Peptides could soon be easier to get in the United States. Here’s what to know

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The US Department of Health and Human Services posted a draft policy that would ease restrictions about how certain peptides may be created in the United States, essentially opening up access to them.

Some wellness advocates applauded the move, while others have raised concerns.

Here’s what to know about peptides and what the change could mean.

Peptides are short chains of amino acids and act as the building blocks of proteins in the body. Some are important prescription medicines. Insulin, for example, is a peptide, as are GLP-1 medications widely used to treat diabetes and obesity, such as Ozempic and Wegovy.

But the six injectable peptides that are included in the new draft HHS policy are different. They’re popular among wellness influencers, elite athletes and some doctors, who say they can help reduce inflammation, improve recovery, promote longevity and boost overall health.

But they’re not approved by the US Food and Drug Administration, meaning they have not been evaluated to meet certain safety, quality and effectiveness standards through the FDA approval process . Currently, some consumers get them through an unregulated gray market, without ever consulting a physician — a potentially risky option.

Andrew Kelly/Reuters/File

FDA advisers support easing restrictions on six peptides. Here’s what those drugs are and what happens next

In July, the FDA’s Pharmacy Compounding Advisory Committee narrowly supported opening the door for six peptides to be created by compounding pharmacies:

BPC-157, proposed for treating ulcerative colitis

KPV for wound healing and inflammatory conditions

TB-500 for wound healing

MOTS-c for obesity and osteoporosis

Semax for certain neurological disorders

Epitalon for insomnia

They wouldn’t be approved by the FDA — the agency doesn’t review compounded drugs for safety, effectiveness or quality before they are marketed — but HHS argues that they could still improve safety.

“Secretary Kennedy is acting on that recommendation with a draft interim policy with a 14-day comment period supporting patient-specific compounding in the U.S. under applicable state and federal oversight,” HHS spokesperson Emily Hilliard said in an email Wednesday.

“The policy does not grant FDA approval or establish clinical safety and effectiveness,” Hilliard said. “It requires patient-specific prescriptions, traceable ingredients, quality testing, and safety reporting to hold compounders accountable and give patients an alternative to unregulated sellers.”

Tomohiro Ohsumi/Bloomberg/Getty Images

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“Compounding is generally a practice in which a licensed pharmacist, a licensed physician or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes or alters ingredients of a drug to create a medication tailored to the needs of an individual patient,” the policy said.

So far, people who use peptides have been able to order products like BPC-157 or TB-500 from places like unregulated websites without ever seeing a doctor. With the interim policy, people seeking peptides would need a doctor’s prescription to get them from a licensed compounding pharmacy.

Although the peptides wouldn’t be FDA-approved or even officially on the list of substances that compounders can prepare, “HHS does not intend to take enforcement action against a State-licensed pharmacy, Federal facility, or licensed physician compounding a drug product using” one of the six peptides, the new policy said.

Inside the gray market peptide industry

“The Secretary of HHS has determined that this limited enforcement-discretion policy will discourage the continued, widespread use of certain research-use-only peptides supplied by foreign manufacturers that pose a safety risk to US patients. By allowing limited compounding of the substances addressed in this guidance under appropriate safeguards, the policy provides patients with a more controlled alternative,” the policy said.

The draft policy appears to target the gray market until a separate final rule addresses whether a peptide is or is not included on the list of ingredients that compounding pharmacies may use to prepare customized medications under specific legal conditions.

After the 14-day comment period for the draft policy, HHS is expected to issue that final policy.

“Although compounded drugs can serve an important medical need for certain patients, they also may pose risks to patients,” the draft policy said. “However, based on the Pharmacy Compounding Advisory Committee (PCAC) meeting and data regarding utilization of peptides, HHS believes that there is significant interest in the use of these peptides in compounding.”

When the FDA advisory committee met in July, its members narrowly agreed to support easing restrictions on the six peptides.

Many of the members who voted in favor argued that doing so would lead to a safer pathway through which people could access the drugs.

“Keeping this in a regulated pharmacy is not the risk in the room. The gray market pipeline is, and it operates in the open because we let it,” said committee member Dr. Hal Mohammed, global chief medical officer of Gameday Men’s Health. “Myself as a physician, I have to make sure that I’m keeping patients as safe as possible. That’s my mandate: Do no harm.”

But many of the committee members who voted against making the peptides more accessible through compounding argued that there is a lack of evidence and research to suggest that the approach would stop the gray market, and that there are still some unknowns around the effectiveness and risks of certain peptides.

