2023年4月6日，美国FDA宣布决定撤回对Makena的批准，Makena是商品名，药品名称是(hydroxyprogesterone caproate injection)己酸羟基孕酮注射剂。这本来真不是大事，这个药本身也不是什么销量很大的药品。只是看了关于这个事的评论中居然也能扯上黑人，感觉有点无语了。难道是暗搓搓地指黑人婚姻生活比较混乱？
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Today, the U.S. Food and Drug Administration announced the final decision to withdraw approval of Makena—a drug that had been approved under the accelerated approval pathway. This drug was approved to reduce the risk of preterm birth in women pregnant with one baby who have a history of spontaneous preterm birth. Thedecisionwas issued jointly by the FDA Commissioner and Chief Scientist. Effective today, Makena and its generics are no longer approved and cannot lawfully be distributed in interstate commerce.
今天，美国食品和药物管理局宣布了撤销Makena批准的最终决定。Makena是一种已通过加速批准途径批准的药物。该药物被批准用于降低有自然早产史的孕妇早产的风险。该决定由美国食品药品监督管理局局长和首席科学家共同发布。从今天起，Makena及其仿制药不再被批准，也不能在州际商业中合法分销。
“It is tragic that the scientific research and medical communities have not yet found a treatment shown to be effective in preventing preterm birth and improving neonatal outcomes—particularly in light of the fact that this serious condition has a disparate impact on communities of color, especially Black women,” said FDA Commissioner Robert M. Califf, M.D. “Fundamentally, however, the touchstone of FDA drug approval is a favorable benefit-risk assessment; without that favorable assessment, the drug should not have the status of being FDA-approved.”
“令人遗憾的是，科学研究和医学界尚未找到一种治疗方法，证明可以有效预防早产和改善新生儿结局 - 特别是考虑到这种严重疾病对有色人种社区，特别是黑人女性有不同的影响，”FDA专员Robert M. Califf博士说，“从根本上说， 然而，FDA药物批准的试金石是有利的益处风险评估;如果没有这种有利的评估，该药物就不应该具有FDA批准的地位。“
The FDA approved Makena under the accelerated approval pathway in 2011 based on a determination that the sponsor had demonstrated a drug effect on an intermediate clinical endpoint that was reasonably likely to predict clinical benefit. The agency’s approval included a requirement that the sponsor conduct a post marketing confirmatory study. The ensuing confirmatory study did not verify clinical benefit and the FDA’s Center for Drug Evaluation and Research (CDER) proposed withdrawing the drug’s approval in 2020. The sponsor requested a hearing, which was held in October 2022.
FDA于2011年根据加速批准途径批准了Makena，其依据是确定申办者已经证明了对中间临床终点的药物作用，该药物具有合理的可能性预测临床益处。该机构的批准包括要求申办方进行上市后验证性研究。随后的验证性研究没有验证临床益处，FDA药物评估和研究中心（CDER）提议在2020年撤回该药物的批准。申办方要求举行听证会，听证会于 2022 年 10 月举行。
Following the hearing, the FDA Commissioner and Chief Scientist reviewed the record for this matter, including the submissions by CDER and sponsor Covis Pharma, public comments tothe docket, the transcript of the hearing and the Presiding Officer’s report. Based on that review, they have decided to withdraw approval of Makena and generic versions of Makena.
听证会结束后，FDA专员和首席科学家审查了此事的记录，包括CDER和赞助商Covis Pharma提交的意见，公众对案件表的评论，听证会记录和主持人的报告。根据这一审查，他们决定撤回对Makena和Makena通用版本的批准。
The decision issued today by the FDA Commissioner and Chief Scientist outlines their rationale and also recognizes the crucial need to develop treatments to reduce the serious risks associated with preterm birth.
FDA专员和首席科学家今天发布的决定概述了他们的理由，并认识到开发治疗方法以减少与早产相关的严重风险的迫切需要。
“We acknowledge at the outset the serious problems of preterm birth with respect to both maternal and neonatal health and the contribution of institutional forces that have led to health disparities, including preterm birth, among Black women,” said FDA Chief Scientist Namandjé Bumpus, Ph.D. “Nothing in this opinion today is intended to minimize these concerns – to the contrary, our hope is that this decision will help galvanize further research.”
“我们首先承认早产在孕产妇和新生儿健康方面的严重问题，以及导致黑人妇女健康差异（包括早产）的制度力量的贡献，”FDA首席科学家Namandjé Bumpus博士说，“今天这个意见中的任何内容都不是为了尽量减少这些担忧 - 相反， 我们希望这一决定将有助于激发进一步的研究。
While the approvals of Makena and its generics have been withdrawn, the agency recognizes that there is a supply of product that has already been distributed. Patients who have questions should talk to their healthcare provider. Approvals of these drugs have been withdrawn because the drugs are no longer shown to be effective and the benefits do not outweigh the risks for the indication for which they were approved. For additional information, seeMakena Information on FDA.gov.
虽然Makena及其仿制药的批准已被撤回，但该机构承认，有一些产品已经分发。有疑问的患者应咨询他们的医疗保健提供者。这些药物的批准已被撤回，因为这些药物不再被证明是有效的，并且其益处不会超过其被批准适应症的风险。需要更多信息, 见Makena Information on FDA.gov.
在官网https://makena.com/也出现了相应的通知
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