FDA approves generic abortion pill; promised to review risks

The U.S. Food and Drug Administration on Tuesday greenlit drugmaker Evita Solutions’ version of the drug mifepristone. It is the second generic alternative to the brand-name pill Mifeprex which has been available in the United States since 2000. GenBioPro in 2019 received approval to distribute its generic version of the drug. Chemical abortions account for about two-thirds of all abortions in the country. The rate increased after the Biden administration in 2023 allowed retail pharmacies to dispense mifepristone and misoprostol directly to women without an in-person medical visit. Meanwhile, Health and Human Services Secretary Robert F. Kennedy Jr. last month told the Senate the FDA would review mifepristone’s safety. He said the Biden administration misrepresented the risks women face by taking it.

The FDA has limited discretion in deciding whether to approve a generic drug if the manufacturer proves it is identical to the brand-name version, said HHS spokesman Andrew Nixon.

How have pro-life advocates responded? Sen. Josh Hawley, R-Miss., criticized the approval, saying he had lost confidence in the agency’s leadership. Additionally, Marjorie Dannenfelser, president of Susan B. Anthony Pro-Life America, called the decision reckless because abortion drugs kill unborn babies, pose significant risks to the women and girls who take them, and allow abusers to hide the evidence of their crimes. She called on the FDA to reinstate its requirements for the drugs to only be distributed in connection with in-person medical oversight.

Dig deeper: Read my report in Vitals about how abusers have used mail-order abortion drugs to kill unborn babies without their mother’s knowledge.