues (Session 5)

Emerge Law Group is continuing its FREE virtual event series “Deep Dive Into the Oregon Psilocybin Services Act“!

Session 5:  Federal Law Issues

Join us on:

Thursday, May 26, 2022
4:00 pm to 6:00 pm Pacific Standard Time
via Zoom

REGISTRATION LINK HERE.

We will take a deep dive into the various federal law issues (both criminal and civil) that psilocybin manufacturers, service center operators, and facilitators will need to consider when organizing and operating their businesses.  The event will feature Emerge Law Group attorneys Dave Kopilak (primary drafter of Oregon Measure 109) and Kathryn Tucker (lead counsel in AIMS, et al v. USDEA, et al), and include guest speakers:  (i) attorney Billy Williams, a partner at Best Best & Krieger and former U.S. attorney for the District of Oregon; (ii) attorney Jodi Avergun, a partner at Cadwalader and former Chief of Staff of the U.S. Drug Enforcement Administration, and (iii) Dr. Rachel Rackow, an Oregon physician specializing in end of life care.  As always, we will provide ample time for an extended Q&A session with attendees.

Virtual Event Series

Mark your calendars because the virtual event series will recur on the last Thursday of every month in 2022 and will cover a variety of interesting topics related to the implementation of the Oregon Psilocybin Services Act in real time.

The series is FREE and open to anyone interested in learning more about the Act.  We look forward to seeing you there!

In the meantime, if you have questions concerning the Oregon Psilocybin Services Act or any other laws involving psilocybin, entheogenic plants, or psychedelics in general, please contact attorneys Dave Kopilak, Kathryn Tucker, Sean Clancy, Kaci Hohmann, Alex Berger, or Corinne Celko  from our Psychedelics Industry Group.

Event Recordings

If you couldn’t make, or would like to revisit, any prior events the video recordings are available on Emerge Law Group’s YouTube Channel.

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Efforts to Open Access to Psilocybin for Therapeutic Use with Those with Life Threatening Illness Continue

Emerge Law Group Special Counsel Kathryn Tucker submitted a Freedom of Information Act (“FOIA“) request to the Drug Enforcement Administration (“DEA“) on March 31, 2022 on behalf of the Seattle area palliative care clinician Dr. Sunil Aggarwal of the Advanced Integrative Medical Science (“AIMS”) Institute, and several of his patients with terminal cancer.  The FOIA Request seeks documents bearing on the DEA’s handling of Dr. Aggarwal’s Request for Waiver and a Petition to Reschedule psilocybin from Schedule I to Schedule II of the federal Controlled Substances Act.  Delay appears to be the DEA’s standard course of action, but in this case where the interests of dying patients are at stake such delay is unacceptable.

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Lions and Tigers and Shell Companies, Oh My! Preparing Your Business for Federal Beneficial Ownership Reporting Requirements

By:  Delia Rojas and Kaci Hohmann

The Corporate Transparency Act (“CTA”), part of the federal Anti-Money Laundering Act of 2020, came into effect in January 2021. Its goal is to prevent money laundering and abuse related to the use of shell companies as a mechanism for concealing illicit business activities.  In December 2021, the Financial Crimes Enforcement Network (“FinCEN”) published proposed rules for public comment implementing the beneficial ownership information reporting requirements of the CTA (the “Draft Rules”).  The Draft Rules address who must report beneficial ownership information to FinCEN, when they must report, and what information the reports must include.  The public comment period for the Draft Rules closed on February 7, 2021. As of the date of this blog post, it isn’t yet clear whether FinCEN will further revise the Draft Rules and open a second public comment period before finalizing and publishing the final rules. Regardless, the scope of the CTA is broad and will impact small and large businesses alike.

Below we summarize some of the most important reporting requirements proposed under the Draft Rules. These requirements are subject to change, and as more information becomes available, Emerge Law Group will keep you updated.

Who must report?

Under the Draft Rules, a corporation, limited liability company (LLC), or similar entity formed or registered to do business in any state by filing documents with a U.S. state or Indian Tribe (“Reporting Company”) must report certain information to FinCEN about anyone who, directly or indirectly, exercises substantial control over, or owns or controls 25% or more (“Beneficial Owners”) of the Reporting Company. The definition of Reporting Company broadly captures many businesses with a number of important exceptions, including certain publicly traded companies; tax-exempt entities, such as 501(c) entities; and heavily regulated businesses that already provide ownership information to a federal government agency. The Draft Rules also specifically exclude financial institutions; insurance companies; and large operating companies that employ more than 20 full-time employees, have an operating presence in the U.S., and have gross receipts or sales in the U.S. exceeding $5 million dollars.

