共和党参议员要求FDA撤销Mifepristone的批准,
51 GOP senators demand FDA reverse generic mifepristone approval over safety and oversight concerns.
共和党51名参议员, 林赛·格雷厄姆领导, 敦促FDA取消9月底对米费普里斯顿的通用版本的批准, 理由是安全问题和缺乏公开通知.
Fifty-one Republican senators, led by Lindsey Graham, urged the FDA to rescind its late September approval of a generic version of mifepristone, citing safety concerns and a lack of public notice.
他们认为,这一决定与HHS秘书Robert F. Kennedy Jr. 领导的正在进行的安全审查相冲突,并声称该药物构成严重风险,10%以上的使用者遭遇严重不良事件。
They argue the decision conflicts with ongoing safety reviews led by HHS Secretary Robert F. Kennedy Jr. and claim the drug poses serious risks, with over 10% of users experiencing severe adverse events.
参议员们以未成年人和贩毒者滥用为借口,要求暂停所有一般性批准,恢复亲自配药的要求,并重新评估毒品的安全性。
The senators called for a pause on all generic approvals, reinstatement of in-person dispensing requirements, and reevaluation of the drug’s safety, citing misuse by minors and traffickers.
美国食品药品管理局尚未作出回应.
The FDA has not yet responded.