In a move that has left anti-abortion advocates reeling, the US Food and Drug Administration (FDA) quietly approved a request to manufacture a new abortion pill earlier this week.<\/p>\n
Thanks to the approval, a company called Evita Solutions will be able to manufacture its generic version of mifepristone, one of two drugs typically used in most US medication abortions. A generic version of mifepristone, which was first approved as a brand-name drug in 2000, is already available on the market.<\/p>\n
Yet the approval stunned and infuriated foes of abortion, who have spent the three years since the 2022 overturning of Roe v Wade<\/a> pressuring the federal government to curb access to mifepristone. Robert F Kennedy Jr, the health secretary, announced last month his department would review the safety of mifepristone.<\/p>\n \u201cFDA had promised to do a top-to-bottom safety review of the chemical abortion drug, but instead they\u2019ve just greenlighted new versions of it for distribution,\u201d Josh Hawley, a Republican senator from Missouri and fierce abortion opponent, posted on X. \u201cI have lost confidence in the leadership at FDA.\u201d<\/p>\n Kristan Hawkins, president of the powerful anti-abortion group Students for Life of America, called the approval \u201ca true failure\u201d.<\/p>\n \u201cThis is a stain on the Trump presidency,\u201d she added in a statement.<\/p>\n To bolster their attack on mifepristone, anti-abortion activists recently seized on an April paper<\/a> by the Ethics and Public Policy Center, a rightwing thinktank, claiming almost 11% of women experience sepsis or other serious complications within 45 days of taking mifepristone. In his letter announcing the review of mifepristone, Kennedy cited the center\u2019s paper.<\/p>\n But that paper was not peer-reviewed nor published in a medical journal, and experts have uncovered multiple flaws<\/a> in it. For example, it counts ectopic pregnancies \u2013 wherein an embryo implants somewhere outside of the uterine lining \u2013 as a serious complication. Mifepristone does not cause or worsen ectopic pregnancies.<\/p>\n Meanwhile, more than 100 studies, conducted across more than three decades and dozens of countries, have concluded that mifepristone is a safe and effective tool<\/a> to end a pregnancy.<\/p>\n Abortion rights supporters celebrated the news of the FDA\u2019s approval, proclaiming it a victory for evidence-backed medicine.<\/p>\n \u201cBy expanding generic options, the agency is reinforcing mifepristone\u2019s impeccable safety record,\u201d Kiki Freedman, co-founder and CEO of the telemedicine abortion provider Hey Jane, said in a statement.<\/p>\n \u201cAt a time when politically motivated attacks threaten to undermine science and restrict care, it\u2019s critical to underscore that the science couldn\u2019t be clearer.\u201d<\/p>\n The health department did not immediately respond to a request for comment. However, a spokesperson for the department told the New York Times<\/a> in a statement that \u201cthe FDA has very limited discretion in deciding whether to approve a generic drug\u201d.<\/p>\n