FDA宣佈決定撤回對Makena的批准也能扯上黑人_風聞

2023年4月6日，美國FDA宣佈決定撤回對Makena的批准，Makena是商品名，藥品名稱是(hydroxyprogesterone caproate injection)己酸羥基孕酮注射劑。這本來真不是大事，這個藥本身也不是什麼銷量很大的藥品。只是看了關於這個事的評論中居然也能扯上黑人，感覺有點無語了。難道是暗搓搓地指黑人婚姻生活比較混亂？

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. The decision was 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，美國食品和藥物管理局宣佈了撤銷Makena批准的最終決定。Makena是一種已通過加速批准途徑批准的藥物。該藥物被批准用於降低有自然早產史的孕婦早產的風險。該決定由美國食品藥品監督管理局局長和首席科學家共同發佈。從今天起，Makena及其仿製藥不再被批准，也不能在州際商業中合法分銷。

“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.”

“令人遺憾的是，科學研究和醫學界尚未找到一種治療方法，證明可以有效預防早產和改善新生兒結局 - 特別是考慮到這種嚴重疾病對有色人種社區，特別是黑人女性有不同的影響，”FDA專員Robert M. Califf博士説，“從根本上説， 然而，FDA藥物批准的試金石是有利的益處風險評估;如果沒有這種有利的評估，該藥物就不應該具有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於2011年根據加速批准途徑批准了Makena，其依據是確定申辦者已經證明了對中間臨牀終點的藥物作用，該藥物具有合理的可能性預測臨牀益處。該機構的批准包括要求申辦方進行上市後驗證性研究。隨後的驗證性研究沒有驗證臨牀益處，FDA藥物評估和研究中心（CDER）提議在2020年撤回該藥物的批准。申辦方要求舉行聽證會，聽證會於 2022 年 10 月舉行。

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 to the 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. 

聽證會結束後，FDA專員和首席科學家審查了此事的記錄，包括CDER和贊助商Covis Pharma提交的意見，公眾對案件表的評論，聽證會記錄和主持人的報告。根據這一審查，他們決定撤回對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專員和首席科學家今天發佈的決定概述了他們的理由，並認識到開發治療方法以減少與早產相關的嚴重風險的迫切需要。

“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.”

“我們首先承認早產在孕產婦和新生兒健康方面的嚴重問題，以及導致黑人婦女健康差異（包括早產）的制度力量的貢獻，”FDA首席科學家Namandjé Bumpus博士説，“今天這個意見中的任何內容都不是為了儘量減少這些擔憂 - 相反， 我們希望這一決定將有助於激發進一步的研究。

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, see Makena Information on FDA.gov.

雖然Makena及其仿製藥的批准已被撤回，但該機構承認，有一些產品已經分發。有疑問的患者應諮詢他們的醫療保健提供者。這些藥物的批准已被撤回，因為這些藥物不再被證明是有效的，並且其益處不會超過其被批准適應症的風險。需要更多信息, 見 Makena Information on FDA.gov.

在官網https://makena.com/也出現了相應的通知