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].