{"id":415442,"date":"2026-04-24T15:57:09","date_gmt":"2026-04-24T15:57:09","guid":{"rendered":"https:\/\/www.newsbeep.com\/ie\/415442\/"},"modified":"2026-04-24T15:57:09","modified_gmt":"2026-04-24T15:57:09","slug":"fda-three-psychedelic-drugs-to-get-review-following-trump-directive","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/ie\/415442\/","title":{"rendered":"FDA: Three psychedelic drugs to get review following Trump directive"},"content":{"rendered":"

WASHINGTON (AP) \u2014 The Food and Drug Administration<\/a> said Friday it will offer ultra-fast review to three psychedelic drugs<\/a> being developed to treat mental health conditions, including depression, the latest step by the Trump administration toward possible approval of the experimental treatments<\/a>.<\/p>\n

President Donald Trump signed an executive order<\/a> last weekend directing the FDA and other federal agencies to speed research and loosen restrictions on psychedelics, a class of hallucinogenic drugs which remain illegal under federal law.<\/p>\n

The FDA said it awarded priority review vouchers<\/a> to two companies studying psilocybin \u2014 the active ingredient in magic mushrooms \u2014 for hard-to-treat forms of depression. A third company received a voucher for methylone, a drug related to MDMA<\/a>, for post-traumatic stress disorder. The FDA did not name the companies in a press release announcing the news.<\/p>\n

\u201cWe owe it to our nation\u2019s veterans and all Americans who are suffering from these conditions to evaluate these potential therapies with urgency,\u201d FDA Commissioner Marty Makary said in a statement.<\/p>\n

The vouchers don\u2019t guarantee approval, but instead mean that regulators will try to shorten their reviews from a period of months to weeks.<\/p>\n

The recent moves on psychedelics reflect growing popular support for the mind-altering substances<\/a> among Trump\u2019s supporters, including combat veterans<\/a> and followers of the Make America Healthy Again movement<\/a> spearheaded by Health Secretary Robert F. Kennedy Jr.<\/p>\n

Last July, Kennedy told members of Congress his department aimed to make psychedelics available<\/a> for hard-to-treat psychiatric conditions within one year. Some of Kennedy\u2019s top allies and staffers are proponents of the drugs.<\/p>\n

Calley Means<\/a>, a former Kennedy campaign staffer now serving as a senior health adviser, has previously written about the \u201cmind-blowing\u201d power of psychedelics and his plans to invest in companies developing the drugs.<\/p>\n

FDA\u2019s special treatment for psychedelics is likely to renew scrutiny of its program for speeding up drug reviews, known as the Commissioner\u2019s National Priority Voucher<\/a> program. <\/p>\n

Democratic members of Congress<\/a> have noted that vouchers have gone to companies that are politically favored by the White House, including those that have agreed to cut prices on their medications.<\/p>\n

In a separate move, the FDA authorized initial testing of a drug related to ibogaine, a powerful psychedelic made from an African shrub, for people with alcohol use disorder. Ibogaine is known to sometimes cause dangerous heart rhythms but has been embraced by combat veterans as a way to treat trauma and addiction. <\/p>\n

The drugmaker, DemeRx, is led by a Florida-based researcher who first began studying ibogaine as a treatment for cocaine addiction in the 1990s, before federal health officials pulled funding for the work. <\/p>\n

\u201cEvery grant proposal that I submitted to (the National Institute on Drug Abuse) was rejected,\u201d Deborah Mash, a neurologist and founder of DemeRx, told The Associated Press. \u201cI couldn\u2019t get that funding and that\u2019s why ibogaine didn\u2019t advance in the 1990s.\u201d<\/p>\n

Ibogaine is known to cause intense hallucinations, nausea, vomiting, tremors and sometimes dangerous irregular heart rhythms. Mash says DemeRx\u2019s drug is a metabolite of ibogaine, and doesn\u2019t carry the same hallucinogenic effects or risks as the original drug.<\/p>\n

Saturday\u2019s White House event on psychedelics suggested Trump\u2019s political allies had a role in pushing the drugs to the top of his agenda.<\/p>\n

Joe Rogan<\/a>, the podcaster who appeared at the Oval Office event, said he texted Trump about the psychedelic ibogaine, which he\u2019s repeatedly discussed on his show. According to Rogan, the president quickly responded: \u201cSounds great. Do you want FDA approval? Let\u2019s do it.\u201d<\/p>\n

Rogan\u2019s endorsement of Trump<\/a> days before the November 2024 election was seen by White House aides as a key factor in his election victory. <\/p>\n

On his show earlier this week, Rogan said he learned about ibogaine from his friend Ed Clay, a mixed martial arts trainer and entrepreneur who runs retreats making use of it in Mexico.<\/p>\n

Virtually all psychedelics, including LSD, psilocybin and MDMA are classified as Schedule I substances, a category for high-risk drugs that have no medically accepted use.<\/p>\n

For decades, drugmakers steered clear of the substances due to the difficulties of studying drugs that are illegal under federal law. <\/p>\n

But dozens of small drugmakers, many fueled by Silicon Valley investors, have recently jumped into the race to win FDA approval for various psychedelics. For example, tech billionaire Peter Thiel<\/a> \u2014 who has made political donations to both Trump and Vice President JD Vance \u2014 has invested in AtaiBeckley, a company studying MDMA and other psychedelic compounds.<\/p>\n

___<\/p>\n

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute\u2019s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.<\/p>\n","protected":false},"excerpt":{"rendered":"WASHINGTON (AP) \u2014 The Food and Drug Administration said Friday it will offer ultra-fast review to three psychedelic…\n","protected":false},"author":2,"featured_media":415443,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[33],"tags":[72,182259,1853,969,182260,4644,99037,10472,1595,103,61,60,5461,52275,66781,71225,371,410,77283,2361,1139,82,439,25173],"class_list":{"0":"post-415442","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-medication","8":"tag-business","9":"tag-deborah-mash","10":"tag-depression","11":"tag-donald-trump","12":"tag-ed-clay","13":"tag-elections","14":"tag-executive-orders","15":"tag-fungi","16":"tag-general-news","17":"tag-health","18":"tag-ie","19":"tag-ireland","20":"tag-jd-vance","21":"tag-joe-rogan","22":"tag-john-f-kennedy","23":"tag-marty-makary","24":"tag-medication","25":"tag-mental-health","26":"tag-peter-thiel","27":"tag-public-health","28":"tag-robert-f-kennedy-jr","29":"tag-science","30":"tag-u-s-food-and-drug-administration","31":"tag-washington-news"},"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/posts\/415442","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/comments?post=415442"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/posts\/415442\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/media\/415443"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/media?parent=415442"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/categories?post=415442"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/tags?post=415442"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}