By Janet Morana
Agency should recall Mifepristone, not increase its availability.
It’s a seeming contradiction that while the FDA is reviewing the safety of the abortion drug Mifepristone, the agency approved a third company’s application to manufacture and distribute the pill.
According to the FDA, the approval became automatic when Evita Solutions – a little-known Virginia-based company – proved that its drug is “bioidentical” to the name-brand drug made by Danco Laboratories and the generic version pumped out by GenBioPro. (Interesting note: The only products manufactured and sold by all three companies are abortion pills.)
The string of approvals of Mifepristone, from the time it was rubber-stamped in 2000 until today, is tragic. The drug kills more babies and, according to some reports, injures more mothers than any other abortion procedure.
Mifepristone was first approved under a Democrat administration through an FDA provision known as Subpart H, which allows the agency to green light drugs that treat life-threatening conditions or fill an unmet medical need faster than the traditional approval route. Killing children in the womb without a surgical abortion, apparently, was the “unmet need.”
Subpart H allows the FDA to impose restrictions to assure safe use of the drug, and some were indeed imposed. Only doctors or those working under physicians qualified to accurately date pregnancies – and diagnose potentially fatal ectopic pregnancies – could prescribe mifepristone. The drug was not available for distribution at retail pharmacies and it could not be sent through the mail.
In 2007, seven years after the chemical abortion killing spree began in the U.S., Congress authorized the FDA to require a Risk Evaluation and Mitigation Strategy (REMS) if the agency thought a drug’s risks might outweigh it benefits. The REMS was approved in 2011, stipulating that the pills required in-person dispensing by or under supervision of a certified physician, that prescribing misoprostol – the second drug in the two-pill regimen – must be done at the provider’s office or clinic, and mandating a follow-up visit 14 days later.
But in 2016, when another Democrat administration began under President Barack Obama, the restrictions governing chemical abortion began to unravel. The regimen initially restricted to the first seven weeks of pregnancy was expanded to 10. Nurse practitioners and physician assistants could now begin to prescribe the drugs. The FDA stopped keeping track of “adverse reactions” other than death.
In 2021, during the waning days of the Covid pandemic and under the administration of Joe Biden, the in-person dispensing requirement was dropped, and the pills were able to be sent through the mail. In 2023, distribution was opened to all pharmacies that applied for certification. National chains like Walgreens and CVS began selling the pills at many of their stores. Some states mandated that public colleges provide chemical abortion pills to students.
Since then, it’s basically been a free-for-all, with news stories popping up about reluctant fathers slipping the deadly pills to pregnant women after ordering them online and having them shipped by mail. Wanted babies whose mothers chose life are being flushed down the toilet.
Others are ordering pills to abort babies way beyond 10 weeks’ gestation, like a horrific case from Nebraska that had a mother and daughter talking on Facebook Messenger about the third-trimester baby they aborted with pills at 29 weeks, then burned and buried in the back yard.
The FDA has said 36 women died from chemical abortion between approval in 2000 and Dec. 31, 2024. To try to get a handle on how many women have been injured, now that the government officially does not care, the Ethics and Public Policy Center did an analysis of insurance claims and found that 1 in 10 women who undergo chemical abortion seek hospital care afterward.
Abortion advocates and their legacy media henchmen shrugged their collective shoulders and predictably questioned the legitimacy of the analysis, but they did go more or less ballistic when Health Secretary Robert Kennedy promised a thorough review of the drug. If followed through objectively, this probe will reveal the inconvenient truth that mifepristone is, after all, unsafe for women.
A case challenging the safety claim last week was transferred from a Texas federal court to one in Missouri. Plaintiffs in the case are the attorneys general of Missouri, Kansas, and Idaho, and they are seeking to restore the 2011 REMS, roll back use of the drug to seven weeks, prohibit it to be sent through the mail and require three in-person doctor visits.
American women deserve at least that much protection from an industry that profits from the death of innocent human beings. They deserve to be able to drink a cup of hot chocolate without then aborting the child whose birth they were happily awaiting.
Abortion advocates like to wave hangers around and say the US will never go back to the days of unsafe abortion. But the truth is that the infamous “back alley” of pre-Roe days is as with us as it ever was, killing babies and harming women right in the comfort of their own homes.
It’s not enough to go back to the pre-2016 rules. We need to recall Mifepristone and put an end to death by chemical abortion for mothers and their babies.
Janet Morana is the executive director of Priests for Life and the co-founder of the Silent No More Awareness Campaign. She is the author of Recall Abortion; Shockwaves: Abortion’s Wider Circle of Victims and Everything You Need to Know About Abortion – For Teens.
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