US FDA to reconsider decision barring compounded versions of Lilly weight loss drug
Adds statement from Outsourcing Facilities Association in paragraph 6
FDA to review if there's a shortage of tirzepatide
Outsourcing Facilities Association lawsuit led to FDA reconsideration
Shortages of Lilly and Novo Nordisk drugs drive demand for compounded versions
By Brendan Pierson
Oct 11 (Reuters) -The U.S. Food and Drug Administration on Friday agreed to reconsider a decision it made last month to bar drug compounders from selling their own versions of Eli Lilly's LLY.N blockbuster weight loss and diabetes drugs.
The agency said in a court filing it would now allow compounding pharmacies and facilities to keep providing the drugs while it reviews whether there is a shortage of their active ingredient. The compounding versions of the drugs are cheaper for patients than the brand-name versions.
The decision was in response to a lawsuit brought on Monday by the Outsourcing Facilities Association, a compounding industry group. After the FDA's decision on Friday to reconsider, U.S. District Judge Mark Pittman in Fort Worth, Texas put the lawsuit on hold.
The Sept. 30 decision by the FDA endangered the ability of compounders to sell versions of Lilly's weight loss drug Zepbound and diabetes drug Mounjaro. The FDA decision removed their active ingredient, tirzepatide, from its list of drugs experiencing shortages.
That would have cut off access for many patients to the compounded versions they relied on during the shortage, which are cheaper than the brand name drugs. Insurers generally cover drugs like tirzepatide for diabetes, but many do not cover them for weight loss.
Outsourcing Facilities Association Chairman Lee Rosebush said in a statement the group was "greatly relieved, for our members and the many patients that they serve, that the FDA has agreed to reconsider its decision."
Shortages of Lilly's drugs and competitors like Novo Nordisk's NOVOb.CO Ozempic have fueled demand for compounders' versions. Mounjaro had been on the FDA's list of drugs in short supply since late 2022, while Zepbound was added in April.
Compounded drugs, unlike conventional brand-name or generic drugs, are sold without first getting FDA approval. Compounding pharmacies may create drugs to fill prescriptions for specific patients, while so-called outsourcing facilities prepare compounded drugs in bulk.
Federal regulations allow compounded versions of an FDA-approved drug to be sold to meet demand if the drug is in short supply. If there is no shortage of a drug, compounded versions of it cannot be made regularly or in large amounts.
The Outsourcing Facilities Association claimed in its lawsuit the FDA removed tirzepatide from its shortage list even though it remained in short supply.
Lilly in August began sending cease-and-desist letters to telehealth companies, wellness centers and medical spas selling compounded versions of Zepbound and Mounjaro. The company has also filed lawsuits against sellers falsely claiming to sell FDA-approved versions of the drug.
The active ingredient in Novo Nordisk's drugs, semaglutide, remains on the FDA's shortage list.
Reporting By Brendan Pierson in New York; Editing by David Gregorio and Chris Reese
免責聲明: XM Group提供線上交易平台的登入和執行服務，允許個人查看和/或使用網站所提供的內容，但不進行任何更改或擴展其服務和訪問權限，並受以下條款與條例約束：（i）條款與條例；（ii）風險提示；（iii）完全免責聲明。網站內部所提供的所有資訊，僅限於一般資訊用途。請注意，我們所有的線上交易平台內容並不構成，也不被視為進入金融市場交易的邀約或邀請 。金融市場交易會對您的投資帶來重大風險。
所有缐上交易平台所發佈的資料，僅適用於教育/資訊類用途，不包含也不應被視爲適用於金融、投資稅或交易相關諮詢和建議，或是交易價格紀錄，或是任何金融商品或非應邀途徑的金融相關優惠的交易邀約或邀請。
本網站的所有XM和第三方所提供的内容，包括意見、新聞、研究、分析、價格其他資訊和第三方網站鏈接，皆爲‘按原狀’，並作爲一般市場評論所提供，而非投資建議。請理解和接受，所有被歸類為投資研究範圍的相關内容，並非爲了促進投資研究獨立性，而根據法律要求所編寫，而是被視爲符合營銷傳播相關法律與法規所編寫的内容。請確保您已詳讀並完全理解我們的非獨立投資研究提示和風險提示資訊，相關詳情請點擊 這裡查看。
