Dive Brief:<\/p>\n
The Food and Drug Administration has cleared the first medicine under its new National Priority Voucher program, approving a U.S.-manufactured version of a decades-old antibiotic. Dive Insight:<\/p>\n The Trump administration forged the National Priority Voucher<\/a> system for medicines that address U.S. \u201cnational interests,\u201d promising it would allow the FDA to evaluate new therapies in as little as one to two months, instead of the usual 10 months under the Prescription Drug User Fee Act.<\/p>\n The idea has drawn controversy<\/a>, with Congressional Democrats<\/a>\u00a0arguing it has the potential to create \u201ca new, lucrative gift for drugmakers and allies politically favored by President Trump.\u201d Concerns about the initiative reportedly factored into the decision<\/a> by Richard Pazdur, the FDA\u2019s top drug reviewer, to retire from the agency<\/a>\u00a0just weeks after taking the job.<\/p>\n FDA officials issued the first round of vouchers<\/a>\u00a0in October to nine drugmakers, including USAntibiotics. The company is the only U.S. producer of amoxicillin and Augmentin and, like other manufacturers, has struggled in a market<\/a>\u00a0that desperately needs a steady supply of generic antibiotics yet pays very little for them.<\/p>\n In its press release<\/a> touting the voucher win in October, USAntibiotics offered a dire warning. \u201cIf our doors close, it would take half a decade and hundreds of millions of dollars to rebuild this capability,\u201d Patrick Cashman, the company\u2019s president, said in the statement. \u201cThat\u2019s five years in which America would be completely reliant on adversarial nations for the most prescribed antibiotic in the country.\u201d<\/p>\n USAntibiotics rescued<\/a> the Bristol facility in 2021 after it had been owned by Neopharma<\/a>, which took it over from Dr. Reddy\u2019s. As of 2024, Augmentin XR was listed on the FDA\u2019s discontinued drug products list, but the agency that year cleared the way for another approval by making note<\/a>\u00a0that the medicine wasn\u2019t withdrawn because of concerns about safety or effectiveness.<\/p>\n The FDA issued a second round of vouchers<\/a>\u00a0last month, a list that included two weight loss drugs. Novo Nordisk is using its voucher to seek approval of a higher-dose version of Wegovy<\/a>, while Lilly is advancing an experimental pill called orforglipron. The vouchers were part of a larger deal<\/a> on obesity drug pricing with the White House.<\/p>\n","protected":false},"excerpt":{"rendered":"Dive Brief: The Food and Drug Administration has cleared the first medicine under its new National Priority Voucher…\n","protected":false},"author":2,"featured_media":178760,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[33],"tags":[134,524,111,139,69],"class_list":{"0":"post-178759","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-medication","8":"tag-health","9":"tag-medication","10":"tag-new-zealand","11":"tag-newzealand","12":"tag-nz"},"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/nz\/wp-json\/wp\/v2\/posts\/178759","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/nz\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/nz\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/nz\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/nz\/wp-json\/wp\/v2\/comments?post=178759"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/nz\/wp-json\/wp\/v2\/posts\/178759\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/nz\/wp-json\/wp\/v2\/media\/178760"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/nz\/wp-json\/wp\/v2\/media?parent=178759"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/nz\/wp-json\/wp\/v2\/categories?post=178759"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/nz\/wp-json\/wp\/v2\/tags?post=178759"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
\nGSK originally developed the drug, Augmentin XR, and won FDA approval<\/a>\u00a0for it in 2002. The British company then struck a deal<\/a> in 2010 to sell its U.S. penicillin business, including its Augmentin franchise, to the generic drugmaker Dr. Reddy\u2019s Laboratories. A Bristol, Tennessee, plant that was part of that deal is now operated by USAntibiotics<\/a>, which won the priority voucher.
\nFDA Commissioner Martin Makary trumpeted the approval as a boon for crucial supply chains of medications that often end up in shortages<\/a>. The move \u201cwill strengthen domestic manufacturing and increase our national security,\u201d Makary said in a statement<\/a> Tuesday.<\/p>\n