By Janet Morana
The Agency should recall Mifepristone and not increase its availability.
It is an apparent contradiction that while the FDA is reviewing the safety of the abortion drug Mifepristone, the FDA has approved a third company’s application to produce and distribute the pill.
According to the FDA it is the approval became automatic then Evita Solutions – a little-known Virginia company – has proven that its drug is “bioidentical” to the brand-name drug used by Dance laboratories and the generic version was pumped out GenBioPro. (Interesting note: the only products manufactured and sold by all three companies are abortion pills.)
Mifepristone’s series of approvals, from when it was approved in 2000 to 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 Democratic administration through an FDA provision known as Subpart H, allowing the agency to greenlight drugs that treat life-threatening conditions or address an unmet medical need more quickly than through the traditional approval route. Killing children in the womb without surgical abortion was apparently an “unmet need.”
Subpart H allows the FDA to impose restrictions to ensure safe use of the drug, and some were indeed imposed. Only physicians or physicians working under physicians qualified to accurately date pregnancies – and diagnose potentially fatal ectopic pregnancies – can prescribe mifepristone. The drug was not available for distribution in pharmacies and could not be sent by mail.
In 2007, seven years after the chemical abortion massacres began in the US, Congress authorized the FDA to require a Risk Evaluation and Mitigation Strategy (REMS) if the agency believed a drug’s risks might outweigh its benefits. The REMS was approved in 2011 and stipulated that the pills had to be personally delivered by or under the supervision of a certified physician, that the prescription of misoprostol – the second drug in the two-pill regimen – had to be done at the provider’s office or clinic, and that a follow-up visit 14 days later was mandated.
But in 2016, as a new Democratic administration began under President Barack Obama, restrictions on chemical abortion began to fade. The regimen initially limited to the first seven weeks of pregnancy was expanded to ten. Nurses and physician assistants could now start prescribing the medications. The FDA stopped tracking “side effects” other than death.
In 2021, during the final days of the Covid pandemic and under Joe Biden’s administration, the personal delivery requirement was dropped and the pills could be sent through the mail. In 2023, distribution was opened to all pharmacies that had applied for certification. National chains like Walgreens and CVS began selling the pills in many of their stores. Some states required public colleges to provide chemical abortion pills to students.
Since then it’s basically been a free for all, with news reports that pop up about reluctant fathers passing the deadly pills on to pregnant women after ordering them online and having them sent by mail. Wanted babies whose mothers have chosen life are flushed down the toilet.
Others order pills to abort babies after a pregnancy of more than ten weeks gruesome case from Nebraska which featured 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 backyard.
That’s what the FDA said 36 women died of chemical abortion between its approval in 2000 and December 31, 2024. To get a handle on the number of women injured, now that the government officially doesn’t care, the Center for Ethics and Public Policy conducted a study. analysis of insurance claims and found that 1 in 10 women who undergo a chemical abortion seek hospital care afterward.
Abortion advocates and their traditional media minions collectively shrugged their shoulders and predictably questioned the legitimacy of the analysis, but they more or less went ballistic when Health Secretary Robert Kennedy promised a major overhaul of the drug. If this research is followed objectively, it will reveal the uncomfortable truth that mifepristone is unsafe for women, after all.
A case last week’s challenge to the security claim was transferred from a federal court in Texas to one in Missouri. The plaintiffs in the case are the attorneys general of Missouri, Kansas and Idaho, and they are seeking to reinstate the 2011 REMS, reducing the drug’s use to seven weeks, banning it from being mailed and requiring three in-person doctor visits.
American women deserve at least as much protection from an industry that profits from the deaths of innocent people. They deserve to be able to drink cup of hot chocolate without then aborting the child whose birth they were joyfully awaiting.
Abortion advocates like to wave placards and say the US will never go back to the days of unsafe abortion. But the truth is that the infamous pre-Roe “back alley” is the same with us as it always was, killing babies and harming women, right in the comfort of their own homes.
It is not enough to go back to pre-2016 rules. We must recall Mifepristone and end the death by chemical abortion of mothers and their babies.
Janet Morana is the Executive Director of Priests for Life and co-founder of the Silent No More Awareness Campaign. She is the author of Recall Abortion; Shockwaves: The Wider Circle of Abortion Victims and Everything You Need to Know About Abortion – for Teens.
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