RFK Jr. proposes FDA look the other way on unproven peptides, report says

Under Health Secretary Robert F. Kennedy Jr., the Food and Drug Administration is moving forward with plans to ease access to unproven peptide drugs that are popular among members of Kennedy’s Make America Healthy Again movement—despite FDA staff scientists finding that the drugs have not been sufficiently studied to establish safety and efficacy and may cause harms.

在卫生部长小罗伯特·F·肯尼迪（Robert F. Kennedy Jr.）的领导下，美国食品药品监督管理局（FDA）正计划放宽对未经证实的多肽药物的获取限制。尽管FDA的科学家们认为这些药物尚未经过充分研究以确定其安全性和有效性，且可能造成伤害，但这些药物在肯尼迪的“让美国再次健康”（Make America Healthy Again）运动成员中颇受欢迎。

The FDA submitted an “Interim Access Policy” on peptides for review by the White House, according to a filing notice posted on an Office of Management and Budget website. The posting does not provide information on the proposed policy. But people familiar with the proposal told The Associated Press that it would give the FDA “enforcement discretion” on certain peptide drugs.

根据管理和预算办公室网站上发布的一份备案通知，FDA已向白宫提交了一份关于多肽药物的“临时获取政策”以供审查。该公告并未提供有关拟议政策的具体信息。但熟悉该提案的人士告诉美联社，该政策将赋予FDA对某些多肽药物的“执法自由裁量权”。

This would allow the agency to choose not to enforce current restrictions on peptides and provide an assurance to specialty pharmacies eager to start making them that they will not be targeted by the agency. The Department of Health and Human Services, which oversees the FDA, did not respond to a request for comment from Ars Technica.

这将允许该机构选择不对现有的多肽药物限制进行执法，并向急于开始生产这些药物的专业药房提供保证，即它们不会成为该机构的目标。负责监管FDA的美国卫生与公众服务部没有回应Ars Technica的置评请求。

The proposal comes as the FDA is currently re-reviewing a dozen popular, but unproven, injectable peptide drugs. In 2023, FDA scientists determined that the peptides lacked data on safety and efficacy and posed risks. As such, they were stricken from a list of drugs that can be made by specialty pharmacies, called compounding pharmacies, which make customized formulas for drugs.

该提案出台之际，FDA目前正在重新审查十几种流行但未经证实的注射用多肽药物。2023年，FDA科学家认定这些多肽药物缺乏安全性和有效性数据，并存在风险。因此，它们被从专业药房（即配制药房，负责制作定制药物配方）可生产的药物清单中剔除。

“Charlatans” Still, the dodgy drugs have grown more popular, with sellers claiming, without evidence, that the drugs can improve appearance, boost energy, and help heal injuries, among other wellness claims. They’re especially popular among the MAHA crowd; many prominent MAHA figures sell peptide products, and Kennedy, a self-proclaimed “big fan” of peptides, vowed to end “FDA’s war” on peptides upon taking office.

“江湖骗子”尽管如此，这些可疑药物却越来越受欢迎。销售商在没有证据的情况下声称，这些药物可以改善外观、增强能量、帮助愈合损伤，以及其他健康功效。它们在“让美国再次健康”（MAHA）群体中尤其受欢迎；许多知名的MAHA人物都在销售多肽产品，而自称是多肽“超级粉丝”的肯尼迪则誓言在上任后结束FDA对多肽的“战争”。

In April, the FDA announced that it would reconsider 12 unproven peptides. In June, Kennedy appointed nine new members to a 13-member FDA advisory panel that would review the peptides. Of the new members, at least six have ties to peptide-related businesses and clinics, raising significant conflict-of-interest concerns.

今年4月，FDA宣布将重新考虑12种未经证实的多肽药物。6月，肯尼迪任命了9名新成员加入一个由13人组成的FDA咨询小组，负责审查这些多肽药物。在新成员中，至少有6人与多肽相关的企业和诊所有关联，这引发了严重的利益冲突担忧。

In a July meeting, the panel voted to recommend adding six of the first seven peptides considered back to the list of drugs compounding pharmacies can make. The recommendations overruled FDA staff scientists who maintained that the drugs still lack data on safety and efficacy and posed risks. It’s unclear if the FDA will follow through with the recommendation.

在7月的一次会议上，该小组投票建议将最初审查的7种多肽中的6种重新加入配制药房可生产的药物清单中。这些建议推翻了FDA科学家的意见，后者坚持认为这些药物仍然缺乏安全性和有效性数据，并存在风险。目前尚不清楚FDA是否会采纳这一建议。

The AP notes that formally adding the peptides back to the compounding list involves a federal rulemaking process that could take years and require multiple rounds of public comment. The new proposed enforcement discretion could ease access in lieu of that rulemaking or provide access during the process.

美联社指出，正式将这些多肽重新加入配制清单涉及联邦规则制定程序，该程序可能需要数年时间，并需要多轮公众意见征询。新提议的执法自由裁量权可能会在规则制定之前放宽获取限制，或在程序进行期间提供获取途径。

Science-based advocacy group the Center for Science in the Public Interest (CSPI) is among those strongly pushing back on Kennedy’s efforts to support unproven peptides. The group sent a letter to Acting Food and Drug Administration Commissioner Kyle Diamantas this week, urging him to disregard the panel’s recommendations.

以科学为基础的倡导组织“公共利益科学中心”（CSPI）是强烈反对肯尼迪支持未经证实的多肽药物努力的组织之一。该组织本周致信FDA代理局长凯尔·迪亚曼塔斯（Kyle Diamantas），敦促他无视该小组的建议。

“If this conflicted committee’s recommendations stand, charlatans will continue to put unsuspecting consumers at risk of serious injury by making unsupported claims about their [peptides’] purported benefits,” Pete Lurie, CSPI president and a former associate commissioner at the FDA, said in a statement.

CSPI主席、前FDA副局长皮特·卢里（Pete Lurie）在一份声明中表示：“如果这个存在利益冲突的委员会的建议得以维持，江湖骗子们将继续通过对其（多肽）所谓益处做出毫无根据的声明，使毫无戒心的消费者面临严重伤害的风险。”