Peptide peddlers cheer as RFK Jr. unilaterally grants access, overruling FDA

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.

反疫苗卫生部长小罗伯特·F·肯尼迪（Robert F. Kennedy Jr.）单方面通过了一项规定，允许专业药房销售六种特定的肽类药物，此举推翻了美国食品药品监督管理局（FDA）科学家的意见。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，许多著名的MAHA人物和肯尼迪的盟友都在销售这些产品。

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.

肯尼迪表示他自己也在使用其中一些肽类药物，并称自己是该产品的“忠实粉丝”。但FDA的科学家们坚持认为，目前没有足够的证据证明这些药物有效，且它们具有潜在的危险性。2023年，出于安全考虑，FDA将这六种肽类药物从专业药房（即配制药房）可生产的药物清单中移除。配制药房通常为患者定制药物配方，或在此类情况下批量生产特殊药物。

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.

肯尼迪的新规定绕过了正式撤销FDA上述行动的程序。该规定名为《关于使用特定肽类原料药进行503A配制的执法自由裁量权政策》，已于周三在《联邦公报》上发布，最终发布日期定于10月30日。该规定并未改变这些肽类药物的监管地位；相反，它声明美国卫生与公众服务部（HHS）将不再对生产这些肽类药物的配制药房采取执法行动，这实际上为它们自由生产和销售这些药物开了绿灯。

Along with the notice in the Federal Register, HHS also posted a more detailed explanation of the policy today that includes more of Kennedy’s rationale for easing enforcement of the six select peptides, which are: BPC-157, Epitalon, KPV, MOTS-c, Semax, and TB-500. One reason cited for all the peptides was that an FDA advisory panel voted in July to add these six peptides back to the list of drugs compound pharmacies can make. However, prior to the vote, Kennedy stacked that 12-member committee with eight new members. At least six of Kennedy’s additions have ties to peptide-related businesses and clinics, raising serious conflict-of-interest concerns.

除了《联邦公报》上的通知外，HHS今天还发布了该政策的详细解释，其中包含了肯尼迪放宽对这六种特定肽类药物（BPC-157、Epitalon、KPV、MOTS-c、Semax和TB-500）执法力度的更多理由。所引用的理由之一是，FDA的一个咨询小组在7月份投票决定将这六种肽类药物重新加入配制药房可生产的药物清单中。然而，在投票前，肯尼迪向该12人委员会安插了8名新成员。肯尼迪任命的成员中至少有6人与肽类相关企业和诊所有关联，这引发了严重的利益冲突担忧。

Peptide sellers online were quick to celebrate the news. Brigham Buhler, who sells peptides in a wellness clinic he runs, cheered the news on X, thanking Kennedy, President Trump, Calley Means, and Joe Rogan. “Medical freedom just took a major step forward!” he wrote. Zachary Shurtleff, a marketing executive for a wellness-focused compounding pharmacy, also celebrated, writing, ” Peptides are BACK like they never shoulda left!”

在线肽类销售商迅速庆祝了这一消息。在自己经营的健康诊所销售肽类药物的布里格姆·布勒（Brigham Buhler）在X平台上欢呼这一消息，并感谢了肯尼迪、特朗普总统、卡利·米恩斯（Calley Means）和乔·罗根（Joe Rogan）。他写道：“医疗自由向前迈出了一大步！”一家专注于健康的配制药房的营销主管扎卡里·舒特勒夫（Zachary Shurtleff）也表示庆祝，写道：“肽类药物回归了，就像它们本就不该离开一样！”

Critics have pushed back, noting that there are already reports of harms from peptides. In a statement released Tuesday, before the new rule was released, the Center for Science in the Public Interest laid out several reasons why making unproven peptides more accessible is dangerous. For one, reports of harms will “continue to mount,” CSPI said. And if any of the peptides actually showed promise of efficacy, reputable pharmaceutical companies will have less incentive to follow up with thorough clinical trials if the peptide is already widely available.

批评人士对此进行了反驳，指出已经有关于肽类药物造成伤害的报告。在周二新规定发布前，公共利益科学中心（CSPI）发表声明，列举了为何让未经证实的肽类药物更容易获得是危险的。CSPI表示，首先，伤害报告将“持续增加”。此外，如果某种肽类药物确实显示出疗效前景，但由于该药物已经广泛流通，信誉良好的制药公司将缺乏动力去进行后续的彻底临床试验。