美国食品药品监督管理局(FDA)召开了为期两天的会议,审议七种肽类物质的监管地位1。这些物质在健康和保健倡导者中日益流行,但缺乏安全性和有效性的充分证据1。
卫生部长罗伯特·肯尼迪表示自己是肽类物质的"大粉丝",誓言推翻拜登政府时期对该行业的限制1。然而,FDA的科学家在会议前的评审中表示,他们找不到足够的安全性或有效性数据,并对污染、过敏反应和质量控制风险表示担忧1。所有七种肽类物质的工作人员都建议反对将其用于药房配制1。
咨询小组的组成引发利益冲突担忧,至少包括七名与肽类行业有财务关联的医生或药剂师1。与此同时,FDA收到超过1900条公众评论,其中包括医生和患者关于肽类物质好处的证词1。
The U.S. Food and Drug Administration convened a two-day meeting to evaluate seven peptide substances that have surged in popularity among health and wellness advocates, despite limited evidence of safety and efficacy 1.
Health Secretary Robert F. Kennedy Jr. publicly declared himself a "big fan" of peptides and pledged to overturn restrictions on the industry imposed during the Biden administration 1. However, FDA scientists expressed significant safety concerns ahead of the meeting, stating they could not locate sufficient data to support the substances' safety or effectiveness 1. The agency's researchers flagged risks including contamination, allergic reactions, and quality control failures 1.
The advisory panel included at least seven doctors or pharmacists with financial ties to the peptide industry, raising potential conflicts of interest 1. Despite these concerns, the FDA received over 1,900 public comments, many containing testimony from physicians and patients about the purported benefits of peptides 1.
Staff scientists recommended against permitting all seven peptide substances for use in compounding pharmacies 1.
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