Dr. Sunil Aggarwal, MD, PhD, FAAPMR, FAAHPM v. United States Drug Enforcement Administration; and Advanced Integrative Medical Science Institute, et al. v. United States Drug Enforcement Administration

Terminally ill patients and their providers are pursuing legal action against the US Drug Enforcement Administration (DEA) to stop the agency from denying patients their legal rights to use psilocybin and other Breakthrough Therapies as part of end-of-life care. Twice in the past five years, the U.S. Food and Drug Administration (FDA) designated psilocybin a Breakthrough Therapy for treatment-resistant depression, confirming that evidence from early clinical trials shows psilocybin may offer a substantial improvement over available therapies for serious or life-threatening conditions. Under these circumstances, we contend, psilocybin should be available for use in treating patients with terminal or life-threating illnesses. The DEA is unlawfully blocking such access and interfering with the practice of medicine to the detriment of terminally ill patients. This case has long-reaching implications for end-of-life care and access to medicine, as well as the rescheduling of psilocybin under the Controlled Substances Act (CSA).

In AIMS v DEA, Vicente LLP along with Yetter Coleman LLP, Emerge Law Group LLP, and Perkins Coie LLP represent a palliative care physician and two of his patients with advanced terminal cancer who have been seeking access to psilocybin to treat their anxiety and depression. Dr. Aggarwal’s patients seek to exercise their rights under federal and state “right to try” (RTT) laws, which recognize the importance of time for this population of patients by allowing the use of unapproved investigational drugs (such as psilocybin) by patients with life-threatening illnesses who have exhausted available treatment options. Psilocybin is an “eligible investigational drug” under RTT requirements. Because psilocybin is a schedule I drug under the CSA (deemed to have no currently accepted medical use)[1], however, obtaining it for these uses—even under severe restrictions—is both practically and legally difficult. Accordingly, we requested guidance, from the DEA on behalf of Aggarwal as to how to get access to psilocybin for therapeutic use under the RTT laws.[2] In response, DEA unlawfully declined to provide access entirely and obstructed patients’ rights by asserting it had no authority to permit such uses because psilocybin is a schedule I drug which can only be used in research. DEA’s action is in clear violation of the RTT laws.

We challenged the DEA in the U.S. Court of Appeals for the Ninth Circuit, where the DEA requested a petition for the agency to reschedule psilocybin that we promptly filed. The DEA denied this petition on clearly unlawful and arbitrary grounds and without following the procedure required by law. We ask the court to vacate this agency decision and instruct DEA to conduct a scientific and medical evaluation request from the Secretary of HHS as the CSA mandates under these circumstances.

If successful, this litigation would reform laws governing the therapeutic use of psilocybin for terminally ill patients and its long-reaching implications for end-of-life care The law is clear that the DEA does not have the authority to obstruct the RTT laws, even if its decision is based on the CSA.[3] The DEA cannot abuse its authority to stand in the way of patients’ rights to access therapies under RTT laws.

Related Freedom of Information Act (“FOIA”) Litigation

In AIMS Institute, PLLC; Sunil Aggarwal; Katherine Tucker; and Matthew C. Zorn v. Merrick Garland, in his official capacity as U.S. Attorney General; Anne Milgram, in her official capacity as Administrator of the U.S. Drug Enforcement Administration; U.S. Department of Justice; and U.S. Drug Enforcement Administration, Vicente LLP represents Matthew Zorn, Kathryn Tucker, and AIMS in a related case against DEA and the Department of Justice (DOJ). Plaintiffs rely heavily and repeatedly on FOIA to obtain relevant public information in their struggle to open access to psilocybin for terminally ill patients. However, the DEA and DOJ are refusing to provide public information within timeframes mandated by law by applying unlawful practices and policies. This lawsuit raises a “pattern or practice” challenge to this DEA practice and policy and a challenge to what is clearly an unlawful DOJ policy. This case is proceeding in the U.S. District Court for the Southern District of Texas.

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What will my donation get me?

Donations to the fund will go toward legal defense and impact litigation advancing drug policy reform in the United States. Donations, however, do not entitle anyone to receive confidential information about on-going litigation or case strategy. A donation does not establish the attorney-client relationship nor entitle anyone to interfere with, or otherwise exert control over, any DPRLDF’s attorney’s work.

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What is DPRLDF?

The Drug Policy Reform Legal Defense Fund is a nonprofit organization organized to raise funds for legal defense and impact litigation advancing drug policy reform in the United States by challenging statutes, regulations, or other legal actions that infringe on rights guaranteed by state or federal cannabis, hemp or psychedelic laws, rights of patients, or the economic health or liberty of the industry. Legal actions may include challenges to unlawful exercises of government authority or government acts that violate the plain language and purpose of federal and state drug or hemp laws.

DPLDF serves to provide cost efficient management for the legal defense of drug policy reform efforts. Consequently, DPRLDF embraces transparency to its donors and the clients directly served by any legal efforts it funds.

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What legal actions will DPRLDF fund?

DPRLDF will help challenge laws or regulations to advance drug policy reform and protection of rights under cannabis, hemp, and psychedelics laws. Application for funding is approved by the fund’s board, depending on the level of assistance sought and purpose of the legal action.

Currently, all DPRLDF funds will go towards the pair of legal actions described above, challenging the DEA’s unlawful actions blocking patient rights to therapeutic medicines under federal Right to Try Laws and violating FOIA. Dr. Sunil Aggarwal, MD, PhD, FAAPMR, FAAHPM v. United States Drug Enforcement Administration; and Advanced Integrative Medical Science Institute, et al. v. United States Drug Enforcement Administration and In AIMS Institute, PLLC; Sunil Aggarwal; Katherine Tucker; and Matthew C. Zorn v. Merrick Garland, in his official capacity as U.S. Attorney General; Anne Milgram, in her official capacity as Administrator of the U.S. Drug Enforcement Administration; U.S. Department of Justice; and U.S. Drug Enforcement Administration. Donations to the link above will go toward paying the litigation costs of this effort to protect the U.S. hemp industry.

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How is DPRLDF and its efforts governed?

DPRLDF has a board comprised of drug reform attorneys who have clients who wanted to contribute to an effort like DPRLDF with appropriate oversight and efficiencies. Funds raised will only be dispersed when the board agrees to do so and only for projects the board has previously agreed serve DPRLDF's goals. Donors and partner organizations will have access to records of expenditures to ensure effective use of funds. Any strategic partnerships with other organizations will be governed by memorandums of understanding documenting shared goals, obligations, and oversight mechanisms.

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How else will DPLDF funds be spent?

A small portion of funds raised will be spend on administrative costs (website, accounting, and communication). All donations are non-refundable. Any funds remaining at the conclusion of the current legal challenges will be reserved for future actions consistent with the DPRLDF’s mission and as approved by the board.

All requests for funding will be weighed by DPRLDF with special consideration for activities that will affect the most far-reaching and positive outcomes.

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