Examples of an individual who exercises “substantial control” over a Reporting Company are those who serve as senior officers; and those who direct, determine, or “substantially influence important matters of a Reporting Company.” FinCEN specifically stated that a person who makes day-to-day managerial decisions with respect to one part of a Reporting Company’s assets or employees should not, in isolation, cause that person to be deemed to exercise “substantial control” of a Reporting Company, unless that person satisfies another element of the “substantial control” criteria.

Examples of an individual who “owns or controls 25% or more” of a Reporting Company are those who hold an ownership interest through stock, LLC units, profit interests, and other convertible equity interests, such as warrants or options.

Additionally, information about individuals who file documents creating, or first registering, a Reporting Company under state law, or who direct or control the filing of such documents (“Company Applicants”), must be included in the report to FinCEN. This means attorneys, legal assistants, entity registration service providers, and any person involved in the preparation and filing of entity formation documents will also have to provide their information to Reporting Companies for reporting obligations.

When must reports be filed?

When a Reporting Company must file their initial report will depend on when the final rules become effective.

For Reporting Companies formed after the effective date, the report must be filed within 14 days of formation. For Reporting Companies formed before the effective date, the report must be filed within one year of the effective date of the final rules.

Furthermore, the Draft Rules require ongoing reporting to ensure that all beneficial ownership information is up to date, requiring updates to be made within 30 days of a change.

What information must reports include?

The Draft Rules provide that Reporting Company reports must include the Reporting Company’s legal entity name, assumed business name, street address, state of organization, and federal employer identification number. The reports for Beneficial Owners and Company Applicants must include the individual’s name, birthdate, residential address, and acceptable photo ID.

Confidentiality will be of concern for many of our firm’s clients. The CTA requires the establishment of security protocols to protect the confidentiality of the reported information. FinCEN is specifically prohibited from sharing the information with the general public and as a general matter, the information can only be disclosed, subject to stringent access protocols, to law enforcement, financial institutions, and other authorized users for the purpose of protecting national security and intelligence, enhancing financial system transparency, and assisting in other enforcement efforts to counter illegal activity. However, rules detailing which agencies will be authorized to view reported information and the security protections for that information have yet to be published for public comment.

What proactive steps should businesses take?

For starters, your business can begin collecting the beneficial ownership information that will eventually need to be reported to FinCEN. Businesses and business attorneys should also consider adding provisions to agreements with owners requiring the owner’s cooperation to collect the owner’s required reporting information and update confidentiality clauses in legal documents to carve out exceptions for these reporting requirements.

Violating the beneficial ownership reporting requirements could result in civil penalties up to $500 per day and criminal fines up to $10,000 or up to two years in jail. Compliance with these impending rules will be crucial and Emerge Law Group will continue to monitor developments.

If you have any questions or concerns about how the beneficial ownership reporting requirements will impact your business, contact an attorney from our Business Group.

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Establishing a Pathway to Access Psilocybin for Use with Patients with Advanced Illness: UPDATE

As counsel to Dr. Sunil Aggarwal of the Advanced Integrative Medical Science (“AIMS”) Institute we have been seeking authorization for him to obtain the investigational drug psilocybin under the Washington and federal Right to Try (“RTT”) Acts for therapeutic use with his patients with advanced cancer.  RTT laws recognize that patients with life-threatening illness do not have the luxury of time to await the completion of the long slow process of new drug approval, and create a path to access investigational drugs which have completed a Phase I clinical trial and remain under investigation.[1]

Psilocybin has shown enormous promise in early clinical trials in relieving debilitating anxiety and depression suffered by terminally ill patients. Psilocybin is currently listed on schedule I of the Controlled Substances Act (“CSA”); accordingly, no supplier would provide psilocybin to Dr. Aggarwal without DEA’s permission.  When we sought DEA’s guidance in January 2021 regarding how he might obtain necessary approval, DEA responded, in February 2021, that it had no authority to waive any of the CSA’s requirements and allow access.

