Food and Drug Administration officials have approved another generic variety of the abortion drug mifepristone.
In a letter dated Sept. 30, the FDA said it had approved Evita Solutions’ generic version of Danco Laboratories’ mifepristone.
“We have completed the review of this [new drug application] and have concluded that adequate information has been presented to demonstrate that the drug meets the requirements for approval under the FD&C Act,” the agency wrote. “We have determined your Mifepristone Tablets, 200 mg to be bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Mifeprex (mifepristone) tablets, 200 mg, of Danco Laboratories, LLC.”
Evita Solutions announced on its website that the FDA had signed off on its low-cost version of the pill, which is approved for use “up to 70 days from the first day of the last menstrual period.”
“Evita Solutions believes that all people should have access to safe, affordable, high-quality, effective, and compassionate abortion care, regardless of their race, sex, gender, age, sexuality, income, or where they live,” the company wrote. “We know that you can make the best choice for your body.”
In a statement on Thursday, Students for Life Action, which describes itself as a “student-centered organization advocating for life-protecting laws in Congress and in state houses across the country,” criticized the Trump administration for greenlighting the new generic version of mifepristone.
“The Trump Administration’s approval of a new and deadly generic version of Mifepristone, without doing anything to protect mothers from abusers, women from reckless distribution leading to injury, infertility, and even death, or the environment from abortion water pollution, represents a true failure,” said Kristan Hawkins, president of Students for Life Action.
“More babies will die; More women will be harmed … as a direct result of this unfathomable decision.”
Sen. Josh Hawley (R-Mo.) wrote on social media on Thursday that he found the FDA’s approval “shocking.”
“FDA has just approved ANOTHER chemical abortion drug, when the evidence shows chemical abortion drugs are dangerous and even deadly for the mother. And of course 100% lethal to the child,” Hawley said.
An FDA spokesperson said the agency “has very limited discretion in deciding whether to approve a generic drug” and that FDA officials do not “endorse any product.”
Trump administration officials, including Health Secretary Robert F. Kennedy Jr., have faced pressure from pro-life groups, which are urging a reevaluation of mifepristone.
Kennedy weighed in on the issue in an Oct. 2 post on X, saying that the Biden administration acted prematurely and “removed mifepristone’s in-person dispensing rule without studying the safety risks.”
The HHS secretary said that he plans to “review all the evidence—including real-world outcomes— on the safety of this drug,” adding that recent studies point to “serious risks” when the drug is used without appropriate oversight.
The FDA first approved the drug in 2000 while gradually easing access in the years since. The agency’s scientists have deemed it safe and effective for its intended purpose.
Kennedy and FDA Commissioner Dr. Marty Makary vowed to initiate a full review of the drug’s safety in a letter to Republican attorneys general in September.
The FDA approved online prescribing and mail-order of mifepristone in 2021, during the Biden administration.
The Associated Press and Savannah Hulsey Pointer contributed to this report.