FDA scientists opposed the Trump administration’s move to ease peptides access

A plan to give people in the United States easier access to unproven peptide drugs favored by Health Secretary Robert F. Kennedy Jr. was opposed by most Food and Drug Administration scientific staff members, who had limited input in drafting the policy, according to six people familiar with its development.

The document posted online Wednesday by Kennedy’s Department of Health and Human Services covers a handful of injectable peptides promoted within the wellness industry for building muscle, healing injuries and boosting energy.

The effort on peptides, driven almost entirely by HHS, faced overwhelming pushback among FDA drug staffers who warned it could undermine the agency’s long-standing mission of keeping unproven health products off the U.S. market, according to the people familiar with its development.

The people spoke to The Associated Press on the condition of anonymity to discuss confidential government deliberations. An HHS spokesperson did not immediately respond to a request for comment.

The policy directs the FDA not to take action against specialty pharmacies that sell a half-dozen wellness peptides, including BPC-157, TB-500 and KPV. Under FDA rules, those chemicals would otherwise be considered illegal drugs because they have not gone through the agency’s rigorous review process for safety and effectiveness.

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Some peptides occur naturally in the human body, where they trigger hormones needed for growth, metabolism and healing. Drug companies have brought several to market as medications, including mainstay treatments for diabetes and weight loss . But the chemicals subject to the new policy haven’t been approved as safe and effective by the FDA.

Kennedy has called himself a “big fan” of peptides and recently described using BPC-157 to treat a muscle injury.

The new document represents a step back from HHS’ original plans, according to two of the people who discussed its development.

HHS officials initially wanted the FDA to draft an official regulation that would add BPC-157 and other peptides to a list of drug substances deemed safe for use by compounding pharmacies, specialty businesses that make customized medications.

FDA officials warned that the agency’s scientific staffers had major safety concerns and would not support a regulation deeming them safe. HHS officials moved to a different approach that directs the FDA not to enforce its rules against pharmacies that compound the substances.

FDA staffers ultimately provided technical assistance in drafting the HHS plan, including guardrails intended to improve safety, such as requiring pharmacies to use peptide ingredients from FDA-registered factories.

Kennedy has said that U.S. compounding pharmacies must be allowed to sell peptides because Americans are turning to “gray market” products imported from China and other countries.

Decisions about regulating peptides and compounding pharmacies have almost always come from the FDA, which has an office dedicated to protecting U.S. consumers from unsafe or poor-quality compounded drugs.

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The issue of compounding safety became a greater focus for the FDA after a deadly outbreak of fungal meningitis in 2012 was linked to contaminated injections from a Massachusetts compounding pharmacy. Once a niche business, compounding has grown into a multibillion-dollar industry, providing customized medications to doctors, clinics and hospitals.

It’s extremely rare for HHS to take the lead in drafting policies over the compounding industry, former FDA officials said. However, federal law technically gives HHS authority over essentially all drug regulations, which are then delegated to the FDA.

Many in the U.S. who are using peptides today do not deal with a doctor or a pharmacy to get the injections, but often order vials online sold by chemical manufacturers based in China. Peptide sellers often try to skirt U.S. regulations by labeling their products as “for research use only” because the FDA does not regulate research chemicals.

In 2023, the FDA added more than a dozen peptides , including BPC-157 and TB-500, to its list of substances that should not be compounded due to risks of allergic reactions, kidney damage and tumor growth.

At a meeting in July , FDA staffers reiterated that more than half a dozen peptides brought forward for reconsideration remained unproven in terms of safety and effectiveness.

The new policy from HHS avoids a direct confrontation with FDA staffers because it only directs the FDA not to enforce certain rules.

HHS ultimately included several safety measures suggested by FDA staffers, according to two of the people. Besides sourcing ingredients from FDA-registered facilities, compounders will be directed to collect information on side effects for safety analysis and verify the chemical identity of peptides.

