Ozempic(司美格鲁肽)

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速递|美国国会议员呼吁FDA:打击司美格鲁肽等GLP-1仿制减重药泛滥!
GLP1减重宝典· 2025-07-26 05:08
Core Viewpoint - A bipartisan group of over 80 U.S. lawmakers is urging the FDA to enhance regulation of the growing market for counterfeit and illegal weight loss drugs, citing rising safety concerns [2][4]. Group 1: Legislative Actions - Lawmakers have sent a letter to the FDA, expressing concern over the surge of illegal and counterfeit anti-obesity medications, particularly generics of GLP-1 drugs like Wegovy and Zepbound [2]. - The initiative is led by Representatives Richard Hudson and Herb Conaway, who are calling for stricter enforcement against illegal weight loss drugs, including monitoring of online retailers and compounding pharmacies [2][4]. - They have requested a written response from the FDA by July 30 to reflect the urgency of the issue [4]. Group 2: FDA's Response and Actions - An FDA spokesperson stated that the agency will work with the HHS to provide a comprehensive response to the lawmakers' concerns, emphasizing the importance of ensuring the safety of the U.S. drug supply [5]. - The FDA has acknowledged the rise of counterfeit GLP-1 drugs in the market and has previously allowed some pharmacies to compound these medications during supply shortages, but this permission has since been revoked as production capacity has increased [5][6]. Group 3: Market Concerns and Risks - Counterfeit drugs are often produced by unlicensed entities using illegally imported ingredients, posing significant health risks to patients [6]. - Some patients are resorting to purchasing raw materials online to compound their medications at home, which is highly risky [6]. - The FDA has confirmed that some hospitalizations may be linked to these counterfeit drugs, although adverse reactions may be underreported [6]. Group 4: Industry Response - Companies like Novo Nordisk and Eli Lilly have been urging consumers not to use compounded or counterfeit GLP-1 products and have taken legal action against telehealth companies providing these products [6]. - There is increasing pressure on federal regulators to balance the rising demand for GLP-1 drugs with the proliferation of counterfeit products, which is becoming a critical challenge for the FDA [7].