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.
上週，FDA確定了禮來公司(NYSE:LLY)開發的替塞帕肽注射劑的短缺問題已得到解決，該藥是一種類胰高血糖素樣肽-1(GLP-1)藥物。
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.
美國衛生監管機構提醒複方製劑師不要製作FDA批准藥物的複製品而受到法律限制。這一更新引起了醫療專業人員、患者和藥物混合製劑廠的關注。
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，曾因生產不足而短缺的蒂澤帕肽注射劑，商標爲Mounjaro和Zepbound，現已得以生產，使混合製劑藥房和外包設施能夠生產該藥以滿足患者需求。
Also Read: Regeneron Chief Flags Health Risks with Popular Weight-Loss Medications Like Ozempic, Says Company Targets Muscle Preservation For Its Obesity Drugs.
此外閱讀: Regeneron首席指出奧澤帕等受歡迎減肥藥物存在健康風險，並表示公司以肌肉保留作爲肥胖藥物的目標。
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.
複方製劑團體外包設施協會和FarmaKeio定製復配提交投訴稱，將該藥從短缺清單中移除完全基於製造商的生產能力。
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未經事先通知或公開磋商即決定撤回該藥物的做法遭到批評，認爲這將剝奪患者的基本護理，可能會推高藥物價格，並偏袒特殊利益。
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.
藥物復配是根據《聯邦食品、藥品和化妝品法案(FDCA)》的合法程序，允許爲患者提供定製治療，特別是在藥物短缺時。
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.
批評人士認爲這一舉措忽視了持續供應中斷的證據。雖然FDA承認存在「間歇性局部供應中斷」，但機構仍繼續實施其決定，這被描述爲武斷行爲並違背了既定的程序。
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.
食品藥品管理局未遵守《行政程序法》(APA)的失誤也引起了關注。 APA要求各機構在實施影響法定權利和義務的實質規則時，提供通知、徵求意見並透明地解決關切。
In this instance, the FDA bypassed these steps, posting the decision on its website without a proper public rulemaking process.
在這種情況下，食品藥品管理局繞過這些步驟，在其網站上發佈決定，而未經適當的公開規則制定過程。
Truist's consumer survey reveals that approximately 10% of consumers currently use compounded GLP-1 medications, while 14% are on branded versions.
特易財富的消費者調查顯示，約有10%的消費者目前使用複方GLP-1藥物，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.
混合藥物供應商Hims＆Hers Health Inc（紐約證券交易所：HIMS）聲稱，即使供應短缺緩解後，對其減肥服務的需求仍可能保持強勁，只要公司遵守混合規定並尊重品牌藥專利。
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譯文內容由第三人軟體翻譯。