“I’m concerned that we’re responding to a market-induced demand rather than a decision based in solid science,” said committee member Dr. Elizabeth Rebello, of the University of Texas MD Anderson Cancer Center.

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

Shabbir Imber Safdar, executive director of the public health coalition Partnership for Safe Medicines, said in a statement Wednesday that the draft policy makes it unclear whether peptides are safe or not, “even though the FDA’s own scientists recommended against voting in favor of these substances due to concerns with evidence.”

Last week, the coalition filed a citizen petition urging the FDA to block the compounding of peptides.

“The Administration’s decision comes after a vote from the FDA’s Pharmacy Compounding Advisory Committee in support of compounding six ‘wellness’ peptides. However, overlooked in this vote is that many newly appointed PCAC members appear to have conflicts of interest directly related to the peptide substances under consideration,” Safdar said.

“This outcome shreds any sense of credibility and transparency, placing their interests above the safety of the American people,” Safdar said. “The Administration should change course and focus on prosecuting the bad actors who have been illegally producing and distributing dangerous products to the public.”

The American Peptide Association, which supports the peptide industry, applauded the new draft policy.

“It is much needed clarity that the peptide industry, clinicians and consumers have hoped and worked for for the past couple years and is a bold step outside the usual pharma driven, FDA managed pathway,” Jeff Cohen, co-founder of the association, said in a written statement.

The draft policy is “potentially good news” for people who want to access peptides through a prescription, says Jay Campbell, co-founder of BioLongevity Labs and author of the book “ Optimize Your Health With Therapeutic Peptides .”

“A physician would be able to prescribe compounds like BPC-157, TB-500, and Semax and have a licensed pharmacy fill it without the threat of federal enforcement. But it’s potentially bad news for the millions of people who get their peptides from the direct-to-consumer marketplace today. This policy only covers compounded prescriptions, which will start to carry higher prices,” Campbell, who also uses peptides himself, said in an email Wednesday.

“As demand rises, these peptides could get substantially more expensive, especially if access at the direct-to-consumer level is restricted or cut off. Pharmacies will also have to source from FDA-registered manufacturers and run full quality testing, and those costs get passed on to the patient,” he wrote. “People who have been paying research-market prices should be prepared for a very different bill at the pharmacy counter.”

KFF Health News illustration/Getty Images

People say these peptides hurt them. Their stories are muffled in MAHA’s push for medical freedom

Cohen from the American Peptide Association said there are still unanswered questions for people already using peptides.

“While the recent regulatory pathway being paved for consumers who want to be clinician led is well served by the recent change, the pathway for consumers who do not want to be clinician led remains obscure,” Cohen said. “Those consumers do not receive clinical guidance from clinicians, and their products do not come from compound pharmacies. They come from non pharmacy manufacturers, where the safety and quality can be unregulated and spotty.”

The Alliance for Pharmacy Compounding, the industry’s trade association, said it welcomes HHS’s move.

“We’ve said all along that the question isn’t whether patients are using these peptides. They are. The question is where they’re getting them,” CEO Scott Brunner said in a statement Wednesday. “Right now, far too many patients are obtaining peptides from illicit suppliers with little assurance about what’s actually in the vial. That’s an existing public health threat, and one that isn’t going away simply because compounding of the substances is prohibited.”

Why Peptides Are So Popular | Chasing Life with Dr. Sanjay Gupta | CNN Audio

The alliance noted that the draft policy includes some safeguards it called for , including “extensive testing and documentation, and reporting of serious adverse events and product quality issues.”

But it said it would seek clarification from HHS on issues like how the policy will be coordinated with state boards of pharmacy and when the policy takes effect.

“A credible federal policy with meaningful patient-safety safeguards gives states a sound basis for their own oversight and helps discourage a patchwork of state rules and restrictions that could undermine the access HHS is trying to provide,” Brunner said.

CNN’s Brenda Goodman contributed to this report.

