U.S. Representatives Mariannette Miller-Meeks (Iowa-01), Dan Crenshaw (Texas-02), and Ro Khanna (Calif.-17) applaud the FDA’s decision to issue its first draft guidance on clinical trials for psychedelic drugs in treating mental health conditions like PTSD and TBI – following the introduction of his legislation calling on the FDA to do exactly that.
“Many Veterans find guided use of psychedelics with assisted therapy as a way to successfully treat the excruciating, post-traumatic pain they face, with better outcomes and less medication side effects,” said Representative Miller-Meeks, M.D. “As a physician, I know the importance of medical research and I am encouraged by the FDA’s support and guidance regarding psychedelic clinical trials. This important step gives our Veterans another option and hope when they feel they’ve run out of methods to cope.”
“I’m glad the FDA is taking this first step of issuing guidance for psychedelic clinical trials — and listening to my bipartisan legislation with Reps. Miller-Meeks and Khanna,” said Representative Dan Crenshaw. “It’s critical we get this right for the researchers doing this important scientific work. We need this guidance to expand clinical trial access so that we can push towards life-saving psychedelic therapies for our veterans, servicemembers, and people living with PTSD, traumatic brain injury, and substance abuse disorder.”
“The FDA’s guidance is a critical step to help protect the well-being of veterans and those living with PTSD,” said Representative Khanna, an original co-sponsor of Rep. Crenshaw’s FDA bill. “I’m proud to cosponsor this bill to expand the body of research on psychedelic therapies in the hopes of improving the health of many Americans.”
“There are open questions related to psychedelic-assisted therapy that need answers,” said Veterans Exploring Treatment Solutions. “Unfortunately researching these compounds can be difficult due to administrative requirements related to scheduling status. We welcome efforts that reduce barriers to research and help pave the way for access to these lifesaving therapies.”
“I was lucky to participate in a life-saving NYU Langone clinical trial, the gold-standard for psychedelic-assisted therapy for alcohol use disorder,” said Jon Kostas, CEO of patient advocacy Apollo Pact and former study participant. “I was treatment-resistant and this was the only therapy that worked for me. There is growing interest in more research, and the demand to participate in these studies is high, as we’re in the midst of a mental health crisis. With Reps. Crenshaw, Miller-Meeks, and Khanna’s leadership, FDA guidance to researchers and universities will allow for additional studies, and hopefully, more people can access these life-saving clinical trials.”
