By Janet Morana
Rather than expanding access, the FDA should be pulling Mifepristone from the market.
It’s a curious paradox: while the FDA undertakes a review of the abortion medication Mifepristone’s safety, it simultaneously grants approval for a third company to manufacture and distribute this controversial pill.
The FDA states that the automatic approval emerged after Evita Solutions, a relatively obscure company from Virginia, demonstrated that its drug is “bioidentical” to the original produced by Danco Laboratories and the generic version manufactured by GenBioPro. (Curiously, these three companies solely produce abortion pills.)
Since its introduction in 2000, the approval history of Mifepristone reads like a tragic saga. This drug has been implicated in more fetal deaths and, according to various reports, has caused significant harm to mothers compared to other abortion procedures.
Mifepristone’s initial approval came under a Democratic administration, leveraging an FDA provision called Subpart H. This clause allows expedited access to drugs addressing life-threatening conditions or unmet medical needs. Apparently, facilitating non-surgical abortions constituted such an “unmet need.”
Subpart H also permits the FDA to impose safety restrictions on drugs. Initially, only qualified physicians could prescribe Mifepristone, and distribution was limited – retail pharmacies could not offer it, nor could it be shipped via postal services.
In 2007, after seven years of Mifepristone’s introduction, Congress gave the FDA authority to enforce a Risk Evaluation and Mitigation Strategy (REMS) if a drug’s potential risks seemed to outweigh its benefits. This REMS, instituted in 2011, mandated that Mifepristone be dispensed only in-person by certified physicians, that misoprostol (the second drug in the regimen) be prescribed in clinics, and that follow-up visits occur 14 days later.
However, when the Obama administration began in 2016, the strictures surrounding chemical abortions began to loosen. The initial limitation of seven weeks into pregnancy was extended to ten, and nurse practitioners gained the right to prescribe the medication. Tracking of adverse effects was limited to life-threatening incidents only.
In 2021, under President Biden, even the requirement for in-person dispensing was removed, allowing Mifepristone to be mailed. By 2023, certification was opened to all pharmacies, enabling large chains like Walgreens and CVS to sell abortion pills. Some states even legislated directives for public universities to distribute these medications to students.
Since then, it has descended into chaos, with cases surfacing of expectant fathers discreetly administering these pills obtained online. Tragically, planned futures for unborn babies are being extinguished with alarming frequency.
Reports have emerged of women using these pills beyond the recommended 10 weeks of gestation, illustrated by a case from Nebraska involving a mother and daughter discussing on Facebook Messenger the abortion of a 29-week-old baby with pills, followed by the heartbreaking act of cremating and burying the remains in their yard.
As of now, the FDA has documented 36 confirmed deaths related to chemical abortions from 2000 through December 31, 2024. With governmental interest seemingly waning, the Ethics and Public Policy Center recently conducted an analysis of insurance claims, revealing that one in ten women who undergo chemical abortions subsequently seek medical care.
While abortion advocates and their allies in mainstream media dismissed the findings as questionable, they reacted strongly when Health Secretary Robert Kennedy announced intentions for a meticulous review of Mifepristone. An objective probe in this vein could uncover an uncomfortable truth about the medication’s safety for women.
A recent lawsuit, initiated by the attorneys general of Missouri, Kansas, and Idaho, seeks to restore the 2011 REMS regulations, revert the use of Mifepristone to the first seven weeks of pregnancy, ban mail distributions, and mandate three in-person doctor visits.
American women deserve robust safeguards against an industry that profits from ending innocent lives. They should be able to enjoy a hot chocolate without fear of complicating their future with impulsive decisions regarding potential lives.
Advocates for abortion like to rally against the rhetoric of “back alley” abortions, insisting we’ll never return to those dark days. Yet, the grim reality is that such back alleys are just as present today, with tragic outcomes emerging within the walls of one’s home.
Merely reinstating pre-2016 regulations is insufficient. We must call for a complete recall of Mifepristone and end the era of chemical abortions that endanger the lives of mothers and their unborn children.
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.
