Posts Tagged:Drug Enforcement Administration (DEA)

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DEA Takes a Rare Step Forward for Telehealth

Author: Matt Brockmeier, Emerge Of Counsel Attorney

The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the Act) amended the Controlled Substances Act (CSA) to help prevent the illegal distribution of controlled substances on the internet. The Act required an in-person medical evaluation before prescribing or otherwise dispensing controlled substances online. It also established seven exceptions to that requirement, allowing practitioners to prescribe medications for a patient without first evaluating that patient in person. One exception allowed DEA to waive the in-person requirement during the COVID Public Health Emergency (PHE). During the pandemic several companies began providing large volumes of controlled substances via telehealth under that exception, including ketamine and Adderall. However, the exception it is set to expire on May 11, 2023, threatening the future of the nascent telehealth prescription industry.

Falling within the Act’s definition of the ‘‘practice of telemedicine’’ is ‘‘a practitioner who has obtained from the [DEA Administrator] a special registration under [21 U.S.C. 831(h)].’’ 21 U.S.C. 802(54)(E) contemplates that the DEA must issue regulations to effectuate this special registration provision. In 2017, under President Trump, DEA was statutorily instructed to finalize a rule on the registration’s application process and procedures. Disappointingly, as of this writing, DEA has yet to promulgate “special registration” rules, despite pleas from patients, clinicians, and the medical and business communities.

Analysts familiar with DEA’s intransigence and stall tactics predicted that the expiration of the PHE declaration would devastate the ketamine telehealth industry. In a surprise to most, including this author, on March 1 DEA issued a notice of rulemaking that would authorize telemedicine where 1) the prescribing practitioner has not conducted an in-person medical evaluation with the patient; 2) the prescription was issued pursuant to a telemedicine encounter and 3) the telemedicine encounter results in a prescription for controlled medications. There are some limitations, including that prescribing practitioners could only issue telehealth prescriptions for up to a 30-day supply, and there are labeling and recordkeeping requirements. Nonetheless, this is an encouraging development from an agency with a reputation for being dilatory and obstructionist, especially when it comes to making regulated medicines available to patients in need.

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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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Court Hears Argument in Landmark Case Seeking to Open Access to Psilocybin Therapy

Nation’s First Legal Challenge to Allow Psilocybin Therapy in End-of-Life Care Under “Right-To-Try” Law Heard by the Ninth Circuit Court of Appeals:

Cancer patients seek relief from anxiety and depression in alignment with ongoing research on the effectiveness of psilocybin in mental health care.

Time: 1 p.m. PST, Thursday, September 2nd, 2021

Pasadena Virtual Courtroom

Live Video Link: https://www.ca9.uscourts.gov/media/streaming/watch/pasadena-virtual-courtroom-1-1200pm-thursday-9-2/

Summary:

Two patients with advanced cancer and their palliative care physician challenge the Drug Enforcement Administration’s position denying patients with life-threatening medical conditions from accessing therapy with psilocybin (the active ingredient in “magic mushrooms”), which has been shown remarkably effective in alleviating depression and/or anxiety.

A Petition for Review was filed in the United States Court of Appeals for the Ninth Circuit on behalf of the Advanced Integrative Medical Science (AIMS) Institute, Dr. Sunil Aggarwal, M.D., Ph.D., Michal Bloom, and Erinn Baldeschwiler, all in the Seattle region.

Psilocybin is classified as a Schedule I Substance by the DEA. Research by some of the world’s leading academic institutions is showing dramatic promise of psilocybin therapy in relieving anxiety and depression of patients with cancer.

The 9th U.S. Circuit Court of Appeals will hear argument in the case challenging the Drug Enforcement Administration’s determination in February that it lacked authority to waive any provision of the Controlled Substances Act to allow medical use of psilocybin. The challenge is brought by a Seattle doctor, Sunil Aggarwal, and his clinic and research institute, the Advanced Integrative Medical Science Institute, seeking to provide psilocybin therapy to terminally ill patients to treat depression and anxiety under Washington’s “right to try” law, which aims to give certain patients access to experimental therapies.

Who:

Erinn Baldeschwiler: is a 49-year-old mother of two teenagers. She has stage IV metastatic triple-negative breast cancer that was found throughout her body. She was informed she had statistically two years left of life and the main focus of treatment and care would be to maintain the highest quality of life for as long as possible. Erinn would like to try psilocybin to alleviate her emotional suffering, which includes anxiety and depression.

