The US Food and Drug Administration (FDA) has stood by an earlier decision confirming that the tirzepatide shortage is over.
The end of the shortage means that pharmacies making compounded versions of the drug will have to stop production. FDA-approved drugs can be compounded under certain conditions such as if the original approved drug is in shortage and unavailable.
Many patients seeking glucagon-like peptide-1 receptor agonists (GLP-1RAs) turned to compound pharmacies as demand for Eli Lilly鈥檚 tirzepatide, branded as Ozempic and Mounjaro, far-outpaced supply, leading to shortages of the FDA-approved products.
The FDA declared the tirzepatide shortage over in October 2023, but a lawsuit by Outsourcing Facilities Association, a trade group for compounding pharmacists, pushed the FDA to reconsider. In a letter sent to Eli Lilly on 19 December, the agency confirmed the same October outcome had been reached after a re-evaluation.
Explaining its decision, the FDA said that Eli Lilly鈥檚 supply is meeting or exceeding demand for tirzepatide products and has taken additional production measures to meet or exceed projected demand in the future. The agency partly blamed the 鈥減ractical dynamics of the portion of the supply chain between Lilly and the individual customers, including wholesale distributors and retailers鈥�.
With the tirzepatide shortage resolved, the FDA has now clarified policies for compounders. The agency started by saying it would not take action against compounders who made their versions of Eli Lilly鈥檚 treatments, as tirzepatide injection products were included on the shortage list. State-licensed pharmacies will be required however to stop manufacturing compounded products by 18 February. Outsourcing facilities meanwhile will have a little longer to stop production, with a deadline of 19 March.
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By GlobalDataAn Eli Lilly spokesperson told Pharmaceutical Technology that the FDA’s decision “reflects the tireless work of our manufacturing and quality colleagues to safely expand our manufacturing capacity to bring these medicines to people who need them.”
The spokesperson added that “anyone聽marketing or selling unapproved tirzepatide knockoffs聽must聽stop,” and that “compounders must immediately begin transitioning patients taking compounded tirzepatide knockoffs聽to FDA-approved tirzepatide medicines.”
Scott Brunner, CEO of Alliance for Pharmacy Compounding said in a statement: 鈥淚鈥檓 just not persuaded that the data on which FDA is relying in this doubling-down on its shortage resolution decision is complete enough to say the shortage is really over.鈥�
Acknowledging the off-ramp, Brunner said this would hopefully 鈥渕ean most patients will not have to experience an interruption of therapy鈥�.
Though he warned the shortage resolution 鈥渕ay not be the end of the story,鈥� with legal matters between the FDA and Outsourcing Facilities Association ongoing.
鈥淭hough the agency is doubling down on its 2 October shortage resolution, there鈥檚 still litigation out there. Today鈥檚 statement from the agency certainly informs that litigation, but it鈥檚 not a decision by a court. It鈥檚 a unilateral action by the agency, so don鈥檛 confuse the two,鈥� he added.
, the latter being the developer of semaglutide therapies Ozempic and Wegovy, have also been busy taking action against unregulated online sellers of their products. Unlike compounded drugs, online pharmacies offering 鈥榢nock-off鈥� drugs are untested and potentially unsafe. The two drugmakers have filed multiple lawsuits against companies, whilst the FDA is also cracking down on those illegally benefitting from the rising popularity of GLP-1RA products.
Zepbound is forecast to generate sales of $25.2bn by 2030 while diabetes treatment Mounjaro could make $32.4bn, according to GlobalData鈥檚 Pharma Intelligence Center.
GlobalData is the parent company of Pharmaceutical Technology.
Editor’s note: This article was updated on 20 December to include comment from an Eli Lilly spokesperson.
