FDA Commissioner Marty Makary released a statement on X stating that the agency is expected to begin moving against copycat drugs promoted as alternatives to approved therapies, reinforcing the agency\u2019s stance that unapproved products pose potential risks when marketed at scale.<\/p>\n
In his post, Makary said, \u201cFDA will take swift action against companies\u2019 mass-marketing illegal copycat drugs, claiming they are similar to FDA-approved products. The FDA cannot verify the quality, safety, or effectiveness of non-approved drugs.\u201d<\/p>\n
The statement comes on the heels of Hims & Hers\u2019 launching a compounded semaglutide pill, which the company claims to have the same active ingredients as Wegovy.2The telehealth platform\u2019s announcement triggered a legal and regulatory confrontation with Novo Nordisk, underscoring growing tensions around copycat glucagon-like peptide-1 (GLP-1) therapies.3<\/p>\n
According to the company, the needle-free option is designed to broaden treatment choice and allow providers to prescribe an alternative formulation for patients who prefer oral administration or require individualized dosing adjustments.2 The compounded product, which the company said is formulated to protect the active ingredient during digestion and support absorption, is being introduced with an initial promotional price of $49 for the first month for eligible customers.2<\/p>\n
Compounded drugs are typically prepared by pharmacies to meet individual patient needs but are not reviewed by FDA for safety, effectiveness, or quality.2Hims & Hers stated that its compounded treatments adhere to applicable federal and state regulatory standards and that active pharmaceutical ingredients are sourced from FDA-registered facilities.2<\/p>\n
Novo Nordisk responded swiftly to the announcement, issuing a statement alleging that the product represents unlawful mass compounding of an unapproved semaglutide pill. \u201cThe action by Hims & Hers is illegal mass compounding that poses a significant risk to patient safety. Novo Nordisk will take legal and regulatory action to protect patients, our intellectual property and the integrity of the US gold-standard drug approval framework. This is another example of Hims & Hers’ historic behavior of duping the American public with knock-off GLP-1 products, and the FDA has previously warned them about their deceptive advertising of GLP-1 knock-offs.\u201d<\/p>\n
The Danish drugmaker further argued that compounded semaglutide products may contain impurities, untested doses, or unnecessary additives and emphasized that only its FDA-approved oral formulation incorporates SNAC technology designed to facilitate absorption when taken orally.3 In its response, Novo Nordisk also referenced guidance from the American Diabetes Association\u2019s Obesity Association discouraging the use of compounded GLP-1 products due to concerns related to safety, quality, and effectiveness.3<\/p>\n
When Hims & Hers announced its new compounded GLP-1 pill, Novo Nordisk CEO Mike Doustdar was in a live-streamed investors meeting in which he was informed of the telehealth platform\u2019s new oral GLP-1 release. Doustdar swiftly responded to the news, saying “You’re wasting $49 in my opinion.\u201d He continued to note that the Wegovy pill had technology called SNAC that aided the absorption of the active compound semaglutide, \u200dwhich a copy would not have. “Your gut enzyme will basically get rid of it, and it will not get to your bloodstream,\u201d said Doustdar.<\/p>\n
Novo Nordisk\u2019s stock rose 5.4% following FDA commissioner Marty Makary\u2019s statement saying the agency will take action against copycat drugs, helping the company rebound from its 8% plummet after Hims & Hers announced its compounded oral GLP-1 drug.5\u00a0<\/p>\n
Dr. Marty Makary X, X February 5, 2026 https:\/\/x.com\/DrMakaryFDA\/status\/2019552255310020616?s=20<\/a>Hims & Hers Expands Personalized Weight Loss Portfolio with Access to Compounded Semaglutide Pills Starting at $49\/Month* Hims & Hers February 5, 2026 https:\/\/www.businesswire.com\/news\/home\/20260205680502\/en\/Hims-Hers-Expands-Personalized-Weight-Loss-Portfolio-with-Access-to-Compounded-Semaglutide-Pills-Starting-at-%2449Month<\/a>Novo Nordisk issues statement on illegal mass compounding and deceptive advertising by Hims & Hers Novo Nordisk February 5, 2026 https:\/\/www.novonordisk.com\/news-and-media\/news-and-ir-materials\/news-details.html?id=916489<\/a>Novo Nordisk CEO: Hims’ $49 compounded Wegovy pill a ‘waste’ of money ReutersFebruary 5, 2026 https:\/\/www.reuters.com\/business\/healthcare-pharmaceuticals\/novo-nordisk-ceo-hims-49-compounded-wegovy-pill-waste-money-2026-02-05\/<\/a>Novo Nordisk shares rebound as FDA targets illegal drug copies Reuters February 6, 2026 https:\/\/www.reuters.com\/sustainability\/boards-policy-regulation\/novo-nordisk-shares-rebound-fda-targets-illegal-drug-copies-2026-02-06\/<\/a> <\/p>\n","protected":false},"excerpt":{"rendered":"FDA Commissioner Marty Makary released a statement on X stating that the agency is expected to begin moving…\n","protected":false},"author":2,"featured_media":271438,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[33],"tags":[134,524,111,139,69],"class_list":["post-271437","post","type-post","status-publish","format-standard","has-post-thumbnail","category-medication","tag-health","tag-medication","tag-new-zealand","tag-newzealand","tag-nz"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/nz\/wp-json\/wp\/v2\/posts\/271437","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=271437"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/nz\/wp-json\/wp\/v2\/posts\/271437\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/nz\/wp-json\/wp\/v2\/media\/271438"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/nz\/wp-json\/wp\/v2\/media?parent=271437"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/nz\/wp-json\/wp\/v2\/categories?post=271437"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/nz\/wp-json\/wp\/v2\/tags?post=271437"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}