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
免责声明: XM Group仅提供在线交易平台的执行服务和访问权限，并允许个人查看和/或使用网站或网站所提供的内容，但无意进行任何更改或扩展，也不会更改或扩展其服务和访问权限。所有访问和使用权限，将受下列条款与条例约束：(i) 条款与条例；(ii) 风险提示；以及(iii) 完整免责声明。请注意，网站所提供的所有讯息，仅限一般资讯用途。此外，XM所有在线交易平台的内容并不构成，也不能被用于任何未经授权的金融市场交易邀约和/或邀请。金融市场交易对于您的投资资本含有重大风险。
所有在线交易平台所发布的资料，仅适用于教育/资讯类用途，不包含也不应被视为用于金融、投资税或交易相关咨询和建议，或是交易价格纪录，或是任何金融商品或非应邀途径的金融相关优惠的交易邀约或邀请。
本网站上由XM和第三方供应商所提供的所有内容，包括意见、新闻、研究、分析、价格、其他资讯和第三方网站链接，皆保持不变，并作为一般市场评论所提供，而非投资性建议。所有在线交易平台所发布的资料，仅适用于教育/资讯类用途，不包含也不应被视为适用于金融、投资税或交易相关咨询和建议，或是交易价格纪录，或是任何金融商品或非应邀途径的金融相关优惠的交易邀约或邀请。请确保您已阅读并完全理解，XM非独立投资研究提示和风险提示相关资讯，更多详情请点击 这里。