On Dr. Aggarwal’s behalf we sought judicial review of that determination in the United States Court of Appeals for the Ninth Circuit. The court dismissed the case on January 31, 2022, concluding that DEA’s action was not “final” for purposes of judicial review under 21 U.S.C. § 877. AIMS v. Garland, 21-70544 (9th Cir. Jan. 31, 2022). This dismissal for lack of jurisdiction did not address the merits of petitioners’ claims, which remain strong.

Dr. Aggarwal and AIMS have subsequently taken two steps with DEA to move this matter forward.

First, on February 2, 2022 a Petition to Reschedule psilocybin from schedule I to schedule II was filed.  The continued placement of psilocybin on schedule I has been described as “absolutely absurd” by one of the nation’s leading researchers of this investigational drug.

https://www.iheart.com/podcast/1119-psychoactive-84544756/episode/30-matt-johnson-on-pioneering-92422650/
(at 19:52)

Second, Petitioners have asked DEA for a waiver from registration requirements which would allow access to psilocybin for therapeutic use under state and federal RTT laws.  The waiver request could be acted upon relatively quickly and should be in light of the urgency patients face with advancing terminal illness. The rescheduling petition will likely take longer but ought not languish.

Keen bipartisan congressional interest in seeing the DEA find a way to accommodate RTT has been expressed.  This interest may well catalyze congressional oversight of the DEA’s handling of the Rescheduling Petition.

The fight to open the pathway intended by state and federal RTT laws continues, with the objective of making psilocybin available for therapeutic use with patients suffering debilitating anxiety and depression in the face of life-threatening illness.

[1] See RCW 69.77 et seq. (Washington RTT); Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017, Pub. L. No. 115-176, § 1, 132 Stat. 1372, codified at 21 U.S.C. § 360bbb-0a (Federal RTT).

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New Federal Trademark Proceedings: What To Know

On December 18, 2021, rules promulgated under the Trademark Modernization Act of 2020 (“Act”) went into effect. The rules, among other things, implement two major additions to the repertoire of trademark proceedings:  (1) expungement, and (2) reexamination.

The purpose of these new proceedings is to assist the United States Patent and Trademark Office (“USPTO”) in addressing “dead wood” and the clutter of registered marks that are not actually in use, or were registered with inaccurate goods or services. With these new rules, the USPTO also seeks to combat fraudulent registrations and the resulting loss of available trademarks.  The Act provides an efficient method for third parties to bring unused trademark registrations to the USPTO’s attention and provides the USPTO new authority to clean things up. Before the Act, the USPTO itself had very limited authority to review and reconsider trademark registrations.

Expungement Proceeding

The purpose of an expungement proceeding is to decide whether or not the registered mark has never been used in commerce in connection with some or all of the listed goods or services . A petition to expunge can be filed between three and ten years following the date of registration. However, the Act provides that until December 27, 2023, the proceeding can be instituted for any registration that is at least three years old.

Reexamination Proceeding

A reexamination proceeding looks to see whether the registered mark was used in commerce with some or all of the goods or services before a certain date depending on the filing basis. For use-based filings under Section 1(a), the record must show use on or before the date of filing. For intent-to-use based filings under Section 1(b), as initially filed or as amended, the date is the later of (1) the filing date of the amendment to allege use, or (2) the expiration of the deadline for filing the statement of use for the goods listed in the petition, including all approved extensions. The reexamination proceeding can be initiated during the first five years of registration.

Process Of Proceedings

The general process of the proceedings is simpler compared to litigation-esque cancellation proceedings. The petition is filed, then the director reviews and decides whether or not to institute the proceeding. If the proceeding moves forward, the USPTO will send an Office action notice to the registrant and the original petitioner has no further responsibilities.

The registrant must respond within three months by either proving use or amending or cancelling the registration (or submit a 30-day extension request). If the USPTO issues a final order of non-use, the registration will be cancelled in whole or in part depending on the petition. However, the registrant has the opportunity to request reconsideration or appeal before the Trademark Trial and Appeal Board.

A few key takeaways:

  • All registrants should retain accurate evidence of first use for each good and service listed on their trademark applications and registrations.
  • All trademark owners should review their registrations to ensure they accurately reflect what’s used in commerce. A registrant can voluntarily amend their registration to delete goods or services, or surrender registration altogether. The fee for voluntarily amending the registration is $0. But if a registrant deletes goods after one of the proceedings starts, there is a $250 fee per class.
  • A registrant can utilize these proceedings as a tool in the clearance, prosecution, and enforcement of their mark.

