Eli Lilly Joins FDA Lawsuit Over Compounded Obesity Drugs, Seeks 'Swift End' And 'To Protect Its Interests'
Eli Lilly Joins FDA Lawsuit Over Compounded Obesity Drugs, Seeks 'Swift End' And 'To Protect Its Interests'
The U.S. health regulator reminded compounders of the legal restrictions on making copies of FDA-approved drugs.As expected by many, Eli Lilly And Co (NYSE:LLY) filed a motion to intervene as a defendant in a case between the Outsourcing Facilities Association and FarmaKeio Custom Compounding against the FDA.
正如许多人所预期，礼来（纽交所：LLY）申请干预，作为外包设施协会与FarmaKeio定制配方公司对抗FDA的案件中的被告。
The court has now ordered the Outsourcing Facilities Association to respond by January 15, with Eli Lilly's reply due by January 21.
法院现在已命令外包设施协会在1月15日前回应，礼来的回复需在1月21日前提交。
What happened: In early October, the FDA determined that Eli Lilly's tirzepatide injection shortage had been resolved.
发生了什么：在十月初，FDA确定礼来的替代品注射剂短缺问题已解决。
The U.S. health regulator reminded compounders of the legal restrictions on making copies of FDA-approved drugs.
美国卫生监管机构提醒复合药剂师有关复制FDA批准药物的法律限制。
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另见：有报告称，美国雇主的健康成本将在2025年因减肥而上升。
Tirzepatide injection, branded as Mounjaro and Zepbound, has been in shortage since 2022 due to increased demand, allowing compounding pharmacies and outsourcing facilities to produce the drug and meet patient demand.
替代品注射剂，品牌为Mounjaro和Zepbound，自2022年以来因需求增加而短缺，这使得复合药房和外包设施能够生产该药物以满足患者需求。
The compounding groups filed a complaint in October 2024 alleging that removing the drug from the shortage list is based solely on the manufacturer's production capabilities.
复合药物集团在2024年10月提交投诉，指控将该药物从短缺名单中移除仅仅基于制造商的生产能力。
Critics argued that this move disregards evidence of continued supply disruptions. While the FDA acknowledged ongoing "intermittent localized supply disruptions," the agency proceeded with its decision, which was described as arbitrary and violated established procedures.
批评者指出，这一举动无视了持续供应中断的证据。尽管FDA承认持续存在“间歇性局部供应中断”，但该机构仍然推进其决定，称其为任意，违反了既定程序。
Later in October, the FDA said it was reassessing its decision to ban compounding pharmacies from supplying cheaper versions of Eli Lilly's weight loss and diabetes drugs.
在10月晚些时候，FDA表示正在重新评估禁止复合药房供应礼来的减肥和糖尿病药物的决定。
In December, the FDA reviewed its earlier decision and announced that the shortage had been resolved based on its current analysis.
在12月，FDA重新审查了之前的决定，并宣布根据目前的分析，短缺问题已得到解决。
The agency allowed the pharmacies and outsourcing facilities to compound, distribute, or dispense tirzepatide injections until February 18 and March 19, 2025, respectively.
该机构允许药店和外包设施在2025年2月18日和3月19日之前配制、分发或配发tirzepatide注射剂。
The FDA emphasized that it may still take action against violations unrelated to the shortage.
FDA强调，可能仍会对与短缺无关的违规行为采取行动。
Why It Matters: In a motion filed on New Year, Eli Lilly said it seeks to intervene to protect its interests and help bring this suit to a swift end.
重要性：在新年提交的动议中，礼来表示希望介入以保护其利益，并帮助使此案件迅速结束。
Eli Lilly says, "Plaintiffs seek to reverse FDA's determination that Mounjaro and Zepbound are not in shortage, so Plaintiffs can claim entitlement to continue to mass-selling and (illegally) mass-marketing unapproved (and, all too often, unsafe) copies of Lilly's medicines. The motive for their suit is transparent: in their words, FDA's shortage determination "will . . . cause [them] to fail to capitalize on their investment" and "destroy their revenues."
礼来说："原告寻求推翻FDA关于Mounjaro和Zepbound不处于短缺状态的裁定，以便原告能够声称有权继续进行大规模销售和（非法）大规模营销未获批准（且常常不安全）版本的礼来药物。他们提起诉讼的动机显而易见：用他们的话说，FDA的短缺裁定"将……导致[他们]无法利用他们的投资"并且"破坏他们的收入。"
The filing highlights Lilly's "direct, substantial, legally protectable interest in the proceedings" as it has invested over $23 billion to increase its manufacturing capacity.
该文件强调了礼来的“直接、实质性、可合法保护的诉讼利益”，因为其已投资超过230亿来增加制造能力。
Price Action: At last check on Friday, LLY stock was down 0.01% at $778 during the premarket session.
价格走势：在周五最后一次检查时，LLY股票在盘前交易中下跌了0.01%，报778美元。
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Image by Mohammed_Al_Ali via Shutterstock
图片来自Shutterstock的Mohammed_Al_Ali。