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By Peter Aitken
Politics Weekend Editor
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The Trump administration's approval of generic abortion pills has prompted an immediate and strong condemnation from conservative lawmakers who question the safety of the pill, given the timeline of initial announcement of review and the date of approval.
Newsweek reached out to the Food and Drug Administration (FDA) for comment via email on Thursday evening, but the government shutdown has impacted response times and staffing across federal entities.
Why It Matters
The FDA approved the use of Evita Solution's generic version of the abortion drug mifepristone, which conservatives have long opposed, making Thursday's decision a major and potentially divisive one.
Trump's FDA approving generic abortion pills sparks conservative backlash on Health
This is the second version of the drug approved by the FDA, following the 2019 approval of the version produced by GenBioPro. Former President Joe Biden early in his administration oversaw an expansion of access to the drug through telehealth prescription and mail-order delivery, which abortion opponents have challenged in courts and continue to fight.
Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. in a letter to Republican attorneys general last month pledged a full review of the drug, with generic approvals usually considered routine.
Major medical groups, including the American Medical Association, oppose restrictions on the pill, saying they are not supported by scientific evidence.
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What To Know
Missouri Republican U.S. Senator Josh Hawley expressed shock and dismay at the decision, writing on X: "This is 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."
He added that he has "lost confidence" in FDA leadership following the decision after they had promised a top-to-bottom safety review, since they have "instead ... greenlighted new versions of it for distribution."
Representative Mark Harris of North Carolina, also a Republican, expressed his surprise at the approval, writing on X: "Wow! The FDA just approved a generic version of the abortion pill, Mifepristone, a drug that ends a baby's life 100% of the time and harms mothers. The FDA announced a new safety study just days ago, so why this new move now?"
Students for Life President Kristan Hawkins called the decision a "stain" on the administration of President Donald Trump that will have disastrous consequences for women, writing on X: "More babies will die. More women will be harmed and killed. And more abusers will be enabled."
Ryan Anderson, president of Washington-based think tank Ethics and Public Policy Center, called the decision "a giant mistake" and accused the FDA of approving the drug "before conducting the safety review."
What People Are Saying
In an email statement to Newsweek, HHS Communications Director Andrew Nixon said 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."
"Generic applicants are not required to submit independent evidence proving safety and effectiveness. HHS is conducting a study of the reported adverse effects of mifepristone to ensure the FDA’s risk mitigation program for the drug is sufficient to protect women from unstated risks," Nixon continued. "he FDA does not endorse any drug product and directs prescribers to follow all labeling."
HHS Secretary Robert F. Kennedy Jr. wrote on X: "The Biden administration removed mifepristone’s in-person dispensing rule without studying the safety risks. We are filling that gap. Last month, I joined [FDA Commissioner Dr. Marty Makary] in writing to state attorneys general, pledging to review all the evidence — including real-world outcomes — on the safety of this drug. Recent studies already point to serious risks when mifepristone is used without proper medical oversight."
"[FDA] only approved a second generic mifepristone tablet because federal law requires approval when an application proves the generic is identical to the brand-name drug," Kennedy added.
What Happens Next
Approval of Evita Solution's pill is not expected to significantly alter access to mifepristone. The medication is typically prescribed with misoprostol, a second drug that causes the uterus to contract and empty. Together, the two drugs account for roughly two-thirds of U.S. abortions.
Still, access to the regimen remains sharply limited in many states. Abortion bans—including bans on medication abortion—have been enacted across large parts of the country.
Update 10/2/25, 6:18 p.m. ET: This article has been updated with additional information and context.
Update 10/2/25, 8:17 p.m. ET: This article has been updated with additional comment.
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