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.
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.
Yet the approval stunned and infuriated foes of abortion, who have spent the three years since the 2022 overturning of Roe v Wade 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.
“FDA had promised to do a top-to-bottom safety review of the chemical abortion drug, but instead they’ve just greenlighted new versions of it for distribution,” Josh Hawley, a Republican senator from Missouri and fierce abortion opponent, posted on X. “I have lost confidence in the leadership at FDA.”
Kristan Hawkins, president of the powerful anti-abortion group Students for Life of America, called the approval “a true failure”.
“This is a stain on the Trump presidency,” she added in a statement.
To bolster their attack on mifepristone, anti-abortion activists recently seized on an April paper 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’s paper.
But that paper was not peer-reviewed nor published in a medical journal, and experts have uncovered multiple flaws in it. For example, it counts ectopic pregnancies – wherein an embryo implants somewhere outside of the uterine lining – as a serious complication. Mifepristone does not cause or worsen ectopic pregnancies.
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 to end a pregnancy.
Abortion rights supporters celebrated the news of the FDA’s approval, proclaiming it a victory for evidence-backed medicine.
“By expanding generic options, the agency is reinforcing mifepristone’s impeccable safety record,” Kiki Freedman, co-founder and CEO of the telemedicine abortion provider Hey Jane, said in a statement.
“At a time when politically motivated attacks threaten to undermine science and restrict care, it’s critical to underscore that the science couldn’t be clearer.”
The health department did not immediately respond to a request for comment. However, a spokesperson for the department told the New York Times in a statement that “the FDA has very limited discretion in deciding whether to approve a generic drug”.
“By law, the secretary of Health and Human Services must approve an application if it demonstrates that the generic drug is identical to the brand-name drug,” the spokesperson said.
