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Eli Y. Adashi et al., The next two decades of mifepristone at FDA: History as destiny, Contraception (2022).


Abstract: Congressional and presidential records reveal a consistent pattern of political intercession with the regulatory authority of the Food and Drug Administration (FDA) over the approval and labeling of mifepristone (RU-486). This pattern is unlikely to abate any time soon. It is against this backdrop that we examine herein the ongoing legislative and legal disputes over mifepristone at a point in time which is just beyond the 20th anniversary of its approval by the FDA “for the medical termination of intrauterine pregnancy.”