If you hold trademark registrations and need assistance with the review of your portfolio, Emerge Law Group is here help. Please feel free to contact attorneys Delia Rojas or Sean Clancy from Intellectual Property Practice Group.

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Landmark Petition to Reschedule Psilocybin filed with DEA

Bipartisan Congressional support for allowing terminal patients to seek relief from anxiety and depression in alignment with ongoing international research on the effectiveness of psilocybin in mental health care

Statement

Following issuance of the Ninth Circuit’s opinion in AIMS v DEA on Monday, January 31, 2022, finding lack of jurisdiction to review the DEA’s refusal to allow access to psilocybin pursuant to duly enacted Right to Try laws, Petitioners have filed a Petition for Rescheduling of Psilocybin from schedule I to schedule II. The Petition offers DEA a way to create a pathway so that terminally ill patients can access to psilocybin.

In a letter to the DEA sent on January 18, bipartisan Congressional members encouraged DEA to use its power to create a pathway to access psilocybin, shown to be remarkably effective in relieving anxiety and depression in patients with advanced illness.  Given that the interests of terminally ill patients are at stake, where the advance of illness makes time short, there is an urgency for DEA’s action on the Petition. Congressional interest in the DEA’s response to this Petition will likely be keen.

On today’s Psychoactive Podcast Matt Johnson, the first researcher to be appointed to an endowed chair in psychedelic studies, the Susan Hill Ward Professor in Psychedelics and Consciousness at Johns Hopkins University, says leaving psilocybin on schedule I is “absolutely absurd.”

https://www.iheart.com/podcast/1119-psychoactive-84544756/episode/30-matt-johnson-on-pioneering-92422650/
(at minute: 19:52)

Media Contacts

Roland Griffiths
Oliver Lee McCabe, III
Professor in the Neuropsychopharmacology of Consciousness
Professor of Psychiatry and Behavioral Sciences
Johns Hopkins University School of Medicine
(D) 410 372-7488

Matthew Zorn
Partner
Yetter Coleman LLP
811 Main Street, Suite 4100, Houston, Texas 77002
(D) 713.632.8064 | (M) 301-221-9608 | (O) 713.632.8000
mzorn@yettercoleman.com | Bio | vCard

Kathryn Tucker
Emerge Law Group
(D) 206.595.0097
kathryn@emergelawgroup.com
https://emergelawgroup.com/

Brad Bawmann
The Bawmann Group
(O) 303.320.7790 (D) 303.870.3949
brad@goteamtbg.com
https://goteamtbg.com/

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Ninth Circuit ducks merits in nation’s first legal challenge to allow access to psilocybin in end-of-life care under “Right-To-Try” laws 

Bipartisan Congressional support for allowing terminal patients to seek relief from anxiety and depression in alignment with ongoing international research on the effectiveness of psilocybin in mental health care

Statement

The Ninth Circuit’s opinion today, January 31, 2022, finding that the agency action in this matter was not final – “the DEA’s response letter was not a final decision…and therefore the panel lacked jurisdiction to review it.” – did not reach the merits.  Rather, the court held that it did not have jurisdiction, on this record, to consider the merits of whether DEA must accommodate duly enacted Right to Try laws.

In view of the opinion, Petitioners will promptly file both a Request for Waiver and a Petition for Rescheduling. The waiver request will require the DEA to issue a decision that will constitute ‘final agency action,’ so that the merits can be reached in judicial review if necessary.  Those merits arguments are strong: DEA must accommodate duly enacted state and federal Right-to-Try laws, as mandated by the Controlled Substances Act. The Petition for Rescheduling offers DEA an alternative and equally compelling way to create a pathway so that terminally ill patients can access to psilocybin. Time is of the essence.

In a letter to the DEA sent on January 18, 2022, bipartisan Congressional members expressed concern that DEA ought and must respect duly enacted state and federal Right to Try laws and use its power to create a pathway to access the investigational drug psilocybin. Given that the interests of terminally ill patients are at stake, where the advance of illness makes time short, there is an urgency for DEA’s action on both the petition and waiver request be prompt. We hope congressional interest in this matter will continue, and possibly include Congressional Oversight Hearings.

