FDA Sparks Controversy With Sudden Removal Of Eli Lilly's Weight Loss Drug From Shortage List
FDA Sparks Controversy With Sudden Removal Of Eli Lilly's Weight Loss Drug From Shortage List
Last week, the FDA determined the shortage of Eli Lilly And Co's (NYSE:LLY) tirzepatide injection, a glucagon-like peptide 1 (GLP-1) medication, has been resolved.
上周，FDA确定了礼来公司(NYSE:LLY)开发的替塞帕肽注射剂的短缺问题已得到解决，该药是一种类胰高血糖素样肽-1(GLP-1)药物。
The U.S. health regulator reminded compounders of the legal restrictions on making copies of FDA-approved drugs. The update has sparked concern among medical professionals, patients, and drug compounding facilities.
美国卫生监管机构提醒复方制剂师不要制作FDA批准药物的复制品而受到法律限制。这一更新引起了医疗专业人员、患者和药物混合制剂厂的关注。
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.
因2022年需求增加，曾因生产不足而短缺的蒂泽帕肽注射剂，商标为Mounjaro和Zepbound，现已得以生产，使混合制剂药房和外包设施能够生产该药以满足患者需求。
Also Read: Regeneron Chief Flags Health Risks with Popular Weight-Loss Medications Like Ozempic, Says Company Targets Muscle Preservation For Its Obesity Drugs.
此外阅读: Regeneron首席指出奥泽帕等受欢迎减肥药物存在健康风险，并表示公司以肌肉保留作为肥胖药物的目标。
The compounding groups Outsourcing Facilities Association and FarmaKeio Custom Compounding have filed a complaint alleging that removing the drug from the shortage list is based solely on the manufacturer's production capabilities.
复方制剂团体外包设施协会和FarmaKeio定制复配提交投诉称，将该药从短缺清单中移除完全基于制造商的生产能力。
The FDA's decision to withdraw the drug without prior notice or public consultation has been criticized for depriving patients of essential care, potentially driving up drug prices, and favoring special interests.
FDA未经事先通知或公开磋商即决定撤回该药物的做法遭到批评，认为这将剥夺患者的基本护理，可能会推高药物价格，并偏袒特殊利益。
Drug compounding is a legal process under the Federal Food, Drug, and Cosmetic Act (FDCA), allowing tailored treatments for patients, especially when a medication is in short supply.
药物复配是根据《联邦食品、药品和化妆品法案(FDCA)》的合法程序，允许为患者提供定制治疗，特别是在药物短缺时。
Critics argue 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.
批评人士认为这一举措忽视了持续供应中断的证据。虽然FDA承认存在“间歇性局部供应中断”，但机构仍继续实施其决定，这被描述为武断行为并违背了既定的程序。
The FDA's failure to follow the Administrative Procedure Act (APA) has also drawn attention. The APA mandates that agencies provide notice, solicit comments, and address concerns transparently when implementing substantive rules that affect legal rights and duties.
食品药品管理局未遵守《行政程序法》(APA)的失误也引起了关注。 APA要求各机构在实施影响法定权利和义务的实质规则时，提供通知、征求意见并透明地解决关切。
In this instance, the FDA bypassed these steps, posting the decision on its website without a proper public rulemaking process.
在这种情况下，食品药品管理局绕过这些步骤，在其网站上发布决定，而未经适当的公开规则制定过程。
Truist's consumer survey reveals that approximately 10% of consumers currently use compounded GLP-1 medications, while 14% are on branded versions.
Truist的消费者调查显示，约有10%的消费者目前使用混合GLP-1药物，而14%使用品牌版本。
Provider of compounded drugs, Hims & Hers Health Inc (NYSE:HIMS) asserts that demand for its weight loss service could remain strong, even after supply shortages ease, as long as the company operates within compounding regulations and respects branded drug patents.
混合药物供应商Hims＆Hers Health Inc（纽约证券交易所：HIMS）声称，即使供应短缺缓解后，对其减肥服务的需求仍可能保持强劲，只要公司遵守混合规定并尊重品牌药专利。
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