贾尔·丰塞卡/iStockphoto/Getty Images

美国卫生与公众服务部发布了一项政策草案，该草案将放宽对某些肽类物质在美国的生产方式的限制，从根本上开放了对这些物质的获取途径。

一些健康倡导者对这一举措表示赞赏，而另一些人则提出了担忧。

以下是关于肽类以及这种变化可能意味着什么需要了解的内容。

肽是由氨基酸组成的短链，是体内蛋白质的组成单元。有些肽是重要的处方药。例如，胰岛素就是一种肽，GLP-1受体激动剂，如奥美沙坦（Ozempic）和维戈维（Wegovy），也广泛用于治疗糖尿病和肥胖症。

但新版美国卫生与公众服务部政策草案中包含的六种注射用肽类药物有所不同。它们在健康领域的意见领袖、精英运动员和一些医生中很受欢迎，他们认为这些药物可以帮助减轻炎症、促进恢复、延年益寿并提升整体健康水平。

但这些药物并未获得美国食品药品监督管理局（FDA）的批准，这意味着它们未经FDA审批流程评估，无法达到特定的安全、质量和有效性标准。目前，一些消费者通过不受监管的灰色市场购买这些药物，从未咨询过医生——这是一种潜在的风险选择。

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。

今年7月，FDA的药房配制咨询委员会以微弱优势支持允许配制药房生产六种肽类药物：

BPC-157，拟用于治疗溃疡性结肠炎

KPV 用于伤口愈合和炎症性疾病

TB-500 用于伤口愈合

MOTS-c 用于肥胖和骨质疏松症

Semax 用于治疗某些神经系统疾病

Epitalon 用于治疗失眠

它们不会获得 FDA 的批准——该机构在复方药物上市前不会对其安全性、有效性或质量进行审查——但 HHS 认为它们仍然可以提高安全性。

美国卫生与公众服务部发言人艾米丽·希利亚德周三在一封电子邮件中表示：“肯尼迪部长正在根据这一建议采取行动，制定了一项临时政策草案，并给予 14 天的意见征询期，以支持在美国适用的州和联邦监管下进行针对特定患者的配药。”

希利亚德说：“这项政策并不授予FDA批准，也不证明其临床安全性和有效性。它要求处方必须针对特定患者，成分必须可追溯，并进行质量检测和安全报告，以便追究配药者的责任，并为患者提供除不受监管的销售商之外的另一种选择。”

大隅知宏/彭博社/盖蒂图片社

肽类药物领域正处于蓬勃发展的“蛮荒西部”状态。以下内容将揭示其真实面貌、潜在风险以及未来发展趋势。

该政策称：“配药通常是指由一名持证药剂师、一名持证医师，或者在外包机构的情况下，由一名持证药剂师监督的人员，将药物的成分进行组合、混合或改变，以制成适合特定患者需求的药物。”

目前，使用肽类药物的人无需就医即可从一些不受监管的网站订购BPC-157或TB-500等产品。根据这项临时政策，需要肽类药物的人必须持有医生处方才能从获得许可的配药药房购买。

尽管这些肽类物质未经 FDA 批准，甚至没有正式列入配药师可以配制的物质清单，但新政策指出，“卫生与公众服务部不打算对使用这六种肽类物质之一配制药品的州许可药房、联邦机构或持证医生采取执法行动”。

灰色市场肽行业内部

“卫生与公众服务部部长已认定，这项有限的执法自由裁量权政策将遏制某些仅供研究使用的肽类物质的持续广泛使用，这些肽类物质由外国制造商提供，会对美国患者构成安全风险。通过允许在适当的保障措施下对本指南中提及的物质进行有限的配制，该政策为患者提供了一种更可控的替代方案，”该政策指出。

该政策草案似乎旨在打击灰色市场，直到一项单独的最终规则出台，明确肽类药物是否包含在配制药房在特定法律条件下可用于配制定制药物的成分清单中。

在为期 14 天的政策草案公众评议期结束后，美国卫生与公众服务部 (HHS) 预计将发布最终政策。

“虽然复方药物可以满足某些患者的重要医疗需求，但也可能对患者构成风险，”政策草案指出。“然而，根据药房复方咨询委员会 (PCAC) 的会议以及有关肽类药物使用情况的数据，美国卫生与公众服务部 (HHS) 认为，人们对在复方药物中使用这些肽类药物有着浓厚的兴趣。”

7 月份 FDA 咨询委员会开会时，其成员以微弱优势同意支持放宽对这六种肽的限制。

许多投赞成票的成员认为，这样做将为人们提供一条更安全的获取毒品的途径。

“把药放在正规药房里并不是真正的风险所在。真正的风险在于灰色市场渠道，而它之所以能公开运作，正是因为我们放任不管，”委员会成员、Gameday Men's Health全球首席医疗官哈尔·穆罕默德博士说道。“作为一名医生，我必须确保患者的安全。这是我的职责：不伤害患者。”

