FDA Sends Pre-Inactivation Letter after Three Years Waiting for Marijuana for Study
Over three years ago, on December 15, 2010, the U.S. Food and Drug Administration (FDA) approved the protocol for our planned study of marijuana for PTSD in U.S. veterans, pending information about the source of the marijuana to be used in the study. Due to the ongoing Drug Enforcement Administration-protected monopoly held by the National Institute on Drug Abuse on marijuana for research, over three years later we’ve still been unable to obtain marijuana for the study. In their January 27, 2014, letter, the FDA asked MAPS to respond within 30 days if we still wish to proceed with the study. In his February 17 response, MAPS Executive Director Rick Doblin, Ph.D., writes, “We still do plan on responding to the clinical hold deficiencies but we can’t say exactly when we will have located a supply of marijuana for the study.” We have now been waiting almost four months for a response from the Public Health Service to our October 24, 2013, protocol resubmission.