Suing the DEA for Access to Psilocybin – Mushroom Revival

Suing the DEA for Access to Psilocybin

A Seattle based doctor, Dr. Sunil Aggarwal, has filed a lawsuit against the DEA for denying him permission to use psilocybin therapy in his palliative care. 

Him and his lawyer, Kathryn Tucker, argue that the DEA is violating the humanitarian Right to Try for terminally ill patients. Most of us aren't lawyers, or even close, but we can visit the basic language of the act to see for ourselves why the lawsuit is legitimate. Taken verbatim from the FDA's website, the act states:

"The Right to Try Act permits/allows eligible patients to have access to eligible investigational drugs."

Eligible patients have:

  • Been diagnosed with a life-threatening disease or condition 
  • Exhausted the approved treatment options, and is unable to participate in a clinical trial involving the eligible investigational drug 
  • Can provide written consent for the investigational drug to the respective physician 

Eligible substances, or investigational drugs are: 

  • Completed a Phase 1 clinical trial 
  • Not been approved or licensed by the FDA 
  • An application has been submitted to the FDA for clinical trial intended to form a claim of effectiveness AND is the subject of an active investigational drug application with the FDA
  • The drug has not been discontinued or put on hold with the FDA

As far as Dr. Aggarwal and his team are concerned, his patient, Erinn Baldeschwiler, and the drug, psilocybin, check all the boxes. 

So Dr. Aggarwal and his clinic, the Advanced Integrative Medical Science (AIMS) Institute, wrote to the DEA for guidance on how to proceed with using a Schedule I drug under right-to-try. Instead the DEA responding with guidance, the team's petition was rejected on February 12th after submission a month prior. 

This unacceptable response led to a lawsuit filed on March 8th with the help of their lawyer, Kathryn Tucker, who has extensive experience in psychedelic legislation. Kathryn is the Co-Chair of the Psychedelic Practice at the Emerge Law Group. She has also worked with the Nowak Society, a 501(c)3 in Colorado, advocating for public health, with a focal point on psychedelics. And their team has actually set up a Right to Try advocacy fund.

To hear more on the case, click the podcast player above where we feature input from Dr. Sunil Aggarwal, his patient Erinn, and lawyer Kathryn.

Topics Covered

  • Psilocybin psychotherapy for terminal patients 
  • Integrative approaches in palliative care, and why practitioners are reaching for psychedelics 
  • Ketamine psychotherapy
  • Legal stance on psilocybin in the United States as of March 2021
  • The Right To Try Act — what it means, who and what is eligible, and a brief history on it's impact
  • A history of lawsuits against the DEA, specifically cannabis
 
 
(Pictured top to bottom: Dr. Sunil Aggarwal,  Erinn Baldeschwiler, Kathryn Tucker)


Show Notes

Donate to the Nowak Society: https://www.thenowaksociety.org/projects

Emerge Law Group: https://emergelawgroup.com/2017/

FDA's Right to Try Act: https://fda.gov/RTTAct

Cannabis' legal history: https://thehia.org/Hemp-Legal-HIA-vs-DEA

Dr. Aggarwal's website: http://www.cannabinologist.org/

AIMS Institute: https://www.aimsinstitute.net/