Michal Bloom: is now retired, due to disability caused by her medical condition. She formerly practiced law as an attorney with the United States Trustee Program, within the United States Department of Justice. She has advanced, recurrent, BRCA+, ovarian cancer with metastasis to her lymph nodes and was first diagnosed in February 2017.

Since then, Michal has undergone several surgeries, and several rounds of chemotherapy for treatment of the cancer. She has also had surgery to install a port for chemotherapy in her chest and has had to manage side effects of various treatments, including persistent recurrent intestinal distress; terrible constipation and recurring bowel obstruction; chronic fatigue; weakness; hospitalization for an infected port; enduring an episode with MRSA; and has experienced the distress of having open wounds for months.

Michal understands that she may have a very limited quantum of time to live and does not have the luxury of time to await the full FDA new drug approval process to run its course to access a promising investigational drug. Michal has experienced severe anxiety and depression, which conventional therapy, even Ketamine-assisted therapy, has not ameliorated.

Kathryn Tucker, special counsel, Emerge Law Group, Portland, OR, one of the nation’s leading patient rights advocates. Kathryn is Special Counsel at Emerge Law Group, where she co-chairs the Psychedelic Practice Group.

Kathryn is also executive director of the End-of-Life Liberty Project (ELLP). Kathryn founded the ELLP during her tenure as executive director of the Disability Rights Legal Center (DRLC), the nation’s oldest disability rights advocacy organization.

Tucker served two decades as Director of Advocacy and Legal Affairs for Compassion & Choices, working to improve care and expand choice at the end of life. She has held faculty appointments as Associate Professor of Law at Loyola Law School, Los Angeles, and as Adjunct Professor of Law at the University of Washington, Seattle University, and Lewis & Clark Schools of Law, teaching in the areas of law, medicine and ethics, with a focus on the end of life.  Tucker was counsel representing patients before the SCOTUS in Glucksberg v WA, Quill v NY, and Oregon et al v Gonzales.

O: 503.227.4525
D: 206.595.0097
kathryn@emergelawgroup.com

 

Sunil Aggarwal: M.D., Ph.D., FAAPMR, Hospice and Palliative Medicine, co-founder and co-director, AIMS Institute. Dr. Aggarwal is a hospice and palliative medicine and physical medicine and rehabilitation physician and medical geographer. His primary clinical work is as an Integrative Pain, Palliative Care, and Rehabilitation Physician in private practice at AIMS Institute (Seattle, WA) and as an on-call MultiCare Palliative Physician and Associate Medical Director of MultiCare Hospice (Tacoma, WA).

Dr. Aggarwal previously ran the palliative care medicine consultation service at the MultiCare Auburn, Washington, hospital and regional cancer center. His medical geographic scholarship interests are in geographies of access, delivery, and development of cannabinologic and psychedelic integrative medicine, especially as they pertain to development in pain management, hospice and palliative medicine, and rehabilitation services.
saggarwal@aimsinstitute.net
D: 206-420-1321

Media contacts:

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

Bad Bawmann
The Bawmann Group
O: 303.320.7790
D: 303.870.3949
brad@goteamtbg.com
https://goteamtbg.com/
Justin Hays
Emerge Law Group
O: 503.227.4525
D: 971.570.6564
justin@emergelawgroup.com
https://emergelawgroup.com/

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Petitioners’ Reply Brief Filed, Briefing Now Complete in AIMS et al v DEA

On Friday, 7/23, Petitioners filed their Reply Brief with the Ninth Circuit Court of Appeals in AIMS et al v DEA. This concludes the briefing. The next event will be the oral argument/hearing on 9/2/21.

The full brief can be accessed here https://bit.ly/3rtVagW. Petitioners’ Reply rebuts DOJ’s attempt to avoid judicial review, refuting the contention that there is insufficient finality to the DEA’s action taken in response to AIMS’ query how DEA would accommodate RTT.

  • Agencies often take ‘final agency action’ in the form of a letter, as was the case here.
  • The official who responded to AIMS’ inquiry, DEA’s Deputy Assistant Administrator of Diversion Control Division, was an official with delegated authority to speak for the agency and did so.

On the merits, Petitioners’ Reply points out that the RTT amends the FDCA, which has primacy over the CSA in case of conflict. Accordingly, DEA must accommodate RTT.

  • DEA has impermissibly construed the CSA to “supersede the provisions of the [FDCA],” which is precisely the opposite of what § 902 commands.
  • DEA cannot construe the CSA—and its restrictions on schedule I drugs specifically—as forbidding RTT use under the FDCA
  • Because DEA does not and cannot regulate medical practice, it must accommodate RTT use (note: the DC Cir just ruled in an important case on this point earlier this month, restating established precedent forbidding agency overreach into medical practice)
    • DEA can, in its discretion, impose controls to prevent diversion
  • RTT is a unique single-subject statute that carves out a “niche” within the FDCA to sweep aside federal obstacles to therapeutic use of certain investigational drugs
  • Section 902 makes clear that in the event of an interpretive conflict, the CSA must yield.
  • DEA’s statement in its brief that “application of the CSA to restrict the use of psilocybin by patients with life-threatening conditions furthers the CSA’s main objectives ‘to conquer drug abuse and to control the legitimate and illegitimate traffic in controlled substances’ is patently ludicrous. Dying patients seek access to psilocybin therapy not for illicit drug abuse purposes but to obtain relief from debilitating depression and anxiety, seeking to achieve peace and comfort in their final days.
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Amici Curiae Supporting Case Seeking to Compel DEA to Allow Access to Psilocybin Therapy for Seriously Ill Patients

A Seattle palliative care physician, co-director of an integrative oncology clinic, and a number of his patients with advanced cancer have sued the Drug Enforcement Administration (DEA) in a case seeking to compel the DEA to allow access to psilocybin therapy for patients with serious illness under state and federal Right to Try (RTT) laws. Well-known patient rights advocate Kathryn Tucker, Special Counsel at Emerge Law Group, along with a team of outstanding co-counsel from Perkins Coie, Yetter Coleman, and Vicente Sederberg, represent the Petitioners in AIMS et. al. v. DEA (CA 9 No. 21-70544).

Last week Petitioners’ Opening Brief was filed in the Ninth Circuit Court of Appeals.  On Friday, May 21, 2021, many parties joined this effort by filing amicus briefs in support of the Petitioners including the following:

  • Eight States and the District of Columbia (DC):

In their brief, the states and DC are defending their respective duly enacted statutes. States, as primary regulators of the practice of medicine, determine what constitutes legitimate medical practice in that state.  For example, the State of Washington enacted its RTT law by unanimous vote in 2017.  State amici contend that clear precedent recognizes it is impermissible for the DEA, a federal agency, to nullify duly enacted state statutes governing medical practice.

Link to the States’ and DC’s Amici Brief.

Media Contact:
Brionna Aho, brionna.aho@atg.wa.gov

  • The Cato Institute and the Goldwater Institute:

As the drafters and primary sponsors of RTT laws, the the Goldwater Institute (GI) has special insight into the legislative history of RTT laws, intended reach and scope, the underlying grassroots democratic nationwide movement to enact laws to allow seriously ill patients access to promising investigational drugs.

Link to Cato’s and GI’s Brief of Amici Curiae.

Media Contact:
JenTiedemann, jtiedemann@goldwaterinstitute.org

  • The American Civil Liberties Association (ACLU) of WA:

Washington’s leading advocate for civil liberties speaks to the civil liberties implicated in the choice of a dying patient to access an investigational drug in hopes of gaining relief from debilitating anxiety and depression in the final stages of life threatening illness.

Link to ACLU of WA’s Amicus Brief.

Media Contacts:
Mark Cooke, mcooke@aclu-wa.org
LaVendrick Smith, Media & Communications, lsmith@aclu-wa.org

  • End of Life Washington, the Washington Psychological Association, EvergreenHealth, A Sacred Passage Death Midwifery,  Past Presidents of the American Academy of Hospice and Palliative Medicine, Dr. Ira Byock, Dr. Timothy Quill,  Roland Griffiths PhD, and other prominent end of life care and palliative care physicians and researchers, and patients with advanced illnesses:

The amici address:  (i) the prevalence of anxiety and depression in those with life threatening illness; (ii) the devastating impact on both quality and quantity of life; (iii) evidence reflecting that anxiety and depression in those with serious illness reduces treatment compliance, which can shorten life expectancy; (iv) the importance of relief of anxiety and depression for both improved quality and extended quantity of life; and (v) how relief of anxiety and depression could impact patient choices for other end of life options, e.g. Aid in Dying (AID).

Link to End of Life Washington, et. al. Amici Brief.

Media Contact:
Judy Kinney, jkinney@endoflifewa.org

  • Law Professors and Bioethicists:

These academics discuss academic and policy criticisms of RTT laws, elucidating how, even if valid in other contexts, such concerns do not arise in context presented by this case, involving psilocybin as AID for relief of anxiety and/or depression; importance of adding palliative care tool to address anxiety and depression, especially in jurisdictions where patients empowered to choose AID.

Link to Professors’ and Bioethicists’ Amici Brief.

Media Contact:
Nico van Aelstyn, nvanaelstyn@sheppardmullin.com

 

 

 

 

 

 

 

 

 

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Opening Access to Psilocybin Therapy for Seriously Ill Patients: The Petitioners’ Opening Brief in AIMS et al v DEA

Emerge Law Group is proud to represent a Seattle palliative care physician and co-director of an integrative oncology clinic, and a number of his patients with advanced cancer in a case seeking to open access to psilocybin therapy for patients with serious illness under state and federal Right to Try laws. Well known patient rights advocate Kathryn Tucker, Emerge Special Counsel, along with a team of outstanding co-counsel from Perkins Coie, Yetter Coleman and Vicente Sederberg, represent the Petitioners in  AIMS et al v DEA.

Today we filed our brief, Petitioners Opening Brief, in the Ninth Circuit Court of Appeals.  The central contention is that the DEA,  a federal law enforcement agency with authority to prevent diversion of controlled substances, overstepped the limits of its authority in failing to recognize that the RTT requires it to allow access to eligible investigational drugs – psilocybin is one such drug – for therapeutic use by patients with serious illness. This is an affront to the autonomy of the states to serve their recognized function as primary regulators of the practice of medicine. It is in contravention of the RTT, which as an amendment to the Federal Food Drug and Cosmetic Act, is the statute with primacy here. And it denies seriously ill patients access to promising investigational drugs, causing irreparable harm.

Next week we expect others to join this effort by filing amicus briefs in support of the Petitioners. In June, the DOJ will file its brief. Petitioners will file a reply and the case will be set for oral argument, likely in September.

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Nation’s First Legal Challenge to Allow Psilocybin Therapy in End-of-Life Care Under “Right-To-Try” Laws Moves Forward

On behalf of terminally ill patients suffering anxiety and depression, we announce an advocacy effort to open access to psilocybin for terminally ill patients under state and federal “Right to Try” (RTT) laws. Well known patient rights advocate Kathryn Tucker, Co-Chair of the Psychedelic Practice Group of Emerge Law Group, represents a Seattle oncology clinic, Advanced Integrative Medical Science (AIMS) Institute, and its co-director Sunil K. Aggarwal, MD, PhD, a noted palliative care specialist in seeking permission to access psilocybin for the purpose of treating terminally ill patients suffering anxiety and/or depression.

Petitioners rely upon state and federal RTT laws, which protect access to investigational drugs not yet been approved for use, recognizing that terminally ill patients do not have the luxury of time to await the slow process of new drug approval. The clinician has approached the federal Drug Enforcement Administration (DEA) to make psilocybin available for use in treating terminally ill patients suffering anxiety and/or depression. See letter to the DEA dated January 15, 2021.  DEA responded in a letter dated February 12, 2021, stating that DEA has no authority to waive any of the provisions of the federal Controlled Substances Act, thereby denying therapeutic use.  Read more about this Right to Try Effort in a recent Seattle Times article.  On March 8, 2021, a Petition for Review was filed in the United States Court of Appeals for the Ninth Circuit by AIMS, Dr. Aggarawal and others seeking review of DEA’s decision in its February 12, 2021 letter.

We will be holding a media briefing today at 10 am PST.  Details can be found at:  https://goteamtbg.com/dying-patients-need-access-to-psilocybin-for-anxiety-and-depression-relief/ 

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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.

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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:

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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.

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

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

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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.

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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:

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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.”

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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: