Exploring Psychedelic Medicine Is A ‘Top Priority’ For Trump Administration, FDA Commissioner Says
From toxifillers.com with love
The head of the Food and Drug Administration (FDA) says exploring the therapeutic potential of psychedelics such as psilocybin and ibogaine is a “top priority” for the Trump administration, especially when it comes to helping military veterans grapple with trauma from being sent to fight “unnecessary wars.”
There appears to be strong momentum behind the push for psychedelic therapy access at top levels of the administration, and FDA Commissioner Marty Makary’s new comments emphasizing the need to cut red tape while undertaking “an expeditious and rapid review” toward federal approval is one of the latest examples.
“When it comes to some of these psychedelics and other plant-based therapies, I don’t think we’re listening to patients,” he said during an interview with NewsNation that aired on Saturday . “I don’t think the medical establishment is listening to doctors. When I listen to the individuals who have tried some of these for real medical conditions—post-traumatic stress disorder, severe refractory depression—people tell me that they believe that psilocybin was successful. It was a curative, or significantly helped, their severe mood disorder.”
“People have told me that other psychedelics, like MDMA, have been helpful in treating PTSD. Doctors have told me that they’ve sent patients for this therapy,” Makary said. “Ibogaine has been used to treat PTSD. There are trials now looking at it for traumatic brain injury—things we have had nothing for in the past. What have we had to treat traumatic brain injury and PTSD that has really had great results up until this time?”
The commissioner stressed that he’s not necessarily endorsing plant-based medicine at this stage because he wants to first ensure FDA collects data demonstrating their efficacy, but “we have to listen to doctors who have these experiences, and this is one of our top priorities at the FDA—to listen to doctors, to listen to patients and to make sure we don’t get in the way with red tape.”
“We want to do proper independent evaluations, but we’ve got to do it quickly, because many young Americans have signed up to serve their country and were sent to unnecessary wars, and they were hurt badly, and we owe it to them to do everything possible to try to seek out what might help them,” he said, suggesting psychedelic medicine could help the veteran community, in which there’s high rates of serious mental health disorders. “So this is a top priority for this FDA in this administration.”
Asked why he thinks psychedelics remain strictly prohibited under federal law given emerging evidence of their medical potential, he said that “we have to take a hard look at everything.”
“I think everything needs to be on the table. I think we need to look at how we evaluate and consider these medications. There are ongoing clinical trials that are going to read out sometime soon, and we have to take an expeditious and rapid review of that data,” Makary said. “We can’t say, ‘Well, our normal process is that it takes a year to give a good look at data.’ We have got a crisis right now. And I don’t think—if these medicines end up showing clinical benefit in their trials—I don’t think it’s a silver bullet. But we owe it to people who are suffering to do everything we can as a government to get a decision on the results as soon as they’re available.”
As FDA commissioner, Makary is uniquely positioned to advance the issue—by promoting research, facilitating approvals of new drug applications for psychedelics and taking steps to reschedule substances such as psilocybin and MDMA.
Under the Biden administration, there was stepped-up interest in examining certain psychedelics, with novel guidance for researchers from FDA in the pursuit of potential approvals, but the agency ultimately rejected an application to make MDMA-assisted therapy available for the treatment of PTSD.
The current commissioner’s remarks also come in the context of a meaningful shift on psychedelics policy within this administration—with the secretaries of the U.S. Department of Veterans Affairs (VA) and the U.S. Department of Health and Human Services (HHS) that oversees FDA also having expressed support for exploring the issue. President Donald Trump’s recent pick for U.S. surgeon general has previously described her personal experience benefitting from psilocybin.
Just last week, VA Secretary Doug Collins touted the fact that he’s “one of the first” secretaries of the agency with a commitment to exploring psychedelics as a potential therapy option for veterans.
“What we’re seeing so far in some of the studies that are related to VA, and also outside of VA as well,” he told lawmakers during a House committee hearing, “is that there has been—especially when it comes to PTSD and also traumatic brain injury and others—we’re seeing some actual positive outcomes there, especially when it is coupled with intense counseling. And I think that’s the one of the keys that we look forward to.”
President Donald Trump’s pick to serve as the next surgeon general, Casey Means, has been public about her own experience benefiting from psilocybin
Meanwhile, Reps. Jack Bergman (R-MI) and Lou Correa (D-CA)—co-chairs of the Congressional Psychedelic Advancing Therapies (PATH) Caucus—introduced a bill last month to provide $30 million in funding annually to establish psychedelics-focused “centers for excellence” at VA facilities, where veterans could receive novel treatment involving substances like psilocybin, MDMA and ibogaine.
Bergman has also expressed optimism about the prospects of advancing psychedelics reform under Trump, arguing that the administration’s efforts to cut spending and the federal workforce will give agencies “spines” to tackle such complex issues.
Collins also recently met with a military veteran who’s become an advocate for psilocybin access to discuss the therapeutic potential of psychedelic medicine for the veteran community.
Earlier this month, the secretary separately informed Trump during a Cabinet meeting that his agency is “opening up the possibility of psychedelic treatment” for veterans.
Also, during a Senate committee hearing this month, he separately reiterated his commitment to exploring the efficacy of psychedelic therapy to address serious mental health conditions that commonly afflict veterans.
Bipartisan congressional lawmakers have also asked the VA head to meet with them to discuss ways to provide access to psychedelic medicine for military veterans.
Collins disclosed last month that he had an “eye-opening” talk with HHS Secretary Robert F. Kennedy Jr. about the medical potential of psychedelic medicine. And Collins said he’s open to the idea of having the government provide vouchers to cover the costs of psychedelic therapy for veterans who receive services outside of VA as Congress considers pathways for access.
In December, VA separately announced that it’s providing $1.5 million in funding to study the efficacy of MDMA-assisted therapy for veterans with PTSD and alcohol use disorder (AUD).
Members Of Congress Want Federal Investigation Into Use Of Florida Medicaid Funds To Oppose Marijuana Legalization By Group Tied To DeSantis
Photo elements courtesy of carlosemmaskype and Apollo.
The post Exploring Psychedelic Medicine Is A ‘Top Priority’ For Trump Administration, FDA Commissioner Says appeared first on Marijuana Moment.