FDA approves more abortion pill distribution despite safety concerns
The Food and Drug Administration (FDA) has granted approval to Evita Solutions to sell mifepristone, a chemical abortion pill used to end 63% of pregnancies nationwide.
Mifepristone is manufactured by Danco Laboratories, which received FDA approval for the drug in 2000. Genbiopro, and now Evita Solutions, are approved to distribute the pill under generic brands.
On September 30th, the FDA notified Evita Solutions that it “concluded that adequate information has been presented to demonstrate that the drug meets the requirements for approval.” Health and Human Services Communications Director Andrew Nixon explained to The Daily Wire 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.”
But the approval comes as the HHS is conducting a study on the safety of mifepristone, which recent data have questioned.
Serious safety risks
In April, the Ethics and Public Policy Center (EPPC) published the largest-ever study on mifepristone. Using an insurance claims database, researchers analyzed 865,727 mifepristone abortions between 2017 and 2023. They found that within 45 days of taking the pill, 10.93% of women experienced serious adverse events such as sepsis, infection, cardiac issues, anaphylaxis, or hemorrhage. EPPC notes that this rate is at least 22 times higher than the 0.5% rate displayed on the drug label.
Pro-abortion activists, including legacy media outlets, tried to discredit the study by pointing out that it has not been peer-reviewed or published in a medical journal, that the researchers lack medical training, and that the authors did not disclose which insurance database they used for their data collection.
The FDA’s prescribing label for mifepristone warns that between 2.9% and 4.6% of women who take the pill require ER visits.
Last year, a team of researchers from the Charlotte Lozier Institute teamed up with physicians from the American Association of Pro-Life Obstetricians and Gynecologists to conduct a study on mifepristone by analyzing ER visits. The researchers selected four cohorts of women: women with no pregnancies, women who gave birth, women who had surgical abortions, and women who had chemical abortions by taking mifepristone. Using data from 2004 to 2015, they looked for any increase in ER visits by these women within 30 days of their outcomes. The group with no pregnancies was analyzed according to all their visits across the 11-year period. They discovered that ER visits among women who gave birth increased by 9.2%, among women with no pregnancies by 42.8%, among women who had surgical abortions by 280.4%, and among women who took mifepristone by 2,649.7%. There was a similar scale for ER visits coded as “severe” or “critical.”
Planned Parenthood describes mifepristone as “very safe” and CNN says it’s even safer than low-risk drugs like penicillin.
‘I have lost confidence in the leadership at FDA’
The FDA’s recent approval sparked fury among pro-life Americans.
“This is shocking,” Sen. Josh Hawley (R-MO) wrote on X. “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.”
“FDA had promised to do a top-to-bottom safety review of the chemical abortion drug, but instead they’ve just greenlighted new versions of it for distribution. I have lost confidence in the leadership at FDA,” he added in a follow-up tweet.
Rep. Mark Harris (R-NC) similarly wrote: “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?”
