Margaret Hamburg is copresident of The InterAcademy Partnership for Science Health and Policy, Washington DC, USA. She served as commissioner of the FDA from 2009 to 2015.
Joshua Sharfstein is a professor of the practice at the Johns Hopkins Bloomberg School of Public Health, Balitmore, MD, USA. He served as principal deputy commissioner of the FDA from 2009 to 2011.
Science. 2023 Apr 21;380(6642):223. doi: 10.1126/science.adi2587. Epub 2023 Apr 13.
In the days since Texas federal judge Matthew J. Kacsmaryk invalidated the approval by the US Food and Drug Administration (FDA) of mifepristone, a medication used to terminate pregnancy, a shock wave of concern has swept through many people, organizations, and companies that work closely with the agency. The strong opposition reflects the high stakes not only for pregnant persons and for the FDA, but also for the scientific process of drug development and public access to safe and effective medications. Twists and turns in the case are already happening. A federal appeals court stayed the full suspension of mifepristone, but permitted multiple restrictions on its availability. Then the Supreme Court, which recently overturned the constitutional right to abortion, kept the status quo in place for a few days while considering the government's appeal. The results of the legal battle will be enormously consequential for reproductive health care-and far beyond, for innovation, science, and health.
在德克萨斯州联邦法官马修·J·卡斯特马雷克（Matthew J. Kacsmaryk）宣布美国食品和药物管理局（FDA）批准的堕胎药米非司酮（mifepristone）失效的几天里，人们、组织和与该机构密切合作的公司都感到震惊。强烈的反对不仅反映了孕妇和 FDA 的利害关系，也反映了药物开发的科学过程和公众获得安全有效的药物的机会。案件中的曲折已经出现。联邦上诉法院暂停了米非司酮的全面暂停，但允许对其供应进行多项限制。然后，最近推翻了堕胎宪法权利的最高法院在考虑政府上诉的同时，将现状维持了几天。这场法律斗争的结果将对生殖保健产生巨大影响——而且远远超出了创新、科学和健康的范围。
