{"id":532299,"date":"2026-03-11T02:09:08","date_gmt":"2026-03-11T02:09:08","guid":{"rendered":"https:\/\/www.newsbeep.com\/au\/532299\/"},"modified":"2026-03-11T02:09:08","modified_gmt":"2026-03-11T02:09:08","slug":"fda-contradicts-trump-admin-declines-to-approve-generic-drug-for-autism","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/au\/532299\/","title":{"rendered":"FDA contradicts Trump admin, declines to approve generic drug for autism"},"content":{"rendered":"

In September, the Trump administration took what it called \u201cbold actions\u201d on autism that included touting the generic drug leucovorin as a promising treatment. In a news release, Marty Makary, commissioner of the Food and Drug Administration, claimed a \u201cgrowing body of evidence<\/a> suggests\u201d the drug could be helpful. And at a White House press event, Makary suggested it might help \u201c20, 40, 50 percent of kids with autism<\/a>.\u201d<\/p>\n

\u201cHundreds of thousands of kids<\/a>, in my opinion, will benefit,\u201d he said at another point in the event.<\/p>\n

The bold claims were apparently persuasive. A study published in The Lancet last week found that new outpatient prescriptions of leucovorin for children ages 5 to 17 shot up 71 percent<\/a> in the three months after the Trump administration\u2019s actions.<\/p>\n

But it became clear today that the rest of the FDA did not share Makary\u2019s and the other administration officials\u2019 view. In an announcement, the regulatory agency said it had approved leucovorin for a rare genetic condition<\/a>\u2014but not for autism.<\/p>\n

In comments to the Associated Press, senior FDA officials said they found little evidence<\/a> for expanding the drug\u2019s use to autism and, thus, narrowed its review to the treatment of the rare genetic condition, which is cerebral folate deficiency (CFD) in adults caused by a genetic mutation in the folate receptor 1 gene (CFD-FOLR1).<\/p>\n","protected":false},"excerpt":{"rendered":"In September, the Trump administration took what it called \u201cbold actions\u201d on autism that included touting the generic…\n","protected":false},"author":2,"featured_media":532300,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[33],"tags":[64,63,137,490],"class_list":["post-532299","post","type-post","status-publish","format-standard","has-post-thumbnail","category-medication","tag-au","tag-australia","tag-health","tag-medication"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/posts\/532299","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/comments?post=532299"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/posts\/532299\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/media\/532300"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/media?parent=532299"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/categories?post=532299"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/tags?post=532299"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}