Does the DEA Have to Allow Psilocybin Access for Terminally Ill Patients?

Trevor BurrusA case at the Ninth Circuit is seeking to compel the DEA to allow psilocybin (magic mushrooms) use by terminally ill patients. The case,Advanced Integrative Medical Science Institute v. DEA, has been brought by a research institute, a doctor, and two terminal cancer patients who wish to use psilocybin.A lot has changed in psilocybin research in recent years. In 2018 and 2019, the FDAdesignated two psilocybin trials as “breakthrough therapies” for treating severe depression.Breakthrough ‐​therapy status can be granted by the FDA when a new drug shows significant improvement over currently available alternatives. Psilocybin has been particularly effective at treating the understandable depression suffered by terminally ill patients, as with the two patients in this case.But psilocybin is a Schedule I drug under the Controlled Substances Act (CSA), meaning that it has no currently accepted medical uses and has a high potential for abuse. In that way, psilocybin is like medical marijuana –also a Schedule I drug –but the DEA is allowing medical marijuana to be used all over the country.This case is about the interaction of the CSA, the FDA, and federal and state right to try laws. The federal right to try law, passed in 2018, allows “the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law. ” Additionally, 41 states have right to try laws, including Wa...
Source: Cato-at-liberty - Category: American Health Authors: Source Type: blogs