{"id":305142,"date":"2026-02-19T00:32:07","date_gmt":"2026-02-19T00:32:07","guid":{"rendered":"https:\/\/www.newsbeep.com\/ie\/305142\/"},"modified":"2026-02-19T00:32:07","modified_gmt":"2026-02-19T00:32:07","slug":"fda-drug-approvals-makary-and-prasad-say-one-study-will-be-enough","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/ie\/305142\/","title":{"rendered":"FDA drug approvals: Makary and Prasad say one study will be enough"},"content":{"rendered":"

WASHINGTON (AP) \u2014 The Food and Drug Administration<\/a> plans to drop its longtime standard of requiring two rigorous studies to win approval for new drugs, the latest change from Trump administration officials vowing to speed up the availability of certain medical products.<\/p>\n

Going forward, the FDA\u2019s \u201cdefault position\u201d will be to require one study for new drugs and other novel health products, FDA Commissioner Dr. Marty Makary<\/a> and a top deputy, Dr. Vinay Prasad<\/a>, wrote in a New England Journal of Medicine piece<\/a> published Wednesday.<\/p>\n

The announcement is the latest example of Makary and his team changing longstanding FDA standards and procedures<\/a> with the stated goal of slashing bureaucracy and accelerating the availability of new medicines.<\/p>\n

Since arriving at the agency last April, Makary has launched a series of directives that he says will shorten FDA reviews, including mandating the use of artificial intelligence by staffers and offering one-month drug assessments<\/a> for new medications that serve \u201cnational interests.\u201d <\/p>\n

It contrasts with the FDA\u2019s more restrictive approach to other products, including vaccines.<\/p>\n

In their piece published Wednesday, Makary and Prasad state that dropping the two-trial requirement reflects modern advances that have made drug research \u201cincreasingly precise and scientific.\u201d<\/p>\n

\u201cIn this setting, overreliance on two trials no longer makes sense,\u201d they write. \u201cIn 2026 there are powerful alternative ways to feel assured that our products help people live longer or better than requiring manufacturers to test them yet again.\u201d<\/p>\n

The FDA officials predicted the shift would lead to \u201ca surge in drug development.\u201d<\/p>\n

Dr. Janet Woodcock, the FDA\u2019s former drug director, said the change makes sense and reflects the FDA\u2019s decades-long move toward relying on one trial, combined with supporting evidence, for various life-threatening diseases, including cancer<\/a>. <\/p>\n

\u201cThe scientific point is well taken that as we move toward greater understanding of biology and disease we don\u2019t need to do two trials all the time,\u201d said Woodcock, who led the FDA\u2019s drug center for about 20 years before retiring in 2024. <\/p>\n

The two-study standard for drugs dates to the early 1960s, when Congress passed a law requiring the FDA to review data from \u201cadequate and well-controlled investigations,\u201d before clearing new medications. For decades, the agency interpreted that requirement as meaning at least two studies, preferably with a large number of patients and significant follow-up time.<\/p>\n

The reason for requiring the second study was to confirm that the first trial\u2019s results weren\u2019t a fluke and could be reproduced. <\/p>\n

But beginning in the 1990s, the FDA increasingly began accepting single studies for the approval of treatments for rare or fatal diseases that companies often struggle to test in large numbers of patients. <\/p>\n

Over the last five years, roughly 60% of first-of-a-kind drugs approved each year have been cleared based on a single study. The shift reflects laws passed by Congress that directed regulators to be more flexible when reviewing drugs for serious or hard-to-treat conditions.<\/p>\n

Woodcock said the new policy announced Wednesday will mainly impact drugs for common diseases that previously weren\u2019t eligible for reduced testing standards.<\/p>\n

\u201cIt\u2019s not the cancers and the rare diseases that will be affected by this,\u201d she noted. \u201cThe agency has been approving those on a single trial already.\u201d<\/p>\n

The latest approach from FDA leadership contrasts with the agency\u2019s recent actions on vaccines, gene therapies and other treatments.<\/p>\n

Last week, the FDA\u2019s vaccine division, headed by Prasad, refused to accept<\/a> Moderna\u2019s application for a new mRNA flu shot, saying its clinical trial was insufficient. Then on Wednesday the agency reversed course<\/a>, saying it would review the vaccine after Moderna agreed to conduct an additional study in older people.<\/p>\n

Separately, Prasad has rejected a string of experimental gene therapies and biotech drugs, citing the need for additional studies or more definitive evidence. The trend has weighed on the stocks of many biotech companies and clashed with Makary\u2019s public statements promoting the speed and flexibility of the FDA\u2019s reviews.<\/p>\n

Woodcock said the drug industry will have to wait and see whether the FDA\u2019s approach to promising experimental therapies changes.<\/p>\n

\u201cImplementation will be everything,\u201d she said. \u201cSince the agency\u2019s approach is unclear, and the industry is already baffled, I don\u2019t think this adds any illumination.\u201d<\/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 plans to drop its longtime standard of requiring two rigorous…\n","protected":false},"author":2,"featured_media":279023,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[33],"tags":[72,1595,103,61,173,60,143829,371,59613,82,439,25173],"class_list":{"0":"post-305142","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-medication","8":"tag-business","9":"tag-general-news","10":"tag-health","11":"tag-ie","12":"tag-inc","13":"tag-ireland","14":"tag-janet-woodcock","15":"tag-medication","16":"tag-moderna","17":"tag-science","18":"tag-u-s-food-and-drug-administration","19":"tag-washington-news"},"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/posts\/305142","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=305142"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/posts\/305142\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/media\/279023"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/media?parent=305142"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/categories?post=305142"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/tags?post=305142"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}