A decision from the Food and Drug Administration that opened up the floodgates of mail-order abortions relied on deeply flawed evidence, a group of researchers found.
Scholars with the pro-life Charlotte Lozier Institute argued in a paper published Tuesday and shared with The Daily Wire that the FDA’s 2021 decision to allow the abortion pill mifepristone to be mailed without an in-person appointment fell significantly short of scientific standards. The publication of the paper comes as pro-life organizations have pressured the FDA for months to roll back the decision to allow the deadly drugs to be shipped through the mail.
Dr. Ingrid Skop, one of the co-authors of the article and a Charlotte Lozier Institute medical expert, told The Daily Wire the findings significantly undercut the FDA’s justification for getting rid of abortion pill guardrails.
“When federal agencies remove regulations designed to safeguard patient health, those decisions should be grounded in evidence that reflects real-world practice,” she said. “Our analysis found that the FDA’s review fell well short of that standard.”
The decision to remove an in-person dispensing requirement came as part of the FDA’s 2021 Risk Evaluation and Mitigation Strategy (REMS) review for the drug. The FDA is currently reviewing the REMS protocol for mifepristone and has promised to produce a new safety study on the deadly drug.
When a woman takes mifepristone, the unborn baby is effectively starved to death. After the baby’s death, a second pill is taken to trigger the delivery of the child’s remains.
The paper, published in “Issues in Law and Medicine,” argues that the FDA relied on evidence that did not take into account real world conditions of how the pill would be used in practice, poor adverse impact reporting standards, and that the agency gave more credence to pro-abortion stakeholders during the review process.
“The FDA relied on studies that do not generalize to real-world conditions, and on complication reporting systems that are plagued by overarching limitations, in part due to previous deregulation,” co-author and Charlotte Lozier Institute researcher Zachary Sluzala said. “Our findings raise important questions about the scientific basis of the agency’s decision.”
Many of the studies the FDA relied on included a woman having an in-person exam, bloodwork done, or an ultrasound before getting the abortion pill. With the availability of the abortion pill online, there are frequently no requirements for any kind of screening.
During the review process, the FDA takes input from external stakeholders. But the review of the abortion pill was influenced more heavily by pro-abortion groups, the researchers argued.
The scholars additionally found that input from pro-life stakeholders was not treated equally as pro-abortion input. They argue that input from pro-lifers was “disproportionately underutilized and underacknowledged,” casting doubt on “an unbiased inclusion strategy.”
In contrast, they found that the FDA referenced material from the radical pro-abortion National Abortion Federation in its literature review that seemed outside the scope of the focus.
To address the problems with the FDA’s 2021 decision, the scholars argued that it should reinstate the in-person dispensing requirements and start tracking complications from the deadly drug more closely. Abortion activists frequently tell women to lie to doctors about their abortion if they show up to the hospital for treatment after a botched abortion.
Medication abortions have quickly become the most common method of ending the life of an unborn child, a condition that has only increased following the overturning of Roe v. Wade. After that decision, leftist activists and doctors continue to mail abortion pills into states where medication abortions are technically illegal.
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