Media Contacts:

Kathryn Tucker
Emerge Law Group
O: 503.227.4525 D: 206.595.0097
kathryn@emergelawgroup.com
https://emergelawgroup.com/ 

Brad Bawmann
The Bawmann Group
O: 303.320.7790 D: 303.870.3949
brad@goteamtbg.com
https://goteamtbg.com/

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Why I Do What I Do: Representing patients with advanced illness

I represent Erinn Baldeschwiler in AIMS et al v DEA.  Erinn is faced with advanced cancer, and the prospect of dying before her two children reach adulthood.  Erinn is seeking access to psilocybin therapy to help her manage debilitating anxiety and depression as she confronts the end of her life.  Read her full letter HERE, urging that her elected representative, Senator Patty Murray, take appropriate action on her behalf to compel the DEA to allow Erinn access to this therapy as contemplated by state and federal Right to Try laws.

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Psilocybin Therapy for Patients with Advanced Illness in Oregon

One of the known beneficial uses of psilocybin is as a palliative care tool for patients with advanced illness who suffer from anxiety and/or depression. A multitude of recent clinical trials shows the clear promise of psilocybin for this population suffering from these debilitating conditions. However, this drug is not presently legally available, as it is classified as a Schedule I drug, severely restricted and regulated by the federal Controlled Substances Act. Accordingly, it cannot be prescribed by a physician and it is not legally accessible to those who might benefit from it as a therapeutic treatment.

Access Pursuant to the Oregon Psilocybin Services Act

Oregon’s Psilocybin Services Act(“PSA”), adopted via initiative in November 2020, makes therapeutic use of psilocybin legal under Oregon state law. Adult Oregonians will be able to access psilocybin therapy under the PSA beginning in January 2023; patients with advanced illness are among those who may benefit from this therapy.

The PSA sets out detailed requirements specifying who will be permitted to provide psilocybin therapy and where such therapy can take place. The provider of the therapy must be a licensed “facilitator” pursuant to the statute. Recommendations for the training required of such facilitators are being developed now by a Psilocybin Advisory Board established by the PSA. The Oregon Health Authority will receive these recommendations and adopt rules regarding requisite training, examination, and licensing of facilitators.  Other than taking the training the OHA determines necessary and passing the required exam, facilitators need not have any other education or credential beyond a high school diploma to be certified as a facilitator.

Certainly, it is likely that some who pursue a facilitator license will have advanced education and/or credentials in a health care specialty. It is likely that some who are palliative care nurses, end-of-life care doulas, social workers, mental health counselors, and/or physicians will become licensed facilitators pursuant to the PSA.

Administration of the psilocybin and the experiencing of its effects must occur in a licensed “facilitation center”. A subsequent “integration session” must be offered to the client; however, participation in the integration session is not mandatory and this session need not be held at a facilitation center.

Patients with advanced illness who could benefit from psilocybin therapy, and who are able to visit a facilitation center, will be able to receive such therapy at a licensed center. As noted, the integration session could be conducted elsewhere, possibly at the patient’s home or at a clinician’s office. For patients with advanced illness, it would likely be desirable to seek psilocybin therapy from a facilitator knowledgeable in providing care to medically fragile patients with advanced illness. Such providers must of course be aware that while psilocybin therapy under Oregon’s new PSA law will be legal for state law purposes, psilocybin remains illegal under federal law.  It is possible that a form of “cooperative federalism” will arise with regard to psilocybin therapy in Oregon. This is a policy where the federal government, the DEA, will refrain from taking prosecutorial action if state law permits, regulates, and carefully controls the use of a drug. The shelter provided by this approach depends on the policy of the U.S. Department of Justice, which can change as the political winds or officeholder changes—as occurred in the case of cannabis.

Access to Psilocybin Therapy Pursuant to Right to Try Laws

In recent years “Right to Try” laws have been adopted by a supermajority of states, including Oregon, and the Federal Congress. These laws recognize that patients with advanced illness ought to be able to access certain investigational drugs for therapeutic use before completion of later-stage clinical trials and the potentially long process of rescheduling. Psilocybin meets the requisites of RTT laws to be deemed an ‘eligible investigational drug’.  Under the letter and spirit of these laws, it is intended to be available for this population of patients while still under investigation. Litigation to compel DEA to respect RTT laws and allow access to psilocybin for therapeutic use is pending before the Ninth Circuit Court of Appeals. If Petitioners prevail in this landmark case, access to psilocybin for patients with advanced illness will become available, protected by both state and federal law. Under this scenario, none of the requirements of the PSA would be applicable. Psilocybin therapy would likely be accessed through the patient’s palliative care physician who would obtain a form of permission from the DEA to obtain this investigational drug from a manufacturer. The therapy could take place wherever most convenient to the patient in light of their advanced illness, for example, if the patient were receiving hospice services at home, the therapy could be provided in the patient’s home, or at the office of the palliative care provider.

Conclusion

There is tremendous interest in the benefits of psilocybin for the relief of a variety of distressing mental health conditions, including anxiety and depression in patients with advanced illness. Oregon has stepped forward in enacting the nation’s first psilocybin therapy law, which will make such therapy legal under a heavily regulatory state law regime beginning in 2023; federal exposure will remain unless a policy of nonenforcement is adopted by the US DOJ. Right to Try laws may compel DEA to allow access sooner and more widely across the nation.

 

 

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FRANCHISE LAW

Franchisors

Franchise law is a heavily regulated area of law.  We help clients expand their businesses through franchising and other distribution methods. We have experience in many industries including, restaurants, health, and beauty, alcohol, and cannabis among others. Our representative services include the following:

Franchisees

We also help potential franchisees interested in buying a franchise. We are able to assist with evaluation of franchise opportunities with respect to:

Alternative Structures

However, not all businesses are suited to franchise. We are also experienced with helping clients structure alternative distribution methods to prevent classification as a franchise.

MERGERS AND ACQUISITIONS

Our M&A attorneys are highly experienced in counseling clients who are considering acquisitions or exit strategies.  We have many years of experience handling deals of various types and sizes, ranging from sales of small closely-held business, private companies, and publicly-traded corporations.  We have represented business owners, private equity firms and investment banks in a wide range of industries. 

We have a deep business bench, and Emerge attorneys have handled transactions of all shapes and sizes.  Whether your deal is valued at $100,000 or $100,000,000, our experienced attorneys will guide you through the deal process.

We understand the intensity, technical skill and judgment needed to get deals done, and we provide our clients with timely, practical and cost-effective legal advice.  We are highly capable in all aspects of M&A, including the following:

CANNABIS INDUSTRY

Emerge Law Group is highly experienced in the cannabis industry.  We have helped many clients obtain state licenses and local permits to operate cannabis businesses throughout California, Oregon, and Washington.

Emerge attorneys were instrumental in the drafting and passage of Oregon Measure 91, legalizing marijuana in the State of Oregon, and have represented cannabis businesses well before many law firms were willing to enter the cannabis industry. As a firm that has provided legal services in the cannabis space for many years, we are familiar with the unique and complex issues businesses and individuals face in an emerging and highly regulated industry.

We regularly help clients with:

Cannabis laws and rules are also regularly changing.  Members of our team are dedicated to attending legislative hearings, state agency and local city and county meetings to stay up-to-date on any new changes and how to adjust to any new changes.

See our Cannabis Industry page for more information.

PSYCHEDELICS

There is tremendous excitement about the potential for psychedelic drugs to benefit a wide variety of populations, including terminally ill patients suffering with anxiety and depression. Until recently, psychedelic substances have been accessible only in the illicit market and are illegal under federal and state to manufacture, distribute, or possess. These substances have, since 1970, been treated as having no legitimate medical use, and no commercial application. As such, no one invested in this area or required legal services, outside of the criminal context.

Today, researchers in a multitude of clinical studies are proving the medical safety and efficacy of these medicines, with the objective of changing the treatment of these substances under the Controlled Substances Act. Companies are now actively raising money to develop intellectual property and seize market opportunities associated with psychedelic drugs.

In addition, advocates at the state and local levels are not waiting for the rescheduling of these substances and are active in undertaking efforts to decriminalize these substances and/or make them affirmatively legal under state and/or municipal law. Decriminalization already has occurred in cities including Denver, Oakland, Santa Cruz, and Ann Arbor. Oregon is poised to be the first state to make psilocybin therapy affirmatively legal. Emerge Law Group is working with a wide array of clients pushing forward in this emerging area.

See our Psychedelics Practice Group page for more information.

