美国卫生与公众服务部（HHS）正推动一项政策调整，旨在放宽对部分未经批准的肽类物质的监管限制，允许其通过复方调配方式更广泛地销售和使用123。这一举措由HHS部长小罗伯特·肯尼迪支持，被视为一种行政“捷径”，意在使特定未获批药物更容易获取23。然而，该计划遭到了食品药品监督管理局（FDA）内部科学家的强烈反对，他们认为此举规避了正常的药品审批程序134。
据六名知情人士表示，大多数FDA科学工作人员在起草政策时输入有限并持反对意见4。此次拟放宽限制的涉及六种特定的肽类化合物，其中包括BPC-157和TB-500等物质13。这些注射类肽类药物主要在健身行业推广，宣称具有增肌、伤口愈合及提振能量等功效4。尽管医生群体对于此类物质的安全性和有效性存在观点分歧，但FDA科学界普遍担忧该政策可能带来潜在风险24。
The U.S. Department of Health and Human Services (HHS), led by Secretary Robert F. Kennedy Jr., has advanced a plan to allow the temporary sale and compounding of specific unapproved peptide injections, a move that faces significant internal opposition from scientists at the Food and Drug Administration 123. The policy aims to ease access restrictions on these substances, which include compounds such as BPC-157 and TB-500, permitting them to be prepared through compounding pharmacies rather than undergoing standard regulatory approval processes 1. HHS released the relevant document online on Wednesday, formalizing the effort to broaden the availability of these drugs 4.
Sources indicate that the initiative is supported by Kennedy and is viewed by critics as an administrative shortcut to bypass rigorous safety evaluations 23. The proposal specifically covers six peptides commonly promoted in the fitness industry for purposes including muscle building, wound healing, and energy enhancement 34. According to six individuals with knowledge of the matter, the majority of scientific staff within the FDA opposed the deregulation efforts, noting that their input during the drafting of the policy was limited 4. While HHS proceeds with this regulatory adjustment, the disagreement highlights ongoing tensions between the administration’s push for easier drug access and the scientific community’s concerns regarding the safety and efficacy of these unapproved treatments 12.
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