美国卫生与公众服务部（HHS）给予复方药房临时许可，允许其生产六种肽类药物，同时该机构继续推进正式的规则变更程序。该机构周三提交的一份通知称，将行使“执法自由裁量权”，即不对生产这六种未获批肽类药物的复方药房采取法律行动。实际上，这意味着这些药房现在即可开始提供这些药物，尽管这些肽类尚未列入美国食品药品监督管理局（FDA）允许复方药房生产的成分清单。
The Department of Health and Human Services is giving compounding pharmacies a temporary green light to make six peptides while the agency continues to work on a formal rule change. In a notice filed Wednesday, the agency said it would exercise “enforcement discretion,” meaning it will not take legal action against compounding pharmacies that make the six unapproved peptides. In practice, that means these pharmacies can start offering them now, even though the peptides aren’t yet on the Food and Drug Administration’s list of ingredients compounding pharmacies are allowed to make.
这六种肽分别为：BPC-157、依帕他仑、KPV、MOTS-c、semax 和 TB-500。网络上宣称它们可治疗从加速愈合到皮肤返老还竭、延长寿命等各种病症。FDA 尚未批准其中任何一种，该机构自身的科学家也得出结论，认为缺乏足够数据证明其安全有效。FDA 要求复方药房必须证明化合物的身份和纯度，并强制要求报告副作用，此前并无此项强制规定。
The six peptides are BPC-157, epitalon, KPV, MOTS-c, semax and TB-500. They’ve been promoted online as treatments for everything from faster healing to younger-looking skin and a longer lifespan. None are approved by the FDA, and the agency’s own scientists concluded there is insufficient data to prove they are safe and effective. The FDA said compounding pharmacies must certify the identity and purity of the compounds.
此举正值围绕肽类药物的“灰色市场”日益扩大之际，零售商以“仅供科研用途”为标签出售这些产品，利用这一法律漏洞声称其非供人类使用。卫生部长小罗伯特·肯尼迪及其他人士主张，允许肽类药物进行复方配制，将引导民众远离灰色市场，转向更安全的产品。HHS 发言人艾米莉·希利亚德在声明中表示：“在特朗普总统的领导下，HHS 正致力于将预防和患者安全置于医疗保健的核心位置——这包括应对黑市肽类药物的风险。”
They must also now report side effects, which was not previously mandated. The move comes as a growing “gray market” has sprung up around peptides, where retailers sell them labeled “for research use only,” a legal workaround that lets them claim they aren’t meant for humans. Health Secretary Robert F. Kennedy Jr. and others have argued that allowing peptides to be compounded would move people away from this gray market and toward safer products.
前 FDA 官员、现任公共利益科学中心（Center for Science in the Public Interest）负责人彼得·卢里博士表示，FDA 实际上是在“睁一只眼闭一只眼”，以扩大尚未被证明有效的药物的获取渠道。
“Under President Trump’s leadership, HHS is working to put prevention and patient safety at the center of health care—and that includes confronting the risks of black-market peptides,” Emily Hilliard, an HHS spokesperson, said in a statement.
配制药房通常只能使用美国食品药品监督管理局（FDA）已列入官方名单（称为“原料药物质清单”）的成分。将某种成分加入清单需要 FDA 提出规则建议、征求公众意见并发布最终规则，这一过程可能需要数月时间。该机构在 7 月迈出了这一步，当时 FDA 咨询小组以微弱多数投票赞成将六种肽类物质加入原料药清单。
Dr. Peter Lurie, a former FDA official who now leads the Center for Science in the Public Interest watchdog group, said the FDA was essentially “turning a blind eye” to widen access to drugs that have not been proven to work. Compounding pharmacies generally may use only ingredients the FDA has added to an official list known as the bulk drugs substances list. Adding an ingredient requires the FDA to propose a rule, take public comment and issue a final rule, a process that can take several months.
该小组包括六名与肽类行业有联系的新任命成员，以及一名美国众议员的儿子，该众议员曾推动肯尼迪让肽类物质更易获得。（在该会议上，一些委员会成员表示担忧，该建议可能会使 FDA 未来更难对其他未获批准的药物说“不”。）根据跟踪政府法规的联邦网站 Reginfo.gov 的信息，周二和周三，FDA 计划与外部团体会面，其中包括提供肽类产品的配制药房 Medivant Healthcare。
The agency took a step toward that process in July, when an FDA advisory panel narrowly voted in favor of adding six peptides to the bulk list. The panel included six new appointees with ties to the peptide industry and another who is the son of a U.S. representative who has pushed Kennedy to make peptides more available. (During that meeting, some committee members expressed concerns that the recommendation could make it harder for the FDA to say no to other unapproved drugs in the future.) On Tuesday and Wednesday, the FDA was scheduled to meet outside groups, including Medivant Healthcare, a compounding pharmacy that offers peptides, according to Reginfo.gov, a federal website that tracks government regulations.
研究假冒药品危害的“安全药物伙伴关系”执行主任沙比尔·萨夫达表示，执法自由裁量权和即将出台的规则变更都将使美国人面临“未经测试的危险物质”。“试想一下，国家最高药品监管机构宣布他们不会对制造完全未经测试的化合物并将其分发给公众的人执行法律，这意味着什么，”萨夫达说。
Shabbir Safdar, executive director of the Partnership for Safe Medicines, which researches the dangers of counterfeit medicines, said both the enforcement discretion and upcoming rule change would expose Americans to “untested dangerous substances.”“Imagine what it means for the nation’s top drug regulator to announce they won’t enforce the laws on people making completely untested compounds and distributing them to the public,” Safdar said.