Stakeholder comment to Reagan-Udall/FDA meeting regarding the treatment for PTSD
Public Citizen made formal comment at the Reagan-Udall Foundation for the Food and Drug Administration’s meeting on Advancing Treatments for Post-Traumatic Stress Disorder (PTSD). Those comments focused on the FDA’s recent rejection of the psychedelic drug midomafetamine (MDMA, “ecstasy,” “molly”) to enable the treatment of PTSD. The drug was previously rejected by the FDA to treat PTSD in combination with intensive (8-hour) psychotherapy. Public Citizen opposes further consideration of such psychedelic drugs until the relevant drug trials better address unblinding-bias, concerns about addiction, other potential adverse physiologic effects, and concerns that the psychotherapy aspects of the treatment are unstandardized and potentially unsafe.