据六位知情人士透露，卫生部长小罗伯特·F·肯尼迪支持的一项旨在让美国民众更容易获得未经证实的肽类药物的计划，遭到了美国食品药品监督管理局大多数科学工作人员的反对，他们在政策制定过程中几乎没有发言权。

肯尼迪卫生与公众服务部周三在网上发布的这份文件涵盖了健康产业推广的几种注射用肽，这些肽可以增强肌肉、治疗伤口和提高能量。

据知情人士透露，这项几乎完全由美国卫生与公众服务部 (HHS) 推动的肽类药物研发工作，遭到了美国食品药品监督管理局 (FDA) 药物工作人员的强烈反对，他们警告说，这可能会破坏该机构长期以来将未经证实的健康产品排除在美国市场之外的使命。

这些人士在匿名的情况下向美联社透露了有关政府机密讨论的内容。美国卫生与公众服务部发言人尚未对此置评。

该政策指示FDA不对销售六种保健肽（包括BPC-157、TB-500和KPV）的专科药房采取行动。根据FDA的规定，这些化学物质原本会被视为非法药物，因为它们尚未经过该机构严格的安全性和有效性审查程序。

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人们说这些肽类药物对他们有害。在MAHA推动医疗自由的运动中，他们的声音被掩盖了。

某些肽类物质天然存在于人体内，它们能够触发人体生长、新陈代谢和伤口愈合所需的激素分泌。制药公司已将其中一些肽类物质作为药物推向市场，包括治疗糖尿病和减肥的主要药物。但此次新政策所涉及的化学物质尚未获得美国食品药品监督管理局（FDA）的批准，证明其安全有效。

肯尼迪称自己是肽的“忠实粉丝”，最近还描述了使用 BPC-157 治疗肌肉损伤的情况。

据两位参与文件制定过程的人士透露，这份新文件代表着美国卫生与公众服务部最初计划的倒退。

美国卫生与公众服务部官员最初希望美国食品药品监督管理局起草一项正式法规，将 BPC-157 和其他肽类药物添加到配制药房（专门生产定制药物的企业）认为安全使用的药物成分清单中。

美国食品药品监督管理局（FDA）官员警告称，该机构的科研人员对药物的安全存在重大担忧，不会支持任何认定这些药物安全的法规。美国卫生与公众服务部（HHS）官员则采取了不同的做法，指示FDA不对配制这些药物的药房强制执行相关规定。

FDA 工作人员最终为 HHS 计划的制定提供了技术援助，其中包括旨在提高安全性的保障措施，例如要求药房使用来自 FDA 注册工厂的肽成分。

肯尼迪曾表示，必须允许美国配制药房销售肽类药物，因为美国人正在转向从中国和其他国家进口的“灰色市场”产品。

关于肽类药物和配制药房的监管决定几乎总是来自美国食品药品监督管理局 (FDA)，该局设有专门的办公室来保护美国消费者免受不安全或劣质配制药的侵害。

安德鲁·凯利/路透社/档案照片

FDA顾问支持放宽对六种肽类药物的限制。以下是这些药物的名称以及后续进展。

2012年，马萨诸塞州一家配药药房的注射剂被污染，导致致命的真菌性脑膜炎疫情爆发，此后，配药安全问题引起了美国食品药品监督管理局（FDA）的更多关注。配药曾经是一个小众行业，如今已发展成为一个价值数十亿美元的产业，为医生、诊所和医院提供定制药物。

前FDA官员表示，美国卫生与公众服务部（HHS）主导制定药品配制行业政策的情况极其罕见。然而，联邦法律实际上赋予HHS几乎所有药品监管的权力，这些权力随后又被下放给FDA。

如今，许多美国肽类药物使用者并不通过医生或药房获取注射剂，而是经常从中国化学品生产商处在线订购药瓶。由于美国食品药品监督管理局（FDA）不监管研究用化学品，肽类药物销售商常常通过将产品标注为“仅供研究使用”来规避美国监管。

2023 年，FDA 将十几种肽类物质（包括 BPC-157 和 TB-500）添加到其不应配制的物质清单中，因为这些物质存在引起过敏反应、肾脏损伤和肿瘤生长的风险。

在 7 月份的一次会议上，FDA 工作人员重申，提交重新考虑的六种以上肽类物质在安全性和有效性方面仍未得到证实。

美国卫生与公众服务部的新政策避免了与美国食品药品监督管理局工作人员的直接对抗，因为它只是指示美国食品药品监督管理局不要执行某些规定。

据两位知情人士透露，美国卫生与公众服务部最终采纳了美国食品药品监督管理局（FDA）工作人员提出的几项安全措施。除了要求原料必须来自FDA注册的机构外，配药人员还将被要求收集副作用信息以进行安全分析，并验证肽的化学成分。