马修·佩罗内 华盛顿 — 美国卫生官员正在推进一项计划，允许特种药房生产某些肽类物质，这是一类基本未受监管的注射剂，已成为卫生部长罗伯特·F·肯尼迪 Jr. 及其他健康影响者追随者的热门选择。
MATTHEW PERRONE WASHINGTON — U.S. health officials are moving ahead with a plan to allow specialty pharmacies to produce certain peptides , a class of largely unregulated injections that have become popular among followers of Health Secretary Robert F. Kennedy Jr. and other wellness influencers.
根据政府网站周四的一则公告，肯尼迪所在的卫生与公众服务部向白宫提交了一份肽类“临时准入政策”以供审查。该计划已送交管理与预算办公室，该办公室负责审查可能产生重大经济影响的联邦规则和法规。卫生与公众服务部官员周四下午未立即回应置评请求。
Kennedy’s Department of Health and Human Services submitted a peptides “interim access policy” to the White House for review, according to a posting Thursday on a government website. The plan was sent to the Office of Management and Budget, which reviews federal rules and regulations with the potential for significant economic impact. HHS officials did not immediately respond to requests for comment Thursday afternoon.
肽是更复杂蛋白质的构建块，能够触发体内对生长、新陈代谢和愈合所需的激素。药企已将多种肽推向市场作为药物，包括糖尿病和减肥的常规治疗药物。
Peptides are the building blocks of more complex proteins, triggering hormones inside the body needed for growth, metabolism and healing. Drug companies have brought several to market as medications, including mainstay treatments for diabetes and weight loss .
但此处涉及的肽尚未经过那样严格的审查程序。尽管如此，它们在美国对增肌、显得更年轻或提升能量感兴趣的人群中已站住脚跟。这些用途未获食品药品监督管理局批准，且肽的大部分数据来源于动物研究。
But the ones at issue here haven’t gone through that rigorous vetting process. Nevertheless, they have gained a foothold among Americans interested in bulking up, looking younger or boosting energy. Those uses are not approved by the Food and Drug Administration and most of the data on peptides comes from animal studies.
在加入政府之前，肯尼迪公开宣称，“FDA 对肽及其他健康产品的战争”很快就会结束。
Before joining the administration, Kennedy publicly declared that “FDA’s war” on peptides and other wellness products would soon end.
成为卫生部长后，肯尼迪表示，美国的调剂药房必须被允许销售肽，因为越来越多的美国人正转向在中国和其他国家生产的“灰色市场”肽。这些产品仍可通过抖音等在线平台广泛购买。
After becoming health secretary, Kennedy said U.S. compounding pharmacies must be allowed to sell peptides because Americans were increasingly turning to “gray market” peptides made in China and other countries. Those products remain widely available for purchase via online platforms like TikTok.
白宫提交的文件未提供新政策的具体细节，但两位熟悉该计划的人士表示，该政策旨在允许药房临时调配一些最受欢迎的肽类物质，包括BPC-157，这种化学物质被宣传用于增肌和愈合伤口。这两人要求匿名，以便讨论保密的政府内部 deliberations。
The White House filing doesn’t give specifics of the new policy, but two people familiar with the plan say it is intended to allow pharmacies to temporarily compound some of the most popular peptides, including BPC-157, a chemical promoted to build muscle and heal injuries. The people spoke on condition of anonymity to discuss confidential government deliberations.
此次更新是肯尼迪及其他特朗普政府官员试图放宽对“让美国再次健康”运动中流行的未经证实产品获取途径的最新迹象。该运动的一些主要人物正在销售肽类注射剂和补充剂。
The update is the latest indication that Kennedy and other Trump administration officials are looking to ease access to unproven products that are popular within the Make America Healthy Again movement. Some of the biggest MAHA figures sell peptide injections and supplements.
此前，FDA曾将BPC-157及十几种其他可注射肽列入其认为药房调配风险过高的物质名单。根据FDA的说法，潜在风险包括污染、过敏反应和肿瘤生长。
The FDA previously placed BPC-157 and more than a dozen other injectable peptides on its list of substances that are too risky to be compounded by pharmacies. Possible risks include contamination, allergic reactions and tumor growth, according to the FDA.
但今年早些时候，肯尼迪指示该机构重新考虑一份由健康博主和健身名人广泛推广的化学品简短名单。
But earlier this year, Kennedy directed the agency to reconsider a short list of chemicals that have been widely promoted by wellness influencers and fitness celebrities.
7月份，FDA的外部顾问小组建议该机构取消对他们审议的七种肽中的六种的限制。这一建议与FDA员工科学家的科学结论相悖，后者重申称，这些肽均未经过足够研究以确立其安全性和有效性。
In July, a panel of external FDA advisers recommended the agency drop its restrictions on six of the seven peptides put before them. That recommendation went against the scientific conclusion of FDA’s staff scientists, who reiterated that none of the peptides had been studied enough to establish their safety and effectiveness.
根据熟悉该计划的人士所述，送至白宫的新政策基本上可以向调配药房——即专门调配传统药厂无法提供的定制药物的特殊企业——保证，他们不会因生产某些肽而成为监管重点。这种做法被称为执行自由裁量权，使FDA能够有选择性地决定不执行其自身的一些法规。
The new policy sent to the White House would essentially assure compounding pharmacies — specialty businesses that mix customized medications that aren’t available from traditional drugmakers — that they won’t be targeted for producing certain peptides, according to the people familiar with the plan. That approach, known as enforcement discretion, allows the FDA to selectively choose to not enforce some of its own regulations.
正式将肽类药物加入FDA可用于配伍的安全药物清单需要进行联邦规章制定，这一过程可能需要数年时间，并涉及多轮公众意见征求。目前尚不清楚政府是否仍计划推进该过程。
Formally adding the peptides to FDA’s list of drugs that are safe for compounding would require federal rulemaking, a process that could take years and involves multiple rounds of public comment. It was not immediately clear if the administration still plans to pursue that process.
该提议在网上迅速得到一些肯尼迪盟友的赞誉，这些盟友正在销售肽类药物。
The proposal was quickly praised online by some Kennedy allies who sell peptides.
“这是件大事，”通过在线服务销售肽类药物的健康诊所运营商布里格姆·布赫勒在X上发文称。“这不是关于你是否支持或反对肽类药物的问题。而是关于你是否支持或反对医疗自由。”7月份召开的外部专家小组由肯尼迪的卫生部门选出，成员包括若干在肽类领域工作的医生、药剂师和顾问。
“This is huge,” Brigham Buhler, a wellness clinic operator who sells peptides through an online service, posted on X. “This isn’t about whether you’re for or against peptides. It’s about whether you’re for or against MEDICAL FREEDOM.”The panel of outside experts that met in July was selected by Kennedy’s health department and included several doctors, pharmacists and consultants who work in the peptide field.
肽类业务已经引起主要远程医疗提供商的关注，包括Hims & Hers和Noom。两家公司最近宣布，如果联邦政府放宽准入，它们计划向客户提供肽类药物。华尔街分析师估计，该市场规模可能达到20亿至30亿美元。
The peptide business has caught the attention of major telehealth providers, including Hims & Hers and Noom. Both companies recently announced plans to offer peptides to their customers if the federal government eases access. Wall Street analysts estimate the market could be worth $2 billion to $3 billion.