反疫苗卫生部长小罗伯特·F·肯尼迪单方面通过了一项规则，允许专业药房销售六种特定肽类药物，推翻了食品药品监督管理局（FDA）科学家的决定。
Anti-vaccine Health Secretary Robert F. Kennedy has unilaterally passed a rule that will allow specialty pharmacies to sell six specific peptide drugs, overruling scientists at the Food and Drug Administration.
这些肽类药物在肯尼迪的“让美国再次健康”（MAHA）运动成员中很受欢迎，许多知名MAHA人士和肯尼迪盟友都在销售它们。肯尼迪表示他自己使用其中一些肽类药物，并称自己是“忠实粉丝”。但FDA科学家继续表示，没有足够证据证明它们有效，且可能存在危险。2023年，出于安全担忧，FDA将这六种肽类药物从可由专业药房（称为配制药房）生产的药物清单中移除——配制药房为患者制作定制配方药物，或在此类情况下批量生产特种药物。
The peptides are popular among members of Kennedy's Make America Health Again movement and many prominent MAHA figures and Kennedy allies sell them. Kennedy said he uses some of the peptides and called himself a "big fan." But FDA scientists continue to say there is insufficient evidence to show if they're effective and they are potentially dangerous. In 2023, the safety concerns led the FDA to remove the six peptides from a list of drugs that can be made by specialty pharmacies called compounding pharmacies—which make customized formulations of drugs for patients, or, in cases such as this, specialty drugs in bulk.
肯尼迪的新规则绕过了正式撤销FDA该行动的必要程序。该规则名为“关于使用某些肽类原料药进行503A配制的执法自由裁量权政策”，于周三在联邦公报上发布，最终发布日期定为10月30日。该规则并未改变肽类药物的监管地位；而是规定卫生与公众服务部（HHS）将不再对配制药房生产这些肽类药物采取执法行动，实际上给了它们自由生产和销售的绿灯。肯尼迪本月早些时候曾悄悄提出这项规则。
Kennedy's new rule sidesteps the need to formally undo that FDA action. The rule is titled "Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances" and was made available Wednesday on the Federal, with the final publication data set for October 30. The rule does not change the regulatory status of the peptide; instead, it states the Department of Health and Human Services (HHS) will no longer take enforcement action against compounding pharmacies for making the peptides, essentially giving them a green light to freely produce and sell them. Kennedy had quietly proposed this rule earlier this month.