New Study Reveals FDA Relied on Cherrypicked Data to Approve Dangerous Mail-Order Abortion Drugs

A new peer-reviewed article highlights major flaws in the data used by the U.S. Food and Drug Administration (FDA) to remove medical safeguards and in-person administering of abortion drugs. These flaws illustrate the ongoing problem of lack of quality abortion reporting data in the U.S. as well as in the United Kingdom.

In April 2021, the FDA removed mifepristone’s in-person requirements, temporarily allowing remote access to abortion drugs during the COVID-19 pandemic, later making these changes permanent in December 2021. The FDA identified four studies used to justify this decision.  The article’s authors highlight multiple flaws and limitations of the U.S. and U.K. data, including:

• The FDA claimed there were only a small number of reported adverse events from abortion drugs in 2020. However, the FDA removed the requirement for abortion drug prescribers to report non-lethal complications in 2016.
• Three of the studies relied on by the FDA, in general, did not replicate the conditions of use the FDA approved. In any case, they showed considerable rates of failures requiring surgery, as well as many women lost to follow-up with unknown outcomes.
• The fourth study, by Texas pro-abortion researcher Abigail Aiken which reported 99.2% effectiveness in “telemedicine” abortions, relied on a U.K. reporting system that was frequently unaware of abortion drug complications.  
• When considering higher quality data which more accurately identifies abortion drug complications in the U.K., there were at least five to ten times as many complications as initially reported – and likely many more.

The study notes that women risk serious complications by taking abortion drugs without in-person medical exams. These include (but are not limited to):

• An inability to perform ultrasounds to screen for complications, such as ectopic pregnancy, which cannot be treated by abortion drugs
• An underestimation of the baby’s gestational age, which will lead to more failed-abortion complications
• An inability to screen pregnant women or girls for coercion and abuse by a partner, family member, or human trafficker

Due to these safety concerns, even leading pro-abortion groups in the U.K., including the Royal College of Paediatrics and Child Health and the National Network of Designated Healthcare Professionals for Children, opposed mail-order abortion drugs, and the U.K. government subsequently sought to ban them. But that was later overruled by a parliamentary vote.

I am a co-author of this study, a copy of which can be found here.

The above post was first published by the Charlotte Lozier Institute on 13 May, 2024.