The Food and Drug Administration (FDA) has quietly approved a new generic version of the abortion medication mifepristone, sparking immediate criticism from conservative leaders concerned about safety and state-level abortion protections.
The approval, communicated via letter to manufacturer Evita Solutions LLC, comes after the agency confirmed it was reviewing the drug’s risks in real-world use.
Evita Solutions, a telehealth abortion company, positions itself as providing “safe, affordable, high-quality, effective, and compassionate abortion care” to all individuals, regardless of location or income.
The company initially submitted its application in 2021, and federal regulators determined that the generic version met the statutory standards required under U.S. law, according to The Daily Caller.
Health and Human Services (HHS) Communications Director Andrew Nixon noted that the FDA has “very limited discretion in deciding whether to approve a generic drug” and that applicants are not required to provide independent evidence of safety or effectiveness.
He added that HHS is conducting a study of reported adverse effects to ensure the FDA’s risk mitigation program adequately protects patients from potential harms.
Conservative voices immediately condemned the approval.
Susan B. Anthony Pro-Life America President Marjorie Dannenfelser called the decision “reckless” and “unconscionable,” warning that chemical abortion drugs put women and girls at risk, empower abusers and violate pro-life statutes enacted by states across the country.
Missouri Sen. Josh Hawley (R) criticized the FDA for issuing approval amid an ongoing safety review.
On X, he wrote that the agency “had promised to do a top-to-bottom safety review of the chemical abortion drug, but instead they’ve just greenlighted new versions for distribution,” calling the drugs “dangerous and even deadly for the mother.”
Hawley added that he has “lost confidence in the leadership at FDA” following the announcement.
Safety concerns are underscored by prior research.
Resist the Mainstream previously reported that an analysis by the Ethics and Public Policy Center, which reviewed insurance claims from 2017 to 2023, found that nearly 11 percent of women who took mifepristone experienced potentially life-threatening complications within 45 days.
Critics argue that removing in-person screening requirements and permitting telehealth distribution heightens risks, particularly for ectopic pregnancies or inaccurate gestational dating.
The FDA’s approval comes amid a surge in chemical abortions nationwide.
According to the Guttmacher Institute, only 39 percent of U.S. abortions involved mifepristone and misoprostol in 2017.
By 2023, that figure had risen to 63 percent of over a million procedures, driven in part by expanded telehealth access and clinic closures after the overturn of Roe v. Wade, the Washington Examiner reports.
HHS Secretary Robert F. Kennedy Jr. confirmed that the agency is conducting a separate review of the drug’s safety and efficacy.
During a Senate hearing, he accused the Biden administration of “twisting the data to bury one of the safety signals” associated with mifepristone, heightening conservative concerns about federal oversight.
For critics, the FDA’s decision reinforces ongoing debates over chemical abortion safety, regulatory authority and the role of telehealth in expanding access.
Conservative leaders say they will continue monitoring the distribution of the new generic and advocate for state-level protections to limit potential harms
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