但许多投票反对通过配制方法使肽更容易获得的委员会成员认为，缺乏证据和研究表明这种方法可以阻止灰色市场，而且某些肽的有效性和风险仍然存在一些未知数。

“我担心我们是在回应市场需求，而不是基于可靠的科学做出决定，”委员会成员、德克萨斯大学MD安德森癌症中心的伊丽莎白·雷贝洛博士说。

FDA科学家反对特朗普政府放宽肽类药物准入限制的举措。

公共卫生联盟“安全药物伙伴关系”的执行主任沙比尔·伊姆伯·萨夫达尔周三在一份声明中表示，该政策草案并未明确说明肽类是否安全，“尽管FDA自己的科学家由于证据方面的担忧，建议不要投票支持这些物质”。

上周，该联盟提交了一份公民请愿书，敦促 FDA 阻止肽的合成。

“政府的这项决定是在FDA药房配制咨询委员会投票支持配制六种‘保健’肽之后做出的。然而，这次投票被忽略的一点是，许多新任命的PCAC成员似乎与正在考虑的肽类物质存在直接的利益冲突，”萨夫达尔说。

萨夫达尔表示：“这一结果彻底摧毁了信誉和透明度，将他们的利益置于美国人民的安全之上。政府应该改变策略，集中精力起诉那些非法生产和向公众分销危险产品的不法分子。”

支持肽产业的美国肽协会对这项新的政策草案表示赞赏。

“这是肽类行业、临床医生和消费者在过去几年里一直希望和努力争取到的非常必要的明确性，也是跳出通常由制药公司驱动、FDA 管理的路径的大胆一步，”该协会联合创始人杰夫·科恩在一份书面声明中表示。

BioLongevity Labs 的联合创始人兼《用治疗性肽优化你的健康》一书的作者 Jay Campbell 表示，该政策草案对于想要通过处方获得肽的人来说“可能是一个好消息”。

“医生可以开具BPC-157、TB-500和Semax等复方制剂，并由有资质的药房配药，而无需担心联邦政府的强制执行。但对于目前从直销市场购买肽类药物的数百万人来说，这可能是个坏消息。这项政策仅涵盖复方处方药，而这类药物的价格将会上涨，”坎贝尔周三在一封电子邮件中写道。他本人也服用肽类药物。

“随着需求增长，这些肽类药物的价格可能会大幅上涨，尤其是在直接面向消费者的渠道受到限制或中断的情况下。药房也必须从FDA注册的生产商处采购，并进行全面的质量检测，而这些成本最终都会转嫁到患者身上，”他写道。“那些一直以来都按市场价购买这些药物的人，应该做好准备，在药房结账时看到截然不同的账单。”

KFF健康新闻插图/Getty Images

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。

美国肽协会的科恩表示，对于已经在使用肽的人来说，仍然存在一些未解之谜。

科恩表示：“虽然近期监管政策的调整为那些希望由临床医生指导的消费者开辟了一条良好的道路，但对于那些不希望由临床医生指导的消费者来说，道路仍然不明朗。这些消费者无法获得临床医生的指导，他们的产品也并非来自配药药房，而是来自非药房生产商，这些产品的安全性和质量可能缺乏监管，参差不齐。”

制药配制联盟（该行业的贸易协会）表示，欢迎美国卫生与公众服务部 (HHS) 的这一举措。

“我们一直强调，问题不在于患者是否在使用这些肽类药物。他们确实在用。问题在于他们从哪里获得这些药物，”首席执行官斯科特·布鲁纳周三在一份声明中表示。“目前，太多患者从非法供应商处获取肽类药物，却无法保证药瓶里究竟装的是什么。这构成了一种公共卫生威胁，而且这种威胁并不会因为禁止配制这些物质而消失。”

肽类药物为何如此受欢迎 | 与桑杰·古普塔博士一起追寻生命 | CNN音频

该联盟指出，该政策草案包含了它所呼吁的一些保障措施，包括“广泛的测试和记录，以及对严重不良事件和产品质量问题的报告”。

但该公司表示，将向美国卫生与公众服务部寻求澄清，以了解该政策将如何与各州药房委员会协调，以及该政策何时生效等问题。

布鲁纳表示：“一项可信的联邦政策，辅以有意义的患者安全保障措施，为各州进行自我监管提供了坚实的基础，并有助于防止出现各州规则和限制的拼凑，从而避免破坏美国卫生与公众服务部 (HHS) 试图提供的医疗服务。”

CNN的布伦达·古德曼对本报道亦有贡献。