Peptide peddlers cheer as RFK Jr. unilaterally grants access, overruling FDA
摘要
美国卫生部长小罗伯特·肯尼迪单方面通过新规，允许专业药房销售六种特定肽类药物，绕过了FDA科学家的反对。这些肽类药物在肯尼迪的MAHA运动支持者中颇受欢迎，肯尼迪本人也称使用过并自称“粉丝”。FDA科学家坚持认为缺乏足够证据证明其有效性且存在潜在风险，2023年曾因安全担忧将这六种肽类从复合药房可制备药物清单中移除。新规不改变肽类的监管地位，仅表示HHS不再
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.
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.
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 Register, 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.
转载信息
评论 (0)
暂无评论，来留下第一条评论吧