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April 10, 2023
美國要聞

逾百多家製藥商抨擊德州法官對墮胎藥物裁決

包括輝瑞在內的 200 多家生物製藥集團簽署了一封公開信,抨擊德州聯邦法官卡斯馬里克(Matthew Kacsmaryk)暫停聯邦批准米非司酮的決定;米非司酮是全美最常用的墮胎方法。

這封信批評卡斯馬里克在「沒有接受過科學培訓」的情況下發布了這項裁決,並忽視了數十年的科學證據和法律先例。

製藥商又指其裁決「破壞了國會兩黨對食品和藥物管理局 FDA 的授權,以批准和監管每個美國人安全、有效的藥物」,並為整個生物製藥行業帶來了不確定性。

除了輝瑞首席執行官布爾拉外,默克和百健的代表、以及公共利益醫學中心等行業非營利組織的代表也簽署了這封信。

另外,製藥行業主要遊說機構 PhRMA 週一發表聲明稱,卡斯馬里克的裁決破壞監管程序,指 FDA 是確定藥物對人們使用是否安全有效的黃金標準。

在上週的裁決中,卡斯馬里克站在一個反對墮胎組織的一邊,該組織挑戰了 FDA 幾十年來對該藥物的批准。卡斯馬里克在其裁定中寫道,「法院不會輕率地對 FDA 的決策進行二次猜測,但在這裡,FDA 基於明顯不合理的理由和不支持其結論的研究,默許了米非司酮的安全擔憂,違反其法定職責。」

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