\n<\/p>\n
The Trump administration issued an executive order earlier this month to accelerate access to psychedelic medication for people with \u201cserious mental illnesses\u201d, but experts say the order is more likely to make a difference symbolically than legally.<\/p>\n
\u201cPolicymakers and the medical field have long struggled to address the burden of suicide and serious mental illness rates in America,\u201d the order reads, noting that some people do not respond to available treatments.<\/p>\n
The order then lists provisions to accelerate access to psychedelic medications, including inter-agency collaboration with the Department of Veterans Affairs to share data and increase clinical trial participation, and timely rescheduling in the case that an illegal psychedelic receives FDA approval.<\/p>\n
Mason Marks, a law professor at Florida State University and senior fellow for psychedelic projects at Harvard Law\u2019s Petrie-Flom Center, said that while the concrete provisions of the order will probably have only \u201csome minimal impact\u201d, he added that \u201cthe overall order itself could have a pretty significant impact, just in terms of its symbolic value\u201d. Marks noted that the order came with a lot of fanfare, including a press conference with Joe Rogan, a podcaster, and Marcus Luttrell, a former Navy Seal.<\/p>\n
\u201cIt\u2019s quite unusual for a president to be promoting psychedelic research in such a public way,\u201d Marks said. During the conference, Rogan said that a text conversation between himself and the president inspired the executive order.<\/p>\n
Cat Packer, director of drug markets and legal regulation at the Drug Policy Alliance, said the order is also a signal of \u201cwho is influencing the administration\u201d, noting that Republican support for psychedelics is expanding and includes elected officials, veteran advocates like Luttrell and \u201chigh-profile public figures with proximity to the president\u201d, such as Rogan.<\/p>\n
\u201cIt\u2019s a welcome sign that the federal government is taking psychedelic research and access seriously,\u201d Packer said, before cautioning that the same framing that seems to have made psychedelic medications more popular with some Republicans could also limit who benefits from legal changes.<\/p>\n
Packer continued: \u201cThe administration is clearly leaning into a medicalized, veteran-centered framework, rather than a broader rights-based or anti-criminalization approach. Without sustained investments in healthcare access, community-based treatment and housing \u2013 resources the Trump administration has continued to divest from \u2013 we cannot truly address America\u2019s mental health crisis.\u201d<\/p>\n
Trump issued a similar executive order in December directing that cannabis be reclassified from a schedule I to a schedule III substance, which would remove restrictions on research as well as potentially easing some of the tax burdens that come with selling it. The Biden administration had initiated the rescheduling process in 2022.<\/p>\n
Even after four years, and the support of two presidents, the acting attorney general, Todd Blanche, only just announced this week that the Department of Justice would be partly delivering on the promise to reschedule cannabis. In his X post announcing the change on Thursday, he wrote the justice department is \u201cordering a new, expedited hearing \u2026 to fully reschedule marijuana\u201d, and \u201cimmediately rescheduling FDA-approved marijuana and state-licensed marijuana from schedule I to schedule IIl\u201d. The FDA-approved part is a bit nonsensical, since anything FDA-approved is by definition not schedule I, as schedule I drugs are classified as having \u201cno accepted medical use\u201d.<\/p>\n
\u201cThere\u2019s already been some evidence of institutional resistance when it comes to cannabis rescheduling. President Trump himself has suggested that parts of his administration have stalled the process \u2013 likely reflecting the reality that the [US Drug Enforcement Administration] has historically resisted efforts to reschedule marijuana,\u201d Packer said.<\/p>\n
Marks echoed that sentiment: \u201cThe reason I think the psychedelic order is different is that we haven\u2019t seen anything like this from the White House.\u201d<\/p>\n
There are a few other reasons that the psychedelics order is more promising. While the cannabis order had one essential provision \u2013 rescheduling \u2013 this one includes more straightforward directives, Packer said, like funding state-level research. Plus, Marks said, \u201cthere\u2019s no question the FDA is very open to this. We are on the cusp of seeing FDA approval potentially for a handful of psychedelics. I would put that somewhere in the one-to-three-year range.\u201d Drugs that are far along in the process include psilocybin for treatment-resistant depression.<\/p>\n
That these drugs are already close to approval render some elements of the order somewhat meaningless. For example, while the order directs the Drug Enforcement Administration to reschedule any drug that successfully completes a phase 3 trial, Marks pointed out that the agency is already obligated to do that within 90 days. \u201cYou can\u2019t get much faster than that,\u201d Marks said.<\/p>\n
The order also indicates that the FDA\u2019s safety review process should be accelerated. Marks is concerned this provision will require reviewers to employ AI to help accelerate the process, which could lead to missed adverse events. Psychedelic clinical trials have already come under scrutiny for failing to report adverse events.<\/p>\n
\u201cThe problem is that if they miss something, and then some adverse event crops up, after the drug is out in the market, it might have to be recalled, and that\u2019s a horrible scenario, it really sets back everything,\u201d Marks said.<\/p>\n
Packer agreed, saying: \u201cFaster review and expanded research can be positive, but only if they are paired with rigorous evidence, strong patient protections and a broader public-health approach. It\u2019s also important to note that while these substances hold promise, they are not a panacea.\u201d<\/p>\n","protected":false},"excerpt":{"rendered":"
The Trump administration issued an executive order earlier this month to accelerate access to psychedelic medication for people with \u201cserious mental illnesses\u201d, but experts say the order is more likely to make a difference symbolically than legally. \u201cPolicymakers and the medical field have long struggled to address the burden of suicide and serious mental illness<\/p>\n","protected":false},"author":1,"featured_media":48724,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[51],"tags":[794,24323,23705,1435,19845,10537,81],"class_list":{"0":"post-48723","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-health","8":"tag-administration","9":"tag-analysts","10":"tag-largely","11":"tag-order","12":"tag-psychedelics","13":"tag-symbolic","14":"tag-trump"},"_links":{"self":[{"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=\/wp\/v2\/posts\/48723","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=48723"}],"version-history":[{"count":0,"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=\/wp\/v2\/posts\/48723\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=\/wp\/v2\/media\/48724"}],"wp:attachment":[{"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=48723"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=48723"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=48723"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}