TAXATION

CORPORATE AND PARTNERSHIP TAX

Businesses of all kinds benefit from a customized but systematic approach to structuring legal relationships. Emerge Law Group helps businesses and business owners with a variety of tax planning matters.

Representative client services include:

ESTATE PLANNING

Estate planning encompasses everything from a will and power of attorney to combined estate and business succession planning. In almost all cases, the purpose of the plan is to help the client protect those they care about most in the event they can no longer be there for them.

Emerge Law Group has experience with a wide range of tools used in estate planning, including wills, trusts, and family business entity planning.

TAX CONTROVERSIES

Emerge Law Group can assist with the resolution of difficult tax controversies. Our areas of emphasis and experience include:

REAL ESTATE TRANSACTIONS

Emerge Law Group assists clients with a wide range of real estate transactional matters.  We regularly help clients with:

LAND USE

Emerge Law Group also assists clients with all aspects of local government land use and development processes, ranging from preliminary property analyses and building permit issues to complex land use reviews and hearings. Our attorneys are experienced in obtaining land use entitlements and development permits for a wide range of uses.

We regularly help clients with:

Above all, we understand the value of working with cities and counties to enhance communities while developing the land to its potential. We strive to create solutions to land use issues that serve to better our clients and the communities in which they live and work.

LITIGATION AND ALTERNATIVE DISPUTE RESOLUTION

The attorneys in Emerge Law Group’s Litigation and Alternative Dispute Resolution practice group litigate commercial, intellectual property, and public interest matters in state and federal courts, as well as private mediation and arbitration proceedings.  Our lawyers have represented national and regional financial institutions, major media, entertainment and technology companies, and other Fortune 500 companies in a broad array of high-stakes disputes.  Our team of litigators has handled leading cases that have shaped the law in cutting-edge business, technology, free speech, and public interest impact lawsuits in trial and the courts of appeal.

We have particular expertise in handling civil litigation and regulatory enforcement matters in the cannabis and psychedelic industries.  While many firms claim expertise in the these industries, few have our depth of experience successfully litigating contract, trademark, partnership, shareholder, land use, and real estate disputes in court and arbitration.  Even fewer firms have our level of experience handling writ of mandate proceedings against the government regulators.

Our litigators practice in California, Oregon, and Washington, but have appeared in state and federal courts nationwide.  Our knowledge of our clients’ businesses, goals and concerns, and our experience litigating at the highest levels, give us unique insight into possible outcomes and pitfalls as we continuously confront issues of new impression.

No matter what the industry, we pride ourselves in achieving our clients’ objectives through efficient and creative solutions primarily designed to avoid disputes in the first place—which is always the best litigation strategy.  Many times, our clients obtain excellent outcomes before or at the earliest stages of litigation because our adversaries quickly recognize the challenges they will face in litigating against us.  When litigation is unavoidable, however, we work hard to provide our clients with both cost-efficient and “big firm” quality representation.

 

INTELLECTUAL PROPERTY

Your intellectual property (or “IP”) strategy can harness your most valuable information and intangible assets including your name, your brand, your designs, your content, your services, and your products — what makes your business stand apart in a competitive world.  We can help you evaluate and build your IP portfolio, then secure it, monetize it, and protect it.

IP encompasses multiple areas of law and different types of information or material.

Our Intellectual Property practice focuses on:

TRADEMARK

Trademarks include names, signs, logos, designs, phrases, slogans, expressions, and sometimes even colors, sounds, or smells that identify or distinguish one business compared to others.  Trademark protection is fundamental in securing your “brand.”

COPYRIGHT

Copyright covers original works of creative authorship fixed in a tangible medium of expression.  This includes literary, dramatic, musical, and artistic works, such as poetry, novels, designs, movies, songs, computer software, and architecture. Copyright does not protect facts, ideas, systems, or methods of operation, although it may protect the way these things are expressed.  Depending upon the type of work, “moral rights” (such as the right of attribution) may be implicated as well.

TRADE SECRET

Trade secret laws can vary somewhat between states, but generally trade secrets cover information, including drawings, cost data, customer lists, formulas, recipes, patterns, compilations, programs, devices, methods, techniques or processes that derive economic value from not being generally known and are the subject of efforts that are “reasonable under the circumstances” to maintain secrecy.

PRIVACY

Depending upon where you live or operate, there is a special patchwork of laws and regulations that protect and regulate personal information.  If you are handling or giving out personal or potentially sensitive information, you may be implicating privacy laws.

PUBLICITY

Publicity rights address the commercial use of an individual’s face, name, image, or likeness.  These rights vary state-to-state.  Marilyn Monroe, for example, lived in multiple states which created complex questions about her publicity rights.

Our Intellectual Property services include:

FINANCIAL INSTITUTIONS

In states where new cannabis banking opportunities exist, Emerge Law Group has the proven expertise in creating canna-banking programs to efficiently capitalize on those opportunities. Our Banking Practice Group specializes in working with banks and credit unions to develop regulatory compliant programs and operational best practices. We also train banking staff to become experts in canna-banking so they can effective understand and manage the risk affiliated with canna-banking.

We regularly help clients with:

EMPLOYMENT LAW

At Emerge Law Group, we recognize that employees are the heart and soul of any successful business.  Our Employment Law Practice Group works with employers to help them effectively manage their workforce, navigate the complex web of federal, state and local employment laws and, if necessary, defend against claims before administrative agencies and in court.

We regularly help clients with:

CORPORATE FINANCE AND SECURITIES

Our corporate finance and securities lawyers are experienced attorneys who have practiced at large law firms, worked as in-house counsel for public companies and investment banks, and owned and operated start-up companies. We work with clients to help achieve their financing goals while safely navigating the highly technical securities law landscape. 

In addition to representing issuers, we also routinely represent institutional and individual investors, including in connection with fund formation and investments.

Our expertise includes:

We have a deep understanding of the financing options available to businesses, including simple unsecured loans, asset-backed financing, convertible debt, common and preferred equity, crowdfunding and various other structures.  We work closely with our clients to understand their business and financing needs, ensure they are prepared to approach investors and choose the right partners, structure and negotiate terms, navigate the due diligence process and successfully close the deal.

COMPLIANCE AND LICENSING

ALCOHOL AND BEVERAGE INDUSTRY

Emerge attorneys have represented businesses in the alcohol and beverage industry, including wineries, breweries, distilleries, restaurants, bars, movie theaters, golf courses, and gas stations.  We can help you vet new locations, acquire existing locations, and apply for the appropriate liquor license.  We also provide training to comply with applicable rules and regulations, prepare operating procedures, submit renewals, and keep clients protected in the event of any potential violations or administrative hearings.

CANNABIS INDUSTRY

Emerge Law Group is highly experienced in the cannabis industry.  We have helped many clients obtain state licenses and local permits to operate cannabis businesses throughout California, Oregon, and Washington.  We regularly help clients with:

Cannabis laws and rules are also regularly changing.  Members of our team are dedicated to attending legislative hearings, state agency and local city and county meetings to stay up-to-date on any new changes and how to adjust to any new changes.

See our Cannabis Industry page for more information.

PSYCHEDELICS INDUSTRY

Emerge Law Group is a leader in the psychedelics industry.  There is tremendous excitement about the potential for psychedelic drugs to benefit a wide variety of populations, including veterans struggling with PTSD and terminally ill patients suffering with anxiety and depression.  Until recently, psychedelic substances have been accessible only in the underground; they are illegal under state and federal law to manufacture, distribute, or possess.  These substances have, since 1970, been treated as having no legitimate medical use, and no commercial application.  As such, businesses have not invested in this area or required legal services, outside of the criminal context.

Today, psychedelics are proceeding toward legalization on multiple paths.  Researchers in a multitude of clinical studies are proving the medical safety and efficacy of these medicines, with the objective of changing the treatment of these substances under the federal Controlled Substances Act, opening legal access to them.  Private and public companies are now actively raising money to develop intellectual property and capitalize on the market opportunities associated with psychedelic drugs.  Opportunities to be early actors in this new arena are tremendous.

See our Psychedelics Practice Group page for more information.

BUSINESS AND CORPORATE

Our business transactions team is made up of highly experienced transactional attorneys who have practiced at large law and accounting firms, worked as in-house counsel for public companies and investment banks, and owned and operated start-up companies. We understand complex legal matters and provide high quality legal services in a cost-effective manner.  Our clients value our experience, knowledge and judgment.

ENTITY FORMATION

Our team routinely advises clients regarding:

CORPORATE GOVERNANCE

Emerge attorneys also advise on-going concerns with: