美国卫生与公众服务部部长小罗伯特·肯尼迪近日发布新规，实质上推翻了食品药品监督管理局此前基于安全性考量对六种特定多肽药物的限制，允许复方药房继续销售这些药物 1。这一政策通过行使执法自由裁量权，声明卫生与公众服务部不再针对生产此类多肽的复方药房采取执法行动，尽管这并未改变多肽本身的监管状态 1。新规则题为《关于使用某些多肽批量药物物质进行503A复配的执法自由裁量政策》，已于周三在《联邦公报》上公开，最终发布日期定于10月30日 1。
回溯至2023年，FDA曾因安全顾虑将这六种多肽从复方药房可制备的药物清单中移除 1。然而，肯尼迪自称是这些多肽的“大粉丝”，并支持旨在迎合其盟友需求的“让美国再次健康”（Make America Health Again）运动，从而促成了此次政策转向 1。
U.S. Health Secretary Robert F. Kennedy Jr. has unilaterally issued a new rule allowing specialty pharmacies to sell six specific peptide drugs, effectively overriding a previous Food and Drug Administration (FDA) ban on these substances due to safety concerns 1. The regulation, titled "Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances," was published in the Federal Register on Wednesday and is scheduled for final release on October 30 1.
Although the FDA had removed these six peptides from the list of compounds available to specialty pharmacies in 2023 citing a lack of effective evidence and potential dangers, the new policy does not alter their regulatory status but instead declares that the Department of Health and Human Services (HHS) will no longer take enforcement action against pharmacies producing them 1. Kennedy, who identified himself as a "big fan" of these peptides, aligned this decision with the needs of the "Make America Health Again" (MAHA) movement supported by him